[Federal Register Volume 64, Number 144 (Wednesday, July 28, 1999)]
[Notices]
[Pages 40887-40888]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-19194]
[[Page 40887]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98D-0017]
International Cooperation on Harmonisation of Technical
Requirements for Registration of Veterinary Medicinal Products (VICH);
Guidance on Validation of Analytical Procedures: Definition and
Terminology; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is publishing a final
guidance for industry entitled ``Validation of Analytical Procedures:
Definition and Terminology.'' This guidance has been adapted for
veterinary use by the International Cooperation on Harmonisation of
Technical Requirements for Registration of Veterinary Medicinal
Products (VICH) from an identically titled guidance adopted by the
International Conference on Harmonisation of Technical Requirements for
Registration of Pharmaceuticals for Human Use (ICH) and published in
the Federal Register of March l, 1995 (60 FR 11260). The document
provides guidance on characteristics that should be considered during
the validation of analytical procedures included as part of
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.
ADDRESSES: Copies of the final guidance document entitled ``Validation
of Analytical Procedures: Definition and Terminology'' may be obtained
on the Internet within the CVM home page at ``http://www.fda.gov/cvm/
fda/TOCs/guideline.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.
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 the guidance: 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]''.
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]''.
SUPPLEMENTARY INFORMATION: 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 seeking
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 ICH for several years to
develop harmonized technical requirements for the approval of human
pharmaceutical products among the European Union, Japan, and the United
States. The VICH is a parallel initiative for veterinary pharmaceutical
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 U.S. Food and Drug
Administration; the U.S. Department of Agriculture; the Animal Health
Institute; the Japanese Veterinary Pharmaceutical Association; 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 MERCOSUR (Argentina, Brazil, Uruguay,
and Paraguay), and one representative from Federacion Latino-Americana
de la Industria para la Salud Animal. 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.
In the Federal Register of January 27, 1998 (63 FR 3907), FDA
published this guidance in draft form, giving interested persons until
March 30, 1998, to submit comments. After consideration of comments
received, a final draft guidance was submitted to the VICH steering
committee.
At a meeting held from October 20 through 22, 1998, the VICH
Steering Committee endorsed the draft guidance entitled ``Validation of
Analytical Procedures: Definition and Terminology.'' This guidance
discusses the characteristics that should be considered during the
validation of the analytical procedures included in an application for
registration of veterinary medicinal products in the European Union,
Japan, and the United States. It is not intended to cover testing
requirements or procedures, rather it is to serve as a collection of
terms and definitions. These common definitions such as ``analytical
procedures,'' ``specificity,'' ``precision,'' ``accuracy,'' etc., are
meant to bridge the differences that often exist among various
compendia and requirements of the European Union, Japan, and the United
States. The final guidance will be implemented in October of 1999.
The final guidance represents the agency's current thinking on
characteristics for consideration during the validation of the
analytical procedures included as part of applications. It does not
create or confer any rights for or on any person and will not operate
to bind FDA or the public. An alternate approach may be used if it
satisfies the requirements of applicable statutes, regulations, or
both.
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.
[[Page 40888]]
Dated: July 21, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-19194 Filed 7-27-99; 8:45 am]
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