[Federal Register: July 7, 2000 (Volume 65, Number 131)]
[Notices]
[Page 42019-42020]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07jy00-83]
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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: 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: Kevin J. Greenlees, Center for
Veterinary Medicine (HFV-150), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-6977, e-mail:
kgreenle@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 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]
BILLING CODE 4160-01-F