[Federal Register: March 22, 2004 (Volume 69, Number 55)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2002D-0369]
International Cooperation on Harmonization 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: Developmental Toxicity Testing; ''
AGENCY: Food and Drug Administration, HHS.
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry (148) entitled
``Studies to Evaluate the Safety of Residues of Veterinary Drugs in
Human Food: Developmental Toxicity Testing'' (VICH GL32). This guidance
has been developed by the International Cooperation on Harmonization of
Technical Requirements for Registration of Veterinary Medicinal
Products (VICH). This guidance document provides harmonized guidance on
the core recommendation for a developmental toxicity study for the
safety evaluation of veterinary drug residues in human food.
DATES: Submit written or electronic comments on agency guidances at any
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 at any time 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 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:
In recent years, many important initiatives have been undertaken by
regulatory authorities, industry associations, and individual sponsors
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 reduce the
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 United States' FDA; the United States' 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
Four observers are eligible to participate in the VICH steering
committee: One representative from the Government of Australia/New
Zealand, one representative from industry in Australia/New Zealand, one
representative from the Government of Canada, and one representative
from industry in Canada. The VICH Secretariat, which coordinates the
preparation of documentation, is provided by the
Conf[eacute]d[eacute]ration Mondiale de L'Industrie de la Sant[eacute]
Animale (COMISA). A COMISA representative also participates in the VICH
steering committee meetings.
II. Guidance on Toxicity Testing
In the Federal Register of September 4, 2002 (67 FR 56572), 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 final 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 guidance for industry, VICH GL32.
This document provides guidance for developmental toxicity testing
for those veterinary medicinal products used in food-producing animals.
The objective of this guidance is to recommend that developmental
toxicity assessment be performed according to an internationally
harmonized guidance. This guidance describes recommended testing
designed to provide information concerning the effects on the pregnant
animal and on the developing organism following prenatal exposure.
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 ``recommended.''
This guidance document represents the agency's current thinking on
developmental toxicity testing for those veterinary medicinal products
used in food-producing animals. This guidance does not create or confer
any rights for or on any person and does not operate to bind FDA or the
public. You may use an alternative method as long as it satisfies the
requirements of the applicable statutes and regulations.
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. Two paper copies of any comments are to be submitted, except
individuals may submit one paper copy. Comments should be identified
with the docket number found in the brackets in the heading of this
document. A copy of the 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
Copies of the guidance document entitled ``Studies to Evaluate the
Safety of Residues of Veterinary Drugs in Human Food: Developmental
Toxicity Testing'' (VICH GL32) may be obtained on the Internet from
FDA's Center for Veterinary Medicine home page at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cvm
Dated: March 12, 2004.
Assistant Commissioner for Policy.
[FR Doc. 04-6287 Filed 3-19-04; 8:45 am]
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