Notice2022-01577
Revising Abbreviated New Drug Application Labeling Following Revision of the Reference Listed Drug Labeling; Draft Guidance for Industry; Availability
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Published
January 27, 2022
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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Revising ANDA Labeling Following Revision of the RLD Labeling."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 This draft guidance revises the guidance for industry entitled "Revising ANDA Labeling Following Revision of the RLD Labeling" issued in April 2000.
Full Text
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<title>Federal Register, Volume 87 Issue 18 (Thursday, January 27, 2022)</title>
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[Federal Register Volume 87, Number 18 (Thursday, January 27, 2022)]
[Notices]
[Pages 4252-4254]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-01577]
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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Revision of the Reference Listed Drug Labeling; Draft Guidance for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the availability of a draft guidance for industry entitled ``Revising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 This draft
guidance revises the guidance for industry entitled ``Revising ANDA
Labeling Following Revision of the RLD Labeling'' issued in April 2000.
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DATES: Submit either electronic or written comments on the draft
guidance by March 28, 2022 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any 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 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 draft 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 draft 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.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft 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. This draft guidance revises the
guidance for industry ``Revising ANDA Labeling Following Revision of
the RLD Labeling'' issued in April 2000. Significant changes from the
2000 version include updates to outdated details about how to obtain
information on changes to RLD labeling and how to submit revised ANDA
labeling to FDA.
A generic drug is 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 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 draft 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
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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 draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent 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. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA.
<bullet> The collections of information in 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) for OMB control number 0910-0191.
<bullet> The collections of information pertaining to the
electronic submission of labeling changes have been approved under OMB
control number 0910-0045.
<bullet> The collections of information pertaining to the content
and format requirements for human prescription 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 draft guidance
at either <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 21, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-01577 Filed 1-26-22; 8:45 am]
BILLING CODE 4164-01-P
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