[Federal Register Volume 67, Number 3 (Friday, January 4, 2002)]
[Notices]
[Pages 602-603]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-193]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1631]


International Cooperation on Harmonisation of Technical 
Requirements for Approval of Veterinary Medicinal Products (VICH); 
Final Guidance for Industry on ``Studies to Evaluate the Safety of 
Residues of Veterinary Drugs in Human Food: Genotoxicity Testing'' 
(VICH GL23); Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a final guidance for industry (#116) entitled ``Studies 
to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: 
Genotoxicity Testing'' (VICH GL23). This final guidance has been 
adapted for veterinary use by the International Cooperation on 
Harmonisation of Technical Requirements for Registration of Veterinary 
Medicinal Products (VICH) from a guidance regarding pharmaceuticals for 
human use, which was adopted by the International Conference on 
Harmonisation of Technical Requirements for Approval of Pharmaceuticals 
for Human Use (ICH). This final VICH guidance document recommends a 
basic battery of tests that can be used to evaluate the genotoxicity of 
veterinary drug residues in human food in the European Union, Japan, 
and the United States.

DATES: Submit written or electronic comments on this final guidance at 
any time.

ADDRESSES: Submit written requests for single copies of the final 
guidance to the Communications Staff (HFV-12), Center for Veterinary 
Medicine (CVM), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855. Send one self-addressed adhesive label to assist 
that office in processing your requests. Submit written comments on the 
final guidance to the Dockets Management Branch (HFA-305), Food and 
Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. 
Submit electronic comments to http://www.fda.gov/dockets/ecomments. 
Comments should be identified with the full title of the final guidance 
and the docket number found in brackets in the heading of this 
document. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the final guidance.

[[Page 603]]


FOR FURTHER INFORMATION CONTACT: Louis T. Mulligan, Center for 
Veterinary Medicine (HFV-153), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-6984, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In recent years, many important initiatives have been undertaken by 
regulatory authorities and industry associations to promote the 
international harmonization of regulatory requirements. FDA has 
participated in efforts to enhance harmonization and has expressed its 
commitment to seek scientifically based harmonized technical procedures 
for the development of pharmaceutical products. 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 ICH for several years 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; European Medicines Evaluation Agency; 
European Federation of Animal Health; Committee on Veterinary Medicinal 
Products; U.S. FDA; U.S. Department of Agriculture; Animal Health 
Institute; Japanese Veterinary Pharmaceutical Association; Japanese 
Association of Veterinary Biologics; and Japanese Ministry of 
Agriculture, Forestry and Fisheries.
    Two observers are eligible to participate in the VICH Steering 
Committee: One representative from the Government of Australia/New 
Zealand and one representative from the industry in Australia/New 
Zealand. The VICH Secretariat, which coordinates the preparation of 
documentation, is provided by the Confederation Mondiale de L'Industrie 
de la Sante Animale (COMISA). A COMISA representative also participates 
in the VICH Steering Committee meetings.

II. Final Guidance on Genotoxicity Studies

    In the Federal Register of December 18, 2000 (65 FR 79106), FDA 
published the notice of availability of the VICH draft guidance, giving 
interested persons until January 17, 2001, to submit comments. After 
consideration of comments received, the final draft guidance was 
changed in response to the comments and submitted to the VICH Steering 
Committee. At a meeting held on June 28, 2001, the VICH Steering 
Committee endorsed the final guidance for industry, VICH GL23. 
Following the endorsement of the final guidance document by the VICH 
Steering Committee, a change was made to the document in which the 
reference for each genotoxicity test in the basic battery of tests was 
moved and used as the heading for the paragraph describing that test. 
The change was of an editorial nature and did not change the scientific 
content or intent of the guidance document.
    This guidance is one of a series of VICH guidances developed to 
facilitate the mutual acceptance of safety data necessary for the 
establishment of acceptable daily intakes for veterinary drug residues 
in human food by the relevant regulatory authorities. The guidance on 
the overall strategy for the evaluation of veterinary drug residues in 
human food (VICH Guidance on General Testing Approach) will be made 
available at a later time. This guidance was developed after 
consideration of the existing ICH guidances for pharmaceuticals for 
human use entitled ``Genotoxicity: A Standard Battery of Genotoxicity 
Testing of Pharmaceuticals'' and ``Guidance on Specific Aspects of 
Regulatory Genotoxicity Tests for Pharmaceuticals.'' Account was also 
taken of the Organization for Economic Cooperation and Development 
methodological guidances and of the current practices for evaluating 
the safety of veterinary drug residues in human food in the European 
Union, Japan, the U.S.A., Australia, and New Zealand.
    This level 1 final guidance document is developed under the VICH 
process and is consistent with FDA's good guidance practices regulation 
(21 CFR 10.115). This document does not create or confer any rights for 
or on any person and will not operate to bind FDA or the public. An 
alternate method may be used as long as it satisfies the requirements 
of applicable statutes and regulations.
    (Information collection is covered under OMB control number 0910-
0117.)

III. Comments

    As with all of FDA's guidances, the public is encouraged to submit 
written or electronic comments pertinent to this guidance. FDA will 
periodically review the comments in the docket and, where appropriate, 
will amend the guidance. The agency will notify the public of any such 
amendments through a notice in the Federal Register.
    Interested persons may, at any time, submit written comments to the 
Dockets Management Branch (address above) regarding this guidance 
document. Two copies of any comments are to be submitted, except that 
individuals may submit one copy. Comments are to be identified with the 
docket number found in brackets in the heading of this document. A copy 
of the document and received comments are available for public 
examination in the Dockets Management Branch between 9 a.m. and 4 p.m., 
Monday through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
http://www.fda.gov/cvm.

    Dated: December 28, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-193 Filed 1-3-02; 8:45 am]
BILLING CODE 4160-02-S