International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Good Manufacturing Practice for Active Pharmaceutical Ingredients Used in Veterinary Medicinal Products; Draft Guidance for Industry; Availability, 4956-4957 [2024-01441]
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Federal Register / Vol. 89, No. 17 / Thursday, January 25, 2024 / Notices
comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in § 60.30 (21
CFR 60.30), any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must
comply with all the requirements of
§ 60.30, including but not limited to:
must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
Dated: January 22, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–01439 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–2023–D–4761]
International Cooperation on
Harmonisation of Technical
Requirements for Registration of
Veterinary Medicinal Products; Good
Manufacturing Practice for Active
Pharmaceutical Ingredients Used in
Veterinary Medicinal Products; Draft
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) 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announcing the availability of a draft
guidance for industry (GFI) #286 (VICH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.’’ This draft
guidance has been developed for
veterinary use by the International
Cooperation on Harmonisation of
Technical Requirements for Registration
of Veterinary Medicinal Products
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:22 Jan 24, 2024
Jkt 262001
(VICH). The objective of this draft
guidance is to provide
recommendations regarding good
manufacturing practice (GMP) for the
manufacturing of active pharmaceutical
ingredients (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.
DATES: Submit either electronic or
written comments on the draft guidance
by March 25, 2024 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:
• 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–
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
2023–D–4761 for ‘‘Good Manufacturing
Practice for Active Pharmaceutical
Ingredients Used in Veterinary
Medicinal Products.’’ 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 Policy and
Regulations Staff (HFV–6), Center for
Veterinary Medicine, Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855. Send one selfaddressed adhesive label to assist that
office in processing your requests. See
E:\FR\FM\25JAN1.SGM
25JAN1
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
]]>Agencies
[Federal Register Volume 89, Number 17 (Thursday, January 25, 2024)]
[Notices]
[Pages 4956-4957]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-01441]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-D-4761]
International Cooperation on Harmonisation of Technical
Requirements for Registration of Veterinary Medicinal Products; Good
Manufacturing Practice for Active Pharmaceutical Ingredients Used in
Veterinary Medicinal Products; Draft 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 draft guidance for industry (GFI) #286 (VICH
GL60) entitled ``Good Manufacturing Practice for Active Pharmaceutical
Ingredients Used in Veterinary Medicinal Products.'' This draft
guidance has been developed for veterinary use by the International
Cooperation on Harmonisation of Technical Requirements for Registration
of Veterinary Medicinal Products (VICH). The objective of this draft
guidance is to provide recommendations regarding good manufacturing
practice (GMP) for the manufacturing of active pharmaceutical
ingredients (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.
DATES: Submit either electronic or written comments on the draft
guidance by March 25, 2024 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:
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-2023-D-4761 for ``Good Manufacturing Practice for Active
Pharmaceutical Ingredients Used in Veterinary Medicinal Products.''
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
Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine,
Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855.
Send one self-addressed adhesive label to assist that office in
processing your requests. See
[[Page 4957]]
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, [email protected].
SUPPLEMENTARY INFORMATION:
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 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/guidance-industry, 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. 2024-01441 Filed 1-24-24; 8:45 am]
BILLING CODE 4164-01-P
