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available reports on the Vaccine Adverse Events Reporting System

Date
2021-09-16

Summary

Document 1-4, filed September 16, 2021 in Case 4:21-cv-01058-P, is Exhibit A.4, a Food and Drug Administration letter dated September 09, 2021 responding to a Freedom of Information Act request from Public Health and Medical Professionals for Transparency, FOIA Control # 2021-5683. The request sought data and information for the Pfizer Vaccine enumerated in 21 C.F.R. § 601.51(e), excluding publicly available reports on the Vaccine Adverse Events Reporting System. Citing 5 U.S.C. 552(a)(6)(E), the letter denies the request for expedited processing, stating that no compelling need was demonstrated. It advises that the request will be processed in the order received and that an appeal must be mailed within 90 days. The letter closes with the signature block of an FDA Director.

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Full text

Case 4:21-cv-01058-P Document 1-4 Filed 09/16/21   Page 1 of 2 PageID 34




                    Exhibit A.4
         Case 4:21-cv-01058-P Document 1-4 Filed 09/16/21                                Page 2 of 2 PageID 35




September 09, 2021
                                                                                                         In Reply refer to
                                                                                                         FOIA Control #:
PUBLIC HEALTH AND MEDICAL PROFESSIONALS FOR                                                              2021-5683
TRANSPARENCY
AARON SIRI                                                                                               Requester reference:
200 Park Avenue                                                                                          IR#0546
17th Floor
New York NY 10166 USA



    Dear Requester:

    This is in reference to your request(s) for record(s) from the 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. § 601.51(e) with the exception of publicly
    available reports on the Vaccine Adverse Events Reporting System.

    The 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 consider requests for expedited processing and grant them
    whenever a "compelling need" is shown and in other cases as determined by the agency. The term "compelling need" is
    defined as (1) involving "an imminent threat to the life or physical safety of an individual," or (2) in the case of a request
    made by "a person primarily engaged in disseminating information, urgency to inform the public concerning actual or
    alleged Federal Government activity."

    I have determined 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 to the life or physical safety of an individual. Neither
    have you demonstrated that there exists an urgency to inform the public concerning actual or alleged Federal
    Government activity. Therefore, I am denying your request for expedited processing. The responding agency office will
    process your request in the order in which it was received.

    You have the right to 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 agency's decision. Your appeal must be mailed within 90
    days from the date of this response, to: Director, Office of the Executive Secretariat, US Food & Drug Administration,
    5630 Fishers Lane, Room 1050, Rockville, MD 20857, E-mail: FDAFOIA@fda.hhs.gov. Please clearly mark both the
    envelope and your 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
    1050, Rockville, 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
    Services (OGIS), the Federal FOIA Ombudsman’s office, offers mediation services to help resolve disputes between
    FOIA requesters and Federal agencies. The contact information for OGIS is: Office of Government Information
    Services, National Archives and Records Administration, 8601 Adelphi Road–OGIS, College Park, MD 20740-6001,
    Telephone: 202-741-5770, Toll-Free: 1-877-684-6448, E-mail: ogis@nara.gov, Fax: 202-741-5769.

                                                                           Sincerely,



                                                                           SARAH KOTLER
                                                                           Director

File and source

File
gov.uscourts.txnd.353278.1.4.pdf
Size
143,186 bytes
SHA-256
0112473679a22480007d8e627b7b3dd6563f90b43dbee3309b594a18a9755b25
Our copy
gov.uscourts.txnd.353278.1.4.pdf
Original
archive.org
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