[Federal Register Volume 75, Number 69 (Monday, April 12, 2010)]
[Notices]
[Pages 18507-18508]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-8229]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-D-0164]
International Cooperation on Harmonisation of Technical
Requirements for Registration of Veterinary Medicinal Products (VICH);
Draft Guidance for Industry on Studies to Evaluate the Metabolism and
Residue Kinetics of Veterinary Drugs in Food-Producing Animals:
Comparative Metabolism Studies in Laboratory Animals (VICH GL47);
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availability of a draft guidance for industry (206) entitled
``Draft Guidance for Industry on Studies to Evaluate the Metabolism and
Residue Kinetics of Veterinary Drugs in Food-Producing Animals:
Comparative Metabolism Studies in Laboratory Animals,'' VICH GL47. 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draft guidance has been developed for veterinary use by the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 is intended to provide recommendations for
internationally harmonized procedures to identify the metabolites of
veterinary food animal drugs in laboratory animals used for
toxicological testing for the purpose of comparison to the residues of
the drugs in food animals.
DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by May 12, 2010.
ADDRESSES: Submit written requests for single copies of the draft
guidance to the Communications Staff (HFV-12), Center for Veterinary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.
Submit written comments on the draft guidance to the Division of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://www.regulations.gov. See the SUPPLEMENTARY INFORMATION
section for electronic access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Julia Oriani, Center for Veterinary
Medicine (HFV-151), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240-276-8204, e-mail: [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
(206) entitled ``Draft Guidance for Industry on Studies to
Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in
Food-Producing Animals: Comparative Metabolism Studies in Laboratory
Animals,'' VICH GL47. 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 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 (EU), 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 EU, 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 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.
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 Studies to Evaluate the Metabolism and Residue
Kinetics of Veterinary Drugs in Food-Producing Animals
The VICH Steering Committee held a meeting on November 5, 2009, and
agreed that the draft guidance document entitled ``Draft Guidance for
Industry on Studies to Evaluate the Metabolism and Residue Kinetics of
Veterinary Drugs in Food-Producing Animals: Comparative Metabolism
Studies in Laboratory Animals,'' VICH GL47 should be made available for
public comment. This draft VICH guidance document is one of a series
developed to facilitate the mutual acceptance of residue chemistry data
for veterinary drugs used in food-producing animals. This guidance was
prepared after consideration of the current requirements for evaluating
veterinary drug residues in the EU, Japan, United States, Australia,
New Zealand and Canada.
The objective of this guidance is to provide recommendations for
internationally harmonized procedures to identify the metabolites of
veterinary food animal drugs in laboratory animals used for
toxicological testing for the purpose of comparison to the residues of
the drugs in food animals. The purpose of comparative metabolism
studies is to determine if laboratory animals used for toxicological
testing have been exposed to the metabolites that humans will be
exposed to as residues in products of food animal origin.
The human food safety evaluation of veterinary drug residues
assures that food derived from treated animals is
[[Page 18508]]
safe for human consumption. As part of the data collection process,
studies are conducted to characterize the metabolites to which
laboratory animals are auto-exposed during the toxicological testing of
the veterinary drug. The purpose of these studies is to determine
whether the metabolites that people will consume from tissues of target
food animals are also produced by metabolism in the laboratory animals
used for the safety testing.
FDA and the VICH Expert Working Group will consider comments about
the draft guidance document.
III. Significance of Guidance
This draft guidance, 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 guidance, when finalized, will represent the agency's
current thinking on this topic. 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 approach may be used if such approach satisfies the
requirements of applicable statutes and regulations.
IV. 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 sections 1-3 of this guidance have been
approved under OMB control no. 0910-0032.
V. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
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. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
VI. Electronic Access
Persons with access to the Internet may obtain the draft guidance
at either http://www.fda.gov/AnimalVeterinary/default.htm or http://www.regulations.gov.
Dated: April 6, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-8229 Filed 4-9-10; 8:45 am]
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