[Federal Register Volume 67, Number 171 (Wednesday, September 4, 2002)]
[Notices]
[Pages 56572-56573]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-22407]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02D0369]


International Cooperation on Harmonisation of Technical 
Requirements for Approval of Veterinary Medicinal Products (VICH); 
Draft Guidance for Industry on ``Studies to Evaluate the Safety of 
Residues of Veterinary Drugs in Human Food: Developmental Toxicity 
Testing (VICH GL32); 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availability for comment of a draft guidance document for industry 
(148) entitled ``Studies to Evaluate the Safety of Residues of 
Veterinary Drugs in Human Food: Developmental Toxicity Testing'' (VICH 
GL32). This draft guidance document has been developed by the 
International Cooperation on Harmonisation of Technical Requirements 
for Registration of Veterinary Medicinal Products (VICH). This draft 
guidance document provides harmonized guidance on the core 
recommendation for a developmental toxicity study for the safety 
evaluation of veterinary drug residues in human food.

DATES: Submit written or electronic comments on the draft guidance 
document by October 4, 2002 to ensure their adequate consideration in 
preparation of the final guidance document. General comments on agency 
guidance documents are welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance document to the Communications Staff (HFV12), Center for 
Veterinary Medicine, 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INFORMATION section for electronic access to the draft guidance 
document.
    Submit written comments on the draft guidance document to the 
Dockets Management Branch (HFA305), 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with the full title of the draft guidance document and the docket 
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Louis T. Mulligan, Center for 
Veterinary Medicine (HFV153), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 3018276984, 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 International Conference on 
Harmonisation of Technical Requirements for Approval of Pharmaceuticals 
for Human Use for several years to develop harmonized technical 
recommendations 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 recommendations 
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 industry in Australia/ New Zealand. 
The VICH Secretariat, which coordinates the preparation of 
documentation, is provided by the Conf[eacute]d[eacute]ration Mondiale 
de L'Industrie de la Sant[eacute] Animale (COMISA). A COMISA 
representative also participates in the VICH Steering Committee 
meetings.

II. Draft Guidance on Toxicity Testing

    The VICH Steering Committee held a meeting in April 2002, and 
agreed that the draft guidance document entitled ``Studies to Evaluate 
the Safety of Residues of Veterinary Drugs in Human Food: Developmental 
Toxicity Testing'' (VICH GL32) should be made available for public 
comment.
    This draft guidance document provides guidance for developmental 
toxicity testing for those veterinary medicinal products used in food-
producing animals. The objective of this draft guidance document is to 
recommend that developmental toxicity assessment is performed according 
to an internationally harmonized guidance. This draft guidance 
describes testing designed to provide information concerning the 
effects on the pregnant animal and on the developing organism following 
prenatal exposure.
    FDA and the VICH will consider comments about the draft guidance 
document. Ultimately, FDA intends to adopt the VICH Steering 
Committee's final guidance and publish it as a final guidance.

III. Significance of Guidance

    This draft guidance document, developed under the VICH process, has 
been revised to conform to FDA's good guidance practices regulation (21 
CFR 10.115). For example, the document has 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 original VICH 
documents have been substituted with ``should.''
    The draft guidance document represents the agency's current 
thinking on developmental toxicity testing for those veterinary 
medicinal products used in food-producing animals. This draft guidance 
document 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

[[Page 56573]]

requirements of applicable statutes and regulations.

IV. Comments

    This draft guidance document is being distributed for comment 
purposes only and is not intended for implementation at this time. 
Interested persons may submit written or electronic comments regarding 
this draft guidance document. Written or electronic comments should be 
submitted to the Dockets Management Branch (see ADDRESSES). Submit 
written or electronic comments by October 4, 2002 to ensure adequate 
consideration in preparation of the final guidance. 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 
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.

V. Electronic Access

    Electronic comments may be submitted on the Internet at http://www.fda.gov/dockets/ecomments. On the Internet site, select ``[insert 
docket number] `Studies to Evaluate the Safety of Residues of 
Veterinary Drugs in Human Food: Developmental Toxicity Testing' '' 
(VICH GL32) and follow the directions.
    Copies of the draft guidance entitled ``Studies to Evaluate the 
Safety of Residues of Veterinary Drugs in Human Food: Developmental 
Toxicity Testing'' (VICH GL32) may be obtained on the Internet from the 
CVM homepage at http://www.fda.gov/cvm.

    Dated: August 27, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-22407 Filed 9302; 8:45 am]
BILLING CODE 416001S