[Federal Register Volume 65, Number 50 (Tuesday, March 14, 2000)]
[Notices]
[Pages 13785-13786]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 00-6119]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99D-2249]


International Cooperation on Harmonisation of Technical 
Requirements for Approval of Veterinary Medicinal Products (VICH); 
Final Guidance on Stability Testing for Medicated Premixes (VICH GL8); 
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 (#91) entitled 
``Stability Testing for Medicated Premixes (VICH GL8).'' 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). This final guidance document 
is an annex to the parent guidance VICH GL3 entitled ``Stability 
Testing of New Veterinary Drug Substances and

[[Page 13786]]

Medicinal Products.'' This final guidance document is the annex and 
addresses the recommendations for stability testing of veterinary 
medicinal Type A medicated articles (referred to as medicated premix 
drug products in the final guidance) intended for submission for 
approval to the European Union, Japan, and the United States.

DATES: You may submit written comments at any time.

ADDRESSES: Copies of the final guidance document entitled ``Stability 
Testing for Medicated Premixes (VICH GL8)'' may be obtained on the 
Internet from the CVM home page at http://www.fda.gov/cvm/fda/mappgs/
vich.html. Persons without Internet access may submit written requests 
for single copies 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.
    You may submit written comments at any time 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 the 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: sthompso@cvm.fda.gov, 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: rlivings@cvm.fda.gov.
    Regarding the guidance document: William G. Marnane, Center for 
Veterinary Medicine (HFV-140), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-6966, e-mail: 
wmarnane@cvm.fda.gov.

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.
    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 
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 pharmaceutical 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 Stability Testing

    In the Federal Register of July 22, 1999 (64 FR 39515), FDA 
published the draft guidance entitled ``Stability Testing for Medicated 
Premixes (VICH GL8),'' 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 GL8, for industry.
    VICH GL8 addresses the generation of acceptable stability 
information for submission in new animal drug applications (referred to 
as registration applications in the final guidance) for Type A 
medicated articles containing new molecular entities. This guidance 
will be implemented in May 2000.
    This final guidance document represents the agency's current 
thinking on acceptable stability testing of Type A medicated articles. 
The document does not create or confer any rights for or on any person 
and will not operate to bind FDA or the public. Alternate approaches 
may be used if they satisfy the requirements of applicable statutes, 
regulations, or both.

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: March 3, 2000.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 00-6119 Filed 3-13-00; 8:45 am]
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