Declaration of Suzann Burk — Director of the Division of Disclosure — Xavier Becerra, et al. — Case 2:21-cv-00702-CLM (Document 24)

Date: 2021-09-16

Summary

The Declaration of Suzann Burk, filed September 16, 2021 as Document 24 in America's Frontline Doctors, et al. v. Xavier Becerra, et al., Civil Action No. 2:21-CV-702-CLM, in the U.S. District Court for the Northern District of Alabama. Burk, Director of the Division of Disclosure and Oversight Management at FDA's Center for Biologics Evaluation and Research, submits it under 28 U.S.C. § 1746 in support of Defendants' Motion to Dismiss and Opposition to Plaintiffs' Motion for a Preliminary Injunction. The declaration attaches Exhibits 1–13: fact sheets for recipients and for healthcare providers, 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 effective version and publicly available on FDA's website as of June 10, 2021.

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Cite this document

“Declaration of Suzann Burk — Director of the Division of Disclosure — Xavier Becerra, et al. — Case 2:21-cv-00702-CLM (Document 24).” Original at archive.org, dated 2021-09-16. Archived at Pandemic Darlings, https://pandemicdarlings.com/source-documents/2021-09-16-plaintiffs-v-xavier-becerra-et-al-d33c799e-1/, SHA-256 d33c799ee003ed8b9b3c89b3ccfdeb9db7466946abb85fa74589d2c7609fbff1.

Full text

Case 2:21-cv-00702-CLM Document 24 Filed 09/16/21 Page 1 of 5 FILED
2021 Sep-16 AM 11:09
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

XAVIER BECERRA, et al.,

Defendants.

DECLARATION OF SUZANN BURK
I, Suzann Burk, make the following declaration under oath pursuant to 28

U.S.C. § 1746. I am aware that this declaration will be filed with the United States

District Court for the Northern District of Alabama in the case referenced above,

and that it is the legal equivalent of a statement under oath, made under penalty of

perjury.
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,

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Case 2:21-cv-00702-CLM Document 24 Filed 09/16/21 Page 2 of 5

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

and a member of the Access Litigation and Freedom of Information Branch

(“ALFOI”) 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
and Opposition to Plaintiffs’ Motion for a Preliminary Injunction in the above-

captioned case. 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
1 Pfizer- Fact Sheet for Recipients and May 10, 2021
BioNTech Caregivers (revised)
2 Pfizer- Fact Sheet for Healthcare May 19, 2021
BioNTech Providers Administering Vaccine (revised)
(Vaccination Providers)
3 Pfizer- Letter of Authorization from May 10, 2021
BioNTech Denise M. Hinton, Chief Scientist,
FDA, to Pfizer Inc.
4 Pfizer- COVID-19 Vaccine Emergency Dec. 11, 2020
BioNTech Use Authorization Review
Memorandum

2
Case 2:21-cv-00702-CLM Document 24 Filed 09/16/21 Page 3 of 5

5 Pfizer- COVID-19 Vaccine EUA May 10, 2021
BioNTech Amendment Review
Memorandum
6 Moderna Fact Sheet for Recipients and Mar. 26, 2021
Caregivers (revised)
7 Moderna Fact Sheet for Healthcare Mar. 31, 2021
Providers Administering Vaccine (revised)
(Vaccination Providers)
8 Moderna Letter of Authorization from Feb. 25, 2021
Denise M. Hinton, Chief Scientist,
FDA, to ModernaTX, Inc.
9 Moderna COVID-19 Vaccine Emergency Dec. 18, 2020
Use Authorization Review
Memorandum
10 Janssen Fact Sheet for Recipients and Apr. 23, 2021
Caregivers (revised)
11 Janssen Fact Sheet for Healthcare Apr. 23, 2021
Providers Administering Vaccine (revised)
(Vaccination Providers)
12 Janssen Letter of Authorization from June 10, 2021
Denise M. Hinton, Chief Scientist,
FDA, to Janssen Biotech, Inc.
13 Janssen COVID-19 Vaccine Emergency Feb. 27, 2021
Use Authorization Review
Memorandum

6. I certify that each document listed in Paragraph 5 was the current

effective version as of June 10, 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 1–13 and

the facts contained in this declaration are true and correct pursuant to 28 U.S.C.

§ 1746.

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Case 2:21-cv-00702-CLM Document 24 Filed 09/16/21 Page 5 of 5

CERTIFICATE OF SERVICE

I hereby certify that on September 16, 2021, I electronically filed the

foregoing with the Clerk of the Court using the CM/ECF system, which will send

notification of such filing to counsel of record.

/s/ James W. Harlow
JAMES W. HARLOW
Senior Trial Attorney

File and source

File: gov.uscourts.alnd.177186.24.0.pdf
Size: 753,828 bytes
SHA-256: d33c799ee003ed8b9b3c89b3ccfdeb9db7466946abb85fa74589d2c7609fbff1
Our copy: gov.uscourts.alnd.177186.24.0.pdf
Original: archive.org