[Federal Register Volume 89, Number 202 (Friday, October 18, 2024)]
[Notices]
[Pages 83887-83889]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-24104]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-2061]


Review of Drug Master Files in Advance of Certain Abbreviated New 
Drug Application Submissions Under Generic Drug User Fee Amendments; 
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 ``Review of 
Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA.'' 
This guidance provides information and recommendations on the Generic 
Drug User Fee Amendments (GDUFA) III program enhancements agreed upon 
by the Agency and industry in ``GDUFA Reauthorization

[[Page 83888]]

Performance Goals and Program Enhancements Fiscal Years 2023-2027'' 
(GDUFA III commitment letter), related to the early assessment of 
certain Type II drug master files (DMFs) 6 months prior to the 
submission of certain abbreviated new drug applications (ANDAs) or 
prior approval supplements (PASs). This guidance describes the process 
outlined in the GDUFA III commitment letter in greater detail and 
provides recommendations to DMF holders on how to provide the relevant 
information to FDA. This guidance finalizes the draft guidance of the 
same title issued on October 6, 2022.

DATES: The announcement of the guidance is published in the Federal 
Register on October 18, 2024.

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:
    <bullet> 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.
    <bullet> 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:
    <bullet> 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.
    <bullet> 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 must include the Docket No. 
FDA-2022-D-2061 for ``Review of Drug Master Files in Advance of Certain 
ANDA Submissions Under GDUFA.'' 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.
    <bullet> 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. Send one self-
addressed adhesive label to assist that office in processing your 
requests. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Ziyang Su, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave, 
Bldg. 51, Rm. 4150, Silver Spring, MD 20993, 240-402-6004.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Review of Drug Master Files in Advance of Certain ANDA 
Submissions Under GDUFA.'' As described in the GDUFA III commitment 
letter,\1\ FDA has agreed to performance goals and program enhancements 
regarding aspects of the generic drug assessment program that build on 
previous authorizations of GDUFA. These enhancements to the program are 
designed to maximize the efficiency and utility of each assessment 
cycle, with the intent of reducing the number of assessment cycles for 
ANDAs and facilitating timely access to generic medicines for American 
patients. One of the enhancements included in the GDUFA III commitment 
letter is a mechanism to enable assessment of DMFs in advance of 
certain ANDA and PAS submissions.
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    \1\ The GDUFA III commitment letter is available at https://www.fda.gov/media/153631/download.
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    Historically, Type II active pharmaceutical ingredient DMFs have 
posed a challenge for ANDA applicants because a DMF holder's response 
time to Agency questions typically limits the likelihood that the DMF 
will be found adequate in one ANDA assessment cycle, often precluding 
approval of the ANDA in one assessment cycle. The program enhancement 
of early assessment of certain Type II DMFs should facilitate more DMFs 
to be found adequate in one assessment cycle, thereby potentially 
promoting additional ANDA approvals in one assessment cycle.
    The purpose of this guidance is to provide information and 
recommendations on the early assessment of DMFs 6 months prior to the 
submission of certain ANDAs or PASs. It describes the process outlined 
in the GDUFA III commitment letter in greater detail and provides

[[Page 83889]]

recommendations on how to provide the relevant information to FDA.
    This guidance finalizes the draft guidance of the same title issued 
on October 6, 2022 (87 FR 60686). FDA considered comments received on 
the draft guidance as the guidance was finalized, and in response a 
footnote was added to clarify the potential impact of unsolicited 
amendments submitted after the prior assessment is granted.
    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 ``Review of Drug Master Files in Advance of 
Certain ANDA Submissions Under GDUFA.'' 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 final 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 
in 21 CFR 314 have been approved under OMB control number 0910-0001.

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/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: October 9, 2024.
Eric Flamm,
Acting Associate Commissioner for Policy.
[FR Doc. 2024-24104 Filed 10-17-24; 8:45 am]
BILLING CODE 4164-01-P