[Federal Register Volume 67, Number 171 (Wednesday, September 4, 2002)]
[Notices]
[Pages 56569-56570]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-22408]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02D0368]


International Cooperation on Harmonisation of Technical 
Requirements for Approval of Veterinary Medicinal Products; Draft 
Guidance for Industry on ``Studies to Evaluate the Safety of Residues 
of Veterinary Drugs in Human Food: Repeat-Dose (90-Day) Toxicity 
Testing'' (VICH GL31); 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availability of a draft guidance for industry (147) entitled 
``Studies to Evaluate the Safety of Residues of Veterinary Drugs in 
Human Food: Repeat-Dose (90-Day) Toxicity Testing'' (VICH GL31). This 
draft guidance has been developed by the International Cooperation on 
Harmonisation of Technical Requirements for Registration of Veterinary 
Medicinal Products (VICH). The objective of this draft guidance is to 
establish the minimum recommendations for an internationally harmonized 
90-day repeat-dose testing strategy for identifying target organ 
toxicity and the no-observed adverse effect level (NOAEL) for toxicity 
of veterinary drug residues in human food based upon repeated dose 90-
day toxicity studies for identifying target organ toxicity.

DATES: Submit written or electronic comments on the draft guidance by 
October 4, 2002 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ADDRESSES: Submit written requests for single copies of the draft 
guidance document to the Communications Staff (HFV12), Center for 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INFORMATION section for electronic access to the draft guidance 
document.
     Submit written comments on the draft guidance document to the 
Dockets Management Branch (HFA305), 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 (HFV153), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 3018276984, 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

[[Page 56570]]

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 International Conference on 
Harmonisation of Technical Requirements for Approval of Pharmaceuticals 
for Human Use for several years to develop harmonized technical 
recommendations 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 recommendations 
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.
    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 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. Draft Guidance on Toxicity Testing

    The VICH Steering Committee held a meeting in April 2002, and 
agreed that the draft guidance document entitled ``Studies to Evaluate 
the Safety of Residues of Veterinary Drugs in Human Food: Repeat-Dose 
(90-Day) Toxicity Testing'' (VICH GL31) should be made available for 
public comment.
    A variety of toxicological evaluations are performed to establish 
the safety of veterinary drug residues in human food. The objective of 
this draft guidance is to establish the minimum recommendations for an 
internationally harmonized 90-day repeat-dose testing strategy for 
identifying target organ toxicity and the NOAEL for toxicity of 
veterinary drug residues in human food based upon repeated dose 90-day 
toxicity studies for identifying target organ toxicity.
    FDA and the VICH will consider comments about the draft guidance 
document. Ultimately, FDA intends to adopt the VICH Steering 
Committee's final guidance and publish it as a final guidance.

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.''
    The draft guidance represents the agency's current thinking on 
establishing the safety of veterinary drug residues in human food in a 
variety of toxicological evaluations. 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 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 on the Internet at http://www.fda.gov/dockets/ecomments. Once on this Internet site, select 
``[insert docket number] ``Studies to Evaluate the Safety of Residues 
of Veterinary Drugs in Human Food: Repeat-Dose (90-Day) Toxicity 
Testing'' (VICH GL31) and follow the directions.
    Copies of the draft guidance entitled ``Studies to Evaluate the 
Safety of Residues of Veterinary Drugs in Human Food: Repeat-Dose (90-
Day) Toxicity Testing'' (VICH GL31) may be obtained on the Internet 
from the CVM home page at http://www.fda.gov/cvm.

    Dated: August 27, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-22408 Filed 9302; 8:45 am]
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