[Federal Register: October 23, 2003 (Volume 68, Number 205)]
[Notices]
[Page 60703-60704]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23oc03-55]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003D-0466]
International Cooperation on Harmonization of Technical
Requirements for Registration of Veterinary Medicinal Products; Draft
Guidance for Industry on ``Studies to Evaluate the Safety of Residues
of Veterinary Drugs in Human Food: Repeat-Dose (Chronic) Toxicity
Testing;'' Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability for comments of a draft guidance document for industry
([numsign]160) entitled ``Studies to Evaluate the Safety of Residues of
Veterinary Drugs in Human Food: Repeat-Dose (Chronic) Toxicity
Testing'' (VICH GL-37). This draft guidance has been developed for
veterinary use by the International Cooperation on Harmonization of
Technical Requirements for Registration of Veterinary Medicinal
Products (VICH). This draft VICH guidance document establishes
recommendations for internationally harmonized repeat-dose chronic
toxicity testing.
DATES: Submit written or electronic comments on the draft guidance by
November 24, 2003 to ensure their adequate consideration in preparation
of the guidance document. General comments on agency guidance documents
are welcome at any time.
[[Page 60704]]
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Communications Staff (HFV-12), Center for Veterinary
Medicine (CVM), Food and Drug Administration, 7519 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INFORMATION section for electronic access to the draft guidance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 Submit written comments on the draft guidance to the Division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with the full title of the draft guidance and the docket number found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: Louis T. Mulligan, Center for
Veterinary Medicine (HFV-153), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-6984, e-mail: lmulliga@cvm.fda.gov.
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 seek 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 in different countries.
FDA has actively participated in the International Conference on
Harmonization of Technical 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. The
VICH is a parallel initiative for veterinary medicinal products. The
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; the United States' 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 industry in Australia/New Zealand, one
representative from the Government of Canada, and one representative
from industry in 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 Microbiological Acceptable Daily Intakes
The VICH Steering Committee held a meeting on May 8, 2003, and
agreed that the draft guidance document entitled ``Studies to Evaluate
the Safety of Residues of Veterinary Drugs in Human Food: Repeat-Dose
(Chronic) Toxicity Testing'' (VICH GL-37) should be made available for
public comment. This draft VICH guidance is one of a series of
guidances developed to facilitate the mutual acceptance of safety data
necessary for the determination of acceptable daily intakes (ADIs) for
veterinary drug residues in human food. This draft guidance was
developed after consideration of the current practices for evaluating
veterinary drug residues in human food in the European Union, Japan,
United States, Australia, New Zealand, and Canada. It also took account
of available data from subchronic and chronic toxicity studies.
FDA and the VICH Expert Working Group on Toxicity Safety will
consider comments about the draft guidance document. Information
collection is covered under Office of Management and Budget control
number 0910-0032.
III. 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).
The draft VICH guidance ([numsign]160) represents the agency's
current thinking on the general approach to establish a microbiological
ADI. This guidance does not create or confer any rights for or on any
person and does not operate to bind FDA or the public. You may use an
alternative method as long as it satisfies the requirements of the
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. Written comments should be submitted to
the Division of Dockets Management (see ADDRESSES). Two copies of any
comments are to be submitted, except that individuals may submit one
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 are available for public examination in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
V. Electronic Access
Comments may be submitted electronically on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments
(select ``[docket number] entitled
`Studies to Evaluate the Safety of Residues of Veterinary Drugs in
Human Food: Repeat-Dose (Chronic) Toxicity Testing' (VICH GL-37).''
Copies of the draft guidance may be obtained on the Internet from
the CVM home page at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cvm.
Dated: October 14, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-26697 Filed 10-22-03; 8:45 am]
BILLING CODE 4160-01-S