[Federal Register Volume 65, Number 131 (Friday, July 7, 2000)]
[Notices]
[Pages 42019-42020]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-17200]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99D-2145]


International Cooperation on Harmonisation of Technical 
Requirements for Registration of Veterinary Medicinal Products (VICH); 
Final Guidance on ``Impurities in New Veterinary Medicinal Products'' 
(VICH GL11); 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 (#92) entitled 
``Impurities in New Veterinary Medicinal Products'' (VICH GL11). This 
guidance document has been developed for veterinary use by the 
International Cooperation on Harmonisation of Technical Requirements 
for Registration of Veterinary Medicinal Products (VICH). The guidance 
is intended to assist in developing registration applications for 
approval of veterinary medicinal products submitted to the European 
Union, Japan, and the United States.

DATES: Submit written comments at any time.

[[Page 42020]]


ADDRESSES: Copies of the final guidance document entitled ``Impurities 
in New Veterinary Medicinal Products'' (VICH GL11) may be obtained on 
the Internet from the CVM home page at http://www.fda.gov/cvm. Persons 
without Internet access may submit written requests for a single copy 
of the final 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.
    Submit written comments on the final guidance document to the 
Policy and Regulations Team (HFV-6), Center for Veterinary Medicine, 
Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855.

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 Robert C. 
Livingston, Center for Veterinary Medicine (HFV-1), Food and Drug 
Administration, 7500 Standish Pl., Rockville, MD 20855, 301-594-5903, 
e-mail: [email protected].
    Regarding the guidance document: Kevin J. Greenlees, Center for 
Veterinary Medicine (HFV-150), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-6977, 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 requirements 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 
Harmonisation of Technical Requirements for Registration 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 meetings are held under the auspices of the Office 
International des Epizooties (OIE). During the initial phase of the 
VICH, an OIE representative chairs the VICH Steering Committee. The 
VICH Steering Committee is composed of member representatives from the 
European Commission; the European Medicines Evaluation Agency; the 
European Federation of Animal Health; the 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.
    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 Impurities in New Veterinary Medicinal Products

    In the Federal Register of July 22, 1999 (64 FR 39514), FDA 
published the draft guidance entitled ``Impurities in New Veterinary 
Medicinal Products'' (VICH GL11) giving interested persons until August 
23, 1999, to submit comments. After consideration of comments received, 
the final draft guidance was submitted to the VICH steering committee. 
At a meeting held on November 16 through 19, 1999, the VICH Steering 
Committee endorsed the final draft guidance, VICH GL11, for industry.
    This document is intended to provide guidance for new animal drug 
applications (referred to as registration applications or marketing 
authorization in the final guidance) on the content and qualification 
of impurities in new drug substances intended to be used for new 
veterinary medicinal products produced by chemical syntheses and not 
previously registered in a region or member State. (Information 
collected is covered under OMB Control No. 0910-0032.)
    This final guidance document represents current FDA thinking on 
impurities in new veterinary medicinal products and does not create or 
confer any rights for or on any person and does not operate to bind FDA 
or the public. Alternative methods may be used as long as they satisfy 
the requirements of applicable statutes and regulations.

III. Comments

    As with all of FDA's guidances, the public is encouraged to submit 
written comments with new data or other new information pertinent to 
this guidance. The comments in the docket will be periodically 
reviewed, and, where appropriate, the guidance will be amended. The 
public will be notified of any such amendments through a notice in the 
Federal Register.

    Dated: June 29, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-17200 Filed 7-6-00; 8:45 am]
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