[Federal Register Volume 65, Number 244 (Tuesday, December 19, 2000)]
[Notices]
[Pages 79373-79374]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-32197]
[[Page 79373]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 00D-1630]
International Cooperation on Harmonisation of Technical
Requirements for Registration of Veterinary Medicinal Products (VICH);
Draft Guidance on ``Safety Studies for Veterinary Drug Residues in
Human Food: Reproduction Studies'' (VICH GL22); 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availability for comment of a draft guidance for industry (#115)
entitled ``Safety Studies for Veterinary Drug Residues in Human Food:
Reproduction Studies'' (VICH GL22). This draft guidance has been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). This draft VICH guidance document recommends a
basic battery of tests that can be used to evaluate the reproduction
safety of veterinary drug residues in human food.
DATES: Submit written comments concerning the draft guidance to ensure
their adequate consideration in preparation of the final document by
February 20, 2001. General comments on agency guidance documents are
welcome at any time.
ADDRESSES: Submit written comments on the draft guidance to the Dockets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. Identify comments with the full
title of the draft guidance and the docket number found in brackets in
the heading of this document.
Copies of the draft guidance entitled ``Safety Studies for
Veterinary Drug Residues in Human Food: Reproduction Studies'' (VICH
GL22) 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access may submit written requests for single copies of the draft
guidance to the Communications Staff (HFV-12), Center for Veterinary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.
FOR FURTHER INFORMATION CONTACT: Regarding VICH: Sharon R. 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 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 the differences in
technical requirements for drug development among regulatory agencies.
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; 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. Guidance on Reproduction Studies
The VICH Steering Committee held a meeting on June 14 through 16,
2000, and agreed that the draft guidance entitled ``Safety Studies for
Veterinary Drug Residues in Human Food: Reproduction Studies'' (VICH
GL22) should be made available for public comment.
This draft guidance is intended to provide harmonized guidance on
the core recommendation for a multigeneration study for the safety
evaluation of veterinary drug residues in human food. The current draft
guidance is one of a series of guidances developed to facilitate the
mutual acceptance of safety data necessary for the determination of
acceptable daily intakes for veterinary drug residues in human food by
the relevant regulatory authorities. The guidance on the overall
strategy for the safety evaluation of veterinary residues in human food
(VICH Guidance on General Testing Approach) will be made available at a
later time. VICH GL22 was developed after consideration of the existing
ICH guidance for pharmaceuticals for human use on ``Detection of
Toxicity to Reproduction for Medicinal Products'' and its addendum,
``Toxicity to Male Fertility,'' in conjunction with the current
practices for evaluating veterinary drug residues in human food in the
European Union, Japan, the United States, Australia, and New Zealand.
(Information collection is covered under OMB Control Nos. 0910-0117 and
0910-0032).
III. Significance of Guidance
This draft guidance is being issued consistent with FDA's good
guidance practices (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
[[Page 79374]]
original VICH documents have been substituted with ``should.''
Similarly, words such as ``requirement'' or ``acceptable'' have been
replaced by ``recommendation'' or ``recommended'' as appropriate to the
context.
This draft guidance represents the agency's current thinking on
reproduction safety studies for veterinary drug residues in human food.
This draft 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. Comments about the draft guidance
documents will be considered by FDA and the VICH Safety Working Group.
Ultimately, FDA intends to adopt the VICH Steering Committee's final
guidances and publish them as future guidances.
IV. Comments
This draft guidance 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. Submit written comments to
ensure adequate consideration in preparation of the final guidance by
February 20, 2001. 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.
Dated: December 7, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-32197 Filed 12-18-00; 8:45 am]
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