Form Fda 356h - Application To Market A New Or Abbreviated New Drug Or Biologic For Human Use Form Page 3
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31. This application contains the following items (Continued; select all that apply)
9. Safety update report (e.g., 21 CFR 314.50(d)(5)(vi)(b);
10. Statistical section (e.g., 21 CFR 314.50(d)(6); 21 CFR 601.2)
21 CFR 601.2)
11. Case report tabulations (e.g., 21 CFR 314.50(f)(1);
12. Case report forms (e.g., 21 CFR 314.50 (f)(2); 21 CFR 601.2)
21 CFR 601.2)
13. Patent information on any patent that claims the drug/
14. A patent certification with respect to any patent that claims the
biologic (21 U.S.C. 355(b) or (c))
drug/biologic (21 U.S.C. 355 (b)(2) or (j)(2)(A))
15. Establishment description (21 CFR Part 600, if applicable)
16. Debarment certification (FD&C Act 306 (k)(1))
17. Field copy certification (21 CFR 314.50 (l)(3))
18. User Fee Cover Sheet (PDUFA Form FDA 3397, GDUFA Form
FDA 3794, BsUFA Form FDA 3792, or MDUFMA Form FDA 3601)
19. Financial Disclosure Information (21 CFR Part 54)
20. Other (Specify):
CERTIFICATION
I agree to update this application with new safety information about the product that may reasonably affect the statement of contraindications,
warnings, precautions, or adverse reactions in the draft labeling. I agree to submit safety update reports as provided for by regulation or as
requested by FDA. If this application is approved, I agree to comply with all applicable laws and regulations that apply to approved applications,
including, but not limited to, the following:
1. Good manufacturing practice regulations in 21 CFR Parts 210, 211 or applicable regulations, Parts 606, and/or 820.
2. Biological establishment standards in 21 CFR Part 600.
3. Labeling regulations in 21 CFR Parts 201, 606, 610, 660, and/or 809.
4. In the case of a prescription drug or biological product, prescription drug advertising regulations in 21 CFR Part 202.
5. Regulations on making changes in application in FD&C Act section 506A, 21 CFR 314.71, 314.72, 314.97, 314.99, and 601.12.
6. Regulations on Reports in 21 CFR 314.80, 314.81, 600.80, and 600.81.
7. Local, state, and Federal environmental impact laws.
If this application applies to a drug product that FDA has proposed for scheduling under the Controlled Substances Act, I agree not to market
the product until the Drug Enforcement Administration makes a final scheduling decision.
The data and information in this submission have been reviewed and, to the best of my knowledge, are certified to be true and accurate.
Warning: A willfully false statement is a criminal offense, U.S. Code, title 18, section 1001.
32. Typed Name and Title of Applicant’s Responsible Official
33. Date (mm/dd/yyyy)
34. Telephone Number (Include country
35. FAX Number (Include country code if
36. Email Address
code if applicable and area code)
applicable and area code)
37. Address of Applicant’s Responsible Official
Address 1 (Street address, P.O. box, company name c/o)
Address 2 (Apartment, suite, unit, building, floor, etc.)
City
State/Province/Region
Country
ZIP or Postal Code
38. Signature of Applicant’s Responsible Official or
39. Countersignature of Authorized U.S. Agent
Sign
Sign
Other Authorized Official
The information below applies only to requirements of the Paperwork Reduction Act of 1995.
The burden time for this collection of information is estimated to average 24 hours per response,
Department of Health and Human Services
including the time to review instructions, search existing data sources, gather and maintain the
Food and Drug Administration
data needed and complete and review the collection of information. Send comments regarding
Office of Chief Information Officer
this burden estimate or any other aspect of this information collection, including suggestions
Paperwork Reduction Act (PRA) Staff
for reducing this burden to the address to the right:
PRAStaff@fda.hhs.gov
“An agency may not conduct or sponsor, and a person is not required to respond to, a
DO NOT SEND YOUR COMPLETED FORM
collection of information unless it displays a currently valid OMB number.”
TO THIS PRA STAFF EMAIL ADDRESS.
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FORM FDA 356h (8/15)
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