Notice2024-01442
Revising Abbreviated New Drug Application Labeling Following Revision of the Reference Listed Drug Labeling; Final Guidance for Industry; Availability
Primary source
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Published
January 25, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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 This guidance finalizes the draft guidance for industry of the same title issued on January 27, 2022.
Full Text
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<title>Federal Register, Volume 89 Issue 17 (Thursday, January 25, 2024)</title>
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[Federal Register Volume 89, Number 17 (Thursday, January 25, 2024)]
[Notices]
[Pages 4957-4959]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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finalizes the draft guidance for industry of the same title issued on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: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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
<a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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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