Form 356h Application to Market a New Drug Biologic or an Antibiot

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Form Approved: OMB No. 0910-0338
Expiration Date: December 31, 2013
See PRA Statement on page 3.

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

APPLICATION TO MARKET A NEW OR ABBREVIATED NEW
DRUG OR BIOLOGIC FOR HUMAN USE

1. Date of Submission (mm/dd/yyyy)

(Title 21, Code of Federal Regulations, Parts 314 & 601)
2. Name of Applicant

APPLICANT INFORMATION

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)

U.S. License Number if previously issued

Address 2 (Apartment, suite, unit, building, floor, etc.)
City

State/Province/Region

Country

ZIP or Postal Code

6. Authorized U.S. Agent Name, Address, Telephone and FAX Number (If applicable)
U.S. Agent Name

Telephone Number (Include area code)

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

State

ZIP or Postal Code

7. NDA, ANDA, or BLA Application Number

PRODUCT DESCRIPTION

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

14. Route of Administration

13. Strengths

15. Proposed Indication for Use

Is this indication for a rare disease (prevalence <200,000 in U.S.)?
Does this product have an FDA
Orphan Designation for this
indication?
Yes
No

16. Application Type
(Select one)

APPLICATION INFORMATION
17. If an NDA, identify the type

505 (b)(1)

If yes, provide the Orphan
Designation number for this
indication:

New Drug Application (NDA)

Yes

No
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Biologics License Application (BLA)

Abbreviated New Drug Application (ANDA)

18. If a BLA, identify the type

505 (b)(2)

351 (a)

351 (k)

19. If a 351(k), identify the biological reference product that is the basis for the submission.
Name of Biologic:

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:

Application Number of Relied Upon Product:

Indicate Patent Certification:

P1

21. Submission (Select one)

Original

Product Correspondence

P2

P3

P4

Labeling Supplement

REMS Supplement

Section viii - MOU
CMC Supplement

Statement of no relevant patents
Efficacy Supplement

Post Marketing Requirements or Commitments

Annual Report

Periodic Safety Report

Other (Specify):

FORM FDA 356h (4/13)

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PSC Publishing Services (301) 443-6740

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22. Submission
Sub-Type

Next Page

Presubmission

Amendment

Initial Submission

Resubmission

24. Does this submission contain only pediatric data?

23. If a supplement, identify
the appropriate category.

Yes

CBE

Prior Approval (PA)

CBE-30

No

25. Reasons for Submission

26. Proposed Marketing Status (Select one)
27. This application is (Select one)

Prescription Product (Rx)

Paper

Paper and Electronic

Over-The-Counter Product (OTC)
Electronic

28. Number of Volumes Submitted

29. Establishment Information (Full establishment information should be provided in the body of the application.)
Provide locations of all manufacturing, packaging and control sites for drug substance and drug product (continuation sheets may be used if necessary).
Include name, address, registration number (FEI), MF number, Establishment DUNS number, and manufacturing steps and/or type of testing (e.g., final
dosage form, stability testing) conducted at the site. Please indicate whether the site is ready for inspection or, if not, when it will be ready.

Establishment Name
Address 1 (Street address, P.O. box, company name c/o)

Registration (FEI) Number

Address 2 (Apartment, suite, unit, building, floor, etc.)
City

MF Number

State/Province/Region

Country

ZIP or Postal Code

Manufacturing Steps7\SHRI7HVWLQJDQG6LWH&RQWDFW,QIRUPDWLRQ

Establishment DUNS Number

Is the site ready for
inspection?

Yes

No

If No, when will site be ready? (mm/dd/yyyy)

Continuation Page for #29

30. Cross References (List related BLAs, INDs, NDAs, PMAs, 510(k)s, IDEs, BMFs, MAFs, and DMFs referenced in the current application.)
Contin.
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#30

31. This application contains the following items (Select all that apply)
1. Index

2. Labeling (Select one):

4. Chemistry Section

Draft Labeling

Final Printed Labeling

3. Summary (21 CFR 314.50 (c))

A. Chemistry, manufacturing, and controls information (e.g., 21 CFR 314.50(d)(1); 21 CFR 601.2)
B. Samples (21 CFR 314.50 (e)(1); 21 CFR 601.2 (a)) (Submit only upon FDA’s request)
C. Methods validation package (e.g., 21 CFR 314.50(e)(2)(i); 21 CFR 601.2)

5. Nonclinical pharmacology and toxicology section
(e.g., 21 CFR 314.50(d)(2); 21 CFR 601.2)

6. Human pharmacokinetics and bioavailability section
(e.g., 21 CFR 314.50(d)(3); 21 CFR 601.2)

7. Clinical microbiology section (e.g., 21 CFR 314.50(d)(4))

8. Clinical data section (e.g., 21 CFR 314.50(d)(5); 21 CFR 601.2)

9. Safety update report (e.g., 21 CFR 314.50(d)(5)(vi)(b);
21 CFR 601.2)

10. Statistical section (e.g., 21 CFR 314.50(d)(6); 21 CFR 601.2)

11. Case report tabulations (e.g., 21 CFR 314.50(f)(1);
21 CFR 601.2)

12. Case report forms (e.g., 21 CFR 314.50 (f)(2); 21 CFR 601.2)

13. Patent information on any patent that claims the drug/
biologic (21 U.S.C. 355(b) or (c))

14. A patent certification with respect to any patent that claims the
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):

FORM FDA 356h (4/13)

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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
34. Telephone Number (Include country
code if applicable and area code)

35. FAX Number (Include country code if
applicable and area code)

33. Date (mm/dd/yyyy)
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

State/Province/Region

Country

ZIP or Postal Code

38. Signature of Applicant’s Responsible Official

Sign

39. Signature of Authorized U.S. Agent

Sign

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FORM FDA 356h (4/13)

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