[Federal Register: March 22, 2004 (Volume 69, Number 55)]
[Notices]               
[Page 13306-13307]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22mr04-70]                         

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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; '' 
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 (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 
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 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: 
lmulliga@cvm.fda.gov.


SUPPLEMENTARY INFORMATION:

I. Background

    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 
Fisheries.
    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.

IV. Comments

    As with all of FDA's guidances, the public is encouraged to submit 
written or electronic comments pertinent to this

[[Page 13307]]

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.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-6287 Filed 3-19-04; 8:45 am]

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