Notice2024-16408
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Impurities: Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients (Revision 2); Guidance for Industry; Availability
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Published
July 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 (GFI) #100 (VICH GL 18(R2)) entitled "Impurities: Residual Solvents in New Veterinary Medicinal Products, Active Substances and Excipients (Revision 2)." This 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 guidance is to recommend acceptable amounts for residual solvents in pharmaceuticals for the safety of the target animal as well as for the safety of residues in products derived from treated food- producing animals. This revision updates the listings and classification of solvents.
Full Text
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<title>Federal Register, Volume 89 Issue 143 (Thursday, July 25, 2024)</title>
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[Federal Register Volume 89, Number 143 (Thursday, July 25, 2024)]
[Notices]
[Pages 60433-60435]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-16408]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-1999-D-2955 (formerly 1999D-4071)]
International Cooperation on Harmonisation of Technical
Requirements for Registration of Veterinary Medicinal Products;
Impurities: Residual Solvents in New Veterinary Medicinal Products,
Active Substances and Excipients (Revision 2); 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 (GFI) #100 (VICH GL
18(R2)) entitled ``Impurities: Residual Solvents in New Veterinary
Medicinal Products, Active Substances and Excipients (Revision 2).''
This 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 guidance is to recommend acceptable amounts for residual
solvents in pharmaceuticals for the safety of the target animal as well
as for the safety of residues in products derived from treated food-
producing animals. This revision updates the listings and
classification of solvents.
DATES: The announcement of the guidance is published in the Federal
Register on July 25, 2024.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances 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
[[Page 60434]]
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-1999-D-2955 (formerly 1999D-4071) for ``Impurities: Residual
Solvents in New Veterinary Medicinal Products, Active Substances and
Excipients (Revision 2).'' 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 this draft guidance to
the Policy and Regulations Staff, 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 request or include a fax number to which the draft guidance may be
sent. See the SUPPLEMENTARY INFORMATION section for information on
electronic access to the draft guidance.
FOR FURTHER INFORMATION CONTACT: Mai Huynh, Center for Veterinary
Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville,
MD 20855, 240-402-0669, <a href="/cdn-cgi/l/email-protection#b9d4d8d097d1ccc0d7d1f9dfddd897d1d1ca97ded6cf"><span class="__cf_email__" data-cfemail="d2bfb3bbfcbaa7abbcba92b4b6b3fcbabaa1fcb5bda4">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a final GFI #100 (VICH
GL18(R2)) entitled ``Impurities: Residual Solvents in New Veterinary
Medicinal Products, Active Substances and Excipients (Revision 2).''
Residual solvents in pharmaceuticals are defined in the guidance as
organic volatile chemicals that are used or produced in the manufacture
of active substances or excipients, or in the preparation of veterinary
medicinal products. The solvents are not completely removed by
practical manufacturing techniques. The objective of this guidance is
to recommend acceptable amounts for residual solvents in
pharmaceuticals for the safety of the target animal as well as for the
safety of residues in products derived from treated food-producing
animals. The guidance recommends use of less toxic solvents and
describes levels considered to be toxicologically acceptable for some
residual solvents. This revision updates the listings and
classification of solvents.
FDA has participated in efforts to enhance 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 Conference on
Harmonization of Technical Requirements for Approval of 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.
In the Federal Register of July 18, 2022 (87 FR 42728), FDA
published the notice of availability for a draft guidance #100 (VICH
GL18(R2)) entitled ``Impurities: Residual Solvents in New Veterinary
Medicinal Products, Active Substances and Excipients (Revision 2)''
giving interested persons until September 16, 2022, to comment on the
draft guidance. FDA and other VICH member regulatory agencies did not
[[Page 60435]]
receive comments on the draft guidance. The guidance announced in this
notice finalizes the draft guidance dated July 2022.
This level 1 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 ``Impurities: Residual Solvents in New
Veterinary Medicinal Products, Active Substances and Excipients
(Revision 2).'' 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 section 512(n)(1) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 360b(n)(1)) have been approved under OMB control number 0910-
0669; the collections of information in 21 CFR part 514 have been
approved under OMB control number 0910-0032.
III. Electronic Access
Persons with access to the internet may obtain an electronic
version of the draft guidance at <a href="https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry">https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry</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: July 22, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-16408 Filed 7-24-24; 8:45 am]
BILLING CODE 4164-01-P
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