[Federal Register Volume 76, Number 179 (Thursday, September 15, 2011)]
[Notices]
[Pages 57057-57058]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-23490]
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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;
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; 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 (206) entitled
``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 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 procedures to identify the metabolites of
veterinary drugs produced by laboratory animals used for toxicological
testing for the purpose of comparison to the residues of veterinary
drugs in edible tissues of 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].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
(206) entitled ``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, 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
[[Page 57058]]
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 Comparative Metabolism Studies in Laboratory Animals
In the Federal Register of April 12, 2010 (75 FR 18507), 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:
Comparative Metabolism Studies in Laboratory Animals (VICH GL47),''
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 GL47). 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.
The objective of this guidance is to provide recommendations for
internationally harmonized procedures to identify the metabolites of
veterinary drugs produced by laboratory animals. The purpose of the
comparative metabolism studies is to compare the metabolites of the
animals used for toxicological testing to the residues of the
veterinary drugs in edible tissues of food-producing animals in order
to determine if the laboratory animals used for toxicological testing
have been exposed to the metabolites that humans can be exposed to as
residues in products of food-producing animal origin.
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 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-
producing animals are also produced by metabolism in the laboratory
animals used for the safety testing.
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.
Dated: September 8, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-23490 Filed 9-14-11; 8:45 am]
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