[Federal Register: September 4, 2002 (Volume 67, Number 171)]
[Notices]
[Page 56570-56572]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04se02-83]
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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Requirements for Approval of Veterinary Medicinal Products; Draft
Guidance for Industry on ``Studies to Evaluate the Safety of Residues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availability of a draft guidance for industry ([xnum]149) entitled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 This draft
guidance has been developed by the International Cooperation on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 This draft guidance outlines a testing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DATES: Submit written or electronic comments on the draft guidance by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ADDRESSES: Submit written requests for single copies of the draft
guidance document to the Communications Staff (HFV12), Center for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INFORMATION section for electronic access to the draft guidance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Submit written comments on the draft guidance document to the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with the full title of the draft guidance and the docket number found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:
lmulliga@cvm.fda.gov.
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]
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