[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Draft Guidance on VICH GL9 Good Clinical Practices; Request for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availability for comment of the following draft guidance document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 This draft guidance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of the draft guidance documents and the docket number found in the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Copies of the draft guidance document entitled ``Good Clinical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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