[Federal Register Volume 65, Number 146 (Friday, July 28, 2000)]
[Notices]
[Pages 46464-46465]
From the Federal Register Online via the Government Publishing 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]
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