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ITEM 1: Therefore, should t" }, { "page": 1, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "following studies as postmarketing requirements (PMRs) under Section 505(o) of FDCA: 1.1 Study mRNA-1273-P903, entitled \u201cPost-marketing safety of SARS-CoV-2 mRNA" }, { "page": 2, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "will be conducted as a postmarketing requirement (PMR) under Section 505(o) of FDCA. 1.2 Study mRNA-1273-P904, entitled \u201cPost-Authorization Active Surveillance" }, { "page": 2, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "will be conducted as a postmarketing requirement (PMR) under Section 505(o) of FDCA. 1.3 Study mRNA-1273-P911, entitled \u201cLong-term outcomes of myocarditis follo" }, { "page": 2, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "will be conducted as a postmarketing requirement (PMR) under Section 505(o) of FDCA. 1.4 Study mRNA-1272-P301 substudy to prospectively assess the incidence of" }, { "page": 2, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "will be conducted as a postmarketing requirement (PMR) under Section 505(o) of FDCA. 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"https://phmpt.org/wp-content/uploads/2024/05/125752_S3_M1_debarment-cert.pdf", "ican_url": null, "total_pages": 2, "matches": [ { "page": 1, "family": "Named act", "normalized": "FD&C Act", "raw": "Federal Food, Drug, and Cosmetic Act", "context": "e in any capacity the services of any person debarred under section 306 of the Federal Food, Drug, and Cosmetic Act in connection with this application. Sincerely, Michelle Ols" } ] }, { "filename": "125752_S3_M1_environmental-analysis.pdf", "id": 771, "module": "M1", "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2024/05/125752_S3_M1_environmental-analysis.pdf", "ican_url": null, "total_pages": 2, "matches": [ { "page": 1, "family": "CFR", "normalized": "21 CFR 25.31", "raw": "21 CFR \n25.31", "context": "n Environmental Assessment or an Environmental Impact Statement (EIS) based on 21 CFR 25.31(c) that this application for marketing approval of a biologic product for subst" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 25.15", "raw": "21 CFR 25.15", "context": "s metabolites, or degradation products in the environment. In accordance with 21 CFR 25.15(a), ModernaTX, Inc hereby confirms that it complies with the categorical exclu" }, { "page": 2, "family": "CFR", "normalized": "21 CFR 25.31", "raw": "21 CFR \u00a7 25.31", "context": "alifies for a categorical exclusion from the requirement to prepare an EA, per 21 CFR \u00a7 25.31(b), because the estimated concentration of the substance at the point of entry" } ] }, { "filename": "125752_S3_M1_form-3674.pdf", "id": 772, "module": "M1", "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2024/05/125752_S3_M1_form-3674.pdf", "ican_url": null, "total_pages": 2, "matches": [ { "page": 1, "family": "Section-of-Act", "normalized": "Section 402(j) of the PHS Act", "raw": "Section 402(j) of the Public Health Service Act", "context": "and explanation) |_| A. I certify that the requirements of 42 U.S.C. \u00a7 282(j), Section 402(j) of the Public Health Service Act, including 42 CFR part 11, do not apply because the application/submission whic" }, { "page": 1, "family": "Section-of-Act", "normalized": "Section 402(j) of the PHS Act", "raw": "Section 402(j) of the Public Health Service Act", "context": "clinical trial. |_| B. I certify that the requirements of 42 U.S.C. \u00a7 282(j), Section 402(j) of the Public Health Service Act, including 42 CFR part 11, do not apply to any clinical trial referenced in the" }, { "page": 1, "family": "USC", "normalized": "42 U.S.C. \u00a7 282", "raw": "42 U.S.C. \u00a7 282", "context": "SERVICES Food and Drug Administration FDA \u00a5 Certification of Compliance Under 42 U.S.C. \u00a7 282(j)(5)(B), with Requirements of ClinicalTrials.gov Data Bank (For submission wi" }, { "page": 1, "family": "USC", "normalized": "42 U.S.C. \u00a7 282", "raw": "42 U.S.C. \u00a7 282", "context": "itional information and explanation) |_| A. I certify that the requirements of 42 U.S.C. \u00a7 282(j), Section 402(j) of the Public Health Service Act, including 42 CFR part 11," }, { "page": 1, "family": "USC", "normalized": "42 U.S.C. \u00a7 282", "raw": "42 U.S.C. \u00a7 282", "context": "es not reference any clinical trial. |_| B. I certify that the requirements of 42 U.S.C. \u00a7 282(j), Section 402(j) of the Public Health Service Act, including 42 CFR part 11," }, { "page": 1, "family": "USC", "normalized": "42 U.S.C. \u00a7 282", "raw": "42 U.S.C. \u00a7 282", "context": "which this certification accompanies. Xx C. I certify that the requirements of 42 U.S.C. \u00a7 282(j), section 402(j) of the Public Health Service Act, apply to one or more of th" }, { "page": 1, "family": "USC", "normalized": "42 U.S.C. \u00a7 282", "raw": "42 U.S.C. 282", "context": "on/submission which this certification accompanies and that the requirements of 42 U.S.C. 282(j), including any applicable provisions of 42 CFR part 11, have been met. Cert" }, { "page": 1, "family": "Named act", "normalized": "FD&C Act", "raw": "Federal Food, Drug, and Cosmetic Act", "context": "ts, supplements, and resubmissions, under \u00a7\u00a7 505, 515, 520(m), or 510(k) of the Federal Food, Drug, and Cosmetic Act or \u00a7 351 of the Public Health Service Act.) SPONSOR / APPLICANT / SUBMITTER IN" }, { "page": 1, "family": "Named act", "normalized": "PHS Act", "raw": "Public Health Service Act", "context": ", 520(m), or 510(k) of the Federal Food, Drug, and Cosmetic Act or \u00a7 351 of the Public Health Service Act.) SPONSOR / APPLICANT / SUBMITTER INFORMATION 1. Name of Sponsor/Applicant/Su" }, { "page": 1, "family": "Named act", "normalized": "PHS Act", "raw": "Public Health Service Act", "context": "C. I certify that the requirements of 42 U.S.C. \u00a7 282(j), section 402(j) of the Public Health Service Act, apply to one or more of the clinical trials referenced in the application/subm" }, { "page": 2, "family": "USC", "normalized": "42 U.S.C. \u00a7 282", "raw": "42 U.S.C. \u00a7 282", "context": "r which you (the sponsor/applicant/submitter) are the \u201cresponsible party\u201d under 42 U.S.C. \u00a7 282(j)(1)(a)(i), section 402(j)(1)(a)(i) of the Public Health Service Act reference" }, { "page": 2, "family": "USC", "normalized": "42 U.S.C. \u00a7 282", "raw": "42 U.S.C. \u00a7 282", "context": "ormation. | understand that the failure to submit the certification required by 42 U.S.C. \u00a7 282(j)(5)(B), section 402(j)(5)(B) of the Public Health Service Act, and the knowin" }, { "page": 2, "family": "USC", "normalized": "21 U.S.C. \u00a7 331", "raw": "21 U.S.C. \u00a7 331", "context": "ubmission of a false certification under such section are prohibited acts under 21 U.S.C. \u00a7 331, section 301 of the Federal Food, Drug, and Cosmetic Act. Warning: A willfully" }, { "page": 2, "family": "Named act", "normalized": "PHS Act", "raw": "Public Health Service\nAct", "context": "nsible party\u201d under 42 U.S.C. \u00a7 282(j)(1)(a)(i), section 402(j)(1)(a)(i) of the Public Health Service Act referenced in the application/ submission which this Certification accompanies." }, { "page": 2, "family": "Named act", "normalized": "PHS Act", "raw": "Public Health\nService Act", "context": "certification required by 42 U.S.C. \u00a7 282(j)(5)(B), section 402(j)(5)(B) of the Public Health Service Act, and the knowing submission of a false certification under such section are pro" }, { "page": 2, "family": "Named act", "normalized": "FD&C Act", "raw": "Federal Food, Drug, and Cosmetic Act", "context": "nder such section are prohibited acts under 21 U.S.C. \u00a7 331, section 301 of the Federal Food, Drug, and Cosmetic Act. Warning: A willfully and knowingly false statement is a criminal offense, U.S" } ] }, { "filename": "125752_S3_M1_form-fda-3454-p201.pdf", "id": 773, "module": "M1", "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2024/05/125752_S3_M1_form-fda-3454-p201.pdf", "ican_url": null, "total_pages": 1, "matches": [ { "page": 1, "family": "CFR", "normalized": "21 CFR 54.2", "raw": "21 CFR 54.2", "context": "includes the spouse and each dependent child of the investigator as defined in 21 CFR 54.2(d). Please mark the applicable check box. (1) As the sponsor of the submitted s" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 54.2", "raw": "21 CFR 54.2", "context": "o the investigator could be affected by the outcome of the study as defined in 21 CFR 54.2(a). I also certify that each listed clinical investigator required to disclose" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 54.2", "raw": "21 CFR 54.2", "context": "interest in this product or a significant equity in the sponsor as defined in 21 CFR 54.2(b) did not disclose any such interests. I further certify that no listed inves" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 54.2", "raw": "21 CFR 54.2", "context": "stigator was the recipient of significant payments of other sorts as defined in 21 CFR 54.2(f). (2) As the applicant who is submitting a study or studies sponsored by a fi" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 54.2", "raw": "21 \nCFR 54.2", "context": "nducting the study could be affected by the outcome of the study (as defined in 21 CFR 54.2(a)); had no proprietary interest in this product or significant equity interest" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 54.2", "raw": "21 CFR 54.2", "context": "significant equity interest in the sponsor of the covered study (as defined in 21 CFR 54.2(b)); and was not the recipient of significant payments of other sorts (as defi" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 54.2", "raw": "21 CFR 54.2", "context": "nd was not the recipient of significant payments of other sorts (as defined in 21 CFR 54.2(f)). (3) As the applicant who is submitting a study or studies sponsored by a f" } ] }, { "filename": "125752_S3_M1_form-fda-3454-p301.pdf", "id": 774, "module": "M1", "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2024/05/125752_S3_M1_form-fda-3454-p301.pdf", "ican_url": null, "total_pages": 1, "matches": [ { "page": 1, "family": "CFR", "normalized": "21 CFR 54.2", "raw": "21 CFR 54.2", "context": "includes the spouse and each dependent child of the investigator as defined in 21 CFR 54.2(d). Please mark the applicable check box. (1) As the sponsor of the submitted s" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 54.2", "raw": "21 CFR 54.2", "context": "o the investigator could be affected by the outcome of the study as defined in 21 CFR 54.2(a). I also certify that each listed clinical investigator required to disclose" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 54.2", "raw": "21 CFR 54.2", "context": "interest in this product or a significant equity in the sponsor as defined in 21 CFR 54.2(b) did not disclose any such interests. I further certify that no listed inves" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 54.2", "raw": "21 CFR 54.2", "context": "stigator was the recipient of significant payments of other sorts as defined in 21 CFR 54.2(f). (2) As the applicant who is submitting a study or studies sponsored by a fi" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 54.2", "raw": "21 \nCFR 54.2", "context": "nducting the study could be affected by the outcome of the study (as defined in 21 CFR 54.2(a)); had no proprietary interest in this product or significant equity interest" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 54.2", "raw": "21 CFR 54.2", "context": "significant equity interest in the sponsor of the covered study (as defined in 21 CFR 54.2(b)); and was not the recipient of significant payments of other sorts (as defi" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 54.2", "raw": "21 CFR 54.2", "context": "nd was not the recipient of significant payments of other sorts (as defined in 21 CFR 54.2(f)). 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Project Code: FZA89935 Product: mRNA-1273 IND" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 312.55", "raw": "21 CFR 312.55", "context": "rm participating investigators of new safety information about the study drug 21 CFR 312.55 (b); 2. Notify participating investigators of all serious, unexpected a" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 312.32", "raw": "21 CFR 312.32", "context": "participating investigators of all serious, unexpected adverse drug reactions 21 CFR 312.32 (c); a. Preparation of Investigator Alert Letters b. 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In addition, the investigator must provide to the Sponsor a commitment to pro" }, { "page": 73, "family": "International", "normalized": "ICH E6", "raw": "ICH E6", "context": "on Prior to beginning the study, the investigator will be asked to comply with ICH E6(R2) 8.2 and Title 21 of the CFR by providing the following essential documents" }, { "page": 73, "family": "International", "normalized": "ICH E6", "raw": "ICH E6", "context": "tigator agrees that the study will be conducted according to the principles of ICH E6(R2). The investigator will conduct all aspects of this study in accordance with" }, { "page": 73, "family": "CFR", "normalized": "21 CFR 54", "raw": "21 CFR 54", "context": "it complete and accurate certification or disclosure statements required under 21 CFR 54. 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Each person involved with the study will have an individual identification co" }, { "page": 264, "family": "International", "normalized": "ICH E6", "raw": "ICH E6", "context": "e for compliance with applicable government regulation with respect to current ICH E6(R2) guidelines and SOPs. 264 FDA-CBER-2022-1614-0666301" }, { "page": 357, "family": "International", "normalized": "ICH E6", "raw": "ICH E6", "context": "mation to other parties. 5.2 Institutional Review Federal regulations and the ICH E6(R2) guidelines require that approval be obtained from an IRB before participat" }, { "page": 357, "family": "International", "normalized": "ICH E6", "raw": "ICH E6", "context": "the IRB. 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In addition, the investigators must provide to the Sponsor a commitment to pr" }, { "page": 88, "family": "CFR", "normalized": "42 CFR 493", "raw": "42 CFR 493", "context": "ference ranges for any local laboratories used by the site, in accordance with 42 CFR 493. 5.7 Study Conduct The investigator agrees that the study will be conducted a" }, { "page": 89, "family": "International", "normalized": "ICH E6", "raw": "ICH \nE6", "context": "tor agrees to conduct the study as outlined in this protocol in accordance with ICH E6(R2) and all applicable guidelines and regulations. 5.10 Reporting Adverse Even" }, { "page": 89, "family": "CFR", "normalized": "21 CFR 11", "raw": "21 CFR 11", "context": "h iMedidata\u00ae via the internet. This EDC system is validated and compliant with 21 CFR 11. 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In addition, the investigators must provide to the Sponsor a commitment to pr" }, { "page": 223, "family": "CFR", "normalized": "42 CFR 493", "raw": "42 CFR 493", "context": "ference ranges for any local laboratories used by the site, in accordance with 42 CFR 493. 5.7 Study Conduct The investigator agrees that the study will be conducted a" }, { "page": 223, "family": "CFR", "normalized": "21 CFR 11", "raw": "21 CFR 11", "context": "h iMedidata\u00ae via the internet. This EDC system is validated and compliant with 21 CFR 11. Each person involved with the study will have an individual identification co" }, { "page": 224, "family": "International", "normalized": "ICH E6", "raw": "ICH \nE6", "context": "tor agrees to conduct the study as outlined in this protocol in accordance with ICH E6(R2) and all applicable guidelines and regulations. 5.10 Reporting Adverse Even" }, { "page": 226, "family": "International", "normalized": "ICH E6", "raw": "ICH E6", "context": "e for compliance with applicable government regulation with respect to current ICH E6(R2) guidelines and SOPs. 226 FDA-CBER-2022-1614-0666690" }, { "page": 258, "family": "International", "normalized": "ICH E6", "raw": "ICH \nE6", "context": "ouncil for Harmonisation (E6(R2) Good Clinical Practice: Integrated Addendum to ICH E6(R1). 258 (b) (6) (b) (6) FDA-CBER-2022-1614-0666722" }, { "page": 356, "family": "International", "normalized": "ICH E6", "raw": "ICH E6", "context": "mation to other parties. 5.2 Institutional Review Federal regulations and the ICH E6(R2) guidelines require that approval be obtained from an IRB before participat" }, { "page": 356, "family": "International", "normalized": "ICH E6", "raw": "ICH E6", "context": "the IRB. 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In addition, the investigator must provide to the Sponsor a commitment to pro" }, { "page": 358, "family": "International", "normalized": "ICH E6", "raw": "ICH E6", "context": "on Prior to beginning the study, the investigator will be asked to comply with ICH E6(R2) 8.2 and Title 21 of the CFR by providing the following essential documents" }, { "page": 358, "family": "International", "normalized": "ICH E6", "raw": "ICH E6", "context": "stigator agrees that the study will be conducted according to the principles of ICH E6(R2). The investigator will conduct all aspects of this study in accordance wit" }, { "page": 358, "family": "CFR", "normalized": "21 CFR 54", "raw": "21 CFR 54", "context": "it complete and accurate certification or disclosure statements required under 21 CFR 54. In addition, the investigators must provide to the Sponsor a commitment to pr" }, { "page": 358, "family": "CFR", "normalized": "42 CFR 493", "raw": "42 CFR 493", "context": "ference ranges for any local laboratories used by the site, in accordance with 42 CFR 493. 5.7 Study Conduct The investigator agrees that the study will be conducted a" }, { "page": 359, "family": "International", "normalized": "ICH E6", "raw": "ICH \nE6", "context": "tor agrees to conduct the study as outlined in this protocol in accordance with ICH E6(R2) and all applicable guidelines and regulations. 5.10 Reporting Adverse Even" }, { "page": 359, "family": "CFR", "normalized": "21 CFR 11", "raw": "21 CFR 11", "context": "h iMedidata\u00ae via the internet. This EDC system is validated and compliant with 21 CFR 11. Each person involved with the study will have an individual identification co" }, { "page": 361, "family": "International", "normalized": "ICH E6", "raw": "ICH E6", "context": "e for compliance with applicable government regulation with respect to current ICH E6(R2) guidelines and SOPs. 361 FDA-CBER-2022-1614-0666825" } ] }, { "filename": "125752_S3_M5_5351_mrna1273p301-16-1-10.pdf", "id": 789, "module": "M5", "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2024/05/125752_S3_M5_5351_mrna1273p301-16-1-10.pdf", "ican_url": null, "total_pages": 54, "matches": [] }, { "filename": "125752_S3_M5_5351_mrna1273p301-16-1-3.pdf", "id": 790, "module": "M5", "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2024/05/125752_S3_M5_5351_mrna1273p301-16-1-3.pdf", "ican_url": null, "total_pages": 36, "matches": [] }, { "filename": "125752_S3_M5_5351_mrna1273p301-16-1-8.pdf", "id": 791, "module": "M5", "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2024/05/125752_S3_M5_5351_mrna1273p301-16-1-8.pdf", "ican_url": null, "total_pages": 7, "matches": [] }, { "filename": "125752_S3_M5_5351_mrna1273p301-16-5.pdf", "id": 792, "module": "M5", "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2024/05/125752_S3_M5_5351_mrna1273p301-16-5.pdf", "ican_url": null, "total_pages": 22, "matches": [] }, { "filename": "125752_S3_M5_5352_dmid-200003-16-1-1.pdf", "id": 793, "module": "M5", "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2024/05/125752_S3_M5_5352_dmid-200003-16-1-1.pdf", "ican_url": null, "total_pages": 396, "matches": [ { "page": 46, "family": "CFR", "normalized": "21 CFR 312.32", "raw": "21 CFR 312.32", "context": "of an intervention in humans, whether or not considered intervention-related (21 CFR 312.32 (a)). An AE can therefore be any unfavorable and unintended sign (including an" }, { "page": 47, "family": "CFR", "normalized": "21 CFR 312.32", "raw": "21 CFR 312.32", "context": "licable 8.3.2 Definition of Serious Adverse Event (SAE) An SAE is defined in 21 CFR 312.32 as follows: \u201cAn AE or suspected adverse reaction is considered serious if, in" }, { "page": 50, "family": "CFR", "normalized": "21 CFR 312.32", "raw": "21 CFR Part 312.32", "context": "ponsor determines that the information qualifies for reporting as specified in 21 CFR Part 312.32. Relevant follow-up information to an IND safety report will be submitted as" }, { "page": 56, "family": "International", "normalized": "ICH E6", "raw": "ICH E6", "context": "fied in 45 CFR Part 46, 21 CFR Part 50 (Protection of Human Subjects), and the ICH E6(R2). An OHRP-registered IRB will review and approve this protocol, associated" }, { "page": 56, "family": "CFR", "normalized": "45 CFR 46", "raw": "45 CFR Part 46", "context": "1979), and the federal policy for the Protection of Human Subjects codified in 45 CFR Part 46, 21 CFR Part 50 (Protection of Human Subjects), and the ICH E6(R2). An OHRP-re" }, { "page": 56, "family": "CFR", "normalized": "21 CFR 50", "raw": "21 CFR Part 50", "context": "ederal policy for the Protection of Human Subjects codified in 45 CFR Part 46, 21 CFR Part 50 (Protection of Human Subjects), and the ICH E6(R2). An OHRP-registered IRB wil" }, { "page": 56, "family": "CFR", "normalized": "45 CFR 46", "raw": "45 CFR 46", "context": "eening, and enrollment of subjects. The IRB review shall be in accordance with 45 CFR 46 and 21 CFR 50, 21 CFR 56 (IRBs), and other federal, state, and local regulation" }, { "page": 56, "family": "CFR", "normalized": "21 CFR 50", "raw": "21 CFR 50", "context": "rollment of subjects. The IRB review shall be in accordance with 45 CFR 46 and 21 CFR 50, 21 CFR 56 (IRBs), and other federal, state, and local regulations and policie" }, { "page": 56, "family": "CFR", "normalized": "21 CFR 56", "raw": "21 CFR 56", "context": "subjects. The IRB review shall be in accordance with 45 CFR 46 and 21 CFR 50, 21 CFR 56 (IRBs), and other federal, state, and local regulations and policies, as appli" }, { "page": 57, "family": "International", "normalized": "ICH E6", "raw": "ICH E6", "context": "CFR 56 for FDA-regulated studies, state and local regulations and policy, and ICH E6 GCP before any study procedures or data collection are performed. The particip" }, { "page": 57, "family": "CFR", "normalized": "45 CFR 46", "raw": "45 \nCFR 46", "context": "will obtain a subject\u2019s informed consent in accordance with the requirements of 45 CFR 46, 21 CFR 50 and 21 CFR 56 for FDA-regulated studies, state and local regulations" }, { "page": 57, "family": "CFR", "normalized": "21 CFR 50", "raw": "21 CFR 50", "context": "a subject\u2019s informed consent in accordance with the requirements of 45 CFR 46, 21 CFR 50 and 21 CFR 56 for FDA-regulated studies, state and local regulations and polic" }, { "page": 57, "family": "CFR", "normalized": "21 CFR 56", "raw": "21 CFR 56", "context": "formed consent in accordance with the requirements of 45 CFR 46, 21 CFR 50 and 21 CFR 56 for FDA-regulated studies, state and local regulations and policy, and ICH E6" }, { "page": 64, "family": "CFR", "normalized": "21 CFR 11", "raw": "21 CFR Part 11", "context": "oratory data, will be entered by the participating IDCRC site into eCRFs via a 21 CFR Part 11-compliant internet data entry system provided by the SDCC. The data system inc" }, { "page": 88, "family": "Named act", "normalized": "PREP \nAct", "raw": "PREP \nAct", "context": "al trial are covered under the Public Readiness and Emergency Preparedness Act (PREP Act). Under the PREP Act, covered persons (such as manufacturers, distributers, pro" }, { "page": 88, "family": "Named act", "normalized": "PREP Act", "raw": "PREP Act", "context": "nder the Public Readiness and Emergency Preparedness Act (PREP Act). Under the PREP Act, covered persons (such as manufacturers, distributers, program planners, and o" }, { "page": 88, "family": "Named act", "normalized": "PREP Act", "raw": "PREP Act", "context": "e or use of a covered countermeasure that is the subject of a declaration. The PREP Act provides immunity for covered persons from liability, unless the injury was ca" }, { "page": 88, "family": "Named act", "normalized": "PREP Act", "raw": "PREP Act", "context": "ersons from liability, unless the injury was caused by willful misconduct. The PREP Act also established the Countermeasures Injury Compensation Program (CICP) to pro" }, { "page": 89, "family": "Named act", "normalized": "PREP Act", "raw": "PREP Act", "context": "aim involves willful misconduct, is pled with particularity required under the PREP Act, verified, and accompanied by an affidavit by a physician who did not treat th" }, { "page": 118, "family": "CFR", "normalized": "21 CFR 312.32", "raw": "21 CFR 312.32", "context": "of an intervention in humans, whether or not considered intervention-related (21 CFR 312.32 (a)). An AE can therefore be any unfavorable and unintended sign (including an" }, { "page": 119, "family": "CFR", "normalized": "21 CFR 312.32", "raw": "21 CFR 312.32", "context": "licable 8.3.2 Definition of Serious Adverse Event (SAE) An SAE is defined in 21 CFR 312.32 as follows: \u201cAn AE or suspected adverse reaction is considered serious if, in" }, { "page": 122, "family": "CFR", "normalized": "21 CFR 312.32", "raw": "21 CFR Part 312.32", "context": "ponsor determines that the information qualifies for reporting as specified in 21 CFR Part 312.32. Relevant follow-up information to an IND safety report will be submitted as" }, { "page": 129, "family": "International", "normalized": "ICH E6", "raw": "ICH E6", "context": "fied in 45 CFR Part 46, 21 CFR Part 50 (Protection of Human Subjects), and the ICH E6(R2). An OHRP-registered IRB will review and approve this protocol, associated" }, { "page": 129, "family": "International", "normalized": "ICH E6", "raw": "ICH E6", "context": "CFR 56 for FDA-regulated studies, state and local regulations and policy, and ICH E6 GCP before any study procedures or data collection are performed. The particip" }, { "page": 129, "family": "CFR", "normalized": "45 CFR 46", "raw": "45 CFR Part 46", "context": "1979), and the federal policy for the Protection of Human Subjects codified in 45 CFR Part 46, 21 CFR Part 50 (Protection of Human Subjects), and the ICH E6(R2). An OHRP-re" }, { "page": 129, "family": "CFR", "normalized": "21 CFR 50", "raw": "21 CFR Part 50", "context": "ederal policy for the Protection of Human Subjects codified in 45 CFR Part 46, 21 CFR Part 50 (Protection of Human Subjects), and the ICH E6(R2). An OHRP-registered IRB wil" }, { "page": 129, "family": "CFR", "normalized": "45 CFR 46", "raw": "45 CFR 46", "context": "reening and enrollment of subjects. The IRB review shall be in accordance with 45 CFR 46 and 21 CFR 50, 21 CFR 56 (IRBs), and other federal, state, and local regulation" }, { "page": 129, "family": "CFR", "normalized": "21 CFR 50", "raw": "21 CFR 50", "context": "rollment of subjects. The IRB review shall be in accordance with 45 CFR 46 and 21 CFR 50, 21 CFR 56 (IRBs), and other federal, state, and local regulations and policie" }, { "page": 129, "family": "CFR", "normalized": "21 CFR 56", "raw": "21 CFR 56", "context": "subjects. The IRB review shall be in accordance with 45 CFR 46 and 21 CFR 50, 21 CFR 56 (IRBs), and other federal, state, and local regulations and policies, as appli" }, { "page": 129, "family": "CFR", "normalized": "45 CFR 46", "raw": "45 \nCFR 46", "context": "will obtain a subject\u2019s informed consent in accordance with the requirements of 45 CFR 46, 21 CFR 50 and 21 CFR 56 for FDA-regulated studies, state and local regulations" }, { "page": 129, "family": "CFR", "normalized": "21 CFR 50", "raw": "21 CFR 50", "context": "a subject\u2019s informed consent in accordance with the requirements of 45 CFR 46, 21 CFR 50 and 21 CFR 56 for FDA-regulated studies, state and local regulations and polic" }, { "page": 129, "family": "CFR", "normalized": "21 CFR 56", "raw": "21 CFR 56", "context": "formed consent in accordance with the requirements of 45 CFR 46, 21 CFR 50 and 21 CFR 56 for FDA-regulated studies, state and local regulations and policy, and ICH E6" }, { "page": 137, "family": "CFR", "normalized": "21 CFR 11", "raw": "21 CFR Part 11", "context": "l laboratory data, will be entered by the participating site into eCRFs via a 21 CFR Part 11-compliant internet data entry system provided by the SDCC. The data system inc" }, { "page": 139, "family": "Named act", "normalized": "PREP Act", "raw": "PREP Act", "context": "e study product mRNA-1273 manufactured by ModernaTX, Inc. is covered under the PREP Act, as described in Section 2.1.1. 10.3 Abbreviations Table 11: Abbreviations A" }, { "page": 163, "family": "Named act", "normalized": "PREP Act", "raw": "PREP Act", "context": "l trial are covered under the Public Readiness and Emergency Preparedness Act (PREP Act) and the Declaration issued by the Secretary of the U.S. Department of Health" }, { "page": 163, "family": "Named act", "normalized": "PREP Act", "raw": "PREP Act", "context": "of the U.S. Department of Health and Human Services under that Act. Under the PREP Act and the Declaration, covered persons (such as manufacturers, distributers, prog" }, { "page": 163, "family": "Named act", "normalized": "PREP Act", "raw": "PREP Act", "context": "the administration, or use of a covered countermeasure, such as mRNA-1273. The PREP Act provides immunity for covered persons from liability, unless the injury was ca" }, { "page": 163, "family": "Named act", "normalized": "PREP Act", "raw": "PREP Act", "context": "less the injury was caused by willful misconduct. The Declaration invoking the PREP Act for COVID-19 covered countermeasures was made on March 10, 2020 and is retroac" }, { "page": 164, "family": "Named act", "normalized": "PREP Act", "raw": "PREP Act", "context": "mRNA-1273 30 March 2020 DMID/NIAID/NIH CONFIDENTIAL Page 18 of 79 The PREP Act also established the Countermeasures Injury Compensation Program (CICP) to pro" }, { "page": 164, "family": "Named act", "normalized": "PREP Act", "raw": "PREP Act", "context": "nvolves willful misconduct and meets the other requirements for suit under the PREP Act. Any award is reduced by any public or private insurance or worker\u2019s compensat" }, { "page": 196, "family": "CFR", "normalized": "21 CFR 312.32", "raw": "21 CFR 312.32", "context": "of an intervention in humans, whether or not considered intervention-related (21 CFR 312.32 (a)). An AE can therefore be any unfavorable and unintended sign (including an" }, { "page": 198, "family": "CFR", "normalized": "21 CFR 312.32", "raw": "21 CFR 312.32", "context": "licable 8.3.2 Definition of Serious Adverse Event (SAE) An SAE is defined in 21 CFR 312.32 as follows: \u201cAn AE or suspected adverse reaction is considered serious if, in" }, { "page": 201, "family": "CFR", "normalized": "21 CFR 312.32", "raw": "21 CFR Part 312.32", "context": "ponsor determines that the information qualifies for reporting as specified in 21 CFR Part 312.32. Relevant follow-up information to an IND safety report will be submitted as" }, { "page": 207, "family": "International", "normalized": "ICH E6", "raw": "ICH E6", "context": "fied in 45 CFR Part 46, 21 CFR Part 50 (Protection of Human Subjects), and the ICH E6(R2). 207 FDA-CBER-2022-1614-0667188" }, { "page": 207, "family": "CFR", "normalized": "45 CFR 46", "raw": "45 CFR Part 46", "context": "1979), and the federal policy for the Protection of Human Subjects codified in 45 CFR Part 46, 21 CFR Part 50 (Protection of Human Subjects), and the ICH E6(R2). 207 FDA-CB" }, { "page": 207, "family": "CFR", "normalized": "21 CFR 50", "raw": "21 CFR Part 50", "context": "ederal policy for the Protection of Human Subjects codified in 45 CFR Part 46, 21 CFR Part 50 (Protection of Human Subjects), and the ICH E6(R2). 207 FDA-CBER-2022-1614-066" }, { "page": 208, "family": "International", "normalized": "ICH E6", "raw": "ICH E6", "context": "CFR 56 for FDA-regulated studies, state and local regulations and policy, and ICH E6 GCP before any study procedures or data collection are performed. The particip" }, { "page": 208, "family": "CFR", "normalized": "45 CFR 46", "raw": "45 CFR 46", "context": "reening and enrollment of subjects. The IRB review shall be in accordance with 45 CFR 46 and 21 CFR 50, 21 CFR 56 (IRBs), and other federal, state, and local regulation" }, { "page": 208, "family": "CFR", "normalized": "21 CFR 50", "raw": "21 CFR 50", "context": "rollment of subjects. The IRB review shall be in accordance with 45 CFR 46 and 21 CFR 50, 21 CFR 56 (IRBs), and other federal, state, and local regulations and policie" }, { "page": 208, "family": "CFR", "normalized": "21 CFR 56", "raw": "21 CFR 56", "context": "subjects. The IRB review shall be in accordance with 45 CFR 46 and 21 CFR 50, 21 CFR 56 (IRBs), and other federal, state, and local regulations and policies, as appli" }, { "page": 208, "family": "CFR", "normalized": "45 CFR 46", "raw": "45 \nCFR 46", "context": "will obtain a subject\u2019s informed consent in accordance with the requirements of 45 CFR 46, 21 CFR 50 and 21 CFR 56 for FDA-regulated studies, state and local regulations" }, { "page": 208, "family": "CFR", "normalized": "21 CFR 50", "raw": "21 CFR 50", "context": "a subject\u2019s informed consent in accordance with the requirements of 45 CFR 46, 21 CFR 50 and 21 CFR 56 for FDA-regulated studies, state and local regulations and polic" }, { "page": 208, "family": "CFR", "normalized": "21 CFR 56", "raw": "21 CFR 56", "context": "formed consent in accordance with the requirements of 45 CFR 46, 21 CFR 50 and 21 CFR 56 for FDA-regulated studies, state and local regulations and policy, and ICH E6" }, { "page": 215, "family": "CFR", "normalized": "21 CFR 11", "raw": "21 CFR Part 11", "context": "al laboratory data, will be entered by the participating site into eCRFs via a 21 CFR Part 11-compliant internet data 215 FDA-CBER-2022-1614-0667196" }, { "page": 218, "family": "Named act", "normalized": "PREP Act", "raw": "PREP Act", "context": "study vaccine, mRNA-1273, manufactured by ModernaTX, Inc. is covered under the PREP Act, as described in Section 2.1.1. 10.3 Abbreviations Table 10: Abbreviations A" }, { "page": 220, "family": "Named act", "normalized": "PREP Act", "raw": "PREP Act", "context": "nvestigator PIV3 Parainfluenza Virus Type 3 PLT Platelet PP Per Protocol PREP Act Public Readiness and Emergency Preparedness Act PT Prothrombin Time PTT Pa" }, { "page": 223, "family": "Named act", "normalized": "PREP Act", "raw": "PREP Act", "context": "blood volumes. Sect. 8.3.9 Clarified AESIs reporting. Sect. 2.1.1 Added PREP Act. 3.0, March 30, 2020 Throughout Administrative. Advanced version and da" }, { "page": 223, "family": "Named act", "normalized": "PREP Act", "raw": "PREP Act", "context": "0 Throughout Administrative. Advanced version and date. Sect. 2.1.1 Revised PREP Act language. To address Office of General Counsel comments. Sect. 5.1 and 5.2" }, { "page": 244, "family": "Named act", "normalized": "PREP Act", "raw": "PREP Act", "context": "l trial are covered under the Public Readiness and Emergency Preparedness Act (PREP Act) and the Declaration issued by the Secretary of the U.S. Department of Health" }, { "page": 244, "family": "Named act", "normalized": "PREP Act", "raw": "PREP Act", "context": "of the U.S. Department of Health and Human Services under that Act. Under the PREP Act and the Declaration, covered persons (such as manufacturers, distributers, prog" }, { "page": 244, "family": "Named act", "normalized": "PREP Act", "raw": "PREP Act", "context": "the administration, or use of a covered countermeasure, such as mRNA-1273. The PREP Act provides immunity for covered persons from liability, unless the injury was ca" }, { "page": 244, "family": "Named act", "normalized": "PREP Act", "raw": "PREP Act", "context": "less the injury was caused by willful misconduct. The Declaration invoking the PREP Act for COVID-19 covered countermeasures was made on March 10, 2020 and is retroac" }, { "page": 244, "family": "Named act", "normalized": "PREP Act", "raw": "PREP Act", "context": "e on March 10, 2020 and is retroactively effective from February 4, 2020. The PREP Act also established the Countermeasures Injury Compensation Program (CICP) to pro" }, { "page": 244, "family": "Named act", "normalized": "PREP Act", "raw": "PREP Act", "context": "nvolves willful misconduct and meets the other requirements for suit under the PREP Act. Any award is reduced by any public or private insurance or worker\u2019s compensat" }, { "page": 278, "family": "CFR", "normalized": "21 CFR 312.32", "raw": "21 CFR 312.32", "context": "of an intervention in humans, whether or not considered intervention-related (21 CFR 312.32 (a)). An AE can therefore be any unfavorable and unintended sign (including an" }, { "page": 280, "family": "CFR", "normalized": "21 CFR 312.32", "raw": "21 CFR 312.32", "context": "licable 8.3.2 Definition of Serious Adverse Event (SAE) An SAE is defined in 21 CFR 312.32 as follows: \u201cAn AE or suspected adverse reaction is considered serious if, in" }, { "page": 283, "family": "CFR", "normalized": "21 CFR 312.32", "raw": "21 CFR Part 312.32", "context": "ponsor determines that the information qualifies for reporting as specified in 21 CFR Part 312.32. Relevant follow-up information to an IND safety report will be submitted as" }, { "page": 290, "family": "International", "normalized": "ICH E6", "raw": "ICH E6", "context": "fied in 45 CFR Part 46, 21 CFR Part 50 (Protection of Human Subjects), and the ICH E6(R2). An OHRP-registered IRB will review and approve this protocol, associated" }, { "page": 290, "family": "International", "normalized": "ICH E6", "raw": "ICH E6", "context": "CFR 56 for FDA-regulated studies, state and local regulations and policy, and ICH E6 GCP before any study procedures or data collection are performed. The particip" }, { "page": 290, "family": "CFR", "normalized": "45 CFR 46", "raw": "45 CFR Part 46", "context": "1979), and the federal policy for the Protection of Human Subjects codified in 45 CFR Part 46, 21 CFR Part 50 (Protection of Human Subjects), and the ICH E6(R2). An OHRP-re" }, { "page": 290, "family": "CFR", "normalized": "21 CFR 50", "raw": "21 CFR Part 50", "context": "ederal policy for the Protection of Human Subjects codified in 45 CFR Part 46, 21 CFR Part 50 (Protection of Human Subjects), and the ICH E6(R2). An OHRP-registered IRB wil" }, { "page": 290, "family": "CFR", "normalized": "45 CFR 46", "raw": "45 CFR 46", "context": "reening and enrollment of subjects. The IRB review shall be in accordance with 45 CFR 46 and 21 CFR 50, 21 CFR 56 (IRBs), and other federal, state, and local regulation" }, { "page": 290, "family": "CFR", "normalized": "21 CFR 50", "raw": "21 CFR 50", "context": "rollment of subjects. The IRB review shall be in accordance with 45 CFR 46 and 21 CFR 50, 21 CFR 56 (IRBs), and other federal, state, and local regulations and policie" }, { "page": 290, "family": "CFR", "normalized": "21 CFR 56", "raw": "21 CFR 56", "context": "subjects. The IRB review shall be in accordance with 45 CFR 46 and 21 CFR 50, 21 CFR 56 (IRBs), and other federal, state, and local regulations and policies, as appli" }, { "page": 290, "family": "CFR", "normalized": "45 CFR 46", "raw": "45 \nCFR 46", "context": "will obtain a subject\u2019s informed consent in accordance with the requirements of 45 CFR 46, 21 CFR 50 and 21 CFR 56 for FDA-regulated studies, state and local regulations" }, { "page": 290, "family": "CFR", "normalized": "21 CFR 50", "raw": "21 CFR 50", "context": "a subject\u2019s informed consent in accordance with the requirements of 45 CFR 46, 21 CFR 50 and 21 CFR 56 for FDA-regulated studies, state and local regulations and polic" }, { "page": 290, "family": "CFR", "normalized": "21 CFR 56", "raw": "21 CFR 56", "context": "formed consent in accordance with the requirements of 45 CFR 46, 21 CFR 50 and 21 CFR 56 for FDA-regulated studies, state and local regulations and policy, and ICH E6" }, { "page": 298, "family": "CFR", "normalized": "21 CFR 11", "raw": "21 CFR Part 11", "context": "al laboratory data, will be entered by the participating site into eCRFs via a 21 CFR Part 11-compliant internet data entry system provided by the SDCC. 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To address Office of General Counsel comments. 305 FDA-CBER-2022-1" }, { "page": 329, "family": "Named act", "normalized": "PREP Act", "raw": "PREP Act", "context": "l trial are covered under the Public Readiness and Emergency Preparedness Act (PREP Act) and the Declaration issued by the Secretary of the U.S. Department of Health" }, { "page": 329, "family": "Named act", "normalized": "PREP Act", "raw": "PREP Act", "context": "of the U.S. Department of Health and Human Services under that Act. Under the PREP Act and the Declaration, covered persons (such as manufacturers, distributers, prog" }, { "page": 329, "family": "Named act", "normalized": "PREP Act", "raw": "PREP Act", "context": "the administration, or use of a covered countermeasure, such as mRNA-1273. 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The data system inc" }, { "page": 139, "family": "Named act", "normalized": "PREP Act", "raw": "PREP Act", "context": "e study product mRNA-1273 manufactured by ModernaTX, Inc. is covered under the PREP Act, as described in Section 2.1.1. 10.3 Abbreviations Table 11: Abbreviations A" }, { "page": 163, "family": "Named act", "normalized": "PREP Act", "raw": "PREP Act", "context": "l trial are covered under the Public Readiness and Emergency Preparedness Act (PREP Act) and the Declaration issued by the Secretary of the U.S. Department of Health" }, { "page": 163, "family": "Named act", "normalized": "PREP Act", "raw": "PREP Act", "context": "of the U.S. Department of Health and Human Services under that Act. Under the PREP Act and the Declaration, covered persons (such as manufacturers, distributers, prog" }, { "page": 163, "family": "Named act", "normalized": "PREP Act", "raw": "PREP Act", "context": "the administration, or use of a covered countermeasure, such as mRNA-1273. 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The IRB review shall be in accordance with 45 CFR 46 and 21 CFR 50, 21 CFR 56 (IRBs), and other federal, state, and local regulations and policies, as appli" }, { "page": 208, "family": "CFR", "normalized": "45 CFR 46", "raw": "45 \nCFR 46", "context": "will obtain a subject\u2019s informed consent in accordance with the requirements of 45 CFR 46, 21 CFR 50 and 21 CFR 56 for FDA-regulated studies, state and local regulations" }, { "page": 208, "family": "CFR", "normalized": "21 CFR 50", "raw": "21 CFR 50", "context": "a subject\u2019s informed consent in accordance with the requirements of 45 CFR 46, 21 CFR 50 and 21 CFR 56 for FDA-regulated studies, state and local regulations and polic" }, { "page": 208, "family": "CFR", "normalized": "21 CFR 56", "raw": "21 CFR 56", "context": "formed consent in accordance with the requirements of 45 CFR 46, 21 CFR 50 and 21 CFR 56 for FDA-regulated studies, state and local regulations and policy, and ICH E6" }, { "page": 215, "family": "CFR", "normalized": "21 CFR 11", "raw": "21 CFR Part 11", "context": "al laboratory data, will be entered by the participating site into eCRFs via a 21 CFR Part 11-compliant internet data 215 FDA-CBER-2022-1614-0667595" }, { "page": 218, "family": "Named act", "normalized": "PREP Act", "raw": "PREP Act", "context": "study vaccine, mRNA-1273, manufactured by ModernaTX, Inc. is covered under the PREP Act, as described in Section 2.1.1. 10.3 Abbreviations Table 10: Abbreviations A" }, { "page": 220, "family": "Named act", "normalized": "PREP Act", "raw": "PREP Act", "context": "nvestigator PIV3 Parainfluenza Virus Type 3 PLT Platelet PP Per Protocol PREP Act Public Readiness and Emergency Preparedness Act PT Prothrombin Time PTT Pa" }, { "page": 223, "family": "Named act", "normalized": "PREP Act", "raw": "PREP Act", "context": "blood volumes. 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The data system inc" }, { "page": 301, "family": "Named act", "normalized": "PREP Act", "raw": "PREP Act", "context": "study vaccine, mRNA-1273, manufactured by ModernaTX, Inc. is covered under the PREP Act, as described in Section 2.1.1. 10.3 Abbreviations Table 10: Abbreviations 2" }, { "page": 303, "family": "Named act", "normalized": "PREP Act", "raw": "PREP Act", "context": "nvestigator PIV3 Parainfluenza Virus Type 3 PLT Platelet PP Per Protocol PREP Act Public Readiness and Emergency Preparedness Act PT Prothrombin Time PTT Pa" }, { "page": 305, "family": "Named act", "normalized": "PREP Act", "raw": "PREP Act", "context": "blood volumes. Sect. 8.3.9 Clarified AESIs reporting. Sect. 2.1.1 Added PREP Act. 3.0, March 30, 2020 Throughout Administrative. Advanced version and da" }, { "page": 305, "family": "Named act", "normalized": "PREP Act", "raw": "PREP Act", "context": "0 Throughout Administrative. Advanced version and date. Sect. 2.1.1 Revised PREP Act language. 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The data system inc" }, { "page": 386, "family": "Named act", "normalized": "PREP Act", "raw": "PREP Act", "context": "study vaccine, mRNA-1273, manufactured by ModernaTX, Inc. is covered under the PREP Act, as described in Section 2.1.1. 10.3 Abbreviations Table 10: Abbreviations" }, { "page": 388, "family": "Named act", "normalized": "PREP Act", "raw": "PREP Act", "context": "nvestigator PIV3 Parainfluenza Virus Type 3 PLT Platelet PP Per Protocol PREP Act Public Readiness and Emergency Preparedness Act PT Prothrombin Time PTT Pa" }, { "page": 390, "family": "Named act", "normalized": "PREP Act", "raw": "PREP Act", "context": "blood volumes. Sect. 8.3.9 Clarified AESIs reporting. Sect. 2.1.1 Added PREP Act. 3.0, March 30, 2020 Throughout Administrative. Advanced version and da" }, { "page": 390, "family": "Named act", "normalized": "PREP Act", "raw": "PREP Act", "context": "0 Throughout Administrative. Advanced version and date. Sect. 2.1.1 Revised PREP Act language. 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The data system inc" }, { "page": 67, "family": "International", "normalized": "ICH E6", "raw": "ICH E6", "context": "ating the study. 3.8.4 Risk Management This study was conducted according to ICH E6(R2) risk and quality processes. 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ICH Q8 Pharmaceutical Development states the following in Microbial Attributes, Sectio" }, { "page": 3, "family": "International", "normalized": "ICH Q9", "raw": "ICH Q9", "context": "initial and final time points, and ...\u201d Finally, the following statement from ICH Q9 Quality Risk Management is extremely relevant to this subject (3): \u201cTt is impo" } ] }, { "filename": "125752_S2_M3_33_mukherjee-2003.pdf", "id": 1092, "module": "M3", "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2024/06/125752_S2_M3_33_mukherjee-2003.pdf", "ican_url": null, "total_pages": 11, "matches": [] }, { "filename": "125752_S2_M3_33_munroe-2008.pdf", "id": 1093, "module": "M3", "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2024/06/125752_S2_M3_33_munroe-2008.pdf", "ican_url": null, "total_pages": 6, "matches": [ { "page": 5, "family": "International", "normalized": "WHO TRS 868", "raw": "WHO TRS 868", "context": "nical Report Series (TRS) No. 868. Available from: http://whqlibdoc.who.int/trs/WHO TRS 868.pdf. JECFA, 2005. Joint FAO/WHO Expert Committee on Food Additives Sixty- Fifth" }, { "page": 5, "family": "International", "normalized": "WHO TRS 934", "raw": "WHO TRS 934", "context": "Technical Report Series, No. 934. Available from: http://whqlibdoc.who.int/trs/WHO TRS 934.pdf. Kroes, R., Galli, C.L., Munro, I., Schilter, B., Tran, L.-A., Walker, R.," } ] }, { "filename": "125752_S2_M3_33_muthukrishnan-1975.pdf", "id": 1094, "module": "M3", "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2024/06/125752_S2_M3_33_muthukrishnan-1975.pdf", "ican_url": null, "total_pages": 5, "matches": [] }, { "filename": "125752_S2_M3_33_nelson-2020.pdf", "id": 1095, "module": "M3", "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2024/06/125752_S2_M3_33_nelson-2020.pdf", "ican_url": null, "total_pages": 14, "matches": [] }, { "filename": "125752_S2_M3_33_nilsen-2013.pdf", "id": 1096, "module": "M3", "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2024/06/125752_S2_M3_33_nilsen-2013.pdf", "ican_url": null, "total_pages": 4, "matches": [] }, { "filename": "125752_S2_M3_33_nist-2015.pdf", "id": 1097, "module": "M3", "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2024/06/125752_S2_M3_33_nist-2015.pdf", "ican_url": null, "total_pages": 18, "matches": [ { "page": 10, "family": "International", "normalized": "ISO 13321:1996", "raw": "ISO 13321:1996", "context": "0 s or longer in duration and up to 10 measurements per sample is recommended (ISO 13321:1996 recommends 6 replicate measurements, but this has been revised down in ISO 224" }, { "page": 10, "family": "International", "normalized": "ISO 22412:2008", "raw": "ISO 22412:2008", "context": "21:1996 recommends 6 replicate measurements, but this has been revised down in ISO 22412:2008). Check the raw correlation data to ensure that the amplitude (y-intercept) is" }, { "page": 11, "family": "International", "normalized": "ISO 22412:2008", "raw": "ISO 22412:2008", "context": "ng ERM-FD100 and ERM-FD304 (colloidal silica, 20 nm and 40 nm, respectively). ISO 22412:2008 recommends that a polystyrene latex with narrow size distribution and average" }, { "page": 13, "family": "International", "normalized": "ISO 13321:1996", "raw": "ISO \n13321:1996", "context": "lysis of measured autocorrelation data is the cumulants method as stipulated in ISO 13321:1996 Annex A. Cumulants analysis yields a mean intensity-weighted size (commonly ca" }, { "page": 13, "family": "International", "normalized": "ISO 13321:1996", "raw": "ISO 13321:1996", "context": "construct a hypothetical size distribution. 5. Reporting Particle Size Data ISO 13321:1996 gives specific recommendations for reporting of test results derived from DLS." }, { "page": 15, "family": "International", "normalized": "ISO 13321:1996", "raw": "ISO 13321:1996", "context": "ight Scattering, NIST-NCL Joint Assay Protocol, PCC-1, Version 1.2 11 9. ISO 13321:1996. Particle Size Analysis - Photon Correlation Spectroscopy. International Organ" }, { "page": 15, "family": "International", "normalized": "ISO 22412:2008", "raw": "ISO 22412:2008", "context": "- available for electronic purchase and download at http://www.iso.org/). 10. ISO 22412:2008. Particle Size Analysis - Dynamic Light Scattering (DLS). Updates and extends" }, { "page": 15, "family": "International", "normalized": "ISO 13321:1996", "raw": "ISO 13321:1996", "context": ". Particle Size Analysis - Dynamic Light Scattering (DLS). Updates and extends ISO 13321:1996 (available for electronic purchase and download at http://www.iso.org/). 11." }, { "page": 16, "family": "International", "normalized": "ISO 13321:1996", "raw": "ISO 13321:1996", "context": "n a DLS experiment as a polynomial expansion in delay time, \u03c4, as described in ISO 13321:1996. Cumulants produces an estimate of the mean (xPCS) and width (polydispersity i" }, { "page": 17, "family": "International", "normalized": "ISO 13321:1996", "raw": "ISO 13321:1996", "context": "size distribution derived from the cumulants analysis of DLS data according to ISO 13321:1996; for a single Gaussian population with standard deviation, \u03c3, and mean size, x" }, { "page": 18, "family": "International", "normalized": "ISO 13321:1996", "raw": "ISO 13321:1996", "context": "rage size, xPCS, derived from a cumulants analysis of DLS data as described in ISO 13321:1996. 8. 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S. C. \u00a71734", "context": "is article must therefore be hereby marked \u201cadvertise- ment\u201d in accordance with 18 U. S. 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I certify that the requirements of 42 U.S.C. \u00a7 282(j), Section 402(j) of the Public Health Service Act, including 42 CFR part 11, do not apply because the application/submission whic" }, { "page": 1, "family": "Section-of-Act", "normalized": "Section 402(j) of the PHS Act", "raw": "Section 402(j) of the Public Health Service Act", "context": "clinical trial. |_| B. I certify that the requirements of 42 U.S.C. \u00a7 282(j), Section 402(j) of the Public Health Service Act, including 42 CFR part 11, do not apply to any clinical trial referenced in the" }, { "page": 1, "family": "USC", "normalized": "42 U.S.C. \u00a7 282", "raw": "42 U.S.C. \u00a7 282", "context": "SERVICES Food and Drug Administration FDA \u00a5 Certification of Compliance Under 42 U.S.C. \u00a7 282(j)(5)(B), with Requirements of ClinicalTrials.gov Data Bank (For submission wi" }, { "page": 1, "family": "USC", "normalized": "42 U.S.C. \u00a7 282", "raw": "42 U.S.C. \u00a7 282", "context": "itional information and explanation) |_| A. I certify that the requirements of 42 U.S.C. \u00a7 282(j), Section 402(j) of the Public Health Service Act, including 42 CFR part 11," }, { "page": 1, "family": "USC", "normalized": "42 U.S.C. \u00a7 282", "raw": "42 U.S.C. \u00a7 282", "context": "es not reference any clinical trial. |_| B. I certify that the requirements of 42 U.S.C. \u00a7 282(j), Section 402(j) of the Public Health Service Act, including 42 CFR part 11," }, { "page": 1, "family": "USC", "normalized": "42 U.S.C. \u00a7 282", "raw": "42 U.S.C. \u00a7 282", "context": "which this certification accompanies. Xx C. I certify that the requirements of 42 U.S.C. \u00a7 282(j), section 402(j) of the Public Health Service Act, apply to one or more of th" }, { "page": 1, "family": "USC", "normalized": "42 U.S.C. \u00a7 282", "raw": "42 U.S.C. 282", "context": "on/submission which this certification accompanies and that the requirements of 42 U.S.C. 282(j), including any applicable provisions of 42 CFR part 11, have been met. Cert" }, { "page": 1, "family": "Named act", "normalized": "FD&C Act", "raw": "Federal Food, Drug, and Cosmetic Act", "context": "ts, supplements, and resubmissions, under \u00a7\u00a7 505, 515, 520(m), or 510(k) of the Federal Food, Drug, and Cosmetic Act or \u00a7 351 of the Public Health Service Act.) SPONSOR / APPLICANT / SUBMITTER IN" }, { "page": 1, "family": "Named act", "normalized": "PHS Act", "raw": "Public Health Service Act", "context": ", 520(m), or 510(k) of the Federal Food, Drug, and Cosmetic Act or \u00a7 351 of the Public Health Service Act.) SPONSOR / APPLICANT / SUBMITTER INFORMATION 1. Name of Sponsor/Applicant/Su" }, { "page": 1, "family": "Named act", "normalized": "PHS Act", "raw": "Public Health Service Act", "context": "C. I certify that the requirements of 42 U.S.C. \u00a7 282(j), section 402(j) of the Public Health Service Act, apply to one or more of the clinical trials referenced in the application/subm" }, { "page": 2, "family": "USC", "normalized": "42 U.S.C. \u00a7 282", "raw": "42 U.S.C. \u00a7 282", "context": "r which you (the sponsor/applicant/submitter) are the \u201cresponsible party\u201d under 42 U.S.C. \u00a7 282(j)(1)(a)(i), section 402(j)(1)(a)(i) of the Public Health Service Act reference" }, { "page": 2, "family": "USC", "normalized": "42 U.S.C. \u00a7 282", "raw": "42 U.S.C. \u00a7 282", "context": "ormation. | understand that the failure to submit the certification required by 42 U.S.C. \u00a7 282(j)(5)(B), section 402(j)(5)(B) of the Public Health Service Act, and the knowin" }, { "page": 2, "family": "USC", "normalized": "21 U.S.C. \u00a7 331", "raw": "21 U.S.C. \u00a7 331", "context": "ubmission of a false certification under such section are prohibited acts under 21 U.S.C. \u00a7 331, section 301 of the Federal Food, Drug, and Cosmetic Act. Warning: A willfully" }, { "page": 2, "family": "Named act", "normalized": "PHS Act", "raw": "Public Health Service\nAct", "context": "nsible party\u201d under 42 U.S.C. \u00a7 282(j)(1)(a)(i), section 402(j)(1)(a)(i) of the Public Health Service Act referenced in the application/ submission which this Certification accompanies." }, { "page": 2, "family": "Named act", "normalized": "PHS Act", "raw": "Public Health\nService Act", "context": "certification required by 42 U.S.C. \u00a7 282(j)(5)(B), section 402(j)(5)(B) of the Public Health Service Act, and the knowing submission of a false certification under such section are pro" }, { "page": 2, "family": "Named act", "normalized": "FD&C Act", "raw": "Federal Food, Drug, and Cosmetic Act", "context": "nder such section are prohibited acts under 21 U.S.C. \u00a7 331, section 301 of the Federal Food, Drug, and Cosmetic Act. 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This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CCO license. Structure-Based Design" }, { "page": 2, "family": "USC", "normalized": "17 U.S.C. \u00a7 105", "raw": "17 USC\n105", "context": "der. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CCO license. Summary Biotin-labele" }, { "page": 3, "family": "USC", "normalized": "17 U.S.C. \u00a7 105", "raw": "17 USC\n105", "context": "der. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CCO license. Introduction Severe a" }, { "page": 4, "family": "USC", "normalized": "17 U.S.C. \u00a7 105", "raw": "17 USC\n105", "context": "der. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CCO license. encoding antibodies ca" }, { "page": 5, "family": "USC", "normalized": "17 U.S.C. \u00a7 105", "raw": "17 USC\n105", "context": "der. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CCO license. efficiently and can be" }, { "page": 6, "family": "USC", "normalized": "17 U.S.C. \u00a7 105", "raw": "17 USC\n105", "context": "der. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CCO license. RRAR at the S1/S2 clea" }, { "page": 7, "family": "USC", "normalized": "17 U.S.C. \u00a7 105", "raw": "17 USC\n105", "context": "der. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CCO license. To provide atomic-leve" }, { "page": 8, "family": "USC", "normalized": "17 U.S.C. \u00a7 105", "raw": "17 USC\n105", "context": "der. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CCO license. separate molecular pro" }, { "page": 9, "family": "USC", "normalized": "17 U.S.C. \u00a7 105", "raw": "17 USC\n105", "context": "der. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CCO license. RBD-L455RA475RG502R-AV" }, { "page": 10, "family": "USC", "normalized": "17 U.S.C. \u00a7 105", "raw": "17 USC\n105", "context": "der. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CCO license. did bind S2P probe wit" }, { "page": 11, "family": "USC", "normalized": "17 U.S.C. \u00a7 105", "raw": "17 USC\n105", "context": "der. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CCO license. sorted the cells with" }, { "page": 12, "family": "USC", "normalized": "17 U.S.C. \u00a7 105", "raw": "17 USC\n105", "context": "der. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CCO license. For probe construction" }, { "page": 13, "family": "USC", "normalized": "17 U.S.C. \u00a7 105", "raw": "17 USC\n105", "context": "der. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CCO license. Acknowledgments We th" }, { "page": 14, "family": "USC", "normalized": "17 U.S.C. \u00a7 105", "raw": "17 USC\n105", "context": "der. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CCO license. analysis; JRM supervis" }, { "page": 15, "family": "USC", "normalized": "17 U.S.C. \u00a7 105", "raw": "17 USC\n\n105", "context": "der. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CCO license. STARU METHODS KEY RES" }, { "page": 17, "family": "USC", "normalized": "17 U.S.C. \u00a7 105", "raw": "17 USC\n\n105", "context": "der. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CCO license. RELION Scheres, 2012 h" }, { "page": 18, "family": "USC", "normalized": "17 U.S.C. \u00a7 105", "raw": "17 USC\n105", "context": "der. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CCO license. approved clinical tria" }, { "page": 19, "family": "USC", "normalized": "17 U.S.C. \u00a7 105", "raw": "17 USC\n105", "context": "der. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CCO license. linker named10InQQ and" }, { "page": 20, "family": "USC", "normalized": "17 U.S.C. \u00a7 105", "raw": "17 USC\n105", "context": "der. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CCO license. was then collected and" }, { "page": 21, "family": "USC", "normalized": "17 U.S.C. \u00a7 105", "raw": "17 USC\n105", "context": "der. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CCO license. synthesized and subclo" }, { "page": 22, "family": "USC", "normalized": "17 U.S.C. \u00a7 105", "raw": "17 USC\n105", "context": "der. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CCO license. Surface plasmon resona" }, { "page": 23, "family": "USC", "normalized": "17 U.S.C. \u00a7 105", "raw": "17 USC\n105", "context": "der. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CCO license. Purified SARS-CoV-2 S" }, { "page": 24, "family": "USC", "normalized": "17 U.S.C. \u00a7 105", "raw": "17 USC\n105", "context": "der. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CCO license. helices, which include" }, { "page": 25, "family": "USC", "normalized": "17 U.S.C. \u00a7 105", "raw": "17 USC\n105", "context": "der. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CCO license. Biotinylated SARS-CoV-" }, { "page": 26, "family": "USC", "normalized": "17 U.S.C. \u00a7 105", "raw": "17 USC\n105", "context": "der. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CCO license. with 4 ng/ul of S2P (A" }, { "page": 27, "family": "USC", "normalized": "17 U.S.C. \u00a7 105", "raw": "17 USC\n105", "context": "der. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CCO license. 100 ng of natively pai" }, { "page": 28, "family": "USC", "normalized": "17 U.S.C. \u00a7 105", "raw": "17 USC\n105", "context": "der. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CCO license. QUANTIFICATION AND STA" }, { "page": 29, "family": "USC", "normalized": "17 U.S.C. \u00a7 105", "raw": "17 USC\n105", "context": "der. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CCO license. References Adams, P.D" }, { "page": 30, "family": "USC", "normalized": "17 U.S.C. \u00a7 105", "raw": "17 USC\n105", "context": "der. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CCO license. Cucinotta, D., and Van" }, { "page": 31, "family": "USC", "normalized": "17 U.S.C. \u00a7 105", "raw": "17 USC\n105", "context": "der. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CCO license. Johnson, G., and Wu, T" }, { "page": 32, "family": "USC", "normalized": "17 U.S.C. \u00a7 105", "raw": "17 USC\n105", "context": "der. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CCO license. Ou, X., Liu, Y., Lei," }, { "page": 33, "family": "USC", "normalized": "17 U.S.C. \u00a7 105", "raw": "17 USC\n105", "context": "der. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CCO license. Suloway, C., Pulokas," }, { "page": 34, "family": "USC", "normalized": "17 U.S.C. \u00a7 105", "raw": "17 USC\n105", "context": "der. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CCO license. Wrapp, D., Wang, N., C" }, { "page": 35, "family": "USC", "normalized": "17 U.S.C. \u00a7 105", "raw": "17 USC\n105", "context": "der. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CCO license. Figure 1 Ay. SARS-CoV" }, { "page": 36, "family": "USC", "normalized": "17 U.S.C. \u00a7 105", "raw": "17 USC\n105", "context": "der. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CCO license. Figure 2 A Ss HRVS3C" }, { "page": 37, "family": "USC", "normalized": "17 U.S.C. \u00a7 105", "raw": "17 USC\n105", "context": "der. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CCO license. Figure 3 MWM A = Baie" }, { "page": 38, "family": "USC", "normalized": "17 U.S.C. \u00a7 105", "raw": "17 USC\n105", "context": "der. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CCO license. Figure 4 PDB: 6VSB PD" }, { "page": 39, "family": "USC", "normalized": "17 U.S.C. \u00a7 105", "raw": "17 USC\n105", "context": "der. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CCO license. A 1200 A280 (mAU) O" }, { "page": 40, "family": "USC", "normalized": "17 U.S.C. \u00a7 105", "raw": "17 USC\n105", "context": "der. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CCO license. Figure 6 scFc HRV3C s" }, { "page": 41, "family": "USC", "normalized": "17 U.S.C. \u00a7 105", "raw": "17 USC\n\n105", "context": "der. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CCO license. A SPR definition of li" }, { "page": 42, "family": "USC", "normalized": "17 U.S.C. \u00a7 105", "raw": "17 USC\n105", "context": "der. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CCO license. Figure 7. 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Reference" }, { "page": 12, "family": "CFR", "normalized": "42 CFR 493.1256", "raw": "42 CFR Part 493.1256", "context": "erminated or revoked sooner. References CLIA Regulations on Control Procedures; 42 CFR Part 493.1256 Appendices Monthly QC Review Log Approved and current. 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Approved a" }, { "page": 7, "family": "Named act", "normalized": "FD&C Act", "raw": "Federal Food, Drug and Cosmetic Act", "context": "stics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. \u00a7 360bbb-3(b)(1), unless the authorization is terminated or revoked" } ] }, { "filename": "19745_S73_M5_5314_21120-705-report.pdf", "id": 2086, "module": "M5", "batch_code": "md-eua", "company": "Moderna", "license": "EUA", "individual_url": null, "ican_url": null, "total_pages": 38, "matches": [ { "page": 37, "family": "USC", "normalized": "42 U.S.C. \u00a7 263a", "raw": "42 U.S.C. \u00a7263a", "context": "certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. \u00a7263a, and meet the requirements to perform high complexity tests; \uf0b7 The Viracor SAR" }, { "page": 37, "family": "USC", "normalized": "21 U.S.C. \u00a7 360b", "raw": "21 U.S.C. \u00a7 360b", "context": "f COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. \u00a7 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. SAFETY Th" }, { "page": 37, "family": "Named act", "normalized": "FD&C Act", "raw": "Federal Food, Drug and Cosmetic Act", "context": "tics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. \u00a7 360bbb-3(b)(1), unless the authorization is terminated or revoked" } ] }, { "filename": "19745_S73_M5_5314_21120-9037-report.pdf", "id": 2087, "module": "M5", "batch_code": "md-eua", "company": "Moderna", "license": "EUA", "individual_url": null, "ican_url": null, "total_pages": 9, "matches": [] }, { "filename": "19745_S73_M5_5314_21120-9109-report.pdf", "id": 2088, "module": "M5", "batch_code": "md-eua", "company": "Moderna", "license": "EUA", "individual_url": null, "ican_url": null, "total_pages": 49, "matches": [] }, { "filename": "19745_S73_M5_5314_21120-9142-report.pdf", "id": 2089, "module": "M5", "batch_code": "md-eua", "company": "Moderna", "license": "EUA", "individual_url": null, "ican_url": null, "total_pages": 22, "matches": [] }, { "filename": "19745_S73_M5_5314_21120-9152-report.pdf", "id": 2090, "module": "M5", "batch_code": "md-eua", "company": "Moderna", "license": "EUA", "individual_url": null, "ican_url": null, "total_pages": 11, "matches": [ { "page": 10, "family": "USC", "normalized": "42 U.S.C. \u00a7 263a", "raw": "42 U.S.C. \u00a7263a", "context": "certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. \u00a7263a, and meet the requirements to perform high complexity tests; \uf0b7 The Viracor SAR" }, { "page": 10, "family": "USC", "normalized": "21 U.S.C. \u00a7 360b", "raw": "21 U.S.C. \u00a7 360b", "context": "f COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. \u00a7 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. SAFETY Th" }, { "page": 10, "family": "Named act", "normalized": "FD&C Act", "raw": "Federal Food, Drug and Cosmetic Act", "context": "tics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. \u00a7 360bbb-3(b)(1), unless the authorization is terminated or revoked" } ] }, { "filename": "19745_S73_M5_5314_21120-9184-report.pdf", "id": 2091, "module": "M5", "batch_code": "md-eua", "company": "Moderna", "license": "EUA", "individual_url": null, "ican_url": null, "total_pages": 25, "matches": [] }, { "filename": "19745_S73_M5_5314_21120-9201-worksheet.pdf", "id": 2092, "module": "M5", "batch_code": "md-eua", "company": "Moderna", "license": "EUA", "individual_url": null, "ican_url": null, "total_pages": 1, "matches": [] }, { "filename": "19745_S73_M5_5314_21120-9457-worksheet.pdf", "id": 2093, "module": "M5", "batch_code": "md-eua", "company": "Moderna", "license": "EUA", "individual_url": null, "ican_url": null, "total_pages": 1, "matches": [] }, { "filename": "19745_S73_M5_5314_covid-pcr-control.pdf", "id": 2094, "module": "M5", "batch_code": "md-eua", "company": "Moderna", "license": "EUA", "individual_url": null, "ican_url": null, "total_pages": 2, "matches": [] }, { "filename": "19745_S73_M5_5314_vsdvac-65-elisa-val-rpt.pdf", "id": 2095, "module": "M5", "batch_code": "md-eua", "company": "Moderna", "license": "EUA", "individual_url": null, "ican_url": null, "total_pages": 57, "matches": [] }, { "filename": "19745_S80_M5_safety-report-20-0003.pdf", "id": 2096, "module": "M5", "batch_code": "md-eua", "company": "Moderna", "license": "EUA", "individual_url": null, "ican_url": null, "total_pages": 1177, "matches": [ { "page": 244, "family": "CFR", "normalized": "21 CFR 312.32", "raw": "21 CFR 312.32", "context": "of an intervention in humans, whether or not considered intervention-related (21 CFR 312.32 (a)). An AE can therefore be any unfavorable and unintended sign (including an" }, { "page": 245, "family": "CFR", "normalized": "21 CFR 312.32", "raw": "21 CFR 312.32", "context": "n established. Definition of Serious Adverse Event (SAE) An SAE is defined in 21 CFR 312.32 as follows: \u201cAn AE or suspected adverse reaction is considered serious if, in" } ] }, { "filename": "19745_S80_M5_unblinded-eua-safety-list.pdf", "id": 2097, "module": "M5", "batch_code": "md-eua", "company": "Moderna", "license": "EUA", "individual_url": null, "ican_url": null, "total_pages": 2690, "matches": [] }, { "filename": "19745_S81_M1_rsp-cmnts-proposed-pre-eau-pkg.pdf", "id": 2098, "module": "M1", "batch_code": "md-eua", "company": "Moderna", "license": "EUA", "individual_url": null, "ican_url": null, "total_pages": 7, "matches": [] }, { "filename": "19745_S83_M1_resp-cmnts-sens-analyses-25nov2020.pdf", "id": 2099, "module": "M1", "batch_code": "md-eua", "company": "Moderna", "license": "EUA", "individual_url": null, "ican_url": null, "total_pages": 2, "matches": [] }, { "filename": "27073_S1_M1_eua-request-moderna-covid-19-vaccine.pdf", "id": 2100, "module": "M1", "batch_code": "md-eua", "company": "Moderna", "license": "EUA", "individual_url": null, "ican_url": null, "total_pages": 41, "matches": [ { "page": 31, "family": "Named act", "normalized": "FD&C Act", "raw": "FD&C Act", "context": "9 Vaccine and warrant consideration for EUA under Section 564 (b)(1)(C) of the FD&C Act. 7.2. Contraindications Moderna COVID-19 Vaccine is contraindicated in indiv" } ] }, { "filename": "27073_S1_M2_clinical-overview.pdf", "id": 2101, "module": "M2", "batch_code": "md-eua", "company": "Moderna", "license": "EUA", "individual_url": null, "ican_url": null, "total_pages": 95, "matches": [ { "page": 17, "family": "Section-of-Act", "normalized": "Section 351 of the PHS Act", "raw": "Section 351 of the Public Health \nService Act", "context": "thorization Act of 2013. The Sponsor will also subsequently submit a BLA under Section 351 of the Public Health Service Act and intends to seek Priority Review for the BLA. The BLA submission is planned" }, { "page": 17, "family": "Named act", "normalized": "FD&C Act", "raw": "Federal Food, Drug, and Cosmetic Act", "context": "gulatory pathway is an EUA described under sections 564, 564A, and 564B of the Federal Food, Drug, and Cosmetic Act as amended or added by the Pandemic and All-Hazards Preparedness Reauthorizati" }, { "page": 84, "family": "Named act", "normalized": "FD&C Act", "raw": "FD&C Act", "context": "mRNA-1273 and warrant consideration for EUA under Section 564 (b)(1)(C) of the FD&C Act. 2.5.7 REFERENCES Anderson EJ, Rouphael NG, Widge AT, Jackson LA, et al. Saf" } ] }, { "filename": "27073_S3_M1_pvp.pdf", "id": 2102, "module": "M1", "batch_code": "md-eua", "company": "Moderna", "license": "EUA", "individual_url": null, "ican_url": null, "total_pages": 20, "matches": [ { "page": 1, "family": "International", "normalized": "ICH E2E", "raw": "ICH E2E", "context": "prepared according to the format and expectations of the Guidance for Industry ICH E2E Pharmacovigilance Planning FDA April 2005. It describes a method for summariz" } ] }, { "filename": "27073_S3_M1_submission-plan-eua.pdf", "id": 2103, "module": "M1", "batch_code": "md-eua", "company": "Moderna", "license": "EUA", "individual_url": null, "ican_url": null, "total_pages": 4, "matches": [] }, { "filename": "27073_S7_M1_draft-702195-eua-vial-label-new-line.pdf", "id": 2104, "module": "M1", "batch_code": "md-eua", "company": "Moderna", "license": "EUA", "individual_url": null, "ican_url": null, "total_pages": 1, "matches": [] }, { "filename": "27073_S7_M1_draft-702196-eua-carton-new-line.pdf", "id": 2105, "module": "M1", "batch_code": "md-eua", "company": "Moderna", "license": "EUA", "individual_url": null, "ican_url": null, "total_pages": 3, "matches": [] }, { "filename": "27073_S7_M1_draft-702208-eua-carton-manual.pdf", "id": 2106, "module": "M1", "batch_code": "md-eua", "company": "Moderna", "license": "EUA", "individual_url": null, "ican_url": null, "total_pages": 3, "matches": [] }, { "filename": "27073_S7_M1_draft-702209-eua-carton-automated.pdf", "id": 2107, "module": "M1", "batch_code": "md-eua", "company": "Moderna", "license": "EUA", "individual_url": null, "ican_url": null, "total_pages": 4, "matches": [] }, { "filename": "27073_S7_M1_draft-702210-eua-vial-label.pdf", "id": 2108, "module": "M1", "batch_code": "md-eua", "company": "Moderna", "license": "EUA", "individual_url": null, "ican_url": null, "total_pages": 1, "matches": [] }, { "filename": "27073_S11_M1_submission-plan-eua.pdf", "id": 2109, "module": "M1", "batch_code": "md-eua", "company": "Moderna", "license": "EUA", "individual_url": null, "ican_url": null, "total_pages": 8, "matches": [] }, { "filename": "27073_S13_M5_moderna-covid-19-vacc-preg-registry-synop.pdf", "id": 2110, "module": "M5", "batch_code": "md-eua", "company": "Moderna", "license": "EUA", "individual_url": null, "ican_url": null, "total_pages": 15, "matches": [] }, { "filename": "27073_S13_M5_non-interventional-study-protocol-synop.pdf", "id": 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CBER will work with Moderna to establish a lot release p" } ] }, { "filename": "7_BLA 125752-0_09-22-2021_Telecon_Information Reques.pdf", "id": 2986, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 2, "matches": [] }, { "filename": "8_BLA 125752-0_09-23-2021_Telecon_Advice.pdf", "id": 2987, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 1, "matches": [] }, { "filename": "9_BLA 125752-0_09-23-2021_Telecon_Information Reques.pdf", "id": 2988, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 1, "matches": [] }, { "filename": "10_BLA 125752-0_09-24-2021_Telecon_Information Reques.pdf", "id": 2989, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 6, "matches": [] }, { "filename": "11_BLA 125752-0_09-27-2021_Memo_Committee Memo_APLB.pdf", "id": 2990, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 5, "matches": [ { "page": 1, "family": "Named act", "normalized": "FD&C Act", "raw": "Federal Food, Drug, and Cosmetic Act", "context": "CBER\u2019s Advertising and Promotional Labeling Branch, we conclude that under the Federal Food, Drug, and Cosmetic Act and applicable regulations your proposed proprietary name, SPIKEVAX, is Accept" }, { "page": 3, "family": "CFR", "normalized": "21 CFR 201.10", "raw": "21 CFR 201.10", "context": "2. Evaluating for Promotional and Safety Concerns a. Promotional Review [21 CFR 201.10 (c)(3), 202.1 (e)(5)(i), and (e)(6)(i)] The proposed proprietary name, SPIKE" }, { "page": 3, "family": "CFR", "normalized": "21 CFR 201.10", "raw": "21 CFR 201.10", "context": "e false, misleading, or fanciful. b. Look-alike Sound-alike Safety Review [21 CFR 201.10 (c)(5)] Since drug products are prescribed through written, verbal, and/or e" } ] }, { "filename": "12_BLA 125752-0_09-27-2021_Telecon_Advice.pdf", "id": 2991, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 11, "matches": [] }, { "filename": "13_BLA 125752-0_09-27-2021_Telecon_Other.pdf", "id": 2992, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 9, "matches": [] }, { "filename": "15_BLA 125752-0_09-28-2021_Telecon_Information Reques.pdf", "id": 2993, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 4, "matches": [] }, { "filename": "16_BLA 125752-0_09-30-2021_Memo_Other.pdf", "id": 2994, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 4, "matches": [ { "page": 1, "family": "CFR", "normalized": "21 CFR 10.115", "raw": "21 C.F.R. \u00a7 10.115", "context": "my concurrence with the decision to depart from the Naming Guidance. 1 See 21 C.F.R. \u00a7 10.115(d)(3) (\u201cAlthough guidance documents do not legally bind FDA, they represent the" }, { "page": 3, "family": "Section-of-Act", "normalized": "Section 2105 of the PHS Act", "raw": "Section 2105 of the Public Health \nService Act", "context": "ulthood. The National Vaccine Advisory Committee (established to comply with Section 2105 of the Public Health Service Act) recommends that public health departments work toward including adults in all" } ] }, { "filename": "17_BLA 125752-0_10-05-2021_Telecon_Information Reques.pdf", "id": 2995, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 3, "matches": [] }, { "filename": "18_BLA 125752-0_10-06-2021_Telecon_Information Reques.pdf", "id": 2996, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 3, "matches": [] }, { "filename": "19_BLA 125752-0_10-14-2021_Letter_Filing Notification.pdf", "id": 2997, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 3, "matches": [ { "page": 2, "family": "CFR", "normalized": "21 CFR 601.2", "raw": "21 CFR 601.2", "context": "ur application is sufficiently complete to permit a substantive review. Under 21 CFR 601.2(a), we have filed your application today. The review classification for this a" }, { "page": 2, "family": "Named act", "normalized": "PHS Act", "raw": "Public Health \nService Act", "context": "tion (BLA) submitted and received August 24, 2021, under section 351(a) of the Public Health Service Act (PHS Act) for COVID-19 Vaccine, mRNA. We also refer to your initial portions" }, { "page": 2, "family": "Named act", "normalized": "PHS Act", "raw": "PHS Act", "context": "ceived August 24, 2021, under section 351(a) of the Public Health Service Act (PHS Act) for COVID-19 Vaccine, mRNA. We also refer to your initial portions of your" }, { "page": 3, "family": "USC", "normalized": "21 U.S.C. \u00a7 355c", "raw": "21 U.S.C. 355c", "context": "ional information if needed. Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new active ingredients, new indications, new dosage for" } ] }, { "filename": "20_BLA 125752-0_10-14-2021_Telecon_Information Reques.pdf", "id": 2998, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 2, "matches": [] }, { "filename": "21_BLA 125752-0_10-14-2021_Telecon_Other.pdf", "id": 2999, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 1, "matches": [] }, { "filename": "21A_BLA 125752-0_10-14-2021_Telecon_Other.pdf", "id": 3000, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 3, "matches": [] }, { "filename": "22_BLA 125752-0_10-15-2021_Letter_PNR Acceptance.pdf", "id": 3001, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 2, "matches": [ { "page": 2, "family": "Named act", "normalized": "PHS Act", "raw": "Public Health Service Act", "context": "ion (BLA) submitted and received August 24, 2021, under section 351(a) of the Public Health Service Act for Covid-19 mRNA vaccine, requesting a proprietary name review for SPIKEVAX." }, { "page": 2, "family": "Named act", "normalized": "FD&C Act", "raw": "Federal Food, \nDrug, and Cosmetic Act", "context": "ising and Promotional Labeling Branch (CBER/APLB), we conclude that, under the Federal Food, Drug, and Cosmetic Act and applicable regulations, SPIKEVAX is acceptable. If you have any question" } ] }, { "filename": "24_BLA 125752-0_10-20-2021_Telecon_Information Reques.pdf", "id": 3002, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 2, "matches": [] }, { "filename": "25_BLA 125752-0_10-21-2021_Telecon_Information Reques.pdf", "id": 3003, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 1, "matches": [] }, { "filename": "26_BLA 125752-0_10-22-2021_Telecon_Information Reques.pdf", "id": 3004, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 3, "matches": [] }, { "filename": "27_BLA 125752-0_10-22-2021_Telecon_Information Reques.pdf", "id": 3005, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 3, "matches": [] }, { "filename": "28_BLA 125752-0_10-26-2021_Telecon_Information Reques.pdf", "id": 3006, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 3, "matches": [] }, { "filename": "30_BLA 125752-0_10-29-2021_Telecon_Other.pdf", "id": 3007, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 637, "matches": [] }, { "filename": "30A_BLA 125752-0_10-29-2021_Telecon_Other.pdf", "id": 3008, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 8, "matches": [] }, { "filename": "30B_BLA 125752-0_10-29-2021_Telecon_Other.pdf", "id": 3009, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 21, "matches": [] }, { "filename": "30C_BLA 125752-0_10-29-2021_Telecon_Other.pdf", "id": 3010, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 3, "matches": [] }, { "filename": "30D_BLA 125752-0_10-29-2021_Telecon_Other.pdf", "id": 3011, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 3, "matches": [] }, { "filename": "31_BLA 125752-0_11-01-2021_Telecon_Information Reques.pdf", "id": 3012, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 4, "matches": [ { "page": 4, "family": "CFR", "normalized": "21 CFR 610.14", "raw": "21 CFR 610.14", "context": "d filled vials. In addition, please include the identity test performed as per 21 CFR 610.14 after all labeling operations are completed (i.e., vial and package labels)." } ] }, { "filename": "32_BLA 125752-0_11-01-2021_Telecon_Information Reques.pdf", "id": 3013, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 1, "matches": [] }, { "filename": "33_BLA 125752-0_11-03-2021_Telecon_Information Reques.pdf", "id": 3014, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 3, "matches": [] }, { "filename": "34_BLA 125752-0_11-03-2021_Telecon_Other.pdf", "id": 3015, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 2, "matches": [] }, { "filename": "35_BLA 125752-0_11-05-2021_Telecon_Information Reques.pdf", "id": 3016, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 2, "matches": [] }, { "filename": "36_BLA 125752-0_11-05-2021_Telecon_Information Reques.pdf", "id": 3017, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 1, "matches": [] }, { "filename": "37_BLA 125752-0_11-10-2021_Telecon_Information Reques.pdf", "id": 3018, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 5, "matches": [] }, { "filename": "38_BLA 125752-0_11-10-2021_Telecon_Information Reques.pdf", "id": 3019, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 2, "matches": [] }, { "filename": "39_BLA 125752-0_11-12-2021_Telecon_Information Reques.pdf", "id": 3020, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 2, "matches": [] }, { "filename": "40_BLA 125752-0_11-15-2021_Telecon_Information Reques.pdf", "id": 3021, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 20, "matches": [ { "page": 1, "family": "CFR", "normalized": "21 CFR 610.62", "raw": "21 CFR 610.62", "context": "e of the proper name and the tradename to ensure they are equal in prominence ((21 CFR 610.62(b)). b. On the carton labels, please increase the font size of \u201cFor 18 years an" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 610.62", "raw": "21 CFR 610.62", "context": "l labels, please increase the prominence and size of \u201cFor 18 years and older\u201d ((21 CFR 610.62(b)). c. Please clarify the purpose of the \u201c2D datamatrix code encoded P/N\u201d lis" } ] }, { "filename": "40A_BLA 125752-0_11-15-2021_Telecon_Information Reques.pdf", "id": 3022, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 18, "matches": [] }, { "filename": "40B_BLA 125752-0_11-15-2021_Telecon_Information Reques.pdf", "id": 3023, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 18, "matches": [] }, { "filename": "42_BLA 125752-0_11-19-2021_Telecon_Advice.pdf", "id": 3024, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 3, "matches": [] }, { "filename": "43_BLA 125752-0_11-19-2021_Telecon_Information Reques.pdf", "id": 3025, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 2, "matches": [] }, { "filename": "44_BLA 125752-0_11-24-2021_Telecon_Other.pdf", "id": 3026, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 2, "matches": [] }, { "filename": "45_BLA 125752-0_11-29-2021_Telecon_Information Reques.pdf", "id": 3027, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 2, "matches": [] }, { "filename": "46_BLA 125752-0_11-29-2021_Telecon_Information Reques.pdf", "id": 3028, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 2, "matches": [] }, { "filename": "47_BLA 125752-0_12-01-2021_Telecon_Information Reques.pdf", "id": 3029, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 2, "matches": [] }, { "filename": "48_BLA 125752-0_12-06-2021_Telecon_Information Reques.pdf", "id": 3030, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 1, "matches": [] }, { "filename": "48A_BLA 125752-0_12-06-2021_Telecon_Information Reques.pdf", "id": 3031, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 5, "matches": [] }, { "filename": "49_BLA 125752-0_12-06-2021_Telecon_Information Reques.pdf", "id": 3032, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 6, "matches": [] }, { "filename": "50_BLA 125752-0_12-07-2021_Telecon_Information Reques.pdf", "id": 3033, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 5, "matches": [ { "page": 2, "family": "CFR", "normalized": "21 CFR 610.2", "raw": "21 CFR 610.2", "context": "intended for lots to be submitted for official lot release in accordance with 21 CFR 610.2 so please change this to \u201cRelease\u201d for all lots submitted. Pages 2 through" }, { "page": 2, "family": "CFR", "normalized": "21 CFR 610.1", "raw": "21 CFR 610.1", "context": "Nanoparticles Drug Substance to be performed and documented in accordance with 21 CFR 610.1, but we are requesting that only the results of testing of the CX-024414 mRNA" } ] }, { "filename": "51_BLA 125752-0_12-09-2021_Telecon_Advice.pdf", "id": 3034, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 7, "matches": [] }, { "filename": "52_BLA 125752-0_12-09-2021_Telecon_Information Reques.pdf", "id": 3035, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 2, "matches": [] }, { "filename": "53_BLA 125752-0_12-10-2021_Telecon_Information Reques.pdf", "id": 3036, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 2, "matches": [] }, { "filename": "54_BLA 125752-0_12-10-2021_Telecon_Information Reques.pdf", "id": 3037, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 2, "matches": [] }, { "filename": "54A_BLA 125752-0_12-10-2021_Telecon_Information Reques.pdf", "id": 3038, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 17, "matches": [] }, { "filename": "55_BLA 125752-0_12-10-2021_Telecon_Information Reques.pdf", "id": 3039, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 3, "matches": [ { "page": 1, "family": "Named act", "normalized": "FD&C Act", "raw": "Federal Food, Drug, and Cosmetic Act", "context": "ontaneous postmarketing adverse events reported under section 505(k)(1) of the Federal Food, Drug, and Cosmetic Act (FDCA) will not be sufficient to identify: \u2022 known serious risks of myocardit" }, { "page": 1, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "reported under section 505(k)(1) of the Federal Food, Drug, and Cosmetic Act (FDCA) will not be sufficient to identify: \u2022 known serious risks of myocarditis and" }, { "page": 1, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "gilance system that FDA is required to maintain under section 505(k)(3) of the FDCA is not sufficient to assess these serious risks. Therefore, should this pr" }, { "page": 1, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "following studies as postmarketing requirements (PMRs) under Section 505(o) of FDCA: 1. Study mRNA-1273-P903, entitled \u201cPost-marketing safety of SARS-CoV-2 mR" } ] }, { "filename": "56_BLA 125752-0_12-10-2021_Telecon_Information Reques.pdf", "id": 3040, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 2, "matches": [] }, { "filename": "57_BLA 125752-0_12-14-2021_Telecon_Information Reques.pdf", "id": 3041, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 1, "matches": [] }, { "filename": "57A_BLA 125752-0_12-14-2021_Telecon_Information Reques.pdf", "id": 3042, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 3, "matches": [] }, { "filename": "59_BLA 125752-0_12-15-2021_Telecon_Advice.pdf", "id": 3043, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 2, "matches": [] }, { "filename": "61_BLA 125752-0_12-16-2021_Telecon_Information Reques.pdf", "id": 3044, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 2, "matches": [] }, { "filename": "62_BLA 125752-0_12-16-2021_Telecon_Information Reques.pdf", "id": 3045, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 2, "matches": [] }, { "filename": "63_BLA 125752-0_12-16-2021_Telecon_Information Reques.pdf", "id": 3046, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 2, "matches": [] }, { "filename": "64_BLA 125752-0_12-16-2021_Telecon_Information Reques.pdf", "id": 3047, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 2, "matches": [] }, { 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207.35", "context": "These labels were reviewed for compliance with the regulations 21 CFR 201.25 & 21 CFR 207.35, Subpart G \u2013 Labeling Standards 21 CFR 610.60 (a)(1) through (7) and 21 CFR 61" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 610.60", "raw": "21 CFR 610.60", "context": "the regulations 21 CFR 201.25 & 21 CFR 207.35, Subpart G \u2013 Labeling Standards 21 CFR 610.60 (a)(1) through (7) and 21 CFR 610.60 (7) (b) through (e), 21 CFR 610.62 (a) th" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 610.60", "raw": "21 CFR 610.60", "context": "FR 207.35, Subpart G \u2013 Labeling Standards 21 CFR 610.60 (a)(1) through (7) and 21 CFR 610.60 (7) (b) through (e), 21 CFR 610.62 (a) through (c), 21 CFR 610.63, 21 CFR 610." }, { "page": 1, "family": "CFR", "normalized": "21 CFR 610.62", "raw": "21 CFR 610.62", "context": "ndards 21 CFR 610.60 (a)(1) through (7) and 21 CFR 610.60 (7) (b) through (e), 21 CFR 610.62 (a) through (c), 21 CFR 610.63, 21 CFR 610.64, 21 CFR 610.67, the Drug Supply" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 610.63", "raw": "21 CFR 610.63", "context": "ough (7) and 21 CFR 610.60 (7) (b) through (e), 21 CFR 610.62 (a) through (c), 21 CFR 610.63, 21 CFR 610.64, 21 CFR 610.67, the Drug Supply Chain Security Act (DSCSA) and" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 610.64", "raw": "21 CFR 610.64", "context": "CFR 610.60 (7) (b) through (e), 21 CFR 610.62 (a) through (c), 21 CFR 610.63, 21 CFR 610.64, 21 CFR 610.67, the Drug Supply Chain Security Act (DSCSA) and CBER Job Aid 90" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 610.67", "raw": "21 CFR 610.67", "context": "(b) through (e), 21 CFR 610.62 (a) through (c), 21 CFR 610.63, 21 CFR 610.64, 21 CFR 610.67, the Drug Supply Chain Security Act (DSCSA) and CBER Job Aid 900.08: National" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 610.62", "raw": "21 CFR 610.62", "context": "tified: \u2022 There is a prominence issue with the proper name and tradename per 21 CFR 610.62 (b). \u2022 The font size of \u201cSuspension\u2026\u201d should be decreased and the font size o" }, { "page": 2, "family": "CFR", "normalized": "21 CFR 610.62", "raw": "21 CFR 610.62", "context": "tified: \u2022 There is a prominence issue with the proper name and tradename per 21 CFR 610.62 (b). \u2022 The font size of \u201cSuspension\u2026\u201d should be decreased and the font size o" }, { "page": 2, "family": "CFR", "normalized": "21 CFR 610.62", "raw": "21 CFR 610.62", "context": "tified: \u2022 There is a prominence issue with the proper name and tradename per 21 CFR 610.62 (b). \u2022 The font size of \u201cSuspension\u2026\u201d should be decreased and the font size o" }, { "page": 2, "family": "CFR", "normalized": "21 CFR 610.62", "raw": "21 CFR 610.62", "context": "tified: \u2022 There is a prominence issue with the proper name and tradename per 21 CFR 610.62 (b). \u2022 The font size of \u201cSuspension\u2026\u201d should be decreased and the font size o" }, { "page": 3, "family": "CFR", "normalized": "21 CFR 201.25", "raw": "21 CFR 201.25", "context": "0777-100-15). Recommendations These labels are currently in compliance with 21 CFR 201.25, 21 CFR 207.35 and 21 CFR 610.60 through 21 CFR 610.67, Drug Supply Chain Secu" }, { "page": 3, "family": "CFR", "normalized": "21 CFR 207.35", "raw": "21 CFR 207.35", "context": "Recommendations These labels are currently in compliance with 21 CFR 201.25, 21 CFR 207.35 and 21 CFR 610.60 through 21 CFR 610.67, Drug Supply Chain Security Act (DSCS" }, { "page": 3, "family": "CFR", "normalized": "21 CFR 610.60", "raw": "21 CFR 610.60", "context": "These labels are currently in compliance with 21 CFR 201.25, 21 CFR 207.35 and 21 CFR 610.60 through 21 CFR 610.67, Drug Supply Chain Security Act (DSCSA), the Guidance fo" }, { "page": 3, "family": "CFR", "normalized": "21 CFR 610.67", "raw": "21 CFR 610.67", "context": "ntly in compliance with 21 CFR 201.25, 21 CFR 207.35 and 21 CFR 610.60 through 21 CFR 610.67, Drug Supply Chain Security Act (DSCSA), the Guidance for Industry, \u201cSelection" }, { "page": 4, "family": "CFR", "normalized": "21 CFR 610.61", "raw": "21 CFR 610.61", "context": "on December 14, 2021 21 CFR 610.61 (a) through (s) Checked items \u201cx\u201d indicate compliance a. The proper name" }, { "page": 5, "family": "CFR", "normalized": "21 CFR 201.25", "raw": "21 CFR 201.25", "context": "Review (Package) appendix 1 JA 900.08: NDC, Bar Code, & Product Identifiers/21 CFR 201.25 & 21 CFR 207.35 (3)(i) Checked items" }, { "page": 5, "family": "CFR", "normalized": "21 CFR 207.35", "raw": "21 \n CFR 207.35", "context": ") appendix 1 JA 900.08: NDC, Bar Code, & Product Identifiers/21 CFR 201.25 & 21 CFR 207.35 (3)(i) Checked items \u201cx\u201d indicate compliance 9. Barcode & Linear or One" }, { "page": 7, "family": "CFR", "normalized": "21 CFR 610.60", "raw": "21 CFR 610.60", "context": "ed on December 14, 2021 21 CFR 610.60(a)(1) through (7) Checked items \u201cx\u201d indicate compliance a. Full label. T" }, { "page": 7, "family": "CFR", "normalized": "21 CFR 610.62", "raw": "21 CFR 610.62", "context": "aced on the package label. N/A 21 CFR 610.62 (7) (b) through (e) Checked items \u201cx\u201d indicate compliance b. Package lab" }, { "page": 8, "family": "CFR", "normalized": "21 CFR 201.25", "raw": "21 CFR 201.25", "context": "ainer) appendix 2 JA 900.08: NDC, Bar Code, & Product Identifiers/21 CFR 201.25 & 21 CFR 207.35 (3)(i) *8. Barcode Linear or One-Dimensional (1D)" }, { "page": 8, "family": "CFR", "normalized": "21 CFR 207.35", "raw": "21 CFR 207.35", "context": "2 JA 900.08: NDC, Bar Code, & Product Identifiers/21 CFR 201.25 & 21 CFR 207.35 (3)(i) *8. Barcode Linear or One-Dimensional (1D) (Parallel Lines" }, { "page": 10, "family": "CFR", "normalized": "21 CFR 610.61", "raw": "21 CFR 610.61", "context": "on December 14, 2021 21 CFR 610.61 (a) through (s) Checked items \u201cx\u201d indicate compliance a. The proper name" }, { "page": 11, "family": "CFR", "normalized": "21 CFR 201.25", "raw": "21 CFR 201.25", "context": "Review (Package) appendix 3 JA 900.08: NDC, Bar Code, & Product Identifiers/21 CFR 201.25 & 21 CFR 207.35 (3)(i) Checked items" }, { "page": 11, "family": "CFR", "normalized": "21 CFR 207.35", "raw": "21 \n CFR 207.35", "context": ") appendix 3 JA 900.08: NDC, Bar Code, & Product Identifiers/21 CFR 201.25 & 21 CFR 207.35 (3)(i) Checked items \u201cx\u201d indicate compliance 9. Barcode & Linear or One" }, { "page": 13, "family": "CFR", "normalized": "21 CFR 610.60", "raw": "21 CFR 610.60", "context": "ed on December 14, 2021 21 CFR 610.60(a)(1) through (7) Checked items \u201cx\u201d indicate compliance b. Full label. T" }, { "page": 13, "family": "CFR", "normalized": "21 CFR 610.62", "raw": "21 CFR 610.62", "context": "aced on the package label. N/A 21 CFR 610.62 (7) (b) through (e) Checked items \u201cx\u201d indicate compliance b. Package lab" }, { "page": 14, "family": "CFR", "normalized": "21 CFR 201.25", "raw": "21 CFR 201.25", "context": "ainer) appendix 4 JA 900.08: NDC, Bar Code, & Product Identifiers/21 CFR 201.25 & 21 CFR 207.35 (3)(i) *8. Barcode Linear or One-Dimensional (1D)" }, { "page": 14, "family": "CFR", "normalized": "21 CFR 207.35", "raw": "21 CFR 207.35", "context": "4 JA 900.08: NDC, Bar Code, & Product Identifiers/21 CFR 201.25 & 21 CFR 207.35 (3)(i) *8. 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13, "matches": [] }, { "filename": "78A_BLA 125752-0_01-11-2022_Memo_Committee Memo_Review.pdf", "id": 3063, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 4, "matches": [] }, { "filename": "78B_BLA 125752-0_01-11-2022_Memo_Committee Memo_Review.pdf", "id": 3064, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 1, "matches": [] }, { "filename": "78C_BLA 125752-0_01-11-2022_Memo_Committee Memo_Review.pdf", "id": 3065, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 3, "matches": [] }, { "filename": "78D_BLA 125752-0_01-11-2022_Memo_Committee Memo_Review.pdf", "id": 3066, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 3, "matches": [] }, { "filename": 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125752-0_01-12-2022_Telecon_Information Reques.pdf", "id": 3071, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 2, "matches": [] }, { "filename": "84_BLA 125752-0_01-13-2022_Telecon_Information Reques.pdf", "id": 3072, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 2, "matches": [] }, { "filename": "85_BLA 125752-0_01-14-2022_Telecon_Information Reques.pdf", "id": 3073, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 2, "matches": [] }, { "filename": "87_BLA 125752-0_01-18-2022_Memo_Test Results.pdf", "id": 3074, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 2, "matches": [] }, { "filename": "89_BLA 125752-0_01-20-2022_Memo_Committee Memo_Review.pdf", "id": 3075, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 3, "matches": [] }, { "filename": "90_BLA 125752-0_01-20-2022_Telecon_Other.pdf", "id": 3076, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 1, "matches": [] }, { "filename": "92_BLA 125752-0_01-24-2022_Telecon_Information Reques.pdf", "id": 3077, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 1, "matches": [] }, { "filename": "93_BLA 125752-0_01-26-2022_Inspection Related_Inspect.pdf", "id": 3078, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 7, "matches": [] }, { "filename": "94_BLA 125752-0_01-26-2022_Memo_Other.pdf", "id": 3079, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 4, "matches": [ { "page": 1, "family": "Named act", "normalized": "FD&C Act", "raw": "FD&C Act", "context": "cated Was this application submitted in an NDA under section 505(b)(1) of the FD&C Act or a BLA under section 351(a) of the Public Health Service Act? If yes list t" }, { "page": 1, "family": "Named act", "normalized": "PHS Act", "raw": "Public Health Service Act", "context": "under section 505(b)(1) of the FD&C Act or a BLA under section 351(a) of the Public Health Service Act? If yes list the application STN YES (The application for Material Threat M" }, { "page": 1, "family": "Named act", "normalized": "PHS Act", "raw": "Public \nHealth Service Act", "context": "Material Threat MCM PRVC was submitted in a BLA under section 351(a) of the Public Health Service Act, STN 125752/2) FDA-CBER-2022-1614-3818231" }, { "page": 2, "family": "Named act", "normalized": "FD&C Act", "raw": "FD&C Act", "context": "in any other application under section 505(b)(1), 505(b)(2), or 505(j) of the FD&C Act or \u2022 for a biological product that contains no active ingredient that has b" }, { "page": 2, "family": "Named act", "normalized": "PHS Act", "raw": "Public Health Service Act", "context": "usly approved in any other application under section 351(a) or 351 (k) of the Public Health Service Act and is the subject of an application submitted under section 351(a) of the Pu" }, { "page": 2, "family": "Named act", "normalized": "PHS Act", "raw": "Public Health \nService Act", "context": "ct and is the subject of an application submitted under section 351(a) of the Public Health Service Act. If no, list the previous product containing the active ingredient that was" }, { "page": 2, "family": "Named act", "normalized": "PHS Act", "raw": "Public Health Service Act", "context": "sly approved in any other application under section 351(a) or 351 (k) of the Public Health Service Act and is the subject of an application submitted under section 351(a) of the P" }, { "page": 2, "family": "Named act", "normalized": "PHS Act", "raw": "Public Health Service Act", "context": "t and is the subject of an application submitted under section 351(a) of the Public Health Service Act FDA-CBER-2022-1614-3818232" }, { "page": 3, "family": "Named act", "normalized": "PHS Act", "raw": "PHS Act", "context": "agent identified as a material threat under section 319F-2(c)(2)(A)(ii) of the PHS Act; (See Public Health Emergency Medical Countermeasure Enterprise (PHEMCE) Stra" }, { "page": 3, "family": "Named act", "normalized": "PHS Act", "raw": "PHS Act", "context": "ent identified as a material threat under section 319F- 2(c)(2)(A)(ii) of the PHS Act. 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The mRNA-1273 DP registration stability program was executed according to ICH Q1A (R2), Stability Testing of New Drug Substances and Products, and ICH Q5C, Stab" }, { "page": 3, "family": "International", "normalized": "ICH Q5C", "raw": "ICH Q5C", "context": "ng to ICH Q1A (R2), Stability Testing of New Drug Substances and Products, and ICH Q5C, Stability Testing of Biotechnological/Biological Products. An initial shelf l" }, { "page": 32, "family": "International", "normalized": "ICH Q1B", "raw": "ICH Q1B", "context": "thawed DP in Ompi\u00ae 10R clear Type 1 borosilicate glass vials (6.3 mL fill) per ICH Q1B guidelines. The chemical and biophysical stability of the product when exposed" }, { "page": 32, "family": "International", "normalized": "ICH Q1B", "raw": "ICH Q1B", "context": "t 25\u00b0C (Table 25). Table 25: Maximum Visible Light and UVA Light Exposure per ICH Q1B Light UVA Light (W h/m2) Visible Light (klx h) Cool white fluorescent and U" } ] }, { "filename": "125752_S29_M3_32p31_manufacturers.pdf", "id": 3540, "module": "M3", "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2025/05/125752_S29_M3_32p31_manufacturers.pdf", "ican_url": null, "total_pages": 1, "matches": [] }, { "filename": "125752_S29_M3_32s21_manufacturer_mrna-1273.pdf", "id": 3541, "module": "M3", "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2025/05/125752_S29_M3_32s21_manufacturer_mrna-1273.pdf", "ican_url": null, "total_pages": 1, "matches": [] }, { "filename": "125752_S30_M1_cover-0030.pdf", "id": 3542, "module": "M1", "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2025/05/125752_S30_M1_cover-0030.pdf", "ican_url": null, "total_pages": 1, "matches": [] }, { "filename": "125752_S30_M1_form-356h-0030.pdf", "id": 3543, "module": "M1", "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2025/05/125752_S30_M1_form-356h-0030.pdf", "ican_url": null, "total_pages": 6, "matches": [] }, { "filename": "125752_S30_M1_rsp-fda-cmts-ir26-cmc-01dec2021.pdf", "id": 3544, "module": "M1", "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2025/05/125752_S30_M1_rsp-fda-cmts-ir26-cmc-01dec2021.pdf", "ican_url": null, "total_pages": 3, "matches": [] }, { "filename": "125752_S31_M1_form-356h-0031.pdf", "id": 3545, "module": "M1", "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2025/05/125752_S31_M1_form-356h-0031.pdf", "ican_url": null, "total_pages": 6, "matches": [] }, { "filename": "125752_S34_M1_form-356h-0034.pdf", "id": 3546, "module": "M1", "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2025/05/125752_S34_M1_form-356h-0034.pdf", "ican_url": null, "total_pages": 6, "matches": [] }, { "filename": "125752_S35_M1_cover-0035.pdf", "id": 3547, "module": "M1", "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2025/05/125752_S35_M1_cover-0035.pdf", "ican_url": null, "total_pages": 2, "matches": [] }, { "filename": "125752_S35_M1_form-356h-0035.pdf", "id": 3548, "module": "M1", "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2025/05/125752_S35_M1_form-356h-0035.pdf", "ican_url": null, "total_pages": 6, "matches": [] }, { "filename": "125752_S36_M1_cover-0036.pdf", "id": 3549, "module": "M1", "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2025/05/125752_S36_M1_cover-0036.pdf", "ican_url": null, "total_pages": 1, "matches": [] }, { "filename": "125752_S36_M1_form-356h-0036.pdf", "id": 3550, "module": "M1", "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2025/05/125752_S36_M1_form-356h-0036.pdf", "ican_url": null, "total_pages": 6, "matches": [] }, { "filename": "125752_S36_M1_rsp-fda-cmts-ir28-cmc-07dec2021.pdf", "id": 3551, "module": "M1", "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2025/05/125752_S36_M1_rsp-fda-cmts-ir28-cmc-07dec2021.pdf", "ican_url": null, "total_pages": 5, "matches": [ { "page": 2, "family": "CFR", "normalized": "21 CFR 610.2", "raw": "21 CFR 610.2", "context": "intended for lots to be submitted for official lot release in accordance with 21 CFR 610.2 so please change this to \u201cRelease\u201d for all lots submitted. Sponsor Response:" }, { "page": 2, "family": "CFR", "normalized": "21 CFR 610.2", "raw": "21 CFR 610.2", "context": "aced on surveillance in lieu of routine release to fulfill the requirements of 21 CFR 610.2 (a) in Section 1.12.5 BLA 125752 SN 0003 dated August 24, 2021. This request i" }, { "page": 3, "family": "CFR", "normalized": "21 CFR 610.1", "raw": "21 CFR 610.1", "context": "Nanoparticles Drug Substance to be performed and documented in accordance with 21 CFR 610.1, but we are requesting that only the results of testing of the CX-024414 mRNA" }, { "page": 3, "family": "CFR", "normalized": "21 CFR 610.1", "raw": "21 CFR 610.1", "context": "mRNA-1273 LNP will continue to be performed and documented in accordance with 21 CFR 610.1, but this testing has been removed from the Spikevax Lot Release Protocol templ" } ] }, { "filename": "125752_S36_M3_32r_qc-oth-0609-lot-release-protocol.pdf", "id": 3552, "module": "M3", "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2025/05/125752_S36_M3_32r_qc-oth-0609-lot-release-protocol.pdf", "ican_url": null, "total_pages": 9, "matches": [] }, { "filename": "125752_S37_M1_form-356h-0037.pdf", "id": 3553, "module": "M1", "batch_code": "md", 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"https://phmpt.org/wp-content/uploads/2025/05/FDA-CBER-2022-1614-3512424%E2%80%933552355_Slipsheet.pdf", "ican_url": null, "total_pages": 1, "matches": [ { "page": 1, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "FOIA FDA/CBER #2022-1614 39,932 pages that are being Withheld in Full as exempt" }, { "page": 1, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "pages that are being Withheld in Full as exempt from disclosure pursuant to FOIA Exemption 4 & FOIA Exemption 6 Bates Numbers: FDA-CBER-2022-1614- 3512424 \u2013" }, { "page": 1, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ng Withheld in Full as exempt from disclosure pursuant to FOIA Exemption 4 & FOIA Exemption 6 Bates Numbers: FDA-CBER-2022-1614- 3512424 \u2013 3552355" } ] }, { "filename": "1_BLA 125752-0_06-09-2021_Letter_Acknowledgement Let.pdf", "id": 3714, "module": null, "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 2, "matches": [ { "page": 1, "family": "Public Law", "normalized": "Pub. L. 110-85", "raw": "Public Law No. 110-85", "context": "Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA) (Public Law No. 110-85, 121 Stat.904). All future correspondence regarding this submission should b" }, { "page": 1, "family": "USC", "normalized": "21 U.S.C. \u00a7 356", "raw": "21 U.S.C. 356", "context": "ovision (c) of Section 506 of the Federal Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. 356) for review of an incomplete application for a Fast Track Product. We acknowl" }, { "page": 1, "family": "Named act", "normalized": "PHS Act", "raw": "Public Health Service Act", "context": "your Biologics License Application (BLA) submitted under section 351(a) of the Public Health Service Act (PHS Act) for the following biological product: Our Submission Tracking Numb" }, { "page": 1, "family": "Named act", "normalized": "PHS Act", "raw": "PHS Act", "context": "ication (BLA) submitted under section 351(a) of the Public Health Service Act (PHS Act) for the following biological product: Our Submission Tracking Number (STN):" }, { "page": 1, "family": "Named act", "normalized": "FD&C Act", "raw": "Federal Food, Drug, and Cosmetic Act", "context": "received your application submitted under provision (c) of Section 506 of the Federal Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. 356) for review of an incomplete application for a Fast Trac" }, { "page": 1, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "nder provision (c) of Section 506 of the Federal Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. 356) for review of an incomplete application for a Fast Track Prod" }, { "page": 1, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "emaining portions of this application. In accordance with this section of the FDCA, our review clock will not start until the date on which you submit the final" }, { "page": 1, "family": "Named act", "normalized": "PHS Act", "raw": "PHS Act", "context": "for complying with the applicable provisions of sections 402(i) and (j) of the PHS Act (42 U.S.C. \u00a7\u00a7 282(i) and (j)), which was amended by Title VIII of the Food and" } ] }, { "filename": "CRFs-for-site-1096.pdf", "id": 3715, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2022/01/CRFs-for-site-1096.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2022/03/CRFs-for-site-1096.pdf", "total_pages": 2937, "matches": [] }, { "filename": "CRFs-for-site-1128.pdf", "id": 3716, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2022/02/CRFs-for-site-1128.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2022/03/CRFs-for-site-1128.pdf", "total_pages": 3452, "matches": [ { "page": 1045, "family": "International", "normalized": "ISO 15189", "raw": "ISO 15189", "context": "uto query (autoquery) Query 1: Answered test conducted at CLIA-certified lab or ISO 15189 accredited lab. Nov-01-2020 12:45:52 (UTC-06:00) Central Time (US & Canada) ACV" }, { "page": 1045, "family": "International", "normalized": "ISO 15189", "raw": "ISO 15189", "context": "(pfe.jvasilio) Data Entry: NALT Unknown test conducted at CLIA-certified lab or ISO 15189 accredited 090177e196ae400d\\Final\\Final On: 01-Apr-2021 05:29 (GMT) FDA-CBER-20" }, { "page": 1046, "family": "International", "normalized": "ISO 15189", "raw": "ISO\n15189", "context": "f not available, please indicate if test conducted at 'CLIA- certified lab' or 'ISO 15189 accredited lab.' If both trade name and lab are not known, enter 'NALT Unknown." }, { "page": 1048, "family": "International", "normalized": "ISO 15189", "raw": "ISO 15189", "context": "uto query (autoquery) Query 1: Answered test conducted at CLIA-certified lab or ISO 15189 accredited lab Nov-01-2020 12:46:24 (UTC-06:00) Central Time (US & Canada) ACV0" }, { "page": 1048, "family": "International", "normalized": "ISO 15189", "raw": "ISO 15189", "context": "(pfe.jvasilio) Data Entry: NALT Unknown test conducted at CLIA-certified lab or ISO 15189 accredited lab Nov-01-2020 11:14:30 (UTC-06:00) Central Time (US & Canada) ACV0" }, { "page": 1048, "family": "International", "normalized": "ISO 15189", "raw": "ISO\n15189", "context": "f not available, please indicate if test conducted at 'CLIA- certified lab' or 'ISO 15189 accredited lab.' If 090177e196ae400d\\Final\\Final On: 01-Apr-2021 05:29 (GMT) FD" }, { "page": 1052, "family": "International", "normalized": "ISO 15189", "raw": "ISO 15189", "context": "e. If not available, please enter if test conducted at 'CLIA-certified lab' or 'ISO 15189 accredited lab.' 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Please note that 21 CFR 610.15(a) requires that \u201cProducts in multiple-dose containers shall contain a preserva" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 610.15", "raw": "21 CFR 610.15", "context": "t and a justification for an exception or alternative to the requirement under 21 CFR 610.15(a) that products in multiple-dose vials include a preservative. RESPONSE 1 The" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 610.15", "raw": "21 CFR 610.15", "context": "est and justification for an exception or alternative to the requirement under 21 CFR 610.15(a) that products in multiple-dose vials include a preservative. The formal re" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 610.15", "raw": "21 CFR 610.15", "context": "al request for an exception is provided in 1.12.5 Request for Exception to the 21 CFR 610.15(a) Requirement for a Preservative. Literature References None SUPPORTING DOCUME" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 610.15", "raw": "21 CFR 610.15", "context": "ON New or Replaced Supporting Documentation 1.12.5 Request for Exception to the 21 CFR 610.15(a) Requirement for a Preservative, new Previously submitted supporting document" } ] }, { "filename": "125742_S12_M1_waiver-req-preservative.pdf", "id": 3997, "module": "M1", "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2023/01/125742_S12_M1_waiver-req-preservative.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/01/125742_S12_M1_waiver-req-preservative.pdf", "total_pages": 5, "matches": [ { "page": 1, "family": "CFR", "normalized": "21 CFR 610.15", "raw": "21 CFR 610.15", "context": "BNT162b2 BLA 125742 Module 1.12.5 Request for a Waiver Exception to 21 CFR 610.15(a) Requirement for a Preservative PFIZER CONFIDENTIAL Page 1 Request for a Wai" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 610.15", "raw": "21 CFR 610.15", "context": "a Waiver COVID-19 Vaccine BNT162 (PF-07302048) Request for Exception to the 21 CFR 610.15(a) Requirement for a Preservative JULY 2021 090177e19791beba\\Approved\\Approved" }, { "page": 2, "family": "CFR", "normalized": "21 CFR 610.15", "raw": "21 CFR 610.15", "context": "BNT162b2 BLA 125742 Module 1.12.5 Request for a Waiver Exception to 21 CFR 610.15(a) Requirement for a Preservative PFIZER CONFIDENTIAL Page 2 TABLE OF CONTENTS" }, { "page": 3, "family": "CFR", "normalized": "21 CFR 610.15", "raw": "21 CFR 610.15", "context": "BNT162b2 BLA 125742 Module 1.12.5 Request for a Waiver Exception to 21 CFR 610.15(a) Requirement for a Preservative PFIZER CONFIDENTIAL Page 3 INTRODUCTION This" }, { "page": 3, "family": "CFR", "normalized": "21 CFR 610.15", "raw": "21 CFR \n610.15", "context": "is submission is a request for an exception to the regulatory requirement under 21 CFR 610.15(a) that a vaccine product in a multi-dose container should contain a preservati" }, { "page": 3, "family": "CFR", "normalized": "21 CFR 610.15", "raw": "21 CFR 610.15", "context": "ith 0.9% Sodium Chloride Injection, USP. Pfizer and BioNTech acknowledge that 21 CFR 610.15(a) requires that Products in multiple-dose containers shall contain a preservat" }, { "page": 3, "family": "CFR", "normalized": "21 CFR 610.15", "raw": "21 CFR 610.15", "context": "at Products in multiple-dose containers shall contain a preservative,\u2026 However, 21 CFR 610.15(d) states that The Director\u2026may approve an exception or alternative to any requ" }, { "page": 3, "family": "CFR", "normalized": "21 CFR 610.15", "raw": "21 CFR 610.15", "context": ". Pfizer and BioNTech are hereby making a written request for an exception to 21 CFR 610.15(a) for the BNT162b2 vaccine as a multi-dose preservative-free presentation. Th" }, { "page": 4, "family": "CFR", "normalized": "21 CFR 610.15", "raw": "21 CFR 610.15", "context": "BNT162b2 BLA 125742 Module 1.12.5 Request for a Waiver Exception to 21 CFR 610.15(a) Requirement for a Preservative PFIZER CONFIDENTIAL Page 4 1. BACKGROUND 1." }, { "page": 5, "family": "CFR", "normalized": "21 CFR 610.15", "raw": "21 CFR 610.15", "context": "BNT162b2 BLA 125742 Module 1.12.5 Request for a Waiver Exception to 21 CFR 610.15(a) Requirement for a Preservative PFIZER CONFIDENTIAL Page 5 Pfizer performed" }, { "page": 5, "family": "CFR", "normalized": "21 CFR 610.15", "raw": "21 CFR 610.15", "context": "ergency supply in the UK on 01 December 2020 through 30 June 2021. As noted in 21 CFR 610.15, \u201cAny preservative used \u2026 shall not denature the specific substances in the pr" }, { "page": 5, "family": "CFR", "normalized": "21 CFR 610.15", "raw": "21 CFR 610.15", "context": "ARY: REQUEST FOR EXCEPTION Pfizer and BioNTech hereby request an exception from 21 CFR 610.15(a) regarding the requirement for using a preservative in a Multi-Dose Vial for" } ] }, { "filename": "125742_S13_M5_5351_c4591001-adae-hiv-listing.pdf", "id": 3998, "module": "M5", "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2023/01/125742_S13_M5_5351_c4591001-adae-hiv-listing.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/01/125742_S13_M5_5351_c4591001-adae-hiv-listing.pdf", "total_pages": 2, "matches": [] }, { "filename": "125742_S13_M5_5351_c4591001-narrative-1226-12262255.pdf", "id": 3999, "module": "M5", "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": 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Nonclinical pharmacology and toxicology section (e.g., 21 CFR 314.50(d)(2); 21 CFR 601.2) 25. Does the submission contain: Only Pediatric data? Ye" }, { "page": 2, "family": "CFR", "normalized": "21 CFR 601.2", "raw": "21 CFR 601.2", "context": "5. Nonclinical pharmacology and toxicology section (e.g., 21 CFR 314.50(d)(2); 21 CFR 601.2) 25. Does the submission contain: Only Pediatric data? Yes No N/A Is the si" }, { "page": 2, "family": "CFR", "normalized": "21 CFR 3.2", "raw": "21 CFR 3.2", "context": "24. For Originals and all Supplements, is the product a combination product (21 CFR 3.2(e))? Yes Yes Yes Prescription Product (Rx) No No No Over-The-Counter Produc" }, { "page": 2, "family": "CFR", "normalized": "21 CFR 314.50", "raw": "21 CFR 314.50", "context": "ns the following items (Select all that apply) 8. Clinical data section (e.g., 21 CFR 314.50(d)(5); 21 CFR 601.2) Item 30 continued on page 3 6. Human pharmacokinetics and" }, { "page": 2, "family": "CFR", "normalized": "21 CFR 601.2", "raw": "21 CFR 601.2", "context": "s (Select all that apply) 8. Clinical data section (e.g., 21 CFR 314.50(d)(5); 21 CFR 601.2) Item 30 continued on page 3 6. Human pharmacokinetics and bioavailability sec" }, { "page": 2, "family": "CFR", "normalized": "21 CFR 314.50", "raw": "21 CFR 314.50", "context": "tinued on page 3 6. Human pharmacokinetics and bioavailability section (e.g., 21 CFR 314.50(d)(3); 21 CFR 601.2) 1. Index 7. Clinical microbiology section (e.g., 21 CFR 3" }, { "page": 2, "family": "CFR", "normalized": "21 CFR 601.2", "raw": "21 CFR 601.2", "context": "Human pharmacokinetics and bioavailability section (e.g., 21 CFR 314.50(d)(3); 21 CFR 601.2) 1. Index 7. Clinical microbiology section (e.g., 21 CFR 314.50(d)(4)) 4. Chem" }, { "page": 2, "family": "CFR", "normalized": "21 CFR 314.50", "raw": "21 CFR 314.50", "context": "R 314.50(d)(3); 21 CFR 601.2) 1. Index 7. 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Methods validati" }, { "page": 2, "family": "CFR", "normalized": "21 CFR 601.2", "raw": "21 CFR 601.2", "context": "on (e.g., 21 CFR 314.50(d)(1); 21 CFR 601.2) B. Samples (21 CFR 314.50 (e)(1); 21 CFR 601.2 (a)) (Submit only upon FDA\u2019s request) C. Methods validation package (e.g., 21" }, { "page": 2, "family": "CFR", "normalized": "21 CFR 314.50", "raw": "21 CFR 314.50", "context": "1.2 (a)) (Submit only upon FDA\u2019s request) C. Methods validation package (e.g., 21 CFR 314.50(e)(2)(i); 21 CFR 601.2) Draft Labeling Final Printed Labeling 2. Labeling (Sel" }, { "page": 2, "family": "CFR", "normalized": "21 CFR 601.2", "raw": "21 CFR 601.2", "context": "on FDA\u2019s request) C. Methods validation package (e.g., 21 CFR 314.50(e)(2)(i); 21 CFR 601.2) Draft Labeling Final Printed Labeling 2. Labeling (Select one): 3. Summary (2" }, { "page": 2, "family": "CFR", "normalized": "21 CFR 314.50", "raw": "21 CFR 314.50", "context": "2) Draft Labeling Final Printed Labeling 2. 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I" }, { "page": 3, "family": "CFR", "normalized": "21 CFR 202", "raw": "21 CFR Part 202", "context": "iption drug or biological product, prescription drug advertising regulations in 21 CFR Part 202. 5. Regulations on making changes in application in FD&C Act section 506A, 21" }, { "page": 3, "family": "CFR", "normalized": "21 CFR 314.71", "raw": "21 CFR 314.71", "context": "202. 5. Regulations on making changes in application in FD&C Act section 506A, 21 CFR 314.71, 314.72, 314.97, 314.99, and 601.12. 6. Regulations on Reports in 21 CFR 314.8" }, { "page": 3, "family": "CFR", "normalized": "21 CFR 314.80", "raw": "21 CFR 314.80", "context": "1 CFR 314.71, 314.72, 314.97, 314.99, and 601.12. 6. Regulations on Reports in 21 CFR 314.80, 314.81, 600.80, and 600.81. 7. Local, state, and Federal environmental impact" }, { "page": 3, "family": "CFR", "normalized": "21 CFR 314.50", "raw": "21 CFR 314.50", "context": "llowing items (Continued; select all that apply) 10. Statistical section (e.g., 21 CFR 314.50(d)(6); 21 CFR 601.2) 12. Case report forms (e.g., 21 CFR 314.50 (f)(2); 21 CFR" }, { "page": 3, "family": "CFR", "normalized": "21 CFR 601.2", "raw": "21 CFR 601.2", "context": "ued; select all that apply) 10. Statistical section (e.g., 21 CFR 314.50(d)(6); 21 CFR 601.2) 12. Case report forms (e.g., 21 CFR 314.50 (f)(2); 21 CFR 601.2) 18. User Fe" }, { "page": 3, "family": "CFR", "normalized": "21 CFR 314.50", "raw": "21 CFR 314.50", "context": "section (e.g., 21 CFR 314.50(d)(6); 21 CFR 601.2) 12. Case report forms (e.g., 21 CFR 314.50 (f)(2); 21 CFR 601.2) 18. User Fee Cover Sheet (PDUFA Form FDA 3397, GDUFA For" }, { "page": 3, "family": "CFR", "normalized": "21 CFR 601.2", "raw": "21 CFR 601.2", "context": "314.50(d)(6); 21 CFR 601.2) 12. Case report forms (e.g., 21 CFR 314.50 (f)(2); 21 CFR 601.2) 18. 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Patent information on any patent that claims the drug/ biologic (21 U.S." }, { "page": 3, "family": "CFR", "normalized": "21 CFR 600", "raw": "21 CFR Part 600", "context": "s the drug/ biologic (21 U.S.C. 355(b) or (c)) 15. Establishment description (21 CFR Part 600, if applicable) 20. Other (Specify): 31. Typed Name and Title of Applicant\u2019s Re" }, { "page": 3, "family": "Named act", "normalized": "FD&C Act", "raw": "FD&C Act", "context": "lations in 21 CFR Part 202. 5. Regulations on making changes in application in FD&C Act section 506A, 21 CFR 314.71, 314.72, 314.97, 314.99, and 601.12. 6. Regulation" }, { "page": 3, "family": "Named act", "normalized": "FD&C Act", "raw": "FD&C Act", "context": "drug/biologic (21 U.S.C. 355 (b)(2) or (j)(2)(A)) 16. Debarment certification (FD&C Act 306 (k)(1)) 9. 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I certify that the requirements of 42 U.S.C. \u00a7 282(j), Section 402(j) of the Public Health Service Act, including 42 CFR part 11, do not apply to any clinical trial referenced in th" }, { "page": 1, "family": "USC", "normalized": "42 U.S.C. \u00a7 282", "raw": "42 U.S.C. \u00a7 282", "context": "D HUMAN SERVICES Food and Drug Administration Certification of Compliance Under 42 U.S.C. \u00a7 282(j)(5)(B), with Requirements of ClinicalTrials.gov Data Bank (For submission wit" }, { "page": 1, "family": "USC", "normalized": "42 U.S.C. \u00a7 282", "raw": "42 U.S.C. \u00a7 282", "context": "additional information and explanation) A. I certify that the requirements of 42 U.S.C. \u00a7 282(j), Section 402(j) of the Public Health Service Act, including 42 CFR part 11," }, { "page": 1, "family": "USC", "normalized": "42 U.S.C. \u00a7 282", "raw": "42 U.S.C. \u00a7 282", "context": "does not reference any clinical trial. B. I certify that the requirements of 42 U.S.C. \u00a7 282(j), Section 402(j) of the Public Health Service Act, including 42 CFR part 11," }, { "page": 1, "family": "USC", "normalized": "42 U.S.C. \u00a7 282", "raw": "42 U.S.C. \u00a7 282", "context": "n which this certification accompanies. C. I certify that the requirements of 42 U.S.C. \u00a7 282(j), section 402(j) of the Public Health Service Act, apply to one or more of th" }, { "page": 1, "family": "USC", "normalized": "42 U.S.C. \u00a7 282", "raw": "42 U.S.C. 282", "context": "on/submission which this certification accompanies and that the requirements of 42 U.S.C. 282(j), including any applicable provisions of 42 CFR part 11, have been met. Certi" }, { "page": 1, "family": "Named act", "normalized": "FD&C Act", "raw": "Federal Food, Drug, and Cosmetic Act", "context": ", supplements, and resubmissions, under \u00a7\u00a7 505, 515, 520(m), or 510(k) of the Federal Food, Drug, and Cosmetic Act or \u00a7 351 of the Public Health Service Act.) SPONSOR / APPLICANT / SUBMITTER INF" }, { "page": 1, "family": "Named act", "normalized": "PHS Act", "raw": "Public Health Service Act", "context": "520(m), or 510(k) of the Federal Food, Drug, and Cosmetic Act or \u00a7 351 of the Public Health Service Act.) SPONSOR / APPLICANT / SUBMITTER INFORMATION 1. Name of Sponsor/Applicant/Subm" }, { "page": 1, "family": "Named act", "normalized": "PHS Act", "raw": "Public Health Service Act", "context": "I certify that the requirements of 42 U.S.C. \u00a7 282(j), section 402(j) of the Public Health Service Act, apply to one or more of the clinical trials referenced in the application/sub" }, { "page": 2, "family": "USC", "normalized": "42 U.S.C. \u00a7 282", "raw": "42 U.S.C. \u00a7 282", "context": "which you (the sponsor/applicant/submitter) are the \u201crespons ble party\u201d under 42 U.S.C. \u00a7 282(j)(1)(a)(i), section 402(j)(1)(a)(i) of the Public Health Service Act referenc" }, { "page": 2, "family": "USC", "normalized": "42 U.S.C. \u00a7 282", "raw": "42 U.S.C. \u00a7 282", "context": "rmation. I understand that the failure to submit the certification required by 42 U.S.C. \u00a7 282(j)(5)(B), section 402(j)(5)(B) of the Public Health Service Act, and the knowi" }, { "page": 2, "family": "USC", "normalized": "21 U.S.C. \u00a7 331", "raw": "21 U.S.C. \u00a7 331", "context": "ubmission of a false certification under such section are prohibited acts under 21 U.S.C. \u00a7 331, section 301 of the Federal Food, Drug, and Cosmetic Act. Warning: A willfully" }, { "page": 2, "family": "Named act", "normalized": "PHS Act", "raw": "Public Health Service \nAct", "context": "ns ble party\u201d under 42 U.S.C. \u00a7 282(j)(1)(a)(i), section 402(j)(1)(a)(i) of the Public Health Service Act referenced in the application/ submission which this Certification accompanies." }, { "page": 2, "family": "Named act", "normalized": "PHS Act", "raw": "Public Health \nService Act", "context": "certification required by 42 U.S.C. \u00a7 282(j)(5)(B), section 402(j)(5)(B) of the Public Health Service Act, and the knowing submission of a false certification under such section are pro" }, { "page": 2, "family": "Named act", "normalized": "FD&C Act", "raw": "Federal Food, Drug, and Cosmetic Act", "context": "der such section are prohibited acts under 21 U.S.C. \u00a7 331, section 301 of the Federal Food, Drug, and Cosmetic Act. 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C. Accordingly, consistent with Section 351(k)(7)(C) of the Public Health Service Act, FDA\u2019s licensure of Pfizer-BioNTech- COVID-19 under 351(a) will constitute the" }, { "page": 1, "family": "Named act", "normalized": "PHS Act", "raw": "Public Health Service Act", "context": "to exclusivity from the date of licensure pursuant to section 351(k)(7) of the Public Health Service Act. B. There are no licensed biological products that are structurally related to" } ] }, { "filename": "125742_S1_M1_fast-track-designation.pdf", "id": 4211, "module": "M1", "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2022/03/125742_S1_M1_fast-track-designation.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2022/03/125742_S1_M1_fast-track-designation.pdf", "total_pages": 2, "matches": [ { "page": 1, "family": "Named act", "normalized": "FD&C Act", "raw": "Federal Food, Drug, and Cosmetic Act", "context": "vestigational New Drug Application (IND) submitted under section 505(i) of the Federal Food, Drug, and Cosmetic Act (FDCA) for \u201cHuman Coronavirus mRNA Vaccines (SARS-CoV-2 Spike Protein; BNT162a" }, { "page": 1, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "D) submitted under section 505(i) of the Federal Food, Drug, and Cosmetic Act (FDCA) for \u201cHuman Coronavirus mRNA Vaccines (SARS-CoV-2 Spike Protein; BNT162a1 (uRN" }, { "page": 1, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "dment 18, submitted and received on June 18, 2020, under section 506(b) of the FDCA. We have reviewed your request and have determined that Human Coronavirus mRNA" }, { "page": 1, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "ion/Guidances/UCM358301.pdf. We remind you that under section 561A(f)(2) of the FDCA, you are required to make your expanded access policy for Human Coronavirus mR" } ] }, { "filename": "125742_S1_M1_financial-cert-3454.pdf", "id": 4212, "module": "M1", "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2022/03/125742_S1_M1_financial-cert-3454.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2022/03/125742_S1_M1_financial-cert-3454.pdf", "total_pages": 81, "matches": [ { "page": 1, "family": "CFR", "normalized": "21 CFR 54.2", "raw": "21 CFR 54.2", "context": "includes the spouse and each dependent child of the investigator as defined in 21 CFR 54.2(d). Please mark the applicable check box. (1) As the sponsor of the submitt" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 54.2", "raw": "21 CFR 54.2", "context": "o the investigator could be affected by the outcome of the study as defined in 21 CFR 54.2(a). I also certify that each listed clinical investigator required to disciose" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 54.2", "raw": "21 CFR 54.2", "context": "interest in this product or a significant equity in the sponsor as defined in 21 CFR 54.2(b) did not disclose any such interests. I further certify that no listed invest" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 54.2", "raw": "21 CFR 54.2", "context": "stigator was the recipient of significant payments of other sorts as defined in 21 CFR 54.2(f). Clinical Investigators (See atached) D (2) As the applicant who is submit" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 54.2", "raw": "21 CFR 54.2", "context": "ducting the study could be affected by the outcome of the study (as defined in 21 CFR 54.2 (a)); had no proprietary interest in this product or significant equity intere" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 54.2", "raw": "21 CFR 54.2", "context": "significant equity interest in the sponsor of the covered study (as defined in 21 CFR 54.2(b)); and was not the recipient of significant payments of other sorts (as defin" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 54.2", "raw": "21 CFR 54.2", "context": "and was not the recipient of significant payments of other sorts (as defined in 21 CFR 54.2(f)). Clinical (See athed} 0 (3) As the applicant who is submitting a study" }, { "page": 78, "family": "CFR", "normalized": "21 CFR 54.2", "raw": "21 CFR 54.2", "context": "nvestigator includes the $pouse and each dependent child of the as defined in 21 CFR 54.2(d). Please mark the applicable check box. 0 (1) As the sponsor of the submit" }, { "page": 78, "family": "CFR", "normalized": "21 CFR 54.2", "raw": "21 CFR 54.2", "context": "o the investigator could be affected by the outcome of the study as defined in 21 CFR 54.2(a). I also certify that each listed clinical investigator required to disclos" }, { "page": 78, "family": "CFR", "normalized": "21 CFR 54.2", "raw": "21 CFR 54.2", "context": "interest in this product or a significant equity in the sponsor as defined in 21 CFR 54.2(b) did not disclose any such interests. I further certify that no listed inves" }, { "page": 78, "family": "CFR", "normalized": "21 CFR 54.2", "raw": "21 CFR 54.2", "context": "tigator was the recipient of significant payments of other sorts as defined in 21 CFR 54.2(f). D (2) As the applicant who is submitting a study or studies sponsored by" }, { "page": 78, "family": "CFR", "normalized": "21 CFR 54.2", "raw": "21 CFR 54.2", "context": "ducting the study could be affected by the outcome of the study (as defined in 21 CFR 54.2 (a)); had no proprietary interest in this product or significant equity inter" }, { "page": 78, "family": "CFR", "normalized": "21 CFR 54.2", "raw": "21 CFR 54.2", "context": "significant equity interest in the sponsor of the covered study (as defined in 21 CFR 54.2(b)); and was not the recipient of significant payments of other sorts (as defi" }, { "page": 78, "family": "CFR", "normalized": "21 CFR 54.2", "raw": "21 CFR 54.2", "context": "nd was not the recipient of significant payments of other sorts (as defined in 21 CFR 54.2(f)). 0 (3) As the applicant who is submitting a study or studies sponsored b" } ] }, { "filename": "125742_S1_M1_financial-cert-bias.pdf", "id": 4213, "module": "M1", "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2022/03/125742_S1_M1_financial-cert-bias.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2022/03/125742_S1_M1_financial-cert-bias.pdf", "total_pages": 3, "matches": [] }, { "filename": "125742_S1_M1_ipsp-agreed-letter.pdf", "id": 4214, "module": "M1", "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2022/03/125742_S1_M1_ipsp-agreed-letter.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2022/03/125742_S1_M1_ipsp-agreed-letter.pdf", "total_pages": 2, "matches": [ { "page": 1, "family": "Named act", "normalized": "FD&C Act", "raw": "Federal Food, Drug, and Cosmetic Act", "context": "vestigational New Drug Application (IND) submitted under section 505(i) of the Federal Food, Drug, and Cosmetic Act for \u201cHuman Coronavirus mRNA Vaccines (SARS-CoV-2 Spike Protein; 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curriculum vitae; financial disclosure information required under 21 CFR 54 21 CFR 312.53(d) Selecting monitors qualified by training and experience" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 312.53", "raw": "21 CFR 312.53", "context": "curriculum vitae; financial disclosure information required under 21 CFR 54 21 CFR 312.53(d) Selecting monitors qualified by training and experience 21 CFR 312.55(a)" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 312.55", "raw": "21 CFR 312.55", "context": "21 CFR 312.53(d) Selecting monitors qualified by training and experience 21 CFR 312.55(a) Providing investigators with the information they need to conduct the inves" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 312.55", "raw": "21 CFR 312.55", "context": "ators with the information they need to conduct the investigation properly 21 CFR 312.55(b) Informing investigators of new observations with respect to adverse events" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 312.56", "raw": "21 CFR 312.56", "context": "vestigators of new observations with respect to adverse events and safe use 21 CFR 312.56(a) Ensuring proper monitoring of the clinical trial 21 CFR 312.56(b) Secure" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 312.56", "raw": "21 CFR 312.56", "context": "fe use 21 CFR 312.56(a) Ensuring proper monitoring of the clinical trial 21 CFR 312.56(b) Secure compliance or discontinue shipments from investigators found not to" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 312", "raw": "21 CFR 312", "context": "ment (FDA 1572), the general investigational plan, or other requirements under 21 CFR 312 21 CFR 312.56(c) Review and evaluate evidence of safety and effectiveness o" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 312.56", "raw": "21 CFR 312.56", "context": "), the general investigational plan, or other requirements under 21 CFR 312 21 CFR 312.56(c) Review and evaluate evidence of safety and effectiveness of drug FDA-CBER-" }, { "page": 2, "family": "CFR", "normalized": "21 CFR 312.56", "raw": "21 CFR 312.56", "context": "NAME AND ADDRESS STUDY(S) CONTRACTED OBLIGATIONS ASSUMED / TRANSFERRED 21 CFR 312.56(d) Ensure discontinuation of the study if the drug presents an unreasonable an" }, { "page": 2, "family": "CFR", "normalized": "21 CFR 312.57", "raw": "21 CFR 312.57", "context": "ant risk to study subjects; notification to FDA and IRB of discontinuation 21 CFR 312.57 Maintenance of records and reports 21 CFR 312.59 Drug accountability (e.g. r" }, { "page": 2, "family": "CFR", "normalized": "21 CFR 312.59", "raw": "21 CFR 312.59", "context": "IRB of discontinuation 21 CFR 312.57 Maintenance of records and reports 21 CFR 312.59 Drug accountability (e.g. record of shipment, receipt, method of disposal); en" } ] }, { "filename": "125742_S1_M1_us-agent-authorization.pdf", "id": 4217, "module": "M1", "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2022/03/125742_S1_M1_us-agent-authorization.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2022/03/125742_S1_M1_us-agent-authorization.pdf", "total_pages": 2, "matches": [] }, { "filename": "125742_S1_M1_userfee.pdf", "id": 4218, "module": "M1", "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2022/03/125742_S1_M1_userfee.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2022/03/125742_S1_M1_userfee.pdf", "total_pages": 2, "matches": [ { "page": 2, "family": "USC", "normalized": "5 U.S.C. \u00a7 552a", "raw": "5 U.S.C. 552a", "context": "rivacy Act Notice: This notice is provided pursuant to the Privacy Act of 1974, 5 U.S.C. 552a. The collection of this information is authorized by 21 U.S.C. 371, 379, 379e," }, { "page": 2, "family": "USC", "normalized": "21 U.S.C. \u00a7 371", "raw": "21 U.S.C. 371", "context": "Act of 1974, 5 U.S.C. 552a. The collection of this information is authorized by 21 U.S.C. 371, 379, 379e, 379h, 379h-1, 379j, 379j- 12, 379j-21, 387s, and 393(d)(2); 42 U.S." }, { "page": 2, "family": "USC", "normalized": "42 U.S.C. \u00a7 263b", "raw": "42 U.S.C. 263b", "context": ".C. 371, 379, 379e, 379h, 379h-1, 379j, 379j- 12, 379j-21, 387s, and 393(d)(2); 42 U.S.C. 263b(r)(1); 5 U.S.C. 301 and 552; and 42 U.S.C. 3101. FDA will use the information t" }, { "page": 2, "family": "USC", "normalized": "5 U.S.C. \u00a7 301", "raw": "5 U.S.C. 301", "context": "9h, 379h-1, 379j, 379j- 12, 379j-21, 387s, and 393(d)(2); 42 U.S.C. 263b(r)(1); 5 U.S.C. 301 and 552; and 42 U.S.C. 3101. FDA will use the information to assess, collect an" }, { "page": 2, "family": "USC", "normalized": "42 U.S.C. \u00a7 3101", "raw": "42\nU.S.C. 3101", "context": ", 379j-21, 387s, and 393(d)(2); 42 U.S.C. 263b(r)(1); 5 U.S.C. 301 and 552; and 42 U.S.C. 3101. FDA will use the information to assess, collect and process user fee payments," } ] }, { "filename": "125742_S1_M1_waiver-req-designated-suffix.pdf", "id": 4219, "module": "M1", "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2022/03/125742_S1_M1_waiver-req-designated-suffix.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2022/03/125742_S1_M1_waiver-req-designated-suffix.pdf", "total_pages": 4, "matches": [ { "page": 3, "family": "Named act", "normalized": "PHS Act", "raw": "Public Health Service Act", "context": "timal pharmacovigilance of biologic products approved under section 351 of the Public Health Service Act (PHS) that do not contain an FDA designated suffix. Further to this the guida" } ] }, { "filename": "125742_S1_M2_22_introduction.pdf", "id": 4220, "module": "M2", "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2022/03/125742_S1_M2_22_introduction.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2022/03/125742_S1_M2_22_introduction.pdf", "total_pages": 2, "matches": [] }, { "filename": "125742_S1_M2_24_nonclinical-overview.pdf", "id": 4221, "module": "M2", "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2022/03/125742_S1_M2_24_nonclinical-overview.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2022/03/125742_S1_M2_24_nonclinical-overview.pdf", "total_pages": 36, "matches": [ { "page": 7, "family": "CFR", "normalized": "21 CFR 58", "raw": "21 CFR Part 58", "context": "y Practice for Nonclinical Laboratory Studies, Code of US Federal Regulations (21 CFR Part 58), in an OECD Mutual Acceptance of Data member state. All nonclinical studies d" } ] }, { "filename": "125742_S1_M2_26_pharmkin-tabulated-summary.pdf", "id": 4222, "module": "M2", "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2022/03/125742_S1_M2_26_pharmkin-tabulated-summary.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2022/03/125742_S1_M2_26_pharmkin-tabulated-summary.pdf", "total_pages": 14, "matches": [] }, { "filename": "125742_S1_M2_26_pharmkin-written-summary.pdf", "id": 4223, "module": "M2", "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2022/03/125742_S1_M2_26_pharmkin-written-summary.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2022/03/125742_S1_M2_26_pharmkin-written-summary.pdf", "total_pages": 10, "matches": [] }, { "filename": "125742_S1_M2_27_literature-references.pdf", "id": 4224, "module": "M2", "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2022/03/125742_S1_M2_27_literature-references.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2022/03/125742_S1_M2_27_literature-references.pdf", "total_pages": 2, "matches": [] }, { "filename": "125742_S1_M2_27_synopses-indiv-studies.pdf", "id": 4225, "module": "M2", "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2022/03/125742_S1_M2_27_synopses-indiv-studies.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2022/03/125742_S1_M2_27_synopses-indiv-studies.pdf", "total_pages": 2, "matches": [] }, { "filename": "125742_S1_M4_4223_185350.pdf", "id": 4226, "module": "M4", "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2022/03/125742_S1_M4_4223_185350.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2022/03/125742_S1_M4_4223_185350.pdf", "total_pages": 77, "matches": [] }, { "filename": "125742_S1_M4_4223_R-20-0072.pdf", "id": 4227, "module": "M4", "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2022/03/125742_S1_M4_4223_R-20-0072.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2022/03/125742_S1_M4_4223_R-20-0072.pdf", "total_pages": 37, "matches": [ { "page": 14, "family": "International", "normalized": "Directive 2010/63/EU", "raw": "Directive 2010/63/EU", "context": "ELASA recommendations and in compliance with the German animal welfare act and Directive 2010/63/EU. 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null, "total_pages": 5, "matches": [ { "page": 4, "family": "CFR", "normalized": "21 CFR 610.62", "raw": "21 CFR 610.62", "context": "of the proper name and the tradename to ensure they are equal in prominence ((21 CFR 610.62(b)). b. 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Pediatric studies will be initiated as described in Section 11, but data wil" }, { "page": 27, "family": "International", "normalized": "ICH S2", "raw": "ICH S2", "context": "was evaluated in genotoxicity studies as an individual agent using a standard ICH S2 (R1) approach (ICH 2011), including a bacterial reverse mutation (Ames) test a" } ] }, { "filename": "125752_S3_M1_agreed-ipsp-fda-agreement.pdf", "id": 5049, "module": "M1", "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 2, "matches": [ { "page": 1, "family": "Named act", "normalized": "FD&C Act", "raw": "Federal Food, Drug, and Cosmetic Act", "context": "vestigational New Drug Application (IND) submitted under section 505(i) of the Federal Food, Drug, and Cosmetic Act for Human Coronavirus, (2019- nCoV; Pre-fusion Spike protein; Lipid Nanoparticl" } ] }, { "filename": "125752_S3_M1_request-for-a-waiver.pdf", "id": 5050, "module": "M1", "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 9, "matches": [ { "page": 1, "family": "CFR", "normalized": "21 CFR 610.15", "raw": "21 CFR 610.15", "context": "ModernaTX, Inc. mRNA-1273 1.12.5 Request for a Waiver {21 CFR 610.15} BLA 125752 Confidential Page 1 Table of Contents Table of Contents ....." }, { "page": 1, "family": "CFR", "normalized": "21 CFR 610.15", "raw": "21 CFR 610.15", "context": ".................................................. 1 Request for a Waiver from 21 CFR 610.15 (a):..........................................................................." }, { "page": 2, "family": "CFR", "normalized": "21 CFR 610.15", "raw": "21 CFR 610.15", "context": "ModernaTX, Inc. mRNA-1273 1.12.5 Request for a Waiver {21 CFR 610.15} BLA 125752 Confidential Page 2 REQUEST FOR A WAIVER FROM 21 CFR 610.15 (A" }, { "page": 2, "family": "CFR", "normalized": "21 CFR 610.15", "raw": "21 CFR 610.15", "context": "r {21 CFR 610.15} BLA 125752 Confidential Page 2 REQUEST FOR A WAIVER FROM 21 CFR 610.15 (A): Pursuant to per 21 CFR 610.15 (d), the Sponsor is requesting an exemptio" }, { "page": 2, "family": "CFR", "normalized": "21 CFR 610.15", "raw": "21 CFR 610.15", "context": "dential Page 2 REQUEST FOR A WAIVER FROM 21 CFR 610.15 (A): Pursuant to per 21 CFR 610.15 (d), the Sponsor is requesting an exemption from the requirement in 21 CFR 610" }, { "page": 2, "family": "CFR", "normalized": "21 CFR 610.15", "raw": "21 CFR 610.15", "context": "CFR 610.15 (d), the Sponsor is requesting an exemption from the requirement in 21 CFR 610.15 (a) Constituent materials; Ingredients, preservatives, diluents and adjuvants." }, { "page": 9, "family": "CFR", "normalized": "21 CFR 610.15", "raw": "21 CFR 610.15", "context": "t justification that the mRNA-1273 DP should be exempt from the requirement of 21 CFR 610.15 (a) that products contained in multiple-dose vial shall contain a preservative." } ] }, { "filename": "125752_S3_M1_rmp-v2-2.pdf", "id": 5051, "module": "M1", "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 491, "matches": [ { "page": 136, "family": "International", "normalized": "Directive 95/46/EC", "raw": "Directive 95/46/EC", "context": "ry effort will be made to protect participant confidentiality according to the Directive 95/46/EC on the protection of individuals, and in compliance with Safe Harbor privacy p" }, { "page": 166, "family": "International", "normalized": "Directive 95/46/EC", "raw": "Directive 95/46/EC", "context": "ry effort will be made to protect participant confidentiality according to the Directive 95/46/EC on the protection of individuals, and in compliance with Safe Harbor privacy p" }, { "page": 166, "family": "CFR", "normalized": "21 CFR 50", "raw": "21 CFR Part 50", "context": "al guidelines. The study will be conducted in compliance with the US FDA Title 21 CFR Part 50 \u2013 Protection of Human Patients and/or Part 56 \u2013 Institutional Review Boards; t" } ] }, { "filename": "125752_S3_M2_23_qos-drug-product.pdf", "id": 5052, "module": "M2", "batch_code": "md", "company": "Moderna", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 66, "matches": [ { "page": 65, "family": "International", "normalized": "ICH Q1A", "raw": "ICH Q1A", "context": "273 drug product (DP) registration stability program was executed according to ICH Q1A (R2), Stability Testing of New Drug Substances and Products, and ICH Q5C, Stabi" }, { "page": 65, "family": "International", "normalized": "ICH Q5C", "raw": "ICH Q5C", "context": "ng to ICH Q1A (R2), Stability Testing of New Drug Substances and Products, and ICH Q5C, Stability Testing of Biotechnological/Biological Products. 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studies to verify clinical benefit and safety [21 CFR 314.610/21 CFR 601.42] PMC response: Indicate by using Bold the type of PMC response Clinical Safety" }, { "page": 6, "family": "CFR", "normalized": "21 CFR 314.50", "raw": "21 CFR 314.50", "context": "(e.g., table of contents) 9 12. Is the submission complete as required under 21 CFR 314.50 (NDAs/NDA efficacy supplements) or under 21 CFR 601.2 (BLAs/BLA efficacy supp" }, { "page": 6, "family": "CFR", "normalized": "21 CFR 601.2", "raw": "21 CFR 601.2", "context": "ete as required under 21 CFR 314.50 (NDAs/NDA efficacy supplements) or under 21 CFR 601.2 (BLAs/BLA efficacy supplements) including: * RTF issues, a \u201cNo\u201d means the appl" }, { "page": 8, "family": "CFR", "normalized": "21 CFR 601.2", "raw": "21 CFR \n601.2", "context": "YES NO NA Comment 17. Is form FDA 356h included with authorized signature per 21 CFR 601.2(a) (BLAs) or per 21 CFR 314.50(a) (NDAs)? 9 18. If foreign applicant, has a U." }, { "page": 8, "family": "CFR", "normalized": "21 CFR 314.50", "raw": "21 CFR \n314.50", "context": "FDA 356h included with authorized signature per 21 CFR 601.2(a) (BLAs) or per 21 CFR 314.50(a) (NDAs)? 9 18. 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"https://icandecide.org/wp-content/uploads/2023/09/125742_S54_M1_diluent-carton-fresenius-kabi.pdf", "total_pages": 1, "matches": [] }, { "filename": "125742_S54_M1_diluent-vial-fresenius-kabi.pdf", "id": 5407, "module": "M1", "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2023/09/125742_S54_M1_diluent-vial-fresenius-kabi.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/09/125742_S54_M1_diluent-vial-fresenius-kabi.pdf", "total_pages": 1, "matches": [] }, { "filename": "125742_S54_M1_vial-rl-7302-rocky-mount-hospira.pdf", "id": 5408, "module": "M1", "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2023/09/125742_S54_M1_vial-rl-7302-rocky-mount-hospira.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/09/125742_S54_M1_vial-rl-7302-rocky-mount-hospira.pdf", "total_pages": 1, "matches": [] }, { "filename": "125742_S6_M5_acrf.pdf", "id": 5409, "module": "M5", "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2023/09/125742_S6_M5_acrf.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/09/125742_S6_M5_acrf.pdf", "total_pages": 131, "matches": [] }, { "filename": "125742_S6_M5_adrg.pdf", "id": 5410, "module": "M5", "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2023/09/125742_S6_M5_adrg.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/09/125742_S6_M5_adrg.pdf", "total_pages": 12, "matches": [] }, { "filename": "125742_S6_M5_csdrg.pdf", "id": 5411, "module": "M5", "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2023/09/125742_S6_M5_csdrg.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/09/125742_S6_M5_csdrg.pdf", "total_pages": 8, "matches": [] }, { "filename": "125742_S79_M1_cover.pdf", "id": 5412, "module": "M1", "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2023/09/125742_S79_M1_cover.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/09/125742_S79_M1_cover.pdf", "total_pages": 2, "matches": [] }, { "filename": "14_BLA 125742-0_07-02-2021_Telecon_Advice.pdf", "id": 5413, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 3, "matches": [] }, { "filename": "16_BLA 125742-0_07-06-2021_Telecon_Information Reques.pdf", "id": 5414, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 2, "matches": [] }, { "filename": "17_BLA 125742-0_07-06-2021_Telecon_Advice_PNR Accepta.pdf", "id": 5415, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 1, "matches": [ { "page": 1, "family": "Named act", "normalized": "FD&C Act", "raw": "Federal Food, Drug, and Cosmetic Act", "context": "CBER\u2019s Advertising and Promotional Labeling Branch, we conclude that under the Federal Food, Drug, and Cosmetic Act and applicable regulations your proposed proprietary name, COMIRNATY, is Accep" } ] }, { "filename": "19_2_BLA 125742-0_07-13-2021_Telecon_Information Reques.pdf", "id": 5416, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 1, "matches": [ { "page": 1, "family": "CFR", "normalized": "21 CFR 610.15", "raw": "21 CFR 610.15", "context": "n a multiple-dose vial that does not contain a preservative. 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null, "total_pages": 41, "matches": [] }, { "filename": "5_BLA 125742-0_06-08-2021_Telecon_Information Reques.pdf", "id": 5438, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 2, "matches": [] }, { "filename": "50_BLA 125742-0_08-06-2021_Memo_Committee Memo_APLB.pdf", "id": 5439, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 6, "matches": [] }, { "filename": "56_BLA 125742-0_08-09-2021_Telecon_Information Reques.pdf", "id": 5440, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 2, "matches": [] }, { "filename": "57_BLA 125742-0_08-09-2021_Telecon_Labeling via FAX_e.pdf", "id": 5441, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 3, "matches": [] }, { 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125742-0_08-13-2021_Telecon_Information Reques.pdf", "id": 5446, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 4, "matches": [ { "page": 1, "family": "Named act", "normalized": "FD&C Act", "raw": "Federal Food, Drug, and Cosmetic Act", "context": "ontaneous postmarketing adverse events reported under section 505(k)(1) of the Federal Food, Drug, and Cosmetic Act (FDCA) will not be sufficient to identify: \u2022 known serious risks of myocardi" }, { "page": 1, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "s reported under section 505(k)(1) of the Federal Food, Drug, and Cosmetic Act (FDCA) will not be sufficient to identify: \u2022 known serious risks of myocarditis an" }, { "page": 1, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "gilance system that FDA is required to maintain under section 505(k)(3) of the FDCA is not sufficient to assess these serious risks. Therefore, should this produc" }, { "page": 1, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "following studies as postmarketing requirements (PMRs) under Section 505(o) of FDCA: 1. 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Please verify a" }, { "page": 310, "family": "International", "normalized": "ISO 15189", "raw": "ISO\n15189", "context": "Authorization) diagnostic list and is not indicated as 'CLIA-certified lab' or 'ISO 15189 accredited lab' Please review and update. Else, clarify. Nov-17-2020 19:31:01 (" }, { "page": 310, "family": "International", "normalized": "ISO 15189", "raw": "ISO\n15189", "context": "Authorization) diagnostic list and is not indicated as 'CLIA-certified lab' or 'ISO 15189 accredited lab' . Please verify and update as appropriate. Otherwise, please pr" }, { "page": 312, "family": "International", "normalized": "ISO 15189", "raw": "ISO\n15189", "context": "'CORONEX- COVID19 RT-qPCR TEST'. However the local lab has no CLIA-certificate,ISO 15189 acredition. There is only the lab has only Turkey's Ministry of Health License." }, { "page": 312, "family": "International", "normalized": "ISO 15189", "raw": "ISO 15189", "context": "20 11:37:42 (UTC+03:00) Istanbul ACV0PFEINFP6000 Query 3: Answered There is no ISO 15189 accretion.The lab has only Turkey's Ministry of Health License. License no:438/" }, { "page": 313, "family": "International", "normalized": "ISO 15189", "raw": "ISO\n15189", "context": "lease indicate whether the test was performed by a laboratory accredited by the ISO 15189 standard by including the text \u2018ISO 15189 accredited lab\u2019 (ie SARS-CoV-2 test I" }, { "page": 313, "family": "International", "normalized": "ISO 15189", "raw": "ISO\n15189", "context": "med by a laboratory accredited by the ISO 15189 standard by including the text \u2018ISO 15189 accredited lab\u2019 (ie SARS-CoV-2 test ISO 15189 accredited lab) Nov-25-2020 00:37" }, { "page": 313, "family": "International", "normalized": "ISO 15189", "raw": "ISO 15189", "context": "9 standard by including the text \u2018ISO 15189 accredited lab\u2019 (ie SARS-CoV-2 test ISO 15189 accredited lab) Nov-25-2020 00:37:17 (UTC+03:00) Istanbul ACV0PFEINFP6000 Quer" }, { "page": 313, "family": "International", "normalized": "ISO 15189", "raw": "ISO\n15189", "context": "lease indicate whether the test was performed by a laboratory accredited by the ISO 15189 standard by including the text \u2018ISO 15189 accredited lab\u2019 (ie SARS-CoV-2 test I" }, { "page": 313, "family": "International", "normalized": "ISO 15189", "raw": "ISO\n15189", "context": "med by a laboratory accredited by the ISO 15189 standard by including the text \u2018ISO 15189 accredited lab\u2019 (ie SARS-CoV-2 test ISO 15189 accredited lab) Nov-24-2020 21:07" }, { "page": 313, "family": "International", "normalized": "ISO 15189", "raw": "ISO 15189", "context": "9 standard by including the text \u2018ISO 15189 accredited lab\u2019 (ie SARS-CoV-2 test ISO 15189 accredited lab) Nov-24-2020 21:07:23 (UTC+03:00) Istanbul ACV0PFEINFP6000 Sali" }, { "page": 314, "family": "International", "normalized": "ISO 15189", "raw": "ISO\n15189", "context": "'CORONEX- COVID19 RT-qPCR TEST'. However the local lab has no CLIA-certificate,ISO 15189 acredition. There is only the lab has only Turkey's 090177e196ae2f28\\Final\\Fina" }, { "page": 315, "family": "International", "normalized": "ISO 15189", "raw": "ISO\n15189", "context": "'CORONEX- COVID19 RT-qPCR TEST'. However the local lab has no CLIA-certificate,ISO 15189 acredition. There is only the lab has only Turkey's Ministry of Health License." }, { "page": 315, "family": "International", "normalized": "ISO 15189", "raw": "ISO\n15189", "context": "performed in a CLIA- certified laboratory or in a laboratory accredited by the ISO 15189 standard by a national or regional accredited body, please enter \u201cNALT Unknown\u201d" }, { "page": 316, "family": "International", "normalized": "ISO 15189", "raw": "ISO 15189", "context": "se Authorization) diagnostic list and is not indicated as CLIA certified lab or ISO 15189 accredited lab . Please verify and update as appropriate. 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Dec-03-2020 07:48:28 ACV0PFEINFP6000" }, { "page": 210, "family": "International", "normalized": "ISO 15189", "raw": "ISO\n15189", "context": "se Authorization) diagnostic list and is not indicated as CLIA certified lab or ISO 15189 accredited lab . Please verify and update as appropriate. Otherwise, please pro" } ] }, { "filename": "125742_S1_M5_CRF_c4591001-1052-10521172.pdf", "id": 6032, "module": "M5", "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2023/07/125742_S1_M5_CRF_c4591001-1052-10521172.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/07/125742_S1_M5_CRF_c4591001-1052-10521172.pdf", "total_pages": 1141, "matches": [] }, { "filename": "125742_S1_M5_CRF_c4591001-1054-10541067.pdf", "id": 6033, "module": "M5", "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2023/07/125742_S1_M5_CRF_c4591001-1054-10541067.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/07/125742_S1_M5_CRF_c4591001-1054-10541067.pdf", "total_pages": 192, "matches": [] }, { "filename": "125742_S1_M5_CRF_c4591001-1054-10541168.pdf", "id": 6034, "module": "M5", "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2023/07/125742_S1_M5_CRF_c4591001-1054-10541168.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/07/125742_S1_M5_CRF_c4591001-1054-10541168.pdf", "total_pages": 164, "matches": [] }, { "filename": "125742_S1_M5_CRF_c4591001-1054-10541173.pdf", "id": 6035, "module": "M5", "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2023/07/125742_S1_M5_CRF_c4591001-1054-10541173.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/07/125742_S1_M5_CRF_c4591001-1054-10541173.pdf", "total_pages": 427, "matches": [] }, { "filename": "125742_S1_M5_CRF_c4591001-1054-10541186.pdf", "id": 6036, "module": "M5", "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2023/07/125742_S1_M5_CRF_c4591001-1054-10541186.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/07/125742_S1_M5_CRF_c4591001-1054-10541186.pdf", "total_pages": 179, "matches": [] }, { "filename": "125742_S1_M5_CRF_c4591001-1056-10561022.pdf", "id": 6037, "module": "M5", "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2023/07/125742_S1_M5_CRF_c4591001-1056-10561022.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/07/125742_S1_M5_CRF_c4591001-1056-10561022.pdf", "total_pages": 141, "matches": [] }, { "filename": "125742_S1_M5_CRF_c4591001-1057-10571052.pdf", "id": 6038, "module": "M5", "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2023/07/125742_S1_M5_CRF_c4591001-1057-10571052.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/07/125742_S1_M5_CRF_c4591001-1057-10571052.pdf", "total_pages": 796, "matches": [ { "page": 462, "family": "International", "normalized": "ISO 15189", "raw": "ISO 15189", "context": "ed DM2: Per CCG section 8.31.7, please consider to add 'CLIA certified lab' or 'ISO 15189 lab' to the 'Trade name Other, Specify' response (SARS-CoV-2 by PCR). Nov-19-20" }, { "page": 463, "family": "International", "normalized": "ISO 15189", "raw": "ISO\n15189", "context": "ents please provide manufacturer and test kit name or add CLIA certified lab or ISO 15189 lab. Nov-17-2020 16:47:48 (UTC-05:00) Eastern Time (US & Canada) ACV0PFEINFP600" }, { "page": 463, "family": "International", "normalized": "ISO 15189", "raw": "ISO\n15189", "context": "Authorization) diagnostic list and is not indicated as 'CLIA-certified lab' or 'ISO 15189 accredited lab' . Please verify and update as appropriate. Otherwise, please pr" } ] }, { "filename": "125742_S1_M5_CRF_c4591001-1057-10571065.pdf", "id": 6039, "module": "M5", "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2023/07/125742_S1_M5_CRF_c4591001-1057-10571065.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/07/125742_S1_M5_CRF_c4591001-1057-10571065.pdf", "total_pages": 165, "matches": [] }, { "filename": "125742_S1_M5_CRF_c4591001-1057-10571137.pdf", "id": 6040, "module": "M5", "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2023/07/125742_S1_M5_CRF_c4591001-1057-10571137.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/07/125742_S1_M5_CRF_c4591001-1057-10571137.pdf", "total_pages": 216, "matches": [] }, { "filename": "125742_S1_M5_CRF_c4591001-1057-10571188.pdf", "id": 6041, "module": "M5", "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2023/07/125742_S1_M5_CRF_c4591001-1057-10571188.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/07/125742_S1_M5_CRF_c4591001-1057-10571188.pdf", "total_pages": 145, "matches": [] }, { "filename": "125742_S1_M5_CRF_c4591001-1057-10571327.pdf", "id": 6042, "module": "M5", "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2023/07/125742_S1_M5_CRF_c4591001-1057-10571327.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/07/125742_S1_M5_CRF_c4591001-1057-10571327.pdf", "total_pages": 426, "matches": [] }, { "filename": "125742_S1_M5_CRF_c4591001-1068-10681066.pdf", "id": 6043, "module": "M5", "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2023/07/125742_S1_M5_CRF_c4591001-1068-10681066.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/07/125742_S1_M5_CRF_c4591001-1068-10681066.pdf", "total_pages": 162, "matches": [] }, { "filename": "125742_S1_M5_CRF_c4591001-1068-10681079.pdf", "id": 6044, "module": "M5", "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2023/07/125742_S1_M5_CRF_c4591001-1068-10681079.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/07/125742_S1_M5_CRF_c4591001-1068-10681079.pdf", "total_pages": 282, "matches": [ { "page": 208, "family": "International", "normalized": "ISO 15189", "raw": "ISO 15189", "context": "uthorization) diagnostic list and is not indicated as 'CLIA- certified lab' or 'ISO 15189 accredited lab' . Please verify and update as appropriate. Otherwise, please pr" } ] }, { "filename": "125742_S1_M5_CRF_c4591001-1068-10681091.pdf", "id": 6045, "module": "M5", "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2023/07/125742_S1_M5_CRF_c4591001-1068-10681091.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/07/125742_S1_M5_CRF_c4591001-1068-10681091.pdf", "total_pages": 217, "matches": [] }, { "filename": "125742_S1_M5_CRF_c4591001-1068-10681111.pdf", "id": 6046, "module": "M5", "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2023/07/125742_S1_M5_CRF_c4591001-1068-10681111.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/07/125742_S1_M5_CRF_c4591001-1068-10681111.pdf", "total_pages": 175, "matches": [] }, { "filename": "125742_S1_M5_CRF_c4591001-1071-10711023.pdf", "id": 6047, "module": "M5", "batch_code": "pd", "company": "Pfizer", "license": "BLA", 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Expanded Access Use, 21 CFR 312.300 |] Emergency Research Exception From Informed Consent | [_| Individual Patient," }, { "page": 1, "family": "CFR", "normalized": "21 CFR 312.23", "raw": "21 CFR 312.23", "context": "sent | [_| Individual Patient, Non- |_| Intermediate Size Patient Requirements, 21 CFR 312.23 (f) Emergency 21 CFR 312.310 Population, 21 CFR 312.315 |] Charge Request, 21" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 312.310", "raw": "21 CFR 312.310", "context": "t, Non- |_| Intermediate Size Patient Requirements, 21 CFR 312.23 (f) Emergency 21 CFR 312.310 Population, 21 CFR 312.315 |] Charge Request, 21 CFR 312.8 | [| Individual Pat" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 312.315", "raw": "21 CFR 312.315", "context": "ze Patient Requirements, 21 CFR 312.23 (f) Emergency 21 CFR 312.310 Population, 21 CFR 312.315 |] Charge Request, 21 CFR 312.8 | [| Individual Patient, Emergency [|_| Treatm" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 312.8", "raw": "21 CFR 312.8", "context": ".23 (f) Emergency 21 CFR 312.310 Population, 21 CFR 312.315 |] Charge Request, 21 CFR 312.8 | [| Individual Patient, Emergency [|_| Treatment IND or Protocol, : 21 CFR 312" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 312.310", "raw": "21 CFR 312.310", "context": "CFR 312.8 | [| Individual Patient, Emergency [|_| Treatment IND or Protocol, : 21 CFR 312.310(d) 21 CFR 312.320 For FDA Use Only CBER/DCC Receipt Stamp DDR Receipt Stamp Di" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 312.320", "raw": "21 CFR 312.320", "context": "dividual Patient, Emergency [|_| Treatment IND or Protocol, : 21 CFR 312.310(d) 21 CFR 312.320 For FDA Use Only CBER/DCC Receipt Stamp DDR Receipt Stamp Division Assignment" }, { "page": 2, "family": "CFR", "normalized": "21 CFR 312.23", "raw": "21 CFR 312.23", "context": "ion contains the following items (Select all that apply) Iv] 1. Form FDA 1571 (21 CFR 312.23(a)(1)) 6. Protocol (Continued) [| 2. Table of Contents (21 CFR 312.23(a)(2)) [|" }, { "page": 2, "family": "CFR", "normalized": "21 CFR 312.23", "raw": "21 CFR 312.23", "context": "FDA 1571 (21 CFR 312.23(a)(1)) 6. Protocol (Continued) [| 2. Table of Contents (21 CFR 312.23(a)(2)) [| d. Institutional Review Board data (21 CFR 312.23(a)(6)(iii) (b)) or" }, { "page": 2, "family": "CFR", "normalized": "21 CFR 312.23", "raw": "21 CFR 312.23", "context": "Table of Contents (21 CFR 312.23(a)(2)) [| d. Institutional Review Board data (21 CFR 312.23(a)(6)(iii) (b)) or completed Form FDA 1572 [3 Introductory statement (217 CFR" }, { "page": 2, "family": "CFR", "normalized": "217 CFR 312.23", "raw": "217 CFR 312.23", "context": "R 312.23(a)(6)(iii) (b)) or completed Form FDA 1572 [3 Introductory statement (217 CFR 312.23(a)(3)) ll7 Chemistry, manufacturing, and control data [| 4. General Investigat" }, { "page": 2, "family": "CFR", "normalized": "27 CFR 312.23", "raw": "27 CFR 312.23", "context": "Chemistry, manufacturing, and control data [| 4. General Investigational plan (27 CFR 312.23(a)(3)) (21 CFR 312.23(a)(7)) [| 5. Investigator\u2019s brochure (21 CFR 312.23(a)(5)" }, { "page": 2, "family": "CFR", "normalized": "21 CFR 312.23", "raw": "21 CFR 312.23", "context": "ng, and control data [| 4. General Investigational plan (27 CFR 312.23(a)(3)) (21 CFR 312.23(a)(7)) [| 5. Investigator\u2019s brochure (21 CFR 312.23(a)(5)) [| Environmental ass" }, { "page": 2, "family": "CFR", "normalized": "21 CFR 312.23", "raw": "21 CFR 312.23", "context": "plan (27 CFR 312.23(a)(3)) (21 CFR 312.23(a)(7)) [| 5. Investigator\u2019s brochure (21 CFR 312.23(a)(5)) [| Environmental assessment or claim for exclusion [| 6. Protocol (21 CF" }, { "page": 2, "family": "CFR", "normalized": "21 CFR 312.23", "raw": "21 CFR 312.23", "context": "12.23(a)(5)) [| Environmental assessment or claim for exclusion [| 6. Protocol (21 CFR 312.23(a)(6)) (21 CFR 312.23(a)(7)(iv)(e)) [| a. Study protocol (21 CFR 312.23(a)(6))" }, { "page": 2, "family": "CFR", "normalized": "21 CFR 312.23", "raw": "21 CFR 312.23", "context": "nmental assessment or claim for exclusion [| 6. Protocol (21 CFR 312.23(a)(6)) (21 CFR 312.23(a)(7)(iv)(e)) [| a. Study protocol (21 CFR 312.23(a)(6)) [| 8. Pharmacology and" }, { "page": 2, "family": "CFR", "normalized": "21 CFR 312.23", "raw": "21 CFR 312.23", "context": "otocol (21 CFR 312.23(a)(6)) (21 CFR 312.23(a)(7)(iv)(e)) [| a. Study protocol (21 CFR 312.23(a)(6)) [| 8. Pharmacology and toxicology data (21 CFR 312.23(a)(8)) \u2018a b.| tig" }, { "page": 2, "family": "CFR", "normalized": "21 CFR 312.23", "raw": "21 CFR 312.23", "context": "a. Study protocol (21 CFR 312.23(a)(6)) [| 8. 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See FOIA exemption regarding circumvention. Product Testing Plans document how CBER" }, { "page": 2, "family": "CFR", "normalized": "21 CFR 610.2", "raw": "21 CFR 610.2", "context": "product including justification for any confirmatory CBER product testing, per 21 CFR 610.2(a). Additionally, for products on Surveillance, summarize the requirements for" } ] }, { "filename": "100A_BLA 125742-0_08-20-2021_Memo_Other.pdf", "id": 6295, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 5, "matches": [ { "page": 1, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ion contained in this document is CONFIDENTIAL and should not be released. See FOIA exemption regarding circumvention. Product Testing Plans document how CBER" }, { "page": 2, "family": "CFR", "normalized": "21 CFR 610.2", "raw": "21 CFR 610.2", "context": "product including justification for any confirmatory CBER product testing, per 21 CFR 610.2(a). Additionally, for products on Surveillance, summarize the requirements for" } ] }, { "filename": "101_Courtesy Copy_BLA 125742-0_Pharmacovigilance Plan Review-Addendum Memo - COMIRNATY.pdf", "id": 6296, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 9, "matches": [ { "page": 6, "family": "Named act", "normalized": "FD&C Act", "raw": "Federal Food, Drug, \nand Cosmetic Act", "context": "oposed PMRs/PMCs: \u2022 Postmarketing requirements (PMR) under Section 505(o) of Federal Food, Drug, and Cosmetic Act (FDCA) to assess known serious risks of myocarditis and pericarditis and an un" }, { "page": 6, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "quirements (PMR) under Section 505(o) of Federal Food, Drug, and Cosmetic Act (FDCA) to assess known serious risks of myocarditis and pericarditis and an unexpect" }, { "page": 8, "family": "CFR", "normalized": "21 CFR 600.80", "raw": "21 CFR 600.80", "context": "pharmacovigilance in accordance with adverse event reporting regulations under 21 CFR 600.80, as per sponsor\u2019s proposed PVP (version 1.1). \u2022 Postmarketing requirement (PMR" }, { "page": 8, "family": "Named act", "normalized": "FD&C Act", "raw": "Federal Food, Drug, and Cosmetic Act", "context": "\u2022 Postmarketing requirement (PMR) safety studies under Section 505(o) of the Federal Food, Drug, and Cosmetic Act (FDCA) to assess the known serious risks of myocarditis and pericarditis and a" }, { "page": 8, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "fety studies under Section 505(o) of the Federal Food, Drug, and Cosmetic Act (FDCA) to assess the known serious risks of myocarditis and pericarditis and an unex" } ] }, { "filename": "102_1_BLA 125742-0_08-20-2021_Memo_Test Results.pdf", "id": 6297, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 2, "matches": [] }, { "filename": "103_2_BLA 125742-0_08-20-2021_Memo_Test Results.pdf", "id": 6298, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 2, "matches": [] }, { "filename": "105_BLA 125742-0_08-20-2021_Telecon_Advice_Information.pdf", "id": 6299, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 3, "matches": [] }, { "filename": "107_1_BLA 125742-0_08-20-2021_Telecon_Labeling via FAX_e.pdf", "id": 6300, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 3, "matches": [] }, { "filename": "107A_1_BLA 125742-0_08-20-2021_Telecon_Labeling via FAX_e.pdf", "id": 6301, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 2, "matches": [] }, { "filename": "108_BLA 125742-0_08-21-2021_Inspection Related_Inspect.pdf", "id": 6302, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 29, "matches": [] }, { "filename": "109_Courtesy Copy_2_BLA 125742-0_CMC Review Memo, August 21, 2021 - COMIRNATY.pdf", "id": 6303, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 63, "matches": [ { "page": 5, "family": "CFR", "normalized": "21 CFR 610.15", "raw": "21 CFR 610.15", "context": "ptance criteria July 15, 2021 STN 125742/0.11 Request for an exception to the 21 CFR 610.15(a) for the vaccine as a preservative-free presentation July 23, 2021 STN 12" }, { "page": 48, "family": "CFR", "normalized": "21 CFR 610.15", "raw": "21 CFR 610.15", "context": "uction concentration of for ALC-0315 and for ALC-0159). Exception to the 21 CFR 610.15(a) Requirement for a Preservative Under 21 CFR 610.15(a), a vaccine product in" }, { "page": 48, "family": "CFR", "normalized": "21 CFR 610.15", "raw": "21 CFR 610.15", "context": "159). Exception to the 21 CFR 610.15(a) Requirement for a Preservative Under 21 CFR 610.15(a), a vaccine product in multiple-dose containers should contain a preservativ" }, { "page": 48, "family": "CFR", "normalized": "21 CFR 610.15", "raw": "21 CFR 610.15", "context": "cant submitted to STN 125742/0 in amendment 11, a request for exception to the 21 CFR 610.15(a) requirement. The justification for the unpreserved multi-dose presentation" }, { "page": 49, "family": "CFR", "normalized": "21 CFR 610.15", "raw": "21 CFR 610.15", "context": "al authorizations. Reviewer\u2019s Comments: The request for an exception to the 21 CFR 610.15(a) for the BNT162b2 vaccine as a multi-dose preservative-free presentation is" } ] }, { "filename": "110_1_Courtesy Copy_BLA 125742-0_Analytical Method Review Memo - COMIRNATY.pdf", "id": 6304, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 31, "matches": [] }, { "filename": "111_BLA 125742-0_08-21-2021_Telecon_Advice.pdf", "id": 6305, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 1, "matches": [] }, { "filename": "115_1_BLA 125742-0_08-21-2021_Telecon_Labeling via FAX_e.pdf", "id": 6306, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 1, "matches": [] }, { "filename": "116_BLA 125742-0_08-21-2021_Inspection Related_Establi.pdf", "id": 6307, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 86, "matches": [] }, { "filename": "117_2_BLA 125742-0_08-22-2021_Inspection Related_Inspect.pdf", "id": 6308, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 3, "matches": [] }, { "filename": "118_1_BLA 125742-0_08-22-2021_Inspection Related_Inspect.pdf", "id": 6309, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 3, "matches": [] }, { "filename": "119_Courtesy Copy_BLA 125742-0_Real World Evidence BLA Memo - COMIRNATY.pdf", "id": 6310, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 7, "matches": [ { "page": 7, "family": "Named act", "normalized": "FD&C Act", "raw": "Federal \nFood, Drug, and Cosmetic Act", "context": "ONS Postmarketing requirement (PMR) safety studies under Section 505(o) of the Federal Food, Drug, and Cosmetic Act (FDCA) to assess the known serious risks of myocarditis and pericarditis, usin" }, { "page": 7, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "fety studies under Section 505(o) of the Federal Food, Drug, and Cosmetic Act (FDCA) to assess the known serious risks of myocarditis and pericarditis, using real" } ] }, { "filename": "120_Courtesy Copy_BLA 125742-0_CBER CMC BLA Review Memo - COMIRNATY.pdf", "id": 6311, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 124, "matches": [] }, { "filename": "121_Courtesy Copy_BLA 125742-0_Employee-Officer List Memo, August 22, 2021 - COMIRNATY.pdf", "id": 6312, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 1, "matches": [] }, { "filename": "122_BLA 125742-0_08-22-2021_Telecon_Labeling via FAX_e.pdf", "id": 6313, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 1, "matches": [] }, { "filename": "123_Courtesy Copy_BLA 125742-0_August 23, 2021 Approval Letter - Comirnaty.pdf", "id": 6314, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 11, "matches": [ { "page": 1, "family": "Named act", "normalized": "PHS Act", "raw": "Public Health Service Act", "context": "ion (BLA) submitted and received on May 18, 2021, under section 351(a) of the Public Health Service Act (PHS Act) for COVID-19 Vaccine, mRNA. LICENSING We are issuing Departmen" }, { "page": 1, "family": "Named act", "normalized": "PHS Act", "raw": "PHS Act", "context": "eived on May 18, 2021, under section 351(a) of the Public Health Service Act (PHS Act) for COVID-19 Vaccine, mRNA. LICENSING We are issuing Department of Heal" }, { "page": 1, "family": "Named act", "normalized": "PHS Act", "raw": "PHS Act", "context": "ufacturing GmbH, Mainz, Germany, under the provisions of section 351(a) of the PHS Act controlling the manufacture and sale of biological products. The license auth" }, { "page": 2, "family": "CFR", "normalized": "21 CFR 601.12", "raw": "21 CFR \n601.12", "context": "ing the expiration dating period of your drug substance and drug product under 21 CFR 601.12. FDA LOT RELEASE Please submit final container samples of the product in fina" }, { "page": 2, "family": "CFR", "normalized": "21 CFR 600.14", "raw": "21 CFR 600.14", "context": "DUCT DEVIATIONS You must submit reports of biological product deviations under 21 CFR 600.14. You should identify and investigate all manufacturing deviations promptly, i" }, { "page": 3, "family": "CFR", "normalized": "21 CFR 601.12", "raw": "21 \nCFR 601.12", "context": "u must submit information to your BLA for our review and written approval under 21 CFR 601.12 for any changes in, including but not limited to, the manufacturing, testing," }, { "page": 3, "family": "CFR", "normalized": "21 CFR 601.14", "raw": "21 CFR 601.14", "context": "ays from the date of this letter, please submit the final content of labeling (21 CFR 601.14) in Structured Product Labeling (SPL) format via the FDA automated drug regist" }, { "page": 4, "family": "USC", "normalized": "21 U.S.C. \u00a7 355c", "raw": "21 U.S.C. 355c", "context": "m. PEDIATRIC REQUIREMENTS Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new active ingredients, new indications, new dosage for" }, { "page": 4, "family": "CFR", "normalized": "21 CFR 601.12", "raw": "21 CFR \n601.12", "context": "he time of initial dissemination or publication, accompanied by Form FDA 2253 (21 CFR 601.12(f)(4)). All promotional claims must be consistent with and not contrary to a" }, { "page": 4, "family": "CFR", "normalized": "21 CFR 202.1", "raw": "21 CFR 202.1", "context": "ubstantial evidence or substantial clinical experience to support such claims (21 CFR 202.1(e)(6)). ADVERSE EVENT REPORTING You must submit adverse experience report" }, { "page": 4, "family": "CFR", "normalized": "21 CFR 600.80", "raw": "21 CFR 600.80", "context": "he adverse experience reporting requirements for licensed biological products (21 CFR 600.80), and you must submit distribution reports at monthly intervals as described i" }, { "page": 4, "family": "CFR", "normalized": "21 CFR 600.81", "raw": "21 CFR \n600.81", "context": "and you must submit distribution reports at monthly intervals as described in 21 CFR 600.81. For information on adverse experience reporting, please refer to the guidance" }, { "page": 5, "family": "CFR", "normalized": "21 CFR 601.28", "raw": "21 CFR 601.28", "context": "dies. The status of these postmarketing studies must be reported according to 21 CFR 601.28 and section 505B(a)(4)(C) of the FDCA. In addition, section 506B of the FDCA" }, { "page": 5, "family": "CFR", "normalized": "21 CFR 601.70", "raw": "21 CFR 601.70", "context": "section 505B(a)(4)(C) of the FDCA. In addition, section 506B of the FDCA and 21 CFR 601.70 require you to report annually on the status of any postmarketing commitments" }, { "page": 5, "family": "Named act", "normalized": "FD&C Act", "raw": "Federal Food, \nDrug, and Cosmetic Act", "context": "arkins Your deferred pediatric studies required under section 505B(a) of the Federal Food, Drug, and Cosmetic Act (FDCA) are required postmarketing studies. The status of these postmarketing" }, { "page": 5, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "es required under section 505B(a) of the Federal Food, Drug, and Cosmetic Act (FDCA) are required postmarketing studies. The status of these postmarketing studie" }, { "page": 5, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "s must be reported according to 21 CFR 601.28 and section 505B(a)(4)(C) of the FDCA. In addition, section 506B of the FDCA and 21 CFR 601.70 require you to repor" }, { "page": 5, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "01.28 and section 505B(a)(4)(C) of the FDCA. In addition, section 506B of the FDCA and 21 CFR 601.70 require you to report annually on the status of any postmark" }, { "page": 5, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "nd Commitments subject to the reporting requirements under section 506B of the FDCA are released or fulfilled. These required studies are listed below: 1. Def" }, { "page": 6, "family": "USC", "normalized": "21 U.S.C. \u00a7 355", "raw": "21 U.S.C. 355", "context": ", if FDA makes certain findings required by the statute (section 505(o)(3)(A), 21 U.S.C. 355(o)(3)(A)). We have determined that an analysis of spontaneous postmarketing" }, { "page": 6, "family": "Named act", "normalized": "FD&C Act", "raw": "Federal Food, Drug, and Cosmetic Act", "context": "on. POSTMARKETING REQUIREMENTS UNDER SECTION 505(o) Section 505(o) of the Federal Food, Drug, and Cosmetic Act (FDCA) authorizes FDA to require holders of approved drug and biological produ" }, { "page": 6, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "R SECTION 505(o) Section 505(o) of the Federal Food, Drug, and Cosmetic Act (FDCA) authorizes FDA to require holders of approved drug and biological product app" }, { "page": 6, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "ontaneous postmarketing adverse events reported under section 505(k)(1) of the FDCA will not be sufficient to assess known serious risks of myocarditis and perica" }, { "page": 6, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "gilance system that FDA is required to maintain under section 505(k)(3) of the FDCA is not sufficient to assess these serious risks. Therefore, based on appropr" }, { "page": 8, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "marketing Final Report under Section 505(o) Section 505(o)(3)(E)(ii) of the FDCA requires you to report periodically on the status of any study or clinical tri" }, { "page": 9, "family": "CFR", "normalized": "21 CFR 601.70", "raw": "21 \nCFR 601.70", "context": "taken to investigate a safety issue. In addition, section 506B of the FDCA and 21 CFR 601.70 require you to report annually on the status of any postmarketing commitments" }, { "page": 9, "family": "CFR", "normalized": "21 CFR 601.70", "raw": "21 CFR 601.70", "context": "number enrolled to date and the total planned enrollment). As described in 21 CFR 601.70(e), we may publicly disclose information regarding these postmarketing studies" }, { "page": 9, "family": "CFR", "normalized": "21 CFR 601.70", "raw": "21 CFR 601.70", "context": "nsider the submission of your annual report under section 506B of the FDCA and 21 CFR 601.70 to satisfy the periodic reporting requirement under section 505(o)(3)(E)(ii) p" }, { "page": 9, "family": "CFR", "normalized": "21 CFR 601.70", "raw": "21 \nCFR 601.70", "context": ")(3)(E)(ii) provided that you include the elements listed in section 505(o) and 21 CFR 601.70. We remind you that to comply with section 505(o), your annual report must a" }, { "page": 9, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "undertaken to investigate a safety issue. In addition, section 506B of the FDCA and 21 CFR 601.70 require you to report annually on the status of any postmark" }, { "page": 9, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "s and Commitments subject to the reporting requirements of section 506B of the FDCA are fulfilled or released. The status report for each study should include:" }, { "page": 9, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "We will consider the submission of your annual report under section 506B of the FDCA and 21 CFR 601.70 to satisfy the periodic reporting requirement under section" }, { "page": 9, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "studies or clinical trials required under section 505(o) may be a violation of FDCA section 505(o)(3)(E)(ii) and could result in regulatory action. POSTMARKETI" }, { "page": 11, "family": "CFR", "normalized": "21 CFR 601.70", "raw": "21 CFR 601.70", "context": "arkins For each postmarketing study subject to the reporting requirements of 21 CFR 601.70, you must describe the status in an annual report on postmarketing studies for" }, { "page": 11, "family": "CFR", "normalized": "21 CFR 601.70", "raw": "21 CFR 601.70", "context": ", number enrolled to date and the total planned enrollment). As described in 21 CFR 601.70(e), we may publicly disclose information regarding these postmarketing studies" }, { "page": 11, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "s and Commitments subject to the reporting requirements of section 506B of the FDCA are fulfilled or released. The status report for each study should include:" } ] }, { "filename": "124_BLA 125742-0_08-23-2021_Memo_Committee Memo_SBRA.pdf", "id": 6315, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 31, "matches": [ { "page": 9, "family": "CFR", "normalized": "21 CFR 610.15", "raw": "21 CFR 610.15", "context": "it does not contain preservative. [See section 10.b regarding exception to the 21 CFR 610.15(a) requirement for a preservative.] Stability of COMIRNATY The Applicant co" }, { "page": 14, "family": "CFR", "normalized": "21 CFR 25.31", "raw": "21 CFR 25.31", "context": "ded a request for categorical exclusion from an Environmental Assessment under 21 CFR 25.31. The FDA concluded that this request is justified, and no extraordinary circum" }, { "page": 23, "family": "Named act", "normalized": "FD&C Act", "raw": "Federal Food, Drug, and Cosmetic Act", "context": "uct postmarketing requirement (PMR) safety studies under Section 505(o) of the Federal Food, Drug, and Cosmetic Act (FDCA) to assess the known serious risks of myocarditis and pericarditis as we" }, { "page": 23, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "fety studies under Section 505(o) of the Federal Food, Drug, and Cosmetic Act (FDCA) to assess the known serious risks of myocarditis and pericarditis as well as" }, { "page": 24, "family": "Named act", "normalized": "FD&C Act", "raw": "Federal \nFood, Drug, and Cosmetic Act", "context": "uct postmarketing requirement (PMR) safety studies under Section 505(o) of the Federal Food, Drug, and Cosmetic Act (FDCA) to assess the known serious risks of myocarditis and pericarditis and a" }, { "page": 24, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "fety studies under Section 505(o) of the Federal Food, Drug, and Cosmetic Act (FDCA) to assess the known serious risks of myocarditis and pericarditis and an unex" }, { "page": 25, "family": "CFR", "normalized": "21 CFR 600.80", "raw": "21 CFR 600.80", "context": "c Recommendation for Postmarketing Activities. Adverse event reporting under 21 CFR 600.80 and the postmarketing studies in Section 11c are adequate to monitor the postm" }, { "page": 27, "family": "CFR", "normalized": "21 CFR 610.15", "raw": "21 CFR 610.15", "context": "d listed at the website included in the Dear HCP letter. b. Exception to the 21 CFR 610.15(a) Requirement for a Preservative Under 21 CFR 610.15(a), a vaccine product in" }, { "page": 27, "family": "CFR", "normalized": "21 CFR 610.15", "raw": "21 CFR 610.15", "context": ". b. Exception to the 21 CFR 610.15(a) Requirement for a Preservative Under 21 CFR 610.15(a), a vaccine product in multiple-dose containers must (absent certain excepti" }, { "page": 27, "family": "CFR", "normalized": "21 CFR 610.15", "raw": "21 CFR 610.15", "context": "preservative. CBER considered the Applicant\u2019s request for an exception to the 21 CFR 610.15(a) for COMIRNATY as a multiple dose preservative-free presentation acceptable." } ] }, { "filename": "125_BLA 125742-0_08-23-2021_Memo_Committee Memo_Toxico.pdf", "id": 6316, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 124, "matches": [] }, { "filename": "125742_S1_M1_1.9.2_ped-studies-deferral-req.pdf", "id": 6317, "module": "M1", "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/125742_S1_M1_1.9.2_ped-studies-deferral-req.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/125742_S1_M1_1.9.2_ped-studies-deferral-req.pdf", "total_pages": 3, "matches": [] }, { "filename": "125742_S1_M1_1.9.4_ipsp-agreed.pdf", "id": 6318, "module": "M1", "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/125742_S1_M1_1.9.4_ipsp-agreed.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/125742_S1_M1_1.9.4_ipsp-agreed.pdf", "total_pages": 23, "matches": [] }, { "filename": "125742_S1_M1_financial-cert-3455.pdf", "id": 6319, "module": "M1", "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/125742_S1_M1_financial-cert-3455.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/125742_S1_M1_financial-cert-3455.pdf", "total_pages": 18, "matches": [ { "page": 1, "family": "CFR", "normalized": "21 CFR 54.2", "raw": "21 CFR 54.2", "context": "d by the clinical investigator; any significant equity interest, as defined in 21 CFR 54.2(b), held by the dinical investigator in the sponsor of the covered study. 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Accordingly, it may vary from an investigator list compiled from Forms FDA 1" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 54", "raw": "21 CFR Part 54", "context": "f other sorts are checked via internal Pfizer procedures. 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"module": "M1", "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/125742_S61_M1_cover.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/125742_S61_M1_cover.pdf", "total_pages": 2, "matches": [] }, { "filename": "125742_S61_M1_response-17aug2021.pdf", "id": 6449, "module": "M1", "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/125742_S61_M1_response-17aug2021.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/125742_S61_M1_response-17aug2021.pdf", "total_pages": 2, "matches": [] }, { "filename": "125742_S63_M1_cover.pdf", "id": 6450, "module": "M1", "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/125742_S63_M1_cover.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/125742_S63_M1_cover.pdf", "total_pages": 2, 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Please acknowledge our request and keep us updated on the progress of your" } ] }, { "filename": "125742_S80_M1_cover.pdf", "id": 6452, "module": "M1", "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/125742_S80_M1_cover.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/125742_S80_M1_cover.pdf", "total_pages": 2, "matches": [] }, { "filename": "125742-0_20219001.P0.pdf", "id": 6453, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/125742-0_20219001.P0.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/125742-0_20219001.P0.pdf", "total_pages": 18, "matches": [] }, { "filename": "125742-0_20219001.PC1.pdf", "id": 6454, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 18, "matches": [] }, { "filename": "125742-0_20219002.P0.pdf", "id": 6455, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/125742-0_20219002.P0.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/125742-0_20219002.P0.pdf", "total_pages": 18, "matches": [] }, { "filename": "125742-0_20219002.PC1.pdf", "id": 6456, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 18, "matches": [] }, { "filename": "125742-0_20219003.P0.pdf", "id": 6457, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/125742-0_20219003.P0.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/125742-0_20219003.P0.pdf", "total_pages": 17, "matches": [] }, { "filename": "125742-0_20219003.PC1.pdf", "id": 6458, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 17, "matches": [] }, { "filename": "125742-0_20219004.P0.pdf", "id": 6459, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/125742-0_20219004.P0.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/125742-0_20219004.P0.pdf", "total_pages": 18, "matches": [] }, { "filename": "125742-0_20219005.P0.pdf", "id": 6460, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/125742-0_20219005.P0.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/125742-0_20219005.P0.pdf", "total_pages": 17, "matches": [] }, { "filename": "125742-0_20219006.P0.pdf", "id": 6461, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/125742-0_20219006.P0.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/125742-0_20219006.P0.pdf", "total_pages": 18, "matches": [] }, { "filename": "125742-0_20219006.PC1.pdf", "id": 6462, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 18, "matches": [] }, { "filename": "125742-0_20219007.P0.pdf", "id": 6463, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/125742-0_20219007.P0.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/125742-0_20219007.P0.pdf", "total_pages": 18, "matches": [] }, { "filename": "125742-0_20219008.P0.pdf", "id": 6464, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/125742-0_20219008.P0.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/125742-0_20219008.P0.pdf", "total_pages": 17, "matches": [] }, { "filename": "125742-0_20219009.P0.pdf", "id": 6465, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/125742-0_20219009.P0.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/125742-0_20219009.P0.pdf", "total_pages": 17, "matches": [] }, { "filename": "127_Courtesy Copy_BLA 125742-0_CBER Sentinel Program Sufficiency Memo - 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FDA has determined that an analysis of spontaneous postmarketing a" }, { "page": 101, "family": "Named act", "normalized": "FD&C Act", "raw": "Federal Food, Drug, and Cosmetic Act", "context": "lication. 11.6 Recommendations on Postmarketing Actions Section 505(o) of the Federal Food, Drug, and Cosmetic Act (FDCA) authorizes FDA to require holders of approved drug and biological produ" }, { "page": 101, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "tmarketing Actions Section 505(o) of the Federal Food, Drug, and Cosmetic Act (FDCA) authorizes FDA to require holders of approved drug and biological product app" }, { "page": 101, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "ontaneous postmarketing adverse events reported under section 505(k)(1) of the FDCA will not be sufficient to assess known serious risks of myocarditis and perica" }, { "page": 101, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "gilance system that FDA is required to maintain under section 505(k)(3) of the FDCA is not sufficient to assess these serious risks. 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[See section 10.b regarding exception to the 21 CFR 610.15(a) requirement for a preservative.] Stability of COMIRNATY The Applicant cond" }, { "page": 14, "family": "CFR", "normalized": "21 CFR 25.31", "raw": "21 CFR 25.31", "context": "ded a request for categorical exclusion from an Environmental Assessment under 21 CFR 25.31. The FDA concluded that this request is justified, and no extraordinary circum" }, { "page": 23, "family": "Named act", "normalized": "FD&C Act", "raw": "Federal Food, Drug, and Cosmetic Act", "context": "uct postmarketing requirement (PMR) safety studies under Section 505(o) of the Federal Food, Drug, and Cosmetic Act (FDCA) to assess the known serious risks of myocarditis and pericarditis as we" }, { "page": 23, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "fety studies under Section 505(o) of the Federal Food, Drug, and Cosmetic Act (FDCA) to assess the known serious risks of myocarditis and pericarditis as well as" }, { "page": 24, "family": "Named act", "normalized": "FD&C Act", "raw": "Federal \nFood, Drug, and Cosmetic Act", "context": "uct postmarketing requirement (PMR) safety studies under Section 505(o) of the Federal Food, Drug, and Cosmetic Act (FDCA) to assess the known serious risks of myocarditis and pericarditis and a" }, { "page": 24, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "fety studies under Section 505(o) of the Federal Food, Drug, and Cosmetic Act (FDCA) to assess the known serious risks of myocarditis and pericarditis and an unex" }, { "page": 25, "family": "CFR", "normalized": "21 CFR 600.80", "raw": "21 CFR 600.80", "context": "11c Recommendation for Postmarketing Activities. Adverse event reporting under 21 CFR 600.80 and the postmarketing studies in Section 11c are adequate to monitor the postm" }, { "page": 27, "family": "CFR", "normalized": "21 CFR 610.15", "raw": "21 CFR 610.15", "context": "and listed at the website included in the Dear HCP letter. b. Exception to the 21 CFR 610.15(a) Requirement for a Preservative Under 21 CFR 610.15(a), a vaccine product in" }, { "page": 27, "family": "CFR", "normalized": "21 CFR 610.15", "raw": "21 CFR 610.15", "context": "er. b. Exception to the 21 CFR 610.15(a) Requirement for a Preservative Under 21 CFR 610.15(a), a vaccine product in multiple-dose containers must (absent certain excepti" }, { "page": 27, "family": "CFR", "normalized": "21 CFR 610.15", "raw": "21 CFR 610.15", "context": "preservative. CBER considered the Applicant\u2019s request for an exception to the 21 CFR 610.15(a) for COMIRNATY as a multiple dose preservative-free presentation acceptable." } ] }, { "filename": "136_BLA_125742_RNAcontent_InSupportTesting.pdf", "id": 6474, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/136_BLA_125742_RNAcontent_InSupportTesting.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/136_BLA_125742_RNAcontent_InSupportTesting.pdf", "total_pages": 2, "matches": [] }, { "filename": "137_BLA_125742_Endotoxin release tests lots FD7220, FE3592, FF2587.pdf", "id": 6475, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 6, "matches": [] }, { "filename": "138_BLA_125742_STN125742 release test (pH) lots FD7220, FE3592, FF2587.pdf", "id": 6476, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 7, "matches": [] }, { "filename": "15_BLA 125742-0_07-02-2021_Telecon_Information Reques.pdf", "id": 6477, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 4, "matches": [] }, { "filename": "18_BLA 125742-0_07-09-2021_Telecon_Information Reques.pdf", "id": 6478, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 2, "matches": [] }, { "filename": "2_IND_19736_214_03-Mar-2021_KERRY_KERRY__RO_ .pdf", "id": 6479, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 2, "matches": [] }, { "filename": "21_BLA 125742-0_07-15-2021_Letter_Filing Notification.pdf", "id": 6480, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 3, "matches": [ { "page": 2, "family": "CFR", "normalized": "21 CFR 601.2", "raw": "21 CFR 601.2", "context": "ur application is sufficiently complete to permit a substantive review. Under 21 CFR 601.2(a), we have filed your application today. The review classification for this" }, { "page": 2, "family": "Named act", "normalized": "PHS Act", "raw": "Public Health Service Act", "context": "ion (BLA) submitted and received on May 18, 2021, under section 351(a) of the Public Health Service Act (PHS Act) for COVID-19 mRNA Vaccine. We also refer to your amendments submi" }, { "page": 2, "family": "Named act", "normalized": "PHS Act", "raw": "PHS Act", "context": "eived on May 18, 2021, under section 351(a) of the Public Health Service Act (PHS Act) for COVID-19 mRNA Vaccine. We also refer to your amendments submitted and" }, { "page": 3, "family": "USC", "normalized": "21 U.S.C. \u00a7 355c", "raw": "21 U.S.C. 355c", "context": "UIRED PEDIATRIC ASSESSMENTS Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new active ingredients, new indications, new dosage for" } ] }, { "filename": "25_1_BLA 125742-0_07-16-2021_Telecon_Information Reques.pdf", "id": 6481, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 2, "matches": [] }, { "filename": "26_2_BLA 125742-0_07-16-2021_Telecon_Information Reques.pdf", "id": 6482, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 1, "matches": [] }, { "filename": "27_BLA 125742-0_07-19-2021_Telecon_Advice.pdf", "id": 6483, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 1, "matches": [] }, { "filename": "3_BLA 125742-0_05-20-2021_Telecon_Information Reques.pdf", "id": 6484, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 2, "matches": [] }, { "filename": "3_IND_19736_243_19-Mar-2021_KERRY_KERRY__RO_ .pdf", "id": 6485, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 2, "matches": [] }, { "filename": "32_1_BLA 125742-0_07-26-2021_Telecon_Information Reques.pdf", "id": 6486, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 4, "matches": [] }, { "filename": "33_1_BLA 125742-0_07-27-2021_Telecon_Information Reques.pdf", "id": 6487, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 2, "matches": [] }, { "filename": "39_2_BLA 125742-0_08-02-2021_Telecon_Information Reques.pdf", "id": 6488, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 3, "matches": [ { "page": 2, "family": "CFR", "normalized": "21 CFR 610.2", "raw": "21 CFR 610.2", "context": "results should a re-validation and/or assay transfer be performed. 5. Under 21 CFR 610.2(a), manufacturers may be required to submit samples from all lots of a license" } ] }, { "filename": "4_IND_19736_289_27-Apr-2021_DEBORAH_DEBORAH__RC_.pdf", "id": 6489, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/4_IND_19736_289_27-Apr-2021_DEBORAH_DEBORAH__RC_.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/4_IND_19736_289_27-Apr-2021_DEBORAH_DEBORAH__RC_.pdf", "total_pages": 2, "matches": [] }, { "filename": "40_2_BLA 125742-0_08-03-2021_Telecon_Information Reques.pdf", "id": 6490, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 3, "matches": [] }, { "filename": "42_1_BLA 125742-0_08-04-2021_Telecon_Information Reques.pdf", "id": 6491, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 3, "matches": [] }, { "filename": "43A_STN 125742.0 4AUG21 LRP FU IR 2.pdf", "id": 6492, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 6, "matches": [] }, { "filename": "44_3_BLA 125742-0_08-04-2021_Telecon_Information Reques.pdf", "id": 6493, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 2, "matches": [] }, { "filename": "45_BLA 125742-0_08-05-2021_Telecon_Advice.pdf", "id": 6494, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 1, "matches": [] }, { "filename": "46_2_BLA 125742-0_08-05-2021_Telecon_Information Reques.pdf", "id": 6495, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 5, "matches": [] }, { "filename": "47_1_BLA 125742-0_08-05-2021_Telecon_Information Reques.pdf", "id": 6496, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 2, "matches": [] }, { "filename": "49_BLA 125742-0_08-06-2021_Letter_UNII Code Notificat.pdf", "id": 6497, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 3, "matches": [ { "page": 2, "family": "Public Law", "normalized": "Pub. L. 110-85", "raw": "Pub. L. No. 110-85", "context": "Dear Ms. Harkins: The Food and Drug Administration Amendments Act of 2007 (Pub. L. No. 110-85) (FDAAA) requires that establishment registration and drug listing be accompli" } ] }, { "filename": "5_IND_19736_335_19-May-2021_DEBORAH_DEBORAH__RC_.pdf", "id": 6498, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/5_IND_19736_335_19-May-2021_DEBORAH_DEBORAH__RC_.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/5_IND_19736_335_19-May-2021_DEBORAH_DEBORAH__RC_.pdf", "total_pages": 2, "matches": [] }, { "filename": "51_Courtesy Copy_BLA 125742-0_Pharmacovigilance Plan Review Memo - COMIRNATY.pdf", "id": 6499, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 33, "matches": [ { "page": 31, "family": "CFR", "normalized": "21 CFR 600.80", "raw": "21 CFR 600.80", "context": "pharmacovigilance in accordance with adverse event reporting regulations under 21 CFR 600.80, as per the sponsor\u2019s proposed PVP." }, { "page": 32, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "\u2022 Post-marketing requirement (PMR) safety study under Section 505(o) of the FDCA (amended by FDAAA, Title IX, Section 901), to assess the serious risk of myope" } ] }, { "filename": "52_1_BLA 125742-0_08-06-2021_Telecon_Information Reques.pdf", "id": 6500, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 2, "matches": [] }, { "filename": "53_2_BLA 125742-0_08-06-2021_Telecon_Information Reques.pdf", "id": 6501, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 2, "matches": [] }, { "filename": "54_BLA 125742-0_08-09-2021_Inspection Related_Inspect.pdf.pdf", "id": 6502, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 5, "matches": [] }, { "filename": "55_BLA 125742-0_08-09-2021_Telecon_Advice.pdf", "id": 6503, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 5, "matches": [ { "page": 4, "family": "CFR", "normalized": "21 CFR 610.2", "raw": "21 CFR 610.2", "context": "on results should a re-validation and/or assay transfer be performed. 5. Under 21 CFR 610.2(a), manufacturers may be required to submit samples from all lots of a license" } ] }, { "filename": "58_2_BLA 125742-0_08-10-2021_Telecon_Information Reques.pdf", "id": 6504, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 2, "matches": [] }, { "filename": "6_IND_19736_366_24-Jun-2021_DEBORAH_DEBORAH__RO_.pdf", "id": 6505, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/6_IND_19736_366_24-Jun-2021_DEBORAH_DEBORAH__RO_.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/6_IND_19736_366_24-Jun-2021_DEBORAH_DEBORAH__RO_.pdf", "total_pages": 2, "matches": [] }, { "filename": "60_BLA 125742-0_08-11-2021_Telecon_Information Reques.pdf", "id": 6506, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 2, "matches": [] }, { "filename": "61_BLA 125742-0_08-11-2021_Telecon_Other.pdf", "id": 6507, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 3, "matches": [] }, { "filename": "62_BLA 125742-0_08-12-2021_Memo_Committee Memo_Requir.pdf", "id": 6508, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 2, "matches": [] }, { "filename": "64_Courtesy Copy_BLA 125742-0_Bioresearch Monitoring Discipline Review Memo, August 13, 2021 - COMIRNATY.pdf", "id": 6509, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 3, "matches": [ { "page": 1, "family": "Named act", "normalized": "FD&C Act", "raw": "Federal Food, Drug, and Cosmetic Act", "context": "f Emergency Use Authorization (EUA) Declaration pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act or the Act)." }, { "page": 1, "family": "Named act", "normalized": "FD&C Act", "raw": "FD&C \nAct", "context": "ration pursuant to Section 564 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act or the Act)." } ] }, { "filename": "65_BLA 125742-0_08-13-2021_Memo_Request For Complianc.pdf", "id": 6510, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 4, "matches": [] }, { "filename": "66_4_BLA 125742-0_08-13-2021_Telecon_Information Reques.pdf", "id": 6511, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 3, "matches": [] }, { "filename": "68_5_BLA 125742-0_08-13-2021_Telecon_Information Reques.pdf", "id": 6512, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 2, "matches": [] }, { "filename": "68A_5_BLA 125742-0_08-13-2021_Telecon_Information Reques.pdf", "id": 6513, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 4, "matches": [] }, { "filename": "68B_5_BLA 125742-0_08-13-2021_Telecon_Information Reques.pdf", "id": 6514, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 4, "matches": [] }, { "filename": "7_IND_19736_409_26-Jul-2021_DEBORAH_DEBORAH__RO_.pdf", "id": 6515, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/7_IND_19736_409_26-Jul-2021_DEBORAH_DEBORAH__RO_.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/7_IND_19736_409_26-Jul-2021_DEBORAH_DEBORAH__RO_.pdf", "total_pages": 2, "matches": [] }, { "filename": "73_2_BLA 125742-0_08-16-2021_Telecon_Information Reques.pdf", "id": 6516, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 2, "matches": [] }, { "filename": "74_3_BLA 125742-0_08-16-2021_Telecon_Information Reques.pdf", "id": 6517, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 1, "matches": [] }, { "filename": "75_1_BLA 125742-0_08-16-2021_Telecon_Information Reques.pdf", "id": 6518, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 2, "matches": [] }, { "filename": "79_3_BLA 125742-0_08-17-2021_Telecon_Information Reques.pdf", "id": 6519, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 2, "matches": [] }, { "filename": "8_1_BLA 125742-0_06-25-2021_Telecon_Information Reques.pdf", "id": 6520, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 4, "matches": [] }, { "filename": "8_IND_19736_453_26-Aug-2021_DEBORAH_DEBORAH__RO_.pdf", "id": 6521, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/8_IND_19736_453_26-Aug-2021_DEBORAH_DEBORAH__RO_.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/8_IND_19736_453_26-Aug-2021_DEBORAH_DEBORAH__RO_.pdf", "total_pages": 2, "matches": [] }, { "filename": "81_1_BLA 125742-0_08-17-2021_Telecon_Information Reques.pdf", "id": 6522, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 2, "matches": [] }, { "filename": "83_BLA 125742-0_08-17-2021_Telecon_Other.pdf", "id": 6523, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 4, "matches": [] }, { "filename": "84_BLA 125742-0_08-18-2021_Memo_Committee Memo_Review.pdf", "id": 6524, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 3, "matches": [] }, { "filename": "85_Courtesy Copy_BLA 125742-0_Statistical Review -- COMIRNATY.pdf", "id": 6525, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 11, "matches": [] }, { "filename": "86_BLA 125742-0_08-18-2021_Telecon_Advice.pdf", "id": 6526, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 4, "matches": [] }, { "filename": "87_3_BLA 125742-0_08-18-2021_Telecon_Information Reques.pdf", "id": 6527, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 3, "matches": [] }, { "filename": "89_1_BLA 125742-0_08-18-2021_Telecon_Information Reques.pdf", "id": 6528, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 2, "matches": [ { "page": 1, "family": "CFR", "normalized": "21 CFR 601.12", "raw": "21 CFR 601.12", "context": "t release protocol template, to CBER as a CBE-30 supplement in accordance with 21 CFR 601.12(c). Please acknowledge our request and keep us updated on the progress of your" } ] }, { "filename": "9_IND_19736_491_29-Sep-2021_DEBORAH_DEBORAH__RO_ The Summary Monthly Safety Report has been reviewed. No furthe.pdf", "id": 6529, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 2, "matches": [] }, { "filename": "92_BLA 125742-0_08-19-2021_Inspection Related_Inspect.pdf", "id": 6530, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 79, "matches": [] }, { "filename": "93_Courtesy Copy_2_BLA 125742-0_Statistical Review - COMIRNATY.pdf", "id": 6531, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 26, "matches": [] }, { "filename": "94_Courtesy Copy_1_BLA 125742-0_Statistical Review-COMIRNATY.pdf", "id": 6532, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 16, "matches": [] }, { "filename": "95_BLA 125742-0_08-19-2021_Memo_Compliance Check Acce.pdf", "id": 6533, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 7, "matches": [] }, { "filename": "99_BLA 125742-0_08-20-2021_Memo_Committee Memo_Labeli.pdf", "id": 6534, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 31, "matches": [ { "page": 1, "family": "CFR", "normalized": "21 CFR 201.25", "raw": "21 CFR 201.25", "context": "urs, Belgium These labels were reviewed for compliance with the regulations 21 CFR 201.25 & 21 CFR 207.35, Subpart G \u2013 Labeling Standards 21 CFR 610.60 (a)(1) through" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 207.35", "raw": "21 CFR 207.35", "context": "These labels were reviewed for compliance with the regulations 21 CFR 201.25 & 21 CFR 207.35, Subpart G \u2013 Labeling Standards 21 CFR 610.60 (a)(1) through (7) and 21 CFR 61" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 610.60", "raw": "21 CFR 610.60", "context": "the regulations 21 CFR 201.25 & 21 CFR 207.35, Subpart G \u2013 Labeling Standards 21 CFR 610.60 (a)(1) through (7) and 21 CFR 610.60 (7) (b) through (e), 21 CFR 610.62 (a) th" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 610.60", "raw": "21 CFR 610.60", "context": "FR 207.35, Subpart G \u2013 Labeling Standards 21 CFR 610.60 (a)(1) through (7) and 21 CFR 610.60 (7) (b) through (e), 21 CFR 610.62 (a) through (c), 21 CFR 610.63, 21 CFR 610." }, { "page": 1, "family": "CFR", "normalized": "21 CFR 610.62", "raw": "21 CFR 610.62", "context": "ndards 21 CFR 610.60 (a)(1) through (7) and 21 CFR 610.60 (7) (b) through (e), 21 CFR 610.62 (a) through (c), 21 CFR 610.63, 21 CFR 610.64, 21 CFR 610.67, the Drug Supply" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 610.63", "raw": "21 CFR 610.63", "context": "ough (7) and 21 CFR 610.60 (7) (b) through (e), 21 CFR 610.62 (a) through (c), 21 CFR 610.63, 21 CFR 610.64, 21 CFR 610.67, the Drug Supply Chain Security Act (DSCSA) and" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 610.64", "raw": "21 CFR 610.64", "context": "CFR 610.60 (7) (b) through (e), 21 CFR 610.62 (a) through (c), 21 CFR 610.63, 21 CFR 610.64, 21 CFR 610.67, the Drug Supply Chain Security Act (DSCSA) and CBER Job Aid 90" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 610.67", "raw": "21 CFR 610.67", "context": "(b) through (e), 21 CFR 610.62 (a) through (c), 21 CFR 610.63, 21 CFR 610.64, 21 CFR 610.67, the Drug Supply Chain Security Act (DSCSA) and CBER Job Aid 900.08: National" }, { "page": 4, "family": "CFR", "normalized": "21 CFR 201.25", "raw": "21 CFR 201.25", "context": "ull review. Recommendations These labels are currently in compliance with 21 CFR 201.25, 21 CFR 207.35 and 21 CFR 610.60 through 21 CFR 610.67, Drug Supply Chain Secu" }, { "page": 4, "family": "CFR", "normalized": "21 CFR 207.35", "raw": "21 CFR 207.35", "context": "Recommendations These labels are currently in compliance with 21 CFR 201.25, 21 CFR 207.35 and 21 CFR 610.60 through 21 CFR 610.67, Drug Supply Chain Security Act (DSCS" }, { "page": 4, "family": "CFR", "normalized": "21 CFR 610.60", "raw": "21 CFR 610.60", "context": "These labels are currently in compliance with 21 CFR 201.25, 21 CFR 207.35 and 21 CFR 610.60 through 21 CFR 610.67, Drug Supply Chain Security Act (DSCSA), the Guidance fo" }, { "page": 4, "family": "CFR", "normalized": "21 CFR 610.67", "raw": "21 CFR 610.67", "context": "ntly in compliance with 21 CFR 201.25, 21 CFR 207.35 and 21 CFR 610.60 through 21 CFR 610.67, Drug Supply Chain Security Act (DSCSA), the Guidance for Industry, \u201cSelection" }, { "page": 5, "family": "CFR", "normalized": "21 CFR 610.61", "raw": "21 CFR 610.61", "context": "and August 19, 2021. 21 CFR 610.61 (a) through (s) Checked items \u201cx\u201d indicate compliance a. The proper name" }, { "page": 6, "family": "CFR", "normalized": "21 CFR 201.25", "raw": "21 CFR 201.25", "context": "Review (Package) appendix 1 JA 900.08: NDC, Bar Code, & Product Identifiers/21 CFR 201.25 & 21 CFR 207.35 (3)(i) Checked items" }, { "page": 6, "family": "CFR", "normalized": "21 CFR 207.35", "raw": "21 \n CFR 207.35", "context": ") appendix 1 JA 900.08: NDC, Bar Code, & Product Identifiers/21 CFR 201.25 & 21 CFR 207.35 (3)(i) Checked items \u201cx\u201d indicate compliance 9. Barcode & Linear or One" }, { "page": 8, "family": "CFR", "normalized": "21 CFR 610.60", "raw": "21 CFR 610.60", "context": ", and August 19, 2021. 21 CFR 610.60(a)(1) through (7) Checked items \u201cx\u201d indicate compliance a. Full label. T" }, { "page": 8, "family": "CFR", "normalized": "21 CFR 610.62", "raw": "21 CFR 610.62", "context": "aced on the package label. N/A 21 CFR 610.62 (7) (b) through (e) Checked items \u201cx\u201d indicate compliance b. Package lab" }, { "page": 9, "family": "CFR", "normalized": "21 CFR 201.25", "raw": "21 CFR 201.25", "context": "ainer) appendix 2 JA 900.08: NDC, Bar Code, & Product Identifiers/21 CFR 201.25 & 21 CFR 207.35 (3)(i) *8. Barcode Linear or One-Dimensional (1D)" }, { "page": 9, "family": "CFR", "normalized": "21 CFR 207.35", "raw": "21 CFR 207.35", "context": "2 JA 900.08: NDC, Bar Code, & Product Identifiers/21 CFR 201.25 & 21 CFR 207.35 (3)(i) *8. Barcode Linear or One-Dimensional (1D) (Parallel Lines" }, { "page": 11, "family": "CFR", "normalized": "21 CFR 610.61", "raw": "21 CFR 610.61", "context": "and August 19, 2021. 21 CFR 610.61 (a) through (s) Checked items \u201cx\u201d indicate compliance a. The proper name" }, { "page": 12, "family": "CFR", "normalized": "21 CFR 201.25", "raw": "21 CFR 201.25", "context": "Review (Package) appendix 3 JA 900.08: NDC, Bar Code, & Product Identifiers/21 CFR 201.25 & 21 CFR 207.35 (3)(i) Checked items" }, { "page": 12, "family": "CFR", "normalized": "21 CFR 207.35", "raw": "21 \n CFR 207.35", "context": ") appendix 3 JA 900.08: NDC, Bar Code, & Product Identifiers/21 CFR 201.25 & 21 CFR 207.35 (3)(i) Checked items \u201cx\u201d indicate compliance 9. Barcode & Linear or One" }, { "page": 14, "family": "CFR", "normalized": "21 CFR 610.60", "raw": "21 CFR 610.60", "context": "1, and August 19, 2021. 21 CFR 610.60(a)(1) through (7) Checked items \u201cx\u201d indicate compliance b. Full label. T" }, { "page": 14, "family": "CFR", "normalized": "21 CFR 610.62", "raw": "21 CFR 610.62", "context": "aced on the package label. N/A 21 CFR 610.62 (7) (b) through (e) Checked items \u201cx\u201d indicate compliance b. Package lab" }, { "page": 15, "family": "CFR", "normalized": "21 CFR 201.25", "raw": "21 CFR 201.25", "context": "ainer) appendix 4 JA 900.08: NDC, Bar Code, & Product Identifiers/21 CFR 201.25 & 21 CFR 207.35 (3)(i) *8. Barcode Linear or One-Dimensional (1D)" }, { "page": 15, "family": "CFR", "normalized": "21 CFR 207.35", "raw": "21 CFR 207.35", "context": "4 JA 900.08: NDC, Bar Code, & Product Identifiers/21 CFR 201.25 & 21 CFR 207.35 (3)(i) *8. Barcode Linear or One-Dimensional (1D) (Parallel Lines" }, { "page": 17, "family": "CFR", "normalized": "21 CFR 610.60", "raw": "21 CFR 610.60", "context": "1; and August 19, 2021. 21 CFR 610.60(a)(1) through (7) Checked items \u201cx\u201d indicate compliance c. Full label. T" }, { "page": 17, "family": "CFR", "normalized": "21 CFR 610.62", "raw": "21 CFR 610.62", "context": "aced on the package label. N/A 21 CFR 610.62 (7) (b) through (e) Checked items \u201cx\u201d indicate compliance b. Package lab" }, { "page": 18, "family": "CFR", "normalized": "21 CFR 201.25", "raw": "21 CFR 201.25", "context": "Stamp) appendix 5 JA 900.08: NDC, Bar Code, & Product Identifiers/21 CFR 201.25 & 21 CFR 207.35 (3)(i) *8. Barcode Linear or One-Dimensional (1D)" }, { "page": 18, "family": "CFR", "normalized": "21 CFR 207.35", "raw": "21 CFR 207.35", "context": "5 JA 900.08: NDC, Bar Code, & Product Identifiers/21 CFR 201.25 & 21 CFR 207.35 (3)(i) *8. Barcode Linear or One-Dimensional (1D) (Parallel Lines" }, { "page": 20, "family": "CFR", "normalized": "21 CFR 610.60", "raw": "21 CFR 610.60", "context": "1; and August 19, 2021. 21 CFR 610.60(a)(1) through (7) Checked items \u201cx\u201d indicate compliance d. Full label. T" }, { "page": 20, "family": "CFR", "normalized": "21 CFR 610.62", "raw": "21 CFR 610.62", "context": "aced on the package label. N/A 21 CFR 610.62 (7) (b) through (e) Checked items \u201cx\u201d indicate compliance b. Package lab" }, { "page": 21, "family": "CFR", "normalized": "21 CFR 201.25", "raw": "21 CFR 201.25", "context": "icker) appendix 6 JA 900.08: NDC, Bar Code, & Product Identifiers/21 CFR 201.25 & 21 CFR 207.35 (3)(i) *8. Barcode Linear or One-Dimensional (1D)" }, { "page": 21, "family": "CFR", "normalized": "21 CFR 207.35", "raw": "21 CFR 207.35", "context": "6 JA 900.08: NDC, Bar Code, & Product Identifiers/21 CFR 201.25 & 21 CFR 207.35 (3)(i) *8. Barcode Linear or One-Dimensional (1D) (Parallel Lines" }, { "page": 23, "family": "CFR", "normalized": "21 CFR 610.61", "raw": "21 CFR 610.61", "context": "nd August 19, 2021. 21 CFR 610.61 (a) through (s) Checked items \u201cx\u201d indicate compliance a. The proper name" }, { "page": 24, "family": "CFR", "normalized": "21 CFR 201.25", "raw": "21 CFR 201.25", "context": "Review (Package) appendix 7 JA 900.08: NDC, Bar Code, & Product Identifiers/21 CFR 201.25 & 21 CFR 207.35 (3)(i) Checked items" }, { "page": 24, "family": "CFR", "normalized": "21 CFR 207.35", "raw": "21 \n CFR 207.35", "context": ") appendix 7 JA 900.08: NDC, Bar Code, & Product Identifiers/21 CFR 201.25 & 21 CFR 207.35 (3)(i) Checked items \u201cx\u201d indicate compliance 9. Barcode & Linear or One" }, { "page": 26, "family": "CFR", "normalized": "21 CFR 610.61", "raw": "21 CFR 610.61", "context": "nd August 19, 2021. 21 CFR 610.61 (a) through (s) Checked items \u201cx\u201d indicate compliance a. The proper name" }, { "page": 27, "family": "CFR", "normalized": "21 CFR 201.25", "raw": "21 CFR 201.25", "context": "Review (Package) appendix 8 JA 900.08: NDC, Bar Code, & Product Identifiers/21 CFR 201.25 & 21 CFR 207.35 (3)(i) Checked items" }, { "page": 27, "family": "CFR", "normalized": "21 CFR 207.35", "raw": "21 \n CFR 207.35", "context": ") appendix 8 JA 900.08: NDC, Bar Code, & Product Identifiers/21 CFR 201.25 & 21 CFR 207.35 (3)(i) Checked items \u201cx\u201d indicate compliance 9. Barcode & Linear or One" }, { "page": 29, "family": "CFR", "normalized": "21 CFR 610.60", "raw": "21 CFR 610.60", "context": "1; and August 19, 2021. 21 CFR 610.60(a)(1) through (7) Checked items \u201cx\u201d indicate compliance e. Full label. T" }, { "page": 29, "family": "CFR", "normalized": "21 CFR 610.62", "raw": "21 CFR 610.62", "context": "aced on the package label. N/A 21 CFR 610.62 (7) (b) through (e) Checked items \u201cx\u201d indicate compliance b. Package lab" }, { "page": 30, "family": "CFR", "normalized": "21 CFR 201.25", "raw": "21 CFR 201.25", "context": "ainer) appendix 9 JA 900.08: NDC, Bar Code, & Product Identifiers/21 CFR 201.25 & 21 CFR 207.35 (3)(i) *8. Barcode Linear or One-Dimensional (1D)" }, { "page": 30, "family": "CFR", "normalized": "21 CFR 207.35", "raw": "21 CFR 207.35", "context": "9 JA 900.08: NDC, Bar Code, & Product Identifiers/21 CFR 201.25 & 21 CFR 207.35 (3)(i) *8. 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This memorandum sets forth C" }, { "page": 1, "family": "CFR", "normalized": "40 CFR 1058.18", "raw": "40 CFR 1058.18", "context": "onmental impact of the action. \u201cMajor Federal Action\u201d is defined broadly, see 40 CFR 1058.18, and FDA has recognized that NEPA potentially applies to the agency\u2019s actions" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 25.20", "raw": "21 CFR 25.20", "context": "plies to the agency\u2019s actions on applications. For example, FDA\u2019s regulations (21 CFR 25.20(l)) acknowledge that, unless categorically excluded, \u201cmarketing approval of a" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 25", "raw": "21 CFR Part 25", "context": "an Environmental Assessment (EA). FDA\u2019s NEPA regulations are set forth at 21 CFR Part 25. They make no specific reference to EUAs, having been promulgated before the" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 25.21", "raw": "21 CFR 25.21", "context": "the FD&C Act. However, unless \u201cextraordinary circumstances\u201d are present (see 21 CFR 25.21), FDA\u2019s regulations categorically exclude certain FDA actions from requiring t" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 25.31", "raw": "21 CFR \n25.31", "context": "lly excluded if: 1) the action does not increase the use of the active moiety (21 CFR 25.31(a)); (2) the action increases the use of the active moiety, but the estimated c" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 25.31", "raw": "21 CFR \n25.31", "context": "e point of entry into the aquatic environment will be below 1 part per billion (21 CFR 25.31(b)); or is an (3) issuance, revocation, or amendment of a standard for a biolog" }, { "page": 1, "family": "Named act", "normalized": "FD&C Act", "raw": "Federal Food, Drug, and \nCosmetic Act", "context": "./BioNTech Manufacturing GmbH (Pfizer/BioNTech) pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 360bbb-3, for a vaccine intended to prevent COVID-19. Th" }, { "page": 1, "family": "Named act", "normalized": "FD&C Act", "raw": "FD&C Act", "context": "BioNTech) pursuant to section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 360bbb-3, for a vaccine intended to prevent COVID-19. This memora" }, { "page": 1, "family": "Named act", "normalized": "FD&C Act", "raw": "FD&C Act", "context": "nce to EUAs, having been promulgated before the EUA mechanism was added to the FD&C Act. However, unless \u201cextraordinary circumstances\u201d are present (see 21 CFR 25.21)" }, { "page": 2, "family": "USC", "normalized": "21 U.S.C. \u00a7 360b", "raw": "21 USC 360b", "context": "ent with both the nature of an EUA (see in particular FD&C Act section 564(b) (21 USC 360bbb-3(b)) on the declaration of emergency or threat justifying emergency authori" }, { "page": 2, "family": "CFR", "normalized": "21 CFR 25.16", "raw": "21 CFR 25.16", "context": "e for just such an alternative arrangement. Specifically, FDA\u2019s regulation at 21 CFR 25.16 provides: Public health and safety emergencies. -- There are certain regul" }, { "page": 2, "family": "Named act", "normalized": "FD&C Act", "raw": "FD&C Act", "context": "the fact. This is consistent with both the nature of an EUA (see in particular FD&C Act section 564(b) (21 USC 360bbb-3(b)) on the declaration of emergency or threat" }, { "page": 3, "family": "CFR", "normalized": "21 CFR 25.31", "raw": "21 CFR 25.31", "context": "would preclude it from being categorically excluded: Under the provisions of 21 CFR 25.31(e), action on an Investigational New Drug (IND) is categorically excluded and" }, { "page": 3, "family": "CFR", "normalized": "21 CFR 25.31", "raw": "21 CFR 25.31", "context": "rical exclusion to the Environmental Assessment requirements in accordance with 21 CFR 25.31 (e) for the investigational vaccine intended to prevent disease COVID-19 cause" }, { "page": 3, "family": "CFR", "normalized": "21 CFR 25.16", "raw": "21 \nCFR 25.16", "context": "this COVID-19 vaccine candidate within the emergency situations contemplated by 21 CFR 25.16. 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Cell. 2020;181(2):271-280.e278. 5. Federal Food, Drug and Cosmetic Act, 21 U.S.C. \u00a7 360bbb\u20133 and 360bbb-3b. (2011). 6. FDA. Guidance for Industry: Development and Licen" }, { "page": 56, "family": "Named act", "normalized": "FD&C Act", "raw": "Federal Food, Drug and Cosmetic Act", "context": "by a Clinically Proven Protease Inhibitor. Cell. 2020;181(2):271-280.e278. 5. Federal Food, Drug and Cosmetic Act, 21 U.S.C. \u00a7 360bbb\u20133 and 360bbb-3b. (2011). 6. FDA. 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Please verify and update as appropriate. 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"individual_url": null, "ican_url": null, "total_pages": 140, "matches": [] }, { "filename": "27034_S2_M5_CRF_c4591001-1116-11161253.pdf", "id": 7426, "module": "M5", "batch_code": "pd-eua", "company": "Pfizer", "license": "EUA", "individual_url": null, "ican_url": null, "total_pages": 554, "matches": [ { "page": 421, "family": "International", "normalized": "ISO 15189", "raw": "ISO 15189", "context": "r the test was conducted in a CLIA- certified lab OR by a lab accredited by the ISO 15189 standard, by including respectively the text \"SARS COV-2 test CLIA-certified la" }, { "page": 421, "family": "International", "normalized": "ISO 15189", "raw": "ISO 15189", "context": "respectively the text \"SARS COV-2 test CLIA-certified lab\" OR \"SARS COV-2 test ISO 15189 accredited lab\" Oct-01-2020 14:49:38 (UTC-06:00) Central Time (US & Canada) ACV" } ] }, { "filename": "27034_S2_M5_CRF_c4591001-1117-11171036.pdf", "id": 7427, "module": "M5", "batch_code": "pd-eua", "company": "Pfizer", 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"matches": [] }, { "filename": "27034_S2_M5_CRF_c4591001-1120-11201127.pdf", "id": 7432, "module": "M5", "batch_code": "pd-eua", "company": "Pfizer", "license": "EUA", "individual_url": null, "ican_url": null, "total_pages": 121, "matches": [] }, { "filename": "27034_S2_M5_CRF_c4591001-1120-11201408.pdf", "id": 7433, "module": "M5", "batch_code": "pd-eua", "company": "Pfizer", "license": "EUA", "individual_url": null, "ican_url": null, "total_pages": 106, "matches": [] }, { "filename": "27034_S2_M5_CRF_c4591001-1122-11221026.pdf", "id": 7434, "module": "M5", "batch_code": "pd-eua", "company": "Pfizer", "license": "EUA", "individual_url": null, "ican_url": null, "total_pages": 136, "matches": [] }, { "filename": "27034_S2_M5_CRF_c4591001-1124-11241106.pdf", "id": 7435, "module": "M5", "batch_code": "pd-eua", "company": "Pfizer", "license": "EUA", "individual_url": null, "ican_url": null, "total_pages": 110, "matches": [] }, { "filename": "27034_S2_M5_CRF_c4591001-1127-11271022.pdf", 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test conducted at CLIA-certified lab or ISO 15189 accredited lab. Nov-01-2020 12:45:52 (UTC-06:00) Central Time ACV0PFEINFP6000" }, { "page": 368, "family": "International", "normalized": "ISO 15189", "raw": "ISO 15189", "context": "tials: --- Generated By: Generated Time (GMT): 17-Nov-2020 23:26 (US & Canada) ISO 15189 accredited lab. Nov-01-2020 11:14:16 (UTC-06:00) Central Time (US & Canada) ACV" }, { "page": 368, "family": "International", "normalized": "ISO 15189", "raw": "ISO\n15189", "context": "f not available, please indicate if test conducted at 'CLIA- certified lab' or 'ISO 15189 accredited lab.' If both trade name and lab are not known, enter 'NALT Unknown." }, { "page": 370, "family": "International", "normalized": "ISO 15189", "raw": "ISO 15189", "context": "uto query (autoquery) Query 1: Answered test conducted at CLIA-certified lab or ISO 15189 accredited lab Nov-01-2020 12:46:24 (UTC-06:00) Central Time (US & Canada) ACV0" }, { "page": 370, "family": "International", "normalized": "ISO 15189", "raw": "ISO 15189", "context": "V0PFEINFP6000 Data Entry: NALT Unknown test conducted at CLIA-certified lab or ISO 15189 accredited lab Nov-01-2020 11:14:30 (UTC-06:00) Central Time (US & Canada) ACV0" }, { "page": 370, "family": "International", "normalized": "ISO 15189", "raw": "ISO\n15189", "context": "f not available, please indicate if test conducted at 'CLIA- certified lab' or 'ISO 15189 accredited lab.' 090177e1958cf7ba\\Final\\Final On: 18-Nov-2020 04:41 (GMT) (b) (" } ] }, { "filename": "27034_S2_M5_CRF_c4591001-1129-11291074.pdf", "id": 7440, "module": "M5", "batch_code": 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Please verify and update as appropriate. 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"individual_url": null, "ican_url": null, "total_pages": 1, "matches": [] }, { "filename": "125742_S0136_M5_smsr-01sep2021-30sep2021.pdf", "id": 7932, "module": "M5", "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://pdata0916.s3.us-east-2.amazonaws.com/pdocs/100123/125742_S0136_M5_smsr-01sep2021-30sep2021.pdf", "ican_url": "https://ican-public.s3.amazonaws.com/productions/100123/125742_S0136_M5_smsr-01sep2021-30sep2021.pdf", "total_pages": 13261, "matches": [] }, { "filename": "125742_S1_M1_meeting-correspondence.pdf", "id": 7933, "module": "M1", "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2023/10/125742_S1_M1_meeting-correspondence.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/10/125742_S1_M1_meeting-correspondence.pdf", "total_pages": 636, "matches": [ { "page": 113, "family": "Named act", "normalized": "FD&C Act", "raw": "Federal Food, Drug, and Cosmetic Act", "context": "vestigational New Drug Application (IND) submitted under section 505(i) of the Federal Food, Drug, and Cosmetic Act (FDCA) for \u201cHuman Coronavirus mRNA Vaccine (SARS-CoV-2 Spike Protein; BNT162b2" }, { "page": 113, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "D) submitted under section 505(i) of the Federal Food, Drug, and Cosmetic Act (FDCA) for \u201cHuman Coronavirus mRNA Vaccine (SARS-CoV-2 Spike Protein; BNT162b2 (modR" }, { "page": 113, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "ising and Promotional Labeling Branch (CBER/APLB), we conclude that, under the FDCA and applicable regulations, COMIRNATY is Acceptable at this time. Please provi" }, { "page": 165, "family": "International", "normalized": "ICH Q2", "raw": "ICH Q2", "context": "ries for DS and DP commercial release will be initially validated according to ICH Q2, will be used for validation. ii. You also indicated that if a test is use" }, { "page": 172, "family": "CFR", "normalized": "21 CFR 600.21", "raw": "21 CFR 600.21", "context": "ime of the <351(a)> BLA submission and ready for inspection in accordance with 21 CFR 600.21 and 601.20(b)(2). Please include in the BLA submission a complete list of the" }, { "page": 174, "family": "International", "normalized": "ISO 8871", "raw": "ISO 8871", "context": "rovide results of testing per USP<381> Elastomeric Closures for Injections and ISO 8871-5, i.e., fragmentation (coring), penetrability (piercing force by hypodermic n" }, { "page": 188, "family": "International", "normalized": "ICH Q2", "raw": "ICH Q2", "context": "ries for DS and DP commercial release will be initially validated according to ICH Q2, ill be used for validation. iii. You also indicated that if a test is used" }, { "page": 188, "family": "International", "normalized": "ICH Q2", "raw": "ICH Q2", "context": "nd includes an assessment of all required elements of validation as defined in ICH Q2(R1) and 21 CFR \u00a7 211.194(a)(2). 090177e1952b9d58\\Approved\\Appro" }, { "page": 188, "family": "CFR", "normalized": "21 CFR 211.194", "raw": "21 \nCFR \u00a7 211.194", "context": "assessment of all required elements of validation as defined in ICH Q2(R1) and 21 CFR \u00a7 211.194(a)(2). 090177e1952b9d58\\Approved\\Approved On: 08-Oct-2020 01:10" }, { "page": 214, "family": "CFR", "normalized": "21 CFR 600.21", "raw": "21 CFR 600.21", "context": "ime of the <351(a)> BLA submission and ready for inspection in accordance with 21 CFR 600.21 and 601.20(b)(2). Please include in the BLA submission a complete list of the" }, { "page": 218, "family": "International", "normalized": "ISO 8871", "raw": "ISO 8871", "context": "rovide results of testing per USP<381> Elastomeric Closures for Injections and ISO 8871-5, i.e., fragmentation (coring), penetrability (piercing force by hypodermic ne" }, { "page": 219, "family": "International", "normalized": "ISO 8871", "raw": "ISO 8871", "context": "i) Regarding multiple penetrations of the stopper, the stoppers meet USP <381>, ISO 8871-5 and Ph. Eur. 3.2.9 requirements for function tests of penetrability, fragmen" }, { "page": 483, "family": "Named act", "normalized": "FD&C Act", "raw": "Federal Food, Drug, and Cosmetic Act", "context": "vestigational New Drug Application (IND) submitted under section 505(i) of the Federal Food, Drug, and Cosmetic Act for \u201cHuman Coronavirus mRNA Vaccines (SARS-CoV-2 Spike Protein; BNT162a1 (uRNA" }, { "page": 486, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "ising and Promotional Labeling Branch (CBER/APLB), we conclude that, under the FDCA and applicable regulations, COVUITY is Acceptable at this time. Please provide" }, { "page": 488, "family": "International", "normalized": "ICH E2E", "raw": "ICH E2E", "context": "ovigilance plan submitted with your BLA contains the elements specified in the ICH E2E Pharmacovigilance Planning Guidance (https://www.fda.gov/ucm/groups/fdagov-pub" }, { "page": 496, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "ising and Promotional Labeling Branch (CBER/APLB), we conclude that, under the FDCA and applicable regulations, COVUITY is Acceptable at this time. Please provide" }, { "page": 499, "family": "International", "normalized": "ICH E2E", "raw": "ICH E2E", "context": "ovigilance plan submitted with your BLA contains the elements specified in the ICH E2E Pharmacovigilance Planning Guidance (https://www.fda.gov/ucm/groups/fdagov- pu" }, { "page": 499, "family": "International", "normalized": "ICH E2E", "raw": "ICH E2E", "context": "covigilance plan submitted with the BLA contains the elements specified in the ICH E2E Pharmacovigilance Planning Guidance (https://database.ich.org/sites/default/fil" }, { "page": 601, "family": "USC", "normalized": "21 U.S.C. \u00a7 360b", "raw": "21 U.S.C. 360b", "context": "1, 2021, under section 564 of the Federal Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. 360bbb-3). Pfizer/BioNTech intend to submit a BLA for the candidate vaccine in April" }, { "page": 601, "family": "Named act", "normalized": "FD&C Act", "raw": "Federal Food, Drug, and Cosmetic Act", "context": "als > 16 years of age wasissued on December 11, 2021, under section 564 of the Federal Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. 360bbb-3). Pfizer/BioNTech intend to submit a BLA for the ca" }, { "page": 601, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "cember 11, 2021, under section 564 of the Federal Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. 360bbb-3). Pfizer/BioNTech intend to submit a BLA for the candidat" } ] }, { "filename": "125742_S1_M5_5351_bnt162-01-interim3-reports.pdf", "id": 7934, "module": "M5", "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://pdata0916.s3.us-east-2.amazonaws.com/pdocs/100123/125742_S1_M5_5351_bnt162-01-interim3-reports.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/10/125742_S1_M5_5351_bnt162-01-interim3-reports.pdf", "total_pages": 524, "matches": [] }, { "filename": "125742_S1_M5_5351_c4591001-fa-interim-interlab-standard.pdf", "id": 7935, "module": "M5", "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2023/10/125742_S1_M5_5351_c4591001-fa-interim-interlab-standard.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/10/125742_S1_M5_5351_c4591001-fa-interim-interlab-standard.pdf", "total_pages": 22, "matches": [] }, { "filename": 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"125742_S17_M1_356h.pdf", "id": 7950, "module": "M1", "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2023/10/125742_S17_M1_356h.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/10/125742_S17_M1_356h.pdf", "total_pages": 6, "matches": [] }, { "filename": "125742_S18_M1_356h.pdf", "id": 7951, "module": "M1", "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2023/10/125742_S18_M1_356h.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/10/125742_S18_M1_356h.pdf", "total_pages": 6, "matches": [] }, { "filename": "125742_S19_M1_356h.pdf", "id": 7952, "module": "M1", "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": "https://phmpt.org/wp-content/uploads/2023/10/125742_S19_M1_356h.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/10/125742_S19_M1_356h.pdf", "total_pages": 6, "matches": [] 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Nonclinical pharmacology and toxicology section (e.g., 21 CFR 314.50(d)(2); 21 CFR 601.2) 25. Does the submission contain: Only Pediatric data? Ye" }, { "page": 2, "family": "CFR", "normalized": "21 CFR 601.2", "raw": "21 CFR 601.2", "context": "5. Nonclinical pharmacology and toxicology section (e.g., 21 CFR 314.50(d)(2); 21 CFR 601.2) 25. Does the submission contain: Only Pediatric data? Yes No N/A Is the si" }, { "page": 2, "family": "CFR", "normalized": "21 CFR 3.2", "raw": "21 CFR 3.2", "context": "24. For Originals and all Supplements, is the product a combination product (21 CFR 3.2(e))? Yes Yes Yes Prescription Product (Rx) No No No Over-The-Counter Produc" }, { "page": 2, "family": "CFR", "normalized": "21 CFR 314.50", "raw": "21 CFR 314.50", "context": "ns the following items (Select all that apply) 8. Clinical data section (e.g., 21 CFR 314.50(d)(5); 21 CFR 601.2) Item 30 continued on page 3 6. 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Table 1 summarizes the nom" }, { "page": 337, "family": "International", "normalized": "ICH S1A", "raw": "ICH S1A", "context": "cines have no carcinogenic or tumorigenic potential. Furthermore, according to ICH S1A (ICH S1A Guideline: \u201cGuideline on the Need for Carcinogenicity Studies of Phar" }, { "page": 337, "family": "International", "normalized": "ICH S1A", "raw": "ICH S1A", "context": "e no carcinogenic or tumorigenic potential. Furthermore, according to ICH S1A (ICH S1A Guideline: \u201cGuideline on the Need for Carcinogenicity Studies of Pharmaceutica" }, { "page": 409, "family": "International", "normalized": "ICH S1A", "raw": "ICH S1A", "context": "Coronavirus Spike Protein and Tropism Changes. Adv Virus Res 2016; 96: 29-57. 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Your request to waive the submission of monthly BLA LDR in lieu of submission" } ] }, { "filename": "8_PM_S102_BLA 125742-8_09-29-2021_Telecon_Other.pdf", "id": 8068, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 2, "matches": [] }, { "filename": "9_PM_S105_BLA 125742-9_09-20-2021_Telecon_Advice.pdf", "id": 8069, "module": null, "batch_code": "pd", "company": "Pfizer", "license": "BLA", "individual_url": null, "ican_url": null, "total_pages": 1, "matches": [] }, { "filename": "001-Complaint-PHMPT-de-Garay-v.-FDA-2022-10-11.pdf", "id": 8070, "module": null, "batch_code": null, "company": null, "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/05/001-Complaint-PHMPT-de-Garay-v.-FDA-2022-10-11.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/08/001-Complaint-PHMPT-de-Garay-v.-FDA-2022-10-11.pdf", "total_pages": 105, "matches": [ { "page": 3, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "erefore issued two requests to FDA pursuant to the Freedom of Information Act (5 U.S.C. \u00a7 552, as amended) (\u201cFOIA\u201d) for \u201c[a]ll data and information for [the COVID-19 Vaccin" }, { "page": 3, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "ectiveness data and information. (2) A protocol for a test or study . . . .\u201d 21 C.F.R. \u00a7 601.51(e). 9. Upon licensure for each of the COVID-19 Vaccines, PHMPT therefore iss" }, { "page": 3, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \n\u00a7 601.51", "context": "OIA\u201d) for \u201c[a]ll data and information for [the COVID-19 Vaccines] enumerated in 21 C.F.R. \u00a7 601.51(e)[6] with the exception of publicly available reports on the Vaccine Adverse E" }, { "page": 3, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "data and information underlying FDA\u2019s approval of the COVID-19 Vaccines. 6 21 C.F.R. \u00a7 601.51(e) provides that, after a biological product is licensed, the following informa" }, { "page": 3, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "all of the data and information in the biological product file, as defined in 21 C.F.R. \u00a7 601.51(a), for [the COVID-19 Vaccines], enumerated in 21 C.F.R. \u00a7 601.51(e), with the" }, { "page": 3, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 \n601.51", "context": "as defined in 21 C.F.R. \u00a7 601.51(a), for [the COVID-19 Vaccines], enumerated in 21 C.F.R. \u00a7 601.51(e), with the exception of publicly available reports on the Vaccine Adverse Eve" }, { "page": 3, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "FDA pursuant to the Freedom of Information Act (5 U.S.C. \u00a7 552, as amended) (\u201cFOIA\u201d) for \u201c[a]ll data and information for [the COVID-19 Vaccines] enumerated in 21" }, { "page": 3, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "d action on a particular lot by the [FDA].\u201d 7 For the avoidance of doubt, the FOIA Request includes, but is not limited to, all of the data and information in the" }, { "page": 4, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 \nU.S.C. \u00a7 552", "context": "e \u201cPlaintiffs\u201d) requested expedited processing of the FOIA requests pursuant to 5 U.S.C. \u00a7 552(a)(6)(E)(v)(II). Case 4:22-cv-00915-P Document 1 Filed 10/11/22 Page" }, { "page": 4, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Garays (collectively, the \u201cPlaintiffs\u201d) requested expedited processing of the FOIA requests pursuant to 5 U.S.C. \u00a7 552(a)(6)(E)(v)(II). Case 4:22-cv-00915-P" }, { "page": 5, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "On March 7, 2022, FDA denied PHMPT\u2019s request for expedited processing of its FOIA request regarding the Moderna Vaccine. PHMPT appealed the decision on June 1," }, { "page": 5, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "n August 15, 2022, FDA denied PHMPT\u2019s request for expedited processing for its FOIA request regarding the 12-15-Year-Old Pfizer Vaccine. 18. Similarly, on August" }, { "page": 5, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "29, 2022, FDA denied the de Garays\u2019 request for expedited processing of their FOIA request regarding the 12-15-Year-Old Pfizer Vaccine. 19. The Plaintiffs bring" }, { "page": 6, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "partment of Health and Human Services. FDA is an agency within the meaning of 5 U.S.C. \u00a7 552(f). JURISDICTION AND VENUE 24. This Court has jurisdiction over this action" }, { "page": 6, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "ICTION AND VENUE 24. This Court has jurisdiction over this action pursuant to 5 U.S.C. \u00a7 552(a)(4)(B) and 28 U.S.C. \u00a7 1331. Venue is proper within this District pursuant" }, { "page": 6, "family": "USC", "normalized": "28 U.S.C. \u00a7 1331", "raw": "28 U.S.C. \u00a7 1331", "context": "ourt has jurisdiction over this action pursuant to 5 U.S.C. \u00a7 552(a)(4)(B) and 28 U.S.C. \u00a7 1331. Venue is proper within this District pursuant to 5 U.S.C. \u00a7 552(a)(4)(B) and" }, { "page": 6, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "(4)(B) and 28 U.S.C. \u00a7 1331. Venue is proper within this District pursuant to 5 U.S.C. \u00a7 552(a)(4)(B) and 28 U.S.C. \u00a7 1391. FACTS I. FDA Licensure of COVID-19 Vaccines" }, { "page": 6, "family": "USC", "normalized": "28 U.S.C. \u00a7 1391", "raw": "28 U.S.C. \u00a7 1391", "context": "Venue is proper within this District pursuant to 5 U.S.C. \u00a7 552(a)(4)(B) and 28 U.S.C. \u00a7 1391. FACTS I. FDA Licensure of COVID-19 Vaccines 25. FDA may only license vac" }, { "page": 6, "family": "USC", "normalized": "21 U.S.C. \u00a7 393", "raw": "21 U.S.C. \u00a7 393", "context": "license vaccines that have been proven to be \u201csafe and effective,\u201d see, e.g., 21 U.S.C. \u00a7 393, and FDA makes this determination based on, inter alia, clinical trial reports" }, { "page": 6, "family": "CFR", "normalized": "21 CFR 601.2", "raw": "21 C.F.R. 601.2", "context": "ust be sufficient to demonstrate the product is both \u201csafe\u201d and \u201ceffective.\u201d9 21 C.F.R. 601.2(a). 26. In order to demonstrate that they are safe and effective, Pfizer an" }, { "page": 7, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ccine, Comirnaty, for use in individuals 18 years and older, PHMPT submitted a FOIA request to obtain the data within the product\u2019s BLA file. Like in the instant" }, { "page": 9, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "ances are shown: (1) All safety and effectiveness data and information . . .\u201d 21 C.F.R. \u00a7 601.51(e) (emphasis added). 36. There is an ongoing, national public debate regard" }, { "page": 17, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "eking the following documents to be produced on an expedited basis pursuant to 5 U.S.C. \u00a7 552(a)(6)(E)(v)(II): All data and information for the Moderna Vaccine enumerated i" }, { "page": 17, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 \nC.F.R. \u00a7 601.51", "context": ")(6)(E)(v)(II): All data and information for the Moderna Vaccine enumerated in 21 C.F.R. \u00a7 601.51(e)47 with the exception of publicly available reports on the Vaccine Adverse E" }, { "page": 17, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "ovid-19/story?id=87130087. 46 https://www.fda.gov/about-fda/transparency. 47 21 C.F.R. \u00a7 601.51(e) provides that after a biological product is licensed, the following informat" }, { "page": 17, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "all of the data and information in the biological product file, as defined in 21 C.F.R. \u00a7 601.51(a), for the Moderna Vaccine enumerated in 21 C.F.R. \u00a7 601.51(e), with the exce" }, { "page": 17, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "ile, as defined in 21 C.F.R. \u00a7 601.51(a), for the Moderna Vaccine enumerated in 21 C.F.R. \u00a7 601.51(e), with the exception of publicly available reports on the Vaccine Adverse Ev" }, { "page": 17, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "already announced a mandate for students ages 12 and older.45 III. PHMPT\u2019s FOIA Request for the Moderna Vaccine\u2019s BLA File 48. In furtherance of PHMPT\u2019s miss" }, { "page": 17, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "t FDA acts consistent with its commitment to transparency,46 PHMPT submitted a FOIA request on February 23, 2022, seeking the following documents to be produced o" }, { "page": 17, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "cessing (\u201cPHMPT\u2019s Denial Letter\u201d or \u201cDenial Letters\u201d) and assigned the request FOIA Control # 2022- 1614. In PHMPT\u2019s Denial Letter, FDA stated, in relevant part:" }, { "page": 17, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "hat your request for expedited processing does not meet the criteria under the FOIA. You have not demonstrated a compelling need that involves an imminent threat" }, { "page": 18, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 \n552", "context": "AA, and declared that the appeal fell under \u201cunusual circumstances\u201d pursuant to 5 U.S.C. \u00a7 552(a)(6)(B)(i) and 5 U.S.C. \u00a7 552(a)(6)(B)(iii) of the FOIA. (Exhibit 4.) 52." }, { "page": 18, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "fell under \u201cunusual circumstances\u201d pursuant to 5 U.S.C. \u00a7 552(a)(6)(B)(i) and 5 U.S.C. \u00a7 552(a)(6)(B)(iii) of the FOIA. (Exhibit 4.) 52. Given the \u201cunusual circumstance" }, { "page": 18, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "A request to FDA on August 8, 2022 and sought expedited processing pursuant to 5 U.S.C. \u00a7 552(a)(6)(E)(v)(II): All data and information for the 12-15-Year-Old Pfizer Vaccin" }, { "page": 18, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "All data and information for the 12-15-Year-Old Pfizer Vaccine enumerated in 21 C.F.R. \u00a7 601.51(e)50 with the exception of 49 https://www.fda.gov/about-fda/transparency. 5" }, { "page": 18, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": ")50 with the exception of 49 https://www.fda.gov/about-fda/transparency. 50 21 C.F.R. \u00a7 601.51(e) provides that after a biological product is licensed, the following informat" }, { "page": 18, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "pursuant to 5 U.S.C. \u00a7 552(a)(6)(B)(i) and 5 U.S.C. \u00a7 552(a)(6)(B)(iii) of the FOIA. (Exhibit 4.) 52. Given the \u201cunusual circumstances\u201d claimed by FDA, it was" }, { "page": 18, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "s of the date of this filing, FDA has not made a determination. IV. PHMPT\u2019s FOIA Request for the 12-15-Year-Old Pfizer Vaccine\u2019s BLA File 53. In furtherance" }, { "page": 18, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "onsistent with its commitment to transparency,49 PHMPT submitted the following FOIA request to FDA on August 8, 2022 and sought expedited processing pursuant to 5" }, { "page": 19, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 \n552", "context": "request to FDA on August 22, 2022 and sought expedited processing pursuant to 5 U.S.C. \u00a7 552(a)(6)(E)(v)(II):: 51 For the avoidance of doubt, this request includes but" }, { "page": 19, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "all of the data and information in the biological product file, as defined in 21 C.F.R. \u00a7 601.51(a), for the 12-15-Year-Old Pfizer Vaccine enumerated in 21 C.F.R. \u00a7 601.51(e)" }, { "page": 19, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 \n601.51", "context": "d in 21 C.F.R. \u00a7 601.51(a), for the 12-15-Year-Old Pfizer Vaccine enumerated in 21 C.F.R. \u00a7 601.51(e) with the exception of publicly available reports on the Vaccine Adverse Even" }, { "page": 19, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "request excludes any data and information responsive to and being produced in FOIA Control # 2021-5683 (previously made on behalf of PHMPT) and is meant to captu" }, { "page": 19, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "hat your request for expedited processing does not meet the criteria under the FOIA. You have not demonstrated a compelling need that involves an imminent threat" }, { "page": 19, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "g your request for expedited processing. (Exhibit 6.) V. The de Garays\u2019 FOIA Request 55. In furtherance of the de Garays\u2019 advocacy for their vaccine-injur" }, { "page": 20, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "dited processing of request for records\u201d upon a showing of \u201ccompelling need.\u201d 5 U.S.C. \u00a7 552(a)(6)(E)(i)(I). As defined by FOIA, a \u201ccompelling need\u201d 53 21 C.F.R. \u00a7 601." }, { "page": 20, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "0 All data and information for the 12-15-Year-Old Pfizer Vaccine enumerated in 21 C.F.R. \u00a7 601.51(e)53 with the exception of publicly available reports on the Vaccine Adverse E" }, { "page": 20, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "5 U.S.C. \u00a7 552(a)(6)(E)(i)(I). As defined by FOIA, a \u201ccompelling need\u201d 53 21 C.F.R. \u00a7 601.51(e) provides that after a biological product is licensed, the following informat" }, { "page": 20, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "all of the data and information in the biological product file, as defined in 21 C.F.R. \u00a7 601.51(a), for the 12-15-Year-Old Pfizer Vaccine enumerated in 21 C.F.R. \u00a7 601.51(e)" }, { "page": 20, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 \n601.51", "context": "d in 21 C.F.R. \u00a7 601.51(a), for the 12-15-Year-Old Pfizer Vaccine enumerated in 21 C.F.R. \u00a7 601.51(e) with the exception of publicly available reports on the Vaccine Adverse Even" }, { "page": 20, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "request excludes any data and information responsive to and being produced in FOIA Control # 2021-5683 (as that will be publicly available) and is meant to captu" }, { "page": 20, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "sing (\u201cde Garays\u2019 Denial Letter\u201d or \u201cDenial Letters\u201d) and assigned the request FOIA Control # 2022- 6129. In the de Garays\u2019 Denial Letter, FDA stated in relevant" }, { "page": 20, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "hat your request for expedited processing does not meet the criteria under the FOIA. You have not demonstrated a compelling need that involves an imminent threat" }, { "page": 20, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ying your request for expedited processing. (Exhibit 8.) ARGUMENT 57. FOIA provides for \u201cexpedited processing of request for records\u201d upon a showing of \u201c" }, { "page": 20, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "a showing of \u201ccompelling need.\u201d 5 U.S.C. \u00a7 552(a)(6)(E)(i)(I). As defined by FOIA, a \u201ccompelling need\u201d 53 21 C.F.R. \u00a7 601.51(e) provides that after a biologic" }, { "page": 21, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "inform the public concerning actual or alleged Federal Government activity.\u201d 5 U.S.C. \u00a7 552(a)(6)(E)(v)(II). 58. When an agency denies a request for expedited processin" }, { "page": 21, "family": "USC", "normalized": "5 U.S.C. \u00a7 522", "raw": "5 U.S.C. \u00a7 522", "context": "r expedited processing, the decision is subject to immediate judicial review. 5 U.S.C. \u00a7 522(a)(6)(E)(iii). A requester is not required to pursue an administrative appeal" }, { "page": 21, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "rate a \u201ccompelling need\u201d for the expedited processing of their FOIA requests. 5 U.S.C. \u00a7 552(a)(6)(E)(i)(I); 5 U.S.C. \u00a7 552(a)(6)(E)(v)(II). I. Plaintiffs Are Primarily" }, { "page": 21, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \n\u00a7 552", "context": "e expedited processing of their FOIA requests. 5 U.S.C. \u00a7 552(a)(6)(E)(i)(I); 5 U.S.C. \u00a7 552(a)(6)(E)(v)(II). I. Plaintiffs Are Primarily Engaged in Disseminating Informa" }, { "page": 21, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "al before seeking judicial review of its request for expedited processing of a FOIA request. Elec. Privacy Info. Ctr. v. Dep\u2019t of Defense, 355 F. Supp. 2d 98, 100" }, { "page": 21, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "iffs can demonstrate a \u201ccompelling need\u201d for the expedited processing of their FOIA requests. 5 U.S.C. \u00a7 552(a)(6)(E)(i)(I); 5 U.S.C. \u00a7 552(a)(6)(E)(v)(II). I." }, { "page": 21, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "D-19 Vaccines. PHMPT intends to make any records produced in response to this FOIA request immediately available to the public through both its website and its i" }, { "page": 22, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "or FDA \u201capproval\u201d) of the COVID-19 Vaccines, that it hopes to receive from its FOIA requests. 63. The de Garays have become influential public advocates in educ" }, { "page": 24, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "s are \u201cprimarily engaged in disseminating information to the general public.\u201d 5 U.S.C. \u00a7 552(a)(6)(E)(v)(II). II. There Is an Urgency to Inform the Public Concerning Ac" }, { "page": 24, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "ces are shown: (1) All safety and effectiveness data and information . . . .\u201d 21 C.F.R. \u00a7 601.51(e) (emphasis added). Therefore, FDA\u2019s own regulations expressly recognize the" }, { "page": 24, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Id. FDA\u2019s regulation not only supports the need for expedited treatment under FOIA but is also an independent legal basis that requires expedited treatment of th" }, { "page": 25, "family": "USC", "normalized": "21 U.S.C. \u00a7 393", "raw": "21 U.S.C. \u00a7 393", "context": "license vaccines that have been proven to be \u201csafe and effective,\u201d see, e.g., 21 U.S.C. \u00a7 393, and FDA makes this determination based on, inter alia, clinical trial reports" }, { "page": 25, "family": "CFR", "normalized": "21 CFR 601.2", "raw": "21 C.F.R. \u00a7 601.2", "context": "st be sufficient to demonstrate the product is both \u201csafe\u201d and \u201ceffective.\u201d76 21 C.F.R. \u00a7 601.2(a). To assure FDA\u2019s commitment to transparency,77 and to promote the public\u2019s" }, { "page": 25, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "ities\u2019 confidence in the conclusions reached by FDA, it is not surprising that 21 C.F.R. \u00a7 601.51(e) requires FDA to immediately disclose all safety and effectiveness data and" }, { "page": 27, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "dependent authorities review the safety and effectiveness data sought in these FOIA requests will only assist the public, as well as private institutions, in eval" }, { "page": 28, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "on and that there is an urgency to inform the public concerning actual or 87 21 C.F.R. \u00a7 601.51(e). 88 Id. 89 See, e.g., supra \u00b6\u00b6 27-30. Case 4:22-cv-00915-P Document 1" }, { "page": 28, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "iveness data and information,88 which is precisely the information Plaintiffs\u2019 FOIA requests seek on an expedited basis. (Exhibit 1, 5 & 8.) 80. The general pu" }, { "page": 29, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "essing for the requested records because Plaintiffs have a \u201ccompelling need\u201d. 5 U.S.C. \u00a7 552(a)(6)(E)(i)(I). REQUESTED RELIEF WHEREFORE, Plaintiffs pray that this Court:" }, { "page": 29, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "ir costs and reasonable attorneys\u2019 fees incurred in this action as provided by 5 U.S.C. \u00a7 552(a)(4)(E); and d. Grant such other and further relief as the Court may deem ju" }, { "page": 32, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "tronic form: All data and information for the Moderna Vaccine enumerated in 21 C.F.R. \u00a7 601.51(e)2 with the exception of publicly available reports on the Vaccine Adverse Ev" }, { "page": 32, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "include Moderna, Inc. and any of its parents, subsidiaries and affiliates. 2 21 C.F.R. \u00a7 601.51(e) provides that after a biological product is licensed, the following informat" }, { "page": 32, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "all of the data and information in the biological product file, as defined in 21 C.F.R. \u00a7 601.51(a), for the Moderna Vaccine enumerated in 21 C.F.R. \u00a7 601.51(e) with the excep" }, { "page": 32, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "ile, as defined in 21 C.F.R. \u00a7 601.51(a), for the Moderna Vaccine enumerated in 21 C.F.R. \u00a7 601.51(e) with the exception of publicly available reports on the Vaccine Adverse Eve" }, { "page": 33, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "ited processing of requests for records\u201d upon a showing of \u201ccompelling need.\u201d 5 U.S.C. \u00a7 552(a)(6)(E)(i)(I). The requestor shows a \u201ccompelling need\u201d when it is \u201cprimarily" }, { "page": 33, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "inform the public concerning actual or alleged Federal Government activity.\u201d 5 U.S.C. \u00a7 552(a)(6)(E)(v)(II). Here, PHMPT is an organization made up of public health p" }, { "page": 33, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "ances are shown: (1) All safety and effectiveness data and information . . .\u201d 21 C.F.R. \u00a7 601.51(e)(1) (emphasis added). Thus, the FDA\u2019s own regulations expressly recognize t" }, { "page": 33, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "request as it meets the requirements for expedited processing under both FDA\u2019s FOIA Regulations as well as FOIA itself. A. PHMPT Qualifies for Expedited Proces" }, { "page": 33, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "irements for expedited processing under both FDA\u2019s FOIA Regulations as well as FOIA itself. A. PHMPT Qualifies for Expedited Processing Under FOIA FOIA pro" }, { "page": 33, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "s as well as FOIA itself. A. PHMPT Qualifies for Expedited Processing Under FOIA FOIA provides for \u201cexpedited processing of requests for records\u201d upon a sho" }, { "page": 33, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "as FOIA itself. A. PHMPT Qualifies for Expedited Processing Under FOIA FOIA provides for \u201cexpedited processing of requests for records\u201d upon a showing of" }, { "page": 33, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "D-19 vaccines. PHMPT intends to make any records produced in response to this FOIA request immediately available to the public through both its website and its i" }, { "page": 33, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "f the Moderna Vaccine. Accordingly, expedited processing of this request under FOIA is warranted. B. PHMPT Qualifies for Expedited Processing Under the FDA\u2019s F" }, { "page": 33, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "A is warranted. B. PHMPT Qualifies for Expedited Processing Under the FDA\u2019s FOIA Regulations Notably, separate and apart from the FDA\u2019s obligation to comply" }, { "page": 33, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "lations Notably, separate and apart from the FDA\u2019s obligation to comply with FOIA, it has an independent duty to inform the public concerning the data and infor" }, { "page": 33, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "at the FDA did not release the documents following licensure necessitated this FOIA request. 4 https://www.fda.gov/news-events/press-announcements/covid-19" }, { "page": 34, "family": "USC", "normalized": "21 U.S.C. \u00a7 393", "raw": "21 U.S.C. \u00a7 393", "context": "license vaccines that have been proven to be \u201csafe and effective,\u201d see, e.g., 21 U.S.C. \u00a7 393, and the FDA makes this determination based on, inter alia, clinical trial rep" }, { "page": 34, "family": "CFR", "normalized": "21 CFR 20.44", "raw": "21 C.F.R. \u00a7 20.44", "context": "y concerns identifiable operations or activities of the Federal Government. 21 C.F.R. \u00a7 20.44(c)(1)-(3). PHMPT easily meets all three requirements. As noted above, PHMPT" }, { "page": 34, "family": "CFR", "normalized": "21 CFR 20.44", "raw": "21 C.F.R. \u00a7 20.44", "context": "ainly \u201cprimarily engaged in disseminating information to the general public.\u201d 21 C.F.R. \u00a7 20.44(c)(1). Next, there is plainly an urgent public need for transparency with re" }, { "page": 34, "family": "CFR", "normalized": "21 CFR 601.2", "raw": "21 C.F.R. 601.2", "context": "ust be sufficient to demonstrate the product is both \u201csafe\u201d and \u201ceffective.\u201d6 21 C.F.R. 601.2(a). There is, however, an ongoing, public national debate regarding the adequ" }, { "page": 34, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "y available the safety and effectiveness data of a licensed vaccine, the FDA\u2019s FOIA regulations anticipate scenarios where FOIA requests must be expedited. Speci" }, { "page": 34, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ta of a licensed vaccine, the FDA\u2019s FOIA regulations anticipate scenarios where FOIA requests must be expedited. Specifically, a requestor is entitled to expedite" }, { "page": 38, "family": "CFR", "normalized": "21 CFR 20.44", "raw": "21 C.F.R. \u00a7 20.44", "context": "particular value that will be lost if not obtained and disseminated quickly.\u201d 21 C.F.R. \u00a7 20.44(c)(2). Finally, PHMPT\u2019s request meets the third requirement for expedited proc" }, { "page": 38, "family": "CFR", "normalized": "21 CFR 20.44", "raw": "21 C.F.R. \u00a7 20.44", "context": "lly concerns identifiable operations or activities of the Federal Government.\u201d 21 C.F.R. \u00a7 20.44(c)(3). Here, PHMPT\u2019s records request specifically concerns identifiable activ" }, { "page": 38, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ties, including PHMPT, review the safety and effectiveness data sought in this FOIA request will almost certainly assist these individuals in evaluating their vac" }, { "page": 38, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "rated that its request qualifies for expedited processing under both the FDA\u2019s FOIA regulations, as well as FOIA itself. PHMPT incorporates by reference, as if c" }, { "page": 38, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ies for expedited processing under both the FDA\u2019s FOIA regulations, as well as FOIA itself. PHMPT incorporates by reference, as if cited and fully set forth here" }, { "page": 39, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 \nU.S.C. \u00a7 552", "context": "is a nonprofit and asks that you waive any and all fees or charges pursuant to 5 U.S.C. \u00a7 552(a)(4)(A)(iii) on the basis that \u201cdisclosure of the [requested] information is i" }, { "page": 43, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "od and Drug Administration (\u201cFDA\u201d) pursuant to the Freedom of Information Act (5 U.S.C. \u00a7 552, as amended) (\u201cFOIA\u201d). The FDA designated the request as FOIA Control #2022-1" }, { "page": 43, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 \nC.F.R. \u00a7 601.51", "context": "g documents: All data and information for the Moderna Vaccine enumerated in 21 C.F.R. \u00a7 601.51(e)1 with the exception of publicly available reports on the Vaccine Adverse Ev" }, { "page": 43, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "ublicly available reports on the Vaccine Adverse Events Reporting System. 1 21 C.F.R. \u00a7 601.51(e) provides that after a biological product is licensed, the following informat" }, { "page": 43, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Rockville, MD 20857 FDAFOIA@fda.hhs.gov Re: Expedited Processing Appeal of FOIA Control #2022-1614 (IR#0710) Dear Sir or Madam: This firm represents" }, { "page": 43, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "DA\u201d) pursuant to the Freedom of Information Act (5 U.S.C. \u00a7 552, as amended) (\u201cFOIA\u201d). The FDA designated the request as FOIA Control #2022-1614 (the \u201cFOIA Reque" }, { "page": 43, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Act (5 U.S.C. \u00a7 552, as amended) (\u201cFOIA\u201d). The FDA designated the request as FOIA Control #2022-1614 (the \u201cFOIA Request\u201d). In a letter dated March 7, 2022, the" }, { "page": 43, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ed) (\u201cFOIA\u201d). The FDA designated the request as FOIA Control #2022-1614 (the \u201cFOIA Request\u201d). In a letter dated March 7, 2022, the FDA denied PHMPT\u2019s request fo" }, { "page": 43, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "e \u201cDenial Letter\u201d). PHMPT writes now to appeal that determination. A. The FOIA Request On February 23, 2022, PHMPT submitted the FOIA Request to the FDA fo" }, { "page": 43, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "rmination. A. The FOIA Request On February 23, 2022, PHMPT submitted the FOIA Request to the FDA for the following documents: All data and information fo" }, { "page": 44, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "PHMPT requested that the FDA expedite processing for this request pursuant to 5 U.S.C. \u00a7 552(a)(6)(E)(v)(II) and provided detailed reasons for requesting expedited process" }, { "page": 44, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \n552", "context": "n Act (EFOIA) Amendments of 1996 amended the FOIA by adding section (a)(6)(E), 5 U.S.C. 552(a)(6)(E), to require agencies to consider requests for expedited processing an" }, { "page": 44, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "ited processing of requests for records\u201d upon a showing of \u201ccompelling need.\u201d 5 U.S.C. \u00a7 552(a)(6)(E)(i)(I). A requestor shows a \u201ccompelling need\u201d when it is \u201cprimarily e" }, { "page": 44, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "inform the public concerning actual or alleged Federal Government activity.\u201d 5 U.S.C. \u00a7 552(a)(6)(E)(v)(II). PHMPT requested expedited processing of the FOIA Request on t" }, { "page": 44, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Page 2 of 11 (Exhibit 1.)2 In the FOIA Request, PHMPT requested that the FDA expedite processing for this request pur" }, { "page": 44, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "expedited processing. (Exhibit 1.) On March 1, 2022, FDA acknowledged the FOIA Request and assigned it Request Number #2022-1614. On March 7, 2022, FDA and d" }, { "page": 44, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "e Electronic Freedom of Information Act (EFOIA) Amendments of 1996 amended the FOIA by adding section (a)(6)(E), 5 U.S.C. 552(a)(6)(E), to require agencies to con" }, { "page": 44, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "hat your request for expedited processing does not meet the criteria under the FOIA. You have not demonstrated a compelling need that involves an imminent threat" }, { "page": 44, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "request in the order in which it was received. (Exhibit 3). B. Argument FOIA provides for \u201cexpedited processing of requests for records\u201d upon a showing of" }, { "page": 44, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "\u201d 5 U.S.C. \u00a7 552(a)(6)(E)(v)(II). PHMPT requested expedited processing of the FOIA Request on the basis that it is \u201cprimarily engaged in disseminating informatio" }, { "page": 44, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ing actual or alleged Federal Government activity.\u201d PHMPT demonstrated in its FOIA Request that it exists for the sole purpose of disseminating to the public the" }, { "page": 45, "family": "Court case", "normalized": "Al-Fayed v. CIA, 254 F.3d 300", "raw": "Al-Fayed v. CIA, 254 F.3d 300", "context": "interest; and (iii) whether the request concerns federal government activity. Al-Fayed v. CIA, 254 F.3d 300, 310 (D.C. Cir. 2001). All three factors are present here and weigh in favor" }, { "page": 45, "family": "USC", "normalized": "21 U.S.C. \u00a7 393", "raw": "21 U.S.C. \u00a7 393", "context": "license vaccines that have been proven to be \u201csafe and effective,\u201d see, e.g., 21 U.S.C. \u00a7 393. The FDA makes this determination based on, inter alia, clinical trial report" }, { "page": 45, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "Request is for the Moderna Vaccine\u2019s biological product file, available under 21 C.F.R. \u00a7 601.51(e). The FDA itself acknowledges the exigency in releasing the biological prod" }, { "page": 45, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 \nC.F.R. \u00a7 601.51", "context": "available for public disclosure unless extraordinary circumstances are shown.\u201d 21 C.F.R. \u00a7 601.51(e) (emphasis added). Under this regulation, a critical part of the biological" }, { "page": 45, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 \n601.51", "context": "e that must be released is \u201call safety and effectiveness data and information.\u201d 21 C.F.R. \u00a7 601.51(e)(1). Therefore, the FDA\u2019s own regulations acknowledge the current exigency i" }, { "page": 45, "family": "CFR", "normalized": "21 CFR 601.2", "raw": "21 C.F.R. 601.2", "context": "ust be sufficient to demonstrate the product is both \u201csafe\u201d and \u201ceffective.\u201d3 21 C.F.R. 601.2(a). There is, however, an ongoing public national debate regarding the adequa" }, { "page": 45, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "s all of the arguments, references, and citations exhaustively detailed in its FOIA Request for expedited processing. Contrary to FDA\u2019s assertions, as set forth i" }, { "page": 45, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "or expedited processing. Contrary to FDA\u2019s assertions, as set forth in PHMPT\u2019s FOIA Request, there exists an urgency to inform the public concerning actual or all" }, { "page": 45, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "re present here and weigh in favor of granting expedited processing of PHMPT\u2019s FOIA Request. (i) PHMPT\u2019s request concerns a matter of current exigency to the Amer" }, { "page": 45, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ter of current exigency to the American public As to the first factor, PHMPT\u2019s FOIA Request concerns a matter of current exigency to the American public. PHMPT\u2019s" }, { "page": 45, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Request concerns a matter of current exigency to the American public. PHMPT\u2019s FOIA Request is for the Moderna Vaccine\u2019s biological product file, available under" }, { "page": 45, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "hus, FDA\u2019s regulation not only supports the need for expedited treatment under FOIA, but it is also an independent legal basis that requires expedited treatment o" }, { "page": 45, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "it is also an independent legal basis that requires expedited treatment of the FOIA Request. Beyond the FDA\u2019s own regulations recognizing the exigency of records" }, { "page": 45, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "he FDA\u2019s own regulations recognizing the exigency of records sought in PHMPT\u2019s FOIA request, there are other reasons why such exigencies exist. As required by Co" }, { "page": 47, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "the data and information underlying the licensure of the Moderna Vaccine. The FOIA Request attempts to expedite the disclosure of this critical information. The" }, { "page": 47, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "s to expedite the disclosure of this critical information. Therefore, PHMPT\u2019s FOIA Request concerns a matter of current exigency to the American public. Secondl" }, { "page": 49, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 \n601.51", "context": "of the biological product file \u201cimmediately available for public disclosure.\u201d 21 C.F.R. \u00a7 601.51(e). The regulation specifically enables the public to see firsthand the safety" }, { "page": 49, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ties, including PHMPT, review the safety and effectiveness data sought in this FOIA request will almost certainly assist these individuals in evaluating their vac" }, { "page": 49, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "rs of current exigency to the American public. Therefore, the first factor in FOIA\u2019s \u201ccompelling need\u201d analysis weighs heavily in favor of granting expedited pro" }, { "page": 49, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "\u201ccompelling need\u201d analysis, the consequences of delaying a response to PHMPT\u2019s FOIA request would compromise significant recognized interests. As described above" }, { "page": 51, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 \n601.51", "context": "\u201cimmediately available for public disclosure\u201d after a license has been issued. 21 C.F.R. \u00a7 601.51(e). Such aspects include all safety and effectiveness data and information. I" }, { "page": 51, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "n. For the reasons set forth above, PHMPT has demonstrated that a delay of its FOIA request would compromise significant recognized interests. Thus, the second fa" }, { "page": 51, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "would compromise significant recognized interests. Thus, the second factor in FOIA\u2019s \u201ccompelling need\u201d analysis weighs heavily in favor of granting expedited pro" }, { "page": 52, "family": "USC", "normalized": "15 U.S.C. \u00a7 3710c", "raw": "15 U.S.C. \u00a7 \n3710c", "context": "1179 & \u201cMaterial Transfer Agreement\u201d executed on 12/16/2019.38 Moreover, under 15 U.S.C. \u00a7 3710c, which regulates the \u201cDistribution of royalties received by Federal agencies,\u201d" }, { "page": 52, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "d under FOIA a \u201ccompelling need\u201d for the expedited processing of its request. 5 U.S.C. \u00a7 552(a)(6)(E)(v)(II) C. Conclusion Given the foregoing, ICAN hereby appeals and" }, { "page": 52, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ansparency into the federal government\u2019s activities. Thus, the third factor in FOIA\u2019s \u201ccompelling need\u201d analysis weighs heavily in favor of granting expedited pro" }, { "page": 52, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "federal government activity. Therefore, PHMPT has reasonably established under FOIA a \u201ccompelling need\u201d for the expedited processing of its request. 5 U.S.C. \u00a7 5" }, { "page": 55, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "tronic form: All data and information for the Moderna Vaccine enumerated in 21 C.F.R. \u00a7 601.51(e)2 with the exception of publicly available reports on the Vaccine Adverse Ev" }, { "page": 55, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "include Moderna, Inc. and any of its parents, subsidiaries and affiliates. 2 21 C.F.R. \u00a7 601.51(e) provides that after a biological product is licensed, the following informat" }, { "page": 55, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "all of the data and information in the biological product file, as defined in 21 C.F.R. \u00a7 601.51(a), for the Moderna Vaccine enumerated in 21 C.F.R. \u00a7 601.51(e) with the excep" }, { "page": 55, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "ile, as defined in 21 C.F.R. \u00a7 601.51(a), for the Moderna Vaccine enumerated in 21 C.F.R. \u00a7 601.51(e) with the exception of publicly available reports on the Vaccine Adverse Eve" }, { "page": 56, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "ited processing of requests for records\u201d upon a showing of \u201ccompelling need.\u201d 5 U.S.C. \u00a7 552(a)(6)(E)(i)(I). The requestor shows a \u201ccompelling need\u201d when it is \u201cprimarily" }, { "page": 56, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "inform the public concerning actual or alleged Federal Government activity.\u201d 5 U.S.C. \u00a7 552(a)(6)(E)(v)(II). Here, PHMPT is an organization made up of public health p" }, { "page": 56, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "ances are shown: (1) All safety and effectiveness data and information . . .\u201d 21 C.F.R. \u00a7 601.51(e)(1) (emphasis added). Thus, the FDA\u2019s own regulations expressly recognize t" }, { "page": 56, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "request as it meets the requirements for expedited processing under both FDA\u2019s FOIA Regulations as well as FOIA itself. A. PHMPT Qualifies for Expedited Proces" }, { "page": 56, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "irements for expedited processing under both FDA\u2019s FOIA Regulations as well as FOIA itself. A. PHMPT Qualifies for Expedited Processing Under FOIA FOIA pro" }, { "page": 56, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "s as well as FOIA itself. A. PHMPT Qualifies for Expedited Processing Under FOIA FOIA provides for \u201cexpedited processing of requests for records\u201d upon a sho" }, { "page": 56, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "as FOIA itself. A. PHMPT Qualifies for Expedited Processing Under FOIA FOIA provides for \u201cexpedited processing of requests for records\u201d upon a showing of" }, { "page": 56, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "D-19 vaccines. PHMPT intends to make any records produced in response to this FOIA request immediately available to the public through both its website and its i" }, { "page": 56, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "f the Moderna Vaccine. Accordingly, expedited processing of this request under FOIA is warranted. B. PHMPT Qualifies for Expedited Processing Under the FDA\u2019s F" }, { "page": 56, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "A is warranted. B. PHMPT Qualifies for Expedited Processing Under the FDA\u2019s FOIA Regulations Notably, separate and apart from the FDA\u2019s obligation to comply" }, { "page": 56, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "lations Notably, separate and apart from the FDA\u2019s obligation to comply with FOIA, it has an independent duty to inform the public concerning the data and infor" }, { "page": 56, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "at the FDA did not release the documents following licensure necessitated this FOIA request. 4 https://www.fda.gov/news-events/press-announcements/covid-19" }, { "page": 57, "family": "USC", "normalized": "21 U.S.C. \u00a7 393", "raw": "21 U.S.C. \u00a7 393", "context": "license vaccines that have been proven to be \u201csafe and effective,\u201d see, e.g., 21 U.S.C. \u00a7 393, and the FDA makes this determination based on, inter alia, clinical trial rep" }, { "page": 57, "family": "CFR", "normalized": "21 CFR 20.44", "raw": "21 C.F.R. \u00a7 20.44", "context": "y concerns identifiable operations or activities of the Federal Government. 21 C.F.R. \u00a7 20.44(c)(1)-(3). PHMPT easily meets all three requirements. As noted above, PHMPT" }, { "page": 57, "family": "CFR", "normalized": "21 CFR 20.44", "raw": "21 C.F.R. \u00a7 20.44", "context": "ainly \u201cprimarily engaged in disseminating information to the general public.\u201d 21 C.F.R. \u00a7 20.44(c)(1). Next, there is plainly an urgent public need for transparency with re" }, { "page": 57, "family": "CFR", "normalized": "21 CFR 601.2", "raw": "21 C.F.R. 601.2", "context": "ust be sufficient to demonstrate the product is both \u201csafe\u201d and \u201ceffective.\u201d6 21 C.F.R. 601.2(a). There is, however, an ongoing, public national debate regarding the adequ" }, { "page": 57, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "y available the safety and effectiveness data of a licensed vaccine, the FDA\u2019s FOIA regulations anticipate scenarios where FOIA requests must be expedited. Speci" }, { "page": 57, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ta of a licensed vaccine, the FDA\u2019s FOIA regulations anticipate scenarios where FOIA requests must be expedited. Specifically, a requestor is entitled to expedite" }, { "page": 61, "family": "CFR", "normalized": "21 CFR 20.44", "raw": "21 C.F.R. \u00a7 20.44", "context": "particular value that will be lost if not obtained and disseminated quickly.\u201d 21 C.F.R. \u00a7 20.44(c)(2). Finally, PHMPT\u2019s request meets the third requirement for expedited proc" }, { "page": 61, "family": "CFR", "normalized": "21 CFR 20.44", "raw": "21 C.F.R. \u00a7 20.44", "context": "lly concerns identifiable operations or activities of the Federal Government.\u201d 21 C.F.R. \u00a7 20.44(c)(3). Here, PHMPT\u2019s records request specifically concerns identifiable activ" }, { "page": 61, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ties, including PHMPT, review the safety and effectiveness data sought in this FOIA request will almost certainly assist these individuals in evaluating their vac" }, { "page": 61, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "rated that its request qualifies for expedited processing under both the FDA\u2019s FOIA regulations, as well as FOIA itself. PHMPT incorporates by reference, as if c" }, { "page": 61, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ies for expedited processing under both the FDA\u2019s FOIA regulations, as well as FOIA itself. PHMPT incorporates by reference, as if cited and fully set forth here" }, { "page": 62, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 \nU.S.C. \u00a7 552", "context": "is a nonprofit and asks that you waive any and all fees or charges pursuant to 5 U.S.C. \u00a7 552(a)(4)(A)(iii) on the basis that \u201cdisclosure of the [requested] information is i" }, { "page": 68, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "our appeal is summarized below: Denial of Expedited Processing\u0003 \u0003 Pursuant to 5 U.S.C. \u00a7 552(a)(6)(B)(i) and 5 U.S.C. \u00a7 552(a)(6)(B)(iii) of the FOIA and 45 CFR 5.24(f) of" }, { "page": 68, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "Denial of Expedited Processing\u0003 \u0003 Pursuant to 5 U.S.C. \u00a7 552(a)(6)(B)(i) and 5 U.S.C. \u00a7 552(a)(6)(B)(iii) of the FOIA and 45 CFR 5.24(f) of the HHS FOIA regulations, your" }, { "page": 68, "family": "CFR", "normalized": "45 CFR 5.24", "raw": "45 CFR 5.24", "context": "to 5 U.S.C. \u00a7 552(a)(6)(B)(i) and 5 U.S.C. \u00a7 552(a)(6)(B)(iii) of the FOIA and 45 CFR 5.24(f) of the HHS FOIA regulations, your appeal falls under \u201cunusual circumstances" }, { "page": 68, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "1 Annalise Beube From: FDA FOIA Sent: Wednesday, June 1, 2022 12:04 PM To: S&G Informatio" }, { "page": 68, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "> Sent: Wednesday, June 1, 2022 12:04 PM To: S&G Information Request Staff; FDA FOIA Subject: RE: [EXTERNAL] Expedited Processing Appeal of FOIA Control #2022-1614" }, { "page": 68, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Request Staff; FDA FOIA Subject: RE: [EXTERNAL] Expedited Processing Appeal of FOIA Control #2022-1614 (IR#0710) Follow Up Flag: Follow up Flag Status: Flagged App" }, { "page": 68, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "llp.com This letter acknowledges receipt of your Freedom of Information Act (FOIA) appeal, submitted to the Food and Drug Administration (FDA). We received your" }, { "page": 68, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Pursuant to 5 U.S.C. \u00a7 552(a)(6)(B)(i) and 5 U.S.C. \u00a7 552(a)(6)(B)(iii) of the FOIA and 45 CFR 5.24(f) of the HHS FOIA regulations, your appeal falls under \u201cunusu" }, { "page": 68, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "(i) and 5 U.S.C. \u00a7 552(a)(6)(B)(iii) of the FOIA and 45 CFR 5.24(f) of the HHS FOIA regulations, your appeal falls under \u201cunusual circumstances\u201d in that our office" }, { "page": 68, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "re information about how your appeal will be processed please refer to the HHS FOIA regulations https://www.federalregister.gov/documents/2016/10/28/2016-25684/fr" }, { "page": 68, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "gov/documents/2016/10/28/2016-25684/freedom-of-information-regulations). The FOIA and the HHS FOIA regulations are available at the following web addresses: htt" }, { "page": 68, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "6/10/28/2016-25684/freedom-of-information-regulations). The FOIA and the HHS FOIA regulations are available at the following web addresses: https://www.justice." }, { "page": 68, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Sarah Kotler FDA FOIA \u0003 \u0003 Sarah\u0003B.\u0003Kotler,\u0003J.D.\u0003 Director,\u0003Division\u0003of\u0003Freedom\u0003of\u0003Information\u0003 Case" }, { "page": 69, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "uest\u0003Staff\u0003\u0003\u0003 Sent:\u0003Wednesday,\u0003June\u00031,\u00032022\u000311:36\u0003AM\u0003 To:\u0003FDA\u0003FOIA\u0003\u0003 Subject:\u0003[EXTERNAL]\u0003Expedited\u0003Processing\u0003Appeal\u0003of\u0003FOIA\u0003" }, { "page": 69, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "\u0003FOIA\u0003\u0003 Subject:\u0003[EXTERNAL]\u0003Expedited\u0003Processing\u0003Appeal\u0003of\u0003FOIA\u0003Control\u0003#2022\u03721614\u0003(IR#0710)\u0003 \u0003 CAUTION:\u0003This\u0003email\u0003originated\u0003from\u0003outside\u0003of\u0003" }, { "page": 71, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "All data and information for the 12-15-Year-Old Pfizer Vaccine enumerated in 21 C.F.R. \u00a7 601.51(e)1 with the exception of publicly available reports on the Vaccine Adverse Ev" }, { "page": 71, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "responsive to and being produced in FOIA Control # 2021-5683 (previously 1 21 C.F.R. \u00a7 601.51(e) provides that after a biological product is licensed, the following informat" }, { "page": 71, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "all of the data and information in the biological product file, as defined in 21 C.F.R. \u00a7 601.51(a), for the 12-15-Year-Old Pfizer Vaccine enumerated in 21 C.F.R. \u00a7 601.51(e)" }, { "page": 71, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 \n601.51", "context": "d in 21 C.F.R. \u00a7 601.51(a), for the 12-15-Year-Old Pfizer Vaccine enumerated in 21 C.F.R. \u00a7 601.51(e) with the exception of publicly available reports on the Vaccine Adverse Even" }, { "page": 71, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "request excludes any data and information responsive to and being produced in FOIA Control # 2021-5683 (previously 1 21 C.F.R. \u00a7 601.51(e) provides that after" }, { "page": 72, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \n\u00a7 552", "context": "ited processing of requests for records\u201d upon a showing of \u201ccompelling need.\u201d 5 U.S.C. \u00a7 552(a)(6)(E)(i)(I). The requestor shows a \u201ccompelling need\u201d when it is \u201cprimarily" }, { "page": 72, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "inform the public concerning actual or alleged Federal Government activity.\u201d 5 U.S.C. \u00a7 552(a)(6)(E)(v)(II). PHMPT is an organization made up of public health profess" }, { "page": 72, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "d Processing Requested PHMPT requests expedited processing for this request. FOIA provides for \u201cexpedited processing of requests for records\u201d upon a showing of" }, { "page": 72, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "D-19 vaccines. PHMPT intends to make any records produced in response to this FOIA request immediately available to the public through both its website and its i" }, { "page": 73, "family": "USC", "normalized": "21 U.S.C. \u00a7 393", "raw": "21 U.S.C. \u00a7 393", "context": "license vaccines that have been proven to be \u201csafe and effective,\u201d see, e.g., 21 U.S.C. \u00a7 393, and the FDA makes this determination based on, inter alia, clinical trial rep" }, { "page": 73, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "rcumstances are shown: (1) All safety and effectiveness data and information\u2026\u201d 21 C.F.R. \u00a7 601.51(e) (emphasis added). The FDA\u2019s own regulations thus expressly recognize the i" }, { "page": 73, "family": "CFR", "normalized": "21 CFR 601.2", "raw": "21 C.F.R. 601.2", "context": "must be sufficient to demonstrate the product is both \u201csafe\u201d and \u201ceffective.\u201d9 21 C.F.R. 601.2(a). On July 8, 2022, the FDA granted approval to the 12-15-Year-Old Pfizer Va" }, { "page": 73, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "The FDA\u2019s regulation not only supports the need for expedited treatment under FOIA but is also an independent legal basis that requires expedited treatment of th" }, { "page": 75, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "iver Requested We ask that you waive any and all fees or charges pursuant to 5 U.S.C. \u00a7 552(a)(4)(A)(iii). PHMPT is a nonprofit and asks that you waive any and all fees" }, { "page": 75, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 \n552", "context": "is a nonprofit and asks that you waive any and all fees or charges pursuant to 5 U.S.C. \u00a7 552(a)(4)(A)(iii) on the basis that \u201cdisclosure of the [requested] information is i" }, { "page": 75, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "MPT has demonstrated that its request qualifies for expedited processing under FOIA. PHMPT incorporates by reference, as if cited and fully set forth herein, any" }, { "page": 80, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "All data and information for the 12-15-Year-Old Pfizer Vaccine enumerated in 21 C.F.R. \u00a7 601.51(e)1 with the exception of publicly available reports on the Vaccine Adverse Ev" }, { "page": 80, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "ly available reports on the Vaccine Adverse Events Reporting System.2 1 21 C.F.R. \u00a7 601.51(e) provides that after a biological product is licensed, the following informat" }, { "page": 80, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "all of the data and information in the biological product file, as defined in 21 C.F.R. \u00a7 601.51(a), for the 12-15-Year-Old Pfizer Vaccine enumerated in 21 C.F.R. \u00a7 601.51(e)" }, { "page": 80, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 \n601.51", "context": "d in 21 C.F.R. \u00a7 601.51(a), for the 12-15-Year-Old Pfizer Vaccine enumerated in 21 C.F.R. \u00a7 601.51(e) with the exception of publicly available reports on the Vaccine Adverse Even" }, { "page": 81, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \n\u00a7 552", "context": "ited processing of requests for records\u201d upon a showing of \u201ccompelling need.\u201d 5 U.S.C. \u00a7 552(a)(6)(E)(i)(I). The requestor shows a \u201ccompelling need\u201d when it is \u201cprimarily" }, { "page": 81, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "inform the public concerning actual or alleged Federal Government activity.\u201d 5 U.S.C. \u00a7 552(a)(6)(E)(v)(II). The de Garays seek this information because their family" }, { "page": 81, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "request excludes any data and information responsive to and being produced in FOIA Control # 2021-5683 (as that will be publicly available) and is meant to captu" }, { "page": 81, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "sing Requested The de Garays request expedited processing for this request. FOIA provides for \u201cexpedited processing of requests for records\u201d upon a showing of" }, { "page": 81, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ld Pfizer Vaccine may cause.4 Thus, this is the primary reason they make this FOIA request. As part of their advocacy, they have worked with a number of media" }, { "page": 82, "family": "USC", "normalized": "21 U.S.C. \u00a7 393", "raw": "21 U.S.C. \u00a7 393", "context": "license vaccines that have been proven to be \u201csafe and effective,\u201d see, e.g., 21 U.S.C. \u00a7 393, and the FDA makes this determination based on, inter alia, clinical trial rep" }, { "page": 82, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "rcumstances are shown: (1) All safety and effectiveness data and information\u2026\u201d 21 C.F.R. \u00a7 601.51(e) (emphasis added). The FDA\u2019s own regulations thus expressly recognize the i" }, { "page": 82, "family": "CFR", "normalized": "21 CFR 601.2", "raw": "21 C.F.R. 601.2", "context": "must be sufficient to demonstrate the product is both \u201csafe\u201d and \u201ceffective.\u201d7 21 C.F.R. 601.2(a). On July 8, 2022, the FDA granted approval to the 12-15-Year-Old Pfizer Va" }, { "page": 82, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Vaccine, and to widely disseminated any and all records they receive from this FOIA request. Therefore, between the de Garays\u2019 history of public advocacy reg" }, { "page": 82, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "volvement with media organizations on the issue, regarding the subject of this FOIA request, they are \u201cprimarily engaged in disseminating information to the gener" }, { "page": 82, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "The FDA\u2019s regulation not only supports the need for expedited treatment under FOIA but is also an independent legal basis that requires expedited treatment of th" }, { "page": 84, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "have demonstrated that their request qualifies for expedited processing under FOIA. The de Garays certify that the information in this request is true and corre" }, { "page": 85, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "iver Requested We ask that you waive any and all fees or charges pursuant to 5 U.S.C. \u00a7 552(a)(4)(A)(iii). The de Garays seek this information to aid in their public adv" }, { "page": 85, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 \n552", "context": "r Vaccine. Thus, we asks that you waive any and all fees or charges pursuant to 5 U.S.C. \u00a7 552(a)(4)(A)(iii) on the basis that \u201cdisclosure of the [requested] information is i" }, { "page": 102, "family": "USC", "normalized": "28 U.S.C. \u00a7 158", "raw": "28 USC 158", "context": "0 Insurance PERSONAL INJURY PERSONAL INJURY 625 Drug Related Seizure 422 Appeal 28 USC 158 375 False Claims Act 120 Marine 310 Airplane 365 Personal Injury - of Property" }, { "page": 102, "family": "USC", "normalized": "21 U.S.C. \u00a7 881", "raw": "21 USC 881", "context": "375 False Claims Act 120 Marine 310 Airplane 365 Personal Injury - of Property 21 USC 881 423 Withdrawal 376 Qui Tam (31 USC 130 Miller Act 315 Airplane Product Product" }, { "page": 102, "family": "USC", "normalized": "31 U.S.C. \u00a7 130", "raw": "31 USC \n130", "context": "plane 365 Personal Injury - of Property 21 USC 881 423 Withdrawal 376 Qui Tam (31 USC 130 Miller Act 315 Airplane Product Product Liability 690 Other 28 USC 157 3729(a))" }, { "page": 102, "family": "USC", "normalized": "28 U.S.C. \u00a7 157", "raw": "28 USC 157", "context": "ui Tam (31 USC 130 Miller Act 315 Airplane Product Product Liability 690 Other 28 USC 157 3729(a)) 140 Negotiable Instrument Liability 367 Health Care/ 400 State Reappor" }, { "page": 102, "family": "USC", "normalized": "15 U.S.C. \u00a7 1681", "raw": "15 USC 1681", "context": "nefits 350 Motor Vehicle 370 Other Fraud 710 Fair Labor Standards Act of 2016 (15 USC 1681 or 1692) 160 Stockholders\u2019 Suits 355 Motor Vehicle 371 Truth in Lending Act 485" }, { "page": 102, "family": "USC", "normalized": "26 U.S.C. \u00a7 7609", "raw": "26 USC 7609", "context": "EY OF RECORD FOR OFFICE USE ONLY RECEIPT # AMOUNT APPLYING IFP JUDGE MAG. JUDGE 26 USC 7609 Public Health and Medical Professionals for Transparency, and Patrick and Step" }, { "page": 102, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "ite 150 - #343, Austin TX 78701, 512-265-5622 Food and Drug Administration \u2716 \u2716 5 U.S.C. \u00a7 552(a)(4)(B) and 28 U.S.C. \u00a7 1331 Freedom of Information Act, 5 U.S.C. \u00a7 552 Mark T" }, { "page": 102, "family": "USC", "normalized": "28 U.S.C. \u00a7 1331", "raw": "28 U.S.C. \u00a7 1331", "context": "8701, 512-265-5622 Food and Drug Administration \u2716 \u2716 5 U.S.C. \u00a7 552(a)(4)(B) and 28 U.S.C. \u00a7 1331 Freedom of Information Act, 5 U.S.C. \u00a7 552 Mark T. Pittman 4:21-cv-01058-P \u2716 Oc" }, { "page": 102, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "on \u2716 \u2716 5 U.S.C. \u00a7 552(a)(4)(B) and 28 U.S.C. \u00a7 1331 Freedom of Information Act, 5 U.S.C. \u00a7 552 Mark T. Pittman 4:21-cv-01058-P \u2716 Oct 11, 2022 /s/ Walker D. Moller Case 4:22-c" }, { "page": 103, "family": "USC", "normalized": "28 U.S.C. \u00a7 1345", "raw": "28 U.S.C. 1345", "context": "in the order shown below. United States plaintiff. (1) Jurisdiction based on 28 U.S.C. 1345 and 1348. Suits by agencies and officers of the United States are included her" }, { "page": 103, "family": "USC", "normalized": "28 U.S.C. \u00a7 1331", "raw": "28 U.S.C. 1331", "context": "s, place an \"X\" in this box. Federal question. (3) This refers to suits under 28 U.S.C. 1331, where jurisdiction arises under the Constitution of the United States, an amen" }, { "page": 103, "family": "USC", "normalized": "28 U.S.C. \u00a7 1332", "raw": "28 U.S.C. 1332", "context": "2 should be marked. Diversity of citizenship. (4) This refers to suits under 28 U.S.C. 1332, where parties are citizens of different states. When Box 4 is checked, the" }, { "page": 103, "family": "USC", "normalized": "47 U.S.C. \u00a7 553", "raw": "47 USC 553", "context": "cite jurisdictional statutes unless diversity. Example: U.S. Civil Statute: 47 USC 553 Brief Description: Unauthorized reception of cable service. VII. Requested i" } ] }, { "filename": "017-Answer-2023-01-06.pdf", "id": 8071, "module": null, "batch_code": null, "company": null, "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/05/017-Answer-2023-01-06.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/08/017-Answer-2023-01-06.pdf", "total_pages": 21, "matches": [ { "page": 3, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "duals 16 years of age or older to PHMPT under the Freedom of Information Act (\u201cFOIA\u201d), in accordance with an order from this Court. This paragraph also contains" }, { "page": 3, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": ". Paragraph 8 contains Plaintiffs\u2019 characterization of the purpose of PHMPT\u2019s FOIA request. Defendant lacks sufficient knowledge or information to form a belief" }, { "page": 4, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \n\u00a7 601.51", "context": "rocessing of \u201c[a]ll data and information for the Moderna Vaccine enumerated in 21 C.F.R. \u00a7 601.51(e), with the exception of publicly available reports on the Vaccine Adverse Ev" }, { "page": 4, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 \nC.F.R. \u00a7 601.51", "context": "\u201c[a]ll data and information for the 12-15-Year-Old Pfizer Vaccine enumerated in 21 C.F.R. \u00a7 601.51(e), with the exception of publicly available reports on [VAERS]\u201d and excluding" }, { "page": 4, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \n\u00a7 601.51", "context": "[a]ll data and information for the 12-15-Year-Old Pfizer Vaccine enumerated in 21 C.F.R. \u00a7 601.51(e) with the exception of publicly available reports on [VAERS]\u201d (citation omit" }, { "page": 4, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "s in paragraph 9 except that Defendant admits that Plaintiff PHMPT submitted a FOIA request to FDA for expedited processing of \u201c[a]ll data and information for the" }, { "page": 4, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "tted). Compl., Ex. 1. Defendant admits that Plaintiff PHMPT also submitted a FOIA request for expedited processing of \u201c[a]ll data and information for the 12-15-" }, { "page": 4, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "]\u201d and excluding \u201cany data and information responsive to and being produced in FOIA Control # 2021-5683 (previously made on behalf of PHMPT)\u201d (citation omitted)." }, { "page": 4, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "onse is required, Defendant respectfully refers the Court to Plaintiff PHMPT\u2019s FOIA requests in Exhibits 1 and 5, and the cited regulation, for complete and accur" }, { "page": 4, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "aragraph 10 except that Defendant admits that Plaintiffs de Garays submitted a FOIA request to FDA requesting \u201c[a]ll data and information for the 12-15-Year-Old P" }, { "page": 5, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "intiffs have requested expedited processing of their FOIA requests pursuant to 5 U.S.C. \u00a7 552(a)(6)(E)(v)(II). Defendant has insufficient information to Case 4:22-cv-00915" }, { "page": 5, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Answer\u2013 Page 5 de Garays\u2019 FOIA request in Exhibit 7 and the cited news article for complete and accurate sta" }, { "page": 5, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Defendant admits that Plaintiffs have requested expedited processing of their FOIA requests pursuant to 5 U.S.C. \u00a7 552(a)(6)(E)(v)(II). Defendant has insufficie" }, { "page": 6, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "dmits that FDA denied Plaintiff PHMPT\u2019s request for expedited processing of its FOIA request related to Spikevax records on March 7, 2022, that Plaintiff PHMPT app" }, { "page": 8, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "the public\u2019s interest in the documents produced in Plaintiff PHMPT\u2019s separate FOIA case and the number of downloads of those documents from Plaintiff PHMPT\u2019s web" }, { "page": 12, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "y the first sentence of Paragraph 48. Defendant admits that PHMPT submitted a FOIA request on February 23, 2022, and that the request sought expedited handling." }, { "page": 12, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "handling. The remainder of the paragraph sets forth a selected portion of the FOIA request, to which no response is required. To the extent a response is requir" }, { "page": 12, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "of the Complaint for a complete and accurate statement of the contents of the FOIA request. 49. Defendant denies the allegations in paragraph 49 except that Def" }, { "page": 12, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ragraph 49 sets forth a selected portion of FDA\u2019s correspondence regarding the FOIA request, to which no response is required. To the extent a response is requir" }, { "page": 13, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "no response is required. Defendant admits that it did not respond to PHMPT\u2019s FOIA appeal prior to the commencement of this action. To the extent Plaintiffs all" }, { "page": 13, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "s action. To the extent Plaintiffs allege that FDA\u2019s determination of PHMPT\u2019s FOIA appeal remains pending, that allegation is denied. 53. To the extent Plaintif" }, { "page": 13, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "n to admit or deny the allegations. Defendant admits that PHMPT submitted the FOIA request quoted in Paragraph 53 on August 8, 2022, and that the request sought" }, { "page": 13, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "contents. The remainder of the paragraph sets forth a selected portion of the FOIA request, to which no response is required. To the extent a response is requir" }, { "page": 13, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "of the Complaint for a complete and accurate statement of the contents of the FOIA request. 54. Defendant denies the allegations in paragraph 54 except that Def" }, { "page": 13, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ragraph 54 sets forth a selected portion of FDA\u2019s correspondence regarding the FOIA request, to which no response is required. To the extent a response is requir" }, { "page": 14, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "t a response is required, Defendant respectfully refers the Court to the FOIA, 5 U.S.C. \u00a7 552, for a complete and accurate statement of its contents. Case 4:22-cv-00915-P" }, { "page": 14, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "55 except that Defendant admits that Plaintiff de Garays submitted the quoted FOIA request to FDA on August 22, 2022, which sought expedited processing. Defenda" }, { "page": 14, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "y the assertion in paragraph 55 regarding Plaintiffs\u2019 reasons for submitting a FOIA request. This paragraph also cites FDA\u2019s website, to which no response is req" }, { "page": 14, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "contents. The remainder of the paragraph sets forth a selected portion of the FOIA request, to which no response is required. To the extent a response is requir" }, { "page": 14, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "of the Complaint for a complete and accurate statement of the contents of the FOIA request. 56. Defendant denies the allegations in paragraph 56 except that" }, { "page": 14, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ragraph 56 sets forth a selected portion of FDA\u2019s correspondence regarding the FOIA request, to which no response is required. To the extent a response is requir" }, { "page": 14, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "dence. 57. Paragraph 57 consists of legal conclusions and quotations from the FOIA, to which no response is required. The allegations in this paragraph also pur" }, { "page": 14, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "extent a response is required, Defendant respectfully refers the Court to the FOIA, 5 U.S.C. \u00a7 552, for a complete and accurate statement of its contents. Case" }, { "page": 15, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "t a response is required, Defendant respectfully refers the Court to the FOIA, 5 U.S.C. \u00a7 552, and to the case citation for a complete and accurate statement of their conte" }, { "page": 15, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "\u2013 Page 15 58. Paragraph 58 consists of legal conclusions, quotations from the FOIA, and a case citation, to which no response is required. To the extent a respo" }, { "page": 15, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "extent a response is required, Defendant respectfully refers the Court to the FOIA, 5 U.S.C. \u00a7 552, and to the case citation for a complete and accurate statemen" }, { "page": 17, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "the extent that Plaintiffs allege that the COVID-19 vaccines referenced in the FOIA requests that are the subject of this action continue to be mandated by entitie" }, { "page": 18, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Paragraph 77 consists of Plaintiffs\u2019 opinion regarding the usefulness of its FOIA requests for the public, to which no response is required. Case 4:22-cv-00915-" }, { "page": 19, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "or all of the requested documents and information are exempt from disclosure. 5 U.S.C. \u00a7 552(b). Case 4:22-cv-00915-P Document 17 Filed 01/06/23 Page 19 of 21 Pag" }, { "page": 20, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \n\u00a7 552", "context": "o the extent it does not reasonably describe the records sought as required by 5 U.S.C. \u00a7 552(a)(3)(A). 3. Defendant is entitled to invoke all exemptions under the FOIA an" }, { "page": 20, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Answer\u2013 Page 20 2. Plaintiff\u2019s FOIA request is improper and unduly burdensome to the extent it does not reasonably" }, { "page": 20, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "\u00a7 552(a)(3)(A). 3. Defendant is entitled to invoke all exemptions under the FOIA and any other applicable laws. 4. To the extent Plaintiff\u2019s complaint seeks d" }, { "page": 20, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "plaint seeks documents or information that were not asserted in their original FOIA request, such matters are barred as unexhausted. 5. Plaintiffs are not entitl" } ] }, { "filename": "019-ORDER-re-Conduct-an-in-person-Scheduling-Conference-and-submit-a-Joint-Status-Report-by-Jan-27-2023-2023-0.pdf", "id": 8072, "module": null, "batch_code": null, "company": null, "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/05/019-ORDER-re-Conduct-an-in-person-Scheduling-Conference-and-submit-a-Joint-Status-Report-by-Jan-27-2023-2023-0.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/08/019-ORDER-re-Conduct-an-in-person-Scheduling-Conference-and-submit-a-Joint-Status-Report-by-Jan-27-2023-2023-0.pdf", "total_pages": 5, "matches": [] }, { "filename": "019736_S444_M5_c4591007-p2-3-children-assent-cont-select-dose-icd.pdf", "id": 8073, "module": "M5", "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/10/019736_S444_M5_c4591007-p2-3-children-assent-cont-select-dose-icd.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/10/019736_S444_M5_c4591007-p2-3-children-assent-cont-select-dose-icd.pdf", "total_pages": 9, "matches": [] }, { "filename": "020-Joint-Scheduling-Report-2023-01-27.pdf", "id": 8074, "module": null, "batch_code": null, "company": null, "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/05/020-Joint-Scheduling-Report-2023-01-27.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/08/020-Joint-Scheduling-Report-2023-01-27.pdf", "total_pages": 7, "matches": [ { "page": 2, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "cords or information may be exempt from disclosure, in whole or in part, under 5 U.S.C. \u00a7 552(b); (2) Plaintiffs\u2019 FOIA request is improper and unduly burdensome to the ext" }, { "page": 2, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 \nU.S.C. \u00a7 552", "context": "to the extent it does not reasonably describe the records sought as required by 5 U.S.C. \u00a7 552(a)(3)(A); (3) Defendant is entitled to invoke all exemptions under the FOIA an" }, { "page": 2, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "requests do not meet the requirements for expedited processing under the FOIA, 5 U.S.C. \u00a7 552(a)(6)(E), and even if Plaintiffs were entitled to expedited processing, the FO" }, { "page": 2, "family": "USC", "normalized": "552 U.S.C. \u00a7 552", "raw": "552 U.S.C. \u00a7 552", "context": "cessing, the FOIA only requires an agency to \u201cprocess as soon as practicable,\u201d 552 U.S.C. \u00a7 552(a)(6)(E)(iii). Case 4:22-cv-00915-P Document 20 Filed 01/27/23 Page 2" }, { "page": 2, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "ing for: (1) \u201c[a]ll data and information for the Moderna Vaccine enumerated in 21 C.F.R. \u00a7 601.51(a), with the exception of publicly available reports on the Vaccine Events Rep" }, { "page": 2, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R \u00a7 601.51", "context": "[a]ll data and information for the 12-15-Year-Old Pfizer Vaccine enumerated in 21 C.F.R \u00a7 601.51(e), with the exception of [public VAERS reports.]\u201d b. Defendant: FDA raised" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "future discussions about the scope of Plaintiffs\u2019 Freedom of Information Act (\u201cFOIA\u201d) requests and an appropriate production schedule for non-exempt portions of r" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ment of the claims and defenses: a. Plaintiffs: This case involves Plaintiffs\u2019 FOIA requests, which sought expedited processing for: (1) \u201c[a]ll data and informati" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "rom disclosure, in whole or in part, under 5 U.S.C. \u00a7 552(b); (2) Plaintiffs\u2019 FOIA request is improper and unduly burdensome to the extent it does not reasonably" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": ". \u00a7 552(a)(3)(A); (3) Defendant is entitled to invoke all exemptions under the FOIA and any other applicable laws; (4) To the extent Plaintiffs\u2019 complaint seeks d" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "plaint seeks documents or information that were not asserted in their original FOIA requests. such matters are barred as unexhausted; and (5) Plaintiffs are not e" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "iffs\u2019 requests do not meet the requirements for expedited processing under the FOIA, 5 U.S.C. \u00a7 552(a)(6)(E), and even if Plaintiffs were entitled to expedited pr" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "52(a)(6)(E), and even if Plaintiffs were entitled to expedited processing, the FOIA only requires an agency to \u201cprocess as soon as practicable,\u201d 552 U.S.C. \u00a7 552(" }, { "page": 3, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "no amendment to the pleadings or joinder of parties will be necessary in this FOIA case. 4. A proposed time limit to file various types of motions, including d" }, { "page": 3, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "the parties agree that designations of experts are likely unnecessary in this FOIA action. 6. A proposed time limit for objections to experts (i.e., Daubert an" }, { "page": 3, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "y should be conducted in phases; \u201c\u2018Discovery is \u2018generally inappropriate\u2019 in FOIA cases.\u2019\u201d Brewer v. DOJ, No. 3:18-CV-1018, 2019 WL 3948351, at *5 n.8 (N.D. Tex" }, { "page": 3, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "nton, 973 F.3d 106, 113 (D.C. Cir. 2020) (\u201c[A]s a general rule, discovery in a FOIA case is \u2018rare.\u2019\u201d) (quoting Baker & Hostetler LLP v. U.S. Dep\u2019t of Commerce, 47" }, { "page": 4, "family": "Court case", "normalized": "Brayton v. Office of the U.S. Trade Representative, 641 F.3d 521", "raw": "Brayton v. Office of the U.S. Trade Representative, \n641 F.3d 521", "context": "ry, as \u201cthe vast majority of FOIA cases can be resolved on summary judgment.\u201d Brayton v. Office of the U.S. Trade Representative, 641 F.3d 521, 527 (D.C. Cir. 2011). 12. A proposed mediation deadline; Case 4:22-cv-00915" }, { "page": 4, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "record . . . after [redaction or] deletion of the portions which are exempt.\u201d 5 U.S.C. \u00a7 552(b). 11. A proposed trial date, the estimated number of days for trial, and wh" }, { "page": 4, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "sought by Plaintiffs will contain information exempt from disclosure under the FOIA, including material that the government is required to protect from disclosure" }, { "page": 4, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "cial information/trade secrets) or Exemption 6 (privacy). Consistent with the FOIA, the parties agree that, where FDA contends that an exemption applies, it will" }, { "page": 4, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "believe the setting of a trial date is not necessary, as \u201cthe vast majority of FOIA cases can be resolved on summary judgment.\u201d Brayton v. Office of the U.S. Tra" }, { "page": 5, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "eve that they will be able to negotiate regarding the scope of the Plaintiffs\u2019 FOIA requests and a production schedule without the assistance of a mediator or othe" }, { "page": 6, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "agree that disclosures under Fed. R. Civ. P. 26(a)(1) are not required in this FOIA case. 14. A statement as to whether the parties will consent to trial (jury or" } ] }, { "filename": "021-Order-re-Joint-Scheduling-Report-20-Next-JSR-Due-February-17-2023-2023-02-07.pdf", "id": 8075, "module": null, "batch_code": null, "company": null, "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/05/021-Order-re-Joint-Scheduling-Report-20-Next-JSR-Due-February-17-2023-2023-02-07.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/08/021-Order-re-Joint-Scheduling-Report-20-Next-JSR-Due-February-17-2023-2023-02-07.pdf", "total_pages": 1, "matches": [] }, { "filename": "022-FDA-Brief-in-Advance-of-Scheduling-Conference.pdf", "id": 8076, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2021/12/022-FDA-Brief-in-Advance-of-Scheduling-Conference.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2022/03/022-FDA-Brief-in-Advance-of-Scheduling-Conference.pdf", "total_pages": 19, "matches": [ { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "\u2026\u2026\u2026...1 FACTUAL BACKGROUND\u2026...\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026.\u2026...\u2026...3 I. Plaintiff\u2019s FOIA Request\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026.3 II. The Parties\u2019 Negotiations Concerning a Pr" }, { "page": 3, "family": "Court case", "normalized": "Responsibility & Ethics in Wash. v. FEC, 711 F.3d 180", "raw": "Responsibility & Ethics in Wash. v. FEC, 711 F.3d 180", "context": "No. 17-cv-2288 (BAH), 2019 WL 450678 (D.D.C. Feb. 5, 2019)\u2026\u2026\u2026\u2026\u202613 Citizens for Responsibility & Ethics in Wash. v. FEC, 711 F.3d 180 (D.C. Cir. 2013)\u2026\u2026\u2026\u2026..1 Colbert v. FBI, No. 16-CV-1790 (DLF), 2018 WL 6299966" }, { "page": 3, "family": "Court case", "normalized": "Dep't of Air Force v. Rose, 425 U.S. 352", "raw": "Dep't of Air Force v. Rose, 425 U.S. 352", "context": "3 (ARR) (VMS), 2013 WL 3288418 (E.D.N.Y. June 27, 2013)\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026...13 Dep't of Air Force v. Rose, 425 U.S. 352 (1976)\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026.1 Elec. Privacy Info. Ctr. v. Dep\u2019t of Justice, 15 F" }, { "page": 3, "family": "Court case", "normalized": "F.B.I. v. Abramson, 456 U.S. 615", "raw": "F.B.I. v. Abramson, 456 U.S. 615", "context": "acy Info. Ctr. v. Dep\u2019t of Justice, 15 F. Supp. 3d 32 (D.D.C. 2014)\u2026\u2026\u2026\u2026\u2026\u2026\u2026..12 F.B.I. v. Abramson, 456 U.S. 615 (1982)\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026..\u202610 Food Mktg. Inst. v. Argus Leader Media, 139 S." }, { "page": 3, "family": "Court case", "normalized": "Food Mktg. Inst. v. Argus Leader Media, 139 S. Ct. 2356", "raw": "Food Mktg. Inst. v. Argus Leader Media, 139 S. Ct. 2356", "context": ")\u2026\u2026\u2026\u2026\u2026\u2026\u2026..12 F.B.I. v. Abramson, 456 U.S. 615 (1982)\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026..\u202610 Food Mktg. Inst. v. Argus Leader Media, 139 S. Ct. 2356 (2019)\u2026\u2026\u2026.\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026.2 Nat\u2019l Sec. Counselors v. Dep\u2019t of Justice, 848 F.3d 467" }, { "page": 3, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "44625 (D.D.C. Sept. 16, 2016)\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026..13 Statutes and Regulations 5 U.S.C. \u00a7 552\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026.passim 18 U.S.C. \u00a7 1905\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026" }, { "page": 3, "family": "USC", "normalized": "18 U.S.C. \u00a7 1905", "raw": "18 U.S.C. \u00a7 1905", "context": "Statutes and Regulations 5 U.S.C. \u00a7 552\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026.passim 18 U.S.C. \u00a7 1905\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026..2 21 U.S.C. \u00a7 331(j)\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026" }, { "page": 3, "family": "USC", "normalized": "21 U.S.C. \u00a7 331", "raw": "21 U.S.C. \u00a7 331", "context": "\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026.passim 18 U.S.C. \u00a7 1905\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026..2 21 U.S.C. \u00a7 331(j)\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u20262 21 C.F.R. \u00a7 20.61\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026" }, { "page": 3, "family": "CFR", "normalized": "21 CFR 20.61", "raw": "21 C.F.R. \u00a7 20.61", "context": "\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026..2 21 U.S.C. \u00a7 331(j)\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u20262 21 C.F.R. \u00a7 20.61\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026.2 Case 4:21-cv-01058-P Document 22 Filed 12" }, { "page": 4, "family": "CFR", "normalized": "21 CFR 20.63", "raw": "21 C.F.R. \u00a7 20.63", "context": "ii 21 C.F.R. \u00a7 20.63\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026.2 21 C.F.R. \u00a7 601.51\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026" }, { "page": 4, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "ii 21 C.F.R. \u00a7 20.63\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026.2 21 C.F.R. \u00a7 601.51\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026\u2026...3 Case 4:21-cv-01058-P Document 22 Filed 12" }, { "page": 5, "family": "Court case", "normalized": "Dep't of Air Force v. Rose, 425 U.S. 352", "raw": "Dep't of Air Force v. Rose, 425 U.S. 352", "context": "s listed in the Act. See 5 U.S.C. \u00a7 552 (a)(3), (a)(4)(B), (b), (c); see also Dep't of Air Force v. Rose, 425 U.S. 352, 362\u201365 (1976) (stating that FOIA \u201cassure[s] public access to all governmental" }, { "page": 5, "family": "Court case", "normalized": "Responsibility & Ethics in Wash. v. FEC, 711 F.3d 180", "raw": "Responsibility & Ethics in Wash. v. FEC, 711 F.3d 180", "context": "rking-day time period does not create a deadline for production. Citizens for Responsibility & Ethics in Wash. v. FEC, 711 F.3d 180, 189\u201390 (D.C. Cir. 2013).1 Rather, \u201cif the agency does not adhere to FOIA\u2019s e" }, { "page": 5, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 \nU.S.C. \u00a7 552", "context": "rom public disclosure by one or more of nine exemptions listed in the Act. See 5 U.S.C. \u00a7 552 (a)(3), (a)(4)(B), (b), (c); see also Dep't of Air Force v. Rose, 425 U.S. 352," }, { "page": 5, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 \nU.S.C. \u00a7 552", "context": "o a federal agency \u201creasonably decrib[ing]\u201d records that s/he seeks to obtain. 5 U.S.C. \u00a7 552(a)(3)(A). An agency that has received a FOIA request is required, as relevant" }, { "page": 5, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "e processing of records responsive to Plaintiff\u2019s Freedom of Information Act (\u201cFOIA\u201d) request. LEGAL BACKGROUND The Freedom of Information Act provides that any" }, { "page": 5, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "see also Dep't of Air Force v. Rose, 425 U.S. 352, 362\u201365 (1976) (stating that FOIA \u201cassure[s] public access to all governmental records whose disclosure would no" }, { "page": 5, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "closure would not significantly harm specific governmental interests\u201d). Under FOIA, a person may submit a request to a federal agency \u201creasonably decrib[ing]\u201d re" }, { "page": 5, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "s/he seeks to obtain. 5 U.S.C. \u00a7 552(a)(3)(A). An agency that has received a FOIA request is required, as relevant here, to \u201cdetermine within 20 days (excepting" }, { "page": 5, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "any such request whether to comply with such request.\u201d Id. \u00a7 552(a)(6)(A)(i). FOIA further provides that a requester \u201cshall be deemed to have exhausted his admin" }, { "page": 5, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "to comply with the applicable time limit provisions.\u201d Id. \u00a7 552(a)(6)(C)(i). FOIA\u2019s 20-working-day time period does not create a deadline for production. Citize" }, { "page": 5, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "F.3d 180, 189\u201390 (D.C. Cir. 2013).1 Rather, \u201cif the agency does not adhere to FOIA\u2019s explicit timelines, the \u2018penalty\u2019 is that the agency cannot rely on the admi" }, { "page": 5, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "1 Courts often rely on case law concerning FOIA from the D.C. Circuit, as it is \u201cthe federal appellate court with the most exp" }, { "page": 6, "family": "Court case", "normalized": "Food Mktg. Inst. v. Argus \nLeader Media, 139 S. Ct. 2356", "raw": "Food Mktg. Inst. v. Argus \nLeader Media, 139 S. Ct. 2356", "context": "types of information from its production requirements. 5 U.S.C. \u00a7 552(b); see Food Mktg. Inst. v. Argus Leader Media, 139 S. Ct. 2356, 2366 (2019) (\u201cFOIA expressly recognizes that \u2018important interests [are] serve" }, { "page": 6, "family": "Court case", "normalized": "FBI v. Abramson, 456 U.S. 615", "raw": "FBI v. Abramson, 456 U.S. 615", "context": "] as the [statute\u2019s disclosure] requirement.\u2019\u201d (brackets in original) (quoting FBI v. Abramson, 456 U.S. 615, 630\u2013631 (1982); Encino Motorcars, LLC v. Navarro, 138 S. Ct. 1134, 1142 (2018" }, { "page": 6, "family": "Court case", "normalized": "Encino Motorcars, LLC v. Navarro, 138 S. Ct. 1134", "raw": "Encino Motorcars, LLC v. \nNavarro, 138 S. Ct. 1134", "context": "(brackets in original) (quoting FBI v. Abramson, 456 U.S. 615, 630\u2013631 (1982); Encino Motorcars, LLC v. Navarro, 138 S. Ct. 1134, 1142 (2018))). As particularly relevant to this case, FOIA Exemption 4 permi" }, { "page": 6, "family": "USC", "normalized": "21 U.S.C. \u00a7 331", "raw": "21 U.S.C. \u00a7 331", "context": "s of information, such as trade secrets and personal medical information. See 21 U.S.C. \u00a7 331(j); 18 U.S.C. \u00a7 1905; 21 C.F.R. \u00a7\u00a7 20.61, 20.63. Consistent with these obliga" }, { "page": 6, "family": "USC", "normalized": "18 U.S.C. \u00a7 1905", "raw": "18 U.S.C. \u00a7 1905", "context": "ch as trade secrets and personal medical information. See 21 U.S.C. \u00a7 331(j); 18 U.S.C. \u00a7 1905; 21 C.F.R. \u00a7\u00a7 20.61, 20.63. Consistent with these obligations to protect sens" }, { "page": 6, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": ", FOIA exempts several types of information from its production requirements. 5 U.S.C. \u00a7 552(b); see Food Mktg. Inst. v. Argus Leader Media, 139 S. Ct. 2356, 2366 (2019) (" }, { "page": 6, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "formation obtained from a person and [that are] privileged or confidential.\u2019\u201d 5 U.S.C. \u00a7 552(b)(4). And Exemption 6 permits agencies to withhold or redact \u201cpersonnel and" }, { "page": 6, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 \nU.S.C. \u00a7 552", "context": "of which would constitute a clearly unwarranted invasion of personal privacy.\u201d 5 U.S.C. \u00a7 552(b)(6). To ensure protection of this information and other information that is" }, { "page": 6, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "2 Id. No other provision in FOIA creates a specific timeframe for the release of records. See 5 U.S.C. \u00a7\u00a7 552(" }, { "page": 6, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "a)(6)(C)(i) (same for litigated cases). Indeed, the time required to process a FOIA request will inherently depend on the scope of the request and the nature of t" }, { "page": 6, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "1, 20.63. Consistent with these obligations to protect sensitive information, FOIA exempts several types of information from its production requirements. 5 U.S." }, { "page": 6, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "b); see Food Mktg. Inst. v. Argus Leader Media, 139 S. Ct. 2356, 2366 (2019) (\u201cFOIA expressly recognizes that \u2018important interests [are] served by [its] exemption" }, { "page": 6, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "e] served by [its] exemptions,\u2019 and \u2018[t]hose exemptions are as much a part of [FOIA\u2019s] purpose[s and policies] as the [statute\u2019s disclosure] requirement.\u2019\u201d (bracke" }, { "page": 6, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "avarro, 138 S. Ct. 1134, 1142 (2018))). As particularly relevant to this case, FOIA Exemption 4 permits withholding of \u201ctrade secrets and commercial or financial" }, { "page": 6, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "of this information and other information that is exempt from disclosure under FOIA, government agencies must carefully review all records and redact exempt infor" }, { "page": 6, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "l records and redact exempt information before the records are released to the FOIA requester. See Daily Caller v. Dep\u2019t of State, 152 F. Supp. 3d 1, 14 (D.D.C." }, { "page": 7, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "aintiff seeking \u201call data and information for the Pfizer Vaccine enumerated in 21 C.F.R. \u00a7 601.51(e) with the exception of publicly available reports on the Vaccine Adverse Eve" }, { "page": 7, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "reinafter \u201cBurk Decl.\u201d) (App011).2 Because the regulation cited by Plaintiff, 21 C.F.R. \u00a7 601.51, addresses \u201cdata and information in applications for biologics licenses,\u201d FDA" }, { "page": 7, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "3 \u201cresponsibility\u201d when processing FOIA requests to \u201csafeguard[] potentially sensitive information\u201d). FACTUAL BACKGRO" }, { "page": 7, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "rd[] potentially sensitive information\u201d). FACTUAL BACKGROUND I. Plaintiff\u2019s FOIA Request On August 27, 2021, FDA received a FOIA request from Plaintiff seeking" }, { "page": 7, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "AL BACKGROUND I. Plaintiff\u2019s FOIA Request On August 27, 2021, FDA received a FOIA request from Plaintiff seeking \u201call data and information for the Pfizer Vaccin" }, { "page": 7, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "formation in applications for biologics licenses,\u201d FDA interpreted Plaintiff\u2019s FOIA request as a request for all publicly releasable information in the original b" }, { "page": 7, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "tial assessment of the number of records potentially responsive to Plaintiff\u2019s FOIA request, FDA determined that the original Comirnaty BLA requested by Plaintiff" }, { "page": 8, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "and production of the non-exempt portions of records responsive to Plaintiff\u2019s FOIA request.3 To assist in negotiations and to assist Plaintiff in prioritizing" }, { "page": 10, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "files (the .txt and SAS files). FDA redacted material from the 91 pages under FOIA Exemptions 4 and 6 to protect the disclosure of trade secrets and commercial o" }, { "page": 10, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ection 5.2 of the original Comirnaty BLA to Plaintiff, making redactions under FOIA Exemption 6 to protect personal privacy. With this 248-page production, FDA c" }, { "page": 12, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "amount of time it will take to process other records responsive to Plaintiff\u2019s FOIA request, following the January 31, 2022 production, FDA proposes to make one p" }, { "page": 13, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "mate is that it takes approximately 8 minutes per page to review records for a FOIA production. Id. \u00b6\u00b6 18, 29 (App007, App016). It is difficult for FDA to know" }, { "page": 13, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ortunity to assess processing times for other records responsive to Plaintiff\u2019s FOIA request, FDA may be able to process and produce the non-exempt portions of rec" }, { "page": 13, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "perly balances the interest of Plaintiff in receiving records responsive to its FOIA request with the interests of the vaccine sponsor in the protection of its con" }, { "page": 13, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "e protection of their personal privacy information, and the interests of other FOIA requesters whose requests are being processed alongside Plaintiff\u2019s. The prop" }, { "page": 14, "family": "Court case", "normalized": "F.B.I. v. Abramson, 456 U.S. 615", "raw": "F.B.I. v. Abramson, 456 U.S. 615", "context": "n is exempt from production under the FOIA. See 5 U.S.C. \u00a7 552(b)(4), (b)(6); F.B.I. v. Abramson, 456 U.S. 615, 621 (1982) (\u201cCongress realized that legitimate governmental and private inter" }, { "page": 14, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "aw and this type of information is exempt from production under the FOIA. See 5 U.S.C. \u00a7 552(b)(4), (b)(6); F.B.I. v. Abramson, 456 U.S. 615, 621 (1982) (\u201cCongress realize" }, { "page": 14, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "o assess whether records contain material that is exempt from production under FOIA and redact that exempt information. Plaintiff has requested records that comp" }, { "page": 14, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ioNTech) to FDA. Id. \u00b6 24 (App011). From FDA\u2019s experience with other similar FOIA requests, such records can be expected to contain both confidential business an" }, { "page": 14, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "under the law and this type of information is exempt from production under the FOIA. See 5 U.S.C. \u00a7 552(b)(4), (b)(6); F.B.I. v. Abramson, 456 U.S. 615, 621 (1982" }, { "page": 14, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "on of this information, and other information subject to withholding under the FOIA exemptions, FDA must carefully review and, if necessary, redact exempt informa" }, { "page": 15, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "formation and an opportunity to file a claim for injunctive relief (a \u201creverse FOIA\u201d claim). See, e.g., 21 C.F.R. \u00a7\u00a7 20.47, 20.48, 20.61(e). FDA has assessed it" }, { "page": 15, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Furthermore, FDA\u2019s proposed schedule adequately protects the interests of other FOIA requesters. FDA, and specifically, the Center for Biologics Evaluation and Re" }, { "page": 15, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "(\u201cCBER\u201d), which maintains the records requested by Plaintiff, has 459 pending FOIA requests. Id. \u00b6 22 (App010). Of the 459 requests pending before CBER, approx" }, { "page": 15, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "sources to process. Id. \u00b6 21 (App009). The branch responsible for processing FOIA requests for CBER-maintained documents, CBER\u2019s Access Litigation and Freedom o" }, { "page": 15, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "7 Along with processing FOIA requests, these ten staff members are also responsible for helping to address n" }, { "page": 15, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "uests, these ten staff members are also responsible for helping to address non- FOIA litigation-related document requests. Case 4:21-cv-01058-P Document 22 Fil" }, { "page": 16, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ter, without diverting significant resources away from the processing of other FOIA requests that are also in litigation, requests that are ahead of Plaintiff\u2019s i" }, { "page": 16, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "hat are ahead of Plaintiff\u2019s in CBER\u2019s processing queues, as well as other non-FOIA record requests (such as, for example, document review to respond to discovery" }, { "page": 16, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "lated document processing deadlines and would be fundamentally unfair to other FOIA requesters, the majority of whom submitted their FOIA requests before Plaintif" }, { "page": 16, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "mentally unfair to other FOIA requesters, the majority of whom submitted their FOIA requests before Plaintiff and who likely believe, as Plaintiff does, that thei" }, { "page": 16, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "equests before Plaintiff and who likely believe, as Plaintiff does, that their FOIA request is important and needs to be processed expeditiously. See id. \u00b6 22 (A" }, { "page": 16, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "reliminary injunction requesting immediate production of documents pursuant to FOIA request and noting that allowing the plaintiff \u201cto jump to the head of the line" }, { "page": 16, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Supp. 3d at 14 (stating that \u201cthe plaintiff\u2019s effort to jump to the head of the FOIA processing line would work a significant burden on both the agency and numerou" }, { "page": 17, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "do not waiver from the standard 500 page per month processing rate even when a FOIA request would take significant time to process. See, e.g., Colbert v. FBI, No" }, { "page": 17, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "invasion of personal privacy. Id. \u00b6 36 (App019\u201320). And it is fair to other FOIA requesters, who should not be prejudiced merely because Plaintiff has the reso" } ] }, { "filename": "022-Joint-Status-Report-2023-02-17.pdf", "id": 8077, "module": null, "batch_code": null, "company": null, "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/05/022-Joint-Status-Report-2023-02-17.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/08/022-Joint-Status-Report-2023-02-17.pdf", "total_pages": 8, "matches": [ { "page": 1, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "ing for: (1) \u201c[a]ll data and information for the Moderna Vaccine enumerated in 21 C.F.R. \u00a7 601.51(e), with the exception of publicly available reports on the Vaccine Events Rep" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R \u00a7 601.51", "context": "[a]ll data and information for the 12- 15-Year-Old Pfizer Vaccine enumerated in 21 C.F.R \u00a7 601.51(e), with the exception of [public VAERS reports.]\u201d 2. Since filing the ini" }, { "page": 1, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "See Doc. 21. 1. This case involves Plaintiffs\u2019 Freedom of Information Act (\u201cFOIA\u201d) requests to FDA which sought expedited processing for: (1) \u201c[a]ll data and i" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "fs to assist the parties\u2019 future discussions regarding the scope of Plaintiffs\u2019 FOIA requests and potential production schedules. On February 6, 2023, Defendant p" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "s and the BLA and sBLA records (many of which may be responsive to Plaintiffs\u2019 FOIA requests), and the fact that Defendant would like to provide a proposal for a" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "at production in this case begin after the completion of production in another FOIA case in this Court. See Doc. 20 at 5 (describing Pub. Health & Med. Pros. for" }, { "page": 4, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ucted an initial assessment of the number of records responsive to Plaintiff\u2019s FOIA request and has determined that more than 329,000 pages of documentary records," }, { "page": 4, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "nt is that where we\u2019re standing right now, at this very early juncture in this FOIA case, the FDA simply has not had an adequate opportunity to get its arms around" }, { "page": 4, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "entitled to the full 400,000 documents under the scope -- you know, under the FOIA statute, the FDA doesn't dispute that. But it is a choice that the plaintiffs a" } ] }, { "filename": "023-FDA-Appendix-in-Support-1.pdf", "id": 8078, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2021/12/023-FDA-Appendix-in-Support-1.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2022/03/023-FDA-Appendix-in-Support-1.pdf", "total_pages": 110, "matches": [] }, { "filename": "023-Order-on-Briefs-2023-02-23.pdf", "id": 8079, "module": null, "batch_code": null, "company": null, "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/05/023-Order-on-Briefs-2023-02-23.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/08/023-Order-on-Briefs-2023-02-23.pdf", "total_pages": 1, "matches": [] }, { "filename": "024-Brief-in-Support-of-Timely-Production-Schedule-2023-03-08.pdf", "id": 8080, "module": null, "batch_code": null, "company": null, "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/05/024-Brief-in-Support-of-Timely-Production-Schedule-2023-03-08.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/08/024-Brief-in-Support-of-Timely-Production-Schedule-2023-03-08.pdf", "total_pages": 26, "matches": [ { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "I. SERIOUS PUBLIC CONCERNS RAISED REGARDING THE FDA\u2019S DECISION ..... 9 IV. THE FOIA REQUESTS ......................................................................" }, { "page": 3, "family": "USC", "normalized": "21 U.S.C. \u00a7 393", "raw": "21 U.S.C. \u00a7 393", "context": "....................................................................... passim 21 U.S.C. \u00a7 393 ..............................................................................." }, { "page": 3, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "........................................................................... 20 5 U.S.C. \u00a7 552 ..............................................................................." }, { "page": 3, "family": "CFR", "normalized": "21 CFR 601.2", "raw": "21 C.F.R. \u00a7 601.2", "context": "iii TABLE OF AUTHORITIES Statutes 21 C.F.R. \u00a7 601.2 ..............................................................................." }, { "page": 3, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "........................................................................... 21 21 C.F.R. \u00a7 601.51 ..............................................................................." }, { "page": 11, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 \nU.S.C. \u00a7 552", "context": "), PHMPT issued two requests to FDA pursuant to the Freedom of Information Act (5 U.S.C. \u00a7 552, as amended) (\u201cFOIA\u201d) for \u201c[a]ll data and information for [the COVID-19 Vaccine" }, { "page": 11, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "ttps://www.fda.gov/news-events/press-announcements/fda-roundup-july-8-2022. 15 21 C.F.R. \u00a7 601.51(e). Case 4:22-cv-00915-P Document 24 Filed 03/08/23 Page 11 of 26 Pa" }, { "page": 11, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "FDA pursuant to the Freedom of Information Act (5 U.S.C. \u00a7 552, as amended) (\u201cFOIA\u201d) for \u201c[a]ll data and information for [the COVID-19 Vaccines] 11See https:/" }, { "page": 12, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "9 enumerated in 21 C.F.R. \u00a7 601.51(e)[16] with the exception of publicly available reports on the Vaccine Adverse" }, { "page": 12, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "onal videos encouraging the uptake for unlicensed uses of these products: 16 21 C.F.R. \u00a7 601.51(e) provides that, after a biological product is licensed, the following informa" }, { "page": 12, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "all of the data and information in the biological product file, as defined in 21 C.F.R. \u00a7 601.51(a), for [the COVID-19 Vaccines], enumerated in 21 C.F.R. \u00a7 601.51(e), with the" }, { "page": 12, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 \n601.51", "context": "as defined in 21 C.F.R. \u00a7 601.51(a), for [the COVID-19 Vaccines], enumerated in 21 C.F.R. \u00a7 601.51(e), with the exception of publicly available reports on the Vaccine Adverse Eve" }, { "page": 12, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "action on a particular lot by the [FDA].\u201d 17 For the avoidance of doubt, the FOIA Request includes, but is not limited to, all of the data and information in the" }, { "page": 20, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "eking the following documents to be produced on an expedited basis pursuant to 5 U.S.C. \u00a7 552(a)(6)(E)(v)(II): All data and information for the Moderna Vaccine enumerated i" }, { "page": 20, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 \nC.F.R. \u00a7 601.51", "context": ")(6)(E)(v)(II): All data and information for the Moderna Vaccine enumerated in 21 C.F.R. \u00a7 601.51(e)42 with the exception of publicly available reports vaccine-mandate-sports" }, { "page": 20, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "accination fully approved by the US Food and Drug Administration (FDA)\u201d). 42 21 C.F.R. \u00a7 601.51(e) provides that after a biological product is licensed, the following informat" }, { "page": 20, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": ", has already announced a mandate for students ages 12 and older.41 IV. THE FOIA REQUESTS PHMPT submitted a FOIA request on February 23, 2022, seeking the foll" }, { "page": 20, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "for students ages 12 and older.41 IV. THE FOIA REQUESTS PHMPT submitted a FOIA request on February 23, 2022, seeking the following documents to be produced o" }, { "page": 21, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "A, and declared that the appeal fell under \u201cunusual circumstances\u201d pursuant to 5 U.S.C. \u00a7 552(a)(6)(B)(i) and 5 U.S.C. \u00a7 552(a)(6)(B)(iii) of the FOIA. (Dkt. No. 1 at 18.)" }, { "page": 21, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "fell under \u201cunusual circumstances\u201d pursuant to 5 U.S.C. \u00a7 552(a)(6)(B)(i) and 5 U.S.C. \u00a7 552(a)(6)(B)(iii) of the FOIA. (Dkt. No. 1 at 18.) Given the \u201cunusual circumstance" }, { "page": 21, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "A request to FDA on August 8, 2022 and sought expedited processing pursuant to 5 U.S.C. \u00a7 552(a)(6)(E)(v)(II): 43 For the avoidance of doubt, this request includes but is" }, { "page": 21, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "all of the data and information in the biological product file, as defined in 21 C.F.R. \u00a7 601.51(a), for the Moderna Vaccine enumerated in 21 C.F.R. \u00a7 601.51(e), with the exce" }, { "page": 21, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "ile, as defined in 21 C.F.R. \u00a7 601.51(a), for the Moderna Vaccine enumerated in 21 C.F.R. \u00a7 601.51(e), with the exception of publicly available reports on the Vaccine Adverse Ev" }, { "page": 21, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "cessing (\u201cPHMPT\u2019s Denial Letter\u201d or \u201cDenial Letters\u201d) and assigned the request FOIA Control # 2022- 1614. In PHMPT\u2019s Denial Letter, FDA stated, in relevant part:" }, { "page": 21, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "hat your request for expedited processing does not meet the criteria under the FOIA. You have not demonstrated a compelling need that involves an imminent threat" }, { "page": 21, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "pursuant to 5 U.S.C. \u00a7 552(a)(6)(B)(i) and 5 U.S.C. \u00a7 552(a)(6)(B)(iii) of the FOIA. (Dkt. No. 1 at 18.) Given the \u201cunusual circumstances\u201d claimed by FDA, it was r" }, { "page": 21, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "filing, FDA has not made a determination. PHMPT also submitted the following FOIA request to FDA on August 8, 2022 and sought expedited processing pursuant to 5" }, { "page": 22, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 \n552", "context": "to license the Pfizer 12-15 Vaccine and sought expedited processing pursuant to 5 U.S.C. \u00a7 552(a)(6)(E)(v)(II). (Dkt. No. 1 at 19-20) On August 29, 2022, FDA denied the de Ga" }, { "page": 22, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "19 All data and information for the Pfizer 12-15 Vaccine enumerated in 21 C.F.R. \u00a7 601.51(e)44 with the exception of publicly available reports on the Vaccine Adverse E" }, { "page": 22, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "2022-6129. In the de Garays\u2019 Denial Letter, FDA stated in relevant part: 44 21 C.F.R. \u00a7 601.51(e) provides that after a biological product is licensed, the following informat" }, { "page": 22, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "all of the data and information in the biological product file, as defined in 21 C.F.R. \u00a7 601.51(a), for the 12-15-Year-Old Pfizer Vaccine enumerated in 21 C.F.R. \u00a7 601.51(e)" }, { "page": 22, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 \n601.51", "context": "d in 21 C.F.R. \u00a7 601.51(a), for the 12-15-Year-Old Pfizer Vaccine enumerated in 21 C.F.R. \u00a7 601.51(e) with the exception of publicly available reports on the Vaccine Adverse Even" }, { "page": 22, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "request excludes any data and information responsive to and being produced in FOIA Control # 2021-5683 (previously made on behalf of PHMPT) and is meant to captu" }, { "page": 22, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "hat your request for expedited processing does not meet the criteria under the FOIA. You have not demonstrated a compelling need that involves an imminent threat" }, { "page": 22, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "sing (\u201cde Garays\u2019 Denial Letter\u201d or \u201cDenial Letters\u201d) and assigned the request FOIA Control # 2022-6129. In the de Garays\u2019 Denial Letter, FDA stated in relevant pa" }, { "page": 23, "family": "USC", "normalized": "21 U.S.C. \u00a7 393", "raw": "21 U.S.C. \u00a7 393", "context": "license vaccines that have been proven to be \u201csafe and effective,\u201d see, e.g., 21 U.S.C. \u00a7 393, and FDA makes this determination based on, inter alia, clinical trial reports" }, { "page": 23, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "onsor, which must be sufficient to demonstrate the product is both \u201csafe\u201d 46 21 C.F.R. \u00a7 601.51(e) (emphasis added). 47 Id. Case 4:22-cv-00915-P Document 24 Filed 03/08" }, { "page": 23, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "hat your request for expedited processing does not meet the criteria under the FOIA. You have not demonstrated a compelling need that involves an imminent threat" }, { "page": 23, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": ".\u201d47 FDA\u2019s regulation not only supports the need for expedited treatment under FOIA but is also an independent legal basis that requires expedited treatment of th" }, { "page": 24, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "ities\u2019 confidence in the conclusions reached by FDA, it is not surprising that 21 C.F.R. \u00a7 601.51(e) requires FDA to immediately disclose all safety and effectiveness data afte" }, { "page": 24, "family": "CFR", "normalized": "21 CFR 601.2", "raw": "21 C.F.R. \u00a7 601.2", "context": "g a number of the scientists and journalists that are members of PHMPT. 48 21 C.F.R. \u00a7 601.2 (a). FDA explains in its guidance materials that the clinical trials relied upo" }, { "page": 25, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "dependent authorities review the safety and effectiveness data sought in these FOIA requests will only assist the public and private institutions in evaluating va" } ] }, { "filename": "026-Brief-Memorandum-in-Support-filed-by-Public-Health-and-Medical-Professionals-for-Transparency-re-21-Order-Setting-DeadlineHearing.pdf", "id": 8081, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2021/12/026-Brief-Memorandum-in-Support-filed-by-Public-Health-and-Medical-Professionals-for-Transparency-re-21-Order-Setting-DeadlineHearing.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2022/03/026-Brief-Memorandum-in-Support-filed-by-Public-Health-and-Medical-Professionals-for-Transparency-re-21-Order-Setting-DeadlineHearing.pdf", "total_pages": 30, "matches": [ { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "nough, the Federal Government Granted Pfizer Immunity ......... 10 F. PHMPT\u2019s FOIA Request ......................................................................." }, { "page": 3, "family": "Court case", "normalized": "TABLE OF AUTHORITIES \nCases \nAl-Fayed v. C.I.A., 254 F.3d 300", "raw": "TABLE OF AUTHORITIES \nCases \nAl-Fayed v. C.I.A., \n 254 F.3d 300", "context": "Page iii TABLE OF AUTHORITIES Cases Al-Fayed v. C.I.A., 254 F.3d 300 (D.C. Cir. 2001) .............................................................." }, { "page": 3, "family": "Court case", "normalized": "Avondale Indus., Inc. v. N.L.R.B., 90 F.3d 955", "raw": "Avondale Indus., Inc. v. N.L.R.B., \n 90 F.3d 955", "context": "......................................................................... 14 Avondale Indus., Inc. v. N.L.R.B., 90 F.3d 955 (5th Cir. 1996) ..............................................................." }, { "page": 3, "family": "Court case", "normalized": "Batton v. Evers, 598 F.3d 169", "raw": "Batton v. Evers, \n 598 F.3d 169", "context": "......................................................................... 13 Batton v. Evers, 598 F.3d 169 (5th Cir 2010) ................................................................" }, { "page": 3, "family": "Court case", "normalized": "Bloomberg, L.P. v. United States Food and Drug Admin., 500 F. Supp. 2d 371", "raw": "Bloomberg, L.P. v. United States Food and Drug Admin., \n 500 F. Supp. 2d 371", "context": "......................................................................... 12 Bloomberg, L.P. v. United States Food and Drug Admin., 500 F. Supp. 2d 371 (S.D.N.Y. 2007) ..............................................................." }, { "page": 3, "family": "Court case", "normalized": "Responsibility and Ethics in Washington v. U.S. Dept. of Justice, 436 F. Supp. 3d 354", "raw": "Responsibility and Ethics in Washington v. U.S. Dept. of Justice, \n 436 F. Supp. 3d 354", "context": ".................................................... 13, 14, 19 Citizens for Responsibility and Ethics in Washington v. U.S. Dept. of Justice, 436 F. Supp. 3d 354 (D.D.C. 2020) ................................................................." }, { "page": 3, "family": "Court case", "normalized": "Clemente v. Fed. Bur. of Investigation, 71 F. Supp. 3d 262", "raw": "Clemente v. Fed. Bur. of Investigation, \n 71 F. Supp. 3d 262", "context": "......................................................................... 13 Clemente v. Fed. Bur. of Investigation, 71 F. Supp. 3d 262 (DDC 2014) ...................................................................." }, { "page": 3, "family": "Court case", "normalized": "Air Force v. Rose, 425 U.S. 352", "raw": "Air Force v. Rose, \n 425 U.S. 352", "context": "D.D.C. Sept. 3, 2018) ...................................... 22 Dep\u2019t of the Air Force v. Rose, 425 U.S. 352 (1976) ........................................................................" }, { "page": 3, "family": "Court case", "normalized": "Justice Initiative v. Cent. Intelligence Agency, 399 F. Supp. 3d 161", "raw": "Justice Initiative v. Cent. Intelligence Agency, \n 399 F. Supp. 3d 161", "context": "............................................................. 23 Open Soc\u2019y. Justice Initiative v. Cent. Intelligence Agency, 399 F. Supp. 3d 161 (S.D.N.Y. 2019) ..............................................................." }, { "page": 4, "family": "Court case", "normalized": "Page iv \n \nPayne Enterprises v. United States, 837 F.2d 486", "raw": "Page iv \n \nPayne Enterprises v. United States, \n 837 F.2d 486", "context": "Page iv Payne Enterprises v. United States, 837 F.2d 486 (D.C. Cir. 1988) .............................................................." }, { "page": 4, "family": "Court case", "normalized": "Pub. Citizen Health Research Group v. F.D.A., 964 F. Supp. 413", "raw": "Pub. Citizen Health Research Group v. F.D.A., \n 964 F. Supp. 413", "context": "......................................................................... 12 Pub. Citizen Health Research Group v. F.D.A., 964 F. Supp. 413 (D.D.C. 1997) ................................................................." }, { "page": 4, "family": "Court case", "normalized": "Seavey v. Dept. of Justice, 266 F. Supp. 3d 241", "raw": "Seavey v. Dept. of Justice, \n 266 F. Supp. 3d 241", "context": "......................................................................... 12 Seavey v. Dept. of Justice, 266 F. Supp. 3d 241 (D.D.C. 2017) ................................................................." }, { "page": 4, "family": "Court case", "normalized": "Seife v. FDA, 492 F. Supp. 3d 269", "raw": "Seife v. FDA, \n 492 F. Supp. 3d 269", "context": "......................................................................... 22 Seife v. FDA, 492 F. Supp. 3d 269 (S.D.N.Y. 2020) ..............................................................." }, { "page": 4, "family": "Court case", "normalized": "United States Dept. of Justice v. Reporters Committee, 489 U.S. 749", "raw": "United States Dept. of Justice v. Reporters Committee, \n 489 U.S. 749", "context": ") ................................................................... 22, 23 United States Dept. of Justice v. Reporters Committee, 489 U.S. 749 (1989) ........................................................................" }, { "page": 4, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "......................................................................... 24 5 U.S.C. \u00a7 552 ..............................................................................." }, { "page": 4, "family": "CFR", "normalized": "21 CFR 20.44", "raw": "21 C.F.R. \u00a7 20.44", "context": "............................................... 13 Statutes and Regulations 21 C.F.R. \u00a7 20.44 ..............................................................................." }, { "page": 4, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "................................................................. 13, 14, 19 21 C.F.R. \u00a7 601.51 ..............................................................................." }, { "page": 4, "family": "CFR", "normalized": "21 CFR 20.63", "raw": "21 C.F.R. \u00a7 20.63", "context": "..................................................................... passim 21 C.F.R. \u00a7 20.63 ..............................................................................." }, { "page": 5, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "requested pursuant to the Freedom of Information Act (the \u201cFOIA Request\u201d) and 21 C.F.R. \u00a7 601.51(e). But when it came to reviewing those same documents to license this produc" }, { "page": 5, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "vaccine that PHMPT requested pursuant to the Freedom of Information Act (the \u201cFOIA Request\u201d) and 21 C.F.R. \u00a7 601.51(e). But when it came to reviewing those same" }, { "page": 5, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "led the FDA\u2019s position \u201coutrageous.\u201d They are correct. The entire purpose of FOIA is government transparency. In multiple recent cases, in upholding the FOIA\u2019s" }, { "page": 5, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "f FOIA is government transparency. In multiple recent cases, in upholding the FOIA\u2019s requirement to \u201cmake the records promptly available,\u201d courts have required C" }, { "page": 6, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "s with the response to the pandemic to date. The context surrounding PHMPT\u2019s FOIA request is truly unprecedented, and the request should be treated as such. Hi" }, { "page": 8, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ith well-established norms in the scientific community and with the purpose of FOIA; but that purpose will be utterly frustrated unless the data is released now," }, { "page": 14, "family": "USC", "normalized": "42 U.S.C. \u00a7 247d-6d", "raw": "42 U.S.C. \u00a7 247d-6d", "context": "ng its vaccine, complete legal immunity for any injury caused by its vaccine. 42 U.S.C. \u00a7 247d-6d (providing that any \u201cmanufacturer\u201d of \u201cany vaccine, used to \u2026 prevent or mitig" }, { "page": 14, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ermit outside scientists to review the data supporting its safety. F. PHMPT\u2019s FOIA Request On August 27, 2021, just four days after the FDA approved the Pfizer v" }, { "page": 14, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "just four days after the FDA approved the Pfizer vaccine, PHMPT submitted the FOIA Request to the agency, seeking the following documents: Case 4:21-cv-01058-P" }, { "page": 15, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \n\u00a7 552", "context": "As part of its FOIA request, PHMPT requested expedited professing pursuant to 5 U.S.C. \u00a7 552 (a) (6)(E)(v)(II). On September 9, 2021, the FDA denied PHMPT\u2019s request (the \u201c" }, { "page": 15, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 \nC.F.R. \u00a7 601.51", "context": "Page 11 All data and information for the Pfizer vaccine enumerated in 21 C.F.R. \u00a7 601.51(e) with the exception of publicly available reports on the Vaccine Adverse Eve" }, { "page": 15, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "le reports on the Vaccine Adverse Events Reporting System. (App000345 \u00b6 41.) 21 C.F.R. \u00a7 601.51(e) lists the \u201cdata and information in the biological product file\u201d that is sup" }, { "page": 15, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "ten summaries of oral discussions relating to the biological product file[.]\u201d 21 C.F.R. \u00a7 601.51(e)(1)-(8). On August 31, 2021, the FDA assigned the FOIA Request case number" }, { "page": 15, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "e[.]\u201d 21 C.F.R. \u00a7 601.51(e)(1)-(8). On August 31, 2021, the FDA assigned the FOIA Request case number 2021-5683. (App000345 \u00b6 43.) As part of its FOIA request," }, { "page": 15, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "gned the FOIA Request case number 2021-5683. (App000345 \u00b6 43.) As part of its FOIA request, PHMPT requested expedited professing pursuant to 5 U.S.C. \u00a7 552 (a) (" }, { "page": 15, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "hat your request for expedited processing does not meet the criteria under the FOIA. You have not demonstrated a compelling need that involves an imminent threat" }, { "page": 15, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "\u201cthat there are more than 329,000 pages potentially responsive to Plaintiff\u2019s FOIA request.\u201d (Id. at p. 3.) This page count does not include other files, \u201ctypic" }, { "page": 15, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "and 10 months to produce all the responsive documents \u2013 not exactly meeting the FOIA Case 4:21-cv-01058-P Document 26 Filed 12/07/21 Page 15 of 30 PageID" }, { "page": 16, "family": "Court case", "normalized": "Batton v. Evers, 598 F.3d 169", "raw": "Batton v. Evers, 598 F.3d 169", "context": "strative secrecy and to open agency action to the light of public scrutiny.\u2019\u201d Batton v. Evers, 598 F.3d 169, 175 (5th Cir 2010) (quoting Dep\u2019t of the Air Force v. Rose, 425 U.S. 352, 361" }, { "page": 16, "family": "Court case", "normalized": "Air Force v. Rose, 425 U.S. 352", "raw": "Air Force v. Rose, 425 U.S. 352", "context": "ny.\u2019\u201d Batton v. Evers, 598 F.3d 169, 175 (5th Cir 2010) (quoting Dep\u2019t of the Air Force v. Rose, 425 U.S. 352, 361 (1976)). And courts have long acknowledged that \u201c\u2018stale information\u2019 pro" }, { "page": 16, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \n\u00a7 552", "context": "ute\u2019s requirement that the agency \u201cshall make the records promptly available.\u201d 5 U.S.C. \u00a7 552(a)(3)(A). The FDA\u2019s proposed schedule is tantamount to a denial of the FOIA Re" }, { "page": 16, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "\u00a7 552(a)(3)(A). The FDA\u2019s proposed schedule is tantamount to a denial of the FOIA Request. PHMPT therefore asked the Court to direct the FDA to produce all re" }, { "page": 16, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "nce. (Dkt. No. 21.) In the more than three months since PHMPT submitted the FOIA request, the FDA has produced only an index of documents, 1 txt file, 1 xpt fi" }, { "page": 16, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ARGUMENT I. THE REQUEST QUALIFIES FOR EXPEDITED REVIEW AND PRODUCTION \u201cThe FOIA was enacted to \u2018pierce the veil of administrative secrecy and to open agency a" }, { "page": 16, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "d courts have long acknowledged that \u201c\u2018stale information\u2019 produced pursuant to FOIA requests \u2018is of little value.\u2019\u201d Huddleston v. Fed. Bur. of Investigation, No." }, { "page": 17, "family": "Court case", "normalized": "Payne Enterprises v. United States, 837 F.2d 486", "raw": "Payne Enterprises v. United States, 837 F.2d 486", "context": "Page 13 Feb. 1, 2021) (quoting Payne Enterprises v. United States, 837 F.2d 486, 494 (D.C. Cir. 1988)). See also Open Soc\u2019y., 399 F. Supp. 3d at 164 (\u201cCongre" }, { "page": 17, "family": "Court case", "normalized": "Bloomberg, L.P. v. United States Food and Drug Admin., 500 F. Supp. 2d 371", "raw": "Bloomberg, L.P. v. United States Food and Drug Admin., 500 F. Supp. 2d 371", "context": "inform the public concerning actual or alleged Federal Government activity.\u201d Bloomberg, L.P. v. United States Food and Drug Admin., 500 F. Supp. 2d 371, 376-77 (S.D.N.Y. 2007) (quoting 5 U.S.C. \u00a7 552 (a)(6)(E)(v)); Citizens for Re" }, { "page": 17, "family": "Court case", "normalized": "Responsibility and Ethics in Washington v. U.S. Dept. of Justice, 436 F. Supp. 3d 354", "raw": "Responsibility and Ethics in Washington \nv. U.S. Dept. of Justice, 436 F. Supp. 3d 354", "context": "71, 376-77 (S.D.N.Y. 2007) (quoting 5 U.S.C. \u00a7 552 (a)(6)(E)(v)); Citizens for Responsibility and Ethics in Washington v. U.S. Dept. of Justice, 436 F. Supp. 3d 354, 358 (D.D.C. 2020) (applying the same standard). The FDA\u2019s regulations contai" }, { "page": 17, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "xpedited processing of request for records\u201d when there is a \u201ccompelling need.\u201d 5 U.S.C. \u00a7 552 (a)(6)(E). The statute states that a compelling need includes: \u201cwith respect" }, { "page": 17, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "tes Food and Drug Admin., 500 F. Supp. 2d 371, 376-77 (S.D.N.Y. 2007) (quoting 5 U.S.C. \u00a7 552 (a)(6)(E)(v)); Citizens for Responsibility and Ethics in Washington v. U.S. De" }, { "page": 17, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "ulations require the information to be \u201cimmediately available\u201d to the public. 21 C.F.R. \u00a7 601.51(e). See also Pub. Citizen Health Research Group v. F.D.A., 964 F. Supp. 413, 4" }, { "page": 17, "family": "CFR", "normalized": "21 CFR 20.44", "raw": "21 C.F.R. \n\u00a7 20.44", "context": "DA\u2019s regulations contain the same definition of when a compelling need exists. 21 C.F.R. \u00a7 20.44 (a). \u201c\u2018Unlike the review of other agency action that must be upheld if support" }, { "page": 17, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "oting H.R. Rep. No. 93-876, at 6271 (1974)). That is why Congress amended the FOIA statute in 1996 to mandate expedited processing of important FOIA requests. H" }, { "page": 17, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "s amended the FOIA statute in 1996 to mandate expedited processing of important FOIA requests. Here, PHMPT is unquestionably entitled to the information sought in" }, { "page": 17, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "uests. Here, PHMPT is unquestionably entitled to the information sought in the FOIA Request because the FDA\u2019s own regulations require the information to be \u201cimmed" }, { "page": 17, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "997) (finding that data submitted for drug licensure had to be disclosed under FOIA because \u201c[o]nce an approval letter has been sent, certain data and information" }, { "page": 17, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ys of November 15, 2021. 1. The Standard For Reviewing Requests to Expedite FOIA provides for \u201cexpedited processing of request for records\u201d when there is a \u201cco" }, { "page": 18, "family": "Court case", "normalized": "Avondale Indus., Inc. v. N.L.R.B., 90 F.3d 955", "raw": "Avondale Indus., Inc. v. N.L.R.B., 90 F.3d 955", "context": "its action and directs the district courts to determine the matter de novo.\u2019\u201d Avondale Indus., Inc. v. N.L.R.B., 90 F.3d 955, 958 (5th Cir. 1996) (quoting United States Dept. of Justice v. Reporters Comm" }, { "page": 18, "family": "Court case", "normalized": "United States \nDept. of Justice v. Reporters Committee, 489 U.S. 749", "raw": "United States \nDept. of Justice v. Reporters Committee, 489 U.S. 749", "context": "\u2019\u201d Avondale Indus., Inc. v. N.L.R.B., 90 F.3d 955, 958 (5th Cir. 1996) (quoting United States Dept. of Justice v. Reporters Committee, 489 U.S. 749, 755 (1989)). See also Bloomberg, L.P., 500 F. Supp. 2d at 374 (\u201cThe Court rev" }, { "page": 18, "family": "Court case", "normalized": "Al-Fayed v. C.I.A., 254 F.3d 300", "raw": "Al-Fayed v. C.I.A., 254 F.3d 300", "context": "deral government activity.\u2019\u201d Bloomberg, L.P., 500 F. Supp. 2d at 377 (quoting Al-Fayed v. C.I.A., 254 F.3d 300, 310 (D.C. Cir. 2001)). The FDA\u2019s FOIA regulations present a similar triparti" }, { "page": 18, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "ged Federal Government activity,\u201d PHMPT\u2019s request easily meets this standard. 5 U.S.C. \u00a7 552 (a)(6)(E)(v). In answering this question, \u201c[c]ourts must consider at least th" }, { "page": 18, "family": "CFR", "normalized": "21 CFR 20.44", "raw": "21 C.F.R. \u00a7 20.44", "context": "ly concerns identifiable operations or activities of the Federal Government.\u201d 21 C.F.R. \u00a7 20.44(c)(2)-(3). PHMPT\u2019s FOIA Case 4:21-cv-01058-P Document 26 Filed 12/07/21" }, { "page": 18, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Page 14 substantial evidence and not arbitrary or capricious, the FOIA expressly places the burden on the agency to sustain its action and directs th" }, { "page": 18, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "rt reviews agency decisions, including those regarding expedited processing of FOIA requests, de novo.\u201d). 2. PHMPT\u2019s Request Must be Expedited There is no questi" }, { "page": 18, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "77 (quoting Al-Fayed v. C.I.A., 254 F.3d 300, 310 (D.C. Cir. 2001)). The FDA\u2019s FOIA regulations present a similar tripartite analysis, and ask whether: (1) \u201c[t]he" }, { "page": 18, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "r activities of the Federal Government.\u201d 21 C.F.R. \u00a7 20.44(c)(2)-(3). PHMPT\u2019s FOIA Case 4:21-cv-01058-P Document 26 Filed 12/07/21 Page 18 of 30 PageID" }, { "page": 19, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "ble for public disclosure unless extraordinary circumstances are shown. . . .\u201d 21 C.F.R. \u00a7 601.51(e) (emphasis added). With respect to the Pfizer vaccine in particular, as q" }, { "page": 20, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "d reaction to the FDA\u2019s request in this case to take 55 years to respond to the FOIA Request. For example, Reuters published an article titled: \u201cWait what? FDA wa" }, { "page": 20, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Reuters published an article titled: \u201cWait what? FDA wants 55 years to process FOIA request over vaccine data,\u201d and other media outlets have expressed similar surp" }, { "page": 21, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "endent review of the data is precisely what PHMPT is seeking here. It filed the FOIA Request within days of the FDA approving the Pfizer vaccine. The organization\u2019" }, { "page": 21, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "thwith Time is of the essence with regard to reviewing the data sought in the FOIA Request. (App000011 \u00b6 16.) Governments, employers, and individuals are makin" }, { "page": 21, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "r vaccine. The longer it takes the FDA to produce documents responsive to the FOIA Request, the more of those decisions will be made without the benefit of any in" }, { "page": 22, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "independent authorities review the safety and effectiveness data sought in the FOIA Request, which is what PHMPT intends, will almost certainly play a role in how" }, { "page": 23, "family": "USC", "normalized": "42 U.S.C. \u00a7 247d", "raw": "42 U.S.C. \u00a7 247d", "context": "ured, cannot sue Pfizer, the FDA, or the doctors that administer the vaccines. 42 U.S.C. \u00a7 247d- 6d. There is almost no other product where an injured consumer cannot sue the" }, { "page": 24, "family": "CFR", "normalized": "21 CFR 20.44", "raw": "21 C.F.R. \u00a7 20.44", "context": "concerning \u201cidentifiable operations or activities of the Federal Government.\u201d 21 C.F.R. \u00a7 20.44 (c)(2)-(3). II. THE FDA\u2019S POSITION IS IRRATIONAL AND HIGHLY CONCERNING T" }, { "page": 24, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "0 iii. The FDA\u2019s Approval of the Pfizer Vaccine is Government Activity The FOIA Request also meets the third factor required for a showing of urgent need beca" }, { "page": 24, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "moting Pfizer\u2019s vaccine. As such, there is no reasonable argument that PHMPT\u2019s FOIA Request seeks anything other than documents concerning \u201cidentifiable operation" }, { "page": 24, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "r 329,000+ pages of documents, in addition to data, that are responsive to the FOIA Request. (Dkt. No. 20 p. 3.) Nevertheless, it proposes to produce just 500 p" }, { "page": 24, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ts The FDA\u2019s first argument for wanting to take decades to produce is that its FOIA office does not have the capacity to produce the documents any faster. This a" }, { "page": 24, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "s any faster. This argument is specious on numerous levels. First, while the FOIA office itself may only have a few employees, the FDA has 18,062 employees as o" }, { "page": 25, "family": "Court case", "normalized": "Justice Initiative v. Cent. Intelligence Agency, 399 F. Supp. 3d 161", "raw": "Justice Initiative v. Cent. Intelligence Agency, \n399 F. Supp. 3d 161", "context": "hin four months in order to meet the court\u2019s production deadline); Open Soc\u2019y. Justice Initiative v. Cent. Intelligence Agency, 399 F. Supp. 3d 161, 169 (S.D.N.Y. 2019) (requiring the Department of Defense to produce documents" }, { "page": 26, "family": "Court case", "normalized": "Seavey v. Dept. of Justice, 266 F. Supp. 3d 241", "raw": "Seavey v. Dept. of Justice, 266 F. Supp. 3d 241", "context": ") (\u201cit would be inappropriate for productions to extend over multiple years\u201d); Seavey v. Dept. of Justice, 266 F. Supp. 3d 241, 248 (D.D.C. 2017) (rejecting Case 4:21-cv-01058-P Document 26 Filed 12/07" }, { "page": 26, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "iv. 1720 (D.D.C.), Dkt. 11 \u00b6 10. In other cases, the underlying acts that the FOIA request concerned occurred years or even decades before the requests were made" }, { "page": 27, "family": "Court case", "normalized": "In Seife v. FDA, 492 F. Supp. 3d 269", "raw": "In Seife v. FDA, 492 F. Supp. 3d 269", "context": "ths for an average production rate of approximately 11,800 pages per month. \u2022 In Seife v. FDA, 492 F. Supp. 3d 269, 273 (S.D.N.Y. 2020), the FDA agreed to produce 45,000 pages in approximately" }, { "page": 27, "family": "Court case", "normalized": "Justice Initiative v. CIA, 399 F. Supp. 3d 161", "raw": "Justice Initiative v. CIA, 399 F. Supp. 3d 161", "context": "ximately four months for an average of 10,000 pages per month. \u2022 In Open Soc\u2019y Justice Initiative v. CIA, 399 F. Supp. 3d 161 (S.D.N.Y. 2019), the CIA produced 288,000 pages at the rate of around 8,000 pa" }, { "page": 28, "family": "Court case", "normalized": "Clemente v. Fed. Bur. \nof Investigation, 71 F. Supp. 3d 262", "raw": "Clemente v. Fed. Bur. \nof Investigation, 71 F. Supp. 3d 262", "context": "and purpose of the FOIA, and the courts have a duty to prevent [such] abuses.\u201d Clemente v. Fed. Bur. of Investigation, 71 F. Supp. 3d 262, 269 (DDC 2014) (internal quotations omitted). Given this goal, the FDA\u2019s one" }, { "page": 28, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "erely requested the documents that are supposed to be publicly available under 21 C.F.R. \u00a7 601.51(e), and as explained above, all of those documents are required for a true ind" }, { "page": 28, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "elays in disclosing non-exempt documents violate the intent and purpose of the FOIA, and the courts have a duty to prevent [such] abuses.\u201d Clemente v. Fed. Bur. o" }, { "page": 29, "family": "CFR", "normalized": "21 CFR 20.63", "raw": "21 C.F.R \u00a7 20.63", "context": "from any record before it is submitted to the Food and Drug Administration.\u201d 21 C.F.R \u00a7 20.63(b) (emphasis added). Thus, the documents submitted by Pfizer, which are the s" }, { "page": 29, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "ulations Require Immediate Production The FDA further argues that even though 21 C.F.R. \u00a7 601.51(e) states that the agency must make \u201cthe biological product file \u2026 immediately" }, { "page": 29, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "rsons wishing to request this information shall submit a request under\u201d FOIA. 21 C.F.R. \u00a7 601.51 (d)(2) (emphasis added). In contrast, paragraph (e) says nothing about a memb" }, { "page": 29, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "added). Thus, the documents submitted by Pfizer, which are the subject of the FOIA Request, would have already been anonymized, and therefore, the risk of disclo" }, { "page": 29, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "anything to the public and, instead, requires that the public make a separate FOIA request in order for those documents to actually become public. A wholistic r" }, { "page": 29, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "t \u201c[p]ersons wishing to request this information shall submit a request under\u201d FOIA. 21 C.F.R. \u00a7 601.51 (d)(2) (emphasis added). In contrast, paragraph (e) says" }, { "page": 29, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": ") obligates the FDA to make those documents (i.e., the documents sought in the FOIA Request) \u201cimmediately available\u201d just as it says. CONCLUSION For the foregoin" }, { "page": 30, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Page 26 order the FDA to produce all documents responsive to the PHMPT\u2019s FOIA Request on or before March 3, 2022, which is 108 days from the parties Second" } ] }, { "filename": "027-1-Declaration-of-Beth-Brockner-Ryan-2023-03-31.pdf", "id": 8082, "module": null, "batch_code": null, "company": null, "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/05/027-1-Declaration-of-Beth-Brockner-Ryan-2023-03-31.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/08/027-1-Declaration-of-Beth-Brockner-Ryan-2023-03-31.pdf", "total_pages": 20, "matches": [ { "page": 1, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "osure of CBER-maintained documents in response to Freedom of Information Act (\u201cFOIA\u201d) requests. I have served as the Branch Chief of ALFOI for approximately twen" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ible for the review and disclosure of CBER-maintained documents in response to FOIA requests and FOIA litigation. ALFOI may also, at times, be responsible for ot" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "w and disclosure of CBER-maintained documents in response to FOIA requests and FOIA litigation. ALFOI may also, at times, be responsible for other litigation-rel" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "uests from other federal agencies and other FDA components that are processing FOIA requests for records that contain information related to CBER. These records" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "5. The purpose of this declaration is to explain ALFOI\u2019s process for handling FOIA requests, to explain ALFOI\u2019s receipt and handling of the FOIA requests submitt" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ess for handling FOIA requests, to explain ALFOI\u2019s receipt and handling of the FOIA requests submitted by Plaintiffs Public Health and Medical Professionals for T" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "R has experienced a dramatic increase in the volume and complexity of incoming FOIA requests, leading to a significant growth in the number of pending FOIA reques" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "coming FOIA requests, leading to a significant growth in the number of pending FOIA requests over the past five years. This surge began in 2019 and accelerated i" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "pandemic. CBER has also experienced an increase in administrative appeals of FOIA 1 As explained in the Sarah Kotler Declaration (\u00b6 8), these requests were a" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "s explained in the Sarah Kotler Declaration (\u00b6 8), these requests were assigned FOIA Control Numbers 2022-1614, 2022-5812, 2022-6129. Case 4:22-cv-00915-P Docum" }, { "page": 3, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "3 determinations and FOIA litigation over the last several years. Importantly, since the beginning of 2" }, { "page": 3, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "obligation to comply with this Court\u2019s Order in PHMPT 1 and increases in other FOIA responsibilities, including other pending FOIA litigation. FDA\u2019s proposed mon" }, { "page": 3, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "PHMPT 1 and increases in other FOIA responsibilities, including other pending FOIA litigation. FDA\u2019s proposed monthly production rate (of 16,000 pages of unpagi" }, { "page": 3, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "requests with CBER\u2019s other important disclosure responsibilities, particularly FOIA requests from other members of the public. Plaintiffs\u2019 request to begin produ" }, { "page": 3, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "PHMPT 1, would divert significant resources away from the processing of other FOIA requests that are also in litigation and FOIA requests that are ahead of Plain" }, { "page": 3, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "away from the processing of other FOIA requests that are also in litigation and FOIA requests that are ahead of Plaintiffs\u2019 in CBER\u2019s FOIA queues. Such diversion" }, { "page": 3, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "e also in litigation and FOIA requests that are ahead of Plaintiffs\u2019 in CBER\u2019s FOIA queues. Such diversion would severely undermine the agency\u2019s ability to meet" }, { "page": 3, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "O PROTECT CONFIDENTIAL INFORMATION 8. The majority of documents responsive to FOIA requests received by CBER contain information that is exempt from disclosure (" }, { "page": 3, "family": "Named act", "normalized": "FD&C Act", "raw": "Federal Food, Drug, and Cosmetic Act", "context": "de secret, confidential commercial, and/or personal privacy information). The Federal Food, Drug, and Cosmetic Act (\u201cFDCA\u201d) Case 4:22-cv-00915-P Document 27-1 Filed 03/31/23 Page 3 of 20" }, { "page": 3, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "d/or personal privacy information). The Federal Food, Drug, and Cosmetic Act (\u201cFDCA\u201d) Case 4:22-cv-00915-P Document 27-1 Filed 03/31/23 Page 3 of 20 Page" }, { "page": 4, "family": "USC", "normalized": "21 U.S.C. \u00a7 331", "raw": "21 U.S.C. \u00a7 331", "context": "to Congress, or to the courts where relevant in cases brought under the FDCA. 21 U.S.C. \u00a7 331(j). The Trade Secrets Act prohibits the release of trade secret information u" }, { "page": 4, "family": "USC", "normalized": "18 U.S.C. \u00a7 1905", "raw": "18 U.S.C. \u00a7 1905", "context": "ts the release of trade secret information unless otherwise authorized by law. 18 U.S.C. \u00a7 1905. In addition, FDA regulations provide, inter alia, that: (a) trade secret and" }, { "page": 4, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "A exempts several categories of information from its disclosure requirements. 5 U.S.C. \u00a7 552(b). For example, FOIA exempts from its disclosure requirements: trade secrets" }, { "page": 4, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "s and confidential commercial or financial information obtained from a person, 5 U.S.C. \u00a7 552(b)(4); and personnel, medical, and similar files if disclosure would result in" }, { "page": 4, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "disclosure would result in a clearly unwarranted invasion of personal privacy, 5 U.S.C. \u00a7 552(b)(6). 10. As a result, it is important for FDA to perform a careful line-by-" }, { "page": 4, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "oyees, to Congress, or to the courts where relevant in cases brought under the FDCA. 21 U.S.C. \u00a7 331(j). The Trade Secrets Act prohibits the release of trade secr" }, { "page": 4, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "9. Consistent with these requirements to protect confidential information, FOIA exempts several categories of information from its disclosure requirements. 5" }, { "page": 4, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "nformation from its disclosure requirements. 5 U.S.C. \u00a7 552(b). For example, FOIA exempts from its disclosure requirements: trade secrets and confidential comme" }, { "page": 4, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "y-word review of all responsive records before producing them in response to a FOIA request to ensure exempt material is not disclosed. ALFOI\u2019S PROCESS FOR H" }, { "page": 4, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "to ensure exempt material is not disclosed. ALFOI\u2019S PROCESS FOR HANDLING FOIA REQUESTS 11. FOIA requests for CBER-maintained documents are forwarded from F" }, { "page": 4, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "aterial is not disclosed. ALFOI\u2019S PROCESS FOR HANDLING FOIA REQUESTS 11. FOIA requests for CBER-maintained documents are forwarded from FDA\u2019s Division of Fr" }, { "page": 5, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "y-word disclosure review of the responsive records to determine which, if any, FOIA exemptions apply, and then electronically redacts the material, as appropriate." }, { "page": 5, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "often requires research to evaluate whether certain information falls within a FOIA exemption. For example, an ALFOI reviewer may perform online research to deter" }, { "page": 5, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "e issues. In recent years, this has become an increasingly necessary step, as FOIA requests received by CBER have increased in complexity and scope. ALFOI may C" }, { "page": 6, "family": "CFR", "normalized": "21 CFR 20.61", "raw": "21 C.F.R. \u00a7 20.61", "context": "ter of requested records, particularly where required by its regulations. See 21 C.F.R. \u00a7 20.61(e) (outlining pre-disclosure notification process for certain records, to incl" }, { "page": 6, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "e review process and inform FDA\u2019s determination about the applicability of any FOIA exemption. 15. After the necessary review and internal and external consult" }, { "page": 6, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "matters that are in litigation. Once that legal review is completed, a senior FOIA reviewer conducts a quality control review to ensure that the responsive docum" }, { "page": 7, "family": "Court case", "normalized": "Batton v. Evers, 598 F.3d 169", "raw": "Batton v. Evers, 598 F.3d 169", "context": "ted and indicates why the exemptions claimed apply to the withheld material.\u201d Batton v. Evers, 598 F.3d 169, 174 (5th Cir. 2010) (quotation omitted). Case 4:22-cv-00915-P Document 27-1" }, { "page": 7, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ss. The strict timetables generally set for producing documents in response to FOIA litigation require ALFOI to shift resources away from processing other FOIA re" }, { "page": 7, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "to FOIA litigation require ALFOI to shift resources away from processing other FOIA requests. 17. When estimating processing rates for disclosure of records unde" }, { "page": 7, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "equests. 17. When estimating processing rates for disclosure of records under FOIA, the agency must account for steps listed in paragraphs 12-15 and ensure that" }, { "page": 7, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "to review. ALFOI\u2019S WORKLOAD 18. Prior to 2019, CBER was able to keep its FOIA queues relatively stable. From 2014 through 2018, CBER had an average of 47 p" }, { "page": 7, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "relatively stable. From 2014 through 2018, CBER had an average of 47 pending FOIA requests at the end of each fiscal 2 \u201cA Vaughn index is a routine device thr" }, { "page": 8, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "8 year. 19. In 2019, the number and complexity of FOIA requests received by CBER began to increase. In fiscal year 2019, CBER receiv" }, { "page": 8, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ts received by CBER began to increase. In fiscal year 2019, CBER received 391 FOIA requests, and in fiscal year 2020, CBER received 399. By fiscal year 2021, CB" }, { "page": 8, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": ", 2023. The following chart illustrates the increase in the number of pending FOIA requests in CBER\u2019s queue during the five previous years. 21. This litiga" }, { "page": 8, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ive previous years. 21. This litigation and PHMPT 1 are also not the only FOIA litigation matters pending 108 161 287 521 611 2019 2020 2021 2022 2023 CBER:" }, { "page": 8, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "g 108 161 287 521 611 2019 2020 2021 2022 2023 CBER: 5-Year History of Pending FOIA Request Numbers Pending FOIA requests in CBER as of February 28 of each year f" }, { "page": 8, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "20 2021 2022 2023 CBER: 5-Year History of Pending FOIA Request Numbers Pending FOIA requests in CBER as of February 28 of each year from 2019 to 2023 Case 4:22-cv-" }, { "page": 9, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "which CBER is assigned. In addition to the increased volume and complexity of FOIA requests received by ALFOI, there has also been an uptick in the amount of FOI" }, { "page": 9, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "OIA requests received by ALFOI, there has also been an uptick in the amount of FOIA litigation to which ALFOI has been required to respond in the last year. Some" }, { "page": 9, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ts and/or court orders. Currently, there are 15 pending lawsuits regarding 20 FOIA requests received by CBER. 22. Imposing Plaintiffs\u2019 requested production sc" }, { "page": 9, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "verely impact ALFOI\u2019s ability to address its now very lengthy queue of pending FOIA requests. Around the time of Plaintiffs\u2019 first request in this litigation (FO" }, { "page": 9, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "IA requests. Around the time of Plaintiffs\u2019 first request in this litigation (FOIA Control No. 2022-1614; received February 23, 2022), CBER had over 500 pending" }, { "page": 9, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Control No. 2022-1614; received February 23, 2022), CBER had over 500 pending FOIA requests. Doubtless, many of the requesters who had FOIA requests pending at" }, { "page": 9, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "had over 500 pending FOIA requests. Doubtless, many of the requesters who had FOIA requests pending at CBER at the time Plaintiffs submitted their first request w" }, { "page": 9, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "nd need to be processed expeditiously. As mentioned previously, many of these FOIA requests also relate to COVID-19 (but for records distinct from those at issue" }, { "page": 9, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "te to other biologics of importance to the public. 23. The number of pending FOIA requests illustrates why it is particularly important that the production sche" }, { "page": 10, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "resources to comply with the modified Order in PHMPT 1, the number of pending FOIA requests has continued to increase\u2014indeed, the FOIA backlog increased by anoth" }, { "page": 10, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "T 1, the number of pending FOIA requests has continued to increase\u2014indeed, the FOIA backlog increased by another 90 pending requests from the end of February 2022" }, { "page": 11, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "equests with more requests being received almost daily. Making progress on the FOIA backlog\u2014or even just preventing a continuing increase in the backlog\u2014will not" }, { "page": 12, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "nal FTE permanent staff for continued processing of PHMPT 1 and to address its FOIA backlog due to the resources already devoted to PHMPT 1. CBER has advertised" }, { "page": 12, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ad, 3 regular staff, and 2 one-year temporary staff) primarily handle all other FOIA requests. 34. Thus, all FOIA requests other than PHMPT 1 are now primarily be" }, { "page": 12, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "year temporary staff) primarily handle all other FOIA requests. 34. Thus, all FOIA requests other than PHMPT 1 are now primarily being handled by a staff of one-" }, { "page": 12, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "of the PHMPT 1 team. Moreover, the 6 remaining staff handling all non-PHMPT 1 FOIA requests are handling a higher workload than during the years just prior to Ca" }, { "page": 13, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "speak directly to capacity as the staff assigned to process these non-PHMPT 1 FOIA requests are also generally the less experienced staff (2 of the permanent staf" }, { "page": 13, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ued hiring efforts represent the agency\u2019s good-faith investment to address the FOIA backlog and requests like those made by Plaintiffs, its resources for the fore" }, { "page": 13, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ntinues to implement work processes to increase efficiency, including triaging FOIA requests to ensure assignment to appropriate processing tracks, posting freque" }, { "page": 13, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "bsite to increase transparency, and, where appropriate, proactively contacting FOIA requesters to attempt to focus the scope of requests in order to produce docum" }, { "page": 14, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "the one in PHMPT 1 would adversely impact CBER\u2019s ability to reduce its growing FOIA backlog and address other COVID-19 related requests. And diverting the bulk of" }, { "page": 14, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "te. And following the conclusion of production in PHMPT 1, in fairness to all FOIA requesters, CBER\u2019s resources should be balanced among the other requesters in" }, { "page": 14, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "uesters, CBER\u2019s resources should be balanced among the other requesters in the FOIA queue as well as the Plaintiffs here. Put simply, the steps CBER has taken to" }, { "page": 15, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "uest seeking \u201c[a]ll data and information for the Moderna Vaccine enumerated in 21 C.F.R. \u00a7 601.51(e), with the exception of publicly available reports on the Vaccine Adverse Ev" }, { "page": 15, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "[a]ll data and information for the 12-15-Year-Old Pfizer Vaccine enumerated in 21 C.F.R. \u00a7 601.51(e), with the exception of publicly available reports on [VAERS]\u201d and excluding" }, { "page": 15, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "R provided Plaintiffs with a 4 The regulation cited in Plaintiffs\u2019 requests, 21 C.F.R. \u00a7 601.51(e), is not a regulation that requires immediate disclosure of any information." }, { "page": 15, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ESTS 40. As explained in the Sarah Kotler Declaration (\u00b6 22), there are three FOIA requests at issue here. On February 23, 2022, FDA received Plaintiff PHMPT\u2019s" }, { "page": 15, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "d become available for public disclosure upon request (subject to review under FOIA and FDA disclosure regulations). Case 4:22-cv-00915-P Document 27-1 File" }, { "page": 16, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "the BLA/sBLA fall into the categories of records specifically contemplated by 21 C.F.R. \u00a7 601.51(e), which Plaintiffs relied upon to define the scope of their requests), typic" }, { "page": 17, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "be in the interest of all parties for Plaintiffs to narrow the scope of their FOIA requests, but provides a proposed production schedule that assumes Plaintiffs" }, { "page": 18, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "to Plaintiffs\u2019 requests, substantially exceeding the production rates in other FOIA cases that typically set monthly production rates at a maximum of hundreds of" }, { "page": 18, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "flect an approach that more equitably balances CBER\u2019s responsibilities to other FOIA requesters/FOIA litigation matters and its consideration of the resources avai" }, { "page": 18, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "that more equitably balances CBER\u2019s responsibilities to other FOIA requesters/FOIA litigation matters and its consideration of the resources available to perform" }, { "page": 19, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ources to the detriment of other important agency functions and other COVID-19 FOIA requests. Plaintiffs\u2019 demands that monthly productions be even faster than in" }, { "page": 20, "family": "USC", "normalized": "28 U.S.C. \u00a7 1746", "raw": "28 U.S.C. \u00a7 1746", "context": "oduction obligations, including this Court\u2019s own Order in PHMPT 1. Pursuant to 28 U.S.C. \u00a7 1746, I declare under the penalty of perjury that the foregoing is true and corr" } ] }, { "filename": "027-2-Declaration-of-Sarah-B.-Kotler-2023-03-31.pdf", "id": 8083, "module": null, "batch_code": null, "company": null, "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/05/027-2-Declaration-of-Sarah-B.-Kotler-2023-03-31.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/08/027-2-Declaration-of-Sarah-B.-Kotler-2023-03-31.pdf", "total_pages": 24, "matches": [ { "page": 2, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "-2- Information Act (FOIA), 5 U.S.C. \u00a7 552. See 21 C.F.R. \u00a7 20.40. In addition, DFOI is responsible for FDA\u2019s FOIA repo" }, { "page": 2, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 \nU.S.C. \u00a7 552", "context": "uests for records pursuant to applicable law, including provisions of the FOIA, 5 U.S.C. \u00a7 552. I am also aware of the workload obligations of offices that process FOIA requ" }, { "page": 2, "family": "CFR", "normalized": "21 CFR 20.40", "raw": "21 C.F.R. \u00a7 20.40", "context": "-2- Information Act (FOIA), 5 U.S.C. \u00a7 552. See 21 C.F.R. \u00a7 20.40. In addition, DFOI is responsible for FDA\u2019s FOIA reporting to HHS and the U.S" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "-2- Information Act (FOIA), 5 U.S.C. \u00a7 552. See 21 C.F.R. \u00a7 20.40. In addition, DFOI is responsible fo" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": ".C. \u00a7 552. See 21 C.F.R. \u00a7 20.40. In addition, DFOI is responsible for FDA\u2019s FOIA reporting to HHS and the U.S. Department of Justice, consulting with other fed" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "e U.S. Department of Justice, consulting with other federal agencies regarding FOIA requests, agency-wide FOIA training, and expedited processing, among other fun" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "e, consulting with other federal agencies regarding FOIA requests, agency-wide FOIA training, and expedited processing, among other functions. DFOI processes abo" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "expedited processing, among other functions. DFOI processes about 25% of all FOIA requests received by FDA; the other 75% are processed by the FOIA reviewers wi" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "t 25% of all FOIA requests received by FDA; the other 75% are processed by the FOIA reviewers within FDA\u2019s other components. 4. As part of my duties, I coordinat" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "s other components. 4. As part of my duties, I coordinate FDA\u2019s processing of FOIA requests that relate to the novel coronavirus known as SARS-CoV-2, also known" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "to requests for records pursuant to applicable law, including provisions of the FOIA, 5 U.S.C. \u00a7 552. I am also aware of the workload obligations of offices that" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": ".C. \u00a7 552. I am also aware of the workload obligations of offices that process FOIA requests across the agency. 5. The statements contained in this declaration" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "of this declaration is to provide an overview of FDA\u2019s procedures for handling FOIA requests, FOIA workloads across the agency, and FDA\u2019s ability to process the F" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "tion is to provide an overview of FDA\u2019s procedures for handling FOIA requests, FOIA workloads across the agency, and FDA\u2019s ability to process the FOIA requests at" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "A requests, FOIA workloads across the agency, and FDA\u2019s ability to process the FOIA requests at issue in this proceeding made by Public Health and Medical Professi" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "tiffs\u2019 requests for expedited processing. 7. As explained below, Plaintiffs\u2019 FOIA requests did not satisfy the standard for expedited processing because they di" }, { "page": 3, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ts of the agency. Since the beginning of the COVID-19 pandemic, the number of FOIA requests submitted to FDA has significantly increased, as has their complexity" }, { "page": 3, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "significantly increased, as has their complexity and the amount of subsequent FOIA litigation. Because of these factors and the agency\u2019s existing FOIA and non- F" }, { "page": 3, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "subsequent FOIA litigation. Because of these factors and the agency\u2019s existing FOIA and non- FOIA workload, other FDA components cannot assist the Center for Biolo" }, { "page": 3, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "A litigation. Because of these factors and the agency\u2019s existing FOIA and non- FOIA workload, other FDA components cannot assist the Center for Biologics Evaluatio" }, { "page": 3, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "dule without diverting significant resources away from the processing of other FOIA requests that are also in litigation, requests that are ahead of Plaintiffs\u2019 r" }, { "page": 3, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "in litigation, requests that are ahead of Plaintiffs\u2019 requests, and other non-FOIA record requests. This would adversely impact the agency\u2019s ability to meet sti" }, { "page": 3, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "and the agency\u2019s public health mission. FDA\u2019S GENERAL PROCEDURE FOR INCOMING FOIA REQUESTS 8. Under FDA\u2019s regulations, DFOI is the office responsible for FDA\u2019s" }, { "page": 3, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "er FDA\u2019s regulations, DFOI is the office responsible for FDA\u2019s compliance with FOIA. See 21 C.F.R. \u00a7\u00a7 20.30, 20.40. When DFOI receives an electronic FOIA request" }, { "page": 3, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "e with FOIA. See 21 C.F.R. \u00a7\u00a7 20.30, 20.40. When DFOI receives an electronic FOIA request, it generates a control number that begins with four digits reflecting" }, { "page": 3, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "request was received, followed by a number reflecting the sequential count of FOIA requests received by DFOI to date in that particular calendar year. Plaintiff" }, { "page": 3, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "led on February 23, 2022 related to Moderna\u2019s COVID-19 vaccine was the 1,614th FOIA request received by FDA in fiscal year (\u201cFY\u201d) 2022 and thus has the control nu" }, { "page": 3, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "19 vaccine for individuals between the ages of 12-15 years old was the 5,812th FOIA request in FY 2022 (FOIA Control # 2022-5812), and Plaintiffs Stephanie and Pa" }, { "page": 3, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ls between the ages of 12-15 years old was the 5,812th FOIA request in FY 2022 (FOIA Control # 2022-5812), and Plaintiffs Stephanie and Patrick de Garay\u2019s request" }, { "page": 4, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "nstrates a \u201ccompelling need\u201d and in other cases determined by the agency. See 5 U.S.C. \u00a7 552(a)(6)(E). A \u201ccompelling need\u201d exists when: (1) a failure to obtain requested" }, { "page": 4, "family": "CFR", "normalized": "21 CFR 20.44", "raw": "21 C.F.R. \u00a7 20.44", "context": "s a letter to the requester documenting its determination. In accordance with 21 C.F.R. \u00a7 20.44, requests that have been granted expedited processing are processed as soon as" }, { "page": 4, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "9 vaccine for individuals between the ages of 12-15 years old, was the 6,129th FOIA request in FY 2022 (FOIA Control # 2022-6129). 9. FDA expedites processing of" }, { "page": 4, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "between the ages of 12-15 years old, was the 6,129th FOIA request in FY 2022 (FOIA Control # 2022-6129). 9. FDA expedites processing of a FOIA request when the" }, { "page": 4, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "quest in FY 2022 (FOIA Control # 2022-6129). 9. FDA expedites processing of a FOIA request when the requester demonstrates a \u201ccompelling need\u201d and in other cases" }, { "page": 4, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ble, on a first-in, first-out basis based on the date of receipt. 10. FDA\u2019s FOIA program is decentralized because of the agency\u2019s size, the large number of rec" }, { "page": 4, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "e course of agency business, and the different components within FDA. After a FOIA request is received and logged by DFOI, the request is assigned to the FDA com" }, { "page": 4, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "nably likely to possess responsive records, which then processes the request. FOIA reviewers within the assigned component process potentially responsive records" }, { "page": 4, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "in full, redacted in part, or withheld in their entirety under any applicable FOIA exemption or other statutory or regulatory provision. FDA\u2019S PUBLICATION OF I" }, { "page": 10, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "rocessing of \u201c[a]ll data and information for the Moderna Vaccine enumerated in 21 C.F.R. \u00a7 601.51(e), with the exception of publicly available reports on the Vaccine Adverse Ev" }, { "page": 10, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "[a]ll data and information for the 12-15-Year-Old Pfizer Vaccine enumerated in 21 C.F.R. \u00a7 601.51(e), with the exception of publicly available reports on [VAERS]\u201d and excluding" }, { "page": 10, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "OCESSING OF PLAINTIFFS\u2019 REQUESTS 22. Collectively, Plaintiffs submitted three FOIA requests to FDA: a) First Request: On February 23, 2022, Plaintiff PHMPT sub" }, { "page": 10, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "]\u201d and excluding \u201cany data and information responsive to and being produced in FOIA Control # 2021-5683 (previously made on behalf of PHMPT)\u201d (citation omitted)." }, { "page": 11, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \n\u00a7 552", "context": "nd 8. 26. I found that Plaintiffs did not demonstrate a compelling need under 5 U.S.C. \u00a7 552(a)(6)(E), in substantial part because large amounts of information have already" }, { "page": 11, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "o inform the public concerning actual or alleged Federal Government activity. 5 U.S.C. \u00a7 552(a)(6)(E)(v). Department of Justice guidance advises agencies to \u201ccarefully\u201d a" }, { "page": 11, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "\u201d) to determine which information is available for release to the public under 21 C.F.R. \u00a7 601.51(e). 24. I assigned Plaintiffs\u2019 requests to CBER for processing because they s" }, { "page": 12, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "a request for expedition necessarily works to the direct disadvantage of other FOIA requesters.\u201d DOJ, FOIA Update: OIP Guidance: When to Expedite FOIA R" }, { "page": 12, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "necessarily works to the direct disadvantage of other FOIA requesters.\u201d DOJ, FOIA Update: OIP Guidance: When to Expedite FOIA Requests, https://www.just" }, { "page": 12, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "er FOIA requesters.\u201d DOJ, FOIA Update: OIP Guidance: When to Expedite FOIA Requests, https://www.justice.gov/oip/blog/foia-update-oip-guidance-when-expe" }, { "page": 13, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "it did here). If Plaintiffs\u2019 view became the standard, a great number of FDA\u2019s FOIA requests would qualify for expedited processing, and requesters with non-exped" }, { "page": 14, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "RESOURCES 31. As detailed in the Brockner-Ryan Declaration (\u00b6\u00b6 23-28), CBER\u2019s FOIA resources are currently stretched to their maximum capacity due to marshaling" }, { "page": 14, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "em conduct work for which they are untrained and unqualified. 32. Further, FOIA administration is an unfunded mandate\u2014that is, it is not a separate \u201cline item" }, { "page": 14, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "te \u201cline item\u201d category in legislative appropriations for the agency, and thus FOIA operations must be funded from general budgetary appropriations. See, e.g., D" }, { "page": 14, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "rations must be funded from general budgetary appropriations. See, e.g., DOJ, FOIA Update: FOIA Affected by Budget Constraints, https://www.justice.gov/oip/bl" }, { "page": 14, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "be funded from general budgetary appropriations. See, e.g., DOJ, FOIA Update: FOIA Affected by Budget Constraints, https://www.justice.gov/oip/blog/foia-updat" }, { "page": 14, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "-foia-affected-budget- constraints. Accordingly, when the agency receives more FOIA requests, it cannot hire more employees with specific FOIA funding. 33. More" }, { "page": 14, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "gency receives more FOIA requests, it cannot hire more employees with specific FOIA funding. 33. Moreover, even when the agency can allocate new monetary resourc" }, { "page": 16, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "although all disclosure staff will be familiar with statutory requirements of FOIA and FDA\u2019s disclosure regulations, staff from different centers will be trained" }, { "page": 16, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "19 pandemic. Since the beginning of this emergency, FDA has been flooded with FOIA requests related to the pandemic. 37. Specifically, in fiscal year 2022, FD" }, { "page": 16, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ic. 37. Specifically, in fiscal year 2022, FDA received approximately 8,529 FOIA requests, many of which are directly related to COVID-19. Complicating matter" }, { "page": 16, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "of which are directly related to COVID-19. Complicating matters, many recent FOIA requests are more complex and are expected to take longer to process than typic" }, { "page": 16, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "quests are more complex and are expected to take longer to process than typical FOIA requests received prior to the beginning of the COVID-19 pandemic. Many reque" }, { "page": 17, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "-17- determinations. DOJ, FOIA Update: OIP Guidance: Referral and Consultation Procedures, https://www.justic" }, { "page": 17, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "consultations add both time and complication to the process for responding to FOIA requests. 38. Coupled with the increased number and complexity of requests," }, { "page": 17, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "r and complexity of requests, FDA has experienced an unprecedented increase in FOIA litigation in recent years. Between calendar years 2018 and 2020, the number" }, { "page": 17, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "tigation in recent years. Between calendar years 2018 and 2020, the number of FOIA lawsuits filed against FDA grew by approximately 200%. In 2022, FDA received" }, { "page": 17, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ts filed against FDA grew by approximately 200%. In 2022, FDA received 26 new FOIA lawsuits. Currently, FDA is involved in approximately 52 active FOIA litigati" }, { "page": 17, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "d 26 new FOIA lawsuits. Currently, FDA is involved in approximately 52 active FOIA litigations. Significantly, 20 of those FOIA lawsuits involve COVID-19 records" }, { "page": 17, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "olved in approximately 52 active FOIA litigations. Significantly, 20 of those FOIA lawsuits involve COVID-19 records\u2014 thus, there are now nearly as many FOIA liti" }, { "page": 17, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "hose FOIA lawsuits involve COVID-19 records\u2014 thus, there are now nearly as many FOIA litigations involving COVID-19 as there were total FOIA litigations brought in" }, { "page": 17, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "are now nearly as many FOIA litigations involving COVID-19 as there were total FOIA litigations brought in 2022. 39. At the review and redaction phase, certai" }, { "page": 17, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ew and redaction phase, certain FDA components have had to shift some of their FOIA reviewers from responding to FOIA requests in the normal course to almost excl" }, { "page": 17, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "A components have had to shift some of their FOIA reviewers from responding to FOIA requests in the normal course to almost exclusively processing FOIA requests i" }, { "page": 17, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ponding to FOIA requests in the normal course to almost exclusively processing FOIA requests in litigation. This diversion of staff resources to respond to ever" }, { "page": 17, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "er increasing litigation and impending court deadlines means that fewer initial FOIA requests are being processed, and at a slower pace, which is causing even more" }, { "page": 17, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "d at a slower pace, which is causing even more litigation. 40. In addition to FOIA, FDA also has numerous other document processing obligations, including those" }, { "page": 17, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "obligations, including those arising from subpoenas; discovery requests in non-FOIA litigations; oversight requests from Congress; requests from domestic and fore" }, { "page": 17, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "tutory disclosure mandates. In some agency offices, the same staff that handles FOIA requests also handles these other disclosure projects, as they rely on similar" }, { "page": 18, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": ") 41. As of February 28, 2023, CDER is responsible for processing 987 pending FOIA requests, of which approximately 48 are related to COVID-19. This is a signif" }, { "page": 18, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "rs. The following chart illustrates the numbers of pending requests in CDER\u2019s FOIA queue on February 28 of the previous five calendar years, showing a marked inc" }, { "page": 18, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ked increase in the numbers of requests beginning in 2021. Figure 1: Pending FOIA Requests in CDER as of February 28 of each year from 2019 to 2023. 42. In add" }, { "page": 18, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "of February 28 of each year from 2019 to 2023. 42. In addition to processing FOIA requests, CDER is also responsible for processing other document requests made" }, { "page": 18, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "564 597 614 882 987 2019 2020 2021 2022 2023 CDER: 5\u2010Year History of Pending FOIA Request Numbers Case 4:22-cv-00915-P Document 27-2 Filed 03/31/23 Page 1" }, { "page": 19, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "-19- under FOIA and are not processed in CDER\u2019s FOIA tracks, they are processed by CDER\u2019s FOIA" }, { "page": 19, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "-19- under FOIA and are not processed in CDER\u2019s FOIA tracks, they are processed by CDER\u2019s FOIA reviewers because of the similar nat" }, { "page": 19, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "FOIA and are not processed in CDER\u2019s FOIA tracks, they are processed by CDER\u2019s FOIA reviewers because of the similar nature of the work to FOIA processing and the" }, { "page": 19, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "rocessed by CDER\u2019s FOIA reviewers because of the similar nature of the work to FOIA processing and the need for consistency in reviewing and redacting responses t" }, { "page": 19, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "wing and redacting responses to information requests. Responding to these non-FOIA requests requires a corresponding decrease in reviewers\u2019 time available to resp" }, { "page": 19, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "s requires a corresponding decrease in reviewers\u2019 time available to respond to FOIA requests. For example, in recent years, CDER has been required to devote time" }, { "page": 19, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ce of the Commissioner (\u201cOC\u201d) 43. As of February 28, 2023, OC has 378 pending FOIA requests. After 2020, OC experienced a significant increase in FOIA requests," }, { "page": 19, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "8 pending FOIA requests. After 2020, OC experienced a significant increase in FOIA requests, with the number approximately doubling between 2020 and 2021. 44." }, { "page": 19, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "or to May 2022, OC had one full-time employee (\u201cFTE\u201d) devoted to processing of FOIA requests for records originating in OC, at times (since the fall of 2020), aide" }, { "page": 19, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "iods. In 2022, due to its increasing backlog \u2013 particularly as it pertains to FOIA litigation \u2013 OC added a second FTE and part-time assistance from others on my" }, { "page": 19, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "DFOI (which division resides in OC) and was thus able to slightly decrease its FOIA queue. However, the number of pending FOIA requests, even after more than dou" }, { "page": 19, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "thus able to slightly decrease its FOIA queue. However, the number of pending FOIA requests, even after more than doubling the FTEs working Case 4:22-cv-00915-P" }, { "page": 20, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "r duties, including management of my division, I have also been assisting with FOIA review for COVID requests in OC, as well as keeping the non-COVID OC FOIA work" }, { "page": 20, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "with FOIA review for COVID requests in OC, as well as keeping the non-COVID OC FOIA workload moving. OC is currently involved in 6 active litigation matters. Th" }, { "page": 20, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "tters. The following chart illustrates the number of pending requests in OC\u2019s FOIA queue as of February 28 of the previous five calendar years. Figure 2: Pendi" }, { "page": 20, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "eue as of February 28 of the previous five calendar years. Figure 2: Pending FOIA Requests in OC as of February 28 of each year from 2019 to 2023. Center for De" }, { "page": 20, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "iological Health (\u201cCDRH\u201d) 45. As of February 28, 2023, CDRH has 1,852 pending FOIA requests, approximately 145 of which are related to COVID-19. The following c" }, { "page": 20, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "are related to COVID-19. The following chart illustrates the length of CDRH\u2019s FOIA queue as of February 28 of each calendar year. Although CDRH\u2019s queue has not c" }, { "page": 20, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "y. 144 218 457 469 378 2019 2020 2021 2022 2023 OC: 5\u2010Year History of Pending FOIA Request Numbers Case 4:22-cv-00915-P Document 27-2 Filed 03/31/23 Page 2" }, { "page": 21, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "-21- Figure 3: Pending FOIA Requests in CDRH as of February 28 of each year from 2019 to 2023. 46. Other" }, { "page": 21, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ests in CDRH as of February 28 of each year from 2019 to 2023. 46. Other than FOIA requests, CDRH\u2019s FOIA Office is also responsible for responding to subpoenas a" }, { "page": 21, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ruary 28 of each year from 2019 to 2023. 46. Other than FOIA requests, CDRH\u2019s FOIA Office is also responsible for responding to subpoenas and non-FOIA record req" }, { "page": 21, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ts, CDRH\u2019s FOIA Office is also responsible for responding to subpoenas and non-FOIA record requests made by Congress; foreign, state, and local governments; and o" }, { "page": 21, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "e, and local governments; and other federal agencies. Responding to these non-FOIA requests requires a corresponding decrease in reviewers\u2019 time available to res" }, { "page": 21, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "s requires a corresponding decrease in reviewers\u2019 time available to respond to FOIA requests. For example, within the past four years alone, CDRH has been requir" }, { "page": 21, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "rnarounds for productions that have required CDRH reviewers to stop processing FOIA requests to respond to these subpoenas. In 2022, one voluminous subpoena alon" }, { "page": 21, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "1 2331 1927 1943 1852 2019 2020 2021 2022 2023 CDRH: 5\u2010year History of Pending FOIA Request Numbers Case 4:22-cv-00915-P Document 27-2 Filed 03/31/23 Page 2" }, { "page": 22, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "-22- pending FOIA requests has increased markedly from 162 in February 2021 to 409 in February 2" }, { "page": 22, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "d Center for Tobacco Products have not encountered the same influx of COVID-19 FOIA requests, so their FOIA queues have remained fairly steady. But they currentl" }, { "page": 22, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ducts have not encountered the same influx of COVID-19 FOIA requests, so their FOIA queues have remained fairly steady. But they currently maintain queues in the" }, { "page": 22, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "re fully consumed with their standard responsibilities, which also include non-FOIA disclosure projects, such as Privacy Act requests. 49. Based on all of the in" }, { "page": 22, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "iew the records at issue in this case. EFFORTS TO REDUCE BACKLOGS 50. FDA\u2019s FOIA offices have taken numerous steps to reduce backlogs and improve processing ti" }, { "page": 22, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ous steps to reduce backlogs and improve processing time. Specifically, FDA\u2019s FOIA offices are recruiting and hiring new employees where funding allows; proactiv" }, { "page": 22, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ively posting online frequently requested documents to reduce the need for new FOIA requests; training FOIA employees to handle types of records within their compo" }, { "page": 22, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "quently requested documents to reduce the need for new FOIA requests; training FOIA employees to handle types of records within their component that they do not t" }, { "page": 22, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "o experienced redactors as needed; and, where possible, proactively contacting FOIA requesters to negotiate the scope of requests to in order to produce records mo" }, { "page": 23, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "-23- contractors (9 full-time and 1 part-time) to assist with FOIA processing and was recently approved to hire and train 6 new full-time disclos" }, { "page": 23, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ployee returning to CDER from the Office of Regulatory Affairs) to assist with FOIA processing. Similarly, CDRH completed a business process improvement review o" }, { "page": 23, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ssing. Similarly, CDRH completed a business process improvement review of its FOIA program in October 2019, which included identifying hiring needs; updating wor" }, { "page": 23, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ows, processes, and procedures; training reviewers; and additional tracking of FOIA requests. Between September and December 2019, CDRH acquired a multi- year con" }, { "page": 23, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "lti- year contract that currently provides 11 contractors to assist in reducing FOIA backlogs and hired additional full-time reviewers to process FOIA requests and" }, { "page": 23, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "in reducing FOIA backlogs and hired additional full-time reviewers to process FOIA requests and other disclosure tasks. CONCLUSION 52. In sum, FDA is committ" }, { "page": 23, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "also taken reasonable steps to assist Plaintiffs with providing a more targeted FOIA request, as discussed in greater detail in the Brockner-Ryan Declaration (\u00b6\u00b6 3" }, { "page": 24, "family": "USC", "normalized": "28 U.S.C. \u00a7 1746", "raw": "28 U.S.C. \u00a7 1746", "context": "-24- Pursuant to 28 U.S.C. \u00a7 1746, I declare under the penalty of perjury that the foregoing is true and correct" } ] }, { "filename": "027-Appendix-in-Support-filed-by-Public-Health-and-Medical-Professionals-for-Transparency-re-26-Brief-Memorandum-in-Support-of-Motion.pdf", "id": 8084, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2021/12/027-Appendix-in-Support-filed-by-Public-Health-and-Medical-Professionals-for-Transparency-re-26-Brief-Memorandum-in-Support-of-Motion.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2022/03/027-Appendix-in-Support-filed-by-Public-Health-and-Medical-Professionals-for-Transparency-re-26-Brief-Memorandum-in-Support-of-Motion.pdf", "total_pages": 633, "matches": [ { "page": 341, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "nd correct copy of an article titled \u201cWait what? FDA wants 55 years to process FOIA request over vaccine data\u201d available at https://www.reuters. com/legal/governme" }, { "page": 341, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "tled \u201cRep. Ralph Norman Introduces Legislation to Expedite FDA Compliance with FOIA Requests for Vaccine Approval Data\u201d available at https://norman.house.gov/news" }, { "page": 347, "family": "USC", "normalized": "28 U.S.C. \u00a7 1746", "raw": "28 U.S.C. \u00a7 1746", "context": "t copy of an email from Courtney D. Enlow dated December 2, 2021. Pursuant to 28 U.S.C. \u00a7 1746, I declare under penalty of perjury under the laws of the United States of Ame" }, { "page": 347, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "13121001/. 41. Exhibit 37, attached hereto, is a true and correct copy of the FOIA request at issue in this case, which is dated August 27, 2021 and was submitte" }, { "page": 347, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "a true and correct copy of the confirmation PHMPT received upon submitting the FOIA Request. 43. Exhibit 39, attached hereto, is a true and correct copy of a let" }, { "page": 370, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "leases Rep. Ralph Norman Introduces Legislation to Expedite FDA Compliance with FOIA Requests for Vaccine Approval Data Washington, D.C., December 2, 2021 Tags: Hea" }, { "page": 371, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ited States since the approval of the vaccine in August 2021 by the FDA.\u00da \u00da The FOIA request and lawsuit are exclusive to the FDA approved P}zer vaccine, but Rep. N" }, { "page": 474, "family": "CFR", "normalized": "21 CFR 10.30", "raw": "21 C.F.R. \u00a7 10.30", "context": "submitted on behalf of the undersigned petitioners (\u201cPetitioners\u201d) pursuant to 21 C.F.R. \u00a7 10.30 and related relevant provisions of the Federal Food, Drug, and Cosmetic Act or" }, { "page": 474, "family": "Named act", "normalized": "FD&C Act", "raw": "Federal \nFood, Drug, and Cosmetic Act", "context": "itioners\u201d) pursuant to 21 C.F.R. \u00a7 10.30 and related relevant provisions of the Federal Food, Drug, and Cosmetic Act or the Public Health Service Act to request that the Commissioner of Food and" }, { "page": 474, "family": "Named act", "normalized": "PHS Act", "raw": "Public Health Service Act", "context": "related relevant provisions of the Federal Food, Drug, and Cosmetic Act or the Public Health Service Act to request that the Commissioner of Food and Drugs (the \u201cCommissioner\u201d) requir" }, { "page": 598, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "denied in part. \"\u0001\u0003G9.7$, This case arises out of Plaintiff Brian Huddleston's FOIA requests against Defendants the Federal Bureau of Investigation (\"FBI\") and t" }, { "page": 599, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ng agency bears the burden to demonstrate its due diligence in fulfilling its FOIA-related obligations). The decision to stay proceedings is \"left to the sound d" }, { "page": 599, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "\u0005// \u0002 \u0015 \u00022\u00182\u0014\u000226\u0019\u0002>, \u0002(\u000e) \u0002\u0015\u0016\u00166? (citing 0\u0004 \u0007 \u0014\u0002\u001533\u0002$ % \u0002\u0004\u0006\u0002 \u00156\u0018-66). Since \"FOIA imposes no limits on courts' equitable [*3] powers in enforcing its terms,\" d" }, { "page": 599, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ers in enforcing its terms,\" deciding whether to grant a stay is unaffected by FOIA. :\u0004* \u000e\u0002 ' \u0006\u000e\u0012 \u0014\u0002 # \u000f \u0002 \u0002 $ \u0007\u0006\u000e \u0002 %\u0006\u0004\u0006\u000e \u0014\u0002 2\u0019\u0013\u0002 ! \u0015 \u0002 \u00182I\u0014\u0002 \u00183\u0018\u0014\u0002 \u0015I\u0013\u0002 $ % \u0002\u0001" }, { "page": 599, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "\u0014\u0002\u0018\u00176\u0002$ % \u0002\u0017\u0014\u0002\u00173-\u0015\u0016\u0014\u00023\u0018\u0002 % \u0002\u0003\u0006 \u0002\u0017\u0016\u00152\u0014\u0002\u00193\u00020 \u0002' \u0002\u0015 \u0002\u0017\u0015\u0019\u0002>\u00173\u0013\u0018??. \u0001,\u00010D%#% Under FOIA, once the responding agency receives a records request, it must, among other t" }, { "page": 599, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ments to review (Dkt. #10 at pp. 2-3; Dkt. #12 at p. 3; Dkt. #15 at p. 2), and FOIA-response resources have lessened due to the COVID-19 pandemic (Dkt. #10 at pp." }, { "page": 599, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "c has severely disrupted the normal functioning of government, and processing FOIA requests is no exception. %\u000e\u000e OFF. OF INFO. POL'Y, U.S. DEP'T OF JUST., 9\u0005\u0007 \u0004 \u000f" }, { "page": 600, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "with the Motion Defendants advance is the due-diligence element required by FOIA. 6\u0002 $ % \u0003 \u0002 K\u0002 66\u0015>\u0004?>I?>\u0003?>\u0007? (\"If the Government can show exceptional circum" }, { "page": 600, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "degree of malleability Defendants propose for the proceedings is unreasonable. FOIA \"represents a strong Congressional commitment to transparency in government t" }, { "page": 600, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "\u0014\u0002\u0018\u0017\u0019\u0002! \u0002%\u0005// \u0002\u0017\u001526\u0014\u0002\u0017\u001523\u0002> \u0003 \u0002 \u00173\u0013I? (explaining that when Congress created FOIA's due-diligence requirement, it did not intend for production to take years)." }, { "page": 600, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "work through requests of this nature is \"about 10 months\" (Dkt. #10 at p. 3). FOIA sets out [*7] temporal guidelines for its procedures to ensure expediti" }, { "page": 600, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "y scheme. 5\u0004 & \u0002 :\b \u0006\u0002 \u0002 %\u0014\u0002 \u001863\u0002 ! \u0002 %\u0005// \u0002 \u0015 \u0002 I\u0017\u0014\u0002 \u0013\u0018\u0002 > \u0003 \u0002 \u0015\u0016\u0016I? (\"FOIA was created to foster public awareness, 1 While Plaintiff's argument regarding" }, { "page": 601, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Page 4 of 5 and failure to process FOIA requests in a timely fashion is 'tantamount to denial.'\" (quoting H.R. REP. NO" }, { "page": 601, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "of exceptional circumstances because \"stale information\" produced pursuant to FOIA requests \"is of little value.\" :\u0004* \u000e\u0002' \u0006\u000e\u0012 \u0014\u0002# \u000f \u0014\u00022\u0019\u0013\u0002! \u0015 \u0002\u0004\u0006\u0002\u00182I. Granting" }, { "page": 601, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "\u0006\u000e\u0012 \u0014\u0002# \u000f \u0014\u00022\u0019\u0013\u0002! \u0015 \u0002\u0004\u0006\u0002\u00182I. Granting the relief Defendants seek would thwart FOIA's \"basic purpose\" of \"open[ing] agency action to the light of public scrutiny" }, { "page": 601, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "in the exceptional circumstances associated with the handling of Huddleston's FOIA requests more precisely, and (2) present a less amorphous processing and produ" }, { "page": 601, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "nd relevant pleadings, the Court does not find the exceptional-circumstances FOIA exception applicable and utilizes its inherent authority to extend the sched" }, { "page": 604, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "intiff's Original Complaint\" (\"Compl.\") 2 6, ECF No. 1, filed Aug. 22, 2019; \"FOIA Request,\" Ex. 1. \u0004\u0004\u0002\b Plaintiff's Opposed Application for Attorney Fees an" }, { "page": 604, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "to compel production on August 22, 2019.10 Toni Fuentes (\"Fuentes\"), a Deputy FOIA Officer for ICE, was immediately responsible for supervising ICE responses to" }, { "page": 604, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "iately responsible for supervising ICE responses to requests for records under FOIA.11 Due to an ICE administrative error, ICE did not become aware of DMRS's FOI" }, { "page": 604, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "OIA.11 Due to an ICE administrative error, ICE did not become aware of DMRS's FOIA request until after the initiation of this lawsuit.12 Fuentes assisted in loca" }, { "page": 604, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "il after the initiation of this lawsuit.12 Fuentes assisted in locating DMRS's FOIA request, at which time she assigned the request to the litigation team of the" }, { "page": 604, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "uest, at which time she assigned the request to the litigation team of the ICE FOIA Office for expedited processing of the request.13 Approximately four-and-a-hal" }, { "page": 605, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "aintiff filed suit and almost eleven months after Plaintiff sent its original FOIA request, ICE forwarded the pages requiring consultation to other agencies for" }, { "page": 605, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "enty-day deadline, excluding weekends and holidays for agencies to respond to FOIA requests). 20 \"Plaintiff's Reply to Defendant's Response to Plaintiff's C\"\u0002*\u0007\u001b" }, { "page": 606, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Page 4 of 17 FOIA requests.24 Each program office within ICE has its own guidelines for record" }, { "page": 606, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "It also ordered ICE to conduct a new search for documents responsive to DMRS's FOIA request by November 2, 2020.36 &\"\u0002, \u00062*\u0007\u001b\b On November 2, 2020, the deadline" }, { "page": 607, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ially responsive documents remained.42 ICE then assigned thirty percent of its FOIA staff to conduct first-line review full-time.43 Ten to fifteen attorneys woul" }, { "page": 607, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "w are now the law of the case. ICE cannot contest either.48 %%\" 7'<\u00017\u0002 *\u0001\u0003\u000e\u0001 \u000e FOIA states \"[t]he court may assess against the United 42 %$\" at 11. 43 %$\" at 47" }, { "page": 608, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "rts to conduct analysis through the lens of the three fundamental purposes of FOIA's legal fee provision. The provision is designed: (1) \"as an incentive for pri" }, { "page": 608, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ed in this action definitively establishes DMRS substantially prevailed in its FOIA action as this court granted all of the requested relief.55 This is not contes" }, { "page": 608, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ight of the circumstances of the case and the [*11] essential purposes of the FOIA legal fee provision. 1. The Benefit to the Public Deriving from the Case \"The" }, { "page": 608, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "sion. 1. The Benefit to the Public Deriving from the Case \"The basic purpose of FOIA is to ensure an informed citizenry, vital to the functioning of a democratic s" }, { "page": 608, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "able to the governed.\"56 Viewing the public benefit factor through the lens of FOIA's high- minded central purpose, attorneys fees are more appropriate \"where the" }, { "page": 609, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "es for asylum seekers fleeing persecution. The documents responsive to DMRS's FOIA request are very likely to be of significant consequence to the large numbers" }, { "page": 609, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "rch, lack of effective and comprehensive procedures for adequately processing FOIA requests, and repeated requests for extensions of deadlines. ICE's ineptitude" }, { "page": 609, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "or. To do so would make a mockery of the accountability principles underlying FOIA. ICE's handling of this FOIA request is precisely encompassed in the Fifth Cir" }, { "page": 609, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ckery of the accountability principles underlying FOIA. ICE's handling of this FOIA request is precisely encompassed in the Fifth Circuit's holding that attorney" }, { "page": 609, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "valid claim or have been otherwise engaged in obdurate behavior.'\"61 Potential FOIA complainants must be incentivized to pursue meritorious claims without fear t" }, { "page": 610, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ther the Government's Withholding of the Records had a Reasonable Basis in Law. FOIA requires federal agencies to make their records promptly available to any pers" }, { "page": 610, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "on who makes a proper request for records.66 \"[T]he threshold question in any FOIA suit is whether the requester can even \u0004\u0004 the documents the character of whic" }, { "page": 610, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "haracter of which determines whether they can be released.\"67 Accordingly, the FOIA statute provides that, when the government withholds information from di" }, { "page": 611, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Page 9 of 17 documents responsive to DMRS's FOIA request. \"Even when an agency does not deny a FOIA request outright, the requ" }, { "page": 611, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "uments responsive to DMRS's FOIA request. \"Even when an agency does not deny a FOIA request outright, the requesting party may still be able to claim 'improper'" }, { "page": 611, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ent and generalized. Fuentes described general ICE procedure for responding to FOIA requests without knowledge of the specifics. Fuentes did not 70 #\" \"\u0002 \u000e\u00046=\u0006\u0002" }, { "page": 611, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "\u00025\u0018\u00027\"\u0002'$\"\u0002\u0014$\u0002 \u00145\u0012\u0002G\u00163/\u0015H (recognizing the judicial authority conferred by the FOIA to devise remedies for agencies contravening the statute through improper with" }, { "page": 612, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ndicate [*20] FOPS is reasonably likely to have records responsive to DMRS's FOIA request. They also indicate ICE was aware that field offices possess records r" }, { "page": 612, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "y also indicate ICE was aware that field offices possess records responsive to FOIA requests for information related to the MPP. Inexplicably, FOPS determined DMR" }, { "page": 612, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "quests for information related to the MPP. Inexplicably, FOPS determined DMRS's FOIA request did not fall within its area of responsibility and declined to conduc" }, { "page": 612, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "publicly available memo in determining it had no records responsive to DMRS's FOIA request. There is no reasonable basis in law to support ICE's inadequate searc" }, { "page": 612, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "d on June 25, 2020. When the applicability of an exemption to disclosure under FOIA is in dispute, an agency is required to provide a detailed 84 Findings of Fac" }, { "page": 616, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "w search in compliance with this court's order.119 ICE disputed only that the FOIA fee shifting provision permitted compensation for work yet to be perfor" }, { "page": 616, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "rs billed reasonably reflect the time spent on litigation and are compensable. FOIA matters present 116 Mot. 10. 117 Mot., \"19-cv-00236 Billing Statement\" 2, ECF" }, { "page": 617, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ve documents. For the first time, [*29] ICE claims the substantial backlog of FOIA requests and its limited personnel makes timely compliance impossible. Howeve" }, { "page": 620, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "rt to determine whether the FBI is entitled to withhold any information under FOIA exemptions 6 and 7(C).1 3\u0002 \u001b!\u001b\u0003\u001b\u0002 II\u0002 33\u0013-\u000f/-*/, -\u0011/ Alternatively, Colbert as" }, { "page": 621, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "wn that the disclosure of certain records would implicate privacy concerns, a FOIA requester can still obtain the records if the requester can show that the publ" }, { "page": 621, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ecords outweighs the privacy interests at stake. \u0007\u001b To satisfy this burden, a FOIA requester must show that (1) the public interest sought to be advanced is a s" }, { "page": 622, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "terest in not having the records released to the public. Consistent with other FOIA cases, the Court will assess the appropriateness of any claimed withholdings a" }, { "page": 622, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "very to determine why the FBI disregarded Rackstraw as a suspect. Discovery in FOIA cases is \"rare\" and \"only appropriate when an agency has not taken adequate" }, { "page": 622, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ion 8, Dkt. 15. The FBI adheres to that policy because it is based on sound FOIA business practice, promotes efficiency, and allows the FBI to maintain proper" }, { "page": 622, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": ". Courts have broad discretion to determine a reasonable processing rate for a FOIA request. Several factors inform the analysis, including the size and compellin" }, { "page": 622, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "rs, as well as the effect of the request on the FBI's ability to review other FOIA requests. !\u0006\u0006\u0012\u0002\u0006\u001b>\u001b, \u0017\u0004\u0007\u0007\u0019\u0006\u00021\u001b\u0002 \u0010#\u000e\u0002\u001a\u001b\u0002 6!\u0012\u0002\u0013,\u0011\u0002 \u001b\u0002!#%%\u001b\u0002&\u0007\u0002\u0015'&\u0012\u0002\u0015'*\u0002- \u001b \u001b\u0003\u001b\u0002" }, { "page": 622, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "\u0003\u001b\u0002 \u0013\u0014\u0015\u0016/. When determining the rate at which a federal agency must respond to FOIA requests, courts often give deference to the agency's release policies. !\u0006\u0006 )\u0006" }, { "page": 624, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "4 ;&\u0001\u0003(' \u0002; \u0003 ;\u0003 This case involves a series of Freedom of Information Act (\"FOIA\") requests about a controversial form of civil asset forfeiture carried out by" }, { "page": 624, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "equester, \"IJ\") now challenges the scope of the IRS's redactions under several FOIA exemptions. Before the Court are the Parties' Motions for Partial Summary Jud" }, { "page": 624, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "[*2] part each Party's respective motion. \" F\u0001)CH&;'\u0003( In 2016, IJ lodged a FOIA request to secure information about how the IRS enforces its structuring laws." }, { "page": 625, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "s unless there are exceptional circumstances.\" TIGTA Report at 3. IJ submitted FOIA requests seeking records relating to that pledge, and over the last 26 months" }, { "page": 625, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": ",000 pages of records, withholding or redacting certain records under various FOIA Exemptions. \u0005\u0007\u0007 Pl.'s Partial Cross-Mot. Summ. J. 1-3, ECF No. 50 (\"Pl.'s Mot." }, { "page": 625, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ard oral argument. \u0005\u0007\u0007 Minute Order !\u0007 Feb. 18, 2021. \" \u0005:\u0001\u0003(\u0001&(\u0002;-\u0002&4< 4B FOIA \"generally require[es] federal agencies to make their records available to the" }, { "page": 625, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ency has the burden of showing that [the] requested information comes within a FOIA exemption.\" $\u0017\"\u0002)\u000e!\u000eN\u0007\u0010\u0002G\u0007 \u0011!\u0006\u0002&\u0007 \u0007 %\u0006\u0002H \b\"\u0002\u0015\"\u0002-(\u0001\u001a\u0002 +6\u0002-\"\u0019 \u0002+8+\u001a\u00028\u001b/\u001a\u0002\u0019\u00190\u0002" }, { "page": 626, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "\u0003\u00013D\u0005 \u0005 \u0001\" :\u0006\u0007\u0002 \u000e\u0015 %*\u00024=\u0007\u0016\b!\u000e\u0004\u0010 Most of the Parties' current dispute turns on FOIA's privacy exemptions. Those exemptions let agencies redact \"names and iden" }, { "page": 626, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "efs.' Opp'n\"). IJ has the better argument. Identification is the touchstone of FOIA's privacy exemptions. The Supreme Court has held that 4=\u0007\u0016\b!\u000e\u0004\u0010\u00027 \"cover[s] d" }, { "page": 628, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "\u0004\u0016 \u0002 \u0005\u0007 \u0015\"\u001a\u00020 \u0002-\"\u0019 \u0002++6\u001a\u0002+87\u001a\u0002\u0019 6\u0002'\"\u0005\"\u0002\u0001\b\b\"\u0002(\")\"\u0002 00\u00021(\")\"\u0002 )\u000e \"\u0002 8862. Indeed, FOIA does not \"permit[] an agency to exempt from disclosure all of the material in" }, { "page": 629, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "r identification of individuals involved,\" it overstepped its authority under FOIA. \u0005\u0007\u0007\u0002 F$NN-\u0007\u0007 \u0002 \u0010%\"\u001a\u0002 \u0018\u001b 8\u0002 B3\u0002 \u00190 +8\u0018+\u001a\u0002 !\u00029\u0018. As the IRS reassesses its prod" }, { "page": 629, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "create anonymous identifiers for the officers or agents listed in its records. FOIA \"does not obligate agencies to create or retain documents; it only obligates" }, { "page": 632, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "zabeth Hill 23, 43-47, ECF No. 36-1. During the intervening time, the IRS's FOIA caseload has dropped from 60 to 49 cases and the agency has added six addition" }, { "page": 632, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "8\u00021(\"(\")\"\u0002\u0018\u001b /2 (5,000 pages per month). And as the IRS's resources to process FOIA requests have substantially improved since the Court first granted its request" } ] }, { "filename": "027-Defendant-Brief-Regarding-Production-Schedule-2023-03-31.pdf", "id": 8085, "module": null, "batch_code": null, "company": null, "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/05/027-Defendant-Brief-Regarding-Production-Schedule-2023-03-31.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/08/027-Defendant-Brief-Regarding-Production-Schedule-2023-03-31.pdf", "total_pages": 36, "matches": [ { "page": 1, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "-P DEFENDANT UNITED STATES FOOD AND DRUG ADMINISTRATION\u2019S BRIEF REGARDING FOIA PRODUCTION SCHEDULE LEIGHA SIMONTON UNITED STATES ATTOR" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "............................................................ 9 1. Plaintiffs\u2019 FOIA Requests .................................................................. 9" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "edited Processing ........ 13 2. FDA\u2019s Proposed Production Schedule Satisfies FOIA\u2019s Reasonableness Requirement and Plaintiffs\u2019 Proposed Production Schedule Doe" }, { "page": 3, "family": "Court case", "normalized": "Al-Fayed v. CIA, 254 F.3d 300", "raw": "Al-Fayed v. CIA, \n \n254 F.3d 300", "context": "(N.D. Tex. Feb. 23, 2001) .................................................. 4 Al-Fayed v. CIA, 254 F.3d 300 (D.C. Cir. 2001) (quoting H.R. Rep. No. 104-795, at 26, 1996 U.S.C.C.A.N. 3448" }, { "page": 3, "family": "Court case", "normalized": "Am. C.L. Union v. DHS, \n \nNo. 20-CV-10083, 2021 WL 5449733", "raw": "Am. C.L. Union v. DHS, \n \nNo. 20-CV-10083, 2021 WL 5449733", "context": "................................................................. 5, 6, 13, 18 Am. C.L. Union v. DHS, No. 20-CV-10083, 2021 WL 5449733 (S.D.N.Y. Nov. 19, 2021) ....................................... 26, 27 Am. Ct" }, { "page": 3, "family": "Court case", "normalized": "Am. Ctr. For Law & Just. v. DHS, \n \nNo. 21-1364, 573 F. Supp. 3d 78", "raw": "Am. Ctr. For Law & Just. v. DHS, \n \nNo. 21-1364, 573 F. Supp. 3d 78", "context": "449733 (S.D.N.Y. Nov. 19, 2021) ....................................... 26, 27 Am. Ctr. For Law & Just. v. DHS, No. 21-1364, 573 F. Supp. 3d 78, 81\u201384 (D.D.C. Nov. 10, 2021) ....................................... 20, 27 C" }, { "page": 3, "family": "Court case", "normalized": "Responsibility & Ethics in Wash. v. FEC, 711 F.3d 180", "raw": "Responsibility & Ethics in Wash. v. FEC, \n \n711 F.3d 180", "context": "............................................................... 5 Citizens for Responsibility & Ethics in Wash. v. FEC, 711 F.3d 180 (D.C. Cir. 2013) .............................................................." }, { "page": 3, "family": "Court case", "normalized": "Colbert v. FBI, \n \nNo. 16-1790, 2018 WK 6299966", "raw": "Colbert v. FBI, \n \nNo. 16-1790, 2018 WK 6299966", "context": "............................................................................ 2 Colbert v. FBI, No. 16-1790, 2018 WK 6299966 (D.D. C. Sept. 3, 2018) ......................................................." }, { "page": 3, "family": "Court case", "normalized": "Encino Motorcars, LLC v. Navarro, 138 S. Ct. 1134", "raw": "Encino Motorcars, LLC v. Navarro, \n \n138 S. Ct. 1134", "context": "............................................................................ 7 Encino Motorcars, LLC v. Navarro, 138 S. Ct. 1134 (2018) ........................................................................" }, { "page": 3, "family": "Court case", "normalized": "Energy Future Coalition v. Office of Mgmt & Budget, 200 F. Supp. 3d 154", "raw": "Energy Future Coalition v. Office of Mgmt & Budget, \n \n200 F. Supp. 3d 154", "context": "............................................................................ 3 Energy Future Coalition v. Office of Mgmt & Budget, 200 F. Supp. 3d 154, 161 (D.D.C. 2016) ............................................................" }, { "page": 3, "family": "Court case", "normalized": "EPIC v. Dept. of Justice, 15 F. Supp. 3d 32", "raw": "EPIC v. Dept. of Justice, 15 F. Supp. 3d 32", "context": "........................................................................... 19 EPIC v. Dept. of Justice, 15 F. Supp. 3d 32 (D.D.C. 2014) ....................................................18, 19 Feds" }, { "page": 3, "family": "Court case", "normalized": "Feds for Med. Freedom v. Biden, \n \nNo. 22-40043, 2023 WL 2609247", "raw": "Feds for Med. Freedom v. Biden, \n \nNo. 22-40043, 2023 WL 2609247", "context": "3d 32 (D.D.C. 2014) ....................................................18, 19 Feds for Med. Freedom v. Biden, No. 22-40043, 2023 WL 2609247 (5th Cir. Mar. 23, 2023) ......................................................" }, { "page": 3, "family": "Court case", "normalized": "FBI v. Abramson, 456 U.S. 615", "raw": "FBI v. Abramson, \n \n456 U.S. 615", "context": "ir. Mar. 23, 2023) ........................................................ 16 FBI v. Abramson, 456 U.S. 615 (1982) ........................................................................" }, { "page": 4, "family": "Court case", "normalized": "Flightsafety Servs. Corp. v. DOL, 326 F.3d 607", "raw": "Flightsafety Servs. Corp. v. DOL, \n \n326 F.3d 607", "context": "iii Flightsafety Servs. Corp. v. DOL, 326 F.3d 607 (5th Cir. 2003) ..............................................................." }, { "page": 4, "family": "Court case", "normalized": "Food Mktg. Inst. v. Argus Leader Media, 139 S. Ct. 2356", "raw": "Food Mktg. Inst. v. Argus Leader Media, \n \n139 S. Ct. 2356", "context": "......................................................................... 3, 4 Food Mktg. Inst. v. Argus Leader Media, 139 S. Ct. 2356 (2019) ........................................................................" }, { "page": 4, "family": "Court case", "normalized": "Gahagan v. DOJ, \n \nNo. CIV.A. 13-5526, 2014 WL 2158479", "raw": "Gahagan v. DOJ, \n \nNo. CIV.A. 13-5526, 2014 WL 2158479", "context": "............................................................................ 3 Gahagan v. DOJ, No. CIV.A. 13-5526, 2014 WL 2158479 (E.D. La. May 23, 2014) (quoting National Archives and Records Administration" }, { "page": 4, "family": "Court case", "normalized": "National \nArchives and Records Administration v. Favish, 541 U.S. 157", "raw": "National \nArchives and Records Administration v. Favish, 541 U.S. 157", "context": "v. DOJ, No. CIV.A. 13-5526, 2014 WL 2158479 (E.D. La. May 23, 2014) (quoting National Archives and Records Administration v. Favish, 541 U.S. 157) (2004)) ................................. 3, 4 Georgia v. President of the Un" }, { "page": 4, "family": "Court case", "normalized": "Georgia v. President of the United States, 46 F.4th 1283", "raw": "Georgia v. President of the United States, \n \n46 F.4th 1283", "context": "ration v. Favish, 541 U.S. 157) (2004)) ................................. 3, 4 Georgia v. President of the United States, 46 F.4th 1283, 1308 (11th Cir. 2022)........................................................." }, { "page": 4, "family": "Court case", "normalized": "Harrington v. FDA, 581 F. Supp. 3d 145", "raw": "Harrington v. FDA, \n \n581 F. Supp. 3d 145", "context": "........................................................................... 16 Harrington v. FDA, 581 F. Supp. 3d 145 (D.D.C. 2022) (citing Colbert v. FBI, No. 16-1790, 2018 WL 6299966, (D.D.C. Se" }, { "page": 4, "family": "Court case", "normalized": "Colbert v. FBI, No. 16-1790, 2018 WL 6299966", "raw": "Colbert v. FBI, No. 16-1790, 2018 WL 6299966", "context": "........... 16 Harrington v. FDA, 581 F. Supp. 3d 145 (D.D.C. 2022) (citing Colbert v. FBI, No. 16-1790, 2018 WL 6299966, (D.D.C. Sept. 3, 2018)......................................................." }, { "page": 4, "family": "Court case", "normalized": "Landmark Legal Found. v. EPA, 910 F. Supp. 2d 270", "raw": "Landmark Legal Found. v. EPA, \n \n910 F. Supp. 2d 270", "context": "1837548 (E.D. Tex. May 7, 2021) ............................................26 Landmark Legal Found. v. EPA, 910 F. Supp. 2d 270 (D.D.C. 2012).................................................................." }, { "page": 4, "family": "Court case", "normalized": "LLC v. Navarro, 138 S. Ct. 1134", "raw": "LLC v. Navarro, \n \n138 S. Ct. 1134", "context": "........................................................................ 6, 18 LLC v. Navarro, 138 S. Ct. 1134 (2018) ........................................................................" }, { "page": 4, "family": "Court case", "normalized": "N.Y. Times Co. v. DOD, \n \nNo. 19-CV-9821, 2022 WL 1547989", "raw": "N.Y. Times Co. v. DOD, \n \nNo. 19-CV-9821, 2022 WL 1547989", "context": "........................................................................... 16 N.Y. Times Co. v. DOD, No. 19-CV-9821, 2022 WL 1547989 (S.D.N.Y. Apr. 21, 2022) ................................................ 26 T" }, { "page": 4, "family": "Court case", "normalized": "Treatment Action Group v. FDA, \n \nNo. 15-CV-976, 2016 WL 5171987", "raw": "Treatment Action Group v. FDA, \n \nNo. 15-CV-976, 2016 WL 5171987", "context": "9 (S.D.N.Y. Apr. 21, 2022) ................................................ 26 Treatment Action Group v. FDA, No. 15-CV-976, 2016 WL 5171987 (D. Conn. Sept. 20, 2016)......................................................" }, { "page": 4, "family": "Court case", "normalized": "True the Vote v. Hosemann, 43 F. Supp. 3d 693", "raw": "True the Vote v. Hosemann, \n \n43 F. Supp. 3d 693", "context": "Sept. 20, 2016)........................................................... 17 True the Vote v. Hosemann, 43 F. Supp. 3d 693 (S.D. Miss. 2014) ............................................................." }, { "page": 4, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": ".................................... 6 Statutes, Rules, and Other Authorities 5 U.S.C. \u00a7 552 (a)(3) ........................................................................" }, { "page": 5, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "iv 5 U.S.C. \u00a7 552(a)(3)(A) ......................................................................" }, { "page": 5, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": ".............................................................................2 5 U.S.C. \u00a7 552(a)(4)(B) ......................................................................" }, { "page": 5, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "............................................................................ 6 5 U.S.C. \u00a7 552(a)(6)(A)(i) ..................................................................." }, { "page": 5, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": ".............................................................................2 5 U.S.C. \u00a7 552(a)(6)(C)(i)...................................................................." }, { "page": 5, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": ".............................................................................2 5 U.S.C. \u00a7 552(a)(6)(E)......................................................................." }, { "page": 5, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": ".........................................................................4, 15 5 U.S.C. \u00a7 552(a)(6)(E)(i) ..................................................................." }, { "page": 5, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "............................................................................ 6 5 U.S.C. \u00a7 552(a)(6)(E)(i)(I) ................................................................" }, { "page": 5, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "..................................................................4, 6, 13, 14 5 U.S.C. \u00a7 552(a)(6)(E)(i)(II) ..............................................................." }, { "page": 5, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": ".............................................................................4 5 U.S.C. \u00a7 552(a)(6)(E)(ii) .................................................................." }, { "page": 5, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": ".............................................................................4 5 U.S.C. \u00a7 552(a)(6)(E)(iii) ................................................................." }, { "page": 5, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": ".................................................................... 6, 13, 18 5 U.S.C. \u00a7 552(a)(6)(E)(v)(I)-(II) ..........................................................." }, { "page": 5, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": ".........................................................................5, 14 5 U.S.C. \u00a7 552(b) ............................................................................" }, { "page": 5, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "..........................................................................2, 3 5 U.S.C. \u00a7 552(b)(4) ........................................................................." }, { "page": 5, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": ".............................................................................3 5 U.S.C. \u00a7 552(b)(6) ........................................................................." }, { "page": 5, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "............................................................................3 5 U.S.C. \u00a7 552(c) ............................................................................" }, { "page": 5, "family": "USC", "normalized": "18 U.S.C. \u00a7 1905", "raw": "18 U.S.C. \u00a7 1905", "context": ".............................................................................2 18 U.S.C. \u00a7 1905 ..............................................................................." }, { "page": 5, "family": "USC", "normalized": "21 U.S.C. \u00a7 331", "raw": "21 U.S.C. \u00a7 331", "context": ".............................................................................2 21 U.S.C. \u00a7 331(j) ............................................................................" }, { "page": 5, "family": "CFR", "normalized": "21 CFR 20.44", "raw": "21 C.F.R. \u00a7 20.44", "context": ".............................................................................2 21 C.F.R. \u00a7 20.44(a)(2) ........................................................................." }, { "page": 5, "family": "CFR", "normalized": "21 CFR 20.44", "raw": "21 C.F.R. \u00a7 20.44", "context": ".........................................................................5, 14 21 C.F.R. \u00a7 20.44(c)(1)-(3) ...................................................................." }, { "page": 5, "family": "CFR", "normalized": "21 CFR 20.61", "raw": "21 C.F.R. \u00a7 20.61", "context": ".........................................................................5, 14 21 C.F.R. \u00a7 20.61 ..............................................................................." }, { "page": 5, "family": "CFR", "normalized": "21 CFR 20.63", "raw": "21 C.F.R. \u00a7 20.63", "context": ".............................................................................2 21 C.F.R. \u00a7 20.63 ..............................................................................." }, { "page": 5, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": ".............................................................................2 21 C.F.R. \u00a7 601.51 ..............................................................................." }, { "page": 5, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "............................................................................ 7 21 C.F.R. \u00a7 601.51(a) ............................................................................" }, { "page": 5, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "............................................................................ 7 21 C.F.R. \u00a7 601.51(b) ............................................................................" }, { "page": 6, "family": "Public Law", "normalized": "Pub. L. 104-231", "raw": "Pub. L. No. 104-231", "context": "Other Authorities Electronic Freedom of Information Act Amendments of 1996, Pub. L. No. 104-231, \u00a7 8, 110 Stat. 3048 ........................................................." }, { "page": 6, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "v 21 C.F.R. \u00a7 601.51(c) ............................................................................" }, { "page": 6, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": ".............................................................................8 21 C.F.R. \u00a7 601.51(d)(1) ........................................................................." }, { "page": 6, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": ".............................................................................8 21 C.F.R. \u00a7 601.51(e) ............................................................................" }, { "page": 6, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "..................................................................... 8, 9, 10 21 C.F.R. \u00a7 601.51(e)(1)-(8) ...................................................................." }, { "page": 6, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "............................................................................ 8 21 C.F.R. \u00a7 601.51(e)(2) ........................................................................." }, { "page": 6, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "............................................................................ 8 21 C.F.R. \u00a7 601.51(e)(3) ........................................................................." }, { "page": 6, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "............................................................................ 8 21 C.F.R. \u00a7 601.51(e)(5) ........................................................................." }, { "page": 6, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "............................................................................ 8 21 C.F.R. \u00a7 601.51(e)(6) ........................................................................." }, { "page": 6, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "............................................................................ 8 21 C.F.R. \u00a7 601.51(e)(7) ........................................................................." }, { "page": 6, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "............................................................................ 8 21 C.F.R. \u00a7 601.51(f) ............................................................................" }, { "page": 6, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "........................................... 7, 18 U. S. Department of Justice, FOIA Update: When to Expedite FOIA Requests (Jan. 1, 1983), https://www.justice.gov" }, { "page": 6, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "............. 7, 18 U. S. Department of Justice, FOIA Update: When to Expedite FOIA Requests (Jan. 1, 1983), https://www.justice.gov/oip/blog/foia-update-oip-guid" }, { "page": 7, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Defendant FDA\u2019s Brief Regarding FOIA Production \u2013 Page 1 I. INTRODUCTION The central issue in this Freedom of Inf" }, { "page": 7, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "age 1 I. INTRODUCTION The central issue in this Freedom of Information Act (\u201cFOIA\u201d) case is what constitutes a practicable schedule for FDA\u2019s processing of resp" }, { "page": 7, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "l Professionals for Transparency (\u201cPHMPT\u201d) and Patrick and Stephanie De Garay\u2019s FOIA requests are for records related to the product applications of Pfizer-BioNTec" }, { "page": 7, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "cines but does not speak to the straightforward issue before the Court in this FOIA case: what rate is reasonable and feasible for the processing of records respo" }, { "page": 7, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "easonable and feasible for the processing of records responsive to Plaintiffs\u2019 FOIA requests. As supported below, FDA\u2019s proposed briefing schedule accounts for" }, { "page": 7, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "rest of the agency\u2019s public health priorities, the increasing and substantial FOIA backlog, and fairness to other FOIA requesters, including hundreds of requeste" }, { "page": 7, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "priorities, the increasing and substantial FOIA backlog, and fairness to other FOIA requesters, including hundreds of requesters who filed their requests prior to" }, { "page": 7, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "on rates at least as high as those in PHMPT 1 as impracticable and contrary to FOIA\u2019s overall goals of transparency and FDA\u2019s public health mission. Case 4:22-cv" }, { "page": 8, "family": "Court case", "normalized": "Responsibility & Ethics in Wash. v. FEC, 711 F.3d 180", "raw": "Responsibility & Ethics in Wash. v. FEC, 711 F.3d 180", "context": "rking-day time period does not create a deadline for production. Citizens for Responsibility & Ethics in Wash. v. FEC, 711 F.3d 180, 189\u201390 (D.C. Cir. 2013). Rather, \u201cif the agency does not adhere to FOIA\u2019s e" }, { "page": 8, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "by one or more of nine exemptions or three exclusions listed in the Act. See 5 U.S.C. \u00a7 552 (a)(3), (b), (c). Under FOIA, a person may submit a request to a federal agen" }, { "page": 8, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "a federal agency \u201creasonably decrib[ing]\u201d records that s/he seeks to obtain. 5 U.S.C. \u00a7 552(a)(3)(A). An agency that has received a FOIA request is required, as relevant" }, { "page": 8, "family": "USC", "normalized": "21 U.S.C. \u00a7 331", "raw": "21 U.S.C. \n\u00a7 331", "context": "es of information, such as trade secrets and personal medical information. See 21 U.S.C. \u00a7 331(j); 18 U.S.C. \u00a7 1905; 21 C.F.R. \u00a7\u00a7 20.61, 20.63. Consistent with these obligat" }, { "page": 8, "family": "USC", "normalized": "18 U.S.C. \u00a7 1905", "raw": "18 U.S.C. \u00a7 1905", "context": "ch as trade secrets and personal medical information. See 21 U.S.C. \u00a7 331(j); 18 U.S.C. \u00a7 1905; 21 C.F.R. \u00a7\u00a7 20.61, 20.63. Consistent with these obligations to protect Case" }, { "page": 8, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Defendant FDA\u2019s Brief Regarding FOIA Production \u2013 Page 2 II. LEGAL BACKGROUND 1. The Freedom of Information Act" }, { "page": 8, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ACKGROUND 1. The Freedom of Information Act The Freedom of Information Act (\u201cFOIA\u201d or the \u201cAct\u201d) provides that any person has a right to obtain access to federa" }, { "page": 8, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ree exclusions listed in the Act. See 5 U.S.C. \u00a7 552 (a)(3), (b), (c). Under FOIA, a person may submit a request to a federal agency \u201creasonably decrib[ing]\u201d re" }, { "page": 8, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "s/he seeks to obtain. 5 U.S.C. \u00a7 552(a)(3)(A). An agency that has received a FOIA request is required, as relevant here, to \u201cdetermine within 20 days (excepting" }, { "page": 8, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ny such request whether to comply with such request.\u201d Id. \u00a7 552(a)(6)(A)(i). FOIA further provides that a requester \u201cshall be deemed to have exhausted his admin" }, { "page": 8, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "to comply with the applicable time limit provisions.\u201d Id. \u00a7 552(a)(6)(C)(i). FOIA\u2019s 20-working-day time period does not create a deadline for production. Citiz" }, { "page": 8, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "F.3d 180, 189\u201390 (D.C. Cir. 2013). Rather, \u201cif the agency does not adhere to FOIA\u2019s explicit timelines, the \u2018penalty\u2019 is that the agency cannot rely on the admi" }, { "page": 8, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "equirement to keep cases from getting into court.\u201d Id. No other provision in FOIA creates a specific timeframe for the release of records. See 5 U.S.C. \u00a7\u00a7 552(" }, { "page": 8, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "le\u201d), (a)(6)(C)(i) (same for litigated cases). The time required to process a FOIA request will inherently depend on the scope of the request and the nature of t" }, { "page": 9, "family": "Court case", "normalized": "Food Mktg. Inst. v. Argus Leader Media, 139 S. Ct. 2356", "raw": "Food Mktg. Inst. v. Argus Leader Media, 139 S. Ct. 2356", "context": "types of information from its production requirements. 5 U.S.C. \u00a7 552(b); see Food Mktg. Inst. v. Argus Leader Media, 139 S. Ct. 2356, 2366 (2019) (\u201cFOIA expressly recognizes that \u2018important interests [are] serve" }, { "page": 9, "family": "Court case", "normalized": "FBI v. Abramson, 456 U.S. 615", "raw": "FBI v. Abramson, 456 U.S. \n615", "context": "as the [statute\u2019s disclosure] requirement.\u2019\u201d) (brackets in original) (quoting FBI v. Abramson, 456 U.S. 615, 630\u2013631 (1982); Encino Motorcars, LLC v. Navarro, 138 S. Ct. 1134, 1142 (2018)" }, { "page": 9, "family": "Court case", "normalized": "Encino Motorcars, LLC v. Navarro, 138 S. Ct. 1134", "raw": "Encino Motorcars, LLC v. Navarro, 138 S. Ct. 1134", "context": "(brackets in original) (quoting FBI v. Abramson, 456 U.S. 615, 630\u2013631 (1982); Encino Motorcars, LLC v. Navarro, 138 S. Ct. 1134, 1142 (2018)); Flightsafety Servs. Corp. v. DOL, 326 F.3d 607, 611 (5th Cir. 2" }, { "page": 9, "family": "Court case", "normalized": "Flightsafety Servs. Corp. v. DOL, 326 F.3d 607", "raw": "Flightsafety Servs. Corp. v. DOL, 326 F.3d 607", "context": "0\u2013631 (1982); Encino Motorcars, LLC v. Navarro, 138 S. Ct. 1134, 1142 (2018)); Flightsafety Servs. Corp. v. DOL, 326 F.3d 607, 611 (5th Cir. 2003) (Congress created nine exemptions in FOIA \u201cbecause \u2018it re" }, { "page": 9, "family": "Court case", "normalized": "Gahagan v. DOJ, No. CIV.A. 13-5526, 2014 WL 2158479", "raw": "Gahagan v. DOJ, No. CIV.A. 13-5526, 2014 WL \n2158479", "context": "rivate interests in safeguarding potentially sensitive information\u201d); see also Gahagan v. DOJ, No. CIV.A. 13-5526, 2014 WL 2158479, at *7 (E.D. La. May 23, 2014) (\u201c\u2018It must be remembered that once there is disc" }, { "page": 9, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": ", FOIA exempts several types of information from its production requirements. 5 U.S.C. \u00a7 552(b); see Food Mktg. Inst. v. Argus Leader Media, 139 S. Ct. 2356, 2366 (2019) (" }, { "page": 9, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "formation obtained from a person and [that are] privileged or confidential.\u2019\u201d 5 U.S.C. \u00a7 552(b)(4). And Exemption 6 permits agencies to withhold or redact \u201cpersonnel and" }, { "page": 9, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "f which would constitute a clearly unwarranted invasion of personal privacy.\u201d 5 U.S.C. \u00a7 552(b)(6). To ensure protection of this information and other information that i" }, { "page": 9, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Defendant FDA\u2019s Brief Regarding FOIA Production \u2013 Page 3 sensitive information, FOIA exempts several types of infor" }, { "page": 9, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "efendant FDA\u2019s Brief Regarding FOIA Production \u2013 Page 3 sensitive information, FOIA exempts several types of information from its production requirements. 5 U.S." }, { "page": 9, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "b); see Food Mktg. Inst. v. Argus Leader Media, 139 S. Ct. 2356, 2366 (2019) (\u201cFOIA expressly recognizes that \u2018important interests [are] served by [its] exemption" }, { "page": 9, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "e] served by [its] exemptions,\u2019 and \u2018[t]hose exemptions are as much a part of [FOIA\u2019s] purpose[s and policies] as the [statute\u2019s disclosure] requirement.\u2019\u201d) (brac" }, { "page": 9, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "v. DOL, 326 F.3d 607, 611 (5th Cir. 2003) (Congress created nine exemptions in FOIA \u201cbecause \u2018it realized that legitimate governmental and private interests could" }, { "page": 9, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "\u201d) (quotations and citations omitted). As particularly relevant to this case, FOIA Exemption 4 permits withholding of \u201ctrade secrets and commercial or financial" }, { "page": 9, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "of this information and other information that is exempt from disclosure under FOIA, government agencies must carefully review all records and redact exempt infor" }, { "page": 9, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "l records and redact exempt information before the records are released to the FOIA requester. See Daily Caller v. Dep\u2019t of State, 152 F. Supp. 3d 1, 14 (D.D.C." }, { "page": 9, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "e, the information belongs to the general public. There is no mechanism under FOIA for a protective order allowing only the requester to see whether the informat" }, { "page": 10, "family": "Court case", "normalized": "National Archives and Records Administration v. Favish, 541 U.S. 157", "raw": "National Archives and Records Administration \nv. Favish, 541 U.S. 157", "context": "ng FOIA Production \u2013 Page 4 proscribing its general dissemination.\u2019\u201d) (quoting National Archives and Records Administration v. Favish, 541 U.S. 157, 171-175) (2004)). Indeed, government records often contain sensitive informa" }, { "page": 10, "family": "Court case", "normalized": "True the Vote v. Hosemann, 43 F. Supp. 3d 693", "raw": "True the Vote v. Hosemann, \n43 F. Supp. 3d 693", "context": "al security numbers, home addresses, home phone numbers, and dates of birth\u201d); True the Vote v. Hosemann, 43 F. Supp. 3d 693, 736 (S.D. Miss. 2014) (\u201c[V]arious courts have recognized in the context of FO" }, { "page": 10, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "Act Amendments of 1996, Pub. L. No. 104- 231, \u00a7 8, 110 Stat. 3048 (codified at 5 U.S.C. \u00a7 552(a)(6)(E)) (\u201cEFOIA\u201d). Expedited processing, when granted, entitles requesters" }, { "page": 10, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "es in which the person requesting the records demonstrates a compelling need,\u201d 5 U.S.C. \u00a7 552(a)(6)(E)(i)(I); and (ii) \u201cin other cases determined by the agency.\u201d Id. \u00a7 552(" }, { "page": 10, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Defendant FDA\u2019s Brief Regarding FOIA Production \u2013 Page 4 proscribing its general dissemination.\u2019\u201d) (quoting Nationa" }, { "page": 10, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "93, 736 (S.D. Miss. 2014) (\u201c[V]arious courts have recognized in the context of FOIA litigation that birthdates are sensitive information and have construed FOIA\u2019s" }, { "page": 10, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "f FOIA litigation that birthdates are sensitive information and have construed FOIA\u2019s \u2018Exemption 6\u2019 to protect the disclosure of birthdates\u201d) (collecting cases)." }, { "page": 10, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "tes\u201d) (collecting cases). a. Expedited Processing Agencies ordinarily process FOIA requests for agency records on a first-in, first-out basis. In 1996, Congress" }, { "page": 10, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "agency records on a first-in, first-out basis. In 1996, Congress amended the FOIA to provide for \u201cexpedited processing\u201d of certain categories of requests. See" }, { "page": 11, "family": "Court case", "normalized": "Al-Fayed v. CIA, 254 F.3d 300", "raw": "Al-Fayed v. CIA, 254 F.3d 300", "context": "cified that the expedited processing categories should be \u201cnarrowly applied.\u201d Al-Fayed v. CIA, 254 F.3d 300, 310 (D.C. Cir. 2001) (quoting H.R. Rep. No. 104-795, at 26, 1996 U.S.C.C.A.N." }, { "page": 11, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "inform the public concerning actual or alleged Federal Government activity.\u201d 5 U.S.C. \u00a7 552(a)(6)(E)(v)(I)-(II). And, in carrying out FOIA\u2019s instruction to further imple" }, { "page": 11, "family": "CFR", "normalized": "21 CFR 20.44", "raw": "21 C.F.R. \n\u00a7 20.44", "context": "th respect to the second of these tests, the \u201curgency\u201d must be \u201cdemonstrated.\u201d 21 C.F.R. \u00a7 20.44(a)(2). Specifically, in order to satisfy 21 C.F.R. \u00a7 20.44(a)(2), a FOIA reque" }, { "page": 11, "family": "CFR", "normalized": "21 CFR 20.44", "raw": "21 C.F.R. \u00a7 20.44", "context": "e \u201cdemonstrated.\u201d 21 C.F.R. \u00a7 20.44(a)(2). Specifically, in order to satisfy 21 C.F.R. \u00a7 20.44(a)(2), a FOIA requester must \u201cdemonstrate\u201d that: (1) The requester is primari" }, { "page": 11, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Defendant FDA\u2019s Brief Regarding FOIA Production \u2013 Page 5 FOIA further defines \u201ccompelling need\u201d as either (1) \u201cthat" }, { "page": 11, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Defendant FDA\u2019s Brief Regarding FOIA Production \u2013 Page 5 FOIA further defines \u201ccompelling need\u201d as either (1) \u201cthat a failure to obtain reque" }, { "page": 11, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "overnment activity.\u201d 5 U.S.C. \u00a7 552(a)(6)(E)(v)(I)-(II). And, in carrying out FOIA\u2019s instruction to further implement these standards via regulation, FDA added t" }, { "page": 11, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": ". \u00a7 20.44(a)(2). Specifically, in order to satisfy 21 C.F.R. \u00a7 20.44(a)(2), a FOIA requester must \u201cdemonstrate\u201d that: (1) The requester is primarily engaged in" }, { "page": 11, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ation is clear: \u201cGiven the finite resources generally available for fulfilling FOIA requests, unduly generous use of the 1 Courts often rely on case law concern" }, { "page": 11, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "uests, unduly generous use of the 1 Courts often rely on case law concerning FOIA from the D.C. Circuit, as it is \u201cthe federal appellate court with the most exp" }, { "page": 12, "family": "Court case", "normalized": "Landmark Legal Found. v. EPA, 910 F. Supp. 2d 270", "raw": "Landmark Legal Found. v. EPA, 910 F. Supp. 2d \n270", "context": "does not assign any particular time frame to release of the records sought.\u201d Landmark Legal Found. v. EPA, 910 F. Supp. 2d 270, 275 (D.D.C. 2012). Rather, the statute directs an agency to \u201cprocess as soon" }, { "page": 12, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "s involving the improper withholding of records under claimed FOIA exemptions, 5 U.S.C. \u00a7 552(a)(4)(B), the requester has the burden to \u201cdemonstrate[] a compelling need\u201d fo" }, { "page": 12, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \n\u00a7 552", "context": "has the burden to \u201cdemonstrate[] a compelling need\u201d for expedited processing. 5 U.S.C. \u00a7 552(a)(6)(E)(i); see also Wadelton v. Dep\u2019t of State, 941 F. Supp. 2d 120, 122 (D.D" }, { "page": 12, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "\u201d in expedited processing cases); Al- Fayed, 254 F.3d at 305 n.4 (same) (citing 5 U.S.C. \u00a7 552(a)(6)(E)(i)(I) and H.R. Rep. No. 104- 795, at 25). b. FOIA\u2019s Reasonableness R" }, { "page": 12, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \n\u00a7 552", "context": "any request for records to which the agency has granted expedited processing.\u201d 5 U.S.C. \u00a7 552(a)(6)(E)(iii); see also, e.g., Muttitt v. Dep\u2019t of State, 926 F. Supp. 2d 284," }, { "page": 12, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Defendant FDA\u2019s Brief Regarding FOIA Production \u2013 Page 6 expedited processing procedure would unfairly disadvantage" }, { "page": 12, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "a request for expedition necessarily works to the direct disadvantage of other FOIA requesters.\u201d U.S. Department of Justice, FOIA Update: OIP Guidance: When to E" }, { "page": 12, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "he direct disadvantage of other FOIA requesters.\u201d U.S. Department of Justice, FOIA Update: OIP Guidance: When to Expedite FOIA Requests (Jan. 1, 1983), https://w" }, { "page": 12, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ers.\u201d U.S. Department of Justice, FOIA Update: OIP Guidance: When to Expedite FOIA Requests (Jan. 1, 1983), https://www.justice.gov/oip/blog/foia-update-oip- guid" }, { "page": 12, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ts action in cases involving the improper withholding of records under claimed FOIA exemptions, 5 U.S.C. \u00a7 552(a)(4)(B), the requester has the burden to \u201cdemonstr" }, { "page": 12, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "(citing 5 U.S.C. \u00a7 552(a)(6)(E)(i)(I) and H.R. Rep. No. 104- 795, at 25). b. FOIA\u2019s Reasonableness Requirement Even in cases of expedited FOIA processing, \u201c[t]h" }, { "page": 12, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "795, at 25). b. FOIA\u2019s Reasonableness Requirement Even in cases of expedited FOIA processing, \u201c[t]he statute does not assign any particular time frame to releas" }, { "page": 12, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "tate, 926 F. Supp. 2d 284, 296 (D.D.C. 2013) (\u201cthe only relief required by the FOIA with regard to expedited processing is moving an individual\u2019s request \u2018to the" }, { "page": 13, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "al BLA (\u201csBLA\u201d) if it seeks approval of a new indication. FDA\u2019s regulation at 21 C.F.R. \u00a7 601.51 governs the confidentiality of data and information in biological product file" }, { "page": 13, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Defendant FDA\u2019s Brief Regarding FOIA Production \u2013 Page 7 consideration entitles requesters to move immediately to t" }, { "page": 13, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "uate whether the processing schedule is reasonable in light of other expedited FOIA requests the agency was already processing, the volume of materials, the need" }, { "page": 14, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \n\u00a7 601.51", "context": "tory confidentiality and become \u201cimmediately available for public disclosure.\u201d 21 C.F.R. \u00a7 601.51(e)(1)-(8) (listing the applicable categories of data and information) (emphasis" }, { "page": 14, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "or will FDA disclose any \u201cdata or information in the biological product file.\u201d 21 C.F.R. \u00a7 601.51(b), (c); see Decl. of Beth Brockner Ryan (\u201cBrockner Ryan Decl.\u201d) \u00b6 37. Even w" }, { "page": 14, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Defendant FDA\u2019s Brief Regarding FOIA Production \u2013 Page 8 biological product file throughout the \u201clifecycle\u201d of the" }, { "page": 14, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "sure, upon request, just like any other public record within the parameters of FOIA. The provision does not, however, require the immediate publication of such i" }, { "page": 14, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "n of such information. Like any other agency record within the parameters of FOIA, records that may include information and data listed in Section 601.51(e) mus" }, { "page": 14, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Section 601.51(e) must be carefully reviewed to determine whether one or more FOIA exemptions apply. Section 601.51(e) itself limits disclosure of several types" }, { "page": 15, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "uction \u2013 Page 9 public disclosure, even after an application is approved. See 21 C.F.R. \u00a7 601.51(f). The categories of information not available for public disclosure can be" }, { "page": 15, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "n be intermingled with the types of information available for disclosure under 21 C.F.R. \u00a7 601.51(e). III. FACTUAL BACKGROUND 1. Plaintiffs\u2019 FOIA Requests As detailed in th" }, { "page": 15, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 \nC.F.R. \u00a7 601.51", "context": "processing of \u201c[a]ll data and information for the Moderna Vaccine enumerated in 21 C.F.R. \u00a7 601.51(e), with the exception of publicly available reports on the Vaccine Adverse Eve" }, { "page": 15, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "[a]ll data and information for the 12-15-Year-Old Pfizer Vaccine enumerated in 21 C.F.R. \u00a7 601.51(e), with the exception of publicly available reports on [VAERS]\u201d and excluding" }, { "page": 15, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Defendant FDA\u2019s Brief Regarding FOIA Production \u2013 Page 9 public disclosure, even after an application is approved." }, { "page": 15, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "closure under 21 C.F.R. \u00a7 601.51(e). III. FACTUAL BACKGROUND 1. Plaintiffs\u2019 FOIA Requests As detailed in the Declaration of Sarah B. Kotler, FDA\u2019s Director of" }, { "page": 15, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "arah B. Kotler (\u201cKotler Decl.\u201d), \u00b6 22, Plaintiffs collectively submitted three FOIA requests to the agency: First Request: On February 23, 2022, Plaintiff PHMPT" }, { "page": 15, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "S]\u201d and excluding \u201cany data and information responsive to and being produced in FOIA Control # 2021-5683 (previously made on behalf of PHMPT)\u201d4 (citation omitted)." }, { "page": 15, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "t: On August 22, 2022, Plaintiffs Stephanie and Patrick de Garay submitted 4 FOIA Control # 2021-5683 is the FOIA request at issue in the PHMPT 1 litigation. Ca" }, { "page": 15, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "s Stephanie and Patrick de Garay submitted 4 FOIA Control # 2021-5683 is the FOIA request at issue in the PHMPT 1 litigation. Case 4:22-cv-00915-P Document 27" }, { "page": 16, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "[a]ll data and information for the 12-15-Year-Old Pfizer Vaccine enumerated in 21 C.F.R. \u00a7 601.51(e) with the exception of publicly available reports on the Vaccine Adverse Eve" }, { "page": 16, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Defendant FDA\u2019s Brief Regarding FOIA Production \u2013 Page 10 a request materially identical to Plaintiff PHMPT\u2019s Augus" }, { "page": 16, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "\u201d). Complaint, Ex. 8. DFOI, the office responsible for FDA\u2019s compliance with FOIA, assigned the requests to FDA\u2019s Center for Biologics Evaluation and Research (" }, { "page": 16, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ffs did not appeal the denials of expedited processing for the Second and Third FOIA requests. Case 4:22-cv-00915-P Document 27 Filed 03/31/23 Page 16 of 3" }, { "page": 17, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Defendant FDA\u2019s Brief Regarding FOIA Production \u2013 Page 11 sBLA for Comirnaty\u2019s ages 12 through 15 years indication" }, { "page": 18, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Defendant FDA\u2019s Brief Regarding FOIA Production \u2013 Page 12 from acknowledging the existence of portions of an IND th" }, { "page": 18, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "be in the interest of all parties for Plaintiffs to narrow the scope of their FOIA requests, and FDA remains committed to engaging in such discussions. Neverthe" }, { "page": 19, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "eir requests because they have failed to demonstrate a \u201ccompelling need\u201d under 5 U.S.C. \u00a7 552(a)(6)(E)(i)(I). Second, even if Plaintiffs are entitled to expedited processi" }, { "page": 19, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "cessing, FOIA still mandates that a production schedule be \u201cpracticable\u201d under 5 U.S.C. \u00a7 552(a)(6)(E)(iii). While FDA\u2019s proposed production schedule satisfies FOIA\u2019s requ" }, { "page": 19, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Defendant FDA\u2019s Brief Regarding FOIA Production \u2013 Page 13 \u2022 8,000 pages of CRFs; or \u2022 1,000 pages of application f" }, { "page": 19, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "aintiffs\u2019 requests while reasonably balancing CBER\u2019s responsibilities to other FOIA requesters and FOIA litigation matters and its consideration of the resources" }, { "page": 19, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "hile reasonably balancing CBER\u2019s responsibilities to other FOIA requesters and FOIA litigation matters and its consideration of the resources available to perform" }, { "page": 19, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "6)(E)(i)(I). Second, even if Plaintiffs are entitled to expedited processing, FOIA still mandates that a production schedule be \u201cpracticable\u201d under 5 U.S.C. \u00a7 55" }, { "page": 19, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": ".S.C. \u00a7 552(a)(6)(E)(iii). While FDA\u2019s proposed production schedule satisfies FOIA\u2019s requirement of reasonableness by balancing CBER\u2019s responsibility to other FOI" }, { "page": 19, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "OIA\u2019s requirement of reasonableness by balancing CBER\u2019s responsibility to other FOIA requesters (as well as Plaintiffs) and accounting for CBER\u2019s current workload" }, { "page": 19, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "intiffs\u2019 proposal would severely undermine the mission and operations of CBER\u2019s FOIA- processing branch, ALFOI (Access Litigation and Freedom of Information Branch)" }, { "page": 19, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "entitled to expedited processing under the applicable standards established by FOIA and agency regulations. In narrowly applied and exceptional situations (see A" }, { "page": 19, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "In narrowly applied and exceptional situations (see Al-Fayed, 254 F.3d at 310), FOIA allows Case 4:22-cv-00915-P Document 27 Filed 03/31/23 Page 19 of 36" }, { "page": 20, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "sts where, as relevant here, a requester establishes a \u201ccompelling need\u201d under 5 U.S.C. \u00a7 552(a)(6)(E)(i)(I). To establish a \u201ccompelling need,\u201d a requester must either sho" }, { "page": 20, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \n\u00a7 552", "context": "inform the public concerning actual or alleged Federal Government activity.\u201d 5 U.S.C. \u00a7 552(a)(6)(E)(v)(I)-(II). FDA\u2019s regulations further provide that a FOIA requester m" }, { "page": 20, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Defendant FDA\u2019s Brief Regarding FOIA Production \u2013 Page 14 agencies to prioritize certain requests where, as relevan" }, { "page": 20, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "5 U.S.C. \u00a7 552(a)(6)(E)(v)(I)-(II). FDA\u2019s regulations further provide that a FOIA requester must \u201cdemonstrate\u201d that: (1) the requester is primarily engaged in d" }, { "page": 20, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "-cv-1058 (Doc. 35), and its Order effectively required FDA to move the PHMPT 1 FOIA request to the front of the FOIA queue immediately. Given that processing in" }, { "page": 20, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "effectively required FDA to move the PHMPT 1 FOIA request to the front of the FOIA queue immediately. Given that processing in PHMPT 1 has not been completed, t" }, { "page": 21, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "l, FDA determined that Plaintiffs had not demonstrated a compelling need under 5 U.S.C. \u00a7 552(a)(6)(E) for expedited processing. Id. For much the same reasons set forth" }, { "page": 21, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Defendant FDA\u2019s Brief Regarding FOIA Production \u2013 Page 15 large amount of information related to the COVID-19 vacci" }, { "page": 22, "family": "Court case", "normalized": "See Feds for Med. Freedom v. Biden, No. 22-40043, 2023 WL 2609247", "raw": "See Feds for Med. Freedom v. Biden, No. 22-40043, 2023 WL 2609247", "context": "urther, the vaccine mandate for federal employees has been stayed nationwide. See Feds for Med. Freedom v. Biden, No. 22-40043, 2023 WL 2609247, at *16 (5th Cir. Mar. 23, 2023). And the vaccine mandate for federal contrac" }, { "page": 22, "family": "Court case", "normalized": "See Georgia v. President of the United States, 46 F.4th 1283", "raw": "See Georgia v. \nPresident of the United States, 46 F.4th 1283", "context": "3). And the vaccine mandate for federal contractors has been partially stayed. See Georgia v. President of the United States, 46 F.4th 1283, 1308 (11th Cir. 2022). Moreover, the Supreme Court has stayed the Occupatio" }, { "page": 22, "family": "Court case", "normalized": "Nat'l Fed'n of Indep. Bus. v. DOL, \nOSHA, 142 S. Ct. 661", "raw": "Nat'l Fed'n of Indep. Bus. v. DOL, \nOSHA, 142 S. Ct. 661", "context": "quire the employees to either undergo COVID-19 vaccination or weekly testing. Nat'l Fed'n of Indep. Bus. v. DOL, OSHA, 142 S. Ct. 661, 666 (2022). Case 4:22-cv-00915-P Document 27 Filed 03/31/23 Page 22 of" }, { "page": 22, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Defendant FDA\u2019s Brief Regarding FOIA Production \u2013 Page 16 these websites on the same topics encompassed by Plaintif" }, { "page": 22, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "duction \u2013 Page 16 these websites on the same topics encompassed by Plaintiffs\u2019 FOIA requests thus undermine any arguable justification to put Plaintiffs\u2019 request" }, { "page": 22, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ay have different opinions about the vaccines does not create an urgency under FOIA or the agency\u2019s regulations. Kotler Decl. \u00b6 30. FDA regularly approves medic" }, { "page": 22, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ocess of producing COVID-19 vaccine-related records to the de Garays in another FOIA suit. See De Garay v. HHS, 1:22-cv-512 (S.D. Ohio), Doc. 16. 10 For examp" }, { "page": 23, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Defendant FDA\u2019s Brief Regarding FOIA Production \u2013 Page 17 Administration in 2020 will expire on May 11, 2023. See" }, { "page": 24, "family": "Court case", "normalized": "Landmark Legal Found. v. EPA, 910 F. Supp. 2d 270", "raw": "Landmark Legal Found. v. EPA, 910 F. Supp. 2d 270", "context": "\u201cdoes not assign any particular time frame to release of the records sought.\u201d Landmark Legal Found. v. EPA, 910 F. Supp. 2d 270, 275 (D.D.C. 2012). Rather, the statute directs an agency to \u201cprocess as soon" }, { "page": 24, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "any request for records to which the agency has granted expedited processing.\u201d 5 U.S.C. \u00a7 552(a)(6)(E)(iii); see also, e.g., Muttitt v. Dep\u2019t of State, 926 F. Supp. 2d 284," }, { "page": 24, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Defendant FDA\u2019s Brief Regarding FOIA Production \u2013 Page 18 amounts to no expedition at all. See Al-Fayed, 254 F.3d" }, { "page": 24, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "to the expedition they seek. 2. FDA\u2019s Proposed Production Schedule Satisfies FOIA\u2019s Reasonableness Requirement and Plaintiffs\u2019 Proposed Production Schedule Does" }, { "page": 24, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "processing schedule is \u201cpracticable\u201d or reasonable in light of other expedited FOIA requests the agency is already processing, the volume of and complexity of the" }, { "page": 24, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "F. Supp. 3d at 43. This is consistent with the spirit of expedition under the FOIA statute, which \u201cdoes not assign any particular time frame to release of the re" }, { "page": 24, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "tate, 926 F. Supp. 2d 284, 296 (D.D.C. 2013) (\u201cthe only relief required by the FOIA with regard to expedited processing is moving an individual\u2019s request \u2018to the" }, { "page": 25, "family": "Court case", "normalized": "Harrington v. FDA, 581 F. Supp. 3d 145", "raw": "Harrington v. FDA, 581 F. Supp. 3d 145", "context": "Defendant FDA\u2019s Brief Regarding FOIA Production \u2013 Page 19 a FOIA request.\u201d Harrington v. FDA, 581 F. Supp. 3d 145, 150 (D.D.C. 2022) (citing Colbert v. FBI, No. 16-1790, 2018 WL 6299966, at *3" }, { "page": 25, "family": "Court case", "normalized": "Colbert v. FBI, No. 16-1790, 2018 WL 6299966", "raw": "Colbert v. \nFBI, No. 16-1790, 2018 WL 6299966", "context": "IA request.\u201d Harrington v. FDA, 581 F. Supp. 3d 145, 150 (D.D.C. 2022) (citing Colbert v. FBI, No. 16-1790, 2018 WL 6299966, at *3 (D.D.C. Sept. 3, 2018) (collecting cases)). Several factors inform tha" }, { "page": 25, "family": "Court case", "normalized": "Energy Future Coalition v. Office of Mgmt. \n& Budget, 200 F. Supp. 3d 154", "raw": "Energy Future Coalition v. Office of Mgmt. \n& Budget, 200 F. Supp. 3d 154", "context": "tiently waiting their turn.\u201d Id.; see, e.g., Colbert, 2018 WL 6299966, at *3; Energy Future Coalition v. Office of Mgmt. & Budget, 200 F. Supp. 3d 154, 161 (D.D.C. 2016); EPIC v. Dept. of Justice, 15 F. Supp. 3d 32, 47 (D.D.C. 20" }, { "page": 25, "family": "Court case", "normalized": "EPIC v. Dept. of Justice, 15 F. Supp. 3d 32", "raw": "EPIC v. Dept. of Justice, 15 F. Supp. 3d 32", "context": "Coalition v. Office of Mgmt. & Budget, 200 F. Supp. 3d 154, 161 (D.D.C. 2016); EPIC v. Dept. of Justice, 15 F. Supp. 3d 32, 47 (D.D.C. 2014). \u201cWhen determining the rate at which a federal agency must" }, { "page": 25, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Defendant FDA\u2019s Brief Regarding FOIA Production \u2013 Page 19 a FOIA request.\u201d Harrington v. FDA, 581 F. Supp. 3d 145," }, { "page": 25, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Defendant FDA\u2019s Brief Regarding FOIA Production \u2013 Page 19 a FOIA request.\u201d Harrington v. FDA, 581 F. Supp. 3d 145, 150 (D.D.C. 2022) (citing Co" }, { "page": 25, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ave increased in recent years, the resources and capacity of the agency, other FOIA litigation in which the agency is involved, the agency\u2019s release policies, and" }, { "page": 25, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ncy\u2019s release policies, and how ordering swifter production would affect other FOIA requesters patiently waiting their turn.\u201d Id.; see, e.g., Colbert, 2018 WL 62" }, { "page": 25, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "C. 2014). \u201cWhen determining the rate at which a federal agency must respond to FOIA requests, courts often give deference to the agency\u2019s release policies.\u201d Colb" }, { "page": 25, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "s case: like the substantial resource needs of PHMPT 1, plaintiff Harrington\u2019s FOIA requests had effectively tied up approximately 69% of FDA\u2019s Center for Veterin" }, { "page": 25, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "DA had produced thousands of pages of records to the plaintiff in similar prior FOIA cases that he had brought against CVM, with approximately 300,000 pages remain" }, { "page": 25, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "\u2019s proposed production schedule was reasonable, the court looked to the \u201cheavy FOIA-related burden that CVM is facing relative to its limited resources.\u201d Id. at 1" }, { "page": 25, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "its limited resources.\u201d Id. at 150. The court explained that CVM had a small FOIA staff \u201cconfronting a significant volume of both FOIA requests and litigation\u201d" }, { "page": 25, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ained that CVM had a small FOIA staff \u201cconfronting a significant volume of both FOIA requests and litigation\u201d and noted that CVM had a backlog of 336 FOIA requests" }, { "page": 25, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "of both FOIA requests and litigation\u201d and noted that CVM had a backlog of 336 FOIA requests. Id. Notably, the court stated that: Case 4:22-cv-00915-P Docume" }, { "page": 26, "family": "Court case", "normalized": "Am. Ctr. for Law & Just. v. DHS, No. 21-1364, 573 F. Supp. 3d 78", "raw": "Am. Ctr. for Law & Just. v. DHS, No. 21-1364, 573 F. Supp. 3d 78", "context": "of agency time a determined individual or entity can require. Id. (citing Am. Ctr. for Law & Just. v. DHS, No. 21-1364, 573 F. Supp. 3d 78, 81\u201384 (D.D.C. Nov. 10, 2021) (emphases added)). As in Harrington, the proces" }, { "page": 26, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Defendant FDA\u2019s Brief Regarding FOIA Production \u2013 Page 20 As the Court has frequently mused with respect to other a" }, { "page": 26, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "t has frequently mused with respect to other agencies struggling under onerous FOIA burdens, one wonders how CVM has time to do anything other than handle FOIA re" }, { "page": 26, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "us FOIA burdens, one wonders how CVM has time to do anything other than handle FOIA requests, particularly those from Harrington. In continuing to address FOIA, C" }, { "page": 26, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "le FOIA requests, particularly those from Harrington. In continuing to address FOIA, Congress may wish to bear in mind how many hours of agency time a determined" }, { "page": 26, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "processing schedule here must be \u201cpracticable\u201d for FDA and account for CBER\u2019s FOIA backlog and resource constraints (indeed, CBER\u2019s FOIA backlog is nearly double" }, { "page": 26, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "A and account for CBER\u2019s FOIA backlog and resource constraints (indeed, CBER\u2019s FOIA backlog is nearly double the backlog in Harrington, see Brockner Ryan Decl. \u00b6" }, { "page": 26, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": ", see Brockner Ryan Decl. \u00b6 20). For several reasons, including the expedited FOIA request in PHMPT 1 that FDA is already processing, Plaintiffs\u2019 proposed schedu" }, { "page": 26, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "raints (particularly its significant workload in PHMPT 1) and respecting other FOIA requesters in the queue who should not be prejudiced merely because Plaintiffs" }, { "page": 26, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "dules. There has been a significant increase in the number and complexity of FOIA requests submitted to CBER in recent years. Prior to 2019, CBER was able to k" }, { "page": 26, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "s submitted to CBER in recent years. Prior to 2019, CBER was able to keep its FOIA backlog relatively low: from 2014 through 2018, CBER had an average of 47 pend" }, { "page": 26, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "klog relatively low: from 2014 through 2018, CBER had an average of 47 pending FOIA requests at the end of each fiscal year. Brockner Ryan Decl. \u00b6 18. Beginning" }, { "page": 26, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ave required significant resources to process. Id. In 2021, CBER received 509 FOIA requests, a Case 4:22-cv-00915-P Document 27 Filed 03/31/23 Page 26 of" }, { "page": 27, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Defendant FDA\u2019s Brief Regarding FOIA Production \u2013 Page 21 73% increase from pre-2019 averages. Id. And in 2022, C" }, { "page": 27, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "e 21 73% increase from pre-2019 averages. Id. And in 2022, CBER received 633 FOIA requests\u2014 more than double the pre-2019 averages. Id. As a result, the number" }, { "page": 27, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "pre-2019 averages. Id. As a result, the number of requests pending in CBER\u2019s FOIA queue has increased substantially, from 108 requests as of February 28, 2019," }, { "page": 27, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "\u00b6 20. Indeed, around the time of Plaintiffs\u2019 first request in this litigation (FOIA Control No. 2022-1614; received February 23, 2022), CBER had over 500 pending" }, { "page": 27, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Control No. 2022-1614; received February 23, 2022), CBER had over 500 pending FOIA requests. Id. \u00b6 22. Imposing Plaintiffs\u2019 requested production schedule here" }, { "page": 27, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "pact CBER\u2019s ability to reduce, or even stabilize, its lengthy queue of pending FOIA requests and allow Plaintiffs to leapfrog these hundreds of requesters who sub" }, { "page": 27, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "equest (not to mention second and third requests). Id. The number of pending FOIA requests thus illustrates why it is particularly important that the production" }, { "page": 27, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "In addition, ALFOI has been required to respond to an increase in the number of FOIA litigation matters. Id. \u00b6 21. Currently, there are 15 pending lawsuits regar" }, { "page": 27, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "tion matters. Id. \u00b6 21. Currently, there are 15 pending lawsuits regarding 20 FOIA requests received by CBER. Id. Some of the pending lawsuits require periodic" }, { "page": 28, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Defendant FDA\u2019s Brief Regarding FOIA Production \u2013 Page 22 complete production in PHMPT 1 by approximately November" }, { "page": 28, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "orms).12 Id. Since ALFOI began devoting most of its resources to PHMPT 1, the FOIA backlog increased by another 90 pending requests from the end of February 2022" }, { "page": 28, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "o comply with PHMPT 1 come at a significant cost to CBER, taxpayers, and other FOIA requesters. Unprecedented staffing burdens have required a reorganization of" }, { "page": 28, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "t hiring and training efforts, and a shifting of resources away from all other FOIA requests (which, as noted above, currently number over 600). Id. \u00b6\u00b6 25-26. Pr" }, { "page": 29, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Defendant FDA\u2019s Brief Regarding FOIA Production \u2013 Page 23 through all possible avenues. In addition to its regular" }, { "page": 29, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "nal FTE permanent staff for continued processing of PHMPT 1 and to address its FOIA backlog due to the resources already devoted to PHMPT 1. Id. \u00b6 31. A staff t" }, { "page": 29, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ff that is one-third the size of the PHMPT 1 team is now primarily handling all FOIA requests other than PHMPT 1. Id. \u00b6 34. CBER has assigned 9 FTEs (4 team lead" }, { "page": 29, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": ", 3 regular staff, and two one-year temporary staff) primarily handle all other FOIA requests and are managing a higher workload than during the years just prior t" }, { "page": 30, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Defendant FDA\u2019s Brief Regarding FOIA Production \u2013 Page 24 continues. Given that disclosure review is highly techni" }, { "page": 30, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ued hiring efforts represent the agency\u2019s good-faith investment to address the FOIA backlog and requests like those made by Plaintiffs, its resources for the fores" }, { "page": 30, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "n producing records in this case. Id. And making progress on the substantial FOIA backlog\u2014or even just preventing a continuing increase in the backlog\u2014will not" }, { "page": 30, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "letion of PHMPT 1, would adversely impact CBER\u2019s ability to reduce its growing FOIA backlog and address other COVID-19 related requests. Id. Diverting the bulk" }, { "page": 31, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Defendant FDA\u2019s Brief Regarding FOIA Production \u2013 Page 25 ALFOI will cost an estimated $1.8 million annually, in ad" }, { "page": 31, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "d be in the interest of all parties for Plaintiffs to focus the scope of their FOIA requests. At least one court has found that \u201cit is reasonable for FDA to ask" }, { "page": 31, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "re not the case, a single requester could hobble an agency and stymie all other FOIA requesters, all without satisfying the statutory criteria for expedited proces" }, { "page": 32, "family": "Court case", "normalized": "N.Y. Times Co. v. DOD, No. 19-CV-9821, 2022 WL 1547989", "raw": "N.Y. Times Co. v. DOD, No. 19-CV-9821, 2022 WL 1547989", "context": "(the agency\u2019s \u201cstandard processing rate\u201d of 500 pages a month was reasonable); N.Y. Times Co. v. DOD, No. 19-CV-9821, 2022 WL 1547989, at *2 (S.D.N.Y. Apr. 21, 2022) (a production rate of 500 pages every 60 days" }, { "page": 32, "family": "Court case", "normalized": "Am. C.L. Union v. DHS, No. 20-CV-10083, 2021 WL 5449733", "raw": "Am. C.L. Union v. DHS, No. 20-CV-10083, 2021 WL 5449733", "context": "and agency\u2019s evidence of making efforts to increase its processing capacity); Am. C.L. Union v. DHS, No. 20-CV-10083, 2021 WL 5449733, at *2 (S.D.N.Y. Nov. 19, 2021) (the 500-page per month processing rate propos" }, { "page": 32, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Defendant FDA\u2019s Brief Regarding FOIA Production \u2013 Page 26 However, assuming that Plaintiffs will not be adjusting t" }, { "page": 32, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "to Plaintiffs\u2019 requests, substantially exceeding the production rates in other FOIA cases that typically set monthly production rates at a maximum of hundreds of" }, { "page": 32, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "No. 4:20-CV-447, 2021 WL 1837548, at *2 (E.D. Tex. May 7, 2021) (a stay of the FOIA proceedings followed by a production rate of 500 pages a month was appropriate" }, { "page": 32, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ages a month was appropriate based on the agency\u2019s strained resources and other FOIA requests); Colbert, 2018 WL 6299966, at *3 (the agency\u2019s \u201cstandard processing" }, { "page": 32, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "production rate of 500 pages every 60 days was practicable given the agency\u2019s FOIA resource constraints, increasing complexity of requests, increasing backlog and" }, { "page": 32, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "FBI, the Eastern District of Texas granted the agency\u2019s requested stay of the FOIA proceedings and production schedule of 500 pages a month, stating that \u201cDefenda" }, { "page": 32, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "at the strained resources of their departments and significant volumes of other FOIA requests should allow for production at a standardized rate of 500 pages per m" }, { "page": 33, "family": "Court case", "normalized": "Am. Ctr. for Law & Justice v. DHS, 573 F. Supp. 3d 78", "raw": "Am. Ctr. for Law & Justice v. DHS, \n573 F. Supp. 3d 78", "context": "which types of documents are of greatest importance or interest to them. Cf. Am. Ctr. for Law & Justice v. DHS, 573 F. Supp. 3d 78, 84 (D.D.C. 2021) (dismissing overly broad request and noting that, due to cer" }, { "page": 33, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Defendant FDA\u2019s Brief Regarding FOIA Production \u2013 Page 27 (E.D. Tex. May 7, 2021). The court emphasized that many" }, { "page": 33, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ction rate of 500 pages \u201creasonable.\u201d Id. (collecting cases). Similarly, in a FOIA case brought against the Department of Homeland Security, the District Court f" }, { "page": 33, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "because COVID-19 had adversely affected staffing and workload constraints and FOIA requests to DHS had increased substantially between 2017 and 2020. Am. C.L. U" }, { "page": 33, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "capacity. FDA\u2019s proposal equitably balances CBER\u2019s responsibilities to other FOIA requesters and FOIA litigation matters and its consideration of the resources" }, { "page": 33, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "oposal equitably balances CBER\u2019s responsibilities to other FOIA requesters and FOIA litigation matters and its consideration of the resources available to perform" }, { "page": 33, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ources to the detriment of other important agency functions and other COVID-19 FOIA requests. Id. Ordering anything more is not sustainable for the agency, othe" }, { "page": 33, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "equests. Id. Ordering anything more is not sustainable for the agency, other FOIA requesters, and taxpayers. Id. To the extent Plaintiffs take issue with the a" }, { "page": 33, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "broad request and noting that, due to certain unintended incentives created by FOIA, requesters often, and perversely, have \u201ceverything to gain and little to lose" }, { "page": 33, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ly, have \u201ceverything to gain and little to lose from posing broad, complicated FOIA requests,\u201d which has, in turn, engendered substantial FOIA backlogs across the" }, { "page": 33, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "broad, complicated FOIA requests,\u201d which has, in turn, engendered substantial FOIA backlogs across the federal government). CBER always stands Case 4:22-cv-0091" }, { "page": 34, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Defendant FDA\u2019s Brief Regarding FOIA Production \u2013 Page 28 willing to discuss ways to provide Plaintiffs with the in" }, { "page": 34, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "s matter as soon as practicable. But the growing backlog of hundreds of other FOIA requesters, including many who submitted their requests prior to the requests" }, { "page": 35, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Defendant FDA\u2019s Brief Regarding FOIA Production \u2013 Page 29 Email: clay.mahaffey@usdoj.gov Counsel for Defendant" }, { "page": 36, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Defendant FDA\u2019s Brief Regarding FOIA Production \u2013 Page 30 CERTIFICATE OF SERVICE On March 31, 2023, I electronic" }, { "page": 36, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "SERVICE On March 31, 2023, I electronically filed the above brief regarding FOIA production schedule with the clerk of court for the U.S. District Court, North" } ] }, { "filename": "028-Plaintiffs-Reply-in-Support-of-Production-Schedule-2023-04-12.pdf", "id": 8086, "module": null, "batch_code": null, "company": null, "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/05/028-Plaintiffs-Reply-in-Support-of-Production-Schedule-2023-04-12.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/08/028-Plaintiffs-Reply-in-Support-of-Production-Schedule-2023-04-12.pdf", "total_pages": 16, "matches": [ { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "........................................ 6 II. FDA\u2019S PROPOSED RATE UNDERMINES FOIA AND ITS OWN REGULATION ......................................................." }, { "page": 3, "family": "Court case", "normalized": "TABLE OF AUTHORITIES \n \nCases \nColbert v. FDA, \nNo. 16-1790, 2018 WL 6299966", "raw": "TABLE OF AUTHORITIES \n \nCases \nColbert v. FDA, \nNo. 16-1790, 2018 WL 6299966", "context": "iii TABLE OF AUTHORITIES Cases Colbert v. FDA, No. 16-1790, 2018 WL 6299966 (D.D.C. Sept. 3, 2018) ........................................................" }, { "page": 3, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "18) ............................................................. 10 Statutes 5 U.S.C. \u00a7 552(a)(6)(E)(v)(I)-(II) ..........................................................." }, { "page": 4, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "disclose that information to PHMPT or to the Court. As we just learned from a FOIA production received a few days ago in a different matter, FDA, sometime prior" }, { "page": 5, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "re is urgency to inform the public concerning Federal Government activity. See 5 U.S.C. \u00a7 552(a)(6)(E)(v)(I)-(II). If release of documents concerning Covid-19 vaccines \u2013 wh" }, { "page": 5, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "g and about overall agency resources. First, in adding expedited processing to FOIA, Congress made clear that expedition is appropriate where there is urgency to" }, { "page": 5, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "roducts. But it did. It did not let diversion of funds or concerns about other FOIA requesters get in its way. It purportedly moved the sun and earth to get these" }, { "page": 7, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ely 1.2 million pages. This is because two days ago, in response to a separate FOIA request, the undersigned obtained the contract FDA awarded on April 22, 2022 f" }, { "page": 8, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "1 and here is the \u201ccareful[] review\u201d needed \u201cto determine whether one or more FOIA exemptions apply.\u201d (Dkt. 27 at 8.) In PHMPT 1, where FDA represents it has pro" }, { "page": 9, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 \nC.F.R. \u00a7 601.51", "context": "n the biological product file are immediately available for public disclosure.\u201d 21 C.F.R. \u00a7 601.51. Hence, even if by FOIA, immediate release is the default. Second, as FDA ackn" }, { "page": 9, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ect to these products. ARGUMENT I. EXPEDITED PROCESSING IS WARRANTED If any FOIA requests to FDA qualify for expedited processing, it is the ones at issue here." }, { "page": 9, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "iately available for public disclosure.\u201d 21 C.F.R. \u00a7 601.51. Hence, even if by FOIA, immediate release is the default. Second, as FDA acknowledges, compelling nee" }, { "page": 12, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "r will it be unless ordered by this Court. II. FDA\u2019S PROPOSED RATE UNDERMINES FOIA AND ITS OWN REGULATION FDA cites to Colbert which recognized that \u201cCourts ha" }, { "page": 12, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "\u201cCourts have broad discretion to determine a reasonable processing rate for a FOIA request\u201d and that \u201c[w]hen determining the rate at which a federal agency must" }, { "page": 12, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "nd that \u201c[w]hen determining the rate at which a federal agency must respond to FOIA requests, courts often give deference to the agency\u2019s release 16 https://cli" }, { "page": 13, "family": "Court case", "normalized": "Colbert v. FDA, No. 16-1790, 2018 WL 6299966", "raw": "Colbert v. FDA, No. 16-1790, 2018 WL 6299966", "context": "10 policies.\u201d Colbert v. FDA, No. 16-1790, 2018 WL 6299966, at *3 (D.D.C. Sept. 3, 2018). Here, the agency\u2019s release policy is \u201cimmediate" }, { "page": 13, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "the agency\u2019s release policy is \u201cimmediately available for public disclosure.\u201d 21 C.F.R. \u00a7 601.51(e). Additionally, the FOIA backlog complained of is of FDA\u2019s own making, not t" }, { "page": 13, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ely available for public disclosure.\u201d 21 C.F.R. \u00a7 601.51(e). Additionally, the FOIA backlog complained of is of FDA\u2019s own making, not that of the Court. The solut" }, { "page": 13, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "g, not that of the Court. The solution is to stop chronically underfunding its FOIA office. Congress made billions of dollars available to FDA to address Covid-19" }, { "page": 13, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "the public. In any event, unless or until Congress changes the requirements of FOIA, FDA is not excused from them. In this case there is extraordinary cause for c" }, { "page": 15, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "cess of producing COVID-19 vaccine-related records to the de Garays in another FOIA suit.\u201d (Id.) That FOIA request, however, is limited to email communications fro" }, { "page": 15, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "-19 vaccine-related records to the de Garays in another FOIA suit.\u201d (Id.) That FOIA request, however, is limited to email communications from 7 individuals within" }, { "page": 15, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "s to the American public. Waiting over 23 years to do so completely undermines FOIA and FDA\u2019s claim of transparency. Plaintiffs therefore respectfully ask the Cour" } ] }, { "filename": "029-FDAs-Reply-re-Brief-in-Support-of-Motion.pdf", "id": 8087, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2021/12/029-FDAs-Reply-re-Brief-in-Support-of-Motion.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2022/03/029-FDAs-Reply-re-Brief-in-Support-of-Motion.pdf", "total_pages": 28, "matches": [ { "page": 1, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "SCHEDULING CONFERENCE INTRODUCTION This is a Freedom of Information Act (\u201cFOIA\u201d) case; it is not a challenge to the decision of the U.S. Food and Drug Admini" }, { "page": 2, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 \n552", "context": "ather only that the agency process responsive records \u201cas soon as practicable.\u201d 5 U.S.C. \u00a7 552(a)(6)(E)(iii). Thus, even in expedited cases, the bottom-line issue still remai" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "easonable and feasible for the processing of records responsive to Plaintiff\u2019s FOIA request, taking into account, inter alia, the breadth of the request, FDA\u2019s mu" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "taking into account, inter alia, the breadth of the request, FDA\u2019s mushrooming FOIA docket, applicable resource constraints, and fairness to other FOIA requesters" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ushrooming FOIA docket, applicable resource constraints, and fairness to other FOIA requesters. Nor is the issue of expedition really at issue. As explained here" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ff is not entitled to expedition under the applicable standards established by FOIA and agency regulations. However, and in any event, FDA has started processing" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "rendering this issue moot. Moreover, even where formal expedition is granted, FOIA does not mandate any particular processing schedule, but rather only that the" }, { "page": 4, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Defendant\u2019s prior filings explain the relevant legal framework established by FOIA for the processing and production of federal records under that Act\u2019s auspices" }, { "page": 4, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "not repeat that framework at length here. In short, when a plaintiff brings a FOIA lawsuit, it is common for the parties to confer and agree upon\u2014or, where agree" }, { "page": 4, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ich the defendant agency will search for, and then process in comportment with FOIA\u2019s enumerated exemptions, records responsive to the plaintiff\u2019s FOIA request. T" }, { "page": 4, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "tment with FOIA\u2019s enumerated exemptions, records responsive to the plaintiff\u2019s FOIA request. This is the stage that the instant case has reached, and thus the issu" }, { "page": 4, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "instant case has reached, and thus the issue now before the Court. Although FOIA allows\u2014in exceptional circumstances where requesters meet the stringent regula" }, { "page": 5, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "request is on \u201cthe record before the agency at the time of the determination,\u201d 5 U.S.C. \u00a7 552(a)(6)(E)(iii), much like a claim brought under the Administrative Procedures A" }, { "page": 6, "family": "Public Law", "normalized": "Pub. L. 104-231", "raw": "Pub. L. \nNo. 104-231", "context": "ries of requests. See Electronic Freedom of Information Act Amendments of 1996, Pub. L. No. 104-231, \u00a7 8, 110 Stat. 3048 (codified at 5 U.S.C. \u00a7 552(a)(6)(E)) (\u201cEFOIA\u201d). Expeditio" }, { "page": 6, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "Act Amendments of 1996, Pub. L. No. 104-231, \u00a7 8, 110 Stat. 3048 (codified at 5 U.S.C. \u00a7 552(a)(6)(E)) (\u201cEFOIA\u201d). Expedition, when granted, entitles requestors to move imm" }, { "page": 6, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "es in which the person requesting the records demonstrates a compelling need,\u201d 5 U.S.C. \u00a7 552(a)(6)(E)(i)(I); and (ii) \u201cin other cases determined by the agency.\u201d Id. \u00a7 552(" }, { "page": 6, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "o inform the public concerning actual or alleged Federal Government activity.\u201d 5 U.S.C. \u00a7 552(a)(6)(E)(v)(I)-(II). And, in carrying out FOIA\u2019s instruction to further implem" }, { "page": 6, "family": "CFR", "normalized": "21 CFR 20.44", "raw": "21 C.F.R. \u00a7 20.44", "context": "th respect to the second of these tests, the \u201curgency\u201d must be \u201cdemonstrated.\u201d 21 C.F.R. \u00a7 20.44(a)(2). Specifically, in order to satisfy 21 C.F.R. \u00a7 20.44(a)(2), a FOIA reque" }, { "page": 6, "family": "CFR", "normalized": "21 CFR 20.44", "raw": "21 C.F.R. \u00a7 20.44", "context": "be \u201cdemonstrated.\u201d 21 C.F.R. \u00a7 20.44(a)(2). Specifically, in order to satisfy 21 C.F.R. \u00a7 20.44(a)(2), a FOIA requester must \u201cdemonstrate\u201d that: (1) The requester is primari" }, { "page": 6, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "al Framework for Requests for Expedited Processing Agencies ordinarily process FOIA requests for agency records on a first-in, first-out basis. In 1996, Congress" }, { "page": 6, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "r agency records on a first-in, first-out basis. In 1996, Congress amended the FOIA to provide for \u201cexpedited processing\u201d of certain categories of requests. See E" }, { "page": 6, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "(ii) \u201cin other cases determined by the agency.\u201d Id. \u00a7 552(a)(6)(E)(i)(II). FOIA further defines \u201ccompelling need\u201d as either (1) \u201cthat a failure to obtain reque" }, { "page": 6, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Government activity.\u201d 5 U.S.C. \u00a7 552(a)(6)(E)(v)(I)-(II). And, in carrying out FOIA\u2019s instruction to further implement these standards via regulation, FDA added th" }, { "page": 6, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "R. \u00a7 20.44(a)(2). Specifically, in order to satisfy 21 C.F.R. \u00a7 20.44(a)(2), a FOIA requester must \u201cdemonstrate\u201d that: (1) The requester is primarily engaged in d" }, { "page": 7, "family": "Court case", "normalized": "Al-Fayed v. CIA, 254 F.3d 300", "raw": "Al-Fayed v. CIA, 254 F.3d 300", "context": "ecified that the expedited processing categories should be \u201cnarrowly applied.\u201d Al-Fayed v. CIA, 254 F.3d 300, 310 (D.C. Cir. 2001) Al- Fayed, 254 F.3d at 310 (quoting H.R. Rep. No. 104-795" }, { "page": 7, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "s involving the improper withholding of records under claimed FOIA exemptions, 5 U.S.C. \u00a7 552(a)(4)(B), the 3 FDA" }, { "page": 7, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ation is clear: \u201cGiven the finite resources generally available for fulfilling FOIA requests, unduly generous use of the expedited processing procedure would unfa" }, { "page": 7, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "a request for expedition necessarily works to the direct disadvantage of other FOIA requesters.\u201d U.S. Department of Justice, FOIA Update: OIP Guidance: When to E" }, { "page": 7, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "he direct disadvantage of other FOIA requesters.\u201d U.S. Department of Justice, FOIA Update: OIP Guidance: When to Expedite FOIA Requests (Jan. 1, 1983), https://" }, { "page": 7, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ers.\u201d U.S. Department of Justice, FOIA Update: OIP Guidance: When to Expedite FOIA Requests (Jan. 1, 1983), https://www.justice.gov/oip/blog/foia-update-oip-guid" }, { "page": 7, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ts action in cases involving the improper withholding of records under claimed FOIA exemptions, 5 U.S.C. \u00a7 552(a)(4)(B), the" }, { "page": 7, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "that qualify for expedition. 4 Courts often rely on the case law concerning FOIA from the D.C. Circuit, as it is \u201cthe federal appellate court with the most exp" }, { "page": 8, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 \nU.S.C. \u00a7 552", "context": "r has the burden to \u201cdemonstrate[] a compelling need\u201d for expedited processing. 5 U.S.C. \u00a7 552(a)(6)(E)(i); see also Wadelton v. Dep\u2019t of State, 941 F. Supp. 2d 120, 122 (D.D" }, { "page": 8, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "\u201d in expedited processing cases); Al-Fayed, 254 F.3d at 305 n.4 (same) (citing 5 U.S.C. \u00a7 552(a)(6)(E)(i)(I) and H.R. Rep. No. 104-795, at 25). Finally, expedition decisi" }, { "page": 8, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "a timely manner to such a request shall be subject to judicial review under [5 U.S.C. \u00a7 552(a)(4)], except that the judicial review shall be based on the record before th" }, { "page": 8, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "be based on the record before the agency at the time of the determination. 5 U.S.C. \u00a7 552(a)(6)(E)(iii) (emphasis added); see also, e.g., Am. Oversight v. U.S. Dep\u2019t of" }, { "page": 8, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "ly limited to \u201cthe record before the agency at the time of the determination,\u201d 5 U.S.C. \u00a7 552(a)(6)(E)(iii)\u2014which, here, excludes each of the supporting declarations submit" }, { "page": 8, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": ".D.C. 2018). Section 552(a)(4), the cross-referenced provision, is the general FOIA provision authorizing judicial review of agency decisions to withhold records" }, { "page": 8, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ision authorizing judicial review of agency decisions to withhold records from FOIA requestors. See id. \u00a7 552(a)(4)(B). A decision denying expedited processing fo" }, { "page": 9, "family": "CFR", "normalized": "21 CFR 20.44", "raw": "21 C.F.R. \u00a7 20.44", "context": "information to the general public and not merely to a narrow interest group,\u201d 21 C.F.R. \u00a7 20.44(c)(1), it had not \u201cdemonstrated urgency to inform the public concerning actual" }, { "page": 9, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "t the significant amount of information publicly available through the agency\u2019s FOIA reading room, and determined that there was not an urgency to inform the publi" }, { "page": 9, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "9 vaccines for their members or employees.\u201d Id.; see Dkt. No. 1-1 (Plaintiff\u2019s FOIA request and request for expedition). As the Kotler Declaration explains, after" }, { "page": 10, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "t did here). If Plaintiff\u2019s view became the standard, a great number of FDA\u2019s FOIA requests would qualify for expedited processing, and requesters with non-exped" }, { "page": 12, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "on, they also have an interest in receiving the documents that they sought Cf. 5 U.S.C. \u00a7 552(a)(6)(E)(v)(II) (stating that one of the criteria for granting expedited proce" }, { "page": 12, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ubstantive, detailed information on the same topics encompassed by Plaintiff\u2019s FOIA request undermined any arguable justification to put Plaintiff\u2019s request at fr" }, { "page": 12, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "y, and regardless of subject matter, FDA must handle its substantial volume of FOIA requests equally and fairly. As FDA has stressed throughout these proceedings," }, { "page": 13, "family": "Court case", "normalized": "Landmark Legal Found. v. EPA, 910 F. Supp. 2d 270", "raw": "Landmark Legal Found. v. EPA, 910 F. Supp. 2d 270", "context": "e does not assign any particular time frame to release of the records sought.\u201d Landmark Legal Found. v. EPA, 910 F. Supp. 2d 270, 275 (D.D.C. 2012). Rather, the statute directs an agency to \u201cprocess as soon" }, { "page": 13, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 \n552", "context": "any request for records to which the agency has granted expedited processing.\u201d 5 U.S.C. \u00a7 552(a)(6)(E)(iii); see also, e.g., Muttitt v. Dep\u2019t of State, 926 F. Supp. 2d 284," }, { "page": 13, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "e unfairness that special treatment of Plaintiff\u2019s request would work on other FOIA requesters, the Court should uphold FDA\u2019s decision to deny the expedition requ" }, { "page": 13, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "d is Proceeding as Fast As Practicable. In any event, even if Plaintiff\u2019s FOIA received expedited treatment, Plaintiff is not entitled to an order requiring" }, { "page": 13, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ll responsive, non-exempt records by March 3, 2022. Even in cases of expedited FOIA processing, \u201c[t]he statute does not assign any particular time frame to releas" }, { "page": 13, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "tate, 926 F. Supp. 2d 284, 296 (D.D.C. 2013) (\u201cthe only relief required by the FOIA with regard to expedited processing is moving an individual\u2019s request \u2018to the" }, { "page": 14, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "within the shortest period of time that is both reasonable and feasible. A. 21 C.F.R. \u00a7 601.51 Does Not Contemplate the Immediate or Automatic Publication of the Records Sou" }, { "page": 14, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "14 processing schedule is practicable in light of other expedited FOIA requests the agency was already processing, the volume of materials, the need" }, { "page": 14, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "follows that, even if, arguendo, the Court were to determine that Plaintiff\u2019s FOIA request is entitled to expedited treatment, the bottom-line issue still remains" }, { "page": 14, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "broad request and noting that, due to certain unintended incentives created by FOIA, requesters often, and perversely, have \u201ceverything to gain and little to lose" }, { "page": 14, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ly, have \u201ceverything to gain and little to lose from posing broad, complicated FOIA requests,\u201d which has, in turn, engendered substantial FOIA backlogs across the" }, { "page": 14, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "broad, complicated FOIA requests,\u201d which has, in turn, engendered substantial FOIA backlogs across the federal government). Conversely, FDA\u2019s proposal\u2014which Plai" }, { "page": 15, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 \nC.F.R. \u00a7 601.51", "context": "IA request seeks \u201call data and information for the Pfizer Vaccine enumerated in 21 C.F.R. \u00a7 601.51(e) with the exception of publicly available reports on the Vaccine Adverse Eve" }, { "page": 15, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 \nC.F.R. \u00a7 601.51", "context": "atory confidentiality and become \u201cimmediately available for public disclosure.\u201d 21 C.F.R. \u00a7 601.51(e)(1)-(8) (listing the applicable categories of data and information) (emphasis" }, { "page": 15, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 \n601.51", "context": "or will FDA disclose any \u201cdata or information in the biological product file.\u201d 21 C.F.R. \u00a7 601.51(b), (c). And even where the existence of a biological product file is \u201cpublicly" }, { "page": 15, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "15 Plaintiff\u2019s FOIA request seeks \u201call data and information for the Pfizer Vaccine enumerated in 21" }, { "page": 16, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 \nC.F.R. \u00a7 601.51", "context": "d otherwise. That a disclosure review is necessary is apparent from the text of 21 C.F.R. \u00a7 601.51(e) itself, which limits disclosure of several types of information if such inf" }, { "page": 16, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "cal product file for an approved BLA are not available for public disclosure. 21 C.F.R. \u00a7 601.51(f). Because the categories of information not available for public disclosure" }, { "page": 16, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "ecause the categories of information not available for public disclosure under 21 C.F.R. \u00a7 601.51(f) or subject to withholding under 21 C.F.R. \u00a7\u00a7 601.51(e)(2), (3), (5), (6), (" }, { "page": 16, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "n be intermingled with the types of information available for disclosure under 21 C.F.R. \u00a7 601.51(e), a disclosure review is essential. And, as discussed at length in other fil" }, { "page": 16, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "y are now available\u2014just like any other public record within the parameters of FOIA\u2014for public disclosure, upon request. But\u2014and again, just like any other public" }, { "page": 16, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "est. But\u2014and again, just like any other public record within the parameters of FOIA\u2014 records that may include information and data listed in Section 601.51(e) must" }, { "page": 16, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Section 601.51(e) must be carefully reviewed to determine whether one or more FOIA exemptions apply. Indeed, Plaintiff does not contend otherwise. That a disclos" }, { "page": 16, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ed at length in other filings and herein, the processing of records subject to FOIA, like any other kind of work, necessarily takes time and simply cannot be perfo" }, { "page": 17, "family": "USC", "normalized": "21 U.S.C. \u00a7 393", "raw": "21 U.S.C. \u00a7 393", "context": "e, its primary mission is to protect and improve public health and safety. See 21 U.S.C. \u00a7 393 (establishing \u201cMission\u201d of FDA). Even if it were theoretically possible for FD" }, { "page": 17, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ified Personnel with Other, Crucial Programmatic Duties to Process Plaintiff\u2019s FOIA Request Plaintiff\u2019s suggestion that FDA may meet its extraordinary demand to" }, { "page": 17, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ing records. Kotler Decl. \u00b6 22 (App120-21). In short, while FDA takes its FOIA obligations seriously, and is fully committed to the important values of trans" }, { "page": 17, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "o re-assign its scientists and other programmatic staff to process Plaintiffs\u2019 FOIA request\u2014which it is not\u2014any such reallocation of personnel would come at an un" }, { "page": 18, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "ndant to disclose documents, not \u201cas soon as practicable\u201d as dictated by FOIA, 5 U.S.C. \u00a7 552(a)(6)(E)(iii), but rather on Plaintiff\u2019s preferred (and wholly infeasible) tim" }, { "page": 18, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "edented measures sought by Plaintiff are nowhere contemplated or authorized by FOIA, and this Court should reject them in no uncertain terms. C. Plaintiff\u2019s Pro" }, { "page": 18, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "g Defendant to disclose documents, not \u201cas soon as practicable\u201d as dictated by FOIA, 5 U.S.C. \u00a7 552(a)(6)(E)(iii), but rather on Plaintiff\u2019s preferred (and wholly" }, { "page": 18, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "lip service to, the public interest of the many hundreds of other parties with FOIA requests pending before FDA\u2019s Center for Biologics Evaluation and Research (\u201cC" }, { "page": 18, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ught in order to further the important interests that motivated them to submit FOIA requests. Plaintiff has offered no explanation as to why its request is more b" }, { "page": 18, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "terests as well as the overall public interest in the proper administration of FOIA, including its provision for expedition. See, e.g., New York Times Co., 2021 W" }, { "page": 18, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ocessing burden on defendants\u201d would \u201cresult[] [in] disruption of the ordinary FOIA processing on similarly-situated FOIA requesters\u201d); id. at *10 (emphasizing th" }, { "page": 18, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "\u201cresult[] [in] disruption of the ordinary FOIA processing on similarly-situated FOIA requesters\u201d); id. at *10 (emphasizing the interests of \u201csimilarly situated FOI" }, { "page": 18, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "OIA requesters\u201d); id. at *10 (emphasizing the interests of \u201csimilarly situated FOIA requesters, who are depending on, and adhering to, regular administrative FOIA" }, { "page": 18, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "FOIA requesters, who are depending on, and adhering to, regular administrative FOIA record production processes to Case 4:21-cv-01058-P Document 29 Filed 12/1" }, { "page": 19, "family": "Court case", "normalized": "Public Citizen Health Research Grp. v. FDA, 704 F.2d 1280", "raw": "Public Citizen Health Research Grp. v. FDA, 704 F.2d 1280", "context": "ommercial and/or trade secret information protected by Exemption 4, see, e.g., Public Citizen Health Research Grp. v. FDA, 704 F.2d 1280, 1290 (D.C. Cir. 1983) (\u201cBecause Case 4:21-cv-01058-P Document 29 Filed 12" }, { "page": 19, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "a date certain, without any factual basis for doing so, might actually disrupt FOIA\u2019s expedited processing regime rather than implement it.\u201d). Second, granting P" }, { "page": 19, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "isclosure of which would cause harm, are carefully redacted consistent with the FOIA exemptions. The exemptions listed in \u00a7 552(b) embody a judgment that the publi" }, { "page": 19, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "manner, the Committee does not intend to weaken any interests protected by the FOIA exemptions. Agencies processing some requests may need additional time to adeq" }, { "page": 20, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "information of clinical trial participants, which is protected by Exemption 6. 5 U.S.C. \u00a7 552(b)(4), (6). Moreover, if FDA determines not to withhold information that might" }, { "page": 20, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "subjects is deleted before the record is disclosed. 21 C.F.R. \u00a7 20.63(a); see 5 U.S.C. \u00a7 552(b)(6). And, indeed, in the productions FDA has already made, the agency has i" }, { "page": 20, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "g FDA to disclose documents, not \u201cas soon as practicable\u201d as dictated by FOIA, 5 U.S.C. \u00a7 552(a)(6)(E)(iii), but rather on any artificial, and indeed unprecedented Case 4:2" }, { "page": 20, "family": "CFR", "normalized": "21 CFR 20.47", "raw": "21 C.F.R. 20.47", "context": "ity to file a claim for injunctive relief (a \u201creverse FOIA\u201d claim). See e.g., 21 C.F.R. 20.47, 20.48, 20.61(e). With respect to the latter category of privacy concerns, Pl" }, { "page": 20, "family": "CFR", "normalized": "21 CFR 20.63", "raw": "21 C.F.R. \u00a7 20.63", "context": "Pl. Br. at 25. But, despite any efforts the sponsor may have made pursuant to 21 C.F.R. \u00a7 20.63(b) to anonymize the data it submitted, FDA has an independent responsibility t" }, { "page": 20, "family": "CFR", "normalized": "21 CFR 20.63", "raw": "21 C.F.R. \u00a7 20.63", "context": "tify patients or research subjects is deleted before the record is disclosed. 21 C.F.R. \u00a7 20.63(a); see 5 U.S.C. \u00a7 552(b)(6). And, indeed, in the productions FDA has already" }, { "page": 20, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "formation and an opportunity to file a claim for injunctive relief (a \u201creverse FOIA\u201d claim). See e.g., 21 C.F.R. 20.47, 20.48, 20.61(e). With respect to the lat" }, { "page": 20, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "asserts that \u201cthe documents submitted by Pfizer, which are the subject of the FOIA Request, would have already been anonymized, and therefore, the risk of disclo" }, { "page": 20, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "inadvertent disclosure is real\u2014and indeed, especially acute where, as here, a FOIA request implicates third party medical information, where the interest in care" }, { "page": 20, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "rdering FDA to disclose documents, not \u201cas soon as practicable\u201d as dictated by FOIA, 5 U.S.C. \u00a7 552(a)(6)(E)(iii), but rather on any artificial, and indeed unprece" }, { "page": 21, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "risk of inadvertent disclosure of records properly subject to exemption under FOIA.\u201d); Protect Democracy Project, 263 F. Supp. 3d at 302 (\u201cImposing on Defendants" }, { "page": 21, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": ", in its haste, Defendant will inadvertently release records which fall under a FOIA exception and Congress has decided should not be released.\u201d). Plaintiff\u2019s dema" }, { "page": 21, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Narrow It In similar situations, courts presented with broad and burdensome FOIA requests and a concomitant dearth in agency resources look to the requester\u2019s" }, { "page": 21, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "3d at 819 (\u201cThe Court is particularly mindful\u201d \u201cof the strain that defendant\u2019s FOIA responsibilities may pose,\u201d \u201cgiven the significant breadth of plaintiffs' requ" }, { "page": 21, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ve stage and during this litigation.\u201d). Plaintiff can control the scope of its FOIA request, and, to date, has refused to narrow it even slightly. In its opening" }, { "page": 22, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "nversely, if Plaintiff continues to decline to narrow, that is its right under FOIA\u2014but in that case, Plaintiff must accept the trade- off that this work will take" }, { "page": 23, "family": "Court case", "normalized": "Nat'l Sec. Counselors v. U.S. Dep't of Justice, 848 F.3d 467", "raw": "Nat'l Sec. Counselors v. U.S. Dep't of Justice, 848 F.3d 467", "context": "2018) (approving 500 pages per month and a decade-long production period); cf. Nat'l Sec. Counselors v. U.S. Dep't of Justice, 848 F.3d 467, 471-72 (D.C. Cir. 2017) (in context of challenge to FOIA processing fees, sta" }, { "page": 23, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "amount of time it will take to process other records responsive to Plaintiff\u2019s FOIA request, following its proposed January 31, 2022 production. Accordingly, from" }, { "page": 23, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "of Justice, 848 F.3d 467, 471-72 (D.C. Cir. 2017) (in context of challenge to FOIA processing fees, stating policy of processing 500 pages per request per month" }, { "page": 24, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "request sought \u201call data and information for the Pfizer Vaccine enumerated in 21 C.F.R. \u00a7 601.51(e) with the exception of publicly available reports on the Vaccine Adverse Eve" }, { "page": 24, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "System.\u201d Burk Decl. \u00b6 24 (App011). Because the regulation cited by Plaintiff, 21 C.F.R. \u00a7 601.51, addresses \u201cdata and information in applications for Case 4:21-cv-01058-P Do" }, { "page": 24, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "24 fair, and efficient administration of FOIA. Accordingly, to the extent that the Court declines to adopt FDA\u2019s proposal in" }, { "page": 24, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ant\u2019s opening brief, and above. III. If Plaintiff Expands the Meaning of its FOIA Request, Substantial Additional Processing Time Will Be Necessary Finally," }, { "page": 24, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Plaintiff in its reply brief takes issue with Defendant\u2019s understanding of the FOIA request at issue. Defendant believes that its interpretation of the request is" }, { "page": 24, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "us add substantial additional time for completion of processing. Plaintiff\u2019s FOIA request sought \u201call data and information for the Pfizer Vaccine enumerated in" }, { "page": 25, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. 601.51", "context": "A/licensure and, thus, publicly available (subject to disclosure review) under 21 C.F.R. 601.51(e). You may already be aware of this, but to make sure we\u2019re on the same pag" }, { "page": 25, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "25 biologics licenses,\u201d FDA interpreted Plaintiff\u2019s FOIA request as a request for all publicly releasable information in the original b" } ] }, { "filename": "029-Order-May-1-2023-Status-Conference-2023-04-21.pdf", "id": 8088, "module": null, "batch_code": null, "company": null, "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/05/029-Order-May-1-2023-Status-Conference-2023-04-21.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/08/029-Order-May-1-2023-Status-Conference-2023-04-21.pdf", "total_pages": 1, "matches": [] }, { "filename": "030-FDAs-Appendix-in-Support-of-Brief.pdf", "id": 8089, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2021/12/030-FDAs-Appendix-in-Support-of-Brief.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2022/03/030-FDAs-Appendix-in-Support-of-Brief.pdf", "total_pages": 36, "matches": [ { "page": 2, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "pt for all requests for records under the Freedom of Information Act (\u201cFOIA\u201d), 5 U.S.C. \u00a7 552. See 21 C.F.R. \u00a7 20.40. In addition, DFOI is responsible for FDA\u2019s FOIA report" }, { "page": 2, "family": "CFR", "normalized": "21 CFR 20.40", "raw": "21 C.F.R. \u00a7 20.40", "context": "for records under the Freedom of Information Act (\u201cFOIA\u201d), 5 U.S.C. \u00a7 552. See 21 C.F.R. \u00a7 20.40. In addition, DFOI is responsible for FDA\u2019s FOIA reporting to HHS and the U.S." }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "of receipt for all requests for records under the Freedom of Information Act (\u201cFOIA\u201d), 5 U.S.C. \u00a7 552. See 21 C.F.R. \u00a7 20.40. In addition, DFOI is responsible for" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": ".S.C. \u00a7 552. See 21 C.F.R. \u00a7 20.40. In addition, DFOI is responsible for FDA\u2019s FOIA reporting to HHS and the U.S. Department of Justice, consulting with other fed" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "e U.S. Department of Justice, consulting with other federal agencies regarding FOIA requests, agency-wide FOIA training, and expedited App112 Case 4:21-cv-01058-P" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "e, consulting with other federal agencies regarding FOIA requests, agency-wide FOIA training, and expedited App112 Case 4:21-cv-01058-P Document 30 Filed 12/1" }, { "page": 3, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "to requests for information from its files pursuant to provisions of the FOIA, 5 U.S.C. \u00a7 552, among others. I am aware of the workload obligations of the various offices t" }, { "page": 3, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "-2- processing, among other functions. DFOI processes about 25% of all FOIA requests received by FDA; the other 75% are processed by the FOIA reviewers wi" }, { "page": 3, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "t 25% of all FOIA requests received by FDA; the other 75% are processed by the FOIA reviewers within FDA\u2019s other components. 4. As part of my duties, I have been c" }, { "page": 3, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "mponents. 4. As part of my duties, I have been coordinating FDA\u2019s processing of FOIA requests that relate to the novel coronavirus known as SARS-CoV-2, also known b" }, { "page": 3, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "onding to requests for information from its files pursuant to provisions of the FOIA, 5 U.S.C. \u00a7 552, among others. I am aware of the workload obligations of the" }, { "page": 3, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "s. I am aware of the workload obligations of the various offices that process FOIA requests across the agency. 5. The statements contained in this declaration ar" }, { "page": 3, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "e of this declaration is to provide an overview of FDA\u2019s procedure for handling FOIA requests and its capabilities in processing Plaintiff\u2019s FOIA request in particu" }, { "page": 3, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "edure for handling FOIA requests and its capabilities in processing Plaintiff\u2019s FOIA request in particular. This declaration also documents the agency\u2019s basis for d" }, { "page": 3, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "tion that FDA should be able to reallocate resources to respond to Plaintiff\u2019s FOIA request is not feasible and could violate FDA\u2019s obligations with respect to ot" }, { "page": 3, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "uest is not feasible and could violate FDA\u2019s obligations with respect to other FOIA requesters. Since the beginning of the COVID-19 pandemic, FDA has experienced" }, { "page": 3, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "nning of the COVID-19 pandemic, FDA has experienced a sudden surge of incoming FOIA requests, an increase in the complexity of those requests, and an uptick in th" }, { "page": 3, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "n increase in the complexity of those requests, and an uptick in the amount of FOIA litigation it faces. These factors, when combined with the Agency\u2019s existing" }, { "page": 3, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "litigation it faces. These factors, when combined with the Agency\u2019s existing FOIA and non-FOIA workload, prevent App113 Case 4:21-cv-01058-P Document 30 Fil" }, { "page": 3, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "t faces. These factors, when combined with the Agency\u2019s existing FOIA and non-FOIA workload, prevent App113 Case 4:21-cv-01058-P Document 30 Filed 12/13/21" }, { "page": 4, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \n\u00a7 552", "context": "demonstrates a compelling need and in other cases determined by the agency. See 5 U.S.C. \u00a7 552(a)(6)(E). A compelling need exists when: (1) A failure to obtain requested reco" }, { "page": 4, "family": "CFR", "normalized": "21 CFR 20.44", "raw": "21 C.F.R. \u00a7 20.44", "context": "o whether expedited processing has been granted or denied. In accordance with 21 C.F.R. \u00a7 20.44, requests that have App114 Case 4:21-cv-01058-P Document 30 Filed 12/13/21" }, { "page": 4, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "uest without diverting significant resources away from the processing of other FOIA requests that are also in litigation, requests that are ahead of Plaintiff\u2019s," }, { "page": 4, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "so in litigation, requests that are ahead of Plaintiff\u2019s, as well as other non-FOIA record requests. Such diversion would adversely impact the Agency\u2019s ability t" }, { "page": 4, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "s and prejudice other pending requests. FDA\u2019S GENERAL PROCEDURE FOR INCOMING FOIA REQUESTS 8. Under FDA\u2019s regulations, DFOI is the office responsible for FDA\u2019s" }, { "page": 4, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "der FDA\u2019s regulations, DFOI is the office responsible for FDA\u2019s compliance with FOIA. See 21 C.F.R. \u00a7\u00a7 20.30, 20.40. When DFOI receives an electronic FOIA request" }, { "page": 4, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ce with FOIA. See 21 C.F.R. \u00a7\u00a7 20.30, 20.40. When DFOI receives an electronic FOIA request, it generates a control number that begins with four digits reflecting" }, { "page": 4, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "the calendar year in which the request was received, followed by the number of FOIA requests received by DFOI to date in that particular calendar year. For examp" }, { "page": 4, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "aintiff\u2019s request has the control number \u201c2021-5683\u201d because it is the 5,683rd FOIA request received by FDA in calendar year 2021. 9. FDA provides expedited pro" }, { "page": 5, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "urse of agency business, and the different components within FDA, the agency\u2019s FOIA program is decentralized. After a FOIA request is received and logged by DFOI" }, { "page": 5, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "nt components within FDA, the agency\u2019s FOIA program is decentralized. After a FOIA request is received and logged by DFOI, the request is assigned to the FDA com" }, { "page": 5, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "sonably likely to possess responsive records, which then process the request. FOIA reviewers within each assigned component process potentially responsive records" }, { "page": 5, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "in full, redacted in part, or withheld in their entirety under any applicable FOIA exemption or other statutory or regulatory provision. FDA\u2019S PUBLICATION OF I" }, { "page": 7, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "est\u201d) seeking, \u201c[a]ll data and information for the Pfizer Vaccine enumerated in 21 C.F.R. \u00a7 601.51(e) with the exception of publicly available reports on the Vaccine Adverse Eve" }, { "page": 7, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "ne to determine which information is available for release to the public under 21 C.F.R. \u00a7 601.51(e). 16. I assigned Plaintiff\u2019s Request to CBER for processing because it sough" }, { "page": 8, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "g, and I determined that Plaintiff did not demonstrate a compelling need under 5 U.S.C. \u00a7 552(a)(6)(E), in substantial part because of the large amounts of information that" }, { "page": 8, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "a request for expedition necessarily works to the direct disadvantage of other FOIA requesters.\u201d U.S. Department of Justice, FOIA Update: OIP Guidance: When to E" }, { "page": 8, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "he direct disadvantage of other FOIA requesters.\u201d U.S. Department of Justice, FOIA Update: OIP Guidance: When to Expedite FOIA Requests, https://www.justice.gov" }, { "page": 8, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ers.\u201d U.S. Department of Justice, FOIA Update: OIP Guidance: When to Expedite FOIA Requests, https://www.justice.gov/oip/blog/foia- update-oip-guidance-when-expe" }, { "page": 10, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "t did here). If Plaintiff\u2019s view became the standard, a great number of FDA\u2019s FOIA requests would qualify for expedited processing, and requesters with non- exped" }, { "page": 11, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "hus, although all disclosure staff will be familiar with general principles of FOIA, staff from different centers will be trained to review information regularly" }, { "page": 12, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "19 pandemic. Since the beginning of this emergency, FDA has been flooded with FOIA requests related to the pandemic. 26. Specifically, in the last fiscal year" }, { "page": 12, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "26. Specifically, in the last fiscal year, FDA received approximately 8,529 FOIA requests, many of which are directly related to COVID-19. Of these, an extrem" }, { "page": 12, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "xpedited process for only 0.017% of requests received. In short, the number of FOIA requests meriting expedited processing has grown exponentially since the begin" }, { "page": 12, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "VID-19 pandemic. 27. Further complicating matters, many of the more recent FOIA requests are more complex and are expected to take longer to process than typi" }, { "page": 12, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "uests are more complex and are expected to take longer to process than typical FOIA requests received prior to the beginning of the COVID-19 pandemic. Many reque" }, { "page": 13, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "originating agency for disclosure determinations. U.S. Department of Justice, FOIA Update: OIP Guidance: Referral and Consultation Procedures, https://www" }, { "page": 13, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "consultations add both time and complication to the process for responding to FOIA requests. 28. Coupled with the unprecedented number of FOIA requests that mer" }, { "page": 13, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "or responding to FOIA requests. 28. Coupled with the unprecedented number of FOIA requests that merit expedited processing and the increased complexity of reque" }, { "page": 13, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "sed complexity of requests, FDA recently experienced a significant increase in FOIA litigation. Between calendar years 2017 and 2019, the number of FOIA lawsuits" }, { "page": 13, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "crease in FOIA litigation. Between calendar years 2017 and 2019, the number of FOIA lawsuits filed against the Agency grew by approximately 70%; between calendar" }, { "page": 13, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "grew by approximately 70%; between calendar years 2018 and 2020, the number of FOIA lawsuits filed against FDA grew by approximately 200%. Although the number of" }, { "page": 13, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "of 83% from 2018 level. Currently, FDA is involved in approximately 34 active FOIA litigations, with nine matters involving COVID-19 records. 29. At the review" }, { "page": 13, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ew and redaction phase, certain FDA components have had to shift some of their FOIA reviewers from responding to FOIA requests in the normal course to almost excl" }, { "page": 13, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "A components have had to shift some of their FOIA reviewers from responding to FOIA requests in the normal course to almost exclusively processing FOIA requests i" }, { "page": 13, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ponding to FOIA requests in the normal course to almost exclusively processing FOIA requests in litigation. This diversion of staff resources to respond to ever i" }, { "page": 13, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "er increasing litigation and impending court deadlines means that fewer initial FOIA requests are being processed, and at a slower pace, which is causing even more" }, { "page": 13, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "and at a slower pace, which is causing even more litigation. 30. In addition to FOIA, FDA also has numerous other document processing obligations, including those a" }, { "page": 13, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "er document processing obligations, including those arising from subpoenas; non-FOIA litigations; oversight requests from Congress; requests and domestic and forei" }, { "page": 14, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "-13- mandates. In some agency offices, the same staff that handles FOIA requests also handles these other disclosure projects as they rely on similar" }, { "page": 14, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": ") 31. As of November 30, 2021, CDER is responsible for processing 855 pending FOIA requests. This is a significant increase in pending requests compared to past" }, { "page": 14, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "years, partly due to increased burden resulting from work related to COVID-19 FOIA requests and other disclosure obligations. CDER is responsible for processing" }, { "page": 14, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "other disclosure obligations. CDER is responsible for processing at least 170 FOIA requests related to COVID- 19. The following chart illustrates the increase in" }, { "page": 14, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "OVID- 19. The following chart illustrates the increase in the length of CDER\u2019s FOIA queue as of November 30 of each calendar year. Figure 1: Pending FOIA Reque" }, { "page": 14, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "DER\u2019s FOIA queue as of November 30 of each calendar year. Figure 1: Pending FOIA Requests in CDER as of November 30 of each year from 2018 to 2021. 1 I do no" }, { "page": 14, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "100 200 300 400 500 600 700 800 900 2017 2018 2019 2020 2021 2022 CDER- Pending FOIA Requests as of Nov. 30 of Each Year App124 Case 4:21-cv-01058-P Document 30" }, { "page": 15, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "-14- 32. In addition to processing FOIA requests, CDER is also responsible for processing other document requests made" }, { "page": 15, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ments; and other federal agencies. Although these requests are not made under FOIA and are not processed in CDER\u2019s FOIA tracks, they are processed by CDER\u2019s FOIA" }, { "page": 15, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "lthough these requests are not made under FOIA and are not processed in CDER\u2019s FOIA tracks, they are processed by CDER\u2019s FOIA reviewers because of the similar nat" }, { "page": 15, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "FOIA and are not processed in CDER\u2019s FOIA tracks, they are processed by CDER\u2019s FOIA reviewers because of the similar nature of the work to FOIA processing and the" }, { "page": 15, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "rocessed by CDER\u2019s FOIA reviewers because of the similar nature of the work to FOIA processing and the need for consistency in reviewing and redacting responses t" }, { "page": 15, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "there was a corresponding decrease in reviewers\u2019 time available to respond to FOIA requests. In recent years, CDER has produced tens of thousands of pages in re" }, { "page": 15, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ice of the Commissioner (\u201cOC\u201d) 33. As of November 30, 2021, OC has 435 pending FOIA requests. At this time, OC has 1 full time employee working on FOIA requests." }, { "page": 15, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "35 pending FOIA requests. At this time, OC has 1 full time employee working on FOIA requests. Since the fall of 2020, OC has brought in detailees for 90 to 120 da" }, { "page": 15, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "l of 2020, OC has brought in detailees for 90 to 120 day periods to assist the FOIA FTE. Despite my other duties, including management of my division, I have bee" }, { "page": 15, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "other duties, including management of my division, I have been assisting with FOIA review for COVID requests in OC, as well as keeping the non-COVID OC FOIA work" }, { "page": 15, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "with FOIA review for COVID requests in OC, as well as keeping the non-COVID OC FOIA workload moving. OC is currently involved in 8 App125 Case 4:21-cv-01058-P" }, { "page": 16, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "past years. The following chart illustrates the increase in the length of OC\u2019s FOIA queue as of November 30 of each calendar year. Figure 2: Pending FOIA Request" }, { "page": 16, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "of OC\u2019s FOIA queue as of November 30 of each calendar year. Figure 2: Pending FOIA Requests in OC as of November 30 of each year from 2018 to 2021. Center for De" }, { "page": 16, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Devices and Radiological Health (\u201cCDRH\u201d) 34. Currently, CDRH has 2,010 pending FOIA requests, approximately 124 of which are related to COVID-19. The following ch" }, { "page": 16, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "are related to COVID-19. The following chart illustrates the length of CDRH\u2019s FOIA queue as of November 30 of each calendar year. Although CDRH\u2019s queue has not c" }, { "page": 16, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "0 100 150 200 250 300 350 400 450 500 2017 2018 2019 2020 2021 2022 OC- Pending FOIA Requests as of Nov. 30 of Each Year App126 Case 4:21-cv-01058-P Document 30" }, { "page": 17, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "-16- Figure 3: Pending FOIA Requests in CDRH as of November 30 of each year from 2018 to 2021. 35. Other t" }, { "page": 17, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "uests in CDRH as of November 30 of each year from 2018 to 2021. 35. Other than FOIA requests, CDRH\u2019s FOIA Office is also responsible for responding to subpoenas an" }, { "page": 17, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "vember 30 of each year from 2018 to 2021. 35. Other than FOIA requests, CDRH\u2019s FOIA Office is also responsible for responding to subpoenas and non-FOIA record requ" }, { "page": 17, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "sts, CDRH\u2019s FOIA Office is also responsible for responding to subpoenas and non-FOIA record requests made by Congress; foreign, state, and local governments; and o" }, { "page": 17, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "there was a corresponding decrease in reviewers\u2019 time available to respond to FOIA requests. Within the past four years alone, CDRH produced tens of thousands of" }, { "page": 17, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "rnarounds for productions that have required CDRH reviewers to stop processing FOIA requests to respond to these subpoenas. Specifically, two of the subpoenas hav" }, { "page": 17, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "related 0 500 1000 1500 2000 2500 2017 2018 2019 2020 2021 2022 CDRH- Pending FOIA Requests as of Nov. 30 of Each Year App127 Case 4:21-cv-01058-P Document 30" }, { "page": 18, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "egulatory Affairs alone has devoted over 1,500 hours to responding to COVID-19 FOIA requests and has seen its number of pending requests increase from 28 in Novem" }, { "page": 18, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "jump from 102 in November 2018 to 318 in November 2021, due to an increase of FOIA requests unrelated to COVID-19. 37. FDA\u2019s Center for Food Safety and Applied N" }, { "page": 18, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "nd Center for Tobacco Products have not encountered the same influx of COVID-19 FOIA requests, so their FOIA queues have remained fairly steady in the 2018-2021 ti" }, { "page": 18, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "oducts have not encountered the same influx of COVID-19 FOIA requests, so their FOIA queues have remained fairly steady in the 2018-2021 timeframe. But they conti" }, { "page": 18, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "re fully consumed with their standard responsibilities, which also include non-FOIA disclosure projects, such as Privacy Act requests. 38. Based on all of the inf" }, { "page": 18, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "e records at issue in this case. EFFORTS TO REDUCE BACKLOGS 39. FDA\u2019s various FOIA offices have taken numerous steps to reduce backlogs and improve processing tim" }, { "page": 18, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "rous steps to reduce backlogs and improve processing time. Specifically, FDA\u2019s FOIA offices are recruiting and hiring new employees where funding allows; proactiv" }, { "page": 18, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "tively posting online frequently requested documents to reduce the need for new FOIA requests; cross-training employees in complex disclosure matters to assist wit" }, { "page": 18, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "to experienced redactors as needed; and, where possible, proactively contacting FOIA requesters to App128 Case 4:21-cv-01058-P Document 30 Filed 12/13/21 Pa" }, { "page": 19, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "cular, since August 2020, CDER has brought on six new employees to assist with FOIA processing. Similarly, CDRH completed a business process improvement review o" }, { "page": 19, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ssing. Similarly, CDRH completed a business process improvement review of its FOIA program in October 2019, which included identifying hiring needs; updating wor" }, { "page": 19, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ows, processes, and procedures; training reviewers; and additional tracking of FOIA requests. Between September and December 2019, CDRH acquired a multi-year con" }, { "page": 19, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "-year contract that currently provides seven contractors to assist in reducing FOIA backlogs and hired additional full-time reviewers to process FOIA requests and" }, { "page": 19, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "in reducing FOIA backlogs and hired additional full-time reviewers to process FOIA requests and other disclosure tasks. Unfortunately, this review was conducted" }, { "page": 19, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Unfortunately, this review was conducted before the onslaught of COVID-related FOIA requests were submitted, and therefore the process changes have not achieved re" }, { "page": 20, "family": "USC", "normalized": "28 U.S.C. \u00a7 1746", "raw": "28 U.S.C. \u00a7 1746", "context": "-19- Pursuant to 28 U.S.C. \u00a7 1746, I declare under the penalty of perjury that the foregoing is true and correct" }, { "page": 35, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21\nC.F.R.\u00a0601.51", "context": "LA/licensure and, thus, publicly available (subject to disclosure review) under 21 C.F.R. 601.51(e). You may already be aware of this, but to make sure we\u2019re on the same page \u2013" }, { "page": 36, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "the material that was not submitted as part of Comirnaty BLA application). The FOIA request, on its face, was for more than just the Comirnaty BLA submitted by Pf" } ] }, { "filename": "031-ORDER-re-FDA-to-Produce-Pfizer-Moderna-12-15-Data-by-June-31-2025-2023-05-09.pdf", "id": 8090, "module": null, "batch_code": null, "company": null, "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/05/031-ORDER-re-FDA-to-Produce-Pfizer-Moderna-12-15-Data-by-June-31-2025-2023-05-09.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/08/031-ORDER-re-FDA-to-Produce-Pfizer-Moderna-12-15-Data-by-June-31-2025-2023-05-09.pdf", "total_pages": 4, "matches": [ { "page": 1, "family": "Court case", "normalized": "Detroit Free Press v. Ashcroft, 303 F.3d 681", "raw": "Detroit Free Press v. Ashcroft, \n303 F.3d 681", "context": "G ADMINISTRATION, Defendant. ORDER \u201cDemocracy dies behind closed doors.\u201d Detroit Free Press v. Ashcroft, 303 F.3d 681 (6th Cir. 2022). To help prevent that from happening, Congress enacted the Fre" }, { "page": 1, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "prevent that from happening, Congress enacted the Freedom of Information Act (\u201cFOIA\u201d). It allows the public access to agency records upon request. But if an agenc" }, { "page": 1, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "der the agency to release the records sought. In this case, Plaintiffs filed a FOIA request for the documents the Food and Drug Administration (\u201cFDA\u201d) relied on t" }, { "page": 1, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "and Medical Professional for Transparency\u2019s (\u201cPHMPT\u201d) second case involving a FOIA request submitted to the FDA for documents related to COVID-19 vaccines. In t" }, { "page": 1, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "r documents related to COVID-19 vaccines. In the first case, PHMPT\u2019s expedited FOIA request sought the documents related to the FDA\u2019s licensing of Pfizer\u2019s COVID-" }, { "page": 1, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": ", at *1 (N.D. Tex. Jan. 6, 2022) (Pittman, J.). Because the FDA denied PHMPT\u2019s FOIA request, PHMPT Case 4:22-cv-00915-P Document 31 Filed 05/09/23 Page 1 o" }, { "page": 2, "family": "Court case", "normalized": "See \nOpen Am. v. Watergate Special Prosecution Force, 547 F.2d 605", "raw": "See \nOpen Am. v. Watergate Special Prosecution Force, 547 F.2d 605", "context": "erally, federal agencies process these requests on a first-in/first-out basis. See Open Am. v. Watergate Special Prosecution Force, 547 F.2d 605, 616 (D.C. Cir. 1976). Sometimes, however, agencies must expedite the process" }, { "page": 2, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "FOIA generally gives citizens the right to access federal agency records. See 5 U.S.C. \u00a7 552. To do so, a person must submit a request to a federal agency describing the r" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "vaccine for adults. As in the first case, the FDA denied Plaintiffs expedited FOIA request, and the Parties have failed to agree on a production schedule. The Co" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ed processing and, if so, an appropriate production schedule. LEGAL STANDARD FOIA generally gives citizens the right to access federal agency records. See 5 U.S" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "8 (D.D.C. 2015). If an agency denies a request for expedited processing under FOIA, the decision is subject to immediate judicial review. \u00a7 552(a)(6)(E)(iii). D" }, { "page": 3, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "3 agency records improperly withheld.\u201d 5 U.S.C. \u00a7 552(a)(4)(B). These determinations are made de novo. See Bloomberg, L.P. v. FDA, 5" }, { "page": 3, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "nces are shown: (1) All safety and effectiveness data and information . . . .\u201d 21 C.F.R. \u00a7 601.51(e). 3 As political theorist Jeremy Bentham once said, \u201c[s]ecrecy, being an i" }, { "page": 4, "family": "Court case", "normalized": "Landmark Legal Found. v. EPA, 910 F. Supp. 2d 270", "raw": "Landmark Legal Found. v. EPA, 910 F. Supp. 2d 270", "context": "\u201cdoes not assign any particular time frame to release of the records sought.\u201d Landmark Legal Found. v. EPA, 910 F. Supp. 2d 270, 275 (D.D.C. 2012). So courts have \u201cbroad discretion\u201d to determine a reasonab" }, { "page": 4, "family": "Court case", "normalized": "Colbert v. FDA, No. 16-1790, 2018 WL 6299966", "raw": "Colbert v. FDA, No. 16-1790, 2018 WL \n6299966", "context": "courts have \u201cbroad discretion\u201d to determine a reasonable processing schedule. Colbert v. FDA, No. 16-1790, 2018 WL 6299966, at *1 (D.D.C. 2014). Defendants propose a production schedule that would take" }, { "page": 4, "family": "Court case", "normalized": "Payne Enters., Inc. v. United States, 837 F.2d 486", "raw": "Payne Enters., Inc. v. United States, 837 \nF.2d 486", "context": "formation sought is timely provided\u2014as \u201cstale information is of little value.\u201d Payne Enters., Inc. v. United States, 837 F.2d 486, 494 (D.C. Cir. 1988). To do so and provide the FDA with as much time as possi" }, { "page": 4, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "n Schedule The Court must next determine the appropriate production schedule. FOIA \u201cdoes not assign any particular time frame to release of the records sought.\u201d" }, { "page": 4, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "while the Court recognizes the limited resources that the FDA has dedicated to FOIA requests, the number of resources an agency dedicates to such requests does no" }, { "page": 4, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ency dedicates to such requests does not dictate the bounds of an individual\u2019s FOIA rights. See Open America, 547 F.2d at 621 (Leventhal, J., concurring). Instead" } ] }, { "filename": "031-REPLY-filed-by-Public-Health-and-Medical-Professionals-for-Transparency-re-22-Brief-Memorandum-in-Support-of-Motion.pdf", "id": 8091, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2021/12/031-REPLY-filed-by-Public-Health-and-Medical-Professionals-for-Transparency-re-22-Brief-Memorandum-in-Support-of-Motion.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2022/03/031-REPLY-filed-by-Public-Health-and-Medical-Professionals-for-Transparency-re-22-Brief-Memorandum-in-Support-of-Motion.pdf", "total_pages": 26, "matches": [ { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": ".................................................................... 6 III. FOIA DEMANDS THE FDA TIMELY PRODUCE THE DOCUMENTS ................... 8 A. FOIA R" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "FOIA DEMANDS THE FDA TIMELY PRODUCE THE DOCUMENTS ................... 8 A. FOIA Requires Productions to Be Made \u201cPromptly\u201d and Expedited Requests Such as the" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "........................................ 16 C. The FDA Failed to Comply with FOIA\u2019s \u201cDue Diligence\u201d Requirement............ 18 CONCLUSION ......................" }, { "page": 3, "family": "Court case", "normalized": "New York Univ. School of Law v. United States Dept. of State, 300 F. Supp. 3d 540", "raw": "New York Univ. School of Law v. United States Dept. of State, \n 300 F. Supp. 3d 540", "context": "Page iii TABLE OF AUTHORITIES Cases Brennan Ctr. for Justice at New York Univ. School of Law v. United States Dept. of State, 300 F. Supp. 3d 540 (S.D.N.Y. 2018)................................................................" }, { "page": 3, "family": "Court case", "normalized": "Elec. Privacy Info. Ctr. v. Dept. of Justice, 416 F. Supp. 2d 30", "raw": "Elec. Privacy Info. Ctr. v. Dept. of Justice, \n 416 F. Supp. 2d 30", "context": "539613 (D.D.C. Dec. 3, 2002) ............................................ 11 Elec. Privacy Info. Ctr. v. Dept. of Justice, 416 F. Supp. 2d 30 (D.D.C. 2006) ................................................................." }, { "page": 3, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": ".......................................................................... 5 5 U.S.C. \u00a7 552 (a)(6)(E)(iii)................................................................." }, { "page": 3, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "...................................................................... 8, 11 5 U.S.C. \u00a7 552 (a)(6)(E)(v) .................................................................." }, { "page": 3, "family": "CFR", "normalized": "21 CFR 20.63", "raw": "21 C.F.R \u00a7 20.63", "context": ".......................................................... 9, 16 Statutes 21 C.F.R \u00a7 20.63(b) ............................................................................" }, { "page": 3, "family": "CFR", "normalized": "21 CFR 20.44", "raw": "21 C.F.R. \u00a7 20.44", "context": "..................................................................... 16, 17 21 C.F.R. \u00a7 20.44 (c)(2)-(3) ...................................................................." }, { "page": 3, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": ".......................................................................... 9 21 C.F.R. \u00a7 601.51 (d)(2) ........................................................................" }, { "page": 3, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": ".......................................................................... 7 21 C.F.R. \u00a7 601.51(e)............................................................................." }, { "page": 3, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "................................................................ 5, 6, 7, 19 21 C.F.R. \u00a7 601.51(e)............................................................................." }, { "page": 4, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "Page iv 5 U.S.C. \u00a7 552(a)(3) ........................................................................." }, { "page": 4, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": ".......................................................................... 8 5 U.S.C. \u00a7 552(a)(6)(C) ......................................................................" }, { "page": 5, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "es down to one thing, and one thing alone: it has not sufficiently staffed its FOIA office to properly meet its legal obligations to respond to the requests it re" }, { "page": 5, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "meet its legal obligations to respond to the requests it receives. In passing FOIA, Congress made the policy decision that it wanted to ensure Case 4:21-cv-01058" }, { "page": 6, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "he FDA is not permitted to thwart Congress\u2019 policy choice by understaffing its FOIA response office. Numerous cases show how other agencies, when dealing with a" }, { "page": 6, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ations. Here, for the reasons explained in PHMPT\u2019s opening brief, the instant FOIA request is the prime example of one that requires expedited processing, and as" }, { "page": 6, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "reviewing for only personally identifiable information and trade secrets under FOIA, assuming a low average of 50 pages per hour per person, even to review the hu" }, { "page": 7, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "for transparency until almost everyone alive today is dead makes a mockery of FOIA and of the promise of transparency. Showing just how misguided the FDA is in i" }, { "page": 7, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "held from disclosure in a timely manner. This is not a novel concept as other FOIA matters have been resolved in this manner wherein the FDA has adopted redaction" }, { "page": 8, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "xclusion from civil society. The FDA also says it is unfair to other pending FOIA requesters to prioritize this request. First, since this request qualifies fo" }, { "page": 8, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "he FDA for choosing, even now during a pandemic, to only have 10 people in its FOIA office (only 8 of whom with experience) despite a budget of over $6.5 billion" }, { "page": 8, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "6.5 billion and over 18,000 employees. Regardless of whether the FDA has made FOIA or transparency a priority, it is an obligation imposed by law and one that mu" }, { "page": 8, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "THE FULL REQUEST The FDA initially disclosed that responding to the instant FOIA request would involve producing 329,000+ pages. As stated in PHMPT\u2019s opening" }, { "page": 9, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "sed on the initial, plainly worded request seeking all documents enumerated in 21 C.F.R. \u00a7 601.51(e). However, the FDA has so far refused to provide a more precise count of th" }, { "page": 9, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "equest is overly broad \u2013 despite it asking for precisely what is enumerated in 21 C.F.R. \u00a7 601.51(e), nothing more. In fact, Plaintiff excluded from the documents any of those" }, { "page": 10, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "e \u201cthe biological product file \u2026 immediately available for public disclosure.\u201d 21 C.F.R. \u00a7 601.51(e). The FDA obviously adopted this regulation when it still believed in trans" }, { "page": 11, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "ge of the regulation itself. The request here seeks the information listed in 21 C.F.R. \u00a7 601.51(e). Directly above section (e) is another section that concerns obtaining doc" }, { "page": 11, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "formation shall submit a request under the Freedom of Information Act [FOIA].\u201d 21 C.F.R. \u00a7 601.51 (d)(2). In stark contrast, paragraph (e) says nothing about a member of the p" }, { "page": 11, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \n\u00a7 601.51", "context": "ns. Hence, this again further makes plain that the disclosure obligation under 21 C.F.R. \u00a7 601.51(e) is separate and apart from FOIA. The Court should, therefore, respectfull" }, { "page": 11, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "ately disclose\u201d all the information required to be immediately disclosed under 21 C.F.R. \u00a7 601.51(e). Case 4:21-cv-01058-P Document 31 Filed 12/13/21 Page 11 of 26 Pa" }, { "page": 11, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "this information shall submit a request under the Freedom of Information Act [FOIA].\u201d 21 C.F.R. \u00a7 601.51 (d)(2). In stark contrast, paragraph (e) says nothing a" }, { "page": 11, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ast, paragraph (e) says nothing about a member of the public needing to make a FOIA request. Rather, it enumerates that the information that must be made \u201cimmedi" }, { "page": 11, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "fference reflects that paragraph (e) obligates the FDA, separate and apart from FOIA, to make those documents (i.e., the documents sought in the current request) \u201c" }, { "page": 11, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": ".\u201d If section (e) was not intending to create a right separate and apart from FOIA, there is no need for these redundant redaction obligations. Hence, this agai" }, { "page": 11, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "e disclosure obligation under 21 C.F.R. \u00a7 601.51(e) is separate and apart from FOIA. The Court should, therefore, respectfully require the FDA to abide by its o" }, { "page": 12, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "cessing, it is to be produced at even greater haste \u201cas soon as practicable.\u201d 5 U.S.C. \u00a7 552(a)(3), 5 U.S.C. \u00a7 552 (a)(6)(E)(iii) (emphasis added). Congress made plain in" }, { "page": 12, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \n\u00a7 552", "context": "produced at even greater haste \u201cas soon as practicable.\u201d 5 U.S.C. \u00a7 552(a)(3), 5 U.S.C. \u00a7 552 (a)(6)(E)(iii) (emphasis added). Congress made plain in FOIA that when there i" }, { "page": 12, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Page 8 III. FOIA DEMANDS THE FDA TIMELY PRODUCE THE DOCUMENTS The FDA also has a separate duty" }, { "page": 12, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "TS The FDA also has a separate duty to disclose the documents requested under FOIA. A. FOIA REQUIRES PRODUCTIONS TO BE MADE \u201cPROMPTLY\u201d AND EXPEDITED REQUESTS" }, { "page": 12, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "also has a separate duty to disclose the documents requested under FOIA. A. FOIA REQUIRES PRODUCTIONS TO BE MADE \u201cPROMPTLY\u201d AND EXPEDITED REQUESTS SUCH AS THE" }, { "page": 12, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "e to abide by the statutory requirements to redact any information required by FOIA. That it must safeguard Pfizer\u2019s trade secrets by conducting a line-by-line," }, { "page": 12, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "cades because no shortcuts can be taken. That it must exactingly abide by the FOIA\u2019s redaction requirements. Taking the FDA at its word that the FOIA obligation" }, { "page": 12, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ide by the FOIA\u2019s redaction requirements. Taking the FDA at its word that the FOIA obligations must be strictly followed, the FDA must also give as much or more" }, { "page": 12, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "he FDA must also give as much or more gravity to the primary requirement under FOIA \u2013 that it \u201cshall make the records promptly available to any person\u201d and that," }, { "page": 12, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "a)(3), 5 U.S.C. \u00a7 552 (a)(6)(E)(iii) (emphasis added). Congress made plain in FOIA that when there is an \u201curgency to inform the public concerning actual or alleg" }, { "page": 13, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "est that Congress had in mind for expedited processing under the FOIA statue. 5 U.S.C. \u00a7 552 (a)(6)(E)(v); 21 C.F.R. \u00a7 20.44 (c)(2)-(3). PHMPT is unquestionably an organi" }, { "page": 13, "family": "CFR", "normalized": "21 CFR 20.44", "raw": "21 C.F.R. \u00a7 20.44", "context": "for expedited processing under the FOIA statue. 5 U.S.C. \u00a7 552 (a)(6)(E)(v); 21 C.F.R. \u00a7 20.44 (c)(2)-(3). PHMPT is unquestionably an organization engaged in the disseminat" }, { "page": 13, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "dibly, the FDA justifies asking for decades to produce documents by noting that FOIA does not have \u201ca specific timeframe for the release of records.\u201d (Dkt. No. 22" }, { "page": 13, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "anding of the word \u201cpromptly\u201d and \u201cas soon as practicable,\u201d and the purpose of FOIA, courts have made clear that, \u201cCongress recognized that delay in complying wit" }, { "page": 13, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "courts have made clear that, \u201cCongress recognized that delay in complying with FOIA requests is \u2018tantamount to denial.\u2019\u201d Elec. Privacy Info. Ctr. v. Dept. of Justi" }, { "page": 13, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": ". Likewise, the D.C. Circuit, the circuit with the most experience concerning FOIA, has \u201cacknowledged that \u2018stale information is of little value.\u2019\u201d Id. (quoting" }, { "page": 13, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "s, 837 F.2d 486, 494 (D.C. Cir. 1988)). That is why \u201c[t]he 1996 amendments to FOIA creating the statutory right to expedition in certain cases \u2018underlined Congre" }, { "page": 13, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "r. 2005)). As shown in PHMPT\u2019s complaint and in its opening brief, its instant FOIA request is exactly the type of request that Congress had in mind for expedited" }, { "page": 13, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "he type of request that Congress had in mind for expedited processing under the FOIA statue. 5 U.S.C. \u00a7 552 (a)(6)(E)(v); 21 C.F.R. \u00a7 20.44 (c)(2)-(3). PHMPT is" }, { "page": 13, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": ". 14.) The FDA has not challenged this fact. All the documents sought in the FOIA request are urgently needed to allow independent scientists to review the FDA\u2019" }, { "page": 14, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "rce, 498 F. Supp. 3d 87, 97 (D.D.C. 2020) (requiring expedited processing of a FOIA request because the 2020 Census had generated substantial media attention and" }, { "page": 14, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "annot satisfy Congress\u2019 expedited processing requirements solely by giving the FOIA request prompt administrative attention, or by giving priority to only the firs" }, { "page": 15, "family": "Court case", "normalized": "New York Univ. School of Law v. United States Dept. of State, 300 F. Supp. 3d 540", "raw": "New York Univ. School of Law v. \nUnited States Dept. of State, 300 F. Supp. 3d 540", "context": "over processing other non-expedited FOIA cases.\u201d Brennan Ctr. for Justice at New York Univ. School of Law v. United States Dept. of State, 300 F. Supp. 3d 540, 549 (S.D.N.Y. 2018); Brennan Ctr., 498 F. Supp. 3d at 100-01 (stating that be" }, { "page": 15, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "statutory obligation to \u201cprocess\u201d the FOIA request \u201cas soon as practicable.\u201d 5 U.S.C. \u00a7 552 (a)(6)(E)(iii). Absent from the FDA\u2019s arguments is any acknowledgement of the" }, { "page": 15, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ts over the course of 75 years meets its statutory obligation to \u201cprocess\u201d the FOIA request \u201cas soon as practicable.\u201d 5 U.S.C. \u00a7 552 (a)(6)(E)(iii). Absent from" }, { "page": 15, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "take decades to process PHMPT\u2019s request because it received 329 other pending FOIA requests before PHMPT\u2019s request. (Dkt. No. 22 p. 11.) This is a specious cla" }, { "page": 15, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": ". No. 22 p. 11.) This is a specious claim given that, \u201c[p]rocessing expedited FOIA cases takes precedence over processing other non-expedited FOIA cases.\u201d Brenn" }, { "page": 15, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "sing expedited FOIA cases takes precedence over processing other non-expedited FOIA cases.\u201d Brennan Ctr. for Justice at New York Univ. School of Law v. United St" }, { "page": 15, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "39613, at *2 (D.D.C. Dec. 3, 2002) (same). Simply put, the \u201chardship on other FOIA requesters is not a bar to relief\u201d where the Court finds that expedited proces" }, { "page": 16, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Page 12 Pub. Integrity, 411 F. Supp. 3d at 14 (noting that FOIA requests often overlap and that processing of documents for one FOIA requests" }, { "page": 16, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ting that FOIA requests often overlap and that processing of documents for one FOIA requests will assist in responding to other similar requests). Moreover, the F" }, { "page": 16, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Info. Ctr. v Dept. of Justice, 416 F. Supp. 2d at 37). The obligations under FOIA must be honored and hence, the FDA should review for information that needs re" }, { "page": 16, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": ". 28, 2021) (noting that ICE had diverted resources and re-assigned 30% of its FOIA staff to first line review, and then 10-15 attorneys to spend half of every wo" }, { "page": 19, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "tion when reviewing for far more than just the disclosure exemptions listed in FOIA, but also for relevance, responsiveness, privilege, hot documents, trade secre" }, { "page": 19, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "eviewed for this far more complex and involved review than the one required by FOIA, which here the Defendant submits only requires reviewing for trade secrets an" }, { "page": 19, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "35 \u00b6 14.) At bottom, the FDA does not treat its transparency obligations under FOIA to produce \u201cas soon as practicable\u201d as an actual statutory requirement. It in" }, { "page": 20, "family": "CFR", "normalized": "21 CFR 20.63", "raw": "21 C.F.R \u00a7 20.63", "context": "er before submission because that is what is required by the FDA regulations. 21 C.F.R \u00a7 20.63(b). (\u201cThe names and other information which would identify patients or researc" }, { "page": 20, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "elays in disclosing non-exempt documents violate the intent and purpose of the FOIA, and the courts have a duty to prevent these abuses.\u2019\u201d (quoting Long v U.S. I.R" }, { "page": 21, "family": "CFR", "normalized": "21 CFR 20.63", "raw": "21 C.F.R \u00a7 20.63", "context": "ubmitting its documents or seek redactions in a \u201creasonable time thereafter.\u201d 21 C.F.R \u00a7 20.63(b). (\u201cA person who submits records to the Government may designate part or all" }, { "page": 21, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "for this product. One of the ingredients was redacted. Our firm submitted a FOIA request on behalf of a client to have that redaction lifted. (App000635 \u00b6 15.)" }, { "page": 22, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "exist for not being able to otherwise comply with statutory time frames. See 5 U.S.C. \u00a7 552(a)(6)(C). Here, the FDA has failed to show due diligence. Despite more than" }, { "page": 22, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "burden at Pfizer\u2019s feet to object to same. C. THE FDA FAILED TO COMPLY WITH FOIA\u2019S \u201cDUE DILIGENCE\u201d REQUIREMENT An agency must show due diligence in responding" }, { "page": 22, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "show due diligence. Despite more than three months elapsing since Plaintiff\u2019s FOIA request was made, more than two months of communication through the parties\u2019 c" }, { "page": 23, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "its obligations to make \u201cimmediately available\u201d the requested documents under 21 C.F.R. \u00a7 601.51(e) as well as the entire purpose of FOIA \u2013 transparency \u2013 and its obligation t" }, { "page": 23, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "quested documents under 21 C.F.R. \u00a7 601.51(e) as well as the entire purpose of FOIA \u2013 transparency \u2013 and its obligation to produce requested documents \u201cas soon as" }, { "page": 24, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "zer\u2019s documents which is what Plaintiff seeks to review. The whole purpose of FOIA and expedited treatment is to review government conduct. True to form, and d" }, { "page": 24, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "there are two things the FDA is certain about: it is certain it can ignore the FOIA obligation to produce these documents \u201cas soon as practicable\u201d and it is certa" }, { "page": 25, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "he importance of timely production, the obligation to \u201cpromptly\u201d produce under FOIA to assure transparency, and the regulation calling for these documents to be \u201c" }, { "page": 25, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Court should order the FDA to produce all documents responsive to the PHMPT\u2019s FOIA Request on or before March 3, 2022, which is 108 days from the parties Second" } ] }, { "filename": "032-Appendix-in-Support-filed-by-Public-Health-and-Medical-Professionals-for-Transparency-re-31-Reply.pdf", "id": 8092, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2021/12/032-Appendix-in-Support-filed-by-Public-Health-and-Medical-Professionals-for-Transparency-re-31-Reply.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2022/03/032-Appendix-in-Support-filed-by-Public-Health-and-Medical-Professionals-for-Transparency-re-31-Reply.pdf", "total_pages": 150, "matches": [ { "page": 6, "family": "USC", "normalized": "28 U.S.C. \u00a7 1746", "raw": "28 U.S.C. \u00a7 1746", "context": "02/pfizer-raises-covid-vaccine-sales-forecast-to-36-billion-.html. Pursuant to 28 U.S.C. \u00a7 1746, I declare under penalty of perjury under the laws of the United States of Ame" }, { "page": 6, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "attached hereto, is a true and correct copy of a Freedom of Information Act (\u201cFOIA\u201d) request submitted by my firm to the FDA on September 14, 2021. 16. Exhibit" }, { "page": 6, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "t copy of the FDA\u2019s response letter and the production made in response to the FOIA request attached hereto as Exhibit 14. 17. Exhibit 16, attached hereto, is a" }, { "page": 9, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "e know why they think their timing is reasonable, though I would point out that FOIA processing to ensure no exempt information is released is entirely different f" }, { "page": 11, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "formation in SAS files. FDA does not usually produce SAS files in response to FOIA requests, so FDA does not know if it may experience any App000640 Case 4:21-cv" }, { "page": 13, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "vide you an update on FDA\u2019s initial assessment of records responsive to PHMPT\u2019s FOIA request. In terms of volume, FDA has determined that the original Cominarty" }, { "page": 14, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "publicly released on any website. We are, of course, happy to narrow PHMPT\u2019s FOIA request, but we want to ensure that the parties are in agreement on which reco" }, { "page": 14, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "that PHMPT provide a list of BLA sections that they wish to exclude from their FOIA request because they have obtained those sections from other sources. With r" }, { "page": 14, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "the order and state that we don\u2019t believe certain sections are applicable to a FOIA case. This will also allow us to set forth different views on different issue" }, { "page": 25, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "the material that was not submitted as part of Comirnaty BLA application). The FOIA request, on its face, was for more than just the Comirnaty BLA submitted by Pfi" }, { "page": 33, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 \nC.F.R. 601.51", "context": "LA/licensure and, thus, publicly available (subject to disclosure review) under 21 C.F.R. 601.51(e). You may already be aware of this, but to make sure we\u2019re on the same pag" }, { "page": 34, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "the material that was not submitted as part of Comirnaty BLA application). The FOIA request, on its face, was for more than just the Comirnaty BLA submitted by Pf" }, { "page": 49, "family": "Named act", "normalized": "FD&C Act", "raw": "Federal Food, Drug, and Cosmetic Act", "context": "rates-for-fiscal-year-2022) in the Federal Register for fees assessed under the Federal Food, Drug, and Cosmetic Act. These fees apply to the period from October 1, 2021, through September 30, 202" }, { "page": 51, "family": "Named act", "normalized": "FD&C Act", "raw": "Federal Food, Drug,\nand Cosmetic Act", "context": "an application for approval of a new drug submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), or licensure of certain biological products under section 351(a) of" }, { "page": 51, "family": "Named act", "normalized": "FD&C Act", "raw": "FD&C Act", "context": "rug submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), or licensure of certain biological products under section 351(a) of the Publi" }, { "page": 51, "family": "Named act", "normalized": "PHS Act", "raw": "Public Health\nService Act", "context": "C Act), or licensure of certain biological products under section 351(a) of the Public Health Service Act (PHS Act). What are application fees? Each person that submits a human drug app" }, { "page": 51, "family": "Named act", "normalized": "PHS Act", "raw": "PHS Act", "context": "tain biological products under section 351(a) of the Public Health Service Act (PHS Act). What are application fees? Each person that submits a human drug application" }, { "page": 52, "family": "Named act", "normalized": "FD&C Act", "raw": "FD&C\u00a0Act", "context": "designated as a drug for a rare disease or condition, under section 526 of the FD&C Act, is not subject to an application fee unless the application includes an indica" }, { "page": 52, "family": "Named act", "normalized": "FD&C Act", "raw": "FD&C Act", "context": "ved and which may be dispensed only by prescription under section 503(b) of the FD&C Act, and is also on the list of \u2022 0 0 0 \u2022 App000681 Case 4:21-cv-01058-P Doc" }, { "page": 53, "family": "Named act", "normalized": "PHS Act", "raw": "Public Health Service Act", "context": "ary of products approved under human drug applications under section 351 of the Public Health Service Act. Are there drugs that are not included in the term prescription drug product? Y" }, { "page": 53, "family": "Named act", "normalized": "PHS Act", "raw": "PHS Act", "context": "t, or an in vitro diagnostic biologic product licensed under section 351 of the PHS Act, A biological product that is licensed for further manufacturing use only, A dr" }, { "page": 53, "family": "Named act", "normalized": "FD&C Act", "raw": "FD&C Act", "context": "was approved under an application filed under sections 505(b) or 505(j) of the FD&C Act, is not in the list of discontinued products compiled under section 505(j)(7) o" }, { "page": 53, "family": "Named act", "normalized": "FD&C Act", "raw": "FD&C Act", "context": "ot in the list of discontinued products compiled under section 505(j)(7) of the FD&C Act. For more information about program fees, please read FDA\u2019s guidance for indu" }, { "page": 56, "family": "Named act", "normalized": "FD&C Act", "raw": "FD&C Act", "context": "ns, and Refunds Are there any waivers of user fees? Under section 736(d) of the FD&C Act, a waiver may be granted for one or more fees where: a waiver or reduction is n" }, { "page": 70, "family": "Named act", "normalized": "FD&C Act", "raw": "FD&C Act", "context": "ation of emergency use of the medical product under Section 564 (b) (1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. Please s" }, { "page": 109, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "o inform the public concerning actual or alleged Federal Government activity.\u201d 5 U.S.C. \u00a7 552(a)(6)(E)(v)(II). Specifically, ICAN\u2019s mission is to raise public awareness abo" }, { "page": 110, "family": "USC", "normalized": "21 U.S.C. \u00a7 393", "raw": "21 \nU.S.C. \u00a7 393", "context": "e a product if its sponsor has proven it to be \u201csafe and effective.\u201d See, e.g., 21 U.S.C. \u00a7 393. The FDA claims that it is committed to \u201copen[ing] the doors of the agency." }, { "page": 115, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "ge and belief. We ask that you waive any and all fees or charges pursuant to 5 U.S.C. \u00a7 552 (a)(4)(A)(iii). ICAN is a not-for-profit 501(c)(3) organization whose mission" }, { "page": 115, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "and through press events and releases. ICAN is seeking the information in this FOIA request to allow it to contribute to the public understanding of the governmen" }, { "page": 115, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "esting will not contribute to any commercial activities. Please note that the FOIA provides that if only portions of a requested file are exempted from release," }, { "page": 117, "family": "USC", "normalized": "5 U.S.C. \u00a7 522", "raw": "5 U.S.C. \u00a7 522", "context": "ions to Table 2. We have withheld portions of pages under Exemption (b)(4), 5 U.S.C. \u00a7 522(b)(4). That exemption permits the withholding of trade secrets and commercial" }, { "page": 117, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ppeal this determination. By filing an appeal, you preserve your rights under FOIA and give the agency a chance to review and reconsider your request and the age" }, { "page": 118, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "6 Main Phone: 240-402-7800 You may also contact the FDA FOIA Public Liaison for assistance at: Office of the Executive Secretariat US F" }, { "page": 118, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "lle, MD 20857 E-mail: FDAFOIA@fda.hhs.gov If you are unable to resolve your FOIA dispute through our FOIA Public Liaison, the Office of Government Information" }, { "page": 118, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "AFOIA@fda.hhs.gov If you are unable to resolve your FOIA dispute through our FOIA Public Liaison, the Office of Government Information Services (OGIS), the Fede" }, { "page": 118, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "lic Liaison, the Office of Government Information Services (OGIS), the Federal FOIA Ombudsman\u2019s office, offers mediation services to help resolve disputes between" }, { "page": 118, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Ombudsman\u2019s office, offers mediation services to help resolve disputes between FOIA requesters and Federal agencies. The contact information for OGIS is: Offic" }, { "page": 128, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "ponents\" and ICE stated they would \"be produced 8 Id. 9 See id. at 5. See also 5 U.S.C. \u00a7 552(a)(6)(A)(i). 10 See generally Compl. 11 Id. at 2-3. 12 \"Transcript of Bench Tri" }, { "page": 128, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "a request for information to ICE pursuant to the Freedom of Information Act (\"FOIA\"), 5 U.S.C. \u00a7\u00a7 552 et seq.7 It 1 \"Findings of Fact and Conclusions of Law\" 3," }, { "page": 128, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ntiff's Original Complaint\" (\"Compl.\") 2 \u00b6 6, ECF No. 1, filed Aug. 22, 2019; \"FOIA Request,\" Ex. 1. See also Plaintiff's Opposed Application for Attorney Fees an" }, { "page": 128, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "to compel production on August 22, 2019.10 Toni Fuentes (\"Fuentes\"), a Deputy FOIA Officer for ICE, was immediately responsible for supervising ICE responses to" }, { "page": 128, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "iately responsible for supervising ICE responses to requests for records under FOIA.11 Due to an ICE administrative error, ICE did not become aware of DMRS's FOI" }, { "page": 128, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "OIA.11 Due to an ICE administrative error, ICE did not become aware of DMRS's FOIA request until after the initiation of this lawsuit.12 Fuentes assisted in loca" }, { "page": 128, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "il after the initiation of this lawsuit.12 Fuentes assisted in locating DMRS's FOIA request, at which time she assigned the request to the litigation team of the" }, { "page": 128, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "uest, at which time she assigned the request to the litigation team of the ICE FOIA Office for expedited processing of the request.13 Approximately four-and-a-hal" }, { "page": 129, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 \nU.S.C. \u00a7 552", "context": "3, filed Nov. 16, 2020. 19 Findings of Fact and Conclusions of Law 2. See also 5 U.S.C. \u00a7 552(a)(6)(A)(i) (providing a twenty-day deadline, excluding weekends and holidays" }, { "page": 129, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 \n552", "context": "ted to uncover responsive records; and 2) whether [*5] redactions pursuant to 5 U.S.C. \u00a7 552(b)(5) (\"exemption (b)(5)\") to the thirty-three pages produced June 25, 2020" }, { "page": 129, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "aintiff filed suit and almost eleven months after Plaintiff sent its original FOIA request, ICE forwarded the pages requiring consultation to other agencies for" }, { "page": 129, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "enty-day deadline, excluding weekends and holidays for agencies to respond to FOIA requests). 20 \"Plaintiff's Reply to Defendant's Response to Plaintiff's B. Tri" }, { "page": 130, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Page 4 of 17 FOIA requests.24 \u2022 Each program office within ICE has its own guidelines for reco" }, { "page": 130, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "It also ordered ICE to conduct a new search for documents responsive to DMRS's FOIA request by November 2, 2020.36 C. Post-Trial On November 2, 2020, the deadline" }, { "page": 131, "family": "Court case", "normalized": "Dec. 1, 2020.\n48 See Arizona v. California, 460 U.S. 605, 618, 103 S. Ct. 1382", "raw": "Dec. 1, 2020.\n48 See Arizona v. California, 460 U.S. 605, 618, 103 S. Ct. \n1382", "context": "ally \"Order Granting Second Motion for Extension of Time,\" ECF No. 71, entered Dec. 1, 2020. 48 See Arizona v. California, 460 U.S. 605, 618, 103 S. Ct. 1382, 75 L. Ed. 2d 318 (1983) (The law-of-the-case doctrine \"posits that when a cou" }, { "page": 131, "family": "Court case", "normalized": "See also Ashe v. Swenson, 397 U.S. 436, 443, 90 S. Ct. 1189", "raw": "See also Ashe v. \nSwenson, 397 U.S. 436, 443, 90 S. Ct. 1189", "context": "uld continue to govern the same issue in subsequent stages in the same case.\") See also Ashe v. Swenson, 397 U.S. 436, 443, 90 S. Ct. 1189, 25 L. Ed. 2d 469 (1970) (The collateral estoppel doctrine stands for the prin" }, { "page": 131, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ially responsive documents remained.42 ICE then assigned thirty percent of its FOIA staff to conduct first-line review full-time.43 Ten to fifteen attorneys woul" }, { "page": 131, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "w are now the law of the case. ICE cannot contest either.48 II. LEGAL STANDARD FOIA states \"[t]he court may assess against the United 42 Id. at \u00b6 11. 43 Id. at \u00b6" }, { "page": 132, "family": "Court case", "normalized": "Batton v. IRS, 718 F.3d 522", "raw": "Batton v. IRS, 718 F.3d 522", "context": "easonable.\"53 An award of attorneys' fees is 49 5 U.S.C. \u00a7 552(a)(4)(E)(i). 50 Batton v. IRS, 718 F.3d 522, 525 (5th Cir. 2013) (emphasis in original). 51 5 USC \u00a7 552(a)(4)(E)(ii); Batt" }, { "page": 132, "family": "Court case", "normalized": "F.3d at 525.\n52 Texas v. ICC, 935 F.2d 728", "raw": "F.3d at 525.\n52 Texas v. ICC, 935 F.2d 728", "context": "th Cir. 2013) (emphasis in original). 51 5 USC \u00a7 552(a)(4)(E)(ii); Batton, 718 F.3d at 525. 52 Texas v. ICC, 935 F.2d 728, 730 (5th Cir. 1991). 53 Cazalas v. Dep't of Justice, 709 F.2d 1051, 1057 (5th" }, { "page": 132, "family": "Court case", "normalized": "Cazalas v. Dep't of Justice, 709 F.2d 1051", "raw": "Cazalas v. Dep't of Justice, 709 F.2d 1051", "context": "Batton, 718 F.3d at 525. 52 Texas v. ICC, 935 F.2d 728, 730 (5th Cir. 1991). 53 Cazalas v. Dep't of Justice, 709 F.2d 1051, 1057 (5th Cir. 1983). particularly appropriate where \"'government officials" }, { "page": 132, "family": "Court case", "normalized": "F.3d at 525.\n56 NLRB v. Robbins Tire & Rubber Co., 437 U.S. 214", "raw": "F.3d at 525.\n56 NLRB v. Robbins Tire & Rubber Co., 437 U.S. 214", "context": "ainant has obtained relief through . . . a judicial order . . .\"); Batton, 718 F.3d at 525. 56 NLRB v. Robbins Tire & Rubber Co., 437 U.S. 214, 242, 98 S. Ct. 2311, 57 L. Ed. 2d 159 (1978). 2021 U.S. Dist. LEXIS 16469, *9" }, { "page": 132, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "t where such opposition is unreasonable.\"53 An award of attorneys' fees is 49 5 U.S.C. \u00a7 552(a)(4)(E)(i). 50 Batton v. IRS, 718 F.3d 522, 525 (5th Cir. 2013) (emphasis in" }, { "page": 132, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 USC \u00a7 552", "context": "50 Batton v. IRS, 718 F.3d 522, 525 (5th Cir. 2013) (emphasis in original). 51 5 USC \u00a7 552(a)(4)(E)(ii); Batton, 718 F.3d at 525. 52 Texas v. ICC, 935 F.2d 728, 730 (5th" }, { "page": 132, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 USC \u00a7 552", "context": "ns may use in 54 Id. at 1054 (quoting S.Rep. No. 93-854, at 19 (1974)). 55 See 5 USC \u00a7 552(a)(4)(E)(ii)(I) (\"a complainant has substantially prevailed if the complainant" }, { "page": 132, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "rts to conduct analysis through the lens of the three fundamental purposes of FOIA's legal fee provision. The provision is designed: (1) \"as an incentive for pri" }, { "page": 132, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ed in this action definitively establishes DMRS substantially prevailed in its FOIA action as this court granted all of the requested relief.55 This is not conte" }, { "page": 132, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ight of the circumstances of the case and the [*11] essential purposes of the FOIA legal fee provision. 1. The Benefit to the Public Deriving from the Case \"The" }, { "page": 132, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "sion. 1. The Benefit to the Public Deriving from the Case \"The basic purpose of FOIA is to ensure an informed citizenry, vital to the functioning of a democratic s" }, { "page": 132, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "able to the governed.\"56 Viewing the public benefit factor through the lens of FOIA's high- minded central purpose, attorneys fees are more appropriate \"where the" }, { "page": 133, "family": "Court case", "normalized": "Blue v. Bureau of Prisons, 570 F.2d 529", "raw": "Blue v. Bureau of Prisons, 570 F.2d 529", "context": "esponsive documents would provide valuable insight into the execution of a 57 Blue v. Bureau of Prisons, 570 F.2d 529, 534 (5th Cir. 1978). 58 Id. at 533. 59 Mot. 5. 60 Mot., \"Declaration of Melis" }, { "page": 133, "family": "Court case", "normalized": "Cazalas v. Dep't of Justice, 709 F.2d 1051", "raw": "Cazalas v. Dep't of Justice, 709 F.2d 1051", "context": "14] would make the information sought \"old news,\" no longer in the public 61 Cazalas v. Dep't of Justice, 709 F.2d 1051, 1054 (5th Cir. 1983) (quoting S.Rep. No. 93-854, at 19 (1974)). 2021 U.S. Dis" }, { "page": 133, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "es for asylum seekers fleeing persecution. The documents responsive to DMRS's FOIA request are very likely to be of significant consequence to the large numbers" }, { "page": 133, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "rch, lack of effective and comprehensive procedures for adequately processing FOIA requests, and repeated requests for extensions of deadlines. ICE's ineptitude" }, { "page": 133, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "or. To do so would make a mockery of the accountability principles underlying FOIA. ICE's handling of this FOIA request is precisely encompassed in the Fifth Cir" }, { "page": 133, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ckery of the accountability principles underlying FOIA. ICE's handling of this FOIA request is precisely encompassed in the Fifth Circuit's holding that attorney" }, { "page": 133, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "valid claim or have been otherwise engaged in obdurate behavior.'\"61 Potential FOIA complainants must be incentivized to pursue meritorious claims without fear t" }, { "page": 134, "family": "Court case", "normalized": "Responsive records \n62 Id.\n63 Blue v. Bureau of Prisons, 570 F.2d 529", "raw": "Responsive records \n62 Id.\n63 Blue v. Bureau of Prisons, 570 F.2d 529", "context": "he public interest in the administration of justice in the immigration system. Responsive records 62 Id. 63 Blue v. Bureau of Prisons, 570 F.2d 529, 533-34 (5th Cir. 1978). 64 Id. at 534 65 Id. (citing S.Rep. No. 854, 93d Cong" }, { "page": 134, "family": "Court case", "normalized": "Cooper Cameron Corp. v. U.S. Dep't of Labor, OSHA, 280 F.3d 539", "raw": "Cooper Cameron Corp. v. U.S. Dep't of Labor, OSHA, 280 \nF.3d 539", "context": "xists to support the adequacy of its search for 66 5 U.S.C. \u00a7 552(a)(3)(A). 67 Cooper Cameron Corp. v. U.S. Dep't of Labor, OSHA, 280 F.3d 539, 543 (5th Cir. 2002). 68 5 U.S.C. \u00a7 552(a)(4)(B); Batton v. Evers, 598 F.3d 169" }, { "page": 134, "family": "Court case", "normalized": "Batton v. Evers, 598 F.3d 169", "raw": "Batton v. Evers, 598 F.3d 169", "context": "of Labor, OSHA, 280 F.3d 539, 543 (5th Cir. 2002). 68 5 U.S.C. \u00a7 552(a)(4)(B); Batton v. Evers, 598 F.3d 169, 175 (5th Cir. 2010). 69 See Texas v. ICC, 935 F.2d 728, 730 (5th Cir. 1991)." }, { "page": 134, "family": "Court case", "normalized": "See Texas v. ICC, 935 F.2d 728", "raw": "See Texas v. ICC, 935 F.2d 728", "context": "U.S.C. \u00a7 552(a)(4)(B); Batton v. Evers, 598 F.3d 169, 175 (5th Cir. 2010). 69 See Texas v. ICC, 935 F.2d 728, 730 (5th Cir. 1991). 2021 U.S. Dist. LEXIS 16469, *14 App000763 Case 4:21-cv-0" }, { "page": 134, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "a colorable basis in law exists to support the adequacy of its search for 66 5 U.S.C. \u00a7 552(a)(3)(A). 67 Cooper Cameron Corp. v. U.S. Dep't of Labor, OSHA, 280 F.3d 539," }, { "page": 134, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "eron Corp. v. U.S. Dep't of Labor, OSHA, 280 F.3d 539, 543 (5th Cir. 2002). 68 5 U.S.C. \u00a7 552(a)(4)(B); Batton v. Evers, 598 F.3d 169, 175 (5th Cir. 2010). 69 See Texas v." }, { "page": 134, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "her the Government's Withholding of the Records had a Reasonable Basis in Law. FOIA requires federal agencies to make their records promptly available to any pers" }, { "page": 134, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "on who makes a proper request for records.66 \"[T]he threshold question in any FOIA suit is whether the requester can even see the documents the character of whic" }, { "page": 134, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "haracter of which determines whether they can be released.\"67 Accordingly, the FOIA statute provides that, when the government withholds information from di" }, { "page": 135, "family": "Court case", "normalized": "U.S. Dep't of Justice v. Tax Analysts, 492 U.S. 136", "raw": "U.S. Dep't of Justice v. Tax Analysts, 492 U.S. 136", "context": "nding to FOIA requests without knowledge of the specifics. Fuentes did not 70 U.S. Dep't of Justice v. Tax Analysts, 492 U.S. 136, 151 n.12 (1991), 109 S. Ct. 2841, 106 L. Ed. 2d 112 (citations omitted). See" }, { "page": 135, "family": "Court case", "normalized": "Weisberg v. U.S. Dep't. of Justice, 705 F.2d 1344", "raw": "Weisberg v. U.S. Dep't. of Justice, 705 F.2d 1344", "context": "edies for agencies contravening the statute through improper withholdings). 71 Weisberg v. U.S. Dep't. of Justice, 705 F.2d 1344, 1351, 227 U.S. App. D.C. 253 (D.C. Cir. 1983); Batton v. Evers, 598 F.3d 169" }, { "page": 135, "family": "Court case", "normalized": "Batton v. Evers, 598 F.3d 169", "raw": "Batton v. Evers, 598 \nF.3d 169", "context": "p't. of Justice, 705 F.2d 1344, 1351, 227 U.S. App. D.C. 253 (D.C. Cir. 1983); Batton v. Evers, 598 F.3d 169, 176 (5th Cir. 2010). 72 Id. 73 Steinberg v. U.S. Dep't of Justice, 23 F.3d 548" }, { "page": 135, "family": "Court case", "normalized": "Id.\n73 Steinberg v. U.S. Dep't of Justice, 23 F.3d 548", "raw": "Id.\n73 Steinberg v. U.S. Dep't of Justice, 23 F.3d 548", "context": ". 253 (D.C. Cir. 1983); Batton v. Evers, 598 F.3d 169, 176 (5th Cir. 2010). 72 Id. 73 Steinberg v. U.S. Dep't of Justice, 23 F.3d 548, 551, 306 U.S. App. D.C. 240 (D.C. Cir. 1994). 74 Valencia-Lucena v. U.S. Coas" }, { "page": 135, "family": "Court case", "normalized": "Valencia-Lucena v. U.S. Coast Guard, 180 F.3d 321", "raw": "Valencia-Lucena v. U.S. Coast Guard, 180 F.3d 321", "context": "ep't of Justice, 23 F.3d 548, 551, 306 U.S. App. D.C. 240 (D.C. Cir. 1994). 74 Valencia-Lucena v. U.S. Coast Guard, 180 F.3d 321, 325, 336 U.S. App. D.C. 386 (D.C. Cir. 1999). conduct any search herself.75 N" }, { "page": 135, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Page 9 of 17 documents responsive to DMRS's FOIA request. \"Even when an agency does not deny a FOIA request outright, the requ" }, { "page": 135, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "uments responsive to DMRS's FOIA request. \"Even when an agency does not deny a FOIA request outright, the requesting party may still be able to claim 'improper'" }, { "page": 135, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ent and generalized. Fuentes described general ICE procedure for responding to FOIA requests without knowledge of the specifics. Fuentes did not 70 U.S. Dep't of" }, { "page": 135, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "63 L. Ed. 2d 267 (1980) (recognizing the judicial authority conferred by the FOIA to devise remedies for agencies contravening the statute through improper with" }, { "page": 136, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ndicate [*20] FOPS is reasonably likely to have records responsive to DMRS's FOIA request. They also indicate ICE was aware that field offices possess records r" }, { "page": 136, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "y also indicate ICE was aware that field offices possess records responsive to FOIA requests for information related to the MPP. Inexplicably, FOPS determined DMR" }, { "page": 136, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "quests for information related to the MPP. Inexplicably, FOPS determined DMRS's FOIA request did not fall within its area of responsibility and declined to conduc" }, { "page": 136, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "publicly available memo in determining it had no records responsive to DMRS's FOIA request. There is no reasonable basis in law to support ICE's inadequate searc" }, { "page": 136, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "d on June 25, 2020. When the applicability of an exemption to disclosure under FOIA is in dispute, an agency is required to provide a detailed 84 Findings of Fac" }, { "page": 137, "family": "Court case", "normalized": "Batton v. Evers, 598 F.3d 169", "raw": "Batton v. Evers, 598 F.3d 169", "context": "tive process privilege shall not apply to records created 25 years or more 88 Batton v. Evers, 598 F.3d 169, 175 (5th Cir. 2010) (citing Vaughn v. Rosen, 484 F.2d 820, 157 U.S. App. D.C." }, { "page": 137, "family": "Court case", "normalized": "Vaughn v. Rosen, 484 F.2d 820, 157 U.S. App. D.C. 340", "raw": "Vaughn v. Rosen, 484 F.2d 820, 157 U.S. App. D.C. 340", "context": "5 years or more 88 Batton v. Evers, 598 F.3d 169, 175 (5th Cir. 2010) (citing Vaughn v. Rosen, 484 F.2d 820, 157 U.S. App. D.C. 340 (D.C. Cir. 1973). 89 See Vaughn, 484 F.2d at 827. 90 Id. at 826-27. 91 Stephen" }, { "page": 137, "family": "Court case", "normalized": "Id. at 826-27.\n91 Stephenson v. IRS, 629 F.2d 1140", "raw": "Id. at 826-27.\n91 Stephenson v. IRS, 629 F.2d 1140", "context": "0, 157 U.S. App. D.C. 340 (D.C. Cir. 1973). 89 See Vaughn, 484 F.2d at 827. 90 Id. at 826-27. 91 Stephenson v. IRS, 629 F.2d 1140, 1144 (5th Cir. 1980). 92 See, e.g., Batton, 598 F.3d at 178-79; Flight Safety" }, { "page": 137, "family": "Court case", "normalized": "Flight Safety Servs. \nCorp. v. Dep't of Labor, 326 F.3d 607", "raw": "Flight Safety Servs. \nCorp. v. Dep't of Labor, 326 F.3d 607", "context": "629 F.2d 1140, 1144 (5th Cir. 1980). 92 See, e.g., Batton, 598 F.3d at 178-79; Flight Safety Servs. Corp. v. Dep't of Labor, 326 F.3d 607, 613 (5th Cir. 2003); Stephenson, 629 F.2d at 1145. 93 Judicial Watch, Inc. v." }, { "page": 137, "family": "Court case", "normalized": "Judicial Watch, Inc. v. U.S. Dep't of Def., 847 F.3d 735", "raw": "Judicial Watch, Inc. v. U.S. Dep't of Def., 847 F.3d 735", "context": "of Labor, 326 F.3d 607, 613 (5th Cir. 2003); Stephenson, 629 F.2d at 1145. 93 Judicial Watch, Inc. v. U.S. Dep't of Def., 847 F.3d 735, 738- 39, 427 U.S. App. D.C. 356 (D.C. Cir. 2017). before the date on which the" }, { "page": 137, "family": "Court case", "normalized": "United States v. Weber Aircraft Corp., 465 U.S. 792", "raw": "United States v. Weber Aircraft Corp., 465 U.S. 792", "context": "E's only witness shed no more light on the factual 94 5 U.S.C. \u00a7 552(b)(5). 95 United States v. Weber Aircraft Corp., 465 U.S. 792, 799, 104 S. Ct. 1488, 79 L. Ed. 2d 814 (14) (citations omitted) (emphasis in" }, { "page": 137, "family": "Court case", "normalized": "Tax Analysts v. IRS, 294 F.3d 71, 76, 352 U.S. App. D.C. 273", "raw": "Tax Analysts v. IRS, 294 F.3d 71, 76, 352 U.S. App. D.C. \n273", "context": "Ct. 1488, 79 L. Ed. 2d 814 (14) (citations omitted) (emphasis in original). 96 Tax Analysts v. IRS, 294 F.3d 71, 76, 352 U.S. App. D.C. 273 (D.C. Cir. 2002). 2021 U.S. Dist. LEXIS 16469, *20 App000766 Case 4:21-cv-01058" }, { "page": 137, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "individual redaction. ICE's only witness shed no more light on the factual 94 5 U.S.C. \u00a7 552(b)(5). 95 United States v. Weber Aircraft Corp., 465 U.S. 792, 799, 104 S. Ct." }, { "page": 137, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "tandard practice for agencies to supply the court with a Vaughn index.92 Under FOIA exemption (b)(5), an agency can withhold information covered by a recognized e" }, { "page": 138, "family": "Court case", "normalized": "Id. at 132-33.\n106 See Batton v. Evers, 598 F.3d 169", "raw": "Id. at 132-33.\n106 See Batton v. Evers, 598 F.3d 169", "context": "within a specific statutory exemption.106 Without 2020. 104 Id. at 146-47. 105 Id. at 132-33. 106 See Batton v. Evers, 598 F.3d 169, 176 (5th Cir. 2010) (\"The central issue . . . is whether the [evidence] submi" }, { "page": 139, "family": "Court case", "normalized": "Hensley v. Eckerhart, 461 U.S. 424, 434, 103 S. Ct. 1933", "raw": "Hensley v. Eckerhart, 461 U.S. 424, 434, 103 S. Ct. 1933", "context": "able attorney fees and other litigation costs reasonably incurred . . .\"). 108 Hensley v. Eckerhart, 461 U.S. 424, 434, 103 S. Ct. 1933, 76 L. Ed. 2d 40 (1983); Watkins v. Fordice, 7 F.3d 453, 457 (5th Cir. 1993)." }, { "page": 139, "family": "Court case", "normalized": "Watkins v. Fordice, 7 F.3d 453", "raw": "Watkins v. Fordice, 7 F.3d 453", "context": "sley v. Eckerhart, 461 U.S. 424, 434, 103 S. Ct. 1933, 76 L. Ed. 2d 40 (1983); Watkins v. Fordice, 7 F.3d 453, 457 (5th Cir. 1993). 109 League of United Latin Am. Citizens No. 4552 v. Rosc" }, { "page": 139, "family": "Court case", "normalized": "United Latin Am. Citizens No. 4552 v. Roscoe \nIndep. Sch. Dist., 119 F.3d 1228", "raw": "United Latin Am. Citizens No. 4552 v. Roscoe \nIndep. Sch. Dist., 119 F.3d 1228", "context": "40 (1983); Watkins v. Fordice, 7 F.3d 453, 457 (5th Cir. 1993). 109 League of United Latin Am. Citizens No. 4552 v. Roscoe Indep. Sch. Dist., 119 F.3d 1228, 1232 (5th Cir. 1997). 110 Hensley, 461 U.S. at 434. hours billed, and billing" }, { "page": 139, "family": "Court case", "normalized": "Saizan v. Delta Concrete Pro. Co., 448 F.3d 795", "raw": "Saizan v. Delta Concrete Pro. Co., 448 F.3d 795", "context": "d by attorney billing records.115 The court must exclude \"excessive, 111 Saizan v. Delta Concrete Pro. Co., 448 F.3d 795, 799 (5th Cir. 2006). 112 City of Burlington v. Dague, 505 U.S. 557, 562, 112" }, { "page": 139, "family": "Court case", "normalized": "City of Burlington v. Dague, 505 U.S. 557, 562, 112 S. Ct. 2638", "raw": "City of Burlington v. Dague, 505 U.S. 557, 562, 112 S. Ct. \n2638", "context": "111 Saizan v. Delta Concrete Pro. Co., 448 F.3d 795, 799 (5th Cir. 2006). 112 City of Burlington v. Dague, 505 U.S. 557, 562, 112 S. Ct. 2638, 120 L. Ed. 2d 449 (1992). See also Walker v. U.S. Dep't. of Hous. and Urban D" }, { "page": 139, "family": "Court case", "normalized": "U.S. at 436-37.\n115 Watkins v. Fordice, 7 F.3d 453", "raw": "U.S. at 436-37.\n115 Watkins v. Fordice, 7 F.3d 453", "context": "t provide an independent basis for increasing the fee award). 114 Hensley, 461 U.S. at 436-37. 115 Watkins v. Fordice, 7 F.3d 453, 457 (5th Cir. 1993). 2021 U.S. Dist. LEXIS 16469, *24 App000768 Case 4:21-cv-0" }, { "page": 139, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "he burden of establishing the reasonableness of fees, withholding.\"). 107 See 5 U.S.C. \u00a7 552(a)(4)(E)(i) (\"The court may assess against the United States reasonable attorn" }, { "page": 140, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "w search in compliance with this court's order.119 ICE disputed only that the FOIA fee shifting provision permitted compensation for work yet to be perfor" }, { "page": 140, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "rs billed reasonably reflect the time spent on litigation and are compensable. FOIA matters present 116 Mot. 10. 117 Mot., \"19-cv-00236 Billing Statement\" 2, ECF" }, { "page": 141, "family": "Court case", "normalized": "Action Ass'n v. Surface Transp. Bd., 602 F.3d 687", "raw": "Action Ass'n v. Surface Transp. Bd., 602 F.3d 687", "context": "ly rate for a particular community is established through affidavits of other Action Ass'n v. Surface Transp. Bd., 602 F.3d 687, 702 (5th Cir. 2010). 124 See Miller v. U.S. Dep't of State, 779 F.2d 1378, 13" }, { "page": 141, "family": "Court case", "normalized": "See Miller v. U.S. Dep't of State, 779 F.2d 1378", "raw": "See Miller v. U.S. Dep't of State, 779 F.2d 1378", "context": "r Action Ass'n v. Surface Transp. Bd., 602 F.3d 687, 702 (5th Cir. 2010). 124 See Miller v. U.S. Dep't of State, 779 F.2d 1378, 1390 (8th Cir. 1985)(holding that attorney fees cannot be denied on the reas" }, { "page": 141, "family": "Court case", "normalized": "Shipes v. Trinity Indus., 987 F.2d 311", "raw": "Shipes v. Trinity Indus., 987 F.2d 311", "context": "r, because these \"are practical explanations, not reasonable bases.\"). 125 Shipes v. Trinity Indus., 987 F.2d 311, 319 (5th Cir. 1993). attorneys practicing there.\"126 DMRS requests an hourly r" }, { "page": 141, "family": "Court case", "normalized": "Tollett v. City of Kemah, 285 F.3d 357", "raw": "Tollett v. City of Kemah, 285 F.3d 357", "context": "arious statutory fee-shifting provisions.132 The line of cases relying on 126 Tollett v. City of Kemah, 285 F.3d 357, 368 (5th Cir. 2002). 127 Id. at 7. 128 See generally Mot., \"Declaration of Chr" }, { "page": 141, "family": "USC", "normalized": "28 U.S.C. \u00a7 1746", "raw": "28 U.S.C. \u00a7 1746", "context": "o. 56-1, Ex. 1. 129 See generally Mot., \"Declaration of Lynn Coyle Pursuant to 28 U.S.C. \u00a7 1746.\" ECF No. 56-1, Ex. 5. 130 See generally Mot., \"Declaration of John P. Mobbs,\"" }, { "page": 141, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ve documents. For the first time, [*29] ICE claims the substantial backlog of FOIA requests and its limited personnel makes timely compliance impossible. Howeve" }, { "page": 142, "family": "Court case", "normalized": "See Tollett v. City of Kemah, 285 F.3d 357", "raw": "See Tollett v. City of Kemah, 285 F.3d 357", "context": "se are $51,937.50. aphic_and_Economic_Trends (last accessed Jan. 20, 2021). 139 See Tollett v. City of Kemah, 285 F.3d 357, 368 (5th Cir. 2002). 2021 U.S. Dist. LEXIS 16469, *31 App000771 Case 4:21-cv-" }, { "page": 143, "family": "USC", "normalized": "28 U.S.C. \u00a7 1920", "raw": "28 U.S.C. \u00a7 1920", "context": "Page 17 of 17 C. Plaintiff's Bill of Costs Pursuant to 28 U.S.C. \u00a7 1920, a judge may include costs for fees of the clerk of court and service of summ" }, { "page": 144, "family": "CFR", "normalized": "28 CFR 16.5", "raw": "28 C.F.R. \u00a7 16.5", "context": "er Freedom of Information Act (FOIA), 5 U.S.C.S. \u00a7 552 et seq., request under 28 C.F.R. \u00a7 16.5(d)(1)(iv). Defendant Federal Bureau of Investigations (FBI) disputed the whis" }, { "page": 144, "family": "CFR", "normalized": "28 CFR 16.5", "raw": "28 C.F.R. \u00a7 \n16.5", "context": "ited processing of her request. Under the Department of Justice's regulations, 28 C.F.R. \u00a7 16.5(d)(1)(iv), the whistleblower did not need to show prejudice or a matter of cur" }, { "page": 144, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "t she was entitled to expedited processing of her Freedom of Information Act (FOIA), 5 U.S.C.S. \u00a7 552 et seq., request under 28 C.F.R. \u00a7 16.5(d)(1)(iv). Defendan" }, { "page": 145, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "HN1[ ] Delays, Exceptional Circumstances Under the Freedom of Information Act (FOIA), 5 U.S.C.S. \u00a7 552 et seq., a court may retain jurisdiction and give an agenc" }, { "page": 145, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "urt may retain jurisdiction and give an agency additional time to respond to a FOIA request if the Government can show exceptional circumstances exist and that t" }, { "page": 146, "family": "Court case", "normalized": "Open America v. Watergate Special \nProsecution Force, 178 U.S. App. D.C. 308", "raw": "Open America v. Watergate Special \nProsecution Force, 178 U.S. App. D.C. 308", "context": "dant's opposition and Cross Motion for Stay of Proceedings [18-1] pursuant to Open America v. Watergate Special Prosecution Force, 178 U.S. App. D.C. 308, 547 F.2d 605 (D.C. Cir. 1976). At issue before the Court is the speed with w" }, { "page": 146, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 \nU.S.C. \u00a7 552", "context": "must comply with plaintiff's Freedom of Information Act (\"FOIA\") request. See 5 U.S.C. \u00a7 552 et seq. Plaintiff asserts that she is entitled to expedited processing of her" }, { "page": 146, "family": "CFR", "normalized": "28 CFR 16.5", "raw": "28 C.F.R. \u00a7 \n16.5", "context": "asserts that she is entitled to expedited processing of her FOIA request under 28 C.F.R. \u00a7 16.5(d)(1)(iv), which provides for expedited processing where a request involves \"[" }, { "page": 146, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "with which defendant must comply with plaintiff's Freedom of Information Act (\"FOIA\") request. See 5 U.S.C. \u00a7 552 et seq. Plaintiff asserts that she is entitled t" }, { "page": 146, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "et seq. Plaintiff asserts that she is entitled to expedited processing of her FOIA request under 28 C.F.R. \u00a7 16.5(d)(1)(iv), which provides for expedited process" }, { "page": 147, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "ts are entitled to expedited processing. See 28 C.F.R. \u00a7 16.5(d)(4); see also 5 U.S.C. \u00a7 552(a)(6)(E)(i)-(ii). Having exhausted her administrative remedies, plaintiff now" }, { "page": 147, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 \n552", "context": "adequate to deal with the volume of such requests within the time limits of \u2026 [5 U.S.C. \u00a7 552(a)(6)(A)], and when the agency can show that it 'is exercising due diligence'" }, { "page": 147, "family": "CFR", "normalized": "28 CFR 16.5", "raw": "28 C.F.R. \u00a7 16.5", "context": "regarding [*3] whether her requests are entitled to expedited processing. See 28 C.F.R. \u00a7 16.5(d)(4); see also 5 U.S.C. \u00a7 552(a)(6)(E)(i)-(ii). Having exhausted her adminis" }, { "page": 147, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Page 4 of 7 Plaintiff made a second FOIA request on April 29, 2002, seeking information pertaining to her security clea" }, { "page": 147, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "t [*4] FBI moves for an Open America stay until April 1, 2003. 1 HN1[ ] Under FOIA, a court may 1 Plaintiff incorrectly argues that defendant has waived its righ" }, { "page": 147, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "titute retain jurisdiction and give an agency additional time to respond to a FOIA request \"if the Government can show exceptional circumstances exist and that t" }, { "page": 147, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "00 requests each month even though it has drastically reduced its backlog. The FOIA personnel also spend time on administrative appeals, litigation, and large pr" }, { "page": 147, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "requests in various federal courts throughout the United States involving 650 FOIA requests. Finally, in response to the events of September 11, 2001, the an af" }, { "page": 147, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "se, since it is unrelated to defendant's defenses to the merits of plaintiff's FOIA claims, and thus, there is no basis for plaintiff's waiver argument. 2002 U.S." }, { "page": 148, "family": "Court case", "normalized": "Amendments of 1996. See, e.g., Emerson v. CIA, 1999 U.S. Dist. LEXIS 19511", "raw": "Amendments of 1996. See, e.g., Emerson v. CIA, 1999 \nU.S. Dist. LEXIS 19511", "context": "hese stays have been granted subsequent to the passage of the Electronic FOIA Amendments of 1996. See, e.g., Emerson v. CIA, 1999 U.S. Dist. LEXIS 19511, at *4 (D.D.C. Dec. 16, 1999) (Hogan, J.). turn its attention. II. Expedited P" }, { "page": 148, "family": "Court case", "normalized": "Opp. at 9, quoting Al-\nFayed v. CIA, 349 U.S. App. D.C. 223, 254 F.3d 300", "raw": "Opp. at 9, quoting Al-\nFayed v. CIA, 349 U.S. App. D.C. 223, 254 F.3d 300", "context": "to cause a significant adverse consequence to a recognized interest.'\" (Def.'s Opp. at 9, quoting Al- Fayed v. CIA, 349 U.S. App. D.C. 223, 254 F.3d 300, 311 (D.C. Cir. 2001).) The problem with defendant's position is that it is a" }, { "page": 148, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 \n552", "context": "to graft onto the DOJ's regulation FOIA's definition of \"compelling need.\" See 5 U.S.C. \u00a7 552(a)(6)(E)(v)(I)and (II). However, the regulation at issue here was [*8] not is" }, { "page": 148, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "ther cases determined by the agency.'\" Al-Fayed, 254 F.3d at 307 n.7, quoting 5 U.S.C. \u00a7 552(a)(6)(E)(i) (emphasis in original). Citing the statute's legislative history," }, { "page": 148, "family": "CFR", "normalized": "28 CFR 16.5", "raw": "28 C.F.R. \u00a7 \n16.5", "context": "to expedited processing under the Department of Justice's (\"DOJ\") regulations. 28 C.F.R. \u00a7 16.5(d)(1)(iv). Defendant responds that plaintiff has not satisfied this standard b" }, { "page": 148, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "as also shown that it is exercising due diligence in responding to plaintiff's FOIA requests and has made reasonable progress in reducing its backlog despite the" }, { "page": 148, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "and these stays have been granted subsequent to the passage of the Electronic FOIA Amendments of 1996. See, e.g., Emerson v. CIA, 1999 U.S. Dist. LEXIS 19511, at" }, { "page": 148, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "fendant's position is that it is attempting to graft onto the DOJ's regulation FOIA's definition of \"compelling need.\" See 5 U.S.C. \u00a7 552(a)(6)(E)(v)(I)and (II)." }, { "page": 148, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "\"compelling need\" standard. As the D.C. Circuit recognized in Al-Fayed, HN3[ ] FOIA directs agencies to provide \"for expedited processing, not only 'in cases in" }, { "page": 149, "family": "Court case", "normalized": "Page 6 of 7\nInformation Center v. FBI, 865 F. Supp. 1", "raw": "Page 6 of 7\nInformation Center v. FBI, 865 F. Supp. 1", "context": "Page 6 of 7 Information Center v. FBI, 865 F. Supp. 1, 2 (D.D.C. 1984); Whitehurst v. FBI, Civil Action No. 96-572 (Feb. 5, 1997) (" }, { "page": 149, "family": "Court case", "normalized": "Cherokee National of Okla. v. Babbitt, 326 U.S. App. D.C. 139, 117 F.3d 1489", "raw": "Cherokee National of Okla. v. \nBabbitt, 326 U.S. App. D.C. 139, 117 F.3d 1489", "context": ", axiomatic that HN4[ ] an \"agency is required to follow its own regulations.\" Cherokee National of Okla. v. Babbitt, 326 U.S. App. D.C. 139, 117 F.3d 1489, 1499 (D.C. Cir. 1997). In addition, the Court has no basis to accord deferen" }, { "page": 149, "family": "Court case", "normalized": "Cf. Halloran v. Veterans \nAdmin., 874 F.2d 315", "raw": "Cf. Halloran v. Veterans \nAdmin., 874 F.2d 315", "context": "g because they are also personal to her and her lawsuit against the defendant. Cf. Halloran v. Veterans Admin., 874 F.2d 315, 323 (5th Cir. 1989) [*12] (\"The HN5[ ] specific motives of the party making" }, { "page": 149, "family": "CFR", "normalized": "28 CFR 16.5", "raw": "28 C.F.R. \u00a7 16.5", "context": "e questions about the government's integrity which affect public confidence.\" 28 C.F.R. \u00a7 16.5(d)(1)(iv). Nothing in the DOJ's regulation disqualifies a plaintiff from obtai" }, { "page": 149, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "discretionary authority. Because that standards falls outside and goes beyond FOIA's definition of \"compelling need,\" the Court has no basis to demand that the" }, { "page": 149, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "3 (5th Cir. 1989) [*12] (\"The HN5[ ] specific motives of the party making the FOIA 4 As is clear from Pl.'s Reply Mem., her allegations continue to receive cove" }, { "page": 150, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 \n552", "context": "nform the Court of the date when the request will be processed consistent with 5 U.S.C. \u00a7 552(a)(6)(E)(iii) and 28 C.F.R. \u00a7 16.5(d)(4) (\"as soon as practicable\"). 5 In this" }, { "page": 150, "family": "CFR", "normalized": "28 CFR 16.5", "raw": "28 C.F.R. \u00a7 16.5", "context": "he request will be processed consistent with 5 U.S.C. \u00a7 552(a)(6)(E)(iii) and 28 C.F.R. \u00a7 16.5(d)(4) (\"as soon as practicable\"). 5 In this regard, the Court is mindful of th" }, { "page": 150, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "um, plaintiff has satisfied the criteria established by the DOJ for expediting FOIA requests. Plaintiff has offered ample evidence that her allegations have been" }, { "page": 150, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "n greater burden on its already strained resources and will disadvantage other FOIA requesters, 5 the Court is constrained to enforce the regulation as written." } ] }, { "filename": "034-Transcript-of-Scheduling-Conference-December-14-2021.pdf", "id": 8093, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2022/03/034-Transcript-of-Scheduling-Conference-December-14-2021.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2022/03/034-Transcript-of-Scheduling-Conference-December-14-2021.pdf", "total_pages": 56, "matches": [ { "page": 7, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "o than the 300,000 pages that we have before us that are being requested in the FOIA request. And I can assure you that they had all kinds of customer information," }, { "page": 10, "family": "CFR", "normalized": "21 CFR 601", "raw": "21 C.F.R. 601", "context": "g requested here is precisely what's provided for in the FDA's own regulations, 21 C.F.R. 601 -- (Court Reporter interrupts) MR. SIRI: 21 C.F.R. 601.51(e). And in that re" }, { "page": 10, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. 601.51", "context": "FDA's own regulations, 21 C.F.R. 601 -- (Court Reporter interrupts) MR. SIRI: 21 C.F.R. 601.51(e). And in that regulation promulgated by the FDA, it says that there are cert" }, { "page": 11, "family": "CFR", "normalized": "21 CFR 20.63", "raw": "21\nC.F.R. 20.63", "context": "nformation. Now, again, the FDA's own regulations, and we cited in our papers, 21 C.F.R. 20.63(b), already provides that Pfizer was to provide redacted, de-identified version" }, { "page": 11, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "11 circumstances are shown.\" The categories of information requested by this FOIA request are exactly what's delineated in that list. So, it's not like they're" }, { "page": 12, "family": "CFR", "normalized": "21 CFR 20.61", "raw": "21 C.F.R. 20.61", "context": "Honor, similarly there is a provision in the FDA's own regulations, and that is 21 C.F.R. 20.61(d), and that's also cited in our papers. And what it provides is that -- it pr" }, { "page": 12, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "eview in that regard. I mean, I think that that undercuts the whole purpose of FOIA in expedited treatment. Separately, with regards to trade secrets, Your Honor," }, { "page": 17, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "17 But it has been more than 108 days since the FOIA request has been submitted. One-hundred-and-eight days is the amount of time th" }, { "page": 18, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "expedited treatment is appropriate here for two reasons. First, as provided in FOIA, you get expedited treatment where there's an urgent need to review Government" }, { "page": 21, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "erican public, would be that Your Honor would order the FDA to comply with what FOIA requires, which is to produce it as soon as practicable. And what's practicabl" }, { "page": 23, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Your Honor, I can only speculate. THE COURT: I mean, I would think if I did a FOIA request to the DOT -- DOD for the ingredients for a thermonuclear weapon that M" }, { "page": 25, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": ", by the statutes passed by Congress, Congress has empowered you to enforce the FOIA statute that says the FDA, in this instance, must produce these documents as so" }, { "page": 26, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "to the front of the line, right? You jump ahead of all the other requests, the FOIA requests. And there's a second piece to it, and second piece to it -- and we'v" }, { "page": 30, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "eement. I think that this is -- in my mind I couldn't think of a more important FOIA case in the entire country or a more important forefront issue that the America" }, { "page": 33, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "re outliers. I can't speak to the particular circumstances of them. But every FOIA case is different. Some are easy, some are hard. The point is that where we're" }, { "page": 33, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "int is that where we're standing right now, at this very early juncture in this FOIA case, the FDA simply has not had an adequate opportunity to get its arms around" }, { "page": 34, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "cuments even before we got to this point, that's not how it normally works in a FOIA case. 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 2" }, { "page": 37, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "e able to talk. I mean, this is -- this should not be World War III, this is a FOIA case. And as counsel has pointed out, and I think the Government agrees, this i" }, { "page": 38, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "rs ago, Federal agencies had databases of information that were searchable, via FOIA searches, via certain categories and types of information. I would be shocked t" }, { "page": 38, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "some sort of a program to organize these documents. They had to have known the FOIA request was coming. MS. KONKOLY: Your Honor, I think -- I don't want to, you k" }, { "page": 39, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "elves? MS. KONKOLY: Your Honor, that's a -- THE COURT: Is that ever done in FOIA litigation? MS. KONKOLY: That's a fair question. I understand 1 2 3 4 5" }, { "page": 40, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "hy you would have that question. But the answer is, no, that does not apply to FOIA litigation. Once the release is made, it's made to the public. There's no suc" }, { "page": 40, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "o the public. There's no such thing as a protected order or a claw back in the FOIA context. THE COURT: So, in other words, the parties couldn't enter -- the Gove" }, { "page": 40, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "e this? MS. KONKOLY: No. That's not -- that's for civil discovery, it's not a FOIA concept. THE COURT: All right. Go ahead. MS. KONKOLY: I would also like to n" }, { "page": 40, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "y entitled to the full 400,000 documents under the scope -- you know, under the FOIA statute, the FDA doesn't dispute that. But it is a choice that the plaintiffs" }, { "page": 41, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "box over the entire set of records. The FDA has an independent obligation under FOIA to make that -- THE COURT: I don't think that that was what I was 1 2 3 4" }, { "page": 42, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "heck, even an amicus-type situation? MS. KONKOLY: I'm not aware of any in the FOIA context, Your Honor. I can't speak definitively to that. THE COURT: And I'm n" }, { "page": 42, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ext, Your Honor. I can't speak definitively to that. THE COURT: And I'm not a FOIA lawyer. MS. KONKOLY: Well, we do a lot of FOIA work in my office, but I haven'" }, { "page": 42, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "that. THE COURT: And I'm not a FOIA lawyer. MS. KONKOLY: Well, we do a lot of FOIA work in my office, but I haven't seen that come up. I can't say definitively w" }, { "page": 42, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "tly in our reply brief on page 20. There's something called informally reverse FOIA, which here, if the FDA determines not to withhold information that might be co" }, { "page": 47, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "hat is 15-times larger than anything that's ever been entered in the history of FOIA, as far as I'm aware. THE COURT: Yeah. And I figured this is 15-times larger" }, { "page": 48, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "hat you can say. But this is not summary judgment in a typical case. This is a FOIA case involving the Pfizer vaccine, something we all agree that the American peo" }, { "page": 49, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "the actual scope that was requested. As I pointed out, I believe earlier, this FOIA request is for the precise scope of documents that the Code of Federal Regulati" }, { "page": 50, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "pically been focused upon. And I quote the Fifth Circuit, which says, you know, FOIA was to \"pierce the veil of administrative secrecy and to open agency action to" }, { "page": 50, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "he light of public scrutiny.\" And that \"stale information produced pursuant to FOIA requests is of little value.\" The quotes go on and on and we have them all in o" }, { "page": 50, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "rust us, we're going to act expeditiously, but it's now been 108 days since the FOIA request and the doctors group has received about an average of 1 2 3 4 5" } ] }, { "filename": "037-Brief-Memorandum-in-Support-filed-by-FDA-re-36-MOTION-To-Partially-Modify-Scheduling-Order-1.pdf", "id": 8094, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2022/01/037-Brief-Memorandum-in-Support-filed-by-FDA-re-36-MOTION-To-Partially-Modify-Scheduling-Order-1.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2022/03/037-Brief-Memorandum-in-Support-filed-by-FDA-re-36-MOTION-To-Partially-Modify-Scheduling-Order-1.pdf", "total_pages": 12, "matches": [ { "page": 1, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "n its best efforts to comply, while also meeting production schedules in other FOIA litigation and continuing to process the thousands of other FOIA requests curr" }, { "page": 1, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ules in other FOIA litigation and continuing to process the thousands of other FOIA requests currently pending with FDA. However, as explained in detail below, an" }, { "page": 5, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "As discussed in prior filings, FDA has disclosure obligations in several other FOIA suits implicating CBER. In at least one case, where CBER had agreed to contrib" }, { "page": 6, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "not contain any trade secret or confidential commercial information subject to FOIA Exemption 4. Once Pfizer-BioNTech has identified those sections (which FDA has" }, { "page": 6, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "review the identified records for other types of information protected by the FOIA Exemptions (most notably, Exemption 6, which protects the privacy interests of" }, { "page": 8, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "sures far exceed what the agency considers tenable for the processing a single FOIA request, and, in fact, represent the absolute maximum efforts FDA can apply to" }, { "page": 9, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Id. \u00b6 22 (APPX009). Further, the Court\u2019s direction for CBER to prioritize this FOIA case above all others will\u2014again, of necessity\u2014require FDA to allocate resourc" }, { "page": 9, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "re FDA to allocate resources away from the processing of the hundreds of other FOIA requests that are currently pending before CBER, many of which also seek inform" }, { "page": 9, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ich also seek information related to COVID-19. Id. \u00b6 23 (APPX009). While these FOIA requesters are not before this Court, the reallocation of resources away from" }, { "page": 9, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "s undertaking in response to the January 6 Order cannot be replicated in other FOIA cases, either presently or in the future. See id. \u00b6 25 (APPX010). Case 4:21" }, { "page": 10, "family": "Court case", "normalized": "See Food Mktg. Inst. v. Argus Leader Media, 139 S. Ct. 2356", "raw": "See Food Mktg. Inst. v. Argus Leader Media, 139 S. Ct. \n2356", "context": "ential information contained within the records, is protected from disclosure. See Food Mktg. Inst. v. Argus Leader Media, 139 S. Ct. 2356, 2366 (2019) (\u201cFOIA expressly recognizes that \u2018important interests [are] served" }, { "page": 10, "family": "Court case", "normalized": "FBI v. Abramson, 456 U.S. 615", "raw": "FBI v. Abramson, 456 \nU.S. 615", "context": "] as the [statute\u2019s disclosure] requirement.\u2019\u201d (brackets in original) (quoting FBI v. Abramson, 456 U.S. 615, 630\u2013631 (1982); Encino Motorcars, LLC v. Navarro, 138 S. Ct. 1134, 1142 (2018)" }, { "page": 10, "family": "Court case", "normalized": "Encino Motorcars, LLC v. Navarro, 138 S. Ct. 1134", "raw": "Encino Motorcars, LLC v. Navarro, 138 S. Ct. 1134", "context": "(brackets in original) (quoting FBI v. Abramson, 456 U.S. 615, 630\u2013631 (1982); Encino Motorcars, LLC v. Navarro, 138 S. Ct. 1134, 1142 (2018))). While FDA is putting every available resource at its disposal" }, { "page": 10, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "re. See Food Mktg. Inst. v. Argus Leader Media, 139 S. Ct. 2356, 2366 (2019) (\u201cFOIA expressly recognizes that \u2018important interests [are] served by [its] exemption" }, { "page": 10, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "e] served by [its] exemptions,\u2019 and \u2018[t]hose exemptions are as much a part of [FOIA\u2019s] purpose[s and policies] as the [statute\u2019s disclosure] requirement.\u2019\u201d (brack" }, { "page": 10, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ense of its competing obligation to protect the categories of information that FOIA exempts from disclosure. Ensuring that such information is fully and properly" }, { "page": 10, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "generally the attached Declaration of Douglas Weinfield (explaining why FDA\u2019s FOIA reviews are often more time-intensive document reviews than those in garden- va" } ] }, { "filename": "038-Appendix-in-Support-filed-by-FDA-re-36-MOTION-To-Partially-Modify-Scheduling-Order.pdf", "id": 8095, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2022/01/038-Appendix-in-Support-filed-by-FDA-re-36-MOTION-To-Partially-Modify-Scheduling-Order.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2022/03/038-Appendix-in-Support-filed-by-FDA-re-36-MOTION-To-Partially-Modify-Scheduling-Order.pdf", "total_pages": 19, "matches": [ { "page": 3, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "transparency by providing copious information to Plaintiff in response to its FOIA request, number 2021-5683 (Plaintiff\u2019s \u201cFOIA Request\u201d). FDA has already produ" }, { "page": 3, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "on to Plaintiff in response to its FOIA request, number 2021-5683 (Plaintiff\u2019s \u201cFOIA Request\u201d). FDA has already produced to Plaintiff over 7,000 pages of responsi" }, { "page": 3, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "stance from other FDA disclosure offices to meet production deadlines in other FOIA litigation; and reaching out to the vaccine sponsors for assistance identifying" }, { "page": 4, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "een full-time contract staff to help process records responsive to Plaintiff\u2019s FOIA Request. FDA anticipates that eleven of those contract staff will be able to" }, { "page": 4, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ld have the background necessary (with training and oversight from the current FOIA staff at CBER) to help process more complex records. In addition to reviewing" }, { "page": 5, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ositions to work on reviewing and producing materials responsive to Plaintiff\u2019s FOIA Request. These details would allow agency staff who work in other parts of FDA" }, { "page": 5, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ady reallocated center resources and staff to prioritize the processing of this FOIA request to attempt to address this matter as quickly as possible. Prior to ent" }, { "page": 6, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Other Litigation Deadlines 12. FDA has disclosure obligations in several other FOIA litigations that involve CBER. In at least one case, where CBER had agreed to" }, { "page": 6, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "not contain any trade secret or confidential commercial information subject to FOIA Exemption 4. FDA has requested the sponsors to provide this information to it" }, { "page": 6, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "wing which records the sponsors believe do not contain information protected by FOIA Exemption 4, FDA will be able to streamline its disclosure review. Although F" }, { "page": 6, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ll need to review these records for other types of information protected by the FOIA Exemptions (most notably, Exemption 6, which protects the privacy interests of" }, { "page": 7, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "tic efforts will greatly increase FDA\u2019s capacity for responding to Plaintiff\u2019s FOIA Request. Between contract staff and detailees, CBER will be adding approximat" }, { "page": 9, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "scribed above exceed what the agency considers feasible for processing a single FOIA request and, in fact, represent the maximum efforts FDA can apply to this matt" }, { "page": 9, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "least three million dollars. Money spent on contractors to review Plaintiff\u2019s FOIA Request is then unavailable to fund other important public health priorities," }, { "page": 9, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "his matter means that other ALFOI disclosure work, including hundreds of other FOIA requests, many of which also seek information related to COVID-19, are, of nec" }, { "page": 9, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "lined. In my December 6, 2021, declaration, I showed the dramatic increase in FOIA backlog that CBER had suffered in recent years. First Burk Decl., \u00b6 21. I co" }, { "page": 10, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "9 Figure 1: Number of pending FOIA requests pending in CBER at the end of each calendar year. (2018 value was ta" }, { "page": 10, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "nt as of November 26, 2021.) Further, FDA has no control over the number of new FOIA requests that it may receive, and that number can be expected to be substantia" }, { "page": 10, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "d in the case of other FDA disclosure offices, many are experiencing their own FOIA backlogs. See Kotler Decl. \u00b6\u00b6 24-38. Any resources diverted from those offic" }, { "page": 10, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "50 500 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 CBER Number of Pending FOIA Requests by Year APPX010 Case 4:21-cv-01058-P Document 38 Filed 01/18/22" }, { "page": 11, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "r Declaration, FDA simply cannot take these same measures in response to every FOIA request or every FOIA litigation. The steps FDA has taken in this case have a" }, { "page": 11, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ply cannot take these same measures in response to every FOIA request or every FOIA litigation. The steps FDA has taken in this case have already placed an extra" }, { "page": 11, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "iewed as precedent for what may be possible in future situations, including for FOIA requests for other records related to COVID-19. Indeed, as outlined above (se" }, { "page": 11, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "agency priorities. It is also reducing the agency\u2019s capacity to process other FOIA requests, thereby extending wait times of other FOIA requesters \u2013 including ot" }, { "page": 11, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "capacity to process other FOIA requests, thereby extending wait times of other FOIA requesters \u2013 including other requesters seeking records related to the COVID-1" }, { "page": 13, "family": "USC", "normalized": "28 U.S.C. \u00a7 1746", "raw": "28 U.S.C. \u00a7 1746", "context": "12 Pursuant to 28 U.S.C. \u00a7 1746, I declare under the penalty of perjury that the foregoing is true and correct" }, { "page": 19, "family": "USC", "normalized": "28 U.S.C. \u00a7 1746", "raw": "28 U.S.C. \u00a7 1746", "context": "FDA will still have a role in reviewing records prior to release. Pursuant to 28 U.S.C. \u00a7 1746, I declare under the penalty of perjury that the foregoing is true and correct" } ] }, { "filename": "041-Memorandum-in-Support-filed-by-Pfizer-Inc.-re-40-MOTION-to-Intervene-for-a-Limited-Purpose.pdf", "id": 8096, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2022/01/041-Memorandum-in-Support-filed-by-Pfizer-Inc.-re-40-MOTION-to-Intervene-for-a-Limited-Purpose.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2022/03/041-Memorandum-in-Support-filed-by-Pfizer-Inc.-re-40-MOTION-to-Intervene-for-a-Limited-Purpose.pdf", "total_pages": 16, "matches": [ { "page": 3, "family": "Court case", "normalized": "Cases \nAdam Joseph Res. v. CNA Metals Ltd., 919 F.3d 856", "raw": "Cases \nAdam Joseph Res. v. CNA Metals Ltd., \n919 F.3d 856", "context": "IZER INC.\u2019S MOTION FOR LEAVE TO INTERVENE ii TABLE OF AUTHORITIES Page(s) Cases Adam Joseph Res. v. CNA Metals Ltd., 919 F.3d 856 (5th Cir. 2019) ..............................................................." }, { "page": 3, "family": "Court case", "normalized": "Appleton v. FDA, 310 F. Supp. 2d 194", "raw": "Appleton v. FDA, \n310 F. Supp. 2d 194", "context": ".............................................................................5 Appleton v. FDA, 310 F. Supp. 2d 194 (D.D.C. 2004) ................................................................." }, { "page": 3, "family": "Court case", "normalized": "DeOtte v. Azar, 332 F.R.D. 173", "raw": "DeOtte v. Azar, \n332 F.R.D. 173", "context": ".............................................................................7 DeOtte v. Azar, 332 F.R.D. 173 (N.D. Tex. 2019) .............................................................." }, { "page": 3, "family": "Court case", "normalized": "Entergy Gulf States Louisiana, L.L.C. v. U.S. EPA, 817 F.3d 198", "raw": "Entergy Gulf States Louisiana, L.L.C. v. U.S. EPA, \n817 F.3d 198", "context": "............................................................................9 Entergy Gulf States Louisiana, L.L.C. v. U.S. EPA, 817 F.3d 198 (5th Cir. 2016) ..............................................................." }, { "page": 3, "family": "Court case", "normalized": "Franciscan All., Inc. v. Azar, 414 F. Supp. 3d 928", "raw": "Franciscan All., Inc. v. Azar, \n414 F. Supp. 3d 928", "context": "......................................................................... 5, 8 Franciscan All., Inc. v. Azar, 414 F. Supp. 3d 928 (N.D. Tex. 2019) .............................................................." }, { "page": 3, "family": "Court case", "normalized": "John Doe No. 1 v. Glickman, 256 F.3d 371", "raw": "John Doe No. 1 v. Glickman, \n256 F.3d 371", "context": ".............................................................................9 John Doe No. 1 v. Glickman, 256 F.3d 371 (5th Cir. 2001) ..............................................................." }, { "page": 3, "family": "Court case", "normalized": "Pub. Citizen Health Rsch. Grp. v. FDA, 185 F.3d 898", "raw": "Pub. Citizen Health Rsch. Grp. v. FDA, \n185 F.3d 898", "context": ".............................................................................5 Pub. Citizen Health Rsch. Grp. v. FDA, 185 F.3d 898 (D.C. Cir. 1999) .............................................................." }, { "page": 3, "family": "Court case", "normalized": "Sierra Club v. Espy, 18 F.3d 1202", "raw": "Sierra Club v. Espy, \n18 F.3d 1202", "context": ".............................................................................7 Sierra Club v. Espy, 18 F.3d 1202 (5th Cir. 1994) ..............................................................." }, { "page": 3, "family": "Court case", "normalized": "Texas v. United States, 805 F.3d 653", "raw": "Texas v. United States, \n805 F.3d 653", "context": ".............................................................................6 Texas v. United States, 805 F.3d 653 (5th Cir. 2015) ..............................................................." }, { "page": 3, "family": "Court case", "normalized": "Trbovich v. United Mine Workers, 404 U.S. 528", "raw": "Trbovich v. United Mine Workers, \n404 U.S. 528", "context": ".............................................................................7 Trbovich v. United Mine Workers, 404 U.S. 528 (1972) ........................................................................" }, { "page": 3, "family": "Court case", "normalized": "United States v. Colvin, 203 B.R. 930", "raw": "United States v. Colvin, \n203 B.R. 930", "context": ".............................................................................8 United States v. Colvin, 203 B.R. 930 (N.D. Tex. 1996)..............................................................." }, { "page": 3, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": ".......................................6 Statutes Freedom of Information Act, 5 U.S.C. \u00a7 552 ........................................................................ passim" }, { "page": 4, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "UM IN SUPPORT OF PFIZER INC.\u2019S MOTION FOR LEAVE TO INTERVENE iii Regulations 21 C.F.R. \u00a7 601.51(e)............................................................................." }, { "page": 6, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "or Transparency (\u201cPlaintiff\u201d or \u201cPHMPT\u201d) under the Freedom of Information Act, 5 U.S.C. \u00a7 552, as amended (\u201cFOIA\u201d) for the limited purpose of protecting statutorily-protect" }, { "page": 6, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "or \u201cPHMPT\u201d) under the Freedom of Information Act, 5 U.S.C. \u00a7 552, as amended (\u201cFOIA\u201d) for the limited purpose of protecting statutorily-protected confidential inf" }, { "page": 6, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "compel the Food and Drug Administration (\u201cFDA\u201d or \u201cAgency\u201d) to respond to its FOIA request on an expedited basis and to produce a significant volume of data and" }, { "page": 6, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "mited purpose of ensuring that information that is exempt from disclosure under FOIA is not disclosed inappropriately. Indeed Pfizer, FDA, the Centers for Disease" }, { "page": 8, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "t information of Pfizer, such as its proprietary manufacturing processes. See 5 U.S.C. \u00a7 552(b)(4), (b)(6). Case 4:21-cv-01058-P Document 41 Filed 01/21/22 Page 8" }, { "page": 8, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": ". 1-1 (the \u201cFOIA Request\u201d). In the FOIA request, Plaintiff seeks, pursuant to 21 C.F.R. \u00a7 601.51(e), data and information contained in the biologics license application (\u201cBLA\u201d" }, { "page": 8, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "g/doi/full/10.1056/NEJMoa2027906. FACTUAL BACKGROUND Plaintiff submitted its FOIA request for this information to FDA on August 27, 2021. Compl., Ex. A.1, ECF" }, { "page": 8, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "his information to FDA on August 27, 2021. Compl., Ex. A.1, ECF No. 1-1 (the \u201cFOIA Request\u201d). In the FOIA request, Plaintiff seeks, pursuant to 21 C.F.R. \u00a7 601." }, { "page": 8, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "n August 27, 2021. Compl., Ex. A.1, ECF No. 1-1 (the \u201cFOIA Request\u201d). In the FOIA request, Plaintiff seeks, pursuant to 21 C.F.R. \u00a7 601.51(e), data and informat" }, { "page": 8, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "blicly available reports on the Vaccine Adverse Events Reporting System.\u201d See FOIA Request 2. While Pfizer supports the public review of much of this informatio" }, { "page": 8, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Plaintiff has requested also contain information exempt from production under FOIA, including the personal privacy information of individuals who participated in" }, { "page": 9, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ERVENE 4 After FDA denied Plaintiff\u2019s request for expedited processing of the FOIA request, Plaintiff commenced this action on September 16, 2021. See Compl. \u00b6\u00b6" }, { "page": 9, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "the Agency supports Plaintiff\u2019s general right to the information sought in its FOIA request, subject to standard exemptions under FOIA for sensitive business and" }, { "page": 9, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "e information sought in its FOIA request, subject to standard exemptions under FOIA for sensitive business and confidential personal information. See, e.g., Firs" }, { "page": 9, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "on of this information, and other information subject to withholding under the FOIA exemptions, FDA must carefully review and, if necessary, redact exempt informa" }, { "page": 9, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "would be advisable given these concerns. Pfizer was not aware of Plaintiff\u2019s FOIA request or this litigation prior to reading news reports about this Scheduling" }, { "page": 10, "family": "Court case", "normalized": "Entergy Gulf States Louisiana, \nL.L.C. v. U.S. EPA, 817 F.3d 198", "raw": "Entergy Gulf States Louisiana, \nL.L.C. v. U.S. EPA, 817 F.3d 198", "context": "irements for intervention as a matter of right. See Fed. R. Civ. P. 24(a)(2); Entergy Gulf States Louisiana, L.L.C. v. U.S. EPA, 817 F.3d 198, 203 (5th Cir. 2016). To intervene pursuant to Rule 24(a), an applicant must" }, { "page": 10, "family": "Court case", "normalized": "Rule 24. Adam Joseph Res. v. CNA Metals \nLtd., 919 F.3d 856", "raw": "Rule 24. Adam Joseph Res. v. CNA Metals \nLtd., 919 F.3d 856", "context": "44, 247 (5th Cir. 2009) (same). Courts in the Fifth Circuit liberally construe Rule 24. Adam Joseph Res. v. CNA Metals Ltd., 919 F.3d 856, 864 (5th Cir. 2019) (\u201cAlthough the movant bears the burden of establishing its" }, { "page": 10, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "disclosure of more than 12,000 pages of information responsive to Plaintiff\u2019s FOIA request by January 31, 2022, and subsequently at a rate of 55,000 pages every" }, { "page": 10, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "the limited purpose of ensuring that information exempt from disclosure under FOIA is adequately protected as FDA complies with this Court\u2019s order. ARGUMENT I" }, { "page": 11, "family": "Court case", "normalized": "Brumfield v. Dodd, 749 F.3d 339", "raw": "Brumfield v. Dodd, 749 F.3d 339", "context": "MORANDUM IN SUPPORT OF PFIZER INC.\u2019S MOTION FOR LEAVE TO INTERVENE 6 (quoting Brumfield v. Dodd, 749 F.3d 339, 341 (5th Cir. 2014)); Wal\u2013Mart Stores, Inc. v. Texas Alcoholic Beverage Comm\u2019" }, { "page": 11, "family": "Court case", "normalized": "John Doe No. 1 v. Glickman, 256 F.3d 371", "raw": "John Doe No. 1 \nv. Glickman, 256 F.3d 371", "context": "llowed \u201cwhere no one would be hurt and the greater justice could be attained.\u201d John Doe No. 1 v. Glickman, 256 F.3d 371, 375 (5th Cir. 2001); see also Wal\u2013Mart Stores, Inc., 834 F.3d at 565 (same)." }, { "page": 11, "family": "Court case", "normalized": "Sierra Club v. Espy, 18 F.3d 1202", "raw": "Sierra Club v. Espy, 18 F.3d 1202", "context": "cause it wastes judicial resources.\u201d John Doe No. 1, 256 F.3d at 376 (quoting Sierra Club v. Espy, 18 F.3d 1202, 1206 (5th Cir. 1994) (internal quotation marks and alterations omitted)). \u201cT" }, { "page": 11, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "statements raising concerns about its ability to review the BLA adequately for FOIA-exempt material under the Court\u2019s timeline shortly thereafter. In light of the" }, { "page": 12, "family": "Court case", "normalized": "Texas v. United States, 805 F.3d 653", "raw": "Texas v. United States, 805 F.3d \n653", "context": "is the most elementary type of right that Rule 24(a) is designed to protect.\u201d Texas v. United States, 805 F.3d 653, 658 (5th Cir. 2015) (internal quotation marks and citation omitted). Courts r" }, { "page": 12, "family": "Court case", "normalized": "Pub. Citizen Health Rsch. Grp. v. FDA, 185 F.3d 898", "raw": "Pub. Citizen Health Rsch. Grp. v. FDA, 185 F.3d 898", "context": "nufacturer seeks to protect its confidential business information. See, e.g., Pub. Citizen Health Rsch. Grp. v. FDA, 185 F.3d 898, 900 (D.C. Cir. 1999) (noting that a drug manufacturer intervened to protect c" }, { "page": 12, "family": "Court case", "normalized": "Appleton v. FDA, 310 F. Supp. 2d 194", "raw": "Appleton v. FDA, 310 F. Supp. 2d 194", "context": "er intervened to protect confidential information from disclosure under FOIA); Appleton v. FDA, 310 F. Supp. 2d 194, 196\u201397 (D.D.C. 2004) (permitting New Drug Application (\u201cNDA\u201d) holders to inte" }, { "page": 12, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "n marks and citation omitted). Courts routinely grant motions to intervene in FOIA cases involving FDA where a manufacturer seeks to protect its confidential bus" }, { "page": 12, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ufacturer intervened to protect confidential information from disclosure under FOIA); Appleton v. FDA, 310 F. Supp. 2d 194, 196\u201397 (D.D.C. 2004) (permitting New D" }, { "page": 12, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ting New Drug Application (\u201cNDA\u201d) holders to intervene as a matter of right in FOIA lawsuit seeking release of materials from the FDA\u2019s review of NDAs). C. Dispo" }, { "page": 12, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ne, there is a risk that this matter could result in inadvertent disclosure of FOIA-protected material. Pfizer\u2019s ability to protect its interests would be direct" }, { "page": 13, "family": "Court case", "normalized": "Trbovich v. United Mine Workers, 404 U.S. 528", "raw": "Trbovich v. United Mine Workers, \n404 U.S. 528", "context": "this burden is \u2018minimal.\u2019\u201d Id. (quoting Brumfield, 749 F.3d at 345); see also Trbovich v. United Mine Workers, 404 U.S. 528, 538 n.10 (1972) (same). Courts in the Fifth Circuit have held that the mere" }, { "page": 14, "family": "Court case", "normalized": "See \nDeOtte v. Azar, 332 F.R.D. 173", "raw": "See \nDeOtte v. Azar, 332 F.R.D. 173", "context": "e relief that is different from that which is sought by a party with standing.\u201d See DeOtte v. Azar, 332 F.R.D. 173, 179 (N.D. Tex. 2019) (citing Town of Chester, N.Y. v. Laroe Ests., Inc., 137" }, { "page": 14, "family": "Court case", "normalized": "Town of Chester, N.Y. v. Laroe Ests., \nInc., 137 S. Ct. 1645", "raw": "Town of Chester, N.Y. v. Laroe Ests., \nInc., 137 S. Ct. 1645", "context": "th standing.\u201d See DeOtte v. Azar, 332 F.R.D. 173, 179 (N.D. Tex. 2019) (citing Town of Chester, N.Y. v. Laroe Ests., Inc., 137 S. Ct. 1645, 1648 (2017)). This Court has found, however, that this standing requirement" }, { "page": 14, "family": "Court case", "normalized": "See Franciscan \nAll., Inc. v. Azar, 414 F. Supp. 3d 928", "raw": "See Franciscan \nAll., Inc. v. Azar, 414 F. Supp. 3d 928", "context": "ted to instances where a plaintiff-intervenor is affirmatively seeking relief. See Franciscan All., Inc. v. Azar, 414 F. Supp. 3d 928, 938 n.3 (N.D. Tex. 2019) (concluding when defendant- intervenors did not \u201cseek" }, { "page": 14, "family": "Court case", "normalized": "Lujan v. Defs. of \nWildlife, 504 U.S. 555", "raw": "Lujan v. Defs. of \nWildlife, 504 U.S. 555", "context": "fact, (2) causation, and (3) redressability. DeOtte, 332 F.R.D. at 179 (citing Lujan v. Defs. of Wildlife, 504 U.S. 555, 560 (1992)). Here, Pfizer\u2019s injury-in-fact is the potential disclosure of its" }, { "page": 14, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "imited purpose of protecting its business interest by ensuring compliance with FOIA\u2019s statutory exemptions, the standing requirement should not apply here. Nonet" }, { "page": 15, "family": "Court case", "normalized": "United States v. Colvin, 203 B.R. 930", "raw": "United States v. Colvin, 203 B.R. \n930", "context": "ion of the rights of the original parties.\u201d Fed. R. Civ. P. 24(b)(3); see also United States v. Colvin, 203 B.R. 930, 941 (N.D. Tex. 1996). Pfizer\u2019s interest in protecting its trade secrets and" }, { "page": 15, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ute that Plaintiff is entitled to non-exempt information from the BLA under its FOIA request and Pfizer does not seek any delay in the production of that informati" }, { "page": 15, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "iciently segregating and redacting any data and information that are subject to FOIA statutory exemptions. Case 4:21-cv-01058-P Document 41 Filed 01/21/22" } ] }, { "filename": "044-PL-PHPMTS-MOL-IN-OPPOSITION-TO-DEFENDANTS-MOTION-TO-MODIFY-THE-SCHEDULING-ORDER-OF-THE-COURT.pdf", "id": 8097, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2022/01/044-PL-PHPMTS-MOL-IN-OPPOSITION-TO-DEFENDANTS-MOTION-TO-MODIFY-THE-SCHEDULING-ORDER-OF-THE-COURT.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2022/03/044-PL-PHPMTS-MOL-IN-OPPOSITION-TO-DEFENDANTS-MOTION-TO-MODIFY-THE-SCHEDULING-ORDER-OF-THE-COURT.pdf", "total_pages": 20, "matches": [ { "page": 3, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "to license this product must take a back seat to the transparency demanded by FOIA and the urgent need and interests of the American people to review that licens" }, { "page": 5, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ramount, and the FDA has chosen to thwart transparency and the requirements of FOIA by anemically understaffing the office it maintains to respond to FOIA requests" }, { "page": 5, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ents of FOIA by anemically understaffing the office it maintains to respond to FOIA requests. It is akin to the boy that kills his parents and asks for sympathy" }, { "page": 6, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ages on March 1st and March 31st is False Plaintiff submitted the instant FOIA request in late August 2021 and filed this action in September 2021. (Dkt. No" }, { "page": 6, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "after the Court entered its order and nine months after Plaintiff submitted its FOIA request. However, the FDA\u2019s excuses for seeking to further delay the producti" }, { "page": 7, "family": "CFR", "normalized": "21 CFR 20.63", "raw": "21 C.F.R. \u00a7 20.63", "context": "g its documents to the FDA (as it was required to do by FDA regulations). See 21 C.F.R. \u00a7 20.63(b). The FDA now just wants to do a second review, which is Case 4:21-cv-01058" }, { "page": 11, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "but rather is just another example of the agency trying to avoid or delay its FOIA obligations. (Dkt. No. 37 at 2.) The Declaration of Douglas Weinfield, Asso" }, { "page": 13, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "No. 37 at 9). Mr. Weinfield attempts to persuade the Court that the instant FOIA review will be much harder and more time consuming than a typical private prac" }, { "page": 13, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ing which records the sponsors believe do not contain information protected by FOIA Exemption 4, FDA will be able to \u2026 move more quickly through the records if it" }, { "page": 14, "family": "CFR", "normalized": "21 CFR 20.61", "raw": "21 C.F.R. 20.61", "context": "ords are submitted to the Government or within a reasonable time thereafter.\u201d 21 C.F.R. 20.61(d). For all these reasons, the FDA\u2019s claim that its current 11 full-time rev" }, { "page": 14, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "t it has submitted to the FDA \u201cas exempt from disclosure under exemption 4 of\u201d FOIA, \u201ceither at the time the records are submitted to the Government or within a r" }, { "page": 14, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "the FDA is already being given leeway with regard to the purpose and intent of FOIA, i.e., timely production. It has been more Case 4:21-cv-01058-P Document 44" }, { "page": 17, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "t, fails to identify the relevant metric. The rate is the tail, and the dog is FOIA\u2019s requirement that the documents be timely produced. Here, the minimum rate o" }, { "page": 18, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ramount, and the FDA has chosen to thwart transparency and the requirements of FOIA by anemically understaffing the office it maintains to respond to FOIA requests" }, { "page": 18, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ents of FOIA by anemically understaffing the office it maintains to respond to FOIA requests. The FDA\u2019s understaffing of its FOIA office is in itself a violation" }, { "page": 18, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "fice it maintains to respond to FOIA requests. The FDA\u2019s understaffing of its FOIA office is in itself a violation of the obligation of FOIA. Decrying that this" }, { "page": 18, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "understaffing of its FOIA office is in itself a violation of the obligation of FOIA. Decrying that this Court is now making it comply with the law \u2013 by making th" }, { "page": 18, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "he unprecedented importance that the Court already found regarding the instant FOIA production. In her declaration, Ms. Burk reiterates the FDA\u2019s earlier claims" }, { "page": 19, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "it is required to do by statute and now by Court order: timely respond to all FOIA requests. It is also remarkable for the FDA to claim, with its over $3.41 bi" }, { "page": 19, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "gripes that it needs to review new product applications and responding to this FOIA at the Court-ordered rate of production adversely affects that. Putting aside" } ] }, { "filename": "046-RESPONSE-filed-by-Food-and-Drug-Administration-re-40-MOTION-to-Intervene-for-a-Limited-Purpose.pdf", "id": 8098, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2022/01/046-RESPONSE-filed-by-Food-and-Drug-Administration-re-40-MOTION-to-Intervene-for-a-Limited-Purpose.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2022/03/046-RESPONSE-filed-by-Food-and-Drug-Administration-re-40-MOTION-to-Intervene-for-a-Limited-Purpose.pdf", "total_pages": 4, "matches": [ { "page": 1, "family": "USC", "normalized": "18 U.S.C. \u00a7 1905", "raw": "18 U.S.C. \u00a7 1905", "context": "ions of the records are subject to Exemption 4, the Trade Secrets Act (\u201cTSA\u201d), 18 U.S.C. \u00a7 1905, or other statutory protections will be a necessary component of the agency\u2019s" }, { "page": 1, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "on, \u201cit is the Government\u2019s province to make the relevant determinations under FOIA.\u201d Dkt. No. 40 at 2. However, due to the unprecedented speed with which the Cou" }, { "page": 2, "family": "Court case", "normalized": "Chrysler v. Brown, 441 U.S. 281", "raw": "Chrysler v. Brown, 441 U.S. 281", "context": ",\u201d \u201cthe agency cannot possibly violate FOIA\u201d in disclosing information (citing Chrysler v. Brown, 441 U.S. 281, 292 (1979)); see also Northrop Grumman Sys. Corp. v. NASA, 346 F. Supp. 3d 10" }, { "page": 2, "family": "Court case", "normalized": "Northrop Grumman Sys. Corp. v. NASA, 346 F. Supp. 3d 109", "raw": "Northrop Grumman Sys. Corp. v. NASA, 346 F. Supp. 3d 109", "context": "ing information (citing Chrysler v. Brown, 441 U.S. 281, 292 (1979)); see also Northrop Grumman Sys. Corp. v. NASA, 346 F. Supp. 3d 109, 116 (D.D.C. 2018) (holding that in \u201creverse-FOIA cases\u201d \u201can aggrieved party m" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ay challenge the disclosure under the Administrative Procedure Act (a \u201creverse FOIA\u201d claim), and may assert a violation of another statute such as the TSA . See D" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "al Election Comm\u2019n, 920 F.3d 866, 872 (D.C. Cir. 2019) (holding that, because \u201cFOIA is a disclosure statute,\u201d \u201cthe agency cannot possibly violate FOIA\u201d in disclos" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "t, because \u201cFOIA is a disclosure statute,\u201d \u201cthe agency cannot possibly violate FOIA\u201d in disclosing information (citing Chrysler v. Brown, 441 U.S. 281, 292 (1979)" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "orp. v. NASA, 346 F. Supp. 3d 109, 116 (D.D.C. 2018) (holding that in \u201creverse-FOIA cases\u201d \u201can aggrieved party may bring an action under the APA to enjoin an agen" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "under the APA to enjoin an agency from releasing proprietary information under FOIA in violation of the Trade Secrets Act\u201d or on the basis that disclosure is othe" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "\u2019\u201d). Thus, this case may require expedited judicial resolution of any \u201creverse FOIA\u201d issues that may arise. It would further judicial efficiency to resolve in the" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ay arise. It would further judicial efficiency to resolve in the same case the FOIA claim and any related \u201creverse FOIA\u201d claims cognizable under the APA, and Pfiz" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "efficiency to resolve in the same case the FOIA claim and any related \u201creverse FOIA\u201d claims cognizable under the APA, and Pfizer\u2019s participation in these proceedi" } ] }, { "filename": "047-PLAINTIFFS-RESPONSE-TO-PFIZER-INC.S-MOTION-FOR-LEAVE-TO-INTERVENE-FOR-A-LIMITED-PURPOSE.pdf", "id": 8099, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2022/01/047-PLAINTIFFS-RESPONSE-TO-PFIZER-INC.S-MOTION-FOR-LEAVE-TO-INTERVENE-FOR-A-LIMITED-PURPOSE.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2022/03/047-PLAINTIFFS-RESPONSE-TO-PFIZER-INC.S-MOTION-FOR-LEAVE-TO-INTERVENE-FOR-A-LIMITED-PURPOSE.pdf", "total_pages": 15, "matches": [ { "page": 3, "family": "Court case", "normalized": "Cruise Hldgs., Inc. v. A&L Sales, Inc., 346 F.3d 552", "raw": "Cruise Hldgs., Inc. v. A&L Sales, Inc., \n 346 F.3d 552", "context": "iii TABLE OF AUTHORITIES Cases Effjohn Int\u2019l Cruise Hldgs., Inc. v. A&L Sales, Inc., 346 F.3d 552 (5th Cir. 2003) ..............................................................." }, { "page": 3, "family": "Court case", "normalized": "New Orleans Pub. Serv., Inc. v. United Gas Pipe Line Co., 732 F.2d 452", "raw": "New Orleans Pub. Serv., Inc. v. United Gas Pipe Line Co., \n 732 F.2d 452", "context": ".......................................................................... 3 New Orleans Pub. Serv., Inc. v. United Gas Pipe Line Co., 732 F.2d 452 (5th Cir. 1984) ..............................................................." }, { "page": 3, "family": "Court case", "normalized": "Nikon Corp. v. ASM, 222 F.R.D. 647", "raw": "Nikon Corp. v. ASM, \n222 F.R.D. 647", "context": ".......................................................................... 4 Nikon Corp. v. ASM, 222 F.R.D. 647 (N.D. Cal. 2004) .............................................................." }, { "page": 3, "family": "Court case", "normalized": "Payne Enters., Inc. v. United States, 837 F.2d 486", "raw": "Payne Enters., Inc. v. United States, \n 837 F.2d 486", "context": ".......................................................................... 4 Payne Enters., Inc. v. United States, 837 F.2d 486 (D.C. Cir. 1988) .............................................................." }, { "page": 3, "family": "Court case", "normalized": "Script Sec. Sols. LLC v. Logitech Inc., \n No. 216CV01400JRGRSP, 2017 WL 10242574", "raw": "Script Sec. Sols. LLC v. Logitech Inc., \n No. 216CV01400JRGRSP, 2017 WL 10242574", "context": "......................................................................... 10 Script Sec. Sols. LLC v. Logitech Inc., No. 216CV01400JRGRSP, 2017 WL 10242574 (E.D. Tex. Nov. 8, 2017)\u2026\u2026\u2026\u2026\u2026.passim Sierra Club v. Espy, 18 F.3d 1202 (5t" }, { "page": 3, "family": "Court case", "normalized": "Sierra Club v. Espy, 18 F.3d 1202", "raw": "Sierra Club v. Espy, \n 18 F.3d 1202", "context": "No. 216CV01400JRGRSP, 2017 WL 10242574 (E.D. Tex. Nov. 8, 2017)\u2026\u2026\u2026\u2026\u2026.passim Sierra Club v. Espy, 18 F.3d 1202 (5th Cir. 1994) ..............................................................." }, { "page": 3, "family": "Court case", "normalized": "Mart Stores, Inc. v. Texas Alcoholic Beverage Commn., 834 F.3d 562", "raw": "Mart Stores, Inc. v. Texas Alcoholic Beverage Commn., \n 834 F.3d 562", "context": "................................................................... 3, 5 Wal\u2013Mart Stores, Inc. v. Texas Alcoholic Beverage Commn., 834 F.3d 562 (5th Cir. 2016) ..............................................................." }, { "page": 3, "family": "CFR", "normalized": "21 CFR 20.61", "raw": "21 C.F.R. 20.61", "context": "................................................................ 5 Statutes 21 C.F.R. 20.61 ..............................................................................." }, { "page": 6, "family": "Court case", "normalized": "Pfizer relies on, Sierra Club v. Espy, 18 F.3d 1202", "raw": "Pfizer relies on, Sierra Club v. Espy, 18 F.3d 1202", "context": "ialogue. I. STANDARD FOR TIMELINESS UNDER RULE 24 One of the primary cases Pfizer relies on, Sierra Club v. Espy, 18 F.3d 1202 (5th Cir. 1994), warns that \u201c[c]ourts should discourage premature intervention" }, { "page": 6, "family": "Court case", "normalized": "Script Sec. Sols. LLC v. Logitech Inc., No. 216CV01400JRGRSP, 2017 WL 10242574", "raw": "Script Sec. Sols. LLC \nv. Logitech Inc., No. 216CV01400JRGRSP, 2017 WL 10242574", "context": "unusual circumstances weighing in favor of, or against, finding timeliness.\u2019\u201d Script Sec. Sols. LLC v. Logitech Inc., No. 216CV01400JRGRSP, 2017 WL 10242574, at *2 (E.D. Tex. Nov. 8, 2017) (quoting Effjohn Int\u2019l Cruise Hldgs., Inc. v." }, { "page": 6, "family": "Court case", "normalized": "Cruise Hldgs., Inc. v. A&L Sales, Inc., 346 F.3d 552", "raw": "Cruise Hldgs., Inc. v. A&L Sales, Inc., 346 F.3d 552", "context": "RGRSP, 2017 WL 10242574, at *2 (E.D. Tex. Nov. 8, 2017) (quoting Effjohn Int\u2019l Cruise Hldgs., Inc. v. A&L Sales, Inc., 346 F.3d 552, 560\u201361 (5th Cir. 2003)). The Script Sec. Sols. decision provides a relevant" }, { "page": 7, "family": "Court case", "normalized": "Nikon Corp. v. ASM, 222 F.R.D. 647", "raw": "Nikon Corp. v. ASM, 222 F.R.D. 647", "context": "arties, and \u2026 to be bound by all existing orders in this action.\u201d Id. (citing Nikon Corp. v. ASM, 222 F.R.D. 647, 651-52 (N.D. Cal. 2004) (permitting intervention under Rule 24(b) with certai" }, { "page": 7, "family": "Court case", "normalized": "New Orleans Pub. Serv., \nInc. v. United Gas Pipe Line Co., 732 F.2d 452", "raw": "New Orleans Pub. Serv., \nInc. v. United Gas Pipe Line Co., 732 F.2d 452", "context": "mize delay and burdens to the parties and keep this case on track\u201d)); see also New Orleans Pub. Serv., Inc. v. United Gas Pipe Line Co., 732 F.2d 452, 470-71 (5th Cir. 1984) (\u201cPermissive intervention is wholly discretionary with" }, { "page": 8, "family": "Court case", "normalized": "Mart Stores, Inc. v. Texas Alcoholic Beverage Commn., 834 F.3d 562", "raw": "Mart Stores, Inc. v. Texas Alcoholic Beverage Commn., 834 \nF.3d 562", "context": "quiry \u2018is contextual; absolute measures of timelines should be ignored.\u2019\u201d Wal\u2013Mart Stores, Inc. v. Texas Alcoholic Beverage Commn., 834 F.3d 562, 565 (5th Cir. 2016) (cited by Pfizer) (quoting Espy, 18 F.3d at 1205). For in" }, { "page": 9, "family": "CFR", "normalized": "21 CFR 20.61", "raw": "21 C.F.R. 20.61", "context": "it companies to engage with the FDA with regard to identifying trade secrets. 21 C.F.R. 20.61(d). Those regulations are particularly enlightening here because they include" }, { "page": 10, "family": "CFR", "normalized": "21 CFR 20.61", "raw": "21 C.F.R. 20.61", "context": "cords are submitted to the Government or within a reasonable time thereafter. 21 C.F.R. 20.61(d) (emphasis added). \u201cWhen the [FDA] receives a request for such records and" }, { "page": 10, "family": "CFR", "normalized": "21 CFR 20.61", "raw": "21 C.F.R. \n20.61", "context": "closure of any part of the records and to state all bases for its objections.\u201d 21 C.F.R. 20.61(e) (emphasis added). Case 4:21-cv-01058-P Document 47 Filed 01/25/22 Pa" }, { "page": 10, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "7 does not slow down the government\u2019s response to the FOIA request.1 Thus, contrary to Pfizer\u2019s claims, even if it is not a party to thi" }, { "page": 12, "family": "Court case", "normalized": "Payne Enters., Inc. v. United States, 837 F.2d 486", "raw": "Payne Enters., Inc. v. United States, 837 F.2d 486", "context": "an issue of national importance, where \u201cstale information is of little value.\u201d Payne Enters., Inc. v. United States, 837 F.2d 486, 494 (D.C. Cir. 1988). Thus, any delays now not only prejudice the parties as" }, { "page": 13, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "te that Plaintiff is entitled to non-exempt information from the BLA under its FOIA request and Pfizer does not seek any delay in the production of that informati" }, { "page": 13, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ciently segregating and redacting any data and information that are subject to FOIA statutory exemptions.\u201d (Dkt. No. 41 at 15.) If that is all Pfizer truly seek" } ] }, { "filename": "056-ORDER-GRANTING-IN-PART-THE-MOTION-TO-MODIFY-THE-PRODUCTION-SCHEDULE-AND-ADDOPTS-THE-JOINT-STATUS-REPORT-MODIFIED-AGREED-PRODUCTION-SCHEDULE.pdf", "id": 8100, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2022/02/056-ORDER-GRANTING-IN-PART-THE-MOTION-TO-MODIFY-THE-PRODUCTION-SCHEDULE-AND-ADDOPTS-THE-JOINT-STATUS-REPORT-MODIFIED-AGREED-PRODUCTION-SCHEDULE.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2022/03/056-ORDER-GRANTING-IN-PART-THE-MOTION-TO-MODIFY-THE-PRODUCTION-SCHEDULE-AND-ADDOPTS-THE-JOINT-STATUS-REPORT-MODIFIED-AGREED-PRODUCTION-SCHEDULE.pdf", "total_pages": 2, "matches": [] }, { "filename": "091621-Complaint.pdf", "id": 8101, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2021/11/091621-Complaint.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2022/03/091621-Complaint.pdf", "total_pages": 37, "matches": [ { "page": 2, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "refore issued a request to the FDA pursuant to the Freedom of Information Act (5 U.S.C. \u00a7 552, as amended) (\u201cFOIA\u201d) for \u201c[a]ll data and information for the Pfizer Vaccine e" }, { "page": 2, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "ffectiveness data and information. (2) A protocol for a test or study . . .\u201d 21 C.F.R. \u00a7 601.51(e). 6. PHMPT therefore issued a request to the FDA pursuant to the Freedom of" }, { "page": 2, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "(\u201cFOIA\u201d) for \u201c[a]ll data and information for the Pfizer Vaccine enumerated in 21 C.F.R. \u00a7 601.51(e)5 with the exception of publicly available reports on the Vaccine Adverse Ev" }, { "page": 2, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "e. 4 https://www.fda.gov/about-fda/transparency (last visited 9/5/2021). 5 21 C.F.R. \u00a7 601.51(e) provides that after a biological product is licensed, the following informat" }, { "page": 2, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "all of the data and information in the biological product file, as defined in 21 C.F.R. \u00a7 601.51(a), for the Pfizer Vaccine enumerated in 21 C.F.R. \u00a7 601.51(e) with the except" }, { "page": 2, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "file, as defined in 21 C.F.R. \u00a7 601.51(a), for the Pfizer Vaccine enumerated in 21 C.F.R. \u00a7 601.51(e) with the exception of publicly available reports on the Vaccine Adverse Eve" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "FDA pursuant to the Freedom of Information Act (5 U.S.C. \u00a7 552, as amended) (\u201cFOIA\u201d) for \u201c[a]ll data and information for the Pfizer Vaccine enumerated in 21 C.F." }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "icly available reports on the Vaccine Adverse Events Reporting System.6\u201d (the \u201cFOIA Request\u201d). 7. The medical and scientific community and the public have a su" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "nd action on a particular lot by the [FDA].\u201d 6 For the avoidance of doubt, the FOIA Request includes but is not limited to all of the data and information in the" }, { "page": 3, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "he issue, PHMPT requested expedited processing of the FOIA Request pursuant to 5 U.S.C. \u00a7 552(a)(6)(E)(v)(II). 9. On September 9, 2021, the FDA denied PHMPT\u2019s request for" }, { "page": 3, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ime sensitive nature of the issue, PHMPT requested expedited processing of the FOIA Request pursuant to 5 U.S.C. \u00a7 552(a)(6)(E)(v)(II). 9. On September 9, 2021," }, { "page": 6, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "ment of Health and Human Services. The FDA is an agency within the meaning of 5 U.S.C. \u00a7 552(f). JURISDICTION AND VENUE 13. This Court has jurisdiction over this action" }, { "page": 6, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "ICTION AND VENUE 13. This Court has jurisdiction over this action pursuant to 5 U.S.C. \u00a7 552(a)(4)(B) and 28 U.S.C. \u00a7 1331. Venue is proper within this District pursuant t" }, { "page": 6, "family": "USC", "normalized": "28 U.S.C. \u00a7 1331", "raw": "28 U.S.C. \u00a7 1331", "context": "ourt has jurisdiction over this action pursuant to 5 U.S.C. \u00a7 552(a)(4)(B) and 28 U.S.C. \u00a7 1331. Venue is proper within this District pursuant to 5 U.S.C. \u00a7 552(a)(4)(B) and 2" }, { "page": 6, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": ")(4)(B) and 28 U.S.C. \u00a7 1331. Venue is proper within this District pursuant to 5 U.S.C. \u00a7 552(a)(4)(B) and 28 U.S.C. \u00a7 1391. FACTS A. FDA Approval of the Pfizer Vaccine" }, { "page": 6, "family": "USC", "normalized": "28 U.S.C. \u00a7 1391", "raw": "28 \nU.S.C. \u00a7 1391", "context": "1. Venue is proper within this District pursuant to 5 U.S.C. \u00a7 552(a)(4)(B) and 28 U.S.C. \u00a7 1391. FACTS A. FDA Approval of the Pfizer Vaccine 14. On August 23, 2021, the" }, { "page": 12, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "xpedited basis: All data and information for the Pfizer Vaccine enumerated in 21 C.F.R. \u00a7 601.51(e)41 with the exception of publicly available reports on the Vaccine Adverse E" }, { "page": 12, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "nouncements/fda-approves-first-covid-19-vaccine (last visited 9/5/2021). 41 21 C.F.R. \u00a7 601.51(e) provides that after a biological product is licensed, the following informat" }, { "page": 12, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "all of the data and information in the biological product file, as defined in 21 C.F.R. \u00a7 601.51(a), for the Pfizer Vaccine enumerated in 21 C.F.R. \u00a7 601.51(e) with the except" }, { "page": 12, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "file, as defined in 21 C.F.R. \u00a7 601.51(a), for the Pfizer Vaccine enumerated in 21 C.F.R. \u00a7 601.51(e) with the exception of publicly available reports on the Vaccine Adverse Eve" }, { "page": 12, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "shots of the vaccine in order to retain a \u201cfully vaccinated\u201d status.39 C. The FOIA Request 33. In furtherance of PHMPT\u2019s mission to disseminate information to t" }, { "page": 12, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "with its commitment to transparency,40 on August 27, 2021, PHMPT submitted the FOIA Request to the FDA. Pursuant to the FOIA Request, PHMPT requested that the fol" }, { "page": 12, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "August 27, 2021, PHMPT submitted the FOIA Request to the FDA. Pursuant to the FOIA Request, PHMPT requested that the following documents be produced on an expedi" }, { "page": 12, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "erse Events Reporting System.42 (Exhibit A.1.)43 34. Upon submitting the FOIA Request, PHMPT immediately received confirmation that the FOIA Request was sub" }, { "page": 12, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "submitting the FOIA Request, PHMPT immediately received confirmation that the FOIA Request was submitted successfully. (Exhibit A.2.) that-a-covid-19-shot-is-" }, { "page": 13, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "uested that the FDA process the FOIA Request on an expedited basis pursuant to 5 U.S.C. \u00a7 552(a)(6)(E)(v)(II). 37. On September 9, 2021, the FDA denied PHMPT\u2019s request for" }, { "page": 13, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "edited processing of request for records\u201d upon a showing of \u201ccompelling need.\u201d 5 U.S.C. \u00a7 552(a)(6)(E)(i)(II). When the person requesting information is \u201cprimarily engaged" }, { "page": 13, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "Government activity\u201d constitutes a \u201ccompelling need\u201d for expedited processing. 5 U.S.C. \u00a7 552(a)(6)(E)(v)(II). 39. PHMPT requested expedited processing of the FOIA Reques" }, { "page": 13, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "equests for expedited processing within ten days from the date of the request. 5 U.S.C. \u00a7 552(a)(6)(E)(ii)(I). The FDA\u2019s denial of PHMPT\u2019s request for expedited processing" }, { "page": 13, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "21, the FDA issued an acknowledgment and assigned case number 2021-5683 to the FOIA Request. (Exhibit A.3.) D. Request for Expedited Processing 36. In the FOI" }, { "page": 13, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "OIA Request. (Exhibit A.3.) D. Request for Expedited Processing 36. In the FOIA Request, PHMPT requested that the FDA process the FOIA Request on an expedited" }, { "page": 13, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Processing 36. In the FOIA Request, PHMPT requested that the FDA process the FOIA Request on an expedited basis pursuant to 5 U.S.C. \u00a7 552(a)(6)(E)(v)(II). 37." }, { "page": 13, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "tember 9, 2021, the FDA denied PHMPT\u2019s request for expedited processing of the FOIA Request (the \u201cDenial Letter\u201d).44 In the Denial Letter, the FDA stated in relev" }, { "page": 13, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "hat your request for expedited processing does not meet the criteria under the FOIA. You have not demonstrated a compelling need that involves an imminent threat" }, { "page": 13, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ing your request for expedited processing. (Exhibit A.4.) ARGUMENT 38. FOIA provides for \u201cexpedited processing of request for records\u201d upon a showing of \u201c" }, { "page": 13, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": ".S.C. \u00a7 552(a)(6)(E)(v)(II). 39. PHMPT requested expedited processing of the FOIA Request on the basis that it is \u201cprimarily engaged in disseminating informatio" }, { "page": 13, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "alleged Federal Government activity.\u201d In the Denial Letter, the FDA 44 The FOIA requires federal agencies to issue determinations on requests for expedited pro" }, { "page": 13, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "T\u2019s request for expedited processing was issued 13 days after PHMPT issued the FOIA Request. Case 4:21-cv-01058-P Document 1 Filed 09/16/21 Page 13 of 20" }, { "page": 14, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "VID-19 vaccines. PHMPT intends to make any records produced in response to the FOIA request immediately available to the public through both its website and its i" }, { "page": 15, "family": "Court case", "normalized": "Al-Fayed v. CIA, 254 F.3d 300", "raw": "Al-Fayed v. CIA, 254 F.3d 300", "context": "d interest; and (3) whether the request concerns federal government activity.\u201d Al-Fayed v. CIA, 254 F.3d 300, 310 (D.D.C. 2001). All three factors are present here. 42. The FOIA Request" }, { "page": 15, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "254 F.3d 300, 310 (D.D.C. 2001). All three factors are present here. 42. The FOIA Request concerns a matter of current exigency to the American public. 45 Se" }, { "page": 16, "family": "USC", "normalized": "21 U.S.C. \u00a7 393", "raw": "21 U.S.C. \u00a7 393", "context": "license vaccines that have been proven to be \u201csafe and effective,\u201d see, e.g., 21 U.S.C. \u00a7 393, and the FDA makes this determination based on, inter alia, clinical trial rep" }, { "page": 16, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "ances are shown: (1) All safety and effectiveness data and information. . . .\u201d 21 C.F.R. \u00a7 601.51(e) (emphasis added). The FDA\u2019s own regulations thus expressly recognize the i" }, { "page": 16, "family": "CFR", "normalized": "21 CFR 601.2", "raw": "21 C.F.R. 601.2", "context": "must be sufficient to demonstrate the product is both \u201csafe\u201d and \u201ceffective.\u201d 21 C.F.R. 601.2(a). The FDA explains in its guidance materials that the clinical trials" }, { "page": 16, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "The FDA\u2019s regulation not only supports the need for expedited treatment under FOIA but is also an independent legal basis that requires expedited treatment of th" }, { "page": 16, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ut is also an independent legal basis that requires expedited treatment of the FOIA Request. 43. This policy is not surprising given the FDA\u2019s commitment to tran" }, { "page": 19, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "edited processing, PHMPT is entitled to immediately seek relief in this Court. 5 U.S.C. \u00a7 552(a)(6)(E)(iii). Requested Relief WHEREFORE, Plaintiff prays that this Court:" }, { "page": 19, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "PHMPT will forthwith disseminate any information it obtains in response to the FOIA Request. PHMPT, as an entity primarily engaged in disseminating information, h" }, { "page": 19, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "to transparency, should immediately release the information PHMPT seeks in the FOIA Request. 53. Because the FDA denied PHMPT\u2019s request for expedited processing" }, { "page": 19, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "b. Enter an Order directing the FDA to produce all documents responsive to the FOIA Request on an expedited basis and in no event later than 10 days from the date" }, { "page": 20, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "ts costs and reasonable attorneys\u2019 fees incurred in this action as provided by 5 U.S.C. \u00a7 552(a)(4)(E); and d. Grant such other and further relief as the Court may deem ju" }, { "page": 22, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "ctronic form: All data and information for the Pfizer Vaccine enumerated in 21 C.F.R. \u00a7 601.51(e)1 with the exception of publicly available reports on the Vaccine Adverse Ev" }, { "page": 22, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "icly available reports on the Vaccine Adverse Events Reporting System.2 1 21 C.F.R. \u00a7 601.51(e) provides that after a biological product is licensed, the following informat" }, { "page": 22, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "all of the data and information in the biological product file, as defined in 21 C.F.R. \u00a7 601.51(a), for the Pfizer Vaccine enumerated in 21 C.F.R. \u00a7 601.51(e) with the except" }, { "page": 22, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "file, as defined in 21 C.F.R. \u00a7 601.51(a), for the Pfizer Vaccine enumerated in 21 C.F.R. \u00a7 601.51(e) with the exception of publicly available reports on the Vaccine Adverse Eve" }, { "page": 23, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \n\u00a7 552", "context": "dited processing of requests for records\u201d upon a showing of \u201ccompelling need.\u201d 5 U.S.C. \u00a7 552(a)(6)(E)(i)(II). When the person requesting information is \u201cprimarily engaged i" }, { "page": 23, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \n\u00a7 552", "context": "Government activity\u201d constitutes a \u201ccompelling need\u201d for expedited processing. 5 U.S.C. \u00a7 552(a)(6)(E)(v)(II). PHMPT is an organization made up of public health profess" }, { "page": 23, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Processing Requested PHMPT requests expedited processing for this request. FOIA provides for \u201cexpedited processing of requests for records\u201d upon a showing of" }, { "page": 23, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "D-19 vaccines. PHMPT intends to make any records produced in response to this FOIA request immediately available to the public through both its website and its i" }, { "page": 24, "family": "USC", "normalized": "21 U.S.C. \u00a7 393", "raw": "21 U.S.C. \u00a7 393", "context": "license vaccines that have been proven to be \u201csafe and effective,\u201d see, e.g., 21 U.S.C. \u00a7 393, and the FDA makes this determination based on, inter alia, clinical trial rep" }, { "page": 24, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "rcumstances are shown: (1) All safety and effectiveness data and information\u2026\u201d 21 C.F.R. \u00a7 601.51(e) (emphasis added). The FDA\u2019s own regulations thus expressly recognize the i" }, { "page": 24, "family": "CFR", "normalized": "21 CFR 601.2", "raw": "21 C.F.R. 601.2", "context": "must be sufficient to demonstrate the product is both \u201csafe\u201d and \u201ceffective.\u201d9 21 C.F.R. 601.2(a). On August 23, 2021, the FDA granted approval to the Pfizer Vaccine10 and," }, { "page": 24, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "The FDA\u2019s regulation not only supports the need for expedited treatment under FOIA but is also an independent legal basis that requires expedited treatment of th" }, { "page": 26, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "pread public debate by immediately producing the information requested in this FOIA request. There is also an urgent need for the public to have immediate access" }, { "page": 28, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 \nU.S.C. \u00a7 552", "context": "is a nonprofit and asks that you waive any and all fees or charges pursuant to 5 U.S.C. \u00a7 552(a)(4)(A)(iii) on the basis that \u201cdisclosure of the [requested] information is i" }, { "page": 33, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "ecords regarding: All data and information for the Pfizer Vaccine enumerated in 21 C.F.R. \u00a7 601.51(e) with the exception of publicly available reports on the Vaccine Adverse Even" }, { "page": 33, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "PROFESSIONALS FOR TRANSPARENCY AARON SIRI Requester reference: August 31, 2021 FOIA Control #: 2021-5683 In Reply refer to Dear Requester: The Food and Drug Admini" }, { "page": 33, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ood and Drug Administration (FDA) has received your Freedom of Information Act (FOIA) request for records regarding: All data and information for the Pfizer Vaccine" }, { "page": 33, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "day time limit in this case, as well as the ten additional days provided by the FOIA. The actual processing time will depend on the complexity of your request and w" }, { "page": 33, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "5630 Fishers Lane, Room 1035 Rockville, MD 20857 If you call or write, use the FOIA control number provided above which will help us to answer your questions more" }, { "page": 33, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "f Government Information Services and/or FDA FOIA Public Liaison National Archives and Administration" }, { "page": 35, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. 552", "context": "on Act (EFOIA) Amendments of 1996 amended the FOIA by adding section (a)(6)(E), 5 U.S.C. 552(a)(6)(E), to require agencies to consider requests for expedited processing and" }, { "page": 35, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "ation Act (FOIA). All data and information for the Pfizer Vaccine enumerated in 21 C.F.R. \u00a7 601.51(e) with the exception of publicly available reports on the Vaccine Adverse Even" }, { "page": 35, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ALS FOR TRANSPARENCY AARON SIRI Requester reference: September 09, 2021 IR#0546 FOIA Control #: 2021-5683 In Reply refer to Dear Requester: This is in reference to" }, { "page": 35, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Food and Drug Administration (FDA) pursuant to the Freedom of Information Act (FOIA). All data and information for the Pfizer Vaccine enumerated in 21 C.F.R. \u00a7 601" }, { "page": 35, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "he Electronic Freedom of Information Act (EFOIA) Amendments of 1996 amended the FOIA by adding section (a)(6)(E), 5 U.S.C. 552(a)(6)(E), to require agencies to cons" }, { "page": 35, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "that your request for expedited processing does not meet the criteria under the FOIA. You have not demonstrated a compelling need that involves an imminent threat" }, { "page": 35, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "appeal this determination. By filing an appeal, you preserve your rights under FOIA and give the agency a chance to review and reconsider your request and the agen" }, { "page": 35, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ur letter \"FDA Freedom of Information Act Appeal.\" You may also contact the FDA FOIA Public Liaison, Office of the Executive Secretariat, 5630 Fishers Lane, Room 10" }, { "page": 35, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "kville, MD 20857; email: FDAFOIA@fda.hhs.gov. If you are unable to resolve your FOIA dispute through our FOIA Public Liaison, the Office of Government Information S" }, { "page": 35, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "FDAFOIA@fda.hhs.gov. If you are unable to resolve your FOIA dispute through our FOIA Public Liaison, the Office of Government Information Services (OGIS), the Feder" }, { "page": 35, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "blic Liaison, the Office of Government Information Services (OGIS), the Federal FOIA Ombudsman\u2019s office, offers mediation services to help resolve disputes between" }, { "page": 35, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Ombudsman\u2019s office, offers mediation services to help resolve disputes between FOIA requesters and Federal agencies. The contact information for OGIS is: Office o" }, { "page": 36, "family": "USC", "normalized": "28 U.S.C. \u00a7 158", "raw": "28 USC 158", "context": "0 Insurance PERSONAL INJURY PERSONAL INJURY 625 Drug Related Seizure 422 Appeal 28 USC 158 375 False Claims Act 120 Marine 310 Airplane 365 Personal Injury - of Property" }, { "page": 36, "family": "USC", "normalized": "21 U.S.C. \u00a7 881", "raw": "21 USC 881", "context": "375 False Claims Act 120 Marine 310 Airplane 365 Personal Injury - of Property 21 USC 881 423 Withdrawal 376 Qui Tam (31 USC 130 Miller Act 315 Airplane Product Product" }, { "page": 36, "family": "USC", "normalized": "31 U.S.C. \u00a7 130", "raw": "31 USC \n130", "context": "plane 365 Personal Injury - of Property 21 USC 881 423 Withdrawal 376 Qui Tam (31 USC 130 Miller Act 315 Airplane Product Product Liability 690 Other 28 USC 157 3729(a))" }, { "page": 36, "family": "USC", "normalized": "28 U.S.C. \u00a7 157", "raw": "28 USC 157", "context": "ui Tam (31 USC 130 Miller Act 315 Airplane Product Product Liability 690 Other 28 USC 157 3729(a)) 140 Negotiable Instrument Liability 367 Health Care/ 400 State Reappor" }, { "page": 36, "family": "USC", "normalized": "15 U.S.C. \u00a7 1681", "raw": "15 USC 1681", "context": "nefits 350 Motor Vehicle 370 Other Fraud 710 Fair Labor Standards Act of 2016 (15 USC 1681 or 1692) 160 Stockholders\u2019 Suits 355 Motor Vehicle 371 Truth in Lending Act 485" }, { "page": 36, "family": "USC", "normalized": "26 U.S.C. \u00a7 7609", "raw": "26 USC 7609", "context": "EY OF RECORD FOR OFFICE USE ONLY RECEIPT # AMOUNT APPLYING IFP JUDGE MAG. JUDGE 26 USC 7609 PUBLIC HEALTH AND MEDICAL PROFESSIONALS FOR TRANSPARENCY Tarrant Howie Law PC" }, { "page": 36, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "bernia Street, Dallas Texas 75204 (212) 622-6340 FOOD AND DRUG ADMINISTRATION 5 U.S.C. \u00a7 552(a)(4)(B) and 28 U.S.C. \u00a7 1331 Freedom of Information Act, 5 U.S.C. \u00a7 552 Sep 16" }, { "page": 36, "family": "USC", "normalized": "28 U.S.C. \u00a7 1331", "raw": "28 U.S.C. \u00a7 1331", "context": "75204 (212) 622-6340 FOOD AND DRUG ADMINISTRATION 5 U.S.C. \u00a7 552(a)(4)(B) and 28 U.S.C. \u00a7 1331 Freedom of Information Act, 5 U.S.C. \u00a7 552 Sep 16, 2021 /s John Howie" }, { "page": 36, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "RATION 5 U.S.C. \u00a7 552(a)(4)(B) and 28 U.S.C. \u00a7 1331 Freedom of Information Act, 5 U.S.C. \u00a7 552 Sep 16, 2021 /s John Howie" }, { "page": 37, "family": "USC", "normalized": "28 U.S.C. \u00a7 1345", "raw": "28 U.S.C. 1345", "context": "in the order shown below. United States plaintiff. (1) Jurisdiction based on 28 U.S.C. 1345 and 1348. Suits by agencies and officers of the United States are included her" }, { "page": 37, "family": "USC", "normalized": "28 U.S.C. \u00a7 1331", "raw": "28 U.S.C. 1331", "context": "s, place an \"X\" in this box. Federal question. (3) This refers to suits under 28 U.S.C. 1331, where jurisdiction arises under the Constitution of the United States, an amen" }, { "page": 37, "family": "USC", "normalized": "28 U.S.C. \u00a7 1332", "raw": "28 U.S.C. 1332", "context": "2 should be marked. Diversity of citizenship. (4) This refers to suits under 28 U.S.C. 1332, where parties are citizens of different states. When Box 4 is checked, the" }, { "page": 37, "family": "USC", "normalized": "47 U.S.C. \u00a7 553", "raw": "47 USC 553", "context": "cite jurisdictional statutes unless diversity. Example: U.S. Civil Statute: 47 USC 553 Brief Description: Unauthorized reception of cable service. VII. Requested i" } ] }, { "filename": "100A_BLA-125742-0_08-20-2021_Memo_Other.pdf", "id": 8102, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/100A_BLA-125742-0_08-20-2021_Memo_Other.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/100A_BLA-125742-0_08-20-2021_Memo_Other.pdf", "total_pages": 5, "matches": [ { "page": 1, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ion contained in this document is CONFIDENTIAL and should not be released. See FOIA exemption regarding circumvention. Product Testing Plans document how CBER" }, { "page": 2, "family": "CFR", "normalized": "21 CFR 610.2", "raw": "21 CFR 610.2", "context": "product including justification for any confirmatory CBER product testing, per 21 CFR 610.2(a). Additionally, for products on Surveillance, summarize the requirements for" } ] }, { "filename": "100_BLA-125742-0_08-20-2021_Memo_Other.pdf", "id": 8103, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/100_BLA-125742-0_08-20-2021_Memo_Other.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/100_BLA-125742-0_08-20-2021_Memo_Other.pdf", "total_pages": 5, "matches": [ { "page": 1, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ion contained in this document is CONFIDENTIAL and should not be released. See FOIA exemption regarding circumvention. Product Testing Plans document how CBER" }, { "page": 2, "family": "CFR", "normalized": "21 CFR 610.2", "raw": "21 CFR 610.2", "context": "product including justification for any confirmatory CBER product testing, per 21 CFR 610.2(a). Additionally, for products on Surveillance, summarize the requirements for" } ] }, { "filename": "101_Courtesy-Copy_BLA-125742-0_Pharmacovigilance-Plan-Review-Addendum-Memo-COMIRNATY.pdf", "id": 8104, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/101_Courtesy-Copy_BLA-125742-0_Pharmacovigilance-Plan-Review-Addendum-Memo-COMIRNATY.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/101_Courtesy-Copy_BLA-125742-0_Pharmacovigilance-Plan-Review-Addendum-Memo-COMIRNATY.pdf", "total_pages": 9, "matches": [ { "page": 6, "family": "Named act", "normalized": "FD&C Act", "raw": "Federal Food, Drug, \nand Cosmetic Act", "context": "oposed PMRs/PMCs: \u2022 Postmarketing requirements (PMR) under Section 505(o) of Federal Food, Drug, and Cosmetic Act (FDCA) to assess known serious risks of myocarditis and pericarditis and an un" }, { "page": 6, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "quirements (PMR) under Section 505(o) of Federal Food, Drug, and Cosmetic Act (FDCA) to assess known serious risks of myocarditis and pericarditis and an unexpect" }, { "page": 8, "family": "CFR", "normalized": "21 CFR 600.80", "raw": "21 CFR 600.80", "context": "pharmacovigilance in accordance with adverse event reporting regulations under 21 CFR 600.80, as per sponsor\u2019s proposed PVP (version 1.1). \u2022 Postmarketing requirement (PMR" }, { "page": 8, "family": "Named act", "normalized": "FD&C Act", "raw": "Federal Food, Drug, and Cosmetic Act", "context": "\u2022 Postmarketing requirement (PMR) safety studies under Section 505(o) of the Federal Food, Drug, and Cosmetic Act (FDCA) to assess the known serious risks of myocarditis and pericarditis and a" }, { "page": 8, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "fety studies under Section 505(o) of the Federal Food, Drug, and Cosmetic Act (FDCA) to assess the known serious risks of myocarditis and pericarditis and an unex" } ] }, { "filename": "102A_BLA-125752-0_01-28-2022_Memo_Compliance-Check-Acce.pdf", "id": 8105, "module": null, "batch_code": null, "company": "Moderna", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2025/05/102A_BLA-125752-0_01-28-2022_Memo_Compliance-Check-Acce.pdf", "ican_url": null, "total_pages": 3, "matches": [] }, { "filename": "102D_BLA-125752-0_01-28-2022_Memo_Compliance-Check-Acce.pdf", "id": 8106, "module": null, "batch_code": null, "company": "Moderna", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2025/05/102D_BLA-125752-0_01-28-2022_Memo_Compliance-Check-Acce.pdf", "ican_url": null, "total_pages": 3, "matches": [] }, { "filename": "102_1_BLA-125742-0_08-20-2021_Memo_Test-Results.pdf", "id": 8107, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/102_1_BLA-125742-0_08-20-2021_Memo_Test-Results.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/102_1_BLA-125742-0_08-20-2021_Memo_Test-Results.pdf", "total_pages": 2, "matches": [] }, { "filename": "102_BLA-125752-0_01-28-2022_Memo_Compliance-Check-Acce.pdf", "id": 8108, "module": null, "batch_code": null, "company": "Moderna", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2025/05/102_BLA-125752-0_01-28-2022_Memo_Compliance-Check-Acce.pdf", "ican_url": null, "total_pages": 4, "matches": [] }, { "filename": "103A_BLA-125752-0_01-28-2022_Memo_Request-For-Complianc.pdf", "id": 8109, "module": null, "batch_code": null, "company": "Moderna", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2025/05/103A_BLA-125752-0_01-28-2022_Memo_Request-For-Complianc.pdf", "ican_url": null, "total_pages": 3, "matches": [] }, { "filename": "103D_BLA-125752-0_01-28-2022_Memo_Request-For-Complianc.pdf", "id": 8110, "module": null, "batch_code": null, "company": "Moderna", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2025/05/103D_BLA-125752-0_01-28-2022_Memo_Request-For-Complianc.pdf", "ican_url": null, "total_pages": 3, "matches": [] }, { "filename": "103_2_BLA-125742-0_08-20-2021_Memo_Test-Results.pdf", "id": 8111, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/103_2_BLA-125742-0_08-20-2021_Memo_Test-Results.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/103_2_BLA-125742-0_08-20-2021_Memo_Test-Results.pdf", "total_pages": 2, "matches": [] }, { "filename": "103_BLA-125752-0_01-28-2022_Memo_Request-For-Complianc.pdf", "id": 8112, "module": null, "batch_code": null, "company": "Moderna", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2025/05/103_BLA-125752-0_01-28-2022_Memo_Request-For-Complianc.pdf", "ican_url": null, "total_pages": 3, "matches": [] }, { "filename": "104A_BLA-125742-0_08-20-2021_Telecon_Information-Reques.pdf", "id": 8113, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/09/104A_BLA-125742-0_08-20-2021_Telecon_Information-Reques.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/09/104A_BLA-125742-0_08-20-2021_Telecon_Information-Reques.pdf", "total_pages": 1, "matches": [] }, { "filename": "104B_BLA-125742-0_08-20-2021_Telecon_Information-Reques.pdf", "id": 8114, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/09/104B_BLA-125742-0_08-20-2021_Telecon_Information-Reques.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/09/104B_BLA-125742-0_08-20-2021_Telecon_Information-Reques.pdf", "total_pages": 1, "matches": [] }, { "filename": "104_BLA-125742-0_08-20-2021_Telecon_Information-Reques.pdf", "id": 8115, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/09/104_BLA-125742-0_08-20-2021_Telecon_Information-Reques.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/09/104_BLA-125742-0_08-20-2021_Telecon_Information-Reques.pdf", "total_pages": 1, "matches": [] }, { "filename": "105A_BLA-125752-0_01-28-2022_Telecon_Information-Reques.pdf", "id": 8116, "module": null, "batch_code": null, "company": "Moderna", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2025/05/105A_BLA-125752-0_01-28-2022_Telecon_Information-Reques.pdf", "ican_url": null, "total_pages": 17, "matches": [] }, { "filename": "105_BLA-125742-0_08-20-2021_Telecon_Advice_Information.pdf", "id": 8117, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/105_BLA-125742-0_08-20-2021_Telecon_Advice_Information.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/105_BLA-125742-0_08-20-2021_Telecon_Advice_Information.pdf", "total_pages": 3, "matches": [] }, { "filename": "105_BLA-125752-0_01-28-2022_Telecon_Information-Reques.pdf", "id": 8118, "module": null, "batch_code": null, "company": "Moderna", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2025/05/105_BLA-125752-0_01-28-2022_Telecon_Information-Reques.pdf", "ican_url": null, "total_pages": 1, "matches": [] }, { "filename": "106A_2_BLA_125742-0_08-20-2021_Telecon_Labeling-via-FAX_e.pdf", "id": 8119, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/01/106A_2_BLA_125742-0_08-20-2021_Telecon_Labeling-via-FAX_e.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/01/106A_2_BLA_125742-0_08-20-2021_Telecon_Labeling-via-FAX_e.pdf", "total_pages": 21, "matches": [] }, { "filename": "106_2_BLA-125742-0_08-20-2021_Telecon_Labeling-via-FAX_e.pdf", "id": 8120, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/09/106_2_BLA-125742-0_08-20-2021_Telecon_Labeling-via-FAX_e.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/09/106_2_BLA-125742-0_08-20-2021_Telecon_Labeling-via-FAX_e.pdf", "total_pages": 2, "matches": [] }, { "filename": "107A_1_BLA-125742-0_08-20-2021_Telecon_Labeling-via-FAX_e.pdf", "id": 8121, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/107A_1_BLA-125742-0_08-20-2021_Telecon_Labeling-via-FAX_e.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/107A_1_BLA-125742-0_08-20-2021_Telecon_Labeling-via-FAX_e.pdf", "total_pages": 2, "matches": [] }, { "filename": "107_1_BLA-125742-0_08-20-2021_Telecon_Labeling-via-FAX_e.pdf", "id": 8122, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/107_1_BLA-125742-0_08-20-2021_Telecon_Labeling-via-FAX_e.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/107_1_BLA-125742-0_08-20-2021_Telecon_Labeling-via-FAX_e.pdf", "total_pages": 3, "matches": [] }, { "filename": "107_BLA-125752-0_01-31-2022_Inspection-Related_Inspect.pdf", "id": 8123, "module": null, "batch_code": null, "company": "Moderna", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2025/05/107_BLA-125752-0_01-31-2022_Inspection-Related_Inspect.pdf", "ican_url": null, "total_pages": 3, "matches": [] }, { "filename": "108_BLA-125742-0_08-21-2021_Inspection-Related_Inspect.pdf", "id": 8124, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/108_BLA-125742-0_08-21-2021_Inspection-Related_Inspect.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/108_BLA-125742-0_08-21-2021_Inspection-Related_Inspect.pdf", "total_pages": 29, "matches": [] }, { "filename": "109_Courtesy-Copy_2_BLA-125742-0_CMC-Review-Memo-August-21-2021-COMIRNATY.pdf", "id": 8125, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/109_Courtesy-Copy_2_BLA-125742-0_CMC-Review-Memo-August-21-2021-COMIRNATY.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/109_Courtesy-Copy_2_BLA-125742-0_CMC-Review-Memo-August-21-2021-COMIRNATY.pdf", "total_pages": 63, "matches": [ { "page": 5, "family": "CFR", "normalized": "21 CFR 610.15", "raw": "21 CFR 610.15", "context": "ptance criteria July 15, 2021 STN 125742/0.11 Request for an exception to the 21 CFR 610.15(a) for the vaccine as a preservative-free presentation July 23, 2021 STN 12" }, { "page": 48, "family": "CFR", "normalized": "21 CFR 610.15", "raw": "21 CFR 610.15", "context": "uction concentration of for ALC-0315 and for ALC-0159). Exception to the 21 CFR 610.15(a) Requirement for a Preservative Under 21 CFR 610.15(a), a vaccine product in" }, { "page": 48, "family": "CFR", "normalized": "21 CFR 610.15", "raw": "21 CFR 610.15", "context": "159). Exception to the 21 CFR 610.15(a) Requirement for a Preservative Under 21 CFR 610.15(a), a vaccine product in multiple-dose containers should contain a preservativ" }, { "page": 48, "family": "CFR", "normalized": "21 CFR 610.15", "raw": "21 CFR 610.15", "context": "cant submitted to STN 125742/0 in amendment 11, a request for exception to the 21 CFR 610.15(a) requirement. The justification for the unpreserved multi-dose presentation" }, { "page": 49, "family": "CFR", "normalized": "21 CFR 610.15", "raw": "21 CFR 610.15", "context": "al authorizations. Reviewer\u2019s Comments: The request for an exception to the 21 CFR 610.15(a) for the BNT162b2 vaccine as a multi-dose preservative-free presentation is" } ] }, { "filename": "10_BLA-125742-11_12-22-2021_Memo_Committee-Memo_CMC.pdf", "id": 8126, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/10_BLA-125742-11_12-22-2021_Memo_Committee-Memo_CMC.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/10_BLA-125742-11_12-22-2021_Memo_Committee-Memo_CMC.pdf", "total_pages": 2, "matches": [] }, { "filename": "10_BLA-125752-0_09-24-2021_Telecon_Information-Reques.pdf", "id": 8127, "module": null, "batch_code": null, "company": "Moderna", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2025/05/10_BLA-125752-0_09-24-2021_Telecon_Information-Reques.pdf", "ican_url": null, "total_pages": 6, "matches": [] }, { "filename": "110_1_Courtesy-Copy_BLA-125742-0_Analytical-Method-Review-Memo-COMIRNATY.pdf", "id": 8128, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/110_1_Courtesy-Copy_BLA-125742-0_Analytical-Method-Review-Memo-COMIRNATY.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/110_1_Courtesy-Copy_BLA-125742-0_Analytical-Method-Review-Memo-COMIRNATY.pdf", "total_pages": 31, "matches": [] }, { "filename": "111521-Second-Joint-Status-Report.pdf", "id": 8129, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2021/11/111521-Second-Joint-Status-Report.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2022/03/111521-Second-Joint-Status-Report.pdf", "total_pages": 14, "matches": [ { "page": 1, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "processing of records in response to Plaintiff\u2019s Freedom of Information Act (\u201cFOIA\u201d) request. Setting a processing schedule does not go to the merits of the case" }, { "page": 1, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "he case, but instead sets the schedule for the necessary deadlines to govern a FOIA case. The processing schedule serves as an important precursor to future dead" }, { "page": 1, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "uture deadlines in the case, including scheduling for dispositive motions. In FOIA cases, a FOIA requestor typically files suit after it has submitted a FOIA requ" }, { "page": 1, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "s in the case, including scheduling for dispositive motions. In FOIA cases, a FOIA requestor typically files suit after it has submitted a FOIA request to an age" }, { "page": 1, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "In FOIA cases, a FOIA requestor typically files suit after it has submitted a FOIA request to an agency and the agency has not yet processed and produced all res" }, { "page": 2, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "Page 2 of 14 requestor. 5 U.S.C. \u00a7 552(a)(4)(B). Once a case is filed and the government has answered the complaint," }, { "page": 2, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "ct that information before providing responsive records to the plaintiff. See 5 U.S.C. \u00a7 552(b)(1)\u2013(b)(9). Reviewing and redacting records for exempt information is a tim" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "nt will search for, process, and produce records responsive to the plaintiff\u2019s FOIA request. If the parties are unable to agree upon a schedule, courts typically" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "e is necessary because many different types of information are exempt from the FOIA, such that the government must redact that information before providing respons" }, { "page": 3, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Page 3 of 14 merits of the case. Summary judgment briefing in a FOIA case is not the appropriate vehicle to set a schedule for the release of recor" }, { "page": 3, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "d that there are more than 329,000 pages potentially responsive to Plaintiff\u2019s FOIA request. (This page count is under-inclusive of the material responsive to th" }, { "page": 4, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "is consistent with processing schedules entered by courts across the country in FOIA cases.3 Plaintiff\u2019s request (as set forth below) that FDA process and produc" }, { "page": 4, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "risk of inadvertent disclosure of records properly subject to exemption under FOIA.\u201d Daily Caller v. Dep\u2019t of State, 152 F. Supp. 3d 1, 14 (D.D.C. 2015). Plaint" }, { "page": 4, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ed by the vaccine sponsor (Pfizer-BioNTech). From FDA\u2019s experience with other FOIA requests, such records can be expected to contain both 3 See, e.g., Document" }, { "page": 5, "family": "Court case", "normalized": "F.B.I. v. Abramson, 456 U.S. 615", "raw": "F.B.I. v. Abramson, 456 U.S. 615", "context": "n is exempt from production under the FOIA. See 5 U.S.C. \u00a7 552(b)(4), (b)(6); F.B.I. v. Abramson, 456 U.S. 615, 621 (1982) (\u201cCongress realized that legitimate governmental and private inter" }, { "page": 5, "family": "USC", "normalized": "5 U.S.C. \u00a7 552", "raw": "5 U.S.C. \u00a7 552", "context": "aw and this type of information is exempt from production under the FOIA. See 5 U.S.C. \u00a7 552(b)(4), (b)(6); F.B.I. v. Abramson, 456 U.S. 615, 621 (1982) (\u201cCongress realized" }, { "page": 5, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "under the law and this type of information is exempt from production under the FOIA. See 5 U.S.C. \u00a7 552(b)(4), (b)(6); F.B.I. v. Abramson, 456 U.S. 615, 621 (198" }, { "page": 5, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "on of this information, and other information subject to withholding under the FOIA exemptions, FDA must carefully review and, if necessary, redact exempt informat" }, { "page": 5, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": ". 3d at 14 (stating that the government has a \u201cresponsibility\u201d when processing FOIA requests to \u201csafeguard[] potentially sensitive information\u201d). This type of re" }, { "page": 5, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "information. Second, the FDA does not have the personnel or resources in its FOIA office to process Plaintiff\u2019s FOIA request at a rate of more than 80,000 pages" }, { "page": 5, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "not have the personnel or resources in its FOIA office to process Plaintiff\u2019s FOIA request at a rate of more than 80,000 pages per month. Plaintiff\u2019s FOIA reques" }, { "page": 5, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "tiff\u2019s FOIA request at a rate of more than 80,000 pages per month. Plaintiff\u2019s FOIA request is being processed by the Access Litigation and Freedom of Information" }, { "page": 5, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ntly responsible for processing a total of approximately 400 currently pending FOIA requests, including Plaintiff\u2019s. CBER is currently involved in 6 active FOIA l" }, { "page": 5, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "g FOIA requests, including Plaintiff\u2019s. CBER is currently involved in 6 active FOIA litigation matters. By processing and making interim responses based on 500-p" }, { "page": 6, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ssentially all of FDA\u2019s resources and leaving little resources to process other FOIA requests. Indeed, the D.C. Circuit has recognized that another agency\u2019s polic" }, { "page": 6, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "reliminary injunction requesting immediate production of documents pursuant to FOIA request and noting that allowing the plaintiff \u201cto jump to the head of the lin" }, { "page": 6, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "upp. 3d at 14 (stating that \u201cthe plaintiff\u2019s effort to jump to the head of the FOIA processing line would work a significant burden on both the agency and numerou" }, { "page": 6, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "dering whether FDA must keep certain information confidential. Moreover, FDA\u2019s FOIA office does not have nearly the same level of personnel or resources dedicated" }, { "page": 6, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "s not have nearly the same level of personnel or resources dedicated to process FOIA requests as FDA has marshaled to review license applications for live-saving p" }, { "page": 7, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "ng of a request submitted under the Freedom of Information Act. See generally 21 C.F.R. \u00a7 601.51. Put another way, the regulations establish the point in time when records th" }, { "page": 7, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "se \u201cimmediately\u201d upon occurrence of the triggering event. Specifically, under 21 C.F.R. \u00a7 601.51, the existence of a biological product file will not be disclosed by FDA prior" }, { "page": 7, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": ", and no data or information in that file is available for public disclosure. 21 C.F.R. \u00a7 601.51(b, c). If the existence of the biological product file has been acknowledged" }, { "page": 7, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "the file available for public disclosure prior to issuance of a BLA license. 21 C.F.R. \u00a7 601.51(d). Once a license has been issued, however, certain data and information in" }, { "page": 7, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "biological product file become \u201cimmediately\u201d available for public disclosure. 21 C.F.R. \u00a7 601.51(e). That means that if a properly submitted FOIA request is received for data" }, { "page": 7, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "properly submitted FOIA request is received for data and information listed in 21 C.F.R. \u00a7 601.51(e), FDA may publicly release such information in response to such request, wit" }, { "page": 7, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "c disclosure. 21 C.F.R. \u00a7 601.51(e). That means that if a properly submitted FOIA request is received for data and information listed in 21 C.F.R. \u00a7 601.51(e)," }, { "page": 7, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "pages at a rate of 500 pages per month, such a result is due to its own broad FOIA request. Courts do not waiver from the standard 500 page per month processing" }, { "page": 7, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "do not waiver from the standard 500 page per month processing rate even when a FOIA request would take years to process. See, e.g., Colbert v. F.B.I., No. 16-CV-" }, { "page": 8, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "quest requested: \u201cAll data and information for the Pfizer Vaccine enumerated in 21 C.F.R. \u00a7 601.51(e)4 with the exception of publicly available reports on the Vaccine Adverse Ev" }, { "page": 8, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "all of the data and information in the biological product file, as defined in 21 C.F.R. \u00a7 601.51(a), for the Pfizer Vaccine enumerated in 21 C.F.R. \u00a7 601.51(e) with the excepti" }, { "page": 8, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "ile, as defined in 21 C.F.R. \u00a7 601.51(a), for the Pfizer Vaccine enumerated in 21 C.F.R. \u00a7 601.51(e) with the exception of publicly available reports on the Vaccine Adverse Eve" }, { "page": 8, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "s not about a vaccine mandate or whether Pfizer can be held liable. This is a FOIA case where the only relevant issue at this stage in the litigation is setting a" }, { "page": 8, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "e protection of their personal privacy information, and the interests of other FOIA requesters whose requests are being processed alongside Plaintiff\u2019s. 3. Plain" }, { "page": 8, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "e records submitted to the FDA by Pfizer to license its COVID-19 vaccine (the \u201cFOIA request\u201d)4 and requests an order requiring the FDA to produce all documents" }, { "page": 8, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "st\u201d)4 and requests an order requiring the FDA to produce all documents 4 The FOIA request requested: \u201cAll data and information for the Pfizer Vaccine enumerated" }, { "page": 8, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "accine Adverse Events Reporting System.4\u201d The CFR provision referenced in the FOIA request provides, in relevant part, as follows: \u201cAfter a license has been issue" }, { "page": 8, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "rds showing the testing of and action on a particular lot by the [FDA].\u201d The FOIA request also explained that \u201cFor the avoidance of doubt, the FOIA Request incl" }, { "page": 8, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "FDA].\u201d The FOIA request also explained that \u201cFor the avoidance of doubt, the FOIA Request includes but is not limited to all of the data and information in the b" }, { "page": 9, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "Page 9 of 14 responsive to its FOIA request no later than March 3, 2022. This 108-day period is the same amount o" }, { "page": 10, "family": "USC", "normalized": "42 U.S.C. \u00a7 247d-6d", "raw": "42 U.S.C. \n\u00a7 247d-6d", "context": "of HHS, Pfizer cannot be sued by anyone receiving this product for any injury. 42 U.S.C. \u00a7 247d-6d. Pfizer also cannot be sued for willful misconduct regarding this product unle" }, { "page": 10, "family": "USC", "normalized": "42 U.S.C. \u00a7 247d-6d", "raw": "42 U.S.C. \u00a7 247d-6d", "context": "ess HHS, which has been promoting this product, agrees to bring such a claim. 42 U.S.C. \u00a7 247d-6d(c)(5).13 It should not be that the public is deprived accessing the document" }, { "page": 10, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 CFR \u00a7 601.51", "context": ",were%202.1%20active%20duty%20members (last visited November 12, 2021). 12 See 21 CFR \u00a7 601.51(e). 13 Reports have recently surfaced that the FDA was aware of concerns about" }, { "page": 11, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "make \u201cimmediately available\u201d all documents underlying licensure of a vaccine. 21 C.F.R. \u00a7 601.51(e). The FDA knew the intense public interest in that data and information. It" }, { "page": 11, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "d scientists should be provided the same forthwith. The entire purpose of the FOIA is to assure government transparency. It is difficult to imagine a greater ne" }, { "page": 12, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "recisely why the need for transparency is so critical and why Congress enacted FOIA. If the FDA claims its obligations under FOIA are too burdensome, it should t" }, { "page": 12, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "itical and why Congress enacted FOIA. If the FDA claims its obligations under FOIA are too burdensome, it should take its complaints to Congress \u2013 not this Court" }, { "page": 13, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "fore March 3, 2022, which is 108 days from today. To require less is to render FOIA meaningless, the FDA\u2019s promise of transparency a lie, and to send a signal to" }, { "page": 13, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "to be able to sell this product. That simply should not be and highlights why FOIA and equity demand the relief Plaintiff requests herein. Dated: November" } ] }, { "filename": "111_BLA-125742-0_08-21-2021_Telecon_Advice.pdf", "id": 8130, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/111_BLA-125742-0_08-21-2021_Telecon_Advice.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/111_BLA-125742-0_08-21-2021_Telecon_Advice.pdf", "total_pages": 1, "matches": [] }, { "filename": "112A_1_BLA-125742-0_08-21-2021_Telecon_Information-Reques.pdf", "id": 8131, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/09/112A_1_BLA-125742-0_08-21-2021_Telecon_Information-Reques.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/09/112A_1_BLA-125742-0_08-21-2021_Telecon_Information-Reques.pdf", "total_pages": 1, "matches": [] }, { "filename": "112_1_BLA-125742-0_08-21-2021_Telecon_Information-Reques.pdf", "id": 8132, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/09/112_1_BLA-125742-0_08-21-2021_Telecon_Information-Reques.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/09/112_1_BLA-125742-0_08-21-2021_Telecon_Information-Reques.pdf", "total_pages": 1, "matches": [] }, { "filename": "112_BLA-125752-0_01-31-2022_Memo_Other.pdf", "id": 8133, "module": null, "batch_code": null, "company": "Moderna", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2025/05/112_BLA-125752-0_01-31-2022_Memo_Other.pdf", "ican_url": null, "total_pages": 2, "matches": [] }, { "filename": "113_2_BLA-125742-0_08-21-2021_Telecon_Information-Reques.pdf", "id": 8134, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/09/113_2_BLA-125742-0_08-21-2021_Telecon_Information-Reques.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/09/113_2_BLA-125742-0_08-21-2021_Telecon_Information-Reques.pdf", "total_pages": 6, "matches": [] }, { "filename": "114A_2_BLA_125742-0_08-21-2021_Telecon_Labeling-via-FAX_e.pdf", "id": 8135, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/01/114A_2_BLA_125742-0_08-21-2021_Telecon_Labeling-via-FAX_e.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/01/114A_2_BLA_125742-0_08-21-2021_Telecon_Labeling-via-FAX_e.pdf", "total_pages": 20, "matches": [] }, { "filename": "114_2_BLA-125742-0_08-21-2021_Telecon_Labeling-via-FAX_e.pdf", "id": 8136, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/09/114_2_BLA-125742-0_08-21-2021_Telecon_Labeling-via-FAX_e.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/09/114_2_BLA-125742-0_08-21-2021_Telecon_Labeling-via-FAX_e.pdf", "total_pages": 1, "matches": [] }, { "filename": "115_1_BLA-125742-0_08-21-2021_Telecon_Labeling-via-FAX_e.pdf", "id": 8137, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/115_1_BLA-125742-0_08-21-2021_Telecon_Labeling-via-FAX_e.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/115_1_BLA-125742-0_08-21-2021_Telecon_Labeling-via-FAX_e.pdf", "total_pages": 1, "matches": [] }, { "filename": "116_BLA-125742-0_08-21-2021_Inspection-Related_Establi.pdf", "id": 8138, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/116_BLA-125742-0_08-21-2021_Inspection-Related_Establi.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/116_BLA-125742-0_08-21-2021_Inspection-Related_Establi.pdf", "total_pages": 86, "matches": [] }, { "filename": "117_2_BLA-125742-0_08-22-2021_Inspection-Related_Inspect.pdf", "id": 8139, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/117_2_BLA-125742-0_08-22-2021_Inspection-Related_Inspect.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/117_2_BLA-125742-0_08-22-2021_Inspection-Related_Inspect.pdf", "total_pages": 3, "matches": [] }, { "filename": "118_1_BLA-125742-0_08-22-2021_Inspection-Related_Inspect.pdf", "id": 8140, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/118_1_BLA-125742-0_08-22-2021_Inspection-Related_Inspect.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/118_1_BLA-125742-0_08-22-2021_Inspection-Related_Inspect.pdf", "total_pages": 3, "matches": [] }, { "filename": "119_Courtesy-Copy_BLA-125742-0_Real-World-Evidence-BLA-Memo-COMIRNATY.pdf", "id": 8141, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/119_Courtesy-Copy_BLA-125742-0_Real-World-Evidence-BLA-Memo-COMIRNATY.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/119_Courtesy-Copy_BLA-125742-0_Real-World-Evidence-BLA-Memo-COMIRNATY.pdf", "total_pages": 7, "matches": [ { "page": 7, "family": "Named act", "normalized": "FD&C Act", "raw": "Federal \nFood, Drug, and Cosmetic Act", "context": "ONS Postmarketing requirement (PMR) safety studies under Section 505(o) of the Federal Food, Drug, and Cosmetic Act (FDCA) to assess the known serious risks of myocarditis and pericarditis, usin" }, { "page": 7, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "fety studies under Section 505(o) of the Federal Food, Drug, and Cosmetic Act (FDCA) to assess the known serious risks of myocarditis and pericarditis, using real" } ] }, { "filename": "11_BLA-125742-0_06-29-2021_Telecon_Information-Reques.pdf", "id": 8142, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/09/11_BLA-125742-0_06-29-2021_Telecon_Information-Reques.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/09/11_BLA-125742-0_06-29-2021_Telecon_Information-Reques.pdf", "total_pages": 2, "matches": [] }, { "filename": "11_BLA-125752-0_09-27-2021_Memo_Committee-Memo_APLB.pdf", "id": 8143, "module": null, "batch_code": null, "company": "Moderna", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2025/05/11_BLA-125752-0_09-27-2021_Memo_Committee-Memo_APLB.pdf", "ican_url": null, "total_pages": 5, "matches": [ { "page": 1, "family": "Named act", "normalized": "FD&C Act", "raw": "Federal Food, Drug, and Cosmetic Act", "context": "CBER\u2019s Advertising and Promotional Labeling Branch, we conclude that under the Federal Food, Drug, and Cosmetic Act and applicable regulations your proposed proprietary name, SPIKEVAX, is Accept" }, { "page": 3, "family": "CFR", "normalized": "21 CFR 201.10", "raw": "21 CFR 201.10", "context": "2. Evaluating for Promotional and Safety Concerns a. Promotional Review [21 CFR 201.10 (c)(3), 202.1 (e)(5)(i), and (e)(6)(i)] The proposed proprietary name, SPIKE" }, { "page": 3, "family": "CFR", "normalized": "21 CFR 201.10", "raw": "21 CFR 201.10", "context": "e false, misleading, or fanciful. b. Look-alike Sound-alike Safety Review [21 CFR 201.10 (c)(5)] Since drug products are prescribed through written, verbal, and/or e" } ] }, { "filename": "11_PM_S136_BLA-125742-31_10-30-2021_Memo_Final-Review-Memo.pdf", "id": 8144, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/10/11_PM_S136_BLA-125742-31_10-30-2021_Memo_Final-Review-Memo.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/10/11_PM_S136_BLA-125742-31_10-30-2021_Memo_Final-Review-Memo.pdf", "total_pages": 2, "matches": [] }, { "filename": "120_Courtesy-Copy_BLA-125742-0_CBER-CMC-BLA-Review-Memo-COMIRNATY.pdf", "id": 8145, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/120_Courtesy-Copy_BLA-125742-0_CBER-CMC-BLA-Review-Memo-COMIRNATY.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/120_Courtesy-Copy_BLA-125742-0_CBER-CMC-BLA-Review-Memo-COMIRNATY.pdf", "total_pages": 124, "matches": [] }, { "filename": "121_Courtesy-Copy_BLA-125742-0_Employee-Officer-List-Memo-August-22-2021-COMIRNATY.pdf", "id": 8146, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/121_Courtesy-Copy_BLA-125742-0_Employee-Officer-List-Memo-August-22-2021-COMIRNATY.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/121_Courtesy-Copy_BLA-125742-0_Employee-Officer-List-Memo-August-22-2021-COMIRNATY.pdf", "total_pages": 1, "matches": [] }, { "filename": "122_BLA-125742-0_08-22-2021_Telecon_Labeling-via-FAX_e.pdf", "id": 8147, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/122_BLA-125742-0_08-22-2021_Telecon_Labeling-via-FAX_e.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/122_BLA-125742-0_08-22-2021_Telecon_Labeling-via-FAX_e.pdf", "total_pages": 1, "matches": [] }, { "filename": "123_Courtesy-Copy_BLA-125742-0_August-23-2021-Approval-Letter-Comirnaty.pdf", "id": 8148, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/123_Courtesy-Copy_BLA-125742-0_August-23-2021-Approval-Letter-Comirnaty.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/123_Courtesy-Copy_BLA-125742-0_August-23-2021-Approval-Letter-Comirnaty.pdf", "total_pages": 11, "matches": [ { "page": 1, "family": "Named act", "normalized": "PHS Act", "raw": "Public Health Service Act", "context": "ion (BLA) submitted and received on May 18, 2021, under section 351(a) of the Public Health Service Act (PHS Act) for COVID-19 Vaccine, mRNA. LICENSING We are issuing Departmen" }, { "page": 1, "family": "Named act", "normalized": "PHS Act", "raw": "PHS Act", "context": "eived on May 18, 2021, under section 351(a) of the Public Health Service Act (PHS Act) for COVID-19 Vaccine, mRNA. LICENSING We are issuing Department of Heal" }, { "page": 1, "family": "Named act", "normalized": "PHS Act", "raw": "PHS Act", "context": "ufacturing GmbH, Mainz, Germany, under the provisions of section 351(a) of the PHS Act controlling the manufacture and sale of biological products. The license auth" }, { "page": 2, "family": "CFR", "normalized": "21 CFR 601.12", "raw": "21 CFR \n601.12", "context": "ing the expiration dating period of your drug substance and drug product under 21 CFR 601.12. FDA LOT RELEASE Please submit final container samples of the product in fina" }, { "page": 2, "family": "CFR", "normalized": "21 CFR 600.14", "raw": "21 CFR 600.14", "context": "DUCT DEVIATIONS You must submit reports of biological product deviations under 21 CFR 600.14. You should identify and investigate all manufacturing deviations promptly, i" }, { "page": 3, "family": "CFR", "normalized": "21 CFR 601.12", "raw": "21 \nCFR 601.12", "context": "u must submit information to your BLA for our review and written approval under 21 CFR 601.12 for any changes in, including but not limited to, the manufacturing, testing," }, { "page": 3, "family": "CFR", "normalized": "21 CFR 601.14", "raw": "21 CFR 601.14", "context": "ays from the date of this letter, please submit the final content of labeling (21 CFR 601.14) in Structured Product Labeling (SPL) format via the FDA automated drug regist" }, { "page": 4, "family": "USC", "normalized": "21 U.S.C. \u00a7 355c", "raw": "21 U.S.C. 355c", "context": "m. PEDIATRIC REQUIREMENTS Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new active ingredients, new indications, new dosage for" }, { "page": 4, "family": "CFR", "normalized": "21 CFR 601.12", "raw": "21 CFR \n601.12", "context": "he time of initial dissemination or publication, accompanied by Form FDA 2253 (21 CFR 601.12(f)(4)). All promotional claims must be consistent with and not contrary to a" }, { "page": 4, "family": "CFR", "normalized": "21 CFR 202.1", "raw": "21 CFR 202.1", "context": "ubstantial evidence or substantial clinical experience to support such claims (21 CFR 202.1(e)(6)). ADVERSE EVENT REPORTING You must submit adverse experience report" }, { "page": 4, "family": "CFR", "normalized": "21 CFR 600.80", "raw": "21 CFR 600.80", "context": "he adverse experience reporting requirements for licensed biological products (21 CFR 600.80), and you must submit distribution reports at monthly intervals as described i" }, { "page": 4, "family": "CFR", "normalized": "21 CFR 600.81", "raw": "21 CFR \n600.81", "context": "and you must submit distribution reports at monthly intervals as described in 21 CFR 600.81. For information on adverse experience reporting, please refer to the guidance" }, { "page": 5, "family": "CFR", "normalized": "21 CFR 601.28", "raw": "21 CFR 601.28", "context": "dies. The status of these postmarketing studies must be reported according to 21 CFR 601.28 and section 505B(a)(4)(C) of the FDCA. In addition, section 506B of the FDCA" }, { "page": 5, "family": "CFR", "normalized": "21 CFR 601.70", "raw": "21 CFR 601.70", "context": "section 505B(a)(4)(C) of the FDCA. In addition, section 506B of the FDCA and 21 CFR 601.70 require you to report annually on the status of any postmarketing commitments" }, { "page": 5, "family": "Named act", "normalized": "FD&C Act", "raw": "Federal Food, \nDrug, and Cosmetic Act", "context": "arkins Your deferred pediatric studies required under section 505B(a) of the Federal Food, Drug, and Cosmetic Act (FDCA) are required postmarketing studies. The status of these postmarketing" }, { "page": 5, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "es required under section 505B(a) of the Federal Food, Drug, and Cosmetic Act (FDCA) are required postmarketing studies. The status of these postmarketing studie" }, { "page": 5, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "s must be reported according to 21 CFR 601.28 and section 505B(a)(4)(C) of the FDCA. In addition, section 506B of the FDCA and 21 CFR 601.70 require you to repor" }, { "page": 5, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "01.28 and section 505B(a)(4)(C) of the FDCA. In addition, section 506B of the FDCA and 21 CFR 601.70 require you to report annually on the status of any postmark" }, { "page": 5, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "nd Commitments subject to the reporting requirements under section 506B of the FDCA are released or fulfilled. These required studies are listed below: 1. Def" }, { "page": 6, "family": "USC", "normalized": "21 U.S.C. \u00a7 355", "raw": "21 U.S.C. 355", "context": ", if FDA makes certain findings required by the statute (section 505(o)(3)(A), 21 U.S.C. 355(o)(3)(A)). We have determined that an analysis of spontaneous postmarketing" }, { "page": 6, "family": "Named act", "normalized": "FD&C Act", "raw": "Federal Food, Drug, and Cosmetic Act", "context": "on. POSTMARKETING REQUIREMENTS UNDER SECTION 505(o) Section 505(o) of the Federal Food, Drug, and Cosmetic Act (FDCA) authorizes FDA to require holders of approved drug and biological produ" }, { "page": 6, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "R SECTION 505(o) Section 505(o) of the Federal Food, Drug, and Cosmetic Act (FDCA) authorizes FDA to require holders of approved drug and biological product app" }, { "page": 6, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "ontaneous postmarketing adverse events reported under section 505(k)(1) of the FDCA will not be sufficient to assess known serious risks of myocarditis and perica" }, { "page": 6, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "gilance system that FDA is required to maintain under section 505(k)(3) of the FDCA is not sufficient to assess these serious risks. Therefore, based on appropr" }, { "page": 8, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "marketing Final Report under Section 505(o) Section 505(o)(3)(E)(ii) of the FDCA requires you to report periodically on the status of any study or clinical tri" }, { "page": 9, "family": "CFR", "normalized": "21 CFR 601.70", "raw": "21 \nCFR 601.70", "context": "taken to investigate a safety issue. In addition, section 506B of the FDCA and 21 CFR 601.70 require you to report annually on the status of any postmarketing commitments" }, { "page": 9, "family": "CFR", "normalized": "21 CFR 601.70", "raw": "21 CFR 601.70", "context": "number enrolled to date and the total planned enrollment). As described in 21 CFR 601.70(e), we may publicly disclose information regarding these postmarketing studies" }, { "page": 9, "family": "CFR", "normalized": "21 CFR 601.70", "raw": "21 CFR 601.70", "context": "nsider the submission of your annual report under section 506B of the FDCA and 21 CFR 601.70 to satisfy the periodic reporting requirement under section 505(o)(3)(E)(ii) p" }, { "page": 9, "family": "CFR", "normalized": "21 CFR 601.70", "raw": "21 \nCFR 601.70", "context": ")(3)(E)(ii) provided that you include the elements listed in section 505(o) and 21 CFR 601.70. We remind you that to comply with section 505(o), your annual report must a" }, { "page": 9, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "undertaken to investigate a safety issue. In addition, section 506B of the FDCA and 21 CFR 601.70 require you to report annually on the status of any postmark" }, { "page": 9, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "s and Commitments subject to the reporting requirements of section 506B of the FDCA are fulfilled or released. The status report for each study should include:" }, { "page": 9, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "We will consider the submission of your annual report under section 506B of the FDCA and 21 CFR 601.70 to satisfy the periodic reporting requirement under section" }, { "page": 9, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "studies or clinical trials required under section 505(o) may be a violation of FDCA section 505(o)(3)(E)(ii) and could result in regulatory action. POSTMARKETI" }, { "page": 11, "family": "CFR", "normalized": "21 CFR 601.70", "raw": "21 CFR 601.70", "context": "arkins For each postmarketing study subject to the reporting requirements of 21 CFR 601.70, you must describe the status in an annual report on postmarketing studies for" }, { "page": 11, "family": "CFR", "normalized": "21 CFR 601.70", "raw": "21 CFR 601.70", "context": ", number enrolled to date and the total planned enrollment). As described in 21 CFR 601.70(e), we may publicly disclose information regarding these postmarketing studies" }, { "page": 11, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "s and Commitments subject to the reporting requirements of section 506B of the FDCA are fulfilled or released. The status report for each study should include:" } ] }, { "filename": "124_BLA-125742-0_08-23-2021_Memo_Committee-Memo_SBRA.pdf", "id": 8149, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/124_BLA-125742-0_08-23-2021_Memo_Committee-Memo_SBRA.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/124_BLA-125742-0_08-23-2021_Memo_Committee-Memo_SBRA.pdf", "total_pages": 31, "matches": [ { "page": 9, "family": "CFR", "normalized": "21 CFR 610.15", "raw": "21 CFR 610.15", "context": "it does not contain preservative. [See section 10.b regarding exception to the 21 CFR 610.15(a) requirement for a preservative.] Stability of COMIRNATY The Applicant co" }, { "page": 14, "family": "CFR", "normalized": "21 CFR 25.31", "raw": "21 CFR 25.31", "context": "ded a request for categorical exclusion from an Environmental Assessment under 21 CFR 25.31. The FDA concluded that this request is justified, and no extraordinary circum" }, { "page": 23, "family": "Named act", "normalized": "FD&C Act", "raw": "Federal Food, Drug, and Cosmetic Act", "context": "uct postmarketing requirement (PMR) safety studies under Section 505(o) of the Federal Food, Drug, and Cosmetic Act (FDCA) to assess the known serious risks of myocarditis and pericarditis as we" }, { "page": 23, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "fety studies under Section 505(o) of the Federal Food, Drug, and Cosmetic Act (FDCA) to assess the known serious risks of myocarditis and pericarditis as well as" }, { "page": 24, "family": "Named act", "normalized": "FD&C Act", "raw": "Federal \nFood, Drug, and Cosmetic Act", "context": "uct postmarketing requirement (PMR) safety studies under Section 505(o) of the Federal Food, Drug, and Cosmetic Act (FDCA) to assess the known serious risks of myocarditis and pericarditis and a" }, { "page": 24, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "fety studies under Section 505(o) of the Federal Food, Drug, and Cosmetic Act (FDCA) to assess the known serious risks of myocarditis and pericarditis and an unex" }, { "page": 25, "family": "CFR", "normalized": "21 CFR 600.80", "raw": "21 CFR 600.80", "context": "c Recommendation for Postmarketing Activities. Adverse event reporting under 21 CFR 600.80 and the postmarketing studies in Section 11c are adequate to monitor the postm" }, { "page": 27, "family": "CFR", "normalized": "21 CFR 610.15", "raw": "21 CFR 610.15", "context": "d listed at the website included in the Dear HCP letter. b. Exception to the 21 CFR 610.15(a) Requirement for a Preservative Under 21 CFR 610.15(a), a vaccine product in" }, { "page": 27, "family": "CFR", "normalized": "21 CFR 610.15", "raw": "21 CFR 610.15", "context": ". b. Exception to the 21 CFR 610.15(a) Requirement for a Preservative Under 21 CFR 610.15(a), a vaccine product in multiple-dose containers must (absent certain excepti" }, { "page": 27, "family": "CFR", "normalized": "21 CFR 610.15", "raw": "21 CFR 610.15", "context": "preservative. CBER considered the Applicant\u2019s request for an exception to the 21 CFR 610.15(a) for COMIRNATY as a multiple dose preservative-free presentation acceptable." } ] }, { "filename": "125742-0_20219001.PC1_.pdf", "id": 8150, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/125742-0_20219001.PC1_.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/125742-0_20219001.PC1_.pdf", "total_pages": 18, "matches": [] }, { "filename": "125742-0_20219002.PC1_.pdf", "id": 8151, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/125742-0_20219002.PC1_.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/125742-0_20219002.PC1_.pdf", "total_pages": 18, "matches": [] }, { "filename": "125742-0_20219003.PC1_.pdf", "id": 8152, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/125742-0_20219003.PC1_.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/125742-0_20219003.PC1_.pdf", "total_pages": 17, "matches": [] }, { "filename": "125742-0_20219006.PC1_.pdf", "id": 8153, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/125742-0_20219006.PC1_.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/125742-0_20219006.PC1_.pdf", "total_pages": 18, "matches": [] }, { "filename": "125742-45_01-05-2022_Letter_Acknowledgement-Le.pdf", "id": 8154, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2024/01/125742-45_01-05-2022_Letter_Acknowledgement-Le.pdf", "ican_url": null, "total_pages": 2, "matches": [ { "page": 1, "family": "Public Law", "normalized": "Pub. L. 110-85", "raw": "Public Law \nNo. 110-85", "context": "Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA) (Public Law No. 110-85, 121 Stat. 904). All future correspondence regarding this submission should be" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 601.12", "raw": "21 CFR 601.12", "context": "e Number: 2229 Your submission is in the form of a \u201cPrior Approval Supplement\u201d (21 CFR 601.12(b)) that requires CBER approval prior to the distribution of product made usin" }, { "page": 1, "family": "Named act", "normalized": "PHS Act", "raw": "Public Health Service Act", "context": "your Biologics License Application (BLA) submitted under section 351(a) of the Public Health Service Act (PHS Act) for COVID-19 Vaccine, mRNA (COMIRNATY). Reason for the submission:" }, { "page": 1, "family": "Named act", "normalized": "PHS Act", "raw": "PHS Act", "context": "ication (BLA) submitted under section 351(a) of the Public Health Service Act (PHS Act) for COVID-19 Vaccine, mRNA (COMIRNATY). Reason for the submission: For activ" }, { "page": 1, "family": "Named act", "normalized": "PHS Act", "raw": "PHS Act", "context": "for complying with the applicable provisions of sections 402(i) and (j) of the PHS Act (42 U.S.C. \u00a7\u00a7 282(i) and (j), amended by Title VIII of the Food and Drug Admin" } ] }, { "filename": "125742-45_01-06-2022_Meeting-Summary_First-Com.pdf", "id": 8155, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2024/01/125742-45_01-06-2022_Meeting-Summary_First-Com.pdf", "ican_url": null, "total_pages": 6, "matches": [] }, { "filename": "125742-45_01-19-2022_Telecon_Information-Reque.pdf", "id": 8156, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2024/01/125742-45_01-19-2022_Telecon_Information-Reque.pdf", "ican_url": null, "total_pages": 3, "matches": [] }, { "filename": "125742-45_01-25-2022_Telecon_Information-Reque.pdf", "id": 8157, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2024/01/125742-45_01-25-2022_Telecon_Information-Reque.pdf", "ican_url": null, "total_pages": 2, "matches": [ { "page": 1, "family": "CFR", "normalized": "21 CFR 25.15", "raw": "21 CFR 25.15", "context": "Environmental Assessment (EA) or a claim of categorical exclusion (CE). 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Note: Financial disclosure is required for bioequivalence studies that ar" }, { "page": 10, "family": "Named act", "normalized": "FD&C Act", "raw": "FD&C Act", "context": "ebarment Certifications]. Note: Debarment Certification should use wording in FD&C Act Section 306(k)(1) i.e.,\u201c[Name of applicant] hereby certifies that it did not" }, { "page": 10, "family": "Named act", "normalized": "FD&C Act", "raw": "Federal Food, Drug, and \nCosmetic Act", "context": "in any capacity the services of any person debarred under section 306 of the Federal Food, Drug, and Cosmetic Act in connection with this application...\u201d Applicant may not use wording such as," } ] }, { "filename": "125742-45_02-07-2022_Memo_Filing-Checklist_RPM_A.pdf", "id": 8160, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2024/01/125742-45_02-07-2022_Memo_Filing-Checklist_RPM_A.pdf", "ican_url": null, "total_pages": 1, "matches": [] }, { "filename": "125742-45_02-09-2022_Letter_Filing-Notificatio.pdf", "id": 8161, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": 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Is the submission complete as required under 21 CFR 314.50 (NDAs/NDA efficacy supplements) or under 21 CFR 601.2 (BLAs/BLA efficacy supp" }, { "page": 6, "family": "CFR", "normalized": "21 CFR 601.2", "raw": "21 CFR 601.2", "context": "ete as required under 21 CFR 314.50 (NDAs/NDA efficacy supplements) or under 21 CFR 601.2 (BLAs/BLA efficacy supplements) including: * RTF issues, a \u201cNo\u201d means the appl" }, { "page": 8, "family": "CFR", "normalized": "21 CFR 601.2", "raw": "21 CFR \n601.2", "context": "YES NO NA Comment 17. Is form FDA 356h included with authorized signature per 21 CFR 601.2(a) (BLAs) or per 21 CFR 314.50(a) (NDAs)? 9 18. If foreign applicant, has a U." }, { "page": 8, "family": "CFR", "normalized": "21 CFR 314.50", "raw": "21 CFR \n314.50", "context": "FDA 356h included with authorized signature per 21 CFR 601.2(a) (BLAs) or per 21 CFR 314.50(a) (NDAs)? 9 18. 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Note: Debarment Certification should use wording in FD&C Act Section 306(k)(1) i.e.,\u201c[Name of applicant] hereby certifies that it did not" }, { "page": 11, "family": "Named act", "normalized": "FD&C Act", "raw": "Federal Food, Drug, and Cosmetic \nAct", "context": "in any capacity the services of any person debarred under section 306 of the Federal Food, Drug, and Cosmetic Act in connection with this application..\u201d Applicant may not use wording such as," }, { "page": 12, "family": "CFR", "normalized": "21 CFR 316.3", "raw": "21 CFR 316.3", "context": "be the same product according to the orphan drug definition of sameness [see 21 CFR 316.3(b)(13)]? If yes, consult CBER Jurisdiction Officer. 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Bioresearch Monitoring inspections of nine clinical sites in study C4591001 d" }, { "page": 15, "family": "CFR", "normalized": "21 CFR 54.2", "raw": "21 CFR 54.2", "context": "r of investigators with interests/arrangements in each category (as defined in 21 CFR 54.2(a), (b), (c) and (f)): Compensation to the investigator for conducting the st" }, { "page": 101, "family": "USC", "normalized": "21 U.S.C. \u00a7 355", "raw": "21 U.S.C. 355", "context": ", if FDA makes certain findings required by the statute (section 505(o)(3)(A), 21 U.S.C. 355(o)(3)(A)). 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[See section 10.b regarding exception to the 21 CFR 610.15(a) requirement for a preservative.] Stability of COMIRNATY The Applicant cond" }, { "page": 14, "family": "CFR", "normalized": "21 CFR 25.31", "raw": "21 CFR 25.31", "context": "ded a request for categorical exclusion from an Environmental Assessment under 21 CFR 25.31. The FDA concluded that this request is justified, and no extraordinary circum" }, { "page": 23, "family": "Named act", "normalized": "FD&C Act", "raw": "Federal Food, Drug, and Cosmetic Act", "context": "uct postmarketing requirement (PMR) safety studies under Section 505(o) of the Federal Food, Drug, and Cosmetic Act (FDCA) to assess the known serious risks of myocarditis and pericarditis as we" }, { "page": 23, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "fety studies under Section 505(o) of the Federal Food, Drug, and Cosmetic Act (FDCA) to assess the known serious risks of myocarditis and pericarditis as well as" }, { "page": 24, "family": "Named act", "normalized": "FD&C Act", "raw": "Federal \nFood, Drug, and Cosmetic Act", "context": "uct postmarketing requirement (PMR) safety studies under Section 505(o) of the Federal Food, Drug, and Cosmetic Act (FDCA) to assess the known serious risks of myocarditis and pericarditis and a" }, { "page": 24, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "fety studies under Section 505(o) of the Federal Food, Drug, and Cosmetic Act (FDCA) to assess the known serious risks of myocarditis and pericarditis and an unex" }, { "page": 25, "family": "CFR", "normalized": "21 CFR 600.80", "raw": "21 CFR 600.80", "context": "11c Recommendation for Postmarketing Activities. 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CBER considered the Applicant\u2019s request for an exception to the 21 CFR 610.15(a) for COMIRNATY as a multiple dose preservative-free presentation acceptable." } ] }, { "filename": "137_BLA_125742_Endotoxin-release-tests-lots-FD7220-FE3592-FF2587.pdf", "id": 8243, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/137_BLA_125742_Endotoxin-release-tests-lots-FD7220-FE3592-FF2587.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/137_BLA_125742_Endotoxin-release-tests-lots-FD7220-FE3592-FF2587.pdf", "total_pages": 6, "matches": [] }, { "filename": "138_BLA_125742_STN125742-release-test-pH-lots-FD7220-FE3592-FF2587.pdf", "id": 8244, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/138_BLA_125742_STN125742-release-test-pH-lots-FD7220-FE3592-FF2587.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/138_BLA_125742_STN125742-release-test-pH-lots-FD7220-FE3592-FF2587.pdf", "total_pages": 7, "matches": [] }, { "filename": "13_BLA-125752-0_09-27-2021_Telecon_Other.pdf", "id": 8245, "module": null, "batch_code": null, "company": "Moderna", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2025/05/13_BLA-125752-0_09-27-2021_Telecon_Other.pdf", "ican_url": null, "total_pages": 9, "matches": [] }, { "filename": "13_BLA_125742-0_07-02-2021_Committee-Memo_APLB.pdf", "id": 8246, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/01/13_BLA_125742-0_07-02-2021_Committee-Memo_APLB.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/01/13_BLA_125742-0_07-02-2021_Committee-Memo_APLB.pdf", "total_pages": 5, "matches": [ { "page": 1, "family": "Named act", "normalized": "FD&C Act", "raw": "Federal Food, Drug, and Cosmetic Act", "context": "CBER\u2019s Advertising and Promotional Labeling Branch, we conclude that under the Federal Food, Drug, and Cosmetic Act and applicable regulations your proposed proprietary name, COMIRNATY, is Accep" }, { "page": 4, "family": "CFR", "normalized": "21 CFR 201.10", "raw": "21 CFR 201.10", "context": "2. Evaluating for Promotional and Safety Concerns a. Promotional Review [21 CFR 201.10 (c)(3), 202.1 (e)(5)(i), and (e)(6)(i)] The proposed proprietary name, COMIRNA" }, { "page": 4, "family": "CFR", "normalized": "21 CFR 201.10", "raw": "21 CFR 201.10", "context": "be false, misleading, or fanciful. b. Look-alike Sound-alike Safety Review [21 CFR 201.10 (c)(5)] Since drug products are prescribed through written, verbal, and/or e" } ] }, { "filename": "14_BLA-125742-0_07-02-2021_Telecon_Advice.pdf", "id": 8247, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/09/14_BLA-125742-0_07-02-2021_Telecon_Advice.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/09/14_BLA-125742-0_07-02-2021_Telecon_Advice.pdf", "total_pages": 3, "matches": [] }, { "filename": "15_BLA-125742-0_07-02-2021_Telecon_Information-Reques.pdf", "id": 8248, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/15_BLA-125742-0_07-02-2021_Telecon_Information-Reques.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/15_BLA-125742-0_07-02-2021_Telecon_Information-Reques.pdf", "total_pages": 4, "matches": [] }, { "filename": "15_BLA-125752-0_09-28-2021_Telecon_Information-Reques.pdf", "id": 8249, "module": null, "batch_code": null, "company": "Moderna", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2025/05/15_BLA-125752-0_09-28-2021_Telecon_Information-Reques.pdf", "ican_url": null, "total_pages": 4, "matches": [] }, { "filename": "16_BLA-125742-0_07-06-2021_Telecon_Information-Reques.pdf", "id": 8250, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/09/16_BLA-125742-0_07-06-2021_Telecon_Information-Reques.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/09/16_BLA-125742-0_07-06-2021_Telecon_Information-Reques.pdf", "total_pages": 2, "matches": [] }, { "filename": "16_BLA-125752-0_09-30-2021_Memo_Other.pdf", "id": 8251, "module": null, "batch_code": null, "company": "Moderna", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2025/05/16_BLA-125752-0_09-30-2021_Memo_Other.pdf", "ican_url": null, "total_pages": 4, "matches": [ { "page": 1, "family": "CFR", "normalized": "21 CFR 10.115", "raw": "21 C.F.R. \u00a7 10.115", "context": "my concurrence with the decision to depart from the Naming Guidance. 1 See 21 C.F.R. \u00a7 10.115(d)(3) (\u201cAlthough guidance documents do not legally bind FDA, they represent the" }, { "page": 3, "family": "Section-of-Act", "normalized": "Section 2105 of the PHS Act", "raw": "Section 2105 of the Public Health \nService Act", "context": "ulthood. The National Vaccine Advisory Committee (established to comply with Section 2105 of the Public Health Service Act) recommends that public health departments work toward including adults in all" } ] }, { "filename": "17_BLA-125742-0_07-06-2021_Telecon_Advice_PNR-Accepta.pdf", "id": 8252, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/09/17_BLA-125742-0_07-06-2021_Telecon_Advice_PNR-Accepta.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/09/17_BLA-125742-0_07-06-2021_Telecon_Advice_PNR-Accepta.pdf", "total_pages": 1, "matches": [ { "page": 1, "family": "Named act", "normalized": "FD&C Act", "raw": "Federal Food, Drug, and Cosmetic Act", "context": "CBER\u2019s Advertising and Promotional Labeling Branch, we conclude that under the Federal Food, Drug, and Cosmetic Act and applicable regulations your proposed proprietary name, COMIRNATY, is Accep" } ] }, { "filename": "17_BLA-125752-0_10-05-2021_Telecon_Information-Reques.pdf", "id": 8253, "module": null, "batch_code": null, "company": "Moderna", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2025/05/17_BLA-125752-0_10-05-2021_Telecon_Information-Reques.pdf", "ican_url": null, "total_pages": 3, "matches": [] }, { "filename": "18_BLA-125742-0_07-09-2021_Telecon_Information-Reques.pdf", "id": 8254, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/18_BLA-125742-0_07-09-2021_Telecon_Information-Reques.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/18_BLA-125742-0_07-09-2021_Telecon_Information-Reques.pdf", "total_pages": 2, "matches": [] }, { "filename": "18_BLA-125752-0_10-06-2021_Telecon_Information-Reques.pdf", "id": 8255, "module": null, "batch_code": null, "company": "Moderna", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2025/05/18_BLA-125752-0_10-06-2021_Telecon_Information-Reques.pdf", "ican_url": null, "total_pages": 3, "matches": [] }, { "filename": "19_2_BLA-125742-0_07-13-2021_Telecon_Information-Reques.pdf", "id": 8256, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/09/19_2_BLA-125742-0_07-13-2021_Telecon_Information-Reques.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/09/19_2_BLA-125742-0_07-13-2021_Telecon_Information-Reques.pdf", "total_pages": 1, "matches": [ { "page": 1, "family": "CFR", "normalized": "21 CFR 610.15", "raw": "21 CFR 610.15", "context": "n a multiple-dose vial that does not contain a preservative. Please note that 21 CFR 610.15(a) requires that \u201cProducts in multiple-dose containers shall contain a preserv" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 610.15", "raw": "21 CFR 610.15", "context": "t and a justification for an exception or alternative to the requirement under 21 CFR 610.15(a) that products in multiple-dose vials include a preservative. Please provi" } ] }, { "filename": "19_BLA-125752-0_10-14-2021_Letter_Filing-Notification.pdf", "id": 8257, "module": null, "batch_code": null, "company": "Moderna", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2025/05/19_BLA-125752-0_10-14-2021_Letter_Filing-Notification.pdf", "ican_url": null, "total_pages": 3, "matches": [ { "page": 2, "family": "CFR", "normalized": "21 CFR 601.2", "raw": "21 CFR 601.2", "context": "ur application is sufficiently complete to permit a substantive review. Under 21 CFR 601.2(a), we have filed your application today. The review classification for this a" }, { "page": 2, "family": "Named act", "normalized": "PHS Act", "raw": "Public Health \nService Act", "context": "tion (BLA) submitted and received August 24, 2021, under section 351(a) of the Public Health Service Act (PHS Act) for COVID-19 Vaccine, mRNA. We also refer to your initial portions" }, { "page": 2, "family": "Named act", "normalized": "PHS Act", "raw": "PHS Act", "context": "ceived August 24, 2021, under section 351(a) of the Public Health Service Act (PHS Act) for COVID-19 Vaccine, mRNA. We also refer to your initial portions of your" }, { "page": 3, "family": "USC", "normalized": "21 U.S.C. \u00a7 355c", "raw": "21 U.S.C. 355c", "context": "ional information if needed. Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new active ingredients, new indications, new dosage for" } ] }, { "filename": "1_BLA-125742-0_05-13-2021_Letter_Acknowledgement-Let.pdf", "id": 8258, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/1_BLA-125742-0_05-13-2021_Letter_Acknowledgement-Let.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/1_BLA-125742-0_05-13-2021_Letter_Acknowledgement-Let.pdf", "total_pages": 2, "matches": [ { "page": 1, "family": "Public Law", "normalized": "Pub. L. 110-85", "raw": "Public Law No. 110-85", "context": "Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA) (Public Law No. 110-85, 121 Stat.904). All future correspondence regarding this submission should b" }, { "page": 1, "family": "USC", "normalized": "21 U.S.C. \u00a7 356", "raw": "21 U.S.C. 356", "context": "ovision (c) of Section 506 of the Federal Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. 356) for review of an incomplete application for a Fast Track Product. We acknowl" }, { "page": 1, "family": "Named act", "normalized": "PHS Act", "raw": "Public Health Service Act", "context": "your Biologics License Application (BLA) submitted under section 351(a) of the Public Health Service Act (PHS Act) for the following biological product: Our Submission Tracking Numb" }, { "page": 1, "family": "Named act", "normalized": "PHS Act", "raw": "PHS Act", "context": "ication (BLA) submitted under section 351(a) of the Public Health Service Act (PHS Act) for the following biological product: Our Submission Tracking Number (STN):" }, { "page": 1, "family": "Named act", "normalized": "FD&C Act", "raw": "Federal Food, Drug, and Cosmetic Act", "context": "received your application submitted under provision (c) of Section 506 of the Federal Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. 356) for review of an incomplete application for a Fast Trac" }, { "page": 1, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "nder provision (c) of Section 506 of the Federal Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. 356) for review of an incomplete application for a Fast Track Prod" }, { "page": 1, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "emaining portions of this application. In accordance with this section of the FDCA, our review clock will not start until the date on which you submit the final" }, { "page": 1, "family": "Named act", "normalized": "PHS Act", "raw": "PHS Act", "context": "for complying with the applicable provisions of sections 402(i) and (j) of the PHS Act (42 U.S.C. \u00a7\u00a7 282(i) and (j)), which was amended by Title VIII of the Food and" } ] }, { "filename": "1_BLA-125752-0_06-09-2021_Letter_Acknowledgement-Let.pdf", "id": 8259, "module": null, "batch_code": null, "company": "Moderna", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2025/05/1_BLA-125752-0_06-09-2021_Letter_Acknowledgement-Let.pdf", "ican_url": null, "total_pages": 2, "matches": [ { "page": 1, "family": "Public Law", "normalized": "Pub. L. 110-85", "raw": "Public Law No. 110-85", "context": "Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA) (Public Law No. 110-85, 121 Stat.904). All future correspondence regarding this submission should b" }, { "page": 1, "family": "USC", "normalized": "21 U.S.C. \u00a7 356", "raw": "21 U.S.C. 356", "context": "ovision (c) of Section 506 of the Federal Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. 356) for review of an incomplete application for a Fast Track Product. We acknowl" }, { "page": 1, "family": "Named act", "normalized": "PHS Act", "raw": "Public Health Service Act", "context": "your Biologics License Application (BLA) submitted under section 351(a) of the Public Health Service Act (PHS Act) for the following biological product: Our Submission Tracking Numb" }, { "page": 1, "family": "Named act", "normalized": "PHS Act", "raw": "PHS Act", "context": "ication (BLA) submitted under section 351(a) of the Public Health Service Act (PHS Act) for the following biological product: Our Submission Tracking Number (STN):" }, { "page": 1, "family": "Named act", "normalized": "FD&C Act", "raw": "Federal Food, Drug, and Cosmetic Act", "context": "received your application submitted under provision (c) of Section 506 of the Federal Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. 356) for review of an incomplete application for a Fast Trac" }, { "page": 1, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "nder provision (c) of Section 506 of the Federal Food, Drug, and Cosmetic Act (FDCA) (21 U.S.C. 356) for review of an incomplete application for a Fast Track Prod" }, { "page": 1, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "emaining portions of this application. In accordance with this section of the FDCA, our review clock will not start until the date on which you submit the final" }, { "page": 1, "family": "Named act", "normalized": "PHS Act", "raw": "PHS Act", "context": "for complying with the applicable provisions of sections 402(i) and (j) of the PHS Act (42 U.S.C. \u00a7\u00a7 282(i) and (j)), which was amended by Title VIII of the Food and" } ] }, { "filename": "1_PM_S85_BLA-125742-4_09-30-2021_Telecon_Advice.pdf", "id": 8260, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/10/1_PM_S85_BLA-125742-4_09-30-2021_Telecon_Advice.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/10/1_PM_S85_BLA-125742-4_09-30-2021_Telecon_Advice.pdf", "total_pages": 2, "matches": [] }, { "filename": "20_1_BLA-125742-0_07-13-2021_Telecon_Information-Reques.pdf", "id": 8261, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/09/20_1_BLA-125742-0_07-13-2021_Telecon_Information-Reques.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/09/20_1_BLA-125742-0_07-13-2021_Telecon_Information-Reques.pdf", "total_pages": 2, "matches": [] }, { "filename": "20_BLA-125752-0_10-14-2021_Telecon_Information-Reques.pdf", "id": 8262, "module": null, "batch_code": null, "company": "Moderna", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2025/05/20_BLA-125752-0_10-14-2021_Telecon_Information-Reques.pdf", "ican_url": null, "total_pages": 2, "matches": [] }, { "filename": "21A_BLA-125752-0_10-14-2021_Telecon_Other.pdf", "id": 8263, "module": null, "batch_code": null, "company": "Moderna", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2025/05/21A_BLA-125752-0_10-14-2021_Telecon_Other.pdf", "ican_url": null, "total_pages": 3, "matches": [] }, { "filename": "21_BLA-125742-0_07-15-2021_Letter_Filing-Notification.pdf", "id": 8264, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/21_BLA-125742-0_07-15-2021_Letter_Filing-Notification.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/21_BLA-125742-0_07-15-2021_Letter_Filing-Notification.pdf", "total_pages": 3, "matches": [ { "page": 2, "family": "CFR", "normalized": "21 CFR 601.2", "raw": "21 CFR 601.2", "context": "ur application is sufficiently complete to permit a substantive review. Under 21 CFR 601.2(a), we have filed your application today. The review classification for this" }, { "page": 2, "family": "Named act", "normalized": "PHS Act", "raw": "Public Health Service Act", "context": "ion (BLA) submitted and received on May 18, 2021, under section 351(a) of the Public Health Service Act (PHS Act) for COVID-19 mRNA Vaccine. We also refer to your amendments submi" }, { "page": 2, "family": "Named act", "normalized": "PHS Act", "raw": "PHS Act", "context": "eived on May 18, 2021, under section 351(a) of the Public Health Service Act (PHS Act) for COVID-19 mRNA Vaccine. We also refer to your amendments submitted and" }, { "page": 3, "family": "USC", "normalized": "21 U.S.C. \u00a7 355c", "raw": "21 U.S.C. 355c", "context": "UIRED PEDIATRIC ASSESSMENTS Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new active ingredients, new indications, new dosage for" } ] }, { "filename": "21_BLA-125752-0_10-14-2021_Telecon_Other.pdf", "id": 8265, "module": null, "batch_code": null, "company": "Moderna", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2025/05/21_BLA-125752-0_10-14-2021_Telecon_Other.pdf", "ican_url": null, "total_pages": 1, "matches": [] }, { "filename": "22_BLA-125742-0_07-15-2021_Meeting-Summary_Committee-.pdf", "id": 8266, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/09/22_BLA-125742-0_07-15-2021_Meeting-Summary_Committee-.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/09/22_BLA-125742-0_07-15-2021_Meeting-Summary_Committee-.pdf", "total_pages": 9, "matches": [] }, { "filename": "22_BLA-125752-0_10-15-2021_Letter_PNR-Acceptance.pdf", "id": 8267, "module": null, "batch_code": null, "company": "Moderna", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2025/05/22_BLA-125752-0_10-15-2021_Letter_PNR-Acceptance.pdf", "ican_url": null, "total_pages": 2, "matches": [ { "page": 2, "family": "Named act", "normalized": "PHS Act", "raw": "Public Health Service Act", "context": "ion (BLA) submitted and received August 24, 2021, under section 351(a) of the Public Health Service Act for Covid-19 mRNA vaccine, requesting a proprietary name review for SPIKEVAX." }, { "page": 2, "family": "Named act", "normalized": "FD&C Act", "raw": "Federal Food, \nDrug, and Cosmetic Act", "context": "ising and Promotional Labeling Branch (CBER/APLB), we conclude that, under the Federal Food, Drug, and Cosmetic Act and applicable regulations, SPIKEVAX is acceptable. If you have any question" } ] }, { "filename": "23_1_BLA-125742-0_07-15-2021_Telecon_Information-Reques.pdf", "id": 8268, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/09/23_1_BLA-125742-0_07-15-2021_Telecon_Information-Reques.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/09/23_1_BLA-125742-0_07-15-2021_Telecon_Information-Reques.pdf", "total_pages": 3, "matches": [] }, { "filename": "24_2_BLA-125742-0_07-15-2021_Telecon_Information-Reques.pdf", "id": 8269, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/09/24_2_BLA-125742-0_07-15-2021_Telecon_Information-Reques.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/09/24_2_BLA-125742-0_07-15-2021_Telecon_Information-Reques.pdf", "total_pages": 2, "matches": [] }, { "filename": 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Under 21 CFR 610.2(a), manufacturers may be required to submit samples from all lots of a license" } ] }, { "filename": "39_BLA-125752-0_11-12-2021_Telecon_Information-Reques.pdf", "id": 8312, "module": null, "batch_code": null, "company": "Moderna", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2025/05/39_BLA-125752-0_11-12-2021_Telecon_Information-Reques.pdf", "ican_url": null, "total_pages": 2, "matches": [] }, { "filename": "3_BLA-125742-0_05-20-2021_Telecon_Information-Reques.pdf", "id": 8313, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/3_BLA-125742-0_05-20-2021_Telecon_Information-Reques.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/3_BLA-125742-0_05-20-2021_Telecon_Information-Reques.pdf", "total_pages": 2, "matches": [] }, { "filename": "3_BLA-125752-0_09-09-2021_Meeting-Summary_Committee-.pdf", "id": 8314, "module": null, "batch_code": null, "company": "Moderna", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2025/05/3_BLA-125752-0_09-09-2021_Meeting-Summary_Committee-.pdf", "ican_url": null, "total_pages": 11, "matches": [ { "page": 7, "family": "CFR", "normalized": "21 CFR 601.2", "raw": "21 CFR 601.2", "context": "a Items/Responses Discussed: 1. 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A more comprehensive review will be completed prior to the filing meeting to" } ] }, { "filename": "3_IND_19736_243_19-Mar-2021_KERRY_KERRY__RO_-.pdf", "id": 8315, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/3_IND_19736_243_19-Mar-2021_KERRY_KERRY__RO_-.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/3_IND_19736_243_19-Mar-2021_KERRY_KERRY__RO_-.pdf", "total_pages": 2, "matches": [] }, { "filename": "3_PM_S89_BLA-125742-5_09-21-2021_Telecon_Other.pdf", "id": 8316, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/10/3_PM_S89_BLA-125742-5_09-21-2021_Telecon_Other.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/10/3_PM_S89_BLA-125742-5_09-21-2021_Telecon_Other.pdf", "total_pages": 1, "matches": [ { "page": 1, "family": "CFR", "normalized": "21 CFR 600.80", "raw": "21 CFR 600.80", "context": "periodic safety reports to BLA 125742, at monthly intervals, in accordance with 21 CFR 600.80(c)(2), and including consolidated aggregate analysis for all post-marketing and" } ] }, { "filename": "40A_BLA-125752-0_11-15-2021_Telecon_Information-Reques.pdf", "id": 8317, "module": null, "batch_code": null, "company": "Moderna", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2025/05/40A_BLA-125752-0_11-15-2021_Telecon_Information-Reques.pdf", "ican_url": null, "total_pages": 18, "matches": [] }, { "filename": "40B_BLA-125752-0_11-15-2021_Telecon_Information-Reques.pdf", "id": 8318, "module": null, "batch_code": null, "company": "Moderna", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2025/05/40B_BLA-125752-0_11-15-2021_Telecon_Information-Reques.pdf", "ican_url": null, "total_pages": 18, "matches": [] }, { "filename": "40_2_BLA-125742-0_08-03-2021_Telecon_Information-Reques.pdf", "id": 8319, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/40_2_BLA-125742-0_08-03-2021_Telecon_Information-Reques.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/40_2_BLA-125742-0_08-03-2021_Telecon_Information-Reques.pdf", "total_pages": 3, "matches": [] }, { "filename": "40_BLA-125752-0_11-15-2021_Telecon_Information-Reques.pdf", "id": 8320, "module": null, "batch_code": null, "company": "Moderna", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2025/05/40_BLA-125752-0_11-15-2021_Telecon_Information-Reques.pdf", "ican_url": null, "total_pages": 20, "matches": [ { "page": 1, "family": "CFR", "normalized": "21 CFR 610.62", "raw": "21 CFR 610.62", "context": "e of the proper name and the tradename to ensure they are equal in prominence ((21 CFR 610.62(b)). b. On the carton labels, please increase the font size of \u201cFor 18 years an" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 610.62", "raw": "21 CFR 610.62", "context": "l labels, please increase the prominence and size of \u201cFor 18 years and older\u201d ((21 CFR 610.62(b)). c. Please clarify the purpose of the \u201c2D datamatrix code encoded P/N\u201d lis" } ] }, { "filename": "41_1_BLA-125742-0_08-03-2021_Telecon_Information-Reques.pdf", "id": 8321, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/09/41_1_BLA-125742-0_08-03-2021_Telecon_Information-Reques.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/09/41_1_BLA-125742-0_08-03-2021_Telecon_Information-Reques.pdf", "total_pages": 2, "matches": [] }, { "filename": "42_1_BLA-125742-0_08-04-2021_Telecon_Information-Reques.pdf", "id": 8322, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/42_1_BLA-125742-0_08-04-2021_Telecon_Information-Reques.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/42_1_BLA-125742-0_08-04-2021_Telecon_Information-Reques.pdf", "total_pages": 3, "matches": [] }, { "filename": "42_BLA-125752-0_11-19-2021_Telecon_Advice.pdf", "id": 8323, "module": null, "batch_code": null, "company": "Moderna", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2025/05/42_BLA-125752-0_11-19-2021_Telecon_Advice.pdf", "ican_url": null, "total_pages": 3, "matches": [] }, { "filename": "43A_STN-125742.0-4AUG21-LRP-FU-IR-2.pdf", "id": 8324, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/43A_STN-125742.0-4AUG21-LRP-FU-IR-2.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/43A_STN-125742.0-4AUG21-LRP-FU-IR-2.pdf", "total_pages": 6, "matches": [] }, { "filename": "43_2_BLA-125742-0_08-04-2021_Telecon_Information-Reques.pdf", "id": 8325, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/09/43_2_BLA-125742-0_08-04-2021_Telecon_Information-Reques.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/09/43_2_BLA-125742-0_08-04-2021_Telecon_Information-Reques.pdf", "total_pages": 4, "matches": [] }, { "filename": "43_BLA-125752-0_11-19-2021_Telecon_Information-Reques.pdf", "id": 8326, "module": null, "batch_code": null, "company": "Moderna", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2025/05/43_BLA-125752-0_11-19-2021_Telecon_Information-Reques.pdf", "ican_url": null, "total_pages": 2, "matches": [] }, { "filename": "44_3_BLA-125742-0_08-04-2021_Telecon_Information-Reques.pdf", "id": 8327, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/44_3_BLA-125742-0_08-04-2021_Telecon_Information-Reques.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/44_3_BLA-125742-0_08-04-2021_Telecon_Information-Reques.pdf", "total_pages": 2, "matches": [] }, { "filename": "44_BLA-125752-0_11-24-2021_Telecon_Other.pdf", "id": 8328, "module": null, "batch_code": null, "company": "Moderna", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2025/05/44_BLA-125752-0_11-24-2021_Telecon_Other.pdf", "ican_url": null, "total_pages": 2, "matches": [] }, { "filename": "45_BLA-125742-0_08-05-2021_Telecon_Advice.pdf", "id": 8329, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/45_BLA-125742-0_08-05-2021_Telecon_Advice.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/45_BLA-125742-0_08-05-2021_Telecon_Advice.pdf", "total_pages": 1, "matches": [] }, { "filename": "45_BLA-125752-0_11-29-2021_Telecon_Information-Reques.pdf", "id": 8330, "module": null, "batch_code": null, "company": "Moderna", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2025/05/45_BLA-125752-0_11-29-2021_Telecon_Information-Reques.pdf", "ican_url": null, "total_pages": 2, "matches": [] }, { "filename": "46_2_BLA-125742-0_08-05-2021_Telecon_Information-Reques.pdf", "id": 8331, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/46_2_BLA-125742-0_08-05-2021_Telecon_Information-Reques.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/46_2_BLA-125742-0_08-05-2021_Telecon_Information-Reques.pdf", "total_pages": 5, "matches": [] }, { "filename": "46_BLA-125752-0_11-29-2021_Telecon_Information-Reques.pdf", "id": 8332, "module": null, "batch_code": null, "company": "Moderna", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2025/05/46_BLA-125752-0_11-29-2021_Telecon_Information-Reques.pdf", "ican_url": null, "total_pages": 2, "matches": [] }, { "filename": "47_1_BLA-125742-0_08-05-2021_Telecon_Information-Reques.pdf", "id": 8333, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": 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"48_BLA-125752-0_12-06-2021_Telecon_Information-Reques.pdf", "id": 8338, "module": null, "batch_code": null, "company": "Moderna", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2025/05/48_BLA-125752-0_12-06-2021_Telecon_Information-Reques.pdf", "ican_url": null, "total_pages": 1, "matches": [] }, { "filename": "49_BLA-125742-0_08-06-2021_Letter_UNII-Code-Notificat.pdf", "id": 8339, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/11/49_BLA-125742-0_08-06-2021_Letter_UNII-Code-Notificat.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/11/49_BLA-125742-0_08-06-2021_Letter_UNII-Code-Notificat.pdf", "total_pages": 3, "matches": [ { "page": 2, "family": "Public Law", "normalized": "Pub. L. 110-85", "raw": "Pub. L. No. 110-85", "context": "Dear Ms. Harkins: The Food and Drug Administration Amendments Act of 2007 (Pub. L. No. 110-85) (FDAAA) requires that establishment registration and drug listing be accompli" } ] }, { "filename": "49_BLA-125752-0_12-06-2021_Telecon_Information-Reques.pdf", "id": 8340, "module": null, "batch_code": null, "company": "Moderna", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2025/05/49_BLA-125752-0_12-06-2021_Telecon_Information-Reques.pdf", "ican_url": null, "total_pages": 6, "matches": [] }, { "filename": "4_BLA-125752-0_09-14-2021_Telecon_Information-Reques.pdf", "id": 8341, "module": null, "batch_code": null, "company": "Moderna", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2025/05/4_BLA-125752-0_09-14-2021_Telecon_Information-Reques.pdf", "ican_url": null, "total_pages": 2, "matches": [] }, { "filename": "4_PM_S89_BLA-125742-5_09-22-2021_Telecon_Advice.pdf", "id": 8342, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/10/4_PM_S89_BLA-125742-5_09-22-2021_Telecon_Advice.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/10/4_PM_S89_BLA-125742-5_09-22-2021_Telecon_Advice.pdf", "total_pages": 2, "matches": [ { "page": 1, "family": "CFR", "normalized": "21 CFR 600.80", "raw": "21 CFR 600.80", "context": "m. CBER Response to Question 1: Please submit ICSRs to VAERS in accordance with 21 CFR 600.80. For serious cases of multisystem inflammatory syndrome in children, if the pa" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 600.80", "raw": "21 CFR 600.80", "context": "eriodic safety reports to BLA 125742, at monthly intervals, in accordance with 21 CFR 600.80(c)(2), and including consolidated aggregate analysis for all post-marketing an" }, { "page": 2, "family": "CFR", "normalized": "21 CFR 600.80", "raw": "21 CFR 600.80", "context": "information portion of PAER, as described in 21 CFR 600.80(c)(2)(ii)(A). A separate quarterly PAER will not be needed. However, Individua" } ] }, { "filename": "50_BLA-125742-0_08-06-2021_Memo_Committee-Memo_APLB.pdf", "id": 8343, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2023/09/50_BLA-125742-0_08-06-2021_Memo_Committee-Memo_APLB.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2023/09/50_BLA-125742-0_08-06-2021_Memo_Committee-Memo_APLB.pdf", "total_pages": 6, "matches": [] }, { "filename": "50_BLA-125752-0_12-07-2021_Telecon_Information-Reques.pdf", "id": 8344, "module": null, "batch_code": null, "company": "Moderna", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2025/05/50_BLA-125752-0_12-07-2021_Telecon_Information-Reques.pdf", "ican_url": null, "total_pages": 5, "matches": [ { "page": 2, "family": "CFR", "normalized": "21 CFR 610.2", "raw": "21 CFR 610.2", "context": "intended for lots to be submitted for official lot release in accordance with 21 CFR 610.2 so please change this to \u201cRelease\u201d for all lots submitted. 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610.60 (a)(1) through (7) and 21 CFR 610.60 (7) (b) through (e), 21 CFR 610.62 (a) through (c), 21 CFR 610.63, 21 CFR 610.64, 21 CFR 610.67, the Drug Supply" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 610.63", "raw": "21 CFR 610.63", "context": "ough (7) and 21 CFR 610.60 (7) (b) through (e), 21 CFR 610.62 (a) through (c), 21 CFR 610.63, 21 CFR 610.64, 21 CFR 610.67, the Drug Supply Chain Security Act (DSCSA) and" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 610.64", "raw": "21 CFR 610.64", "context": "CFR 610.60 (7) (b) through (e), 21 CFR 610.62 (a) through (c), 21 CFR 610.63, 21 CFR 610.64, 21 CFR 610.67, the Drug Supply Chain Security Act (DSCSA) and CBER Job Aid 90" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 610.67", "raw": "21 CFR 610.67", "context": "(b) through (e), 21 CFR 610.62 (a) through (c), 21 CFR 610.63, 21 CFR 610.64, 21 CFR 610.67, the Drug Supply Chain Security Act (DSCSA) and CBER Job Aid 900.08: National" }, { "page": 1, "family": "CFR", "normalized": "21 CFR 610.62", "raw": "21 CFR 610.62", "context": "tified: \u2022 There is a prominence issue with the proper name and tradename per 21 CFR 610.62 (b). \u2022 The font size of \u201cSuspension\u2026\u201d should be decreased and the font size o" }, { "page": 2, "family": "CFR", "normalized": "21 CFR 610.62", "raw": "21 CFR 610.62", "context": "tified: \u2022 There is a prominence issue with the proper name and tradename per 21 CFR 610.62 (b). \u2022 The font size of \u201cSuspension\u2026\u201d should be decreased and the font size o" }, { "page": 2, "family": "CFR", "normalized": "21 CFR 610.62", "raw": "21 CFR 610.62", "context": "tified: \u2022 There is a prominence issue with the proper name and tradename per 21 CFR 610.62 (b). \u2022 The font size of \u201cSuspension\u2026\u201d should be decreased and the font size o" }, { "page": 2, "family": "CFR", "normalized": "21 CFR 610.62", "raw": "21 CFR 610.62", "context": "tified: \u2022 There is a prominence issue with the proper name and tradename per 21 CFR 610.62 (b). \u2022 The font size of \u201cSuspension\u2026\u201d should be decreased and the font size o" }, { "page": 3, "family": "CFR", "normalized": "21 CFR 201.25", "raw": "21 CFR 201.25", "context": "0777-100-15). Recommendations These labels are currently in compliance with 21 CFR 201.25, 21 CFR 207.35 and 21 CFR 610.60 through 21 CFR 610.67, Drug Supply Chain Secu" }, { "page": 3, "family": "CFR", "normalized": "21 CFR 207.35", "raw": "21 CFR 207.35", "context": "Recommendations These labels are currently in compliance with 21 CFR 201.25, 21 CFR 207.35 and 21 CFR 610.60 through 21 CFR 610.67, Drug Supply Chain Security Act (DSCS" }, { "page": 3, "family": "CFR", "normalized": "21 CFR 610.60", "raw": "21 CFR 610.60", "context": "These labels are currently in compliance with 21 CFR 201.25, 21 CFR 207.35 and 21 CFR 610.60 through 21 CFR 610.67, Drug Supply Chain Security Act (DSCSA), the Guidance fo" }, { "page": 3, "family": "CFR", "normalized": "21 CFR 610.67", "raw": "21 CFR 610.67", "context": "ntly in compliance with 21 CFR 201.25, 21 CFR 207.35 and 21 CFR 610.60 through 21 CFR 610.67, Drug Supply Chain Security Act (DSCSA), the Guidance for Industry, \u201cSelection" }, { "page": 4, "family": "CFR", "normalized": "21 CFR 610.61", "raw": "21 CFR 610.61", "context": "on December 14, 2021 21 CFR 610.61 (a) through (s) Checked items \u201cx\u201d indicate compliance a. The proper name" }, { "page": 5, "family": "CFR", "normalized": "21 CFR 201.25", "raw": "21 CFR 201.25", "context": "Review (Package) appendix 1 JA 900.08: NDC, Bar Code, & Product Identifiers/21 CFR 201.25 & 21 CFR 207.35 (3)(i) Checked items" }, { "page": 5, "family": "CFR", "normalized": "21 CFR 207.35", "raw": "21 \n CFR 207.35", "context": ") appendix 1 JA 900.08: NDC, Bar Code, & Product Identifiers/21 CFR 201.25 & 21 CFR 207.35 (3)(i) Checked items \u201cx\u201d indicate compliance 9. Barcode & Linear or One" }, { "page": 7, "family": "CFR", "normalized": "21 CFR 610.60", "raw": "21 CFR 610.60", "context": "ed on December 14, 2021 21 CFR 610.60(a)(1) through (7) Checked items \u201cx\u201d indicate compliance a. Full label. T" }, { "page": 7, "family": "CFR", "normalized": "21 CFR 610.62", "raw": "21 CFR 610.62", "context": "aced on the package label. N/A 21 CFR 610.62 (7) (b) through (e) Checked items \u201cx\u201d indicate compliance b. Package lab" }, { "page": 8, "family": "CFR", "normalized": "21 CFR 201.25", "raw": "21 CFR 201.25", "context": "ainer) appendix 2 JA 900.08: NDC, Bar Code, & Product Identifiers/21 CFR 201.25 & 21 CFR 207.35 (3)(i) *8. Barcode Linear or One-Dimensional (1D)" }, { "page": 8, "family": "CFR", "normalized": "21 CFR 207.35", "raw": "21 CFR 207.35", "context": "2 JA 900.08: NDC, Bar Code, & Product Identifiers/21 CFR 201.25 & 21 CFR 207.35 (3)(i) *8. Barcode Linear or One-Dimensional (1D) (Parallel Lines" }, { "page": 10, "family": "CFR", "normalized": "21 CFR 610.61", "raw": "21 CFR 610.61", "context": "on December 14, 2021 21 CFR 610.61 (a) through (s) Checked items \u201cx\u201d indicate compliance a. The proper name" }, { "page": 11, "family": "CFR", "normalized": "21 CFR 201.25", "raw": "21 CFR 201.25", "context": "Review (Package) appendix 3 JA 900.08: NDC, Bar Code, & Product Identifiers/21 CFR 201.25 & 21 CFR 207.35 (3)(i) Checked items" }, { "page": 11, "family": "CFR", "normalized": "21 CFR 207.35", "raw": "21 \n CFR 207.35", "context": ") appendix 3 JA 900.08: NDC, Bar Code, & Product Identifiers/21 CFR 201.25 & 21 CFR 207.35 (3)(i) Checked items \u201cx\u201d indicate compliance 9. Barcode & Linear or One" }, { "page": 13, "family": "CFR", "normalized": "21 CFR 610.60", "raw": "21 CFR 610.60", "context": "ed on December 14, 2021 21 CFR 610.60(a)(1) through (7) Checked items \u201cx\u201d indicate compliance b. Full label. T" }, { "page": 13, "family": "CFR", "normalized": "21 CFR 610.62", "raw": "21 CFR 610.62", "context": "aced on the package label. N/A 21 CFR 610.62 (7) (b) through (e) Checked items \u201cx\u201d indicate compliance b. 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The proper name" }, { "page": 6, "family": "CFR", "normalized": "21 CFR 201.25", "raw": "21 CFR 201.25", "context": "Review (Package) appendix 1 JA 900.08: NDC, Bar Code, & Product Identifiers/21 CFR 201.25 & 21 CFR 207.35 (3)(i) Checked items" }, { "page": 6, "family": "CFR", "normalized": "21 CFR 207.35", "raw": "21 \n CFR 207.35", "context": ") appendix 1 JA 900.08: NDC, Bar Code, & Product Identifiers/21 CFR 201.25 & 21 CFR 207.35 (3)(i) Checked items \u201cx\u201d indicate compliance 9. Barcode & Linear or One" }, { "page": 8, "family": "CFR", "normalized": "21 CFR 610.60", "raw": "21 CFR 610.60", "context": ", and August 19, 2021. 21 CFR 610.60(a)(1) through (7) Checked items \u201cx\u201d indicate compliance a. Full label. T" }, { "page": 8, "family": "CFR", "normalized": "21 CFR 610.62", "raw": "21 CFR 610.62", "context": "aced on the package label. N/A 21 CFR 610.62 (7) (b) through (e) Checked items \u201cx\u201d indicate compliance b. Package lab" }, { "page": 9, "family": "CFR", "normalized": "21 CFR 201.25", "raw": "21 CFR 201.25", "context": "ainer) appendix 2 JA 900.08: NDC, Bar Code, & Product Identifiers/21 CFR 201.25 & 21 CFR 207.35 (3)(i) *8. Barcode Linear or One-Dimensional (1D)" }, { "page": 9, "family": "CFR", "normalized": "21 CFR 207.35", "raw": "21 CFR 207.35", "context": "2 JA 900.08: NDC, Bar Code, & Product Identifiers/21 CFR 201.25 & 21 CFR 207.35 (3)(i) *8. Barcode Linear or One-Dimensional (1D) (Parallel Lines" }, { "page": 11, "family": "CFR", "normalized": "21 CFR 610.61", "raw": "21 CFR 610.61", "context": "and August 19, 2021. 21 CFR 610.61 (a) through (s) Checked items \u201cx\u201d indicate compliance a. The proper name" }, { "page": 12, "family": "CFR", "normalized": "21 CFR 201.25", "raw": "21 CFR 201.25", "context": "Review (Package) appendix 3 JA 900.08: NDC, Bar Code, & Product Identifiers/21 CFR 201.25 & 21 CFR 207.35 (3)(i) Checked items" }, { "page": 12, "family": "CFR", "normalized": "21 CFR 207.35", "raw": "21 \n CFR 207.35", "context": ") appendix 3 JA 900.08: NDC, Bar Code, & Product Identifiers/21 CFR 201.25 & 21 CFR 207.35 (3)(i) Checked items \u201cx\u201d indicate compliance 9. Barcode & Linear or One" }, { "page": 14, "family": "CFR", "normalized": "21 CFR 610.60", "raw": "21 CFR 610.60", "context": "1, and August 19, 2021. 21 CFR 610.60(a)(1) through (7) Checked items \u201cx\u201d indicate compliance b. Full label. T" }, { "page": 14, "family": "CFR", "normalized": "21 CFR 610.62", "raw": "21 CFR 610.62", "context": "aced on the package label. N/A 21 CFR 610.62 (7) (b) through (e) Checked items \u201cx\u201d indicate compliance b. Package lab" }, { "page": 15, "family": "CFR", "normalized": "21 CFR 201.25", "raw": "21 CFR 201.25", "context": "ainer) appendix 4 JA 900.08: NDC, Bar Code, & Product Identifiers/21 CFR 201.25 & 21 CFR 207.35 (3)(i) *8. Barcode Linear or One-Dimensional (1D)" }, { "page": 15, "family": "CFR", "normalized": "21 CFR 207.35", "raw": "21 CFR 207.35", "context": "4 JA 900.08: NDC, Bar Code, & Product Identifiers/21 CFR 201.25 & 21 CFR 207.35 (3)(i) *8. Barcode Linear or One-Dimensional (1D) (Parallel Lines" }, { "page": 17, "family": "CFR", "normalized": "21 CFR 610.60", "raw": "21 CFR 610.60", "context": "1; and August 19, 2021. 21 CFR 610.60(a)(1) through (7) Checked items \u201cx\u201d indicate compliance c. Full label. T" }, { "page": 17, "family": "CFR", "normalized": "21 CFR 610.62", "raw": "21 CFR 610.62", "context": "aced on the package label. N/A 21 CFR 610.62 (7) (b) through (e) Checked items \u201cx\u201d indicate compliance b. Package lab" }, { "page": 18, "family": "CFR", "normalized": "21 CFR 201.25", "raw": "21 CFR 201.25", "context": "Stamp) appendix 5 JA 900.08: NDC, Bar Code, & Product Identifiers/21 CFR 201.25 & 21 CFR 207.35 (3)(i) *8. Barcode Linear or One-Dimensional (1D)" }, { "page": 18, "family": "CFR", "normalized": "21 CFR 207.35", "raw": "21 CFR 207.35", "context": "5 JA 900.08: NDC, Bar Code, & Product Identifiers/21 CFR 201.25 & 21 CFR 207.35 (3)(i) *8. Barcode Linear or One-Dimensional (1D) (Parallel Lines" }, { "page": 20, "family": "CFR", "normalized": "21 CFR 610.60", "raw": "21 CFR 610.60", "context": "1; and August 19, 2021. 21 CFR 610.60(a)(1) through (7) Checked items \u201cx\u201d indicate compliance d. Full label. T" }, { "page": 20, "family": "CFR", "normalized": "21 CFR 610.62", "raw": "21 CFR 610.62", "context": "aced on the package label. N/A 21 CFR 610.62 (7) (b) through (e) Checked items \u201cx\u201d indicate compliance b. Package lab" }, { "page": 21, "family": "CFR", "normalized": "21 CFR 201.25", "raw": "21 CFR 201.25", "context": "icker) appendix 6 JA 900.08: NDC, Bar Code, & Product Identifiers/21 CFR 201.25 & 21 CFR 207.35 (3)(i) *8. Barcode Linear or One-Dimensional (1D)" }, { "page": 21, "family": "CFR", "normalized": "21 CFR 207.35", "raw": "21 CFR 207.35", "context": "6 JA 900.08: NDC, Bar Code, & Product Identifiers/21 CFR 201.25 & 21 CFR 207.35 (3)(i) *8. Barcode Linear or One-Dimensional (1D) (Parallel Lines" }, { "page": 23, "family": "CFR", "normalized": "21 CFR 610.61", "raw": "21 CFR 610.61", "context": "nd August 19, 2021. 21 CFR 610.61 (a) through (s) Checked items \u201cx\u201d indicate compliance a. The proper name" }, { "page": 24, "family": "CFR", "normalized": "21 CFR 201.25", "raw": "21 CFR 201.25", "context": "Review (Package) appendix 7 JA 900.08: NDC, Bar Code, & Product Identifiers/21 CFR 201.25 & 21 CFR 207.35 (3)(i) Checked items" }, { "page": 24, "family": "CFR", "normalized": "21 CFR 207.35", "raw": "21 \n CFR 207.35", "context": ") appendix 7 JA 900.08: NDC, Bar Code, & Product Identifiers/21 CFR 201.25 & 21 CFR 207.35 (3)(i) Checked items \u201cx\u201d indicate compliance 9. Barcode & Linear or One" }, { "page": 26, "family": "CFR", "normalized": "21 CFR 610.61", "raw": "21 CFR 610.61", "context": "nd August 19, 2021. 21 CFR 610.61 (a) through (s) Checked items \u201cx\u201d indicate compliance a. The proper name" }, { "page": 27, "family": "CFR", "normalized": "21 CFR 201.25", "raw": "21 CFR 201.25", "context": "Review (Package) appendix 8 JA 900.08: NDC, Bar Code, & Product Identifiers/21 CFR 201.25 & 21 CFR 207.35 (3)(i) Checked items" }, { "page": 27, "family": "CFR", "normalized": "21 CFR 207.35", "raw": "21 \n CFR 207.35", "context": ") appendix 8 JA 900.08: NDC, Bar Code, & Product Identifiers/21 CFR 201.25 & 21 CFR 207.35 (3)(i) Checked items \u201cx\u201d indicate compliance 9. Barcode & Linear or One" }, { "page": 29, "family": "CFR", "normalized": "21 CFR 610.60", "raw": "21 CFR 610.60", "context": "1; and August 19, 2021. 21 CFR 610.60(a)(1) through (7) Checked items \u201cx\u201d indicate compliance e. Full label. T" }, { "page": 29, "family": "CFR", "normalized": "21 CFR 610.62", "raw": "21 CFR 610.62", "context": "aced on the package label. N/A 21 CFR 610.62 (7) (b) through (e) Checked items \u201cx\u201d indicate compliance b. 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PEDIATRIC REQUIREMENTS Under the Pediatric Research Equity Act (PREA) (21 U.S.C. 355c), all applications for new active ingredients, new indications, new dosage for" } ] }, { "filename": "Courtesy-Copy_BLA-125742-45_07-08-2022_Memo_Committee-Memo-Clinical-Review.pdf", "id": 8462, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2024/01/Courtesy-Copy_BLA-125742-45_07-08-2022_Memo_Committee-Memo-Clinical-Review.pdf", "ican_url": null, "total_pages": 61, "matches": [ { "page": 4, "family": "Named act", "normalized": "FD&C Act", "raw": "FDCA", "context": "9 EUA emergency use authorization FDA Food and Drug Administration FDCA Federal Food, Drug, and Cosmetic Act ICU intensive care unit IND" }, { "page": 4, "family": "Named act", "normalized": "FD&C Act", "raw": "Federal Food, Drug, and Cosmetic Act", "context": "emergency use authorization FDA Food and Drug Administration FDCA Federal Food, Drug, and Cosmetic Act ICU intensive care unit IND investigational new drug application L" }, { "page": 14, "family": "CFR", "normalized": "21 CFR 312", "raw": "21 CFR 312", "context": "inical study C4591001, including compliance with Good Clinical Practice as per 21 CFR 312. Bioresearch Monitoring inspections of three clinical sites in study C4591001" }, { "page": 14, "family": "CFR", "normalized": "21 CFR 54.2", "raw": "21 CFR 54.2", "context": "r of investigators with interests/arrangements in each category (as defined in 21 CFR 54.2(a), (b), (c) and (f)): Compensation to the investigator for conducting the st" } ] }, { "filename": "IND-019736_S434_IND-19736_09-24-2021_Telecon-.pdf", "id": 8857, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2024/01/IND-019736_S434_IND-19736_09-24-2021_Telecon-.pdf", "ican_url": null, "total_pages": 4, "matches": [] }, { "filename": "IND-019736_S434_IND-19736_11-12-2021_Telecon-.pdf", "id": 8858, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2024/01/IND-019736_S434_IND-19736_11-12-2021_Telecon-.pdf", "ican_url": null, "total_pages": 3, "matches": [] }, { "filename": "IND-019736_S434_IND-19736_RAMACHANDRA_RE_-Request-for-Comments-and-Advice-_-Proposal-for-adolesc.pdf", "id": 8859, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2024/01/IND-019736_S434_IND-19736_RAMACHANDRA_RE_-Request-for-Comments-and-Advice-_-Proposal-for-adolesc.pdf", "ican_url": null, "total_pages": 1, "matches": [] }, { "filename": "ORDER_2022_01_06.pdf", "id": 8860, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2022/01/ORDER_2022_01_06.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2022/03/ORDER_2022_01_06.pdf", "total_pages": 4, "matches": [ { "page": 1, "family": "CFR", "normalized": "21 CFR 601.51", "raw": "21 C.F.R. \u00a7 601.51", "context": "quest seeking \u201c[a]ll data and information for the Pfizer Vaccine enumerated in 21 C.F.R. \u00a7 601.51(e) with the exception of publicly available reports on the Vaccine Adverse Ev" }, { "page": 1, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "N, Defendant. ORDER This case involves the Freedom of Information Act (\u201cFOIA\u201d). Specifically, at issue is Plaintiff\u2019s FOIA request seeking \u201c[a]ll data and" }, { "page": 1, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "the Freedom of Information Act (\u201cFOIA\u201d). Specifically, at issue is Plaintiff\u2019s FOIA request seeking \u201c[a]ll data and information for the Pfizer Vaccine enumerated" }, { "page": 2, "family": "Court case", "normalized": "NLRB v. Robbins Tire & Rubber Co., 437 U.S. 214", "raw": "NLRB v. Robbins Tire & Rubber Co., 437 U.S. 214", "context": "ormed citizenry, [which is] vital to the functioning of a democratic society.\u201d NLRB v. Robbins Tire & Rubber Co., 437 U.S. 214, 242 (1977). \u201cFOIA was [therefore] enacted to \u2018pierce the veil of administrati" }, { "page": 2, "family": "Court case", "normalized": "Batton v. Evers, 598 F.3d 169", "raw": "Batton \nv. Evers, 598 F.3d 169", "context": "istrative secrecy and to open agency action to the light of public scrutiny.\u2019\u201d Batton v. Evers, 598 F.3d 169, 175 (5th Cir. 2010) (quoting Dep\u2019t of the Air Force v. Rose, 425 U.S. 352, 36" }, { "page": 2, "family": "Court case", "normalized": "Air Force v. Rose, 425 U.S. 352", "raw": "Air Force \nv. Rose, 425 U.S. 352", "context": "ny.\u2019\u201d Batton v. Evers, 598 F.3d 169, 175 (5th Cir. 2010) (quoting Dep\u2019t of the Air Force v. Rose, 425 U.S. 352, 361 (1976)). And \u201cCongress has long recognized that \u2018information is often use" }, { "page": 2, "family": "Court case", "normalized": "Just. Initiative v. CIA, 399 F. Supp. 3d 161", "raw": "Just. Initiative v. CIA, 399 F. Supp. 3d 161", "context": "elay by the agency in its response is often tantamount to denial.\u2019\u201d Open Soc\u2019y Just. Initiative v. CIA, 399 F. Supp. 3d 161, 165 (S.D.N.Y. 2019) (quoting H.R. REP. NO. 93-876, at 6271 (1974)). When nee" }, { "page": 2, "family": "Court case", "normalized": "Clemente v. FBI, 71 F. Supp. 3d 262", "raw": "Clemente v. \nFBI, 71 F. Supp. 3d 262", "context": "require an agency to process documents according to a court-imposed timeline.\u201d Clemente v. FBI, 71 F. Supp. 3d 262, 269 (D.D.C. 2014). Here, the Court recognizes the \u201cunduly burdensome\u201d challe" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "idence in the government.\u201d5 Echoing these sentiments, \u201c[t]he basic purpose of FOIA is to ensure an informed citizenry, [which is] vital to the functioning of a d" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ratic society.\u201d NLRB v. Robbins Tire & Rubber Co., 437 U.S. 214, 242 (1977). \u201cFOIA was [therefore] enacted to \u2018pierce the veil of administrative secrecy and to o" }, { "page": 2, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "14). Here, the Court recognizes the \u201cunduly burdensome\u201d challenges that this FOIA request may present to the FDA. See generally ECF Nos. 23, 30, 34. But, as exp" }, { "page": 3, "family": "Court case", "normalized": "Payne Enters., Inc. v. United \nStates, 837 F.2d 486", "raw": "Payne Enters., Inc. v. United \nStates, 837 F.2d 486", "context": "is of paramount public importance. \u201c[S]tale information is of little value.\u201d Payne Enters., Inc. v. United States, 837 F.2d 486, 494 (D.C. Cir. 1988). The Court, agreeing with this truism, therefore conclud" }, { "page": 3, "family": "Court case", "normalized": "See Bloomberg, L.P. v. FDA, 500 F. Supp. 2d 371", "raw": "See Bloomberg, L.P. v. \nFDA, 500 F. Supp. 2d 371", "context": "ious completion of Plaintiff\u2019s request is not only practicable, but necessary. See Bloomberg, L.P. v. FDA, 500 F. Supp. 2d 371, 378 (S.D.N.Y. Aug. 15, 2007) (\u201c[I]t is the compelling need for such public un" }, { "page": 3, "family": "Court case", "normalized": "See Halpern v. FBI, 181 F.3d 279", "raw": "See Halpern v. FBI, 181 \nF.3d 279", "context": "sing this request with the FDA\u2019s concerns regarding the burdens of production. See Halpern v. FBI, 181 F.3d 279, 284\u201385 (2nd Cir. 1991) (\u201c[FOIA] emphasizes a preference for the fullest possi" }, { "page": 3, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "3 Accordingly, the Court concludes that this FOIA request is of paramount public importance. \u201c[S]tale information is of little" }, { "page": 3, "family": "Named act", "normalized": "FOIA", "raw": "FOIA", "context": "ens of production. See Halpern v. FBI, 181 F.3d 279, 284\u201385 (2nd Cir. 1991) (\u201c[FOIA] emphasizes a preference for the fullest possible agency disclosure of such in" } ] }, { "filename": "Order-February-7-2022.pdf", "id": 8861, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2022/02/Order-February-7-2022.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2022/03/Order-February-7-2022.pdf", "total_pages": 2, "matches": [ { "page": 1, "family": "Court case", "normalized": "Entergy Gulf States La., L.L.C. v. EPA, 817 F.3d 198", "raw": "Entergy Gulf States La., L.L.C. v. EPA, 817 F.3d 198", "context": "Stores, Inc. v. Tex. Alcoholic Beverage Comm\u2019n, 834 F.3d 562 (5th Cir. 2016); Entergy Gulf States La., L.L.C. v. EPA, 817 F.3d 198 (5th Cir. 2016); Texas v. United States, 805 F.3d 653 (5th Cir. 2015). Case" }, { "page": 1, "family": "Court case", "normalized": "Texas v. United States, 805 F.3d 653", "raw": "Texas v. United States, 805 F.3d 653", "context": "2016); Entergy Gulf States La., L.L.C. v. EPA, 817 F.3d 198 (5th Cir. 2016); Texas v. United States, 805 F.3d 653 (5th Cir. 2015). 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The" } ] }, { "filename": "reissue_5.3.6-postmarketing-experience.pdf", "id": 8864, "module": null, "batch_code": null, "company": "Pfizer", "license": null, "individual_url": "https://phmpt.org/wp-content/uploads/2022/04/reissue_5.3.6-postmarketing-experience.pdf", "ican_url": "https://icandecide.org/wp-content/uploads/2022/04/reissue_5.3.6-postmarketing-experience.pdf", "total_pages": 38, "matches": [] } ] }