Target Animal Safety Evaluation for Veterinary Monoclonal Antibody Products; Draft Guidance for Industry; Availability

Issuing agencies

Abstract

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #298 (VICH GL62) titled "Target Animal Safety Evaluation for Veterinary Monoclonal Antibody Products." This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal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). This draft guidance contributes to the international harmonization of methods used for the target animal safety (TAS) evaluation of veterinary monoclonal antibody products (VMAPs) and aids in preparing and conducting VMAP TAS studies under laboratory and field conditions. A harmonized standard is intended to aid in development of mutually acceptable VMAP TAS programs.

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<title>Federal Register, Volume 91 Issue 180 (Friday, September 18, 2026)</title>
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[Federal Register Volume 91, Number 180 (Friday, September 18, 2026)]
[Notices]
[Pages 59141-59143]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-19141]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2026-D-7233]


Target Animal Safety Evaluation for Veterinary Monoclonal 
Antibody Products; Draft Guidance for Industry; Availability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the availability of a draft guidance for industry (GFI) #298 (VICH 
GL62) titled ``Target Animal Safety Evaluation for Veterinary 
Monoclonal Antibody 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 This draft guidance has been developed 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). This draft guidance contributes to the international 
harmonization of methods used for the target animal safety (TAS) 
evaluation of veterinary monoclonal antibody products (VMAPs) and aids 
in preparing and conducting VMAP TAS studies under laboratory and field 
conditions. A harmonized standard is intended to aid in development of 
mutually acceptable VMAP TAS programs.

DATES: Submit either electronic or written comments on the draft 
guidance by November 17, 2026 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-2026-D-7233 for ``Target Animal Safety Evaluation for Veterinary 
Monoclonal Antibody Products; Draft 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

[[Page 59142]]

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 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 draft guidance document.

FOR FURTHER INFORMATION CONTACT: Joy Rachel Ganchingco, Center for 
Veterinary Medicine, Food and Drug Administration, 5001 Campus Drive, 
College Park, MD 20740, 301-837-7327, <a href="/cdn-cgi/l/email-protection#84eeebfdf6e5e7ece1e8aae3e5eae7ecedeae3e7ebc4e2e0e5aaececf7aae3ebf2"><span class="__cf_email__" data-cfemail="8de7e2f4ffeceee5e8e1a3eaece3eee5e4e3eaeee2cdebe9eca3e5e5fea3eae2fb">[email&#160;protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft GFI #298 (VICH GL62) 
titled ``Target Animal Safety Evaluation for Veterinary Monoclonal 
Antibody Products.''
    Currently, no VICH GL specifically supports marketing applications 
for VMAPs in the regions participating in the VICH. The VICH GLs 
available for TAS (i.e., VICH GL43 for pharmaceutical products and VICH 
GL44 for vaccines) do not fully address the TAS evaluation for a VMAP. 
Furthermore, International Council for Harmonisation of Technical 
Requirements for Pharmaceuticals for Human Use (ICH) S6 (R1) for the 
preclinical safety evaluation of biotechnology-derived pharmaceuticals 
is not fully applicable to VMAPs. Hence, there is a need for specific 
guidance on the TAS evaluation of a VMAP. Therefore, this guideline 
summarizes scientifically acceptable general principles for the TAS 
evaluation of a VMAP and should be used in conjunction with VICH GL43.
    This guideline is for VMAPs intended for use in companion animals 
and livestock animals. The active ingredient of a VMAP is a monoclonal 
antibody (mAb) or a mAb fragment, which could be engineered to be 
specific for a target animal and target(s). When needed, advice should 
be sought from the relevant regulatory authority for specific guidance 
on the design of the TAS study(ies) prior to their initiation or if the 
applicant determines an alternative approach to the TAS evaluation of a 
VMAP may be more appropriate.
    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 
goal of the VICH is to develop harmonized technical requirements for 
the approval of veterinary medicinal products in the European Union, 
Japan, and the United States, and receives 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's Center for Veterinary Medicine; U.S. 
Department of Agriculture's 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: 1 
representative from government and 1 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 level 1 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 ``Target 
Animal Safety Evaluation for Veterinary Monoclonal Antibody 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.
    As we develop final guidance on this topic, FDA will consider 
comments on costs or cost savings the guidance may generate, relevant 
for Executive Order 14192.

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)) and in 21 CFR part 514 have been approved under OMB 
control number 0910-0032. The collections of information in 21 CFR part 
511 have been approved under OMB control number 0910-0117.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at <a href="https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm">https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm</a>, https://www.fda.gov/regulatory-
information/search-fda-guidance-

[[Page 59143]]

documents, 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. 2026-19141 Filed 9-17-26; 8:45 am]
BILLING CODE 4164-01-P


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