[Federal Register Volume 70, Number 28 (Friday, February 11, 2005)]
[Notices]
[Pages 7278-7279]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-2643]


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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.

ACTION: Notice.

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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://
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: 
[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 differences in technical 
requirements for drug development among regulatory agencies in 
different countries.
    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 
meetings.

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 
of

[[Page 7279]]

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.

IV. Comments

    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 
through Friday.

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://www.fda.gov/cvm.

    Dated: February 3, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-2643 Filed 2-10-05; 8:45 am]
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