[Federal Register Volume 65, Number 243 (Monday, December 18, 2000)]
[Notices]
[Pages 79106-79107]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-32113]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1631]


International Cooperation on Harmonisation of Technical 
Requirements for Approval of Veterinary Medicinal Products (VICH); 
Draft Guidance for Industry on ``Safety Studies for Veterinary Drug 
Residues in Human Food: Genotoxicity Studies'' (VICH GL23); 
Availability; Request for Comments

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability for comment of a draft guidance document for industry (No. 
116) entitled ``Safety Studies for Veterinary Drug Residues in Human 
Food: Genotoxicity Studies'' (VICH GL23). This draft guidance document 
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). This draft VICH guidance document recommends a 
basic battery of tests that can be used to evaluate the genotoxicity of 
veterinary drug residues in human food in the European Union, Japan, 
and the United States.

DATES: Submit written comments on the draft guidance document by 
January 17, 2001, to ensure their adequate consideration in preparation 
of the final guidance document. General comments on agency guidance 
documents are welcome at any time.

ADDRESSES: Copies of the draft guidance document entitled ``Safety 
Studies for Veterinary Drug Residues in Human Food: Genotoxicity 
Studies'' (VICH GL23) may be obtained on the Internet from the CVM home 
page at http://www.fda.gov/cvm/fda/TOCs/guideline.html. Persons without 
Internet access may submit written requests for single copies of the 
draft guidance document to the Communications Staff (HFV-12), Center 
for Veterinary Medicine, Food and Drug Administration, 7500 Standish 
Pl., Rockville, MD 20855. Send one self-addressed adhesive label to 
assist that office in processing your requests.
    You may submit written comments on the draft guidance document to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:
    Regarding the VICH: Sharon Thompson, Center for Veterinary 
Medicine, (HFV-3), Food and Drug Administration, 7500 Standish Pl., 
Rockville, MD 20855, 301-594-1798, e-mail: [email protected], or 
Carole R. Andres, Center for Veterinary Medicine (HFV-1), Food and Drug 
Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-6524, 
e-mail: [email protected].
    Regarding the draft guidance document: 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; U.S. FDA; U.S. Department of Agriculture; Animal Health 
Institute; Japanese Veterinary Pharmaceutical Association; Japanese 
Association of Veterinary Biologics; and 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 Genotoxicity Studies

    The VICH Steering Committee held a meeting on June 14 through 16, 
2000, and agreed that the draft guidance document entitled ``Safety 
Studies for Veterinary Drug Residues in Human Food: Genotoxicity 
Studies'' (VICH GL23) should be made available for public comment. This 
draft guidance document has been adapted for veterinary use by the VICH 
from guidances regarding pharmaceuticals for human use which were 
adopted by the ICH and published in the Federal Register of April 24, 
1996 (61 FR 18197), and November 21, 1997 (62 FR 62471). This draft 
guidance document 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

[[Page 79107]]

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. This guidance 
was developed after consideration of the existing ICH guidances for 
pharmaceuticals for human use: ``Genotoxicity: A Standard Battery of 
Genotoxicity Testing of Pharmaceuticals'' and ``Guidance on Specific 
Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals.'' Account 
was also taken of the Organisation for Economic Cooperation and 
Development methodological guidances and of the current practices for 
evaluating the safety of veterinary drug residues in human food in the 
European Union, Japan, the U.S.A., Australia, and New Zealand.
    Comments about the draft guidance documents will be considered by 
the FDA and the VICH Safety Working Group. Ultimately, FDA intends to 
adopt the VICH Steering Committee's final guidances and publish them 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 guidance document, developed under the VICH process, has 
been revised to conform to FDA's good guidance practices regulation (65 
FR 56468, September 19, 2000). For example, the documents have 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 document represents the agency's current 
thinking on genotoxicity safety studies for veterinary drug residues in 
human food. This guidance document 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 to the Dockets Management Branch (address 
above) written comments regarding this draft guidance document. Submit 
written comments by January 17, 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 document and 
received comments are available for public examination in the Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: December 8, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-32113 Filed 12-15-00; 8:45 am]
BILLING CODE: 4160-01-S