[Federal Register: November 13, 2003 (Volume 68, Number 219)]
[Notices]
[Page 64354-64356]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr13no03-62]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003D-0474]
International Cooperation on Harmonization of Technical
Requirements for Registration of Veterinary Medicinal Products; Draft
Guidance for Industry on ``Studies to Evaluate the Safety of Residues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 Establish a
Microbiological Acceptable Daily Intake;'' Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability for comments of a draft guidance document for industry
([numsign]159) entitled ``Studies to Evaluate the Safety of Residues of
Veterinary Drugs in Human Food: General Approach to Establish a
Microbiological ADI'' (VICH GL-36). This draft guidance has been
developed for veterinary use by the International Cooperation on
Harmonization of Technical Requirements for Registration of Veterinary
Medicinal Products (VICH).
[[Page 64355]]
This draft VICH guidance document provides guidance for assessing the
human food safety of residues from veterinary antimicrobial drugs with
regard to effects on the human intestinal flora.
DATES: Submit written or electronic comments on the draft guidance by
December 15, 2003 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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Communications Staff (HFV-12), Center for Veterinary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, 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INFORMATION section for electronic access to the draft guidance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Submit written comments on the draft guidance to the Division of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://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with the full title of the draft guidance and the docket number found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: 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
Harmonization of Technical Requirements for Approval of Pharmaceuticals
for Human Use 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 United States' 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 of Canada, and one
representative from the industry of 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
meetings.
II. Draft Guidance on Microbiological Acceptable Daily Intake (ADI)
The VICH steering committee held a meeting on May 8, 2003, and
agreed that the draft guidance document entitled ``Studies to Evaluate
the Safety of Residues of Veterinary Drugs in Human Food: General
Approach to Establish a Microbiological ADI'' (VICH GL-36) should be
made available for public comment. This draft VICH guidance provides
guidance for assessing the human food safety of residues from
veterinary antimicrobial drugs with regard to effects on the human
intestinal flora. The objectives of this guidance are as follows: (1)
To outline the recommended steps in determining the need for
establishing a microbiological ADI; (2) to recommend test systems and
methods for determining no-observable adverse effect concentrations
(NOAECs) and no-observable adverse effect levels (NOAELs) for the
endpoints of health concern; and (3) to recommend a procedure to derive
a microbiological ADI. It is recognized that different tests may be
useful. The experience gained with the recommended tests may result in
future modifications to this guidance and its recommendations.
FDA and the VICH Safety Working Group will consider comments about
the draft guidance document. Information collection is covered under
Office of Management and Budget (OMB) control number 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).
The draft VICH guidance ([numsign]159) is consistent with the
agency's current thinking on the general approach to establish a
microbiological ADI. 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 comments should be submitted to
the Division of Dockets Management (see ADDRESSES). Submit written or
electronic comments by December 15, 2003 to ensure adequate
consideration in preparation of the final guidance. Two copies of any
mailed 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
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
V. Electronic Access
Electronic comments may also be submitted electronically on the
Internet at http://www.fda.gov/dockets/ecomments. Once on this Internet
site, select ``[docket number] entitled `Studies to evaluate the safety
of residues of Veterinary Drugs in Human Food: General Approach to
Establish a Microbiological ADI' (VICH GL-36)'' and follow the
directions.
Copies of the draft guidance document entitled ``Studies to
evaluate the safety of residues of Veterinary Drugs in Human Food:
General Approach to Establish a Microbiological ADI'' (VICH GL-36) may
be obtained on
[[Page 64356]]
the Internet from the CVM home page at http://www.fda.gov/cvm.
Dated: October 31, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-28373 Filed 11-12-03; 8:45 am]
BILLING CODE 4160-01-S