Declaration Of Suzann Burk
- Date
- 2018-06-24
Summary
A declaration of Suzann Burk, Director of the Division of Disclosure and Oversight Management at the FDA's Center for Biologics Evaluation and Research, filed December 17, 2021 as Document 40 in America's Frontline Doctors, et al. v. United States of America, et al., Civil Action No. 2:21-CV-702-CLM, in the U.S. District Court for the Northern District of Alabama. It is submitted in support of Defendants' Motion to Dismiss Plaintiffs' Amended Complaint and in opposition to Plaintiffs' Motion for a Preliminary Injunction. The declaration lists attached Exhibits 1–22: fact sheets, letters of authorization and emergency use authorization review memoranda for the Pfizer-BioNTech, Moderna and Janssen COVID-19 vaccines. It certifies that each listed document was the current version and publicly available on FDA's website as of November 5, 2021, and is made under 28 U.S.C. § 1746.
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Case 2:21-cv-00702-CLM Document 40 Filed 12/17/21 Page 1 of 5 FILED
2021 Dec-17 PM 01:27
U.S. DISTRICT COURT
N.D. OF ALABAMA
IN THE UNITED STATES DISTRICT COURT
FOR THE NORTHERN DISTRICT OF ALABAMA
SOUTHERN DIVISION
AMERICA’S FRONTLINE
DOCTORS, et al.,
Plaintiffs,
CIVIL ACTION NO.
v. 2:21-CV-702-CLM
UNITED STATES OF AMERICA, et
al.,
Defendants.
DECLARATION OF SUZANN BURK
I, Suzann Burk, declare as follows:
1. I am the Director of the Division of Disclosure and Oversight
Management (“DDOM”), Office of Communication Outreach and Development,
Center for Biologics Evaluation and Research (“CBER”), United States Food and
Drug Administration (“FDA”), in Silver Spring, Maryland.
2. As the Director of DDOM, I have overall responsibility for the
disclosure of documents officially maintained by CBER, the center in FDA that
regulates biologic products such as blood, vaccines, gene therapy, and human cells,
tissues, and cellular and tissue-based products. I have been the Director of DDOM
since June 24, 2018. Prior to that date, I was the Team Lead of the Electronic
Disclosure Team in DDOM for approximately nine and one-half years. Prior to that,
I was a member of the Congressional and Oversight Branch in DDOM for two years
1
Case 2:21-cv-00702-CLM Document 40 Filed 12/17/21 Page 2 of 5
and a member of the Access Litigation and Freedom of Information Branch in
DDOM for four years.
3. In my capacity as Director of DDOM I have access to official CBER
documents. I am responsible for disclosing documents in litigation on behalf of
CBER.
4. I submit this declaration in support of Defendants’ Motion to Dismiss
Plaintiffs’ Amended Complaint and in opposition to Plaintiffs’ Motion for a
Preliminary Injunction. The statements made in this declaration are based on my
personal knowledge and official records available to me in my official capacity.
5. Attached hereto are copies of the following documents:
Exhibit Vaccine Document Date
Manufacturer
Exhibit 1 Pfizer- Fact Sheet for Recipients and Oct. 29, 2021
BioNTech Caregivers 12 years of age and
older
Exhibit 2 Pfizer- Fact Sheet for Recipients and Oct. 29, 2021
BioNTech Caregivers 5–11 years of age
Exhibit 3 Pfizer- Fact Sheet for Healthcare Oct. 29, 2021
BioNTech Providers Administering Vaccine
(Vaccination Providers), 12 years
of age and older, purple cap
Exhibit 4 Pfizer- Fact Sheet for Healthcare Oct. 29, 2021
BioNTech Providers Administering Vaccine
(Vaccination Providers), 12 years
of age and older, gray cap
Exhibit 5 Pfizer- Fact Sheet for Healthcare Oct. 29, 2021
BioNTech Providers Administering Vaccine
(Vaccination Providers), 5–11
years of age, orange cap
2
Case 2:21-cv-00702-CLM Document 40 Filed 12/17/21 Page 3 of 5
Exhibit 6 Pfizer- Letter of Authorization from Oct. 29, 2021
BioNTech Jacqueline A. O'Shaughnessy, (revised)
Acting Chief Scientist, FDA, to
Pfizer Inc.
Exhibit 7 Pfizer- COVID-19 Vaccine Emergency Dec. 11, 2020
BioNTech Use Authorization Review
Memorandum
Exhibit 8 Pfizer- COVID-19 Vaccine EUA May 10, 2021
BioNTech Amendment Review
Memorandum
Exhibit 9 Pfizer- COVID-19 Vaccine EUA Aug. 12, 2021
BioNTech Amendment Review
Memorandum
Exhibit 10 Pfizer- COVID-19 Vaccine EUA Sept. 24, 2021
BioNTech Amendment Review
Memorandum
Exhibit 11 Pfizer- COVID-19 Vaccine EUA Oct. 20, 2021
BioNTech Amendment Review
Memorandum
Exhibit 12 Moderna Fact Sheet for Recipients and Oct. 20, 2021
Caregivers (revised)
Exhibit 13 Moderna Fact Sheet for Healthcare Oct. 20, 2021
Providers Administering Vaccine (revised)
(Vaccination Providers)
Exhibit 14 Moderna Letter of Authorization from Oct. 20, 2021
Jacqueline A. O'Shaughnessy, (reissued)
Acting Chief Scientist, FDA, to
ModernaTX, Inc.
Exhibit 15 Moderna COVID-19 Vaccine Emergency Dec. 18, 2020
Use Authorization Review
Memorandum
Exhibit 16 Moderna COVID-19 Vaccine EUA Aug. 12, 2021
Amendment Review
Memorandum
Exhibit 17 Moderna COVID-19 Vaccine EUA Oct. 20, 2021
Amendment Review
Memorandum
Exhibit 18 Janssen Fact Sheet for Recipients and Oct. 20, 2021
Caregivers (revised)
3
Case 2:21-cv-00702-CLM Document 40 Filed 12/17/21 Page 4 of 5
Exhibit 19 Janssen Fact Sheet for Healthcare Oct. 20, 2021
Providers Administering Vaccine (revised)
(Vaccination Providers)
Exhibit 20 Janssen Letter of Authorization from Oct. 20, 2021
Jacqueline A. O'Shaughnessy, (reissued)
Acting Chief Scientist, FDA, to
Janssen Biotech, Inc.
Exhibit 21 Janssen COVID-19 Vaccine Emergency Feb. 27, 2021
Use Authorization Review
Memorandum
Exhibit 22 Janssen COVID-19 Vaccine EUA Oct. 20, 2021
Amendment Review
Memorandum
6. I certify that each document listed in Paragraph 5 was the current
effective version as of November 5, 2021, and was publicly available on FDA’s
website, https://www.fda.gov, as of that date.
7. I declare under penalty of perjury that the foregoing Exhibits 1–22 and
the facts contained in this declaration are true and correct pursuant to 28 U.S.C.
§ 1746.
4
Case 2:21-cv-00702-CLM Document 40 Filed 12/17/21 Page 5 of 5
Digitally signed by Suzann H. Burk -S
Suzann H. Burk - DN: c=US, o=U.S. Government, ou=HHS,
ou=FDA, ou=People, cn=Suzann H. Burk -S,
S________________________________
0.9.2342.19200300.100.1.1=1300129983
Date: 2021.12.16 13:11:10 -05'00'
SUZANN BURK
Division Director
Office of Communication,
Division of Disclosure and Oversight
Management, Outreach and Development
Center for Biologics Evaluation and Research
Food and Drug Administration
U.S. Department of Health and Human
Services
Executed on December ____,
16 2021
5
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