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available reports on the Vaccine Adverse Events Reporting System

Date
2021-09-16

Summary

Exhibit A.3, filed September 16, 2021 as Document 1-3 in Case 4:21-cv-01058-P, is a two-page attachment reproducing an August 31, 2021 letter from the Food and Drug Administration. The letter acknowledges a Freedom of Information Act request from Public Health and Medical Professionals for Transparency, assigned FOIA Control # 2021-5683. The request seeks all data and information for the Pfizer Vaccine enumerated in 21 C.F.R. § 601.51(e), except publicly available reports on the Vaccine Adverse Events Reporting System. The letter states that the FDA may charge processing fees and may be unable to meet the twenty-working-day time limit because of an increase in incoming requests. It lists dispute resolution contacts and closes with the signature block of Sarah Kotler, Director.

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Full text

Case 4:21-cv-01058-P Document 1-3 Filed 09/16/21   Page 1 of 2 PageID 32




                    Exhibit A.3
         Case 4:21-cv-01058-P Document 1-3 Filed 09/16/21                             Page 2 of 2 PageID 33




August 31, 2021
                                                                                                      In Reply refer to
                                                                                                      FOIA Control #:
PUBLIC HEALTH AND MEDICAL PROFESSIONALS FOR                                                           2021-5683
TRANSPARENCY
AARON SIRI                                                                                            Requester reference:
200 Park Avenue
17th Floor
New York NY 10166 USA



    Dear Requester:

    The Food and Drug Administration (FDA) has received your Freedom of Information Act (FOIA) request for records
    regarding:

    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.

    We will respond as soon as possible and may charge you a fee for processing your request. If your informational needs
    change, and you no longer need the requested records, please contact us to cancel your request, as charges may be
    incurred once processing of your request has begun. For more information on processing fees, please see
    http://www.fda.gov/RegulatoryInformation/FOI/FOIAFees/default.htm.

    Due to an increase in the number of incoming requests, we may be unable to comply with the twenty-working-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 whether sensitive records, voluminous records, extensive search, and/or consultation
    with other HHS components or other executive branch agencies are involved. Please note that requests for medical
    device approval records (e.g. 510K, PMA, DEN) may take up to 18 to 24 months to process.

    If you have any questions about your request, please call Claire B. Stansbury, Information Technician, at (301) 796-
    8979 or write to us at:
    Food and Drug Administration
    Division of Freedom of Information
    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
    quickly.

    You also have the right to seek dispute resolution services from:

    Office of Government Information Services              and/or             FDA FOIA Public Liaison
    National Archives and Administration                                      Office of the Executive Secretariat
    8601 Adelphi Road – OGIS                                                  US Food Administration
    College Park, MD 20740-6001                                               5630 Fishers Lane, Room 1050
    Telephone:202-741-5770                                                    Email: FDAFOIA@fda.hhs.gov
    Toll-Free: 1-877-684-6448
    Email:ogis@nara.gov
    Fax: 202-741-5769




                                                                         Sincerely,



                                                                         SARAH KOTLER
                                                                         Director

File and source

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gov.uscourts.txnd.353278.1.3.pdf
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Our copy
gov.uscourts.txnd.353278.1.3.pdf
Original
archive.org
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