Navigating the complexities of introducing new or abbreviated drug and biologic products for human use in the United States involves a crucial step: completing and submitting the Form FDA 356h to the Food and Drug Administration (FDA). This form, under the auspices of the Department of Health and Human Services, gathers comprehensive details about the applicant, including contact information and addresses, and robust product descriptions ranging from the application number to the dosage form, strengths, route of administration, and proposed indications for use. Not only does it differentiate among New Drug Applications (NDAs), Biologics License Applications (BLAs), and Abbreviated New Drug Applications (ANDAs), but it also requires information on the type of submission, whether it's an original labeling, supplement, or a resubmission, alongside details about the manufacturing establishments involved. The form demands acknowledgment of the applicants' agreement to adhere to all applicable laws and regulations if the application is approved, including good manufacturing practices and labeling regulations. Applicants must certify the accuracy and truthfulness of the information provided, under penalty of law. Lastly, the form plays a role in regulatory frameworks beyond the FDA, stipulating compliance with local, state, and federal environmental impact laws and even touching upon scheduling under the Controlled Substances Act. Understanding the nuances of Form FDA 356h is essential for those seeking market approval for their pharmaceutical products in a highly regulated and competitive environment.
| Question | Answer |
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| Form Name | Form Fda 356H |
| Form Length | 3 pages |
| Fillable? | No |
| Fillable fields | 0 |
| Avg. time to fill out | 45 sec |
| Other names | OMB, Rockville, is form 356h required for fda annual reports, is 356h required for annual report submissions |
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DEPARTMENT OF HEALTH AND HUMAN SERVICES |
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Form Approved: OMB No. |
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Food and Drug Administration |
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Expiration Date: December 31, 2013 |
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APPLICATION TO MARKET A NEW OR ABBREVIATED NEW |
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See PRA Statement on page 3. |
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DRUG OR BIOLOGIC FOR HUMAN USE |
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1. Date of Submission (mm/dd/yyyy) |
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(Title 21, Code of Federal Regulations, Parts 314 & 601) |
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APPLICANT INFORMATION
2. Name of Applicant
3. Telephone Number (Include country code if applicable and area code) 4. Facsimile (FAX) Number (Include country code if applicable and area code)
5. Applicant Address
Address 1 (Street address, P.O. box, company name c/o)
Address 2 (Apartment, suite, unit, building, floor, etc.)
City |
State/Province/Region |
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ZIP or Postal Code |
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U.S. License Number if previously issued
6. Authorized U.S. Agent Name, Address, Telephone and FAX Number (If applicable)
U.S. Agent Name |
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Telephone Number (Include area code) |
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Address 1 |
(Street address, P.O. box, company name c/o) |
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Address 2 |
(Apartment, suite, unit, building, floor, etc.) |
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FAX Number (Include area code) |
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State |
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ZIP or Postal Code
PRODUCT DESCRIPTION
7. NDA, ANDA, or BLA Application Number
8. Supplement Number (If applicable)
9.Established Name (e.g., proper name, USP/USAN name)
10.Proprietary Name (Trade Name) (If any)
11.Chemical/Biochemical/Blood Product Name (If any)
12. Dosage Form
13. Strengths
14. Route of Administration
15. Proposed Indication for Use |
Is this indication for a rare disease (prevalence <200,000 in U.S.)? |
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Does this product have an FDA |
If yes, provide the Orphan |
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Orphan Designation for this |
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Designation number for this |
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indication? |
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indication: |
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Yes |
No |
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Yes No
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APPLICATION INFORMATION
16.Application Type
(Select one)
New Drug Application (NDA) |
Biologics License Application (BLA) |
Abbreviated New Drug Application (ANDA)
17. If an NDA, identify the type
505 (b)(1)
505 (b)(2)
18. If a BLA, identify the type
351 (a)
351 (k)
19. If a 351(k), identify the biological reference product that is the basis for the submission.
Name of Biologic: |
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Holder of Licensed Application: |
20. If an ANDA, or 505(b)(2), identify the listed drug product that is the basis for the submission.
Name of Drug: |
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Application Number of Relied Upon Product: |
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Indicate Patent Certification: |
P1 |
P2 |
P3 |
P4 |
Section viii - MOU |
Statement of no relevant patents |
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21. Submission (Select one) |
Original |
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Labeling Supplement |
CMC Supplement |
Efficacy Supplement |
Annual Report |
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Product Correspondence
Other (Specify):
REMS Supplement |
Post Marketing Requirements or Commitments |
Periodic Safety Report |
FORM FDA 356h (4/13) |
Page 1 of 3 |
PSC Publishing Services (301) |
EF |
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22. Submission |
Presubmission |
Amendment |
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Initial Submission |
Resubmission |
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23. If a supplement, identify |
CBE |
Prior Approval (PA) |
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the appropriate category. |
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24. |
Does this submission contain only pediatric data? |
Yes |
No |
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25. |
Reasons for Submission |
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26. |
Proposed Marketing Status (Select one) |
Prescription Product (Rx) |
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27. |
This application is (Select one) |
Paper |
Paper and Electronic |
Electronic |
28. Number of Volumes Submitted |
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29.Establishment Information (Full establishment information should be provided in the body of the application.)
Establishment Name
Address 1 |
(Street address, P.O. box, company name c/o) |
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Registration (FEI) Number |
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Address 2 |
(Apartment, suite, unit, building, floor, etc.) |
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MF Number |
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City |
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State/Province/Region |
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Establishment DUNS Number |
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ZIP or Postal Code |
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Manufacturing Steps
3 |
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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 Responsible Official or Agent signing this form
33.Date (mm/dd/yyyy)
34.Telephone Number (Include country code if applicable and area code)
35.FAX Number (Include country code if applicable and area code)
36. Email Address
37. Address
Address 1 (Street address, P.O. box, company name c/o)
Address 2 (Apartment, suite, unit, building, floor, etc.)
City
Country
State/Province/Region
ZIP or Postal Code
38. Signature of Applicant’s Responsible Official
Sign
39. Signature of Authorized U.S. Agent
Sign
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 ADDRESS. |
FORM FDA 356h (4/13) |
Page 3 of 3 |