[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Draft Guidance for Industry on ``Studies to Evaluate the Safety of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availability of a draft guidance for industry (#141) entitled ``Studies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 This draft guidance has been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DATES: Submit written or electronic comments on the draft guidance by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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Communications Staff (HFV-12), Center for Veterinary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INFORMATION section for electronic access to the draft guidance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Submit written comments on the draft guidance to the Dockets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]
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