[Federal Register Volume 89, Number 17 (Thursday, January 25, 2024)]
[Notices]
[Pages 4957-4959]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-01442]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-0092]


Revising Abbreviated New Drug Application Labeling Following 
Revision of the Reference Listed Drug Labeling; Final 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 ``Revising 
ANDA Labeling Following Revision of the RLD Labeling.'' This guidance 
provides recommendations for updating labeling for abbreviated new drug 
applications (ANDAs) following revisions to the labeling of a reference 
listed drug (RLD), including information on how to identify RLD 
labeling updates and how to submit labeling updates to both unapproved 
and approved ANDAs to conform to RLD labeling updates. This guidance 
finalizes the draft guidance for industry of the same title issued on 
January 27, 2022.

DATES: The announcement of the guidance is published in the Federal 
Register on January 25, 2024.

ADDRESSES: You may submit electronic or written comments on Agency 
guidance 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

[[Page 4958]]

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-0092 for ``Revising ANDA Labeling Following Revision of the 
RLD Labeling.'' 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 the 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: Jonathan Hughes, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 75, Rm. 1688, Silver Spring, MD 20993-0002, 301-
796-9291, <a href="/cdn-cgi/l/email-protection#33795c5d52475b525d1d7b46545b5640735557521d5b5b401d545c45"><span class="__cf_email__" data-cfemail="69230607081d01080747211c0e010c1a290f0d084701011a470e061f">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Revising ANDA Labeling Following Revision of the RLD 
Labeling.'' This guidance provides recommendations for updating 
labeling for ANDAs following revisions to the labeling of an RLD, 
including information on how to identify RLD labeling updates and how 
to submit labeling updates to both unapproved and approved ANDAs to 
conform to RLD labeling updates.
    A generic drug is generally required to have the same labeling as 
the RLD, except for changes required because of differences approved 
under a suitability petition (see section 505(j)(2)(C) of the Federal 
Food, Drug, and Cosmetic Act (FD&C Act)) (21 U.S.C. 355(j)(2)(C) and 21 
CFR 314.93) or because the generic drug and the RLD are produced or 
distributed by different manufacturers (see e.g., section 
505(j)(2)(A)(v) of the FD&C Act and Sec.  314.94(a)(8)(iv) (21 CFR 
314.94(a)(8)(iv))). FDA will refuse to approve an ANDA if, among other 
things, it does not include such information regarding the proposed 
labeling (see e.g., Sec.  314.127(a)(7)). FDA regulations provide 
examples of permissible differences in labeling that may result when a 
proposed generic drug and the RLD are ``produced or distributed by 
different manufacturers,'' including the omission of an indication or 
other aspect of labeling protected by patent or exclusivity and 
``labeling revisions made to comply with current FDA labeling 
guidelines or other guidance'' (Sec.  314.94(a)(8)(iv)).
    An ANDA holder is expected to update its labeling after FDA has 
approved relevant changes to the labeling for the corresponding RLD. 
Prompt revision, submission to the Agency, and implementation of 
revised labeling are important to ensure that the generic drug 
continues to be as safe and effective as the corresponding RLD. Because 
the labeling of a generic drug must be the same as the labeling for the 
RLD, except for permissible differences, the revision should be made at 
the earliest time possible.
    In this guidance, FDA is providing information on how ANDA 
applicants and holders should monitor for changes to RLD labeling, 
procedures for the electronic submission of labeling updates, 
information describing the type of submission that should be made to 
FDA, as well as other considerations for submitting a labeling update 
to FDA.
    This guidance finalizes the draft guidance for industry of the same 
title issued on January 27, 2022 (87 FR 4252). The January 2022 draft 
guidance revised the final guidance for industry entitled ``Revising 
ANDA Labeling Following Revision of the RLD Labeling'' issued in April 
2000. FDA considered comments received on the January 2022 draft 
guidance as the guidance was finalized. Minor revisions from the draft 
to the final guidance were made to improve clarity.
    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 ``Revising ANDA Labeling Following Revision 
of the RLD Labeling.'' 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 in part 314 (21 CFR part 314) for 
the submission of ANDAs (including the content and format of ANDAs and 
supplements and amendments) have been approved under OMB control number 
0910-0001 and in part 314 (included under the 21 CFR parts 10 through 
16 hearing regulations) under OMB control number 0910-0191.
    The collections of information pertaining to the electronic 
submission of labeling changes have been approved under OMB control 
number 0910-0045. The collections of information pertaining to the 
content and format requirements for human prescription

[[Page 4959]]

drugs and biological products and the submission of such labeling have 
been approved under OMB control number 0910-0572.

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: January 22, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-01442 Filed 1-24-24; 8:45 am]
BILLING CODE 4164-01-P


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