[Federal Register Volume 66, Number 167 (Tuesday, August 28, 2001)]
[Notices]
[Pages 45319-45320]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-21664]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D-0357]


International Cooperation on Harmonisation of Technical 
Requirements for Approval of Veterinary Medicinal Products (VICH); 
Draft Guidance for Industry on ``Studies to Evaluate the Safety of 
Residues of Veterinary Drugs in Human Food: Carcinogenicity Testing'' 
(VICH GL28); Request for Comments; 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availability of a draft guidance for industry (#141) entitled ``Studies 
to Evaluate the Safety of Residues of Veterinary Drugs in Human Food: 
Carcinogenicity Testing'' (VICH GL28). This draft guidance has been 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 was adopted by the International Conference on 
Harmonisation of Technical Requirements for Approval of Pharmaceuticals 
for Human Use (ICH). The objective of this draft VICH guidance 
document, when final, will be to help ensure that the assessment of 
carcinogenic potential is appropriate to human exposure through 
residues of veterinary drugs in food in the European Union, Japan, and 
the United States.

DATES: Submit written or electronic comments on the draft guidance by 
September 28, 2001, to ensure their adequate consideration in 
preparation of the final document. General comments on agency guidance 
documents are welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Communications Staff (HFV-12), Center for Veterinary 
Medicine (CVM), Food and Drug Administration, 7500 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INFORMATION section for electronic access to the draft guidance 
document.
    Submit written comments on the draft guidance to the Dockets 
Management Branch (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 draft 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

[[Page 45320]]

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, 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.
    Two observers are eligible to participate in the VICH Steering 
Committee: One representative from the Government of Australia/New 
Zealand and one representative from the industry in Australia/ New 
Zealand. The VICH Secretariat, which coordinates the preparation of 
documentation, is provided by the Confederation Mondiale de L'Industrie 
de la Sante Animale (COMISA). A COMISA representative also participates 
in the VICH Steering Committee meetings.

II. Draft Guidance on Carcinogenicity Testing

    The VICH Steering Committee held a meeting on June 28, 2001, and 
agreed that the draft guidance document entitled ``Studies to Evaluate 
the Safety of Residues of Veterinary Drugs in Human Food: 
Carcinogenicity Testing'' (VICH GL28) should be made available for 
public comment. 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 draft guidance after consideration of the 
existing ICH guidances for pharmaceuticals for human use entitled 
``Final Guideline on the Need for Long-Term Rodent Carcinogenicity 
Studies of Pharmaceuticals'' and ``Testing for Carcinogenicity of 
Pharmaceuticals,'' which published in the Federal Register of March 1, 
1996 (61 FR 8153), and February 23, 1998 (63 FR 8983), respectively. 
The draft 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, Australia, and New Zealand.
    FDA and the VICH Safety Working Group will consider comments about 
the draft guidance document. Ultimately, FDA intends to adopt the VICH 
Steering Committee's final guidance and publish it as future guidance. 
(Information collection is covered under OMB No. 0910-0117. Information 
collection also could be covered by OMB No. 0910-0032.)

III. Significance of Guidance

    This draft 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.'' Similarly, words such 
as ``require'' or ``requirement'' have been replaced by 
``recommendation'' or ``recommended'' as appropriate to the context.
    The draft guidance 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

    This draft guidance document is being distributed for comment 
purposes only and is not intended for implementation at this time. 
Interested persons may submit written or electronic comments regarding 
this draft guidance document. Written or electronic comments should be 
submitted to the Dockets Management Branch (address above). Submit 
written or electronic comments by September 28, 2001, to ensure 
adequate consideration in preparation of the final guidance. Two copies 
of any comments are to be submitted, except that individuals may submit 
one copy. Comments are to be identified with the docket number found in 
brackets in the heading of this document. A copy of the draft guidance 
and received comments are available for public examination in the 
Dockets Management Branch between 9 a.m. and 4 p.m., Monday through 
Friday.

V. Electronic Access

    Electronic comments may be submitted electronically on the Internet 
at http://www.fda.gov/dockets/ecomments. Once on this Internet site, 
select ``01D-0357 Studies to Evaluate the Safety of Residues of 
Veterinary Drugs in Human Food: Carcinogenicity Testing (VICH GL28)'' 
and follow the directions.
    Copies of the draft guidance 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: August 21, 2001.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 01-21664 Filed 8-27-01; 8:45 am]
BILLING CODE 4160-01-S