[Federal Register Volume 68, Number 205 (Thursday, October 23, 2003)]
[Notices]
[Pages 60703-60704]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-26697]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0466]


International Cooperation on Harmonization of Technical 
Requirements for Registration of Veterinary Medicinal Products; Draft 
Guidance for Industry on ``Studies to Evaluate the Safety of Residues 
of Veterinary Drugs in Human Food: Repeat-Dose (Chronic) Toxicity 
Testing;'' Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing the 
availability for comments of a draft guidance document for industry 
([numsign]160) entitled ``Studies to Evaluate the Safety of Residues of 
Veterinary Drugs in Human Food: Repeat-Dose (Chronic) Toxicity 
Testing'' (VICH GL-37). This draft guidance has been developed for 
veterinary use by the International Cooperation on Harmonization of 
Technical Requirements for Registration of Veterinary Medicinal 
Products (VICH). This draft VICH guidance document establishes 
recommendations for internationally harmonized repeat-dose chronic 
toxicity testing.

DATES: Submit written or electronic comments on the draft guidance by 
November 24, 2003 to ensure their adequate consideration in preparation 
of the guidance document. General comments on agency guidance documents 
are welcome at any time.

[[Page 60704]]


ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Communications Staff (HFV-12), Center for Veterinary 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INFORMATION section for electronic access to the draft guidance 
document. Submit written comments on the draft guidance to the Division 
of Dockets Management (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with the full title of the draft guidance and the docket number found 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, industry associations, and individual sponsors 
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 reduce the 
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 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; the United States' FDA; the U.S. Department of Agriculture; 
the Animal Health Institute; the Japanese Veterinary Pharmaceutical 
Association; the Japanese Association of Veterinary Biologics; and the 
Japanese Ministry of Agriculture, Forestry and Fisheries.
    Four observers are eligible to participate in the VICH steering 
committee: One representative from the Government of Australia/New 
Zealand, one representative from industry in Australia/New Zealand, one 
representative from the Government of Canada, and one representative 
from industry in Canada. The VICH Secretariat, which coordinates the 
preparation of documentation, is provided by the International 
Federation for Animal Health (IFAH). An IFAH representative also 
participates in the VICH steering committee meetings.

II. Draft Guidance on Microbiological Acceptable Daily Intakes

    The VICH Steering Committee held a meeting on May 8, 2003, and 
agreed that the draft guidance document entitled ``Studies to Evaluate 
the Safety of Residues of Veterinary Drugs in Human Food: Repeat-Dose 
(Chronic) Toxicity Testing'' (VICH GL-37) should be made available for 
public comment. This draft VICH 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 (ADIs) for 
veterinary drug residues in human food. This draft guidance was 
developed after consideration of the current practices for evaluating 
veterinary drug residues in human food in the European Union, Japan, 
United States, Australia, New Zealand, and Canada. It also took account 
of available data from subchronic and chronic toxicity studies.
    FDA and the VICH Expert Working Group on Toxicity Safety will 
consider comments about the draft guidance document. Information 
collection is covered under Office of Management and Budget control 
number 0910-0032.

III. Significance of Guidance

    This draft document, developed under the VICH process, has been 
revised to conform to FDA's good guidance practices regulation (21 CFR 
10.115).
    The draft VICH guidance ([numsign]160) represents the agency's 
current thinking on the general approach to establish a microbiological 
ADI. This guidance does not create or confer any rights for or on any 
person and does not operate to bind FDA or the public. You may use an 
alternative method as long as it satisfies the requirements of the 
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 comments should be submitted to 
the Division of Dockets Management (see ADDRESSES). 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 
Division of Dockets Management between 9 a.m. and 4 p.m., Monday 
through Friday.

V. Electronic Access

    Comments may be submitted electronically on the Internet at http://www.fda.gov/dockets/ecomments (select ``[docket number] entitled 
`Studies to Evaluate the Safety of Residues of Veterinary Drugs in 
Human Food: Repeat-Dose (Chronic) Toxicity Testing' (VICH GL-37).''
    Copies of the draft guidance may be obtained on the Internet from 
the CVM home page at http://www.fda.gov/cvm.

    Dated: October 14, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-26697 Filed 10-22-03; 8:45 am]
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