[Federal Register Volume 65, Number 146 (Friday, July 28, 2000)]
[Notices]
[Pages 46464-46465]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 00-19048]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 98D-0969]


Establishment of Resistance and Monitoring Thresholds in Food-
Producing Animals; Public Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of meeting.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
following meeting: Public Meeting Regarding the Establishment of 
Resistance and Monitoring Thresholds in Food-Producing Animals. The 
topic to be discussed is the Center for Veterinary Medicine's (CVM's) 
current thinking on concepts for the establishment of resistance and 
monitoring thresholds in food-producing animals. CVM will seek 
scientific input from experts at this meeting on these concepts as well 
as suggestions for alternative approaches.
    Date and Time: The meeting will be held on October 10 and 11, 2000, 
8:30 a.m. to 5 p.m. Written comments may be submitted until December 
11, 2000.
    Addresses: The meeting will be held at The DoubleTree Hotel, 1750 
Rockville Pike, Rockville, MD 20852. Submit written comments to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852.
    For general inquiries about the meeting and registration contact: 
Lynda W. Cowatch, Center for Veterinary Medicine (HFV-150), Food and 
Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 301-827-
5281, FAX: 301-594-2298.
    For technical inquiries contact: Aleta Sindelar, Center for 
Veterinary Medicine (HFV-1), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-827-0148.
    Registration: Registration is required. There is no registration 
fee for the meeting. Limited space is available, and early registration 
is encouraged. Logistics for the meeting and the registration form are 
available on the Internet at http://www.fda.gov/cvm/fda/mappgs/
registration.html. Please send the registration form to Lynda Cowatch 
(address above). Additional information about the meeting and the 
agenda will be available on the Internet (Internet site above) before 
the meeting.
    If you need special accommodations due to a disability, please 
contact the DoubleTree Hotel at least 7 days in advance, 800-222-8733.
    Transcripts: Transcripts of the meeting will be available on the 
Internet at http://www.fda.gov/cvm.

SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of January 6, 1999 (64 FR 887), FDA 
announced the availability of a discussion paper entitled ``A 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'' (the Framework Document). FDA made the Framework 
Document

[[Page 46465]]

available to the public to initiate discussions with the scientific 
community and other interested parties on the agency's thinking about 
appropriate underlying concepts to be used to develop microbial safety 
policies protective of the public health. This document discussed 
several risk management approaches to the regulatory management of 
antimicrobial drug resistance associated with food-producing animal use 
of antimicrobials. These strategies covered both preapproval and 
postapproval approaches and included: (1) Revision of the preapproval 
safety assessment for antimicrobial resistance for new animal drug 
applications to assess all uses for microbial safety, (2) 
categorization of antimicrobials based upon the importance of the drug 
for human medicine and upon which pre- and postapproval requirements 
would be based, (3) postapproval monitoring of the development of 
antimicrobial drug resistance and, (4) elaboration of resistance and 
monitoring thresholds.
    The Framework Document discussed the concept of two thresholds, the 
resistance threshold and the monitoring threshold, that would be 
established prior to the approval of an antimicrobial new animal drug 
for use in food-producing animals to ensure that food products derived 
from treated animals are safe for consumers. The resistance threshold 
would be established in humans to represent the upper limit of 
resistant bacteria that can be transferred from animals to consumers. 
The Framework Document discussed the possibility of establishing 
resistance thresholds based on human data, animal data, or both.
    Monitoring thresholds would also be established to guide the 
postapproval monitoring of resistance development in animals. According 
to the Framework Document, a monitoring threshold would need to be 
determined for each antimicrobial prior to approval, and the threshold 
may vary depending on the human or animal pathogen of concern. 
Monitoring thresholds would be established in animals so that they 
would serve as an early warning system, signaling when loss of 
susceptibility or resistance prevalence is approaching the resistance 
threshold.
    If a monitoring threshold were reached, the drug sponsor would 
implement mitigation actions to address the loss of susceptibility or 
increasing resistance trend. If mitigation were not successful, and 
resistance continued to increase and reach the resistance threshold, 
withdrawal of the approval of the drug for the use(s) of concern would 
be warranted.

II. Submission of Comments

    Interested persons may submit written comments regarding this 
meeting until December 11, 2000. Written comments should be submitted 
to the Dockets Management Branch (address above), or by fax to 301-827-
6870. Comments should be identified with the docket number found in the 
brackets in the heading of this document.

III. Related Information

    Transcripts of the three previous CVM public meetings on 
antimicrobial resistance, related public comments, the ``Draft Risk 
Assessment on the Human Health Impact of Fluoroquinolone Resistant 
Campylobacter Associated with the Consumption of Chicken (Revised as of 
February 9, 2000),'' and ``A 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'' can be found 
on the Internet at http://www.fda.gov/cvm/fda/mappgs/antitoc.html.

    Dated: July 20, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-19048 Filed 7-27-00; 8:45 am]
BILLING CODE 4160-01-F