
[Federal Register Volume 88, Number 178 (Friday, September 15, 2023)]
[Notices]
[Pages 63580-63582]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-20014]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-3771]


Annual Status Report Information and Other Submissions for 
Postmarketing Requirements and Commitments: Using Forms FDA 3988 and 
FDA 3989; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing 
the availability of a final guidance for industry entitled ``Annual 
Status Report Information and Other Submissions for Postmarketing 
Requirements and Commitments: Using Forms FDA 3988 and FDA 3989.'' 
Forms FDA 3988, Transmittal of PMR/PMC Submissions for Drugs and 
Biologics, and FDA 3989, PMR/PMC Annual Status Report for Drugs and 
Biologics, are intended to facilitate submissions by drug and 
biological product application holders of complete and accurate 
information on postmarketing requirements (PMRs) and postmarketing 
commitments (PMCs) in a consistent format. These forms are expected to 
result in improved accuracy and timeliness of FDA's identification and 
review of those submissions containing information on PMRs and PMCs. 
This guidance covers the purpose of each form, when to use these forms, 
and how to submit these forms. The guidance also explains where 
applicants will be able to find the forms and instructions. This 
guidance finalizes the draft guidance of the same name issued on 
October 21, 2020.

DATES: The announcement of the guidance is published in the Federal 
Register on September 15, 2023.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked, and identified 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received should include the Docket 
No. FDA-2018-N-3771 for ``Annual Status Report Information and Other 
Submissions for Postmarketing Requirements and Commitments: Using Forms 
FDA 3988 and FDA 3989.'' Received comments will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the 
Division of Drug Information, Center for Drug Evaluation and Research, 
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale 
Building, 4th Floor, Silver Spring, MD 20993-0002; or the Office of 
Communication, Outreach and Development, Center for Biologics 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist that office in processing 
your

[[Page 63581]]

requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Kathy Weil, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 22, Rm. 5367, Silver Spring, MD 20993-0002, 301-796-6054; or Anne 
Taylor, Center for Biologics Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver 
Spring, MD 20993-0002, 240-402-7911.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a final guidance for industry 
entitled ``Annual Status Report Information and Other Submissions for 
Postmarketing Requirements and Commitments: Using Forms FDA 3988 and 
FDA 3989.'' This guidance is intended for applicants that are required 
to report annually on the status of postmarketing studies and clinical 
trials for human drug and biological products under section 506B of the 
Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 356b) and 
its implementing regulations at Sec. Sec.  314.81(b)(2)(vii) and 601.70 
(21 CFR 314.81(b)(2)(vii) and 601.70). The forms were developed, in 
part, in response to the recommendations from the Government 
Accountability Office (GAO) and the Department of Health and Human 
Services (HHS) Office of the Inspector General (OIG) regarding the need 
for comparable information across annual status reports (ASRs) on PMRs 
and PMCs, to eliminate manual data entry and to enhance FDA's ability 
to track PMRs and PMCs. These forms are expected to result in improved 
accuracy and timeliness of FDA's identification and review of those 
submissions containing information on PMRs and PMCs. The purpose of the 
guidance is to explain why Forms FDA 3988 and FDA 3989 were created, 
describe the contents of the forms, and explain how to submit the forms 
electronically. The guidance also explains where applicants will be 
able to find the forms and instructions for their completion. Forms FDA 
3988 and FDA 3989 are available for use at FDA's Forms web page 
(https://www.fda.gov/about-fda/reports-manuals-forms/forms).
    PMRs and PMCs are studies or clinical trials conducted by the 
applicant after FDA has approved a drug or biological product for 
marketing or licensing. These studies or clinical trials can be 
required under statute or regulation (PMRs) or agreed upon in writing 
by FDA and the applicant (PMCs). Section 130(a) of the Food and Drug 
Administration Modernization Act of 1997 amended the FD&C Act by adding 
section 506B of the FD&C Act. Under section 506B of the FD&C Act and 
its implementing regulations at Sec. Sec.  314.81(b)(2)(vii) and 
601.70, applicants must submit an ASR on PMRs and PMCs.\1\ This report 
must address the progress of the PMR/PMC or the reasons for failing to 
conduct the requirement or commitment (section 506B(a) of the FD&C 
Act).
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    \1\ FDA defines postmarketing studies or clinical trials for 
which ASRs must be submitted under section 506B of the FD&C Act as 
those concerning a human drug or biological product's clinical 
safety, clinical efficacy, clinical pharmacology, or nonclinical 
toxicology that are either required by FDA (PMRs) or that are 
committed to, in writing, (PMCs) either at the time of approval of 
an application or a supplement or after approval of an application 
or supplement. See Sec. Sec.  314.81(b)(2)(vii) and 601.70. FDA 
interprets section 506B of the FD&C Act to apply to postmarketing 
studies and clinical trials that are required under section 505B of 
the FD&C Act (21 U.S.C. 355c), the animal efficacy rule (21 CFR 
314.610(b)(1) and 601.91(b)(1)), accelerated approval (section 
506(c)(2)(A) of the FD&C Act (21 U.S.C. 356(c)(2)(A)); 21 CFR 
314.510 and 601.41), and the Food and Drug Administration Amendments 
Act of 2007 (section 505(o)(3) of the FD&C Act (21 U.S.C. 
355(o)(3)).
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    This guidance does not apply to postmarketing studies or clinical 
trials that are not subject to the reporting requirements of section 
506B of the FD&C Act.\2\ For example, the guidance does not apply to 
voluntary studies or clinical trials performed by an applicant or on an 
applicant's behalf that are neither required nor agreed upon in 
writing. This guidance also does not apply to PMCs related to 
chemistry, manufacturing, and controls or stability studies.
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    \2\ Under Sec.  314.81(b)(2)(viii), applicants submitting an 
annual report for human drug products must include a status report 
of postmarketing studies and clinical trials not included under 
Sec.  314.81(b)(2)(vii) that are being performed by, or on behalf 
of, the applicant.
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    In a December 2015 report from the GAO entitled ``Drug Safety: FDA 
Expedites Many Applications, but Data for Postapproval Oversight Need 
Improvement,'' \3\ the GAO recommended that FDA improve its data 
tracking to ensure the completeness, timeliness, and accuracy of 
information in its database on PMRs/PMCs. Additionally, in a July 2016 
HHS OIG study entitled ``FDA is Issuing More Postmarketing 
Requirements, but Challenges with Oversight Persist,'' \4\ the HHS OIG 
noted that FDA continued to have problems with its data management 
system and work processes, thereby hindering its ability to track PMRs. 
OIG recommended that FDA provide standardized forms for ASRs, ensure 
that the forms are complete, and require applicants to submit the forms 
electronically.
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    \3\ Available at https://www.gao.gov/products/GAO-16-192.
    \4\ Available at https://oig.hhs.gov/oei/reports/oei-01-14-00390.asp.
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    Based in part on the recommendations from GAO and HHS OIG, FDA 
created Forms FDA 3988 and FDA 3989 to improve the collection, 
identification, and use of information regarding PMRs and PMCs. Form 
FDA 3988 was developed to accompany an applicant's PMR/PMC-related 
submissions (e.g., draft protocols, final protocols, interim reports, 
final reports, and PMR/PMC-related correspondence), except the ASR on 
PMRs and PMCs. Form FDA 3988 allows applicants to identify, in a 
standardized format, the type of PMR/PMC-related submission the 
applicant is making (e.g., draft protocol) and the PMR or PMC to which 
the submission applies. Form FDA 3989 was developed so that applicants 
may provide ASR information on their PMRs and PMCs in a standardized 
format. The purpose of these forms is to assist applicants in providing 
clearly identified PMR/PMC-related submissions and in meeting their 
annual reporting requirements under section 506B of the FD&C Act and 
Sec. Sec.  314.81(b)(2)(vii) and 601.70.
    Use of Forms FDA 3988 and 3989 is optional, but FDA encourages 
their use because the forms should facilitate FDA management and review 
of the applicant's submissions, as well as enhance the accuracy of data 
within FDA's electronic document archiving systems. FDA uses these 
archiving systems as a source from which to obtain data published 
annually in the Federal Register as required under section 506B(c) of 
the FD&C Act and to provide quarterly status updates of the PMR and PMC 
data on FDA's Postmarket Requirements and Commitments public web page 
(available at https://www.accessdata.fda.gov/scripts/cder/pmc/index.cfm). This guidance finalizes the draft guidance of the same name 
issued on October 21, 2020 (85 FR 66995). In addition to editorial 
changes for clarification, changes from the draft to the final included 
a minor change regarding what to enter into field 9.g. of Form FDA 2252 
and the removal of the appendices to the guidance, which contained 
drafts of Forms FDA 3988 and 3989.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on ``Annual Status

[[Page 63582]]

Report Information and Other Submissions for Postmarketing Requirements 
and Commitments: Using Forms FDA 3988 and FDA 3989.'' It does not 
establish any rights for any person and is not binding on FDA or the 
public. You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections of information. The 
previously approved collections of information are subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information 
for applicants required to submit ASRs on PMCs and PMRs under section 
506B of the FD&C Act and the implementing regulations at Sec. Sec.  
314.81(b)(2)(vii) and 601.70 are approved under OMB control numbers 
0910-0001 and 0910-0338, respectively.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: September 12, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-20014 Filed 9-14-23; 8:45 am]
BILLING CODE 4164-01-P


