[Federal Register: September 27, 1999 (Volume 64, Number 186)]
[Notices]
[Page 52099-52100]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27se99-70]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98D-0969]


Antimicrobial Resistance in Food-Producing Animals; Notice of
General Public Meeting and Public Workshops; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY:  The Food and Drug Administration (FDA) will sponsor a general
public meeting and two public workshops to discuss important issues
related to antimicrobial resistance (AR) in food-producing animals. The
agency is seeking public comment on the general public meeting in its
further planning of the two public workshops.
 DATES: The general public meeting and the public workshops are
scheduled as follows:
1. ``General Public Meeting,'' Monday, October 4, 1999, 1 p.m. to 5
p.m.
2. ``The Risk Assessment and the Establishment of Resistance Thresholds
Workshop,'' Thursday and Friday, December 9 and 10, 1999, 9 a.m. to 5
p.m.
3. ``Preapproval Studies in AR,'' Tuesday and Wednesday, February 22
and 23, 2000, 9 a.m. to 5 p.m.

ADDRESSES: The general public meeting and the public workshops will be
held at the DoubleTree Hotel, 1750 Rockville Pike, Rockville, MD, 301-
468-1100.

FOR FURTHER INFORMATION CONTACT:
     For general information regarding the general public meeting and
public workshops: Lynda W. Cowatch, Center for Veterinary Medicine
(CVM) (HFV-150), Food and Drug Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301-827-5281, e-mail: lcowatch@cvm.fda.gov.
     For information regarding technical inquiries: Sharon R. Thompson
or Aleta M. Sindelar at 301-594-1798, FAX 301-594-1830.

    Registration: The general public meeting and the public workshops
are free, however, registration is required. Limited space is available
and early registration is encouraged. Registration forms are available
on CVM's home page at ``http://www.fda.gov/cvm/fda/mappqs/
arregis1.doc''. If you need special accommodations for a disability,
please contact the DoubleTree Hotel at least 7 days in advance.

SUPPLEMENTARY INFORMATION:  The agency believes it is essential to
provide opportunities for public input regarding the following:

I. The General Public Meeting

     The general public meeting is intended to provide an opportunity
for stakeholders to give input to FDA on the appropriate issues,
experts, and agenda items to be included in two subsequent scientific
workshops related to AR. In general terms, the first scientific public
workshop on December 9 and 10, 1999, is intended to focus on issues
related to risk assessment and the establishment of resistance
thresholds in food-producing animals. The second scientific public
workshop on February 22 and 23, 2000, is intended to discuss the design
of preapproval studies in food-producing animals to model the rate and
extent of resistance development. FDA will consider comments received
at the general public meeting in its further planning of the two
scientific public workshops. We also encourage the submission of
written comments at any time, but no later than 30 days after the date
of publication of this notice to ensure time for full consideration in
planning the December meeting. Comments should be identified with the
docket number found in brackets in the heading of this document and
submitted to the Dockets Management Branch (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

[[Page 52100]]

II. The Risk Assessment and the Establishment of Resistance
Thresholds Workshop

    The risk assessment and the establishment of resistance thresholds
workshop is intended to allow a public discussion of FDA's risk
assessment model to evaluate the risk to human health from resistant
foodborne pathogens associated with the use of antimicrobials in food-
producing animals. The meeting will also discuss FDA's current thinking
on the use of this model to establish resistance and monitoring
thresholds in food-producing animals. The agency seeks scientific input
from experts at the meeting on these issues as well as suggestions for
alternative approaches.

III. The Preapproval Studies in AR

    The preapproval studies in AR public workshop is intended to allow
a public discussion of FDA's current thinking on the appropriate design
of preapproval studies in food-producing animals to model the rate and
extent of resistance development. The agency will seek suggestions for
alternative approaches.
    Supportive documents for discussion, including the ``Framework
Document,'' can be found on CVM's Internet home page at http://
www.fda.gov/cvm. Information including meeting agendas and relevant
background information will be posted on the CVM home page in
anticipation of each meeting and workshop.

    Dated: September 22, 1999.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 99-25083 Filed 9-22-99; 4:28 pm]
BILLING CODE 4160-01-F