[Federal Register Volume 64, Number 149 (Wednesday, August 4, 1999)]
[Notices]
[Pages 42392-42393]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 99-19977]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99D-0017]


International Cooperation on Harmonisation of Technical 
Requirements for Registration of Veterinary Medicinal Products (VICH); 
Guidance on Validation of Analytical Procedures: Methodology; 
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 entitled ``Validation of 
Analytical Procedures: Methodology.'' 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. The guidance provides recommendations on how to 
consider various validation characteristics for each analytical 
procedure 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: Methodology'' may be obtained on the Internet 
from 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 this 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 ``wmarnane@cvm.fda.gov''.
    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''.
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. FDA; 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 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.
    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 May 19, 1997 (62 FR 27464).
    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 on October 20 through 22, 1998, the VICH Steering 
Committee endorsed the draft guidance for industry entitled 
``Validation of Analytical Procedures: Methodology.'' This guidance 
discusses common analytical procedures and provides guidance and 
recommendations on how to consider the various validation 
characteristics for each analytical procedure included as part of a 
registration application for approval of veterinary medicinal products. 
It also indicated the various data that should

[[Page 42393]]

be included in registration applications. This guidance will be 
implemented in October 1999.
    This 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 guidance, 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: July 28, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-19977 Filed 8-3-99; 8:45 am]
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