[Federal Register Volume 66, Number 94 (Tuesday, May 15, 2001)]
[Notices]
[Pages 26868-26869]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-12092]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99D-2406]


International Cooperation on Harmonisation of Technical 
Requirements for Registration of Veterinary Medicinal Products (VICH); 
Final Guidance for Industry entitled ``Good Clinical Practice'' (VICH 
GL9); 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 (No. 85) entitled ``Good 
Clinical Practice'' (VICH GL9). 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 final VICH guidance is intended to 
provide a unified standard for designing, conducting, monitoring, 
recording, and reporting studies used in registration applications for 
approval of veterinary products submitted to the European Union, Japan, 
and the United States.

DATES: Submit written comments at any time. This guidance will be 
implemented July 1, 2001.

ADDRESSES: 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. See the SUPPLEMENTARY INFORMATION section 
for electronic access to the final guidance document.
    Submit written comments at any time on the final guidance to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852,-- e-mail: 
[email protected].

FOR FURTHER INFORMATION CONTACT: Herman M. Schoenemann (HFV-120), 
Center for Veterinary Medicine, Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0220, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In recent years, many important initiatives have been undertaken by 
regulatory authorities and industry associations to promote the 
international harmonization of regulatory recommendations. FDA has 
participated in efforts to enhance harmonization and has expressed its 
commitment to seek scientifically based harmonized technical 
recommendations for the development of pharmaceutical products. One of 
the goals of harmonization is to identify and then reduce the 
differences in technical recommendations 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 recommendations 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 
recommendations 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 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; 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 Good Clinical Practice

    In the Federal Register of August 3, 1999 (64 FR 42135), FDA 
published the notice of availability of the draft guidance entitled 
``Good Clinical Practices'' (VICH GL9), giving interested persons until 
September 2, 1999 to submit comments. After considering the comments 
received, FDA made principally editorial changes. The final guidance 
was submitted to the VICH Steering Committee. At a meeting held on June 
14 through 16, 2000, the VICH Steering Committee endorsed the final 
guidance for industry, VICH GL9.
    The guidance is intended to be an international ethical and 
scientific quality standard for designing, conducting, monitoring, 
recording, auditing, analyzing, and reporting clinical studies 
evaluating veterinary products. This final guidance document is 
intended to be consistent with the laws of the European Union, Japan, 
and the United States.
    VICH GL9 is a revision of and will replace CVM guidance No. 58 
entitled ``Good Target Animal Studies Practices: Investigators and 
Monitors.'' In addition, there are some minor conflicts between this 
guidance and recent CVM guidance No. 56 entitled ``Protocol Development 
Guideline for Clinical Effectiveness and Target Animal Safety Trials,'' 
and No. 104 entitled ``Guidance for Industry: Content and Format of 
Effectiveness and Target Animal Safety Technical Sections and Final 
Study Reports for Submission to the Division of Therapeutic Drugs for 
Non-Food Animals.'' Until the center revises these guidances, sponsors 
should follow the

[[Page 26869]]

recommendations in VICH GL9 when differences among the guidances occur.
    This Level 1 final guidance is being issued consistent with FDA's 
good guidance practices (21 CFR 10.115; 65 FR 56468, September 19, 
2000). This guidance document represents FDA's current thinking on 
design and conduct of all clinical studies of veterinary products in 
the target species. It does not create or confer any rights for or on 
any person, and does not operate to bind FDA or the public. An 
alternative method may be used as long as it satisfies the requirements 
of applicable statutes and regulations.
    Information collected is covered under OMB control number 0910-
0032.

III. Electronic Access

    Copies of the final guidance documents entitled ``Good Clinical 
Practice'' (VICH GL9) may be obtained on the Internet from the CVM home 
page at http://www.fda.gov/cvm. Comments may also be submitted 
electronically on the Internet at http://www.fda.gov/dockets/ecomments. 
Once on this Internet site, select ``99D-2406 Good Clinical Practice'' 
and follow the directions.

IV. 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 final guidance. FDA will periodically review the comments in the 
docket and, where appropriate, will amend this guidance. The agency 
will notify the public of any such amendments through a notice in the 
Federal Register.
    Interested persons may submit to the Dockets Management Branch 
(address above) written or electronic comments regarding this final 
guidance document at any time. Two copies of any comments are to be 
submitted, except that individuals may submit one copy. Comments should 
be identified with the docket number found in brackets in the heading 
of this document. A copy of this final guidance document and received 
comments are available in the Dockets Management Branch between 9 a.m. 
and 4 p.m., Monday through Friday.

    Dated: May 7, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-12092 Filed 5-14-01; 8:45 am]
BILLING CODE 4160-01-S