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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
Page 1 of 2
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
PRAStaff@fda.hhs.gov
“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
Page 2 of 2
File Type | application/pdf |
File Title | FDA 2252 |
Subject | Transmittal of Annual Reports for Drugs and Biologics for Human Use |
Author | PSC Printing Services |
File Modified | 2018-04-02 |
File Created | 2010-06-23 |