[Federal Register Volume 67, Number 3 (Friday, January 4, 2002)]
[Notices]
[Pages 603-605]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-194]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1630]


International Cooperation on Harmonisation of Technical 
Requirements for Approval of Veterinary Medicinal Products (VICH); 
Final Guidance on ``Safety Studies for Veterinary Drug Residues in 
Human Food: Reproduction Toxicity Testing'' (VICH GL22); 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 (#115) entitled ``Safety 
Studies for Veterinary Drug Residues in Human Food: Reproduction 
Toxicity Testing'' (VICH GL22). 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

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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 
reproduction safety of veterinary drug residues in human food.

DATES: Submit written or electronic comments 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, 7519 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 final guidance 
document.
    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.

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 the 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. Guidance on Reproduction Studies

    In the Federal Register of December 19, 2000 (65 FR 79373), FDA 
published the notice of availability of VICH draft guidance entitled 
``Safety Studies for Veterinary Drug Residues in Human Food: 
Reproduction Studies'' giving interested persons until February 20, 
2001, to submit comments. FDA received no comments. The final guidance 
was submitted to the VICH Steering Committee. At a meeting held on June 
28, 2001, the VICH Steering Committee endorsed the final guidance for 
industry entitled ``Studies to Evaluate the Safety of Residues of 
Veterinary Drugs in Human Food: Reproductive Toxicity Testing'' (VICH 
GL22).
    In order to establish the safety of veterinary drug residues in 
human food, a number of toxicological evaluations are recommended, 
including the assessment of any risks to reproduction. The objective of 
this guidance is to ensure international harmonization of reproduction 
toxicity testing, which is appropriate for the evaluation of risks to 
reproduction from long-term, low-dose exposures, such as may be 
encountered from the presence of veterinary drug residues in food.
    The current final guidance is one of a series of guidances 
developed to facilitate the mutual acceptance of safety data necessary 
for the determination of acceptable daily intakes for veterinary drug 
residues in human food by the relevant regulatory authorities. The 
guidance on the overall strategy for the safety evaluation of 
veterinary residues in human food (VICH Guidance on General Testing 
Approach) will be made available at a later time. VICH GL22 was 
developed after consideration of the existing ICH guidance for 
pharmaceuticals for human use on ``Detection of Toxicity to 
Reproduction for Medicinal Products'' and its addendum, ``Toxicity to 
Male Fertility,'' in conjunction with the current practices for 
evaluating veterinary drug residues in human food in the European 
Union, Japan, the United States, Australia, and New Zealand.
    This final level 1 guidance document was developed under the VICH 
process and is consistent with FDA's good guidance practices regulation 
(21 CFR 10.115). This guidance 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 Nos. 0910-0117 and 0910-0032.)

III. Comments

    As with all of FDA's guidances, the public is encouraged to submit 
written or electronic comments with new data or other new information 
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

    Comments may also be submitted electronically on the Internet site 
at http://www.fda.gov/dockets/ecomments. Once on this Internet site, 
select 00D-1630 ``Safety Studies for Veterinary Drug Residues in Human

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Food: Reproduction Toxicity Testing'' (VICH GL22) and follow the 
directions.
    Copies of the final guidance document entitled ``Safety Studies for 
Veterinary Drug Residues in Human Food: Reproduction Toxicity Testing'' 
(VICH GL22) may be obtained on the Internet from the CVM home page at 
http://www.fda.gov/cvm.

    Dated: December 28, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-194 Filed 1-3-02; 8:45 am]
BILLING CODE 4160-02-S