Subpart B - Applications

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INSTRUCTIONS FOR FILLING OUT FORM FDA 2252
(The field numbers below correspond to the numbered boxes on the Form FDA 2252)
NOTE: Form FDA 2252 should accompany all annual report submissions for NDAs, ANDAs, and BLAs. (21 CFR
314.81(b)(2), 601.70(b), and 601.12(d)) and may accompany other reports

Field 1. Select appropriate Center
Field 2: Identify the appropriate application type, New Drug Application (NDA), Abbreviated New Drug Application
(ANDA), or Biologics License Application (BLA), to which the annual report submission applies.
Field 3: Enter the application number. For CBER submissions, both the application and the supplement number,
as applicable, should be entered.
Fields 4 and 5: When U.S. applicants are submitting the report on their own behalf: Enter the name and phone
number of the applicant in these fields.
When authorized U.S. agents are submitting the report on behalf of an applicant: Enter the name and phone
number of the U.S. agent in Field 4 and Field 5. Note that an authorized U.S. agent is required if the applicant
does not reside or have a place of business within the United States (21 CFR 314.50(a)(5)). For biologic products,
the name of applicant in Field 4 is the name of the person or legal entity to whom the license has been issued.
Field 6: Enter the type of report being submitted.
Field 7: Enter the proprietary and established names for the product.
Field 8: Enter additional NDA, ANDA, or BLA number(s) if any part of the report applies to more than one
application number. Use the continuation page as needed.
Field 9: Enter the beginning and end dates that encompass the reporting period covered by the report.
Field 10: NDA/ANDA REPORT INFORMATION REQUIRED
Under the IDENTIFICATION column, enter the type of information included in the report, the electronic file name
or volume number(s) if a paper submission, and the pages of the report the designated information can be found
on. If you have nothing to report for the type of information listed in the table, enter ‘none’ under
IDENTIFICATION. See 21 CFR 314.81(b)(2) for the full details of each type of information.
a. Summary of Significant New Information: A brief summary of significant new information, relative to the
previous year’s report, that might affect the safety, effectiveness, or labeling of the drug product.
b. Distribution Data: Information about the quantity of the drug product distributed under the approved
application, including that distributed to distributors. Under TYPE OF INFORMATION, indicate if distribution data
for an authorized generic drug product is included. Also include in the body of the report information about the
authorized generic described under 21 CFR 314.81(b)(2)(ii)(b).
c. Labeling: Provide the currently used professional labeling, patient brochures or package inserts, and a
representative sample of the package (e.g., carton, container) labels.
d. Chemistry, Manufacturing, and Controls Changes: Reports of studies or tests involving the physical or
chemical properties of the drug as described under 21 CFR 314.81(b)(2)(iv) and a full description of the
manufacturing and controls changes that do not require a supplemental application under 21 CFR 314.70 (b) and
(c).
e. Nonclinical Laboratory Studies: Copies of unpublished reports and summaries of published reports of new
toxicological finding in animal studies and in vitro studies concerning the ingredients of the drug product (21 CFR
314.81(b)(2)(v)).
f. Clinical Data: Published clinical trials of the drug concerning safety and effectiveness: (e.g., studies of new
uses, biopharmaceutic, pharmacokinetic, and clinical pharmacology studies, epidemiologic)

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(21 CFR 314.81(b)(2)(vi)(a)); summaries of completed unpublished clinical trials (21 CFR 314.81(b) (2)(vi)(b));
analysis of available safety and efficacy data in the pediatric population (21 CFR 314.81(b)(2)(vi)(c)).
g. Status Reports of Open PMRs/PMCs: Complete this field only if you have “open” postmarketing requirements
(PMRs) and postmarketing commitments (PMCs) to report on that concern clinical safety, clinical efficacy, clinical
pharmacology, and nonclinical toxicology and are required by FDA or that the applicant agreed in writing to
conduct (21 CFR 314.81(b)(2)(vii)). Enter None if you have no “open” PMRs or 506B Reportable PMCs to report..
“Open” PMRs/PMCs are those with statuses of: Pending, Ongoing, Delayed, Submitted, or Terminated.
“Closed” PMRs/PMCs are those with statuses of: Released or Fulfilled.
h. Status of Other Open Postmarketing Studies: Complete this field only if you have “open” postmarketing
studies to report on that are not included under 21 CFR 314.81(b)(2)(vii). These include chemistry, manufacturing,
and controls studies that the applicant has agreed to conduct and all product stability studies (21 CFR
314.81(b)(2)(viii)). Enter None if you have no “open” CMC postmarketing studies to report. Do not include “closed”
PMCs in the status report.
“Open” PMCs are those with statuses of: Pending, Ongoing, Delayed, Submitted, or Terminated.
“Closed” PMCs are those with statuses of: Released or Fulfilled.
i. Log of Outstanding Regulatory Business (optional): A list of any open regulatory business with FDA
concerning the drug product (e.g., a list of the applicant’s unanswered correspondence with the agency, a list of
the agency’s unanswered correspondence with the applicant) (21 CFR 314.81(b)(2)(ix)).

Field 11: BLA REPORT INFORMATION REQUIRED
Status Reports of Postmarketing Studies: A status report of each postmarketing study of the drug concerning
clinical safety, clinical efficacy, clinical pharmacology, and nonclinical toxicology that is required by FDA (e.g.,
accelerated approval clinical benefit studies, pediatric studies) or that the applicant committed to conduct (21 CFR
601.70). Check the box under CONTENTS if the submission is the STATUS REPORT OF A POSTMARKETING
STUDY COMMITMENT(S).
Fields12-14: In Fields 12 and 13 of the form, enter the name, title, and street address of the applicant’s
Responsible Official or Authorized U.S. Agent to which any correspondence regarding the annual report should be
sent. This person is responsible for certifying compliance with applicable laws and regulations regarding annual
reporting requirements. The authorized U.S. agent named in Field 4 of the form may also act as the applicant’s
Responsible Official. The form must be signed in Field 14 by the applicant, or the applicant’s attorney, agent, or
other authorized official. 21 CFR 601.2(a). If the person named in Field 4 does not reside or have a place of
business within the United States, the form must be signed in Field 14 by an attorney, agent, or other authorized
official who resides or maintains a place of business within the United States. 21 CFR 314.50(a)(5).