[Federal Register: May 19, 2004 (Volume 69, Number 97)]
[Notices]
[Page 28933-28934]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr19my04-63]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2002D-0326]
International Cooperation on Harmonization of Technical
Requirements for Approval of Veterinary Medicinal Products; Final
Guidance for Industry on Studies to Evaluate the Safety of Residues of
Veterinary Drugs in Human Food: General Approach to Testing;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; availability.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry ([numsign]149) entitled
``Studies to Evaluate the Safety of Residues of Veterinary Drugs in
Human Food: General Approach to Testing'' (VICH GL33). This guidance
has been developed by the International Cooperation on Harmonization of
Technical Requirements for Registration of Veterinary Medicinal
Products (VICH). This guidance outlines a recommended testing approach
to assure human food safety following the consumption of food products
derived from animals treated with veterinary drugs.
DATES: Submit written or electronic comments 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 requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the guidance document.
Submit written comments on the 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
Comments should be identified with the
full title of the guidance and the docket number found in brackets in
the heading of this document.
FOR FURTHER INFORMATION CONTACT: Louis T. Mulligan, Center for
Veterinary Medicine (HFV-153), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 301-827-6984, e-mail:
lmulliga@cvm.fda.gov.
SUPPLEMENTARY INFORMATION:
I. Background
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
Harmonization 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 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 General Testing
In the Federal Register of September 4, 2002 (67 FR 56570), FDA
published the notice of availability of the VICH draft guidance, giving
interested persons until October 4, 2002, to submit comments. After
consideration of comments received, the draft guidance was changed in
response to the comments and submitted to the VICH Steering Committee.
At a meeting held on October 10 and 11, 2002, the VICH Steering
Committee endorsed the final guidance for industry, VICH GL33.
Existing toxicological testing recommendations for veterinary drugs
have evolved from the toxicological tests for human medicines, food
additives, and pesticides. The following guidance was developed to
include tests particularly relevant to the identification of a no-
observable adverse effect level (NOAEL) for veterinary drugs. The scope
of this guidance is to identify the following tests: (1) Basic tests
recommended for all new animal drugs used in food-producing animals in
order to assess the safety of drug residues present in human food; (2)
[[Page 28934]]
additional tests recommended based on specific toxicological concerns
associated with the structure, class, mode of action, etc., of the
drug; and (3) special tests that might be useful in the evaluation of
the relevance or the interpretation of data obtained in the basic or
additional tests.
III. Significance of Guidance
This document, 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.'' Because guidance documents are not binding, unless
specifically supported by statute or regulation, mandatory words such
as ``must,'' ``shall,'' and ``will'' in the original VICH documents
have been substituted with ``should.''
This guidance document represents the agency's current thinking to
establish the safety of veterinary drug residues in human food in a
variety of toxicological evaluations. This guidance does not create or
confer any rights for or on any person and will not operate to bind FDA
or the public. An alternative method may be used as long as it
satisfies the requirements of applicable statutes and regulations.
IV. Comments
As with all of FDA's guidances, the public is encouraged to submit
written or electronic comments pertinent to this guidance. FDA will
periodically review the comments in the docket and, where appropriate,
will amend the guidance. The agency will notify the public of any such
amendments through a notice in the Federal Register.
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.
V. Electronic Access
Copies of the guidance document entitled ``Studies to Evaluate the
Safety of Residues of Veterinary Drugs in Human Food: General Approach
to Testing'' (VICH GL33) may be obtained on the Internet from the CVM
home page at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cvm.
Dated: May 13, 2004.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 04-11254 Filed 5-18-04; 8:45 am]
BILLING CODE 4160-01-S