[Federal Register Volume 68, Number 207 (Monday, October 27, 2003)]
[Notices]
[Page 61221]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-27113]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 1998D-1146]


Guidance for Industry: Evaluating the Safety of Antimicrobial New 
Animal Drugs With Regard to Their Microbiological Effects on Bacteria 
of Human Health Concern; 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 (152) entitled ``Guidance for 
Industry: Evaluating the Safety of Antimicrobial New Animal Drugs with 
Regard to Their Microbiological Effects on Bacteria of Human Health 
Concern.'' This guidance document discusses a recommended approach for 
assessing the safety of antimicrobial new animal drugs with regard to 
their microbiological effects on bacteria of human health concern.

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

ADDRESSES: Submit written comments on the guidance document 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 document and the docket 
number found 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 document 
to the Communications Staff (HFV-12), Center for Veterinary Medicine, 
Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. 
Send one self-addressed adhesive label to assist that office in 
processing your requests.

FOR FURTHER INFORMATION CONTACT: Jeffrey M. Gilbert, Center for 
Veterinary Medicine (HFV-157), 7500 Standish Pl., Rockville, MD 20855, 
301-827-0233, e-mail: [email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of September 13, 2002 (67 FR 58058), FDA 
published a notice of availability for a draft guidance entitled 
``Guidance for Industry: Evaluating the Safety of Antimicrobial New 
Animal Drugs With Regard to Their Microbiological Effects on Bacteria 
of Human Health Concern'' giving interested persons until November 27, 
2002, to submit comments. FDA considered all comments received and, 
where appropriate, incorporated them into the guidance.
    This document provides guidance for industry on a possible process 
for evaluating the potential effects of antimicrobial new animal drugs 
on non-target bacteria as part of the new animal drug application 
process. This guidance document outlines a risk assessment approach for 
evaluating the microbial food safety of antimicrobial new animal drugs. 
Alternative processes that may be more appropriate to a sponsor's drug 
and its intended conditions of use, may be used to characterize the 
microbial food safety of that drug. FDA's purpose in this guidance is 
to ensure the safety of animal drugs used in food-producing animals and 
to evaluate the human health impact of their intended use.

II. Significance of Guidance

    This level 1 guidance is being issued consistent with FDA's good 
guidance practices (21 CFR 10.115). The guidance represents the 
agency's current thinking about the safety of new animal drugs, with 
regard to their microbiological effects on bacteria of human health 
concern. The document does not create or confer any rights for or on 
any person and will not operate to bind FDA or the public. Alternative 
methods may be used as long as they satisfy the requirements of the 
applicable statutes and regulations.

III. Paperwork Reduction Act of 1995

    FDA is announcing that a collection of information entitled 
``Guidance for Industry: Evaluating the Safety of Antimicrobial New 
Animal Drugs With Regard to Their Microbiological Effects on Bacteria 
of Human Health Concern'' has been approved by the Office of Management 
and Budget (OMB) under the Paperwork Reduction Act of 1995. In the 
Federal Register of September 19, 2003 (68 FR 54906), 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 0910-0522 (expires April 30, 2005). A 
copy of the supporting statement for this information collection is 
available on the Internet at http://www.fda.gov/ohrms/dockets.

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 periodically will 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 on 
the final guidance at any time. Comments should be identified with the 
docket number found in brackets in the heading of this document. A copy 
of the document 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

    Persons with access to the Internet may obtain a copy of the 
guidance document entitled ``Guidance for Industry: Evaluating the 
Safety of Antimicrobial New Animal Drugs With Regard to Their 
Microbiological Effects on Bacteria of Human Health Concern'' from the 
Center for Veterinary Medicine home page at http://www.fda.gov/cvm.

    Dated: October 6, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-27113 Filed 10-23-03; 12:30 pm]
BILLING CODE 4160-01-S