[Federal Register: May 25, 2004 (Volume 69, Number 101)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2001D-0357]
International Cooperation on Harmonisation of Technical
Requirements for Approval of Veterinary Medicinal Products; Guidance
for Industry on Studies to Evaluate the Safety of Residues of
Veterinary Drugs in Human Food: Carcinogenicity Testing; Availability
AGENCY: Food and Drug Administration, HHS.
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a final guidance for industry (141) entitled
``Studies to Evaluate the Safety of Residues of Veterinary Drugs in
Human Food: Carcinogenicity Testing'' (VICH GL28). This 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 VICH guidance document is to help ensure
that the assessment of carcinogenic potential is appropriate to human
exposure to residues of veterinary drugs in human food in the European
Union, Japan, and the United States.
DATES: Submit written or electronic comments at any time.
ADDRESSES: Submit written requests for single copies of the guidance to
the Communications Staff (HFV-12), 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 guidance document.
Submit electronic or written comments at any time on the guidance
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Submit electronic comments to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
Comments should be identified with the full title of the 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:
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
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; 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.
Four observers are eligible to participate in the VICH Steering
Committee: One representative from the government of Australia/New
Zealand, one representative from the industry in Australia/New Zealand,
one representative from the government in Canada, and one
representative from the industry in Canada. The VICH Secretariat, which
coordinates the preparation of documentation, is provided by the
International Federation for Animal Health (IFAH). An IFAH
representative also participates in the VICH Steering Committee
II. Guidance on Carcinogenicity Testing
In the Federal Register of August 28, 2001 (66 FR 45319), FDA
published the notice of availability of the VICH draft guidance, giving
interested persons until September 28, 2001 to submit comments. No
comments were received. At a meeting held on October 10-11, 2002, the
VICH Steering Committee endorsed the guidance for industry, VICH GL28.
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 guidance after consideration of the existing
ICH guidances for pharmaceuticals for human use: ``Final Guideline on
the Need for Long-Term Rodent Carcinogenicity Studies of
Pharmaceuticals''; and ``S1B Testing for Carcinogenicity of
Pharmaceuticals.'' Notices of availability for these guidances
published in the Federal Register of March 1, 1996, (61 FR 8153) and
February 23, 1998, (63 FR 8983) respectively. The 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 of America, Australia and New Zealand.
(Information collection for new animal drug applications is covered
under OMB control number 0910-0032.)
III. Significance of Guidance
This 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'' or ``it is recommended.''
This guidance document 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.
As with all of FDA's guidances, the public is encouraged to submit
written or electronic comments pertinent to this guidance. FDA will
periodically review the comments in the docket and, where appropriate,
will amend the guidance. The agency will notify the public of any such
amendments through a notice in the Federal Register.
Interested persons may, at any time, submit written comments to the
Division of Dockets Management (see ADDRESSES) regarding this guidance
document. Two copies of any comments are to be submitted, except
individuals may submit one copy. Comments should be identified with the
docket number found in the brackets in the heading of this document. A
copy of the document and received comments are available for public
examination in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
V. Electronic Access
Copies of the guidance document 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cvm.
Dated: May 18, 2004.
Assistant Commissioner for Policy.
[FR Doc. 04-11781 Filed 5-24-04; 8:45 am]
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