Biologics Electronic Reading Room (eFOIA)
The Center for Biologics Evaluation and Research Freedom of Information Act (FOIA) Electronic Reading Room contains copies of CBER records (or links to other locations of CBER records) that we are making publicly available: (1) because the records are required to be published on the web by the Food, Drug and Cosmetic Act, (2) because they are “frequently requested” records under the FOIA (5 U.S.C. § 552(a)(2)(D)) or (3) proactively at our discretion. We will continue to add records to reflect public interest.
Information of Interest
Pfizer-BioNTech Comirnaty COVDI-19 Vaccine Related Records | Powered by BOX
*Due to the volume, complexity and file size of this collection, the majority of the records are not Section 508 compliant. If you need assistance with any of these files, please call 240-402-7800. In addition, this collection of records contains .xml, .mp3, .txt, .xsl, and .xpt files which may require additional software in order to access.
Note: The majority of the files utilize a special file naming rubric that is indicative of the standard submission format used in the Electronic Common Technical Document (eCTD) database. For additional information regarding the eCTD, please see the link below: https://www.fda.gov/drugs/electronic-regulatory-submission-and-review/electronic-common-technical-document-ectd
Additional Comirnaty Related Records
Frequently Requested Records*
* - The Freedom of Information Act, 5 U.S.C. § 552(a)(2)(D) “copies of all records, regardless of form or format - (i) that have been released to any person under paragraph (3); and (ii)(I) that because of the nature of their subject matter, the agency determines have become or are likely to become the subject of subsequent requests for substantially the same records; or (II) that have been requested 3 or more times;”
