[Federal Register: May 18, 2007 (Volume 72, Number 96)]
[Notices]
[Page 28058-28059]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18my07-66]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2007D-0166]
International Cooperation on Harmonisation of Technical
Requirements for Registration of Veterinary Medicinal Products (VICH);
Draft Guidance for Industry on Target Animal Safety for Veterinary
Pharmaceutical Products, VICH GL43, Request for Comments; Availability
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availability for comments of a draft guidance document for industry
(185) entitled ``Draft Guidance for Industry on Target Animal
Safety for Veterinary Pharmaceutical Products,''VICH GL43. This draft
guidance has been developed for veterinary use by the International
Cooperation on Harmonisation of Technical Requirements for Registration
of Veterinary Medicinal Products (VICH). This draft VICH guidance
document has been developed as a harmonized standard to aid in
development of mutually acceptable target animal safety (TAS) studies
for the relevant governmental regulatory bodies.
DATES: Submit written or electronic comments on the draft guidance by
June 18, 2007, to ensure their adequate consideration in preparation of
the final document. General comments on agency guidance documents are
welcome at any time.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Communications Staff (HFV-12), Center for Veterinary
Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville,
MD 20855. Send one self-addressed adhesive label to assist that office
in processing your request. See the SUPPLEMENTARY INFORMATION section
for electronic access to the draft guidance document.
Submit written comments on the draft guidance to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments
to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Comments should be identified
with the full title of the draft guidance and the docket number found
in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Laura Hungerford, Center for
Veterinary Medicine, (HFV-100), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-6439, e-mail:
laura.hungerford@fda.hhs.gov.
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 requirements. FDA has
participated in efforts to enhance harmonization and has expressed its
commitment to seek scientifically based harmonized technical procedures
for the development of pharmaceutical products. One of the goals of
harmonization is to identify and then reduce 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
[[Page 28059]]
Requirements for Approval of Pharmaceuticals for Human Use for several
years to develop harmonized technical requirements for the approval of
human pharmaceutical and biological products among the European Union,
Japan, and the United States. VICH is a parallel initiative for
veterinary medicinal products. VICH is concerned with developing
harmonized technical requirements 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; European Medicines Evaluation Agency;
European Federation of Animal Health; Committee on Veterinary Medicinal
Products; 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.
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 the government of Canada, and one
representative from the industry of Canada. The VICH Secretariat, which
coordinates the preparation of documentation, is provided by the
International Federation for Animal Health (IFAH). An IFAH
representative also participates in the VICH steering committee
meetings.
II. Draft Guidance on Target Animal Safety
The VICH steering committee held a meeting in December 2006 and
agreed that the draft guidance document entitled ``Draft Guidance for
Industry on Target Animal Safety for Veterinary Pharmaceutical
Products,''VICH GL43 should be made available for public comment. This
draft VICH guidance document has been developed as a harmonized
standard to aid in development of mutually acceptable TAS studies for
the relevant governmental regulatory bodies. This draft guidance
document is intended to cover TAS studies for any Investigational
Veterinary Pharmaceutical Product used in the following species:
Bovine, ovine, caprine, feline, canine, porcine, equine, and poultry
(chickens and turkeys). Minor species and minor uses may be excluded
from this guidance for local registration. The guidance does not
provide information for the design of TAS studies in other species
including aquatic animals. For other species, TAS studies should be
designed following local guidance.
FDA and the VICH Expert Working Group will consider comments about
the draft guidance document.
III. Paperwork Reduction Act of 1995
This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in section 1-5 of the draft guidance have
been approved under OMB Control No. 0910-0032.
IV. Significance of Guidance
This draft document, developed under the VICH process, has been
revised to conform to FDA's good guidance practices regulation (21 CFR
10.115). For example, the document has been designated ``guidance''
rather than ``guideline.'' In addition, guidance documents must not
include mandatory language such as ``shall,'' ``must,'' ``require,'' or
``requirement,'' unless FDA is using these words to describe a
statutory or regulatory requirement.
The draft VICH guidance (GFI 185) is consistent with the
agency's current thinking on this topic. This guidance does not create
or confer any rights for or on any person and will 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.
IV. Comments
This draft guidance document is being distributed for comment
purposes only and is not intended for implementation at this time.
Interested persons may submit written or electronic comments regarding
this draft guidance document to the Division of Dockets Management (see
ADDRESSES). Submit a single copy of electronic comments or two paper
copies of any mailed comments, except that individuals may submit one
paper copy. Comments are to be identified with the docket number found
in brackets in the heading of this document. A copy of the draft
guidance and received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
V. Electronic Access
Electronic comments may also be submitted electronically on the Web
site at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Once on this Internet
site, select Docket No. 2007D-0166 entitled ``Draft Guidance for
Industry on Target Animal Safety for Veterinary Pharmaceutical
Products,''VICH GL43 and follow the directions.
Copies of the draft guidance document entitled ``Draft Guidance for
Industry on Target Animal Safety for Veterinary Pharmaceutical
Products,''VICH GL43 may be obtained on the Web site from the Center
for Veterinary Medicine home page at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cvm.
Dated: May 10, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-9592 Filed 5-17-07; 8:45 am]
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