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Form Approved: OMB No. 0910-0616. Expiration Date: 3/31/2021. See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Certification of Compliance
Under 42 U.S.C. § 282(j)(5)(B), with Requirements of ClinicalTrials.gov Data Bank
(For submission with an application/submission, including amendments, supplements, and resubmissions, under §§ 505, 515,
520(m), or 510(k) of the Federal Food, Drug, and Cosmetic Act or § 351 of the Public Health Service Act.)
SPONSOR / APPLICANT / SUBMITTER INFORMATION
1. Name of Sponsor/Applicant/Submitter
BioNTech Manufacturing GmbH2. Date of the Application/Submission
05/06/2021
3. Address
Address 1 (Street address, P.O. box, company name c/o)
An der Goldgrube 12
Address 2 (Apartment, suite, unit, building, floor, etc.)
City
MainzState/Province/Region
N/A
Country
GermanyZIP or Postal Code
551314. Telephone and Fax Numbers
(Include country code if applicable and
area code)
(Tel): +49 (0) 6131 9084-7593
(Fax): +49 (0) 6131 9084-390
PRODUCT INFORMATION
5. For Drugs/Biologics: Include Any/All Available Established, Proprietary and/or Chemical/Biochemical/Blood/Cellular/Gene Therapy Product
Name(s).
For Devices: Include Any/All Common or Usual Name(s), Classification, Trade or Proprietary or Model Name(s) and/or Model Number(s)
COVID-19 Vaccine (BNT162, PF-07302048), [COVID-19 mRNA Vaccine (nucleoside modified)], COMIRNATY
Continuation Page for #5
APPLICATION / SUBMISSION INFORMATION
6. Type of Application/Submission Which This Certification Accompanies
IND NDA ANDA BLA PMA HDE 510(k) PDP Other
7. Include IND/NDA/ANDA/BLA/PMA/HDE/510(k)/PDP/ Other Number
(If number previously assigned)
125742If BLA was selected in item 6, provide Supplement Number
8. Serial Number Assigned to Application/Submission Which This Certification Accompanies
00001
CERTIFICATION STATEMENT / INFORMATION
9. Check only one of the following boxes (See instructions for additional information and explanation)
A. I certify that the requirements of 42 U.S.C. § 282(j), Section 402(j) of the Public Health Service Act, including 42 CFR part 11, do not
apply because the application/submission which this certification accompanies does not reference any clinical trial.
B. I certify that the requirements of 42 U.S.C. § 282(j), Section 402(j) of the Public Health Service Act, including 42 CFR part 11, do not
apply to any clinical trial referenced in the application/submission which this certification accompanies.
C. I certify that the requirements of 42 U.S.C. § 282(j), section 402(j) of the Public Health Service Act, apply to one or more of the clinical
trials referenced in the application/submission which this certification accompanies and that the requirements of 42 U.S.C. 282(j),
including any applicable provisions of 42 CFR part 11, have been met.
Certification Statement / Information section continued on page 2
FORM FDA 3674 (4/18)PSC Publishing Services (301) 443-6740 EF Page 1 of 2
FDA-CBER-2021-5683-0013736
CERTIFICATION STATEMENT / INFORMATION (Continued)
10. If you checked box C, in number 9, provide the National Clinical Trial (NCT) Number(s) for any “applicable clinical trial(s),” for which you (the
sponsor/applicant/submitter) are the “respons ble party” under 42 U.S.C. § 282(j)(1)(a)(i), section 402(j)(1)(a)(i) of the Public Health Service
Act referenced in the application/ submission which this Certification accompanies. (Add continuation page as necessary.)
NCT Number(s): NCT04368728 NCT04380701
Continuation Page for #10
The undersigned declares, to the best of her/his knowledge, that this is an accurate, true, and complete submission of information. I understand that the failure to submit the certification required by 42 U.S.C. § 282(j)(5)(B), section 402(j)(5)(B) of the Public Health Service Act, and the knowing submission of a false certification under such section are prohibited acts under 21 U.S.C. § 331, section
301 of the Federal Food, Drug, and Cosmetic Act.
Warning: A willfully and knowingly false statement is a criminal offense, U.S. Code, title 18, section 1001.
11. Name and Title of the Person who Signs Number 15
Name
Elisa HarkinsTitle
Global Regulatory Lead, Global Regulatory Affairs - Vaccines, Pfizer Inc.
12. Address
Address 1 (Street address, P.O. box, company name c/o)
500 Arcola Road
Address 2 (Apartment, suite, unit, building, floor, etc.)
City
CollegevilleState/Province/Region
PA
Country
United StatesZIP or Postal Code
1942613. Telephone and Fax Numbers
(Include country code if applicable and
area code)
(Tel): 215-280-5503
(Fax): 845-474-3500
14. Date of Certification
05/06/202115. Signature of Sponsor/Applicant/Submitter or an Authorized
Representative (Sign)Sign
This section applies only to requirements of the Paperwork Reduction Act of 1995.
***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.***
The burden time for this collection of information is estimated to average 15 minutes and 45 minutes (depending on the type of application/
submission) per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and
complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection,
including suggestions for reducing this burden to:
Department of Health and Human Services
Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff
[email protected]“An agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays a currently valid OMB number.”
FORM FDA 3674 (4/18) Page 2 of 2
Elisa Harkins TullDigitally signed by Elisa Harkins Tull
DN: o=Pfizer Inc, cn=Elisa Harkins Tull Reason: I attest to the accuracy and integrity of this document Date: 2021.05.05 18:44:42 -04'00'
FDA-CBER-2021-5683-0013737