[Federal Register Volume 68, Number 219 (Thursday, November 13, 2003)]
[Notices]
[Pages 64353-64354]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-28371]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2002D-0368]


International Cooperation on Harmonisation of Technical 
Requirements for Approval of Veterinary Medicinal Products; Guidance 
for Industry on ``Studies to Evaluate the Safety of Residues of 
Veterinary Drugs in Human Food: Repeat-Dose (90-Day) Toxicity Testing'' 
(VICH GL31); 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 guidance for industry ([numsign]147) entitled 
``Studies to Evaluate the Safety of Residues of Veterinary Drugs in 
Human Food: Repeat-Dose (90-Day) Toxicity Testing'' (VICH GL31). This 
guidance has been developed by the International Cooperation on 
Harmonization of Technical Requirements for Registration of Veterinary 
Medicinal Products (VICH). The objective of this guidance is to 
establish recommendations for an internationally harmonized 90-day 
repeat-dose testing.

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies of this 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.
    Submit written comments on the 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 are to be identified with the

[[Page 64354]]

docket number found in brackets in the heading of this document. See 
the SUPPLEMENTARY INFORMATION section for electronic access to the 
guidance 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 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 U.S. 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 the industry in Australia/New Zealand, 
one representative from the government of Canada, and one 
representative from the industry of 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. Guidance on Toxicity Testing

    In the Federal Register of September 4, 2002 (67 FR 56569), FDA 
published the notice of availability of the VICH draft guidance, giving 
interested persons until October 4, 2002 to submit comments. After 
consideration of comments received, the draft guidance was changed in 
response to the comments and submitted to the VICH Steering Committee. 
At a meeting held from October 10 to 11, 2002, the VICH Steering 
Committee endorsed the guidance for industry, VICH GL31.
    A variety of toxicological evaluations are performed to establish 
the safety of veterinary drug residues in human food. The objective of 
this guidance is to establish recommendations for an internationally 
harmonized 90-day repeat-dose testing.

III. Significance of Guidance

    This 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'' or ``it is recommended.''
    This guidance document represents the agency's current thinking on 
establishing the safety of veterinary drug residues in human food. 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 alternative method may 
be used as long as it satisfies the requirements of applicable statutes 
and regulations.

IV. 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 submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this guidance 
document. Submit a single copy of electronic comments or two paper 
copies of any mailed comments, except that individuals may submit one 
paper copy. Comments should be identified with the docket number found 
in brackets in the heading of this document. A copy of the guidance 
document 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

    Persons with Internet access may obtain copies of the guidance 
document entitled ``Studies to Evaluate the Safety of Residues of 
Veterinary Drugs in Human Food: Repeat-Dose (90-Day) Toxicity Testing'' 
(VICH GL31), from the CVM home page at http://www.fda.gov/cvm.

    Dated: October 31, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-28371 Filed 11-12-03; 8:45 am]
BILLING CODE 4160-01-S