[Federal Register Volume 69, Number 101 (Tuesday, May 25, 2004)]
[Notices]
[Pages 29740-29742]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-11781]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2001D-0357]


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: Carcinogenicity 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 final guidance for industry (141) entitled 
``Studies to Evaluate the Safety of Residues of Veterinary Drugs in 
Human Food: Carcinogenicity Testing'' (VICH GL28). This guidance has 
been adapted for veterinary use by the International Cooperation on 
Harmonisation of Technical Requirements for Registration of Veterinary 
Medicinal Products (VICH) from a guidance regarding pharmaceuticals for 
human use, which

[[Page 29741]]

was adopted by the International Conference on Harmonisation of 
Technical Requirements for Approval of Pharmaceuticals for Human Use 
(ICH). The objective of this VICH guidance document is to help ensure 
that the assessment of carcinogenic potential is appropriate to human 
exposure to residues of veterinary drugs in human food in the European 
Union, Japan, and the United States.

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 electronic or 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://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: 
[email protected].

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 ICH 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 in Canada, and one 
representative from the industry in 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 Carcinogenicity Testing

    In the Federal Register of August 28, 2001 (66 FR 45319), FDA 
published the notice of availability of the VICH draft guidance, giving 
interested persons until September 28, 2001 to submit comments. No 
comments were received. At a meeting held on October 10-11, 2002, the 
VICH Steering Committee endorsed the guidance for industry, VICH GL28.
    This guidance is one of a series of VICH guidances developed to 
facilitate the mutual acceptance of safety data necessary for the 
establishment of acceptable daily intakes for veterinary drug residues 
in human food by the relevant regulatory authorities. The guidance on 
the overall strategy for the evaluation of veterinary drug residues in 
human food (``VICH Guidance on General Testing Approach'') will be made 
available at a later time.
    VICH developed this guidance after consideration of the existing 
ICH guidances for pharmaceuticals for human use: ``Final Guideline on 
the Need for Long-Term Rodent Carcinogenicity Studies of 
Pharmaceuticals''; and ``S1B Testing for Carcinogenicity of 
Pharmaceuticals.'' Notices of availability for these guidances 
published in the Federal Register of March 1, 1996, (61 FR 8153) and 
February 23, 1998, (63 FR 8983) respectively. The guidance has been 
adapted for veterinary use by the VICH from the aforementioned 
guidances regarding pharmaceuticals for human use. VICH also took into 
account the Organisation for Economic Cooperation and Development 
methodological guidances and the current practices for evaluating the 
safety of veterinary drug residues in human food in the European Union, 
Japan, the United States of America, Australia and New Zealand. 
(Information collection for new animal drug applications is covered 
under OMB control number 0910-0032.)

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 
carcinogenicity testing for 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, at any time, submit written comments to the 
Division of Dockets Management (see ADDRESSES) regarding this guidance 
document. Two copies of any comments are to be submitted, except 
individuals may submit one 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

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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: Carcinogenicity 
Testing'' (VICH GL28) may be obtained on the Internet from the CVM home 
page at http://www.fda.gov/cvm.

    Dated: May 18, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-11781 Filed 5-24-04; 8:45 am]
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