[Federal Register: February 11, 2005 (Volume 70, Number 28)]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2003D-0474]
International Cooperation on Harmonisation of Technical
Requirements for Registration of Veterinary Medicinal Products (VICH);
Final Guidance for Industry on Studies to Evaluate the Safety of
Residues of Veterinary Drugs in Human Food: General Approach to
Establish a Microbiological ADI (VICH GL-36); Availability
AGENCY: Food and Drug Administration, HHS.
SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance document for industry (159)
entitled ``Studies to Evaluate the Safety of Residues of Veterinary
Drugs in Human Food: General Approach to Establish a Microbiological
ADI'' (VICH GL36). This guidance has been developed for veterinary use
by the International Cooperation on Harmonisation of Technical
Requirements for Registration of Veterinary Medicinal Products (VICH).
This 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 at any time.
ADDRESSES: Submit written requests for single copies of the 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 guidance document.
Submit written comments 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 International Conference on
Harmonisation 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 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 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
II. Guidance on Microbiological Acceptable Daily Intake
In the Federal Register of November 13, 2003 (68 FR 64354), FDA
published the notice of availability of the VICH draft guidance, giving
interested persons until December 15, 2003, to submit comments. After
consideration of comments received, the draft guidance was changed in
response to the comments and submitted to the VICH Steering Committee.
At a meeting held on May 3, 2004, the VICH Steering Committee endorsed
the final guidance for industry (VICH GL-36). This 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: (1) To outline
the recommended steps in determining the need for establishing a
microbiological acceptable daily intake (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. Information collection is covered under Office
Management and Budget (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, mandatory
words such as ``must,'' ``shall,'' and ``will'' in the original VICH
document have been substituted with ``should.'' Similarly, words such
as ``require'' or ``requirement'' have been replaced by ``recommend''
or ``recommendation'' as appropriate to the context.
The VICH guidance (159) is consistent with the agency's
current thinking on the subject matter. 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 submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified with the docket number found in brackets
in the heading of this document. Received comments may be seen 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: General Approach
to Establish a Microbiological ADI'' (VICH GL-36) 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: February 3, 2005.
Assistant Commissioner for Policy.
[FR Doc. 05-2643 Filed 2-10-05; 8:45 am]
BILLING CODE 4160-01-S