[Federal Register Volume 68, Number 219 (Thursday, November 13, 2003)]
[Notices]
[Pages 64354-64356]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-28373]


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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Requirements for Registration of Veterinary Medicinal Products; Draft 
Guidance for Industry on ``Studies to Evaluate the Safety of Residues 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availability for comments of a draft guidance document for industry 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 This draft guidance has been 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DATES: Submit written or electronic comments on the draft guidance by 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Communications Staff (HFV-12), Center for Veterinary 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INFORMATION section for electronic access to the draft guidance 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    Submit written comments on the draft guidance to the Division of 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with the full title of the draft guidance and the docket number found 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: 
[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 
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]
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