Notice2026-17928
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Studies To Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing (Revision 2); Guidance for Industry; Availability
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Published
September 2, 2026
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) #116 (VICH GL23(R2)) titled "Studies to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity Testing (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 ensure international harmonization of genotoxicity testing of veterinary drug residues.
Full Text
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<title>Federal Register, Volume 91 Issue 169 (Wednesday, September 2, 2026)</title>
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[Federal Register Volume 91, Number 169 (Wednesday, September 2, 2026)]
[Notices]
[Pages 56454-56455]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-17928]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2000-D-0598]
International Cooperation on Harmonisation of Technical
Requirements for Registration of Veterinary Medicinal Products; Studies
To Evaluate the Safety of Residues of Veterinary Drugs in Human Food:
Genotoxicity Testing (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) #116 (VICH
GL23(R2)) titled ``Studies to Evaluate the Safety of Residues of
Veterinary Drugs in Human Food: Genotoxicity Testing (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 ensure international harmonization of
genotoxicity testing of veterinary drug residues.
DATES: The announcement of the guidance is published in the Federal
Register on September 2, 2026.
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 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-2000-D-0598 for ``International Cooperation on Harmonisation of
Technical Requirements for Registration of Veterinary Medicinal
Products; Studies to Evaluate the Safety of Residues of Veterinary
Drugs in Human Food: Genotoxicity Testing (Revision 2); Guidance for
Industry; Availability.'' 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
[[Page 56455]]
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
Policy and Regulations Staff, Center for Veterinary Medicine, Food and
Drug Administration, 5001 Campus Drive, College Park, MD 20740. 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: Tong Zhou, Center for Veterinary
Medicine, Food and Drug Administration, 5001 Campus Drive, College
Park, MD 20740, 240-402-0826, <a href="/cdn-cgi/l/email-protection#4d1922232a63172522380d2b292c6325253e632a223b"><span class="__cf_email__" data-cfemail="d98db6b7bef783b1b6ac99bfbdb8f7b1b1aaf7beb6af">[email protected]</span></a>
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of final GFI #116 (VICH
GL23(R2)) titled ``Studies to Evaluate the Safety of Residues of
Veterinary Drugs in Human Food: Genotoxicity Testing (Revision 2).''
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 founding member
representatives from the European Commission and European Medicines
Agency; AnimalhealthEurope; FDA--Center for Veterinary Medicine; the
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 standing members 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 guidance document is intended to provide study design
recommendations that will facilitate the mutual acceptance by the
relevant regulatory authorities of safety data for the determination of
Acceptable Daily Intakes (ADIs) for veterinary drug residues in human
food. The guidance reflects the recommendations of the VICH set forth
in the VICH GL23(R2) guideline.
In the Federal Register of September 30, 2024 (89 FR 79614), FDA
published the notice of availability for a draft guidance titled
``International Cooperation on Harmonisation of Technical Requirements
for Registration of Veterinary Medicinal Products; Studies to Evaluate
the Safety of Residues of Veterinary Drugs in Human Food: Genotoxicity
Testing (Revision 2); Draft Guidance for Industry; Availability,''
giving interested persons until November 29, 2024, to comment on the
draft guidance. FDA received one comment on the draft guidance and this
comment was considered as the guidance was finalized. After
consideration of the comment received and revisions to the VICH
guideline, a final draft of the guideline was submitted to the VICH
Steering Committee and endorsed by the regulatory agencies in August
2025. The guidance announced in this notice finalizes the draft
guidance dated September 2024.
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 ``Studies to Evaluate the Safety of
Residues of Veterinary Drugs in Human Food: Genotoxicity Testing.'' 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 21 CFR part 514 have been approved under OMB control number 0910-
0032.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
<a href="https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm">https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm</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>.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-17928 Filed 9-1-26; 8:45 am]
BILLING CODE 4164-01-P
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