FDA 3674 Certification of Compliance

Form Approved: OMB No. 0910-0616. Expiration Date: 2/28/2018. 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 for 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

2. Date of the Application/Submission

3. Address

4. Telephone and Fax Numbers
(Include country code if applicable and
area code)

Address 1 (Street address, P.O. box, company name c/o)
Address 2 (Apartment, suite, unit, building, floor, etc.)
City

(Tel):

State/Province/Region

Country

(Fax):

ZIP or Postal Code

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)

Continuation Page for #5

APPLICATION / SUBMISSION INFORMATION
6. Type of Application/Submission Which This Certification Accompanies
IND

NDA

ANDA

BLA

PMA

HDE

7. Include IND/NDA/ANDA/BLA/PMA/HDE/510(k)/PDP/ Other Number
(If number previously assigned)

510(k)

PDP

Other

If BLA was selected in item 6, provide Supplement Number

8. Serial Number Assigned to Application/Submission Which This Certification Accompanies

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 (6/17)

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PSC Publishing Services (301) 443-6740

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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 “responsible 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):
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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

Title

12. Address

13. Telephone and Fax Numbers
(Include country code if applicable and
area code)

Address 1 (Street address, P.O. box, company name c/o)
Address 2 (Apartment, suite, unit, building, floor, etc.)
City

(Tel):

State/Province/Region

Country

(Fax):

ZIP or Postal Code

15. Signature Of Sponsor/Applicant/Submitter or an Authorized
Representative (Sign)

14. Date of Certification

Sign

This section applies only to requirements of the Paperwork Reduction Act of 1995.
***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF 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]

FORM FDA 3674 (6/17)

“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.”

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CONTINUATION PAGE FOR ITEM 5 – Product Information for Drugs/Biologics and/or for Devices
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)

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FORM FDA 3674 (6/17)

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CONTINUATION PAGE FOR ITEM 10 – NCT Number(s)
If you have additional NCT Number(s) to enter, use as many of the provided slots below as needed.
NCT Number(s):

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FORM FDA 3674 (6/17)

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