[Federal Register Volume 67, Number 171 (Wednesday, September 4, 2002)]
[Notices]
[Pages 56570-56572]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-22406]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02D0326]


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Requirements for Approval of Veterinary Medicinal Products; Draft 
Guidance for Industry on ``Studies to Evaluate the Safety of Residues 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: General Approach to Testing'' (VICH 
GL33); Request for Comments

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availability of a draft guidance for industry ([xnum]149) entitled 
``Studies to Evaluate the Safety of Residues of Veterinary Drugs in 
Human Food: General Approach to Testing'' (VICH GL33). This draft 
guidance has been developed by the International Cooperation on 
Harmonisation of Technical Requirements for Registration of Veterinary 
Medicinal Products (VICH). This draft guidance outlines a testing 
approach to assure human food safety following the consumption of food 
products derived from animals treated with veterinary drugs.

DATES:  Submit written or electronic comments on the draft guidance by 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.

[[Page 56571]]


ADDRESSES: Submit written requests for single copies of the draft 
guidance document to the Communications Staff (HFV12), Center for 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INFORMATION section for electronic access to the draft guidance 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    Submit written comments on the draft guidance document to the 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with the full title of the draft guidance and the docket number found 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 
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 General 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: General 
Approach to Testing'' (VICH GL33) should be made available for public 
comment.
    Existing toxicological testing recommendations for veterinary drugs 
have evolved from the toxicological tests for human medicines, food 
additives and pesticides. The draft guidance was developed to include 
tests particularly relevant to the identification of a no-observable 
adverse effect level for veterinary drugs. The scope of this draft 
guidance is to identify: (1) Basic tests recommended for all new animal 
drugs used in food-producing animals in order to assess the safety of 
drug residues present in human food, (2) additional tests recommended 
based on specific toxicological concerns associated with the structure, 
class, mode of action, etc., of the drug and (3) special tests which 
might be useful in the evaluation of the relevance or the 
interpretation of data obtained in the basic or additional tests.
    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 a ``guidance'' 
rather than a ``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 to 
establish 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 by October 4, 2002, 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: General Approach to Testing'' (VICH 
GL33) and follow the directions.
    Copies of the draft guidance entitled ``Studies to Evaluate the 
Safety of Residues of Veterinary Drugs in Human Food: General Approach 
to Testing'' (VICH GL33) may be obtained on the Internet from the CVM 
home page at http://www.fda.gov/cvm.


[[Page 56572]]


    Dated: August 27, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-22406 Filed 9302; 8:45 am]
BILLING CODE 416001S