Declaration — CHD v. FDA

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Declaration of Suzann Burk in Support of Defendants' Motion to Dismiss, Document 18-1, filed 04/25/22 in Children's Health Defense, et al. v. Food & Drug Administration, et al., Case No. 6:22-cv-00093-ADA-DTG, in the United States District Court for the Western District of Texas, Waco Division. Burk states that she is the Director of the Division of Disclosure and Oversight Management at the FDA's Center for Biologics Evaluation and Research and is responsible for disclosing CBER documents in litigation. She attaches Exhibit 1, a Letter of Authorization to Pfizer Inc. dated Jan. 3, 2022 (reissuance), and Exhibit 2, a Fact Sheet for Recipients and Caregivers for Use in Individuals 5-11 years of age dated Jan. 3, 2022 (revised). She certifies that each was the current effective version as of January 24, 2022. The declaration is executed on April 21, 2022.

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UNITED STATES DISTRICT COURT 
FOR THE WESTERN DISTRICT OF TEXAS 
WACO DIVISION 
 
 
Children’s Health Defense, et al., 
 
 
 
 
 
Plaintiffs, 
 
 
v. 
 
Food & Drug Administration, et al., 
 
 
 
 
 
Defendants. 
 
 
 
 
Case No. 6:22-cv-00093-ADA-DTG 
Declaration of Suzann Burk in Support of Defendants’ Motion to Dismiss 
 
 
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 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. 
Case 6:22-cv-00093-ADA-DTG   Document 18-1   Filed 04/25/22   Page 1 of 2

4. 
I submit this declaration in support of Defendants’ Motion to Dismiss 
Plaintiffs’ Complaint. 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 
Document 
Date 
Exhibit 1 
Letter of Authorization from Jacqueline A. 
O’Shaughnessy, Acting Chief Scientist, FDA, 
to Pfizer Inc. 
Jan. 3, 2022 
(reissuance) 
Exhibit 2 
Fact Sheet for Recipients and Caregivers for 
Use in Individuals 5–11 years of age  
Jan. 3, 2022 
(revised) 
 
6. 
I certify that each document listed in Paragraph 5 was the current effective 
version as of January 24, 2022, 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 and 2 and the 
facts contained in this declaration are true and correct pursuant to 28 U.S.C. § 1746. 
 
 
________________________________ 
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 April 21, 2022 
Suzann H. Burk -S
Digitally signed by Suzann H. Burk 
-S 
Date: 2022.04.21 08:16:23 -04'00'
Case 6:22-cv-00093-ADA-DTG   Document 18-1   Filed 04/25/22   Page 2 of 2

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