[Federal Register Volume 89, Number 189 (Monday, September 30, 2024)]
[Notices]
[Pages 79614-79615]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-22301]


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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Genotoxicity Testing (Revision 2); Draft Guidance for Industry; 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 revised guidance for industry (GFI) #116 
(VICH GL23) entitled ``Studies to Evaluate the Safety of Residues of 
Veterinary Drugs in Human Food: Genotoxicity Testing (Revision 2).'' 
This draft guidance has been developed for veterinary use by the 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 This draft 
guidance recommends a Standard Battery of Tests that can be used for 
the evaluation of the genotoxicity of veterinary drug residues in food.

DATES: Submit either electronic or written comments on the draft 
guidance by November 29, 2024 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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:
    <bullet> 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.
    <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 ``Studies to Evaluate the Safety of Residues of 
Veterinary Drugs in Human Food: Genotoxicity Testing (Revision 2).'' 
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.
    <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

[[Page 79615]]

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, 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 the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Li You, Center for Veterinary 
Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, 
MD 20855, 240-402-0828, <a href="/cdn-cgi/l/email-protection#98d4f1b6c1f7edd8fefcf9b6f0f0ebb6fff7ee"><span class="__cf_email__" data-cfemail="fbb792d5a2948ebb9d9f9ad5939388d59c948d">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft GFI #116 (VICH GL23) 
entitled ``Studies to Evaluate the Safety of Residues of Veterinary 
Drugs in Human Food: Genotoxicity Testing (Revision 2).'' This draft 
revised guidance recommends a Standard Battery of Tests that can be 
used for the evaluation of the genotoxicity of veterinary drug 
residues. The Standard Battery of Tests intends to achieve reasonable 
confidence in the assessment of the genotoxicity potential of 
veterinary drug residues and to be in harmony with the requirements of 
International Council for Harmonisation of Technical Requirements for 
Pharmaceuticals for Human Use for testing human drugs for genotoxicity. 
This draft guidance also advises on modifications to the Standard 
Battery of Tests and on interpretation of test results. The objective 
of this guidance is to ensure international harmonization of 
genotoxicity testing of veterinary drug residues.
    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 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: 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 ``Studies 
to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: 
Genotoxicity Testing (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 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 https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: September 24, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-22301 Filed 9-27-24; 8:45 am]
BILLING CODE 4164-01-P


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