Revising Abbreviated New Drug Application Labeling Following Revision of the Reference Listed Drug Labeling; Final Guidance for Industry; Availability, 4957-4959 [2024-01442]
Download as PDF
<![CDATA[
Federal Register / Vol. 89, No. 17 / Thursday, January 25, 2024 / Notices
the SUPPLEMENTARY INFORMATION section
for electronic access to the draft
guidance document.
FOR FURTHER INFORMATION CONTACT: Mai
Huynh, Center for Veterinary Medicine
(HFV–140), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–0669,
mai.huynh@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
khammond on DSKJM1Z7X2PROD with NOTICES
I. Background
FDA is announcing the availability of
a draft guidance for industry GFI #286
(VICH GL60) entitled ‘‘Good
Manufacturing Practice for Active
Pharmaceutical Ingredients Used in
Veterinary Medicinal Products.’’ The
objective of this guidance is to provide
recommendations regarding GMP for the
manufacturing of APIs under an
appropriate system for managing
quality. It is also intended to help
ensure that APIs meet the requirements
for quality and purity that they purport
or are represented to possess.
FDA has participated in efforts to
enhance international harmonization
and is committed to seeking
scientifically based harmonized
technical procedures for pharmaceutical
development. One of the goals of
harmonization is to identify, and then
reduce, differences in technical
requirements for drug development
among regulatory agencies in different
countries. FDA has actively participated
in the International Council for
Harmonisation of Technical
Requirements for Pharmaceuticals for
Human Use to develop harmonized
technical requirements for the approval
of human pharmaceutical and biological
products among the European Union,
Japan, and the United States. The VICH
is a parallel initiative for veterinary
medicinal products. The VICH is
concerned with developing harmonized
technical requirements for the approval
of veterinary medicinal products in the
European Union, Japan, and the United
States, and includes input from both
regulatory and industry representatives.
The VICH Steering Committee is
composed of member representatives
from the European Commission and
European Medicines Agency;
AnimalhealthEurope; FDA—Center for
Veterinary Medicine and U.S.
Department of Agriculture—Center for
Veterinary Biologics; the U.S. Animal
Health Institute; the Japanese Ministry
of Agriculture, Forestry and Fisheries;
and the Japanese Veterinary Products
Association. There are 10 observers to
the VICH Steering Committee: one
representative from government and one
representative from industry of
VerDate Sep<11>2014
17:22 Jan 24, 2024
Jkt 262001
Australia, New Zealand, Canada, South
Africa, and the United Kingdom. The
World Organisation for Animal Health
is an associate member of the VICH. The
VICH Secretariat, which coordinates the
preparation of documentation, is
provided by HealthforAnimals.
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 ‘‘Good Manufacturing Practice for
Active Ingredients Used in Veterinary
Medicinal Products.’’ 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 (44 U.S.C. 3501–
3521). The collections of information in
21 CFR part 514 have been approved
under OMB control number 0910–0032;
and the collections of information in
section 512(n)(1) of the FD&C Act (21
U.S.C. 360b(n)(1)) have been approved
under OMB control number 0910–0669.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/animal-veterinary/
guidance-regulations/guidanceindustry, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: January 22, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–01441 Filed 1–24–24; 8:45 am]
BILLING CODE 4164–01–P
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.
PO 00000
Frm 00067
Fmt 4703
Sfmt 4703
ACTION:
4957
Notice of availability.
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:
SUMMARY:
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
E:\FR\FM\25JAN1.SGM
25JAN1
khammond on DSKJM1Z7X2PROD with NOTICES
4958
Federal Register / Vol. 89, No. 17 / Thursday, January 25, 2024 / Notices
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.
• 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-201509-18/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
VerDate Sep<11>2014
17:22 Jan 24, 2024
Jkt 262001
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, Jonathan.Hughes@
fda.hhs.gov.
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 § 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., § 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’’ (§ 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
PO 00000
Frm 00068
Fmt 4703
Sfmt 4703
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
E:\FR\FM\25JAN1.SGM
25JAN1
Federal Register / Vol. 89, No. 17 / Thursday, January 25, 2024 / Notices
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/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
regulatory-information/search-fdaguidance-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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–E–0448]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; VOCABRIA
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for VOCABRIA and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of an application to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that human drug
product.
DATES: Anyone with knowledge that any
of the dates as published (see
SUPPLEMENTARY INFORMATION) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by March 25, 2024.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
July 23, 2024. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. The https://
www.regulations.gov electronic filing
system will accept comments until
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:22 Jan 24, 2024
Jkt 262001
11:59 p.m. Eastern Time at the end of
March 25, 2024. Comments received by
mail/hand delivery/courier (for written/
paper submissions) will be considered
timely if they are postmarked or the
delivery service acceptance receipt is on
or before that date.
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
must include the Docket No. FDA–
2022–E–0448 for ‘‘Determination of
Regulatory Review Period for Purposes
of Patent Extension; VOCABRIA.’’
Received comments, those filed in a
timely manner (see ADDRESSES), 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.
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
4959
• 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 § 10.20 (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-201509-18/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.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
Rm. 6250, Silver Spring, MD 20993,
301–796–3600.
SUPPLEMENTARY INFORMATION:
I. Background
The Drug Price Competition and
Patent Term Restoration Act of 1984
(Pub. L. 98–417) and the Generic
Animal Drug and Patent Term
Restoration Act (Pub. L. 100–670)
generally provide that a patent may be
extended for a period of up to 5 years
so long as the patented item (human
drug or biologic product, animal drug
product, medical device, food additive,
or color additive) was subject to
E:\FR\FM\25JAN1.SGM
25JAN1
]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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:
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
[[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.
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, [email protected].
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
