[Federal Register Volume 65, Number 244 (Tuesday, December 19, 2000)]
[Notices]
[Pages 79373-79374]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-32197]



[[Page 79373]]

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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 Registration of Veterinary Medicinal Products (VICH); 
Draft Guidance on ``Safety Studies for Veterinary Drug Residues in 
Human Food: Reproduction Studies'' (VICH GL22); Availability; Request 
for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability for comment of a draft guidance for industry (#115) 
entitled ``Safety Studies for Veterinary Drug Residues in Human Food: 
Reproduction Studies'' (VICH GL22). This draft guidance has been 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 draft 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DATES: Submit written comments concerning the draft guidance to ensure 
their adequate consideration in preparation of the final document by 
February 20, 2001. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Submit written comments on the draft guidance to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. Identify comments with the full 
title of the draft guidance and the docket number found in brackets in 
the heading of this document.
    Copies of the draft guidance entitled ``Safety Studies for 
Veterinary Drug Residues in Human Food: Reproduction Studies'' (VICH 
GL22) may be obtained on the Internet from the CVM home page at http://www.fda.gov/cvm/fda/TOCs/guideline.html. Persons without Internet 
access may submit written requests for single copies of the draft 
guidance to the Communications Staff (HFV-12), Center for Veterinary 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.

FOR FURTHER INFORMATION CONTACT: Regarding VICH: Sharon R. Thompson, 
Center for Veterinary Medicine (HFV-3), Food and Drug Administration, 
7500 Standish Pl., Rockville, MD 20855, 301-594-1798, e-mail: 
[email protected], or Carole R. Andres, Center for Veterinary 
Medicine (HFV-1), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-827-6524, e-mail: [email protected].
    Regarding the guidance document: 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.
    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; 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

    The VICH Steering Committee held a meeting on June 14 through 16, 
2000, and agreed that the draft guidance entitled ``Safety Studies for 
Veterinary Drug Residues in Human Food: Reproduction Studies'' (VICH 
GL22) should be made available for public comment.
    This draft guidance is intended to provide harmonized guidance on 
the core recommendation for a multigeneration study for the safety 
evaluation of veterinary drug residues in human food. The current draft 
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. 
(Information collection is covered under OMB Control Nos. 0910-0117 and 
0910-0032).

III. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good 
guidance practices (65 FR 56468, September 19, 2000). For example, the 
documents have been designated ``guidance'' rather than ``guideline.'' 
Because guidance documents are not binding, unless specifically 
supported by statute or regulation, mandatory words such as ``must,'' 
``shall,'' and ``will'' in the

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original VICH documents have been substituted with ``should.'' 
Similarly, words such as ``requirement'' or ``acceptable'' have been 
replaced by ``recommendation'' or ``recommended'' as appropriate to the 
context.
    This draft guidance represents the agency's current thinking on 
reproduction safety studies for veterinary drug residues in human food. 
This draft guidance does not create or confer any rights for or on any 
person and will not operate to bind FDA or the public. An alternative 
method may be used as long as it satisfies the requirements of 
applicable statutes and regulations. Comments about the draft guidance 
documents will be considered by FDA and the VICH Safety Working Group. 
Ultimately, FDA intends to adopt the VICH Steering Committee's final 
guidances and publish them as future guidances.

IV. Comments

    This draft guidance is being distributed for comment purposes only 
and is not intended for implementation at this time. Interested persons 
may submit to the Dockets Management Branch (address above) written 
comments regarding this draft guidance. Submit written comments to 
ensure adequate consideration in preparation of the final guidance by 
February 20, 2001. 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 draft guidance and received comments are 
available for public examination in the Dockets Management Branch 
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: December 7, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-32197 Filed 12-18-00; 8:45 am]
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