Final Version of Certification Form

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Print Form

FOOD AND DRUG ADMINISTRATION

Certification of Compliance, under 42 U.S.C. § 282(j)(5)(B), with
Requirements of ClinicalTrials.gov Data Bank (42 U.S.C. § 282(j))
(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.)

Form Approved:
Expiration Date:
See OMB Statement on Reverse

SPONSOR/APPLICANT/SUBMITTER INFORMATION
1. NAME OF SPONSOR/APPLICANT/SUBMITTER

2. DATE OF THE APPLICATION/SUBMISSION WHICH

3. ADDRESS (Number, Street, State, and Zip Code)

4. TELEPHONE AND FAX NUMBER
(Include Area Code)

THIS CERTIFICATION ACCOMPANIES

(T)
(F)
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)
(Attach extra pages as necessary)

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)

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, enacted by 121 Stat. 823, Public Law
110-85, 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, enacted by 121 Stat. 823, Public Law
110-85, 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, enacted by 121 Stat. 823, Public Law
110-85, apply to one or more of the clinical trials referenced in the application/submission which this certification accompanies and that
those requirements have been met.

10. IF YOU CHECKED BOX C, IN # 9, PROVIDE THE NATIONAL CLINICAL TRIAL (NCT) NUMBER(S) FOR ANY "APPLICABLE
CLINICAL TRIAL(S)," 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
(Attach extra pages as necessary)
NCT Number(s)

FORM FDA 3674 (12/07)

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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. SIGNATURE OF SPONSOR/APPLICANT/SUBMITTER OR AN
AUTHORIZED REPRESENTATIVE
(SIGN)

12. NAME AND TITLE OF THE PERSON WHO
SIGNED IN #11

13. ADDRESS (Number, Street, State, and Zip Code)
(of person identified in #11 & 12)

14. TELEPHONE AND FAX NUMBER
(Include Area Code)
(T)
(F)

15. DATE OF CERTIFICATION
Paperwork Reduction Act Statement
Public Reporting Burden for this collection of information is estimated to average 15 minutes and 45 minutes (depending on the type of
application/submission) per response, including time for reviewing instructions. Send comments regarding this burden estimate or any other
aspect of this collection of information, including suggestions for reducing this burden to the applicable address below.
Food and Drug Administration
Center for Drug Evaluation and Research
Central Document Room
Form No. FDA 3674
5901-B Ammendale Road
Beltsville, MD 20705-1266

Food and Drug Administration
Center for Biologics Evaluation and Research
1401 Rockville Pike
Rockville, MD 20852-1448

Food and Drug Administration
Center for Devices and Radiological Health
Program Operations Staff (HFZ-403)
9200 Corporate Blvd.
Rockville, MD 20850

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 control number.

FORM FDA 3674 (12/07)

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Instructions for Completion of Form FDA 3674
Certification of Compliance, under 42 U.S.C. § 282(j)(5)(B), with Requirements of ClinicalTrials.gov Data Bank (42 U.S.C. § 282(j))
Form 3674 must accompany an application/submission, including amendments, supplements, and resubmissions, submitted under §§ 505, 515, 520(m),
or 510(k) of the Federal Food, Drug, and Cosmetic Act or § 351 of the Public Health Service Act.
1. Name of Sponsor/Applicant/Submitter - This is the name of the sponsor/applicant/submitter of the drug/biologic/device application/submission
which the certification accompanies. The name must be identical to that listed on the application/submission.
2. Date - This is the date of the application/submission which the certification accompanies.
3. & 4. - Provide complete address, telephone number and fax number of the sponsor/applicant/submitter.
5. Product Information - For Drugs/Biologics: Provide the established, proprietary name, and/or chemical/biochemical/blood product/cellular/gene
therapy name(s) for the product covered by the application/ submission. Include all available names by which the product is known.
For Devices: Provide the common or usual name, classification, trade or proprietary or model name(s), and/or model number(s). Include all available
names/model numbers by which the product is known.
6. Type of Application/Submission - Identify the type of application/submission which the certification accompanies by checking the appropriate box. If
the name of the type of application/submission is not identified, check the box labeled "Other."
7. IND/NDA/ANDA/BLA/PMA/HDE/510(k)/PDP/Other Number - If FDA has previously assigned a number associated with the application/
submission which this certification accompanies, list that number in this field. For example, if the application/submission accompanied by this
certification is an IND protocol amendment and the IND number has already been issued by FDA, that number should be provided in this field.
8. Serial Number - In some instances a sequential serial number is assigned to the application. If there is such a serial number, provide it in this field.
9. Certification - This section contains three different check-off boxes.
Box A should be checked if the sponsor/applicant/submitter has concluded that the requirements of 42 U.S.C. § 282(j), section 402(j) of the
Public Health Service Act, do not apply because no clinical trials are included, relied upon, or otherwise referred to, in the application/submission which
the certification accompanies.
Box B should be checked if the sponsor/applicant/submitter has concluded that the requirements of 42 U.S.C. § 282(j), section 402(j) of the
Public Health Service Act, do not apply at the time of submission to any clinical trials that are included, relied upon, or otherwise referred to, in the
application/submission which the certification accompanies. This means that, at the time the application/submission is being made, the requirements of
42 U.S.C. § 282(j), section 402(j) of the Public Health Service Act, do not apply to any of the clinical trials included, relied upon, or otherwise referred to,
in the application/submission which this certification accompanies.
Box C should be checked if the sponsor/applicant/submitter has concluded that the requirements of 42 U.S.C. § 282(j), section 402(j) of the
Public Health Service Act, do apply at the time of submission to some or all of the clinical trials that are included, relied upon, or otherwise referred to, in
the application/submission which the certification accompanies. This means that, at the time the application/submission is being made, 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 included, relied upon, or otherwise
referred to, in the application/submission which this certification accompanies.
10. National Clinical Trial (NCT) Numbers - If you have checked Box C in # 9 (Certification), provide the NCT Number obtained from www.
ClinicalTrials.gov for each clinical trial that is an "applicable clinical trial" under 42 U.S.C. § 282(j)(1)(A)(i), section 402(j)(1)(A)(i) of the Public Health
Service Act, and that is included, relied upon, or otherwise referred to, in the application/submission which the certification accompanies. Type only the
number, as NCT will be added automatically before number. Include any and all NCT numbers assigned to the clinical trials included, relied upon, or
otherwise referred to, in the application/submission which this certification accompanies. Multiple NCT numbers may be required for a particular
certification, depending on the number of "applicable clinical trials" included, relied upon, or otherwise referred to, in the application/submission which
the certification accompanies.
11. Signature of Sponsor/Applicant/Submitter or an Authorized Representative - The person signing the certification must sign in this field.
12. Name and Title of Person Who Signed in #11. - Include the name and title of the person who is signing the certification. If the person signing the
certification is not the sponsor/applicant/submitter of the application/submission, he or she must be an authorized representative of the sponsor/applicant/
submitter.
13. & 14. & 15. - Provide the full address, telephone and fax number of the person who is identified in number 11 and signs the certification in number
12. Provide the date the certification is signed. This date may be different from the date provided in #2.

FORM FDA 3674 (12/07)

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