Free 3674 - Federal

See OMB Statement on Reverse. Form Approved: OMB No. 0910-0616, Expiration Date: 10-31-2011

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 (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.)
1. NAME OF SPONSOR/APPLICANT/SUBMITTER

SPONSOR / APPLICANT / SUBMITTER INFORMATION
2.

DATE OF THE APPLICATION/SUBMISSION WHICH THIS CERTIFICATION ACCOMPANIES TELEPHONE AND FAX NUMBERS (Include Area Code)

3.

ADDRESS (Number, Street, State, and ZIP Code)

4.

(Tel.) (Fax)
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)

PRODUCT INFORMATION

6.

TYPE OF APPLICATION/SUBMISSION WHICH THIS CERTIFICATION ACCOMPANIES IND NDA ANDA BLA PMA

APPLICATION / SUBMISSION INFORMATION
HDE 510(k) PDP Other

7. 8.

INCLUDE IND/NDA/ANDA/BLA/PMA/HDE/510(k)/PDP/OTHER NUMBER (If number previously assigned) SERIAL NUMBER ASSIGNED TO APPLICATION/SUBMISSION WHICH THIS CERTIFICATION ACCOMPANIES

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

CERTIFICATION STATEMENT / INFORMATION

110-85, do not apply because the application/submission which this certification accompanies does not reference any clinical trial. 110-85, do not apply to any clinical trial referenced in the application/submission which this certification accompanies.

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 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 NUMBER 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): 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 NO. 11

(Name) (Title)
13. ADDRESS (Number, Street, State, and ZIP Code) (of person identified in Nos. 11 and 12) 14. TELEPHONE AND FAX NUMBERS (Include Area Code) (Tel.) (Fax) 15. DATE OF CERTIFICATION

Form FDA 3674 (11/08) (FRONT)

PSC Graphics: (301) 443-1090 EF

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. If there is no such number, leave this field blank. 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 of the certification to any clinical trials that are included, relied upon, or otherwise referred to, in the application/submission which the certification accompanies. This means that, even though some or all of the clinical trials included, relied upon, or otherwise referred to in the application/submission may be "applicable clinical trials" under 42 U.S.C. § 282(j)(1)(A)(i), section 402(j)(1)(A)(i) of the Public Health Service Act, on the date the certification is signed, 42 U.S.C. § 282(j), section 402(j) of the Public Health Service Act, does not require that any information be submitted to the ClinicalTrials.gov Data Bank with respect to those clinical trials. 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, on the date the certification is signed, 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, as of the date the certification is signed, 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 number 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 the term "NCT" will be added automatically before number. Include any and all NCT numbers that, as of the date the certification is signed, have been 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. Leave this field blank if you have checked Box 9.C but, at the time the certification is completed, you have not yet received any NCT numbers for the "applicable clinical trial(s)" included, relied upon, or otherwise referred to in the application/ submission. 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 number 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. - Provide the full address, telephone and fax numbers of the person who is identified in number 11 and signs the certification in number 11. 15. Provide the date the certification is signed. This date may be different from the date provided in number 2.
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 address below. Department of Health and Human Services Food and Drug Administration Office of the Chief Information Officer (HFA-250) 5600 Fishers Lane Rockville, MD 20857 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 (11/08) (BACK)