[Federal Register Volume 69, Number 33 (Thursday, February 19, 2004)]
[Notices]
[Pages 7760-7761]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-3557]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 1993D-0398]


Guidance for Industry: Assessment of the Effects of Antimicrobial 
Drug Residues from Food of Animal Origin on the Human Intestinal Flora; 
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 for industry (52) entitled 
``Assessment of the Effects of Antimicrobial Drug Residues from Food of 
Animal Origin on the Human Intestinal Flora.'' This guidance is a 
revision of the guidance document 52 entitled 
``Microbiological Testing of Antimicrobial Drug Residues in Food,'' 
which was implemented in 1996. In this guidance, the agency recommends 
a pathway approach for assessing the microbiological safety of 
antimicrobial drug residues in food, rather than the approach described 
in the 1996 version of the guidance. The agency's decision to revise 
this guidance is based on new information available to the agency.

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written comments on this 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. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance document.
    Submit written requests for single copies of the guidance to the 
Communications Staff (HFV-12), Center for Veterinary Medicine (CVM), 
Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. 
Send one self-addressed adhesive label to assist that office in 
processing your requests.

FOR FURTHER INFORMATION CONTACT: Haydee Fernandez, Center for 
Veterinary Medicine (HFV-150), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-6981, e-mail: 
[email protected].

SUPPLEMENTARY INFORMATION:

[[Page 7761]]

I. Background

    In the Federal Register of December 27, 2001 (66 FR 66910), FDA 
published a notice of availability for a draft guidance document 
entitled ``Assessment of the Effects of Antimicrobial Drug Residues 
from Food of Animal Origin on the Human Intestinal Flora.'' The agency 
gave interested persons until March 27, 2002, to comment on the draft 
guidance. FDA received several comments that were considered in the 
preparation of this guidance document. This guidance replaces former 
guidance 52 entitled ``Microbiological Testing of 
Antimicrobial Drug Residues in Food.'' A document entitled ``History 
and Scientific Issues Related to Guidance 52'' provides the 
scientific rationale for the revisions made (Docket No. 93D-0398).
    CVM is aware that the International Cooperation on Harmonisation of 
Technical Requirements for Registration of Veterinary Medicinal 
Products (VICH) is currently drafting a related guideline and that this 
guidance may be superceded at a future date by the guideline published 
by VICH.

II. Paperwork Reduction Act of 1995

    FDA is announcing that a collection of information entitled 
``Guidance for Industry: Assessment of the Effects of Antimicrobial 
Drug Residues from Food of Animal Origin on the Human Intestinal 
Flora'' has been approved by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995. In the Federal Register of 
March 4, 2003 (68 FR 10253), the agency announced that the proposed 
information collection had been submitted to OMB for review and 
clearance under 44 U.S.C. 3507. According to the Paperwork Reduction 
Act of 1995, a collection of information should display a valid OMB 
control number. The valid OMB control number for this information 
collection is 0910-0521. It expires on January 31, 2007. A copy of the 
supporting statement for this information collection is available on 
the Internet at http://www.fda.gov/ohrms/dockets.

III. Significance of Guidance

    This level 1 guidance document is being issued consistent with 
FDA's good guidance practices regulation (21 CFR 10.115). This guidance 
document represents the agency's current thinking on the topic. It does 
not create or confer any rights for or on any person and does not 
operate to bind FDA or the public. An alternative approach 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 with new data or other new information 
pertinent to this guidance. FDA will periodically review the comments 
in the docket and, where appropriate, amend the guidance. The agency 
will notify the public of any such amendments through a notice in the 
Federal Register.

V. Electronic Access

    Persons with access to the Internet may obtain a copy of the 
guidance document entitled ``Guidance for Industry: Assessment of the 
Effects of Antimicrobial Drug Residues from Food of Animal Origin on 
the Human Intestinal Flora'' from FDA's CVM home page at http://www.fda.gov/cvm.

    Dated: October 6, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-3557 Filed 2-18-04; 8:45 am]
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