[Federal Register Volume 75, Number 69 (Monday, April 12, 2010)]
[Notices]
[Pages 18508-18509]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-8228]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2010-D-0163]
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Draft Guidance for Industry on Studies to Evaluate the Metabolism and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:
Metabolism Study to Determine the Quantity and Identify the Nature of
Residues (VICH GL46); 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availability of a draft guidance for industry (205) entitled
``Draft Guidance for Industry on Studies to Evaluate the Metabolism and
Residue Kinetics of Veterinary Drugs in Food-Producing Animals:
Metabolism Study to Determine the Quantity and Identify the Nature of
Residues (MRK),'' VICH GL46. This draft guidance has been developed for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 test procedures
to study the quantity and nature of residues of veterinary drugs in
food-producing 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draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Communications Staff (HFV-12), Center for Veterinary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Submit written comments on the draft guidance to the Division of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
(205) entitled ``Draft Guidance for Industry on Studies to
Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in
Food-Producing Animals: Metabolism Study to Determine the Quantity and
Identify the Nature of Residues (MRK),'' VICH GL46. 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, 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.
[[Page 18509]]
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 Study to Determine the Quantity and Identify the
Nature of Residues
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: Metabolism Study to
Determine the Quantity and Identify the Nature of Residues (MRK),''
VICH GL46 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
European Union, Japan, United States, Australia, New Zealand, and
Canada.
Although this guidance recommends a framework for metabolism
testing, it is important that the design of the studies remains
flexible. It is recommended that studies be tailored to sufficiently
characterize the components of the residue of toxicological concern.
The human food safety evaluation of veterinary drugs assures that
food derived from treated animals is safe for human consumption. As
part of the data collection process, studies are conducted to permit an
assessment of the quantity and nature of residues in food derived from
animals treated with a veterinary drug. These metabolism studies
provide data on the following topics: (1) The depletion of residues of
toxicological concern from edible tissues of treated animals at varying
times after drug administration; (2) the individual components, or
residues, that comprise the residue of toxicological concern in edible
tissues; (3) the residue(s) that may serve as marker for analytical
methods intended for compliance purposes (i.e., monitoring of
appropriate drug use); and (4) the identification of a target tissue or
tissues, as applicable to national or regional programs.
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 1-4 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. 2010-8228 Filed 4-9-10; 8:45 am]
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