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Form Approved: OMB No. 0910 - 0297 Expiration Date: March 31, 2022. See instructions
for OMB Statement, below.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
FOOD AND DRUG ADMINISTRATIONPRESCRIPTION DRUG USER FEE
COVERSHEET FY 2021
A completed form must be signed and accompany each new drug or biologic product
application. If payment is sent by U.S. mail or courier, please include a copy of thiscompleted form with payment. Payment instructions and fee rates can be found on FDA'swebsite:
http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm119184.htm
1. APPLICANT'S NAME AND ADDRESS
%LR17HFK
0DQXIDFWXULQJ *PE+$Q GHU *ROGJUXEH 0DLQ]*HUPDQ\4. BLA SUBMISSION TRACKING NUMBER(STN) / NDA NUMBER
125742
5. DOES THIS APPLICATION REQUIRE
CLINICAL DATA FOR APPROVAL?
[X] YES [ ] NOIF YOUR RESPONSE IS "NO", STOP HERE
AND SIGN THIS FORM.IF RESPONSE IS "YES", CHECK THEAPPROPRIATE RESPONSE BELOW:
[X] THE REQUIRED CLINICAL DATA ARE
CONTAINED IN THE APPLICATION
[ ] THE REQUIRED CLINICAL DATA ARE
SUBMITTED BY REFERENCE TO:2. NAME AND TELEPHONE NUMBER OF
REPRESENTATIVE
1HGD $JKDMDQL 0HPDU
3. PRODUCT NAMECOMIRNATY ( COVID-19 mRNA Vaccine(nucleoside modified) )6. USER FEE I.D. NUMBERPD3017966
7. ARE YOU REDEEMING A PRIORITY REVIEW VOUCHER FOR THE TREATMENT OFTROPICAL DISEASES? [ ] YES [X] NO
PRIORITY REVIEW VOUCHER NUMBER:
8. ARE YOU REDEEMING A PRIORITY REVIEW VOUCHER FOR MEDICAL COUNTER
MEASURES? [ ] YES [X] NO
PRIORITY REVIEW VOUCHER NUMBER:
9. IS THIS APPLICATION COVERED BY ANY OF THE FOLLOWING USER FEE EXCEPTIONS?
IF SO, CHECK THE APPLICABLE EXCEPTION. [ ] THE APPLICATION QUALIFIES FOR THE ORPHAN EXCEPTION UNDER SECTION 736(a)(1)(F) of the Federal Food,Drug, and Cosmetic Act
FDA-CBER-2021-5683-0013734
[ ] THE APPLICATION IS SUBMITTED BY A STATE OR FEDERAL GOVERNMENT ENTITY
FOR A DRUG THAT IS NOT DISTRIBUTED COMMERCIALLY
10. HAS A WAIVER OF AN APPLICATION FEE BEEN GRANTED FOR THIS APPLICATION?
[ ] YES [X] NO If a waiver has been granted, include a copy of the official FDA notification with yoursubmission.
Privacy Act Notice:This notice is provided pursuant to the Privacy Act of 1974, 5 U.S.C. 552a. The collectionof this information is authorized by 21 U.S.C. 371, 379, 379e, 379h, 379h-1, 379j, 379j-12, 379j-21, 387s, and 393(d)(2); 42 U.S.C. 263b(r)(1); 5 U.S.C. 301 and 552; and 42U.S.C. 3101. FDA will use the information to assess, collect and process user feepayments, and, facilitate debt collection under the Debt Collection Improvement Act. FDAmay disclose information to courts and the Department of Justice in the context oflitigation and requests for legal advice; to other Federal agencies in response tosubpoenas issued by such agencies; to HHS and FDA employees and contractors toperform user fee services; to the National Archives and Records Administration andGeneral Services Administration for records management inspections; to the Departmentof Homeland Security and other Federal agencies and contractors in order to respond tosystem breaches; to banks in order to process payment made by credit card; to Dun andBradstreet to validate submitter contact information, and to other entities as permittedunder the Debt Collection Improvement Act. Furnishing the requested information ismandatory. Failure to supply the information could prevent FDA from processing user feepayments. Additional detail regarding FDA's use of information is available online:
http://www.fda.gov/RegulatoryInformation/FOI/PrivacyAct/default.htm.
OMB Statement:
Public reporting burden for this collection of information is estimated to average
30 minutes per response, including the time for reviewing instructions, searching existingdata sources, gathering and maintaining the data needed, and completing and reviewingthe collection of information. Send comments regarding this burden estimate or any otheraspect of this collection of information, including suggestions for reducing this burden to:
Department of Health and Human
ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaper Reduction Act (PRA) [email protected] An agency may not conduct or sponsor, and aperson is not required to respond to, acollection of information unless it displays acurrently valid OMB control number.
PRINTED NAME AND SIGNATURE OFAUTHORIZED REPRESENTATIVETITLE DATE
11. USER FEE PAYMENT AMOUNT FOR THIS APPLICATION$2,875,842.00
Form FDA 3397 (04/19)
Director,
Global Regulatory Affairs4/20/2021 Neda Aghajani MemarDigitally signed by Neda Aghajani Memar
DN: cn=Neda Aghajani Memar, o, ou, email=neda aghajanimemar@pfizer com, c=US Reason: I attest to the accuracy and integrity of this document Date: 2021.04.20 09:40:33 -04'00'
FDA-CBER-2021-5683-0013735