[Federal Register Volume 64, Number 148 (Tuesday, August 3, 1999)]
[Notices]
[Pages 42135-42136]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-19871]


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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); 
Draft Guidance on VICH GL9 Good Clinical Practices; Request for 
Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability for comment of the following draft guidance document 
entitled: VICH GL9 ``Good Clinical Practices.'' This draft guidance 
document was developed by the International Cooperation on 
Harmonisation of Technical Requirements for Registration of Veterinary 
Medicinal Products (VICH). It 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 by September 2, 1999. FDA must receive 
comment before the deadline in order to ensure their consideration.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm 1061, 
Rockville, MD 20852. Comments should be identified with the full title 
of the draft guidance documents and the docket number found in the 
heading of this document.
     Copies of the draft guidance document entitled ``Good Clinical 
Practices'' 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 
draft guidances to the Communications Staff (HFV-12), Center for 
Veterinary Medicine, Food and Drug Administration, 7500 Standish Place, 
Rockville, MD 20855. Send one self-addressed adhesive label to assist 
that office in processing your requests.
FOR FURTHER INFORMATION CONTACT:
     Regarding VICH: Sharon R. Thompson (HFV-3), Center for Veterinary 
Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, 
MD 20855, 301-594-1798, e-mail: ``[email protected]''.
     Regarding the guidance document: 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, 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 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 (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 products. The 
VICH is concerned with developing harmonized technical requirements for 
the approval of veterinary 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). 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 the industry in Australia/New Zealand, 
one representative from Mercado Comun Sudamericano (MERCOSUR) 
representing 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 
participates in the VICH Steering Committee meetings.
     At a meeting held on October 20 through 22, l998, the VICH 
Steering Committee agreed that the draft guidance document entitled 
``Good Clinical Practices'' should be made available for public 
comment.
     The draft 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. Comments about these draft guidance 
documents will be considered by the FDA and the VICH Good Clinical

[[Page 42136]]

Practices Working Group. Ultimately, FDA intends to adopt the VICH 
Steering Committee's final guidance and publish it as future guidance 
for sponsors of domestic animal drug approvals or as proposed 
regulations for future comment and final rulemaking.
     This document has been revised to conform to FDA's good guidance 
practices regulations (62 FR 8961, February 27, l997). For example, the 
document has been designated ``guidance'' rather than ``guideline.'' 
Since guidance documents are not binding, mandatory words such as 
``must'' in the original VICH document have been substituted with the 
verb ``should.'' These revisions are identified by placing the original 
word in brackets followed by the substitute verb.
     This draft document represents current FDA thinking on design and 
conduct of all clinical studies of veterinary products in the target 
species. 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.

 II. Comments

     Interested persons should submit written comments on or before 
September 2, 1999 to the Dockets Management Branch (address above) 
regarding this guidance document. 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 the document and received comments are 
available for public examination in the Dockets Management Branch 
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: July 27, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 99-19871 Filed 8-2-99; 8:45 am]
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