[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Draft Guidance for Industry on Studies to Evaluate the Metabolism and 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availability of a draft guidance for industry (205) entitled 
``Draft Guidance for Industry on Studies to Evaluate the Metabolism and 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 This draft guidance has been developed for 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draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Communications Staff (HFV-12), Center for Veterinary 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    Submit written comments on the draft guidance to the Division of 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]
BILLING CODE 4160-01-S