Form FDA 2252 TRANSMITTAL OF ANNUAL REPORTS FOR DRUGS AND BIOLOGICS FO

DATE SUBMITTED

TRANSMITTAL OF ANNUAL REPORTS FOR DRUGS
AND BIOLOGICS FOR HUMAN USE
(21 CFR 314.81)

NOTE: This report is required by law (21 USC 355; 21 CFR 314.81). Failure to report can
result in withdrawal of approval of the New Drug or Biologics License Application.

1. Application Type
2. Application Number

INSTRUCTIONS
Complete a transmittal for each application for which an annual report is being
submitted. If submitting electronically, submit one copy of the form and annual
report to FDA. If submitting in paper, submit two copies of the transmittal form
along with two copies of the annual report to FDA.

Report No. (For
FDA Use Only)

If any part of the annual report applies to more than one application, list in item 7
all other applications to which such parts apply.
3. APPLICANT

Form Approved: OMB No. 0910-0001
Expiration Date: March 31, 2021
See OMB Statement on Reverse Side.

APPLICANT NOTE
Reference NDA and Y, or BLA numbers (entered
on Acknowledgement Copy) in any subsequent
correspondence regarding report.

4. PHONE NUMBER

(

5. TYPE OF REPORT (Check one)

)

ANNUAL

OTHER

6. DRUG/BIOLOGIC NAME
7. OTHER NDA OR BLA NUMBERS (List all numbers if any part of report applies to more than one number.)

8. PERIOD COVERED BY REPORT
FROM
YEAR

TO

MONTH

YEAR

MONTH

Add Continuation Page
NDA REPORT INFORMATION REQUIRED (See § 314.81 for description)
(Enter type of information attached under “Identification.” If you have nothing to report, enter None.)
(INFORMATION IN “9b” AND “9c” IS ALWAYS REQUIRED.)

9.

IDENTIFICATION (Electronic file name or eCTD location or
Volume No.(s) / Tab(s) / Page(s) of Report)

TYPE OF INFORMATION
a. SUMMARY OF SIGNIFICANT NEW
INFORMATION
b. DISTRIBUTION DATA

Authorized
Generic info

c. LABELING (Whether or not
previously submitted)
d. CHEMISTRY MANUFACTURING AND
CONTROLS CHANGES
SUPAC
e. NONCLINICAL LABORATORY STUDIES
f. CLINICAL DATA
g. STATUS REPORTS OF POSTMARKETING
STUDY COMMITMENTS
h. STATUS OF OTHER POSTMARKETING
STUDIES (e.g.,voluntary studies,CMC
commitment studies, and product stability studies)
i.

LOG OF OUTSTANDING REGULATORY
BUSINESS (Optional)

BLA REPORT INFORMATION REQUIRED (See § 601.70 for description)

10.

TYPE OF INFORMATION

CONTENTS (Check box)

a. ANNUAL PROGRESS REPORTS OF POSTMARKETING STUDIES
11. TYPED NAME AND TITLE OF RESPONSIBLE OFFICIAL OR AGENT

13. SIGNATURE

12. APPLICANT’S RETURN ADDRESS
Name of Sponsor / Applicant / Submitter

Sign

FDA USE ONLY
NDA OR ANDA NUMBER

Address 1
DATE OF RECEIPT
Address 2
City

FORM FDA 2252 (03/18)

State

Previous Edition Is Obsolete

ZIP or Postal Code

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PSC Publishing Services (301) 443-6740

EF

This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 5 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
[email protected]
“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 number.”

FORM FDA 2252 (03/18)

Previous Edition Is Obsolete

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