[Federal Register Volume 76, Number 179 (Thursday, September 15, 2011)]
[Notices]
[Pages 57054-57056]
From the Federal Register Online via the Government Publishing 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, [email protected].
[[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]
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