[Federal Register Volume 65, Number 50 (Tuesday, March 14, 2000)]
[Notices]
[Pages 13785-13786]
From the Federal Register Online via the Government Publishing 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: [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: William G. Marnane, Center for
Veterinary Medicine (HFV-140), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-6966, 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.
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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