[Federal Register: December 18, 2000 (Volume 65, Number 243)]
[Notices]
[Page 79106-79107]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18de00-99]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 00D-1631]
International Cooperation on Harmonisation of Technical
Requirements for Approval of Veterinary Medicinal Products (VICH);
Draft Guidance for Industry on ``Safety Studies for Veterinary Drug
Residues in Human Food: Genotoxicity Studies'' (VICH GL23);
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availability for comment of a draft guidance document for industry (No.
116) entitled ``Safety Studies for Veterinary Drug Residues in Human
Food: Genotoxicity Studies'' (VICH GL23). This draft guidance document
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 genotoxicity of
veterinary drug residues in human food in the European Union, Japan,
and the United States.
DATES: Submit written comments on the draft guidance document by
January 17, 2001, to ensure their adequate consideration in preparation
of the final guidance document. General comments on agency guidance
documents are welcome at any time.
ADDRESSES: Copies of the draft guidance document entitled ``Safety
Studies for Veterinary Drug Residues in Human Food: Genotoxicity
Studies'' (VICH GL23) may be obtained on the Internet from the CVM home
page at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cvm/fda/TOCs/guideline.html. Persons without
Internet access may submit written requests for single copies of the
draft guidance document to the Communications Staff (HFV-12), Center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.
You may submit written comments on the draft guidance document to
the Dockets Management Branch (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Regarding the VICH: Sharon Thompson, Center for Veterinary
Medicine, (HFV-3), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-594-1798, e-mail: sthompso@cvm.fda.gov, 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: candres1@cvm.fda.gov.
Regarding the draft 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:
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 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; 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. Draft Guidance on Genotoxicity Studies
The VICH Steering Committee held a meeting on June 14 through 16,
2000, and agreed that the draft guidance document entitled ``Safety
Studies for Veterinary Drug Residues in Human Food: Genotoxicity
Studies'' (VICH GL23) should be made available for public comment. This
draft guidance document has been adapted for veterinary use by the VICH
from guidances regarding pharmaceuticals for human use which were
adopted by the ICH and published in the Federal Register of April 24,
1996 (61 FR 18197), and November 21, 1997 (62 FR 62471). This draft
guidance document 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
[[Page 79107]]
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. This guidance
was developed after consideration of the existing ICH guidances for
pharmaceuticals for human use: ``Genotoxicity: A Standard Battery of
Genotoxicity Testing of Pharmaceuticals'' and ``Guidance on Specific
Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals.'' Account
was also taken of the Organisation for Economic Cooperation and
Development methodological guidances and of the current practices for
evaluating the safety of veterinary drug residues in human food in the
European Union, Japan, the U.S.A., Australia, and New Zealand.
Comments about the draft guidance documents will be considered by
the FDA and the VICH Safety Working Group. Ultimately, FDA intends to
adopt the VICH Steering Committee's final guidances and publish them 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 guidance document, developed under the VICH process, has
been revised to conform to FDA's good guidance practices regulation (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 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 document represents the agency's current
thinking on genotoxicity safety studies for veterinary drug residues in
human food. This guidance document 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 to the Dockets Management Branch (address
above) written comments regarding this draft guidance document. Submit
written comments by January 17, 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 document 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 8, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-32113 Filed 12-15-00; 8:45 am]
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