[Federal Register Volume 67, Number 178 (Friday, September 13, 2002)]
[Notices]
[Pages 58057-58058]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 02-23386]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D-1146]


Discussion of ``Draft Guidance for Industry: Evaluating the 
Safety of Antimicrobial New Animal Drugs with Regard to Their 
Microbiological Effects on Bacteria of Human Health Concern;'' Notice 
of Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
following meeting: ``Discussion of Draft Guidance for Industry: 
Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to 
Their Microbiological Effects on Bacteria of Human Health Concern.'' 
The topic to be discussed is this draft guidance document that 
describes an approach for implementing concepts previously considered 
in the FDA framework document on antimicrobial resistance (64 FR 887, 
January 6, 1999). The draft guidance outlines a method for assessing 
the safety of antimicrobial new animal drugs intended for use in food-
producing animals.
    Date and Time: The public meeting will be held on Wednesday, 
October 2, 2002, from 9 a.m. to 5 p.m. Interested persons, who wish 
their comments to be considered during the meeting, may submit written 
or electronic comments by September 25, 2002, to the Dockets Management 
Branch (see Comments and Electronic Access).
    Location: The meeting will be held at the DoubleTree Hotel, 1750 
Rockville Pike, Rockville, MD, 20852, 301-468-1100.
    Comments and Electronic Access. Submit written comments to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Two copies of written 
comments are to be submitted, except that individuals may submit one 
copy. Submit electronic comments to http://www.fda.gov/dockets/
ecomments. Comments should be identified with the full title and Docket 
No. 98D-1146 found in brackets in the heading of this document. A copy 
of the received comments is available for public examination in the 
Dockets Management Branch between 9 a.m. and 4 p.m., Monday through 
Friday.
    Oral comments regarding the draft guidance may be provided during 
the public comment sessions. Since time for public comments is limited, 
prior notification of your intent to comment is encouraged. Please 
register and submit a short summary of your comments by September 25, 
2002; faxed copies of comments are permissible. We encourage 
consolidation of like-minded presentations to provide sufficient 
opportunity for public comment.
    For General Information Contact: Aleta Sindelar, Center for 
Veterinary Medicine (HFV-3), Food and Drug Administration, 7519 
Standish Pl., Rockville, MD 20855, 301-827-4515; FAX 301-827-4335 or e-
mail: asindela@cvm.fda.gov.
    For Information About Registration/Oral Comments Contact: Anna Roy, 
Center for Veterinary Medicine (HFV-6), Food and Drug Administration, 
7519 Standish Pl., Rockville, MD 20855, 301-827-2947; FAX 301-827-4335 
or e-mail: aroy@cvm.fda.gov.
    Registration: Registration is required. There is no registration 
fee for the

[[Page 58058]]

meeting. Limited space is available, and early registration is 
encouraged. Registration forms are available on the Dockets Management 
Branch Web site at www.accessdata.fda.gov/scripts/oc/dockets/meetings/
meetingdocket.cfm
    If you need special accommodations for a disability, please contact 
the DoubleTree Hotel at least 7 days in advance of the meeting.
    Meeting Agenda: The meeting will consist of a series of oral 
presentations in the morning to explain the content of the draft 
guidance document. The agenda in the afternoon will consist primarily 
of sessions to address specific questions and to provide opportunity 
for public comment. The meeting agenda will be made available on the 
CVM Web site at www.fda.gov/cvm/antimicrobial/ar_meetings.htm.
    Transcripts: You may request a transcript of the meeting in writing 
from the Freedom of Information Office (HFI-35), Food and Drug 
Administration, 5600 Fishers Lane, rm. 12A-16, Rockville, MD 20857. The 
transcript of the public meeting will be after the meeting, at a cost 
of 10 cents per page. You may also examine the transcript of the 
meeting at the Dockets Management Branch (see Comments and Electronic 
Access) between 9 a.m. and 4 p.m., Monday through Friday and on the CVM 
Web site at www.fda.gov/cvm/antimicrobial/ar_meetings.htm.

SUPPLEMENTARY INFORMATION:

Background

    In January 1999, FDA announced the availability of a discussion 
document entitled ``Proposed Framework for Evaluating and Assuring the 
Human Safety of the Microbial Effects of Antimicrobial New Animal Drugs 
Intended for Use in Food-Producing Animals'' (framework document) (64 
FR 887, January 6, 1999). The framework document laid out possible 
strategies for managing the potential risks associated with use of 
antimicrobial drugs in food-producing animals.
    The current draft guidance document outlines an approach for 
implementing concepts described in the Framework Document. The draft 
document provides guidance on a risk analysis process as a possible 
means for evaluating antimicrobial resistance concerns as part of the 
preapproval safety evaluation of a new animal drug. The new animal drug 
sponsor may use this guidance and the methodology described to conduct 
a qualitative risk assessment to help evaluate antimicrobial resistance 
concerns as part of an overall preapproval safety evaluation of their 
proposed animal drug product. If the sponsor elects to use this 
process, the qualitative antimicrobial resistance risk assessment and 
supporting data should be submitted to FDA for review. FDA's purpose in 
this guidance is to ensure that antimicrobial new animal drugs intended 
for use in food-producing animals are safe with regard to human health.
    Also in this issue of the Federal Register, FDA is publishing the 
notice of availability of the guidance document entitled ``Draft 
Guidance for Industry: Evaluating the Safety of Antimicrobial New 
Animal Drugs with Regard to Their Microbiological Effects on Bacteria 
of Human Health Concern.''

    Dated: September 9, 2002.
Margaret M. Dotzel
Associate Commissioner for Policy.
[FR Doc. 02-23386 Filed 9-10-02; 4:37 pm]
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