
[Federal Register Volume 76, Number 179 (Thursday, September 15, 2011)]
[Notices]
[Pages 57054-57056]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-23489]


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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; 
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; 
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 guidance for industry (205) entitled 
``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 guidance has been developed for 
veterinary use by the International Cooperation on Harmonisation of 
Technical Requirements for Registration of Veterinary Medicinal 
Products (VICH). This 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: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of the 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 guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852.

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, julia.oriani@fda.hhs.gov.

[[Page 57055]]


SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
(205) entitled ``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.
    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. Guidance on Metabolism Study To Determine the Quantity and Identify 
the Nature of Residues

    In the Federal Register of April 12, 2010 (75 FR 18508), FDA 
published a notice of availability for a draft guidance 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)'' which gave interested persons until May 
12, 2010, to comment on the draft guidance. FDA received a few comments 
on the draft guidance and those comments as well as those received by 
other VICH member regulatory agencies were considered as the guidance 
was finalized. At a meeting held in February 2011, the VICH Steering 
Committee endorsed the final guidance for industry (VICH GL46). The 
guidance announced in this notice finalizes the draft guidance dated 
April 12, 2010.
    This VICH guidance document is one of a series developed to 
facilitate the mutual acceptance by national/regional regulators of 
residue chemistry data for veterinary drugs used in food-producing 
animals. This guidance was prepared after consideration of the current 
national/regional requirements and recommendations for evaluating 
veterinary drug residues in the European Union, Japan, the 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 concern.
    The human food safety evaluation of veterinary drug residues helps 
ensure that food derived from treated food-producing animals is safe 
for human consumption. As part of the data collection process, studies 
should be 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: (1) The depletion of 
residues of concern from edible tissues of treated animals at varying 
times after drug administration; (2) the individual components, or 
residues, that comprise the residue of concern in edible tissues; (3) 
the residue(s) that can 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.

III. Significance of Guidance

    This 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.
    This guidance represents 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 the applicable 
statutes and regulations.

IV. Paperwork Reduction Act of 1995

    This 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 this guidance have been approved under 
OMB control number 0910-0032.

V. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments 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 guidance at 
either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov.


[[Page 57056]]


    Dated: September 8, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-23489 Filed 9-14-11; 8:45 am]
BILLING CODE 4160-01-P


