[Federal Register: November 13, 2003 (Volume 68, Number 219)]
[Notices]
[Page 64353-64354]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13no03-61]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2002D-0368]
International Cooperation on Harmonisation of Technical
Requirements for Approval of Veterinary Medicinal Products; Guidance
for Industry on ``Studies to Evaluate the Safety of Residues of
Veterinary Drugs in Human Food: Repeat-Dose (90-Day) Toxicity Testing''
(VICH GL31); 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 ([numsign]147) entitled
``Studies to Evaluate the Safety of Residues of Veterinary Drugs in
Human Food: Repeat-Dose (90-Day) Toxicity Testing'' (VICH GL31). This
guidance has been developed by the International Cooperation on
Harmonization of Technical Requirements for Registration of Veterinary
Medicinal Products (VICH). The objective of this guidance is to
establish recommendations for an internationally harmonized 90-day
repeat-dose testing.
DATES: Submit written or electronic comments on agency guidances at any
time.
ADDRESSES: Submit written requests for single copies of this guidance
to the Communications Staff (HFV-12), Center for Veterinary Medicine
(CVM), Food and Drug Administration, 7519 Standish Pl., Rockville, MD
20855. Send one self-addressed adhesive label to assist that office in
processing your requests.
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 are to be identified with the
[[Page 64354]]
docket number found in brackets in the heading of this document. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
guidance 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 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 Toxicity Testing
In the Federal Register of September 4, 2002 (67 FR 56569), 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 from October 10 to 11, 2002, the VICH Steering
Committee endorsed the guidance for industry, VICH GL31.
A variety of toxicological evaluations are performed to establish
the safety of veterinary drug residues in human food. The objective of
this guidance is to establish recommendations for an internationally
harmonized 90-day repeat-dose testing.
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'' or ``it is recommended.''
This guidance document represents the agency's current thinking on
establishing the safety of veterinary drug residues in human food. 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 guidance
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 should be identified with the docket number found
in brackets in the heading of this document. A copy of the guidance
document and received comments are available for public examination in
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
V. Electronic Access
Persons with Internet access may obtain copies of the guidance
document entitled ``Studies to Evaluate the Safety of Residues of
Veterinary Drugs in Human Food: Repeat-Dose (90-Day) Toxicity Testing''
(VICH GL31), 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: October 31, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-28371 Filed 11-12-03; 8:45 am]
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