[Federal Register Volume 72, Number 54 (Wednesday, March 21, 2007)]
[Notices]
[Page 13289]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-5153]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
National Antimicrobial Resistance Monitoring System Program
Subcommittee of the Science Advisory Board to the Food and Drug
Administration; Notice of Public Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting.
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The Food and Drug Administration (FDA) is announcing the following
public meeting: Science Board to the FDA National Antimicrobial
Resistance Monitoring System (NARMS) Program Subcommittee meeting. The
topic to be discussed is the National Antimicrobial Resistance
Monitoring System (NARMS) Program. The subcommittee will provide advice
to the Science Advisory Board to FDA regarding the NARMS program.
Date and Time: The public meeting will be held on April 10, 2007,
beginning at 9 a.m.
Location: The DoubleTree Hotel and Executive Meeting Center, 1750
Rockville Pike, Rockville, MD 20852.
Contact: Carlos Pena, Office of Science and Health Coordination,
Office of the Commissioner (HF-33), Food and Drug Administration, 5600
Fishers Lane (for express delivery, rm. 14B-08), Rockville, MD 20857,
301-827-3340, e-mail: [email protected].
Agenda: The subcommittee will evaluate the NARMS program and
address four questions relevant to the continued success of the program
including:
(1) Are there inherent biases in the sampling strategies employed
in NARMS? If so, how can they be improved to ensure that the data and
interpretation are scientifically sound given current resources?
(2) Are there epidemiological and/or microbiological research
studies that would better serve the goals of NARMS and the regulatory
work of FDA?
(3) Are current plans for data harmonization and reporting
appropriate? If not, what are the top priorities for advancing
harmonized reporting? and
(4) Are the current NARMS international activities adequate to
address the worldwide spread of antimicrobial-resistant foodborne
bacteria?
The subcommittee will discuss the NARMS Program and hear comments
on the NARMS Program, including oral presentations from the public on
scope, strengths, weaknesses, and areas for improvement.
Registration and Requests for Oral Presentations: Send registration
information (including name, title, firm name, address, telephone and
fax number, and e-mail address), and written material and requests to
make oral presentations, to the contact person on or before March 28,
2007. Interested persons may present data, information, or views,
orally or in writing, on the issues pending before this subcommittee.
Written submissions may be made to the contact person on or before
March 28, 2007. Oral presentations from the public will be scheduled to
begin at 11 a.m. on April 10, 2007. Those desiring to make formal oral
presentations should notify the contact person and submit a brief
statement of the general nature of the evidence or arguments they wish
to present, the names and addresses of proposed participants, and an
indication of the approximate time requested to make their presentation
on or before March 20, 2007. Time allotted for each presentation may be
limited. If the number of registrants requesting to speak is greater
than can be reasonably accommodated during the scheduled open public
hearing session, FDA may conduct a lottery to determine the speakers
for the scheduled open pubic hearing session. The contact person will
notify interested person regarding their request to speak by March 20,
2007.
If you need special accommodations due to a disability, please
notify the hotel (301-468-1100) at least 7 days in advance of the
meeting.
Transcripts: Transcripts of the public meeting may be requested in
writing from the Freedom of Information Office (HFI-35), Food and Drug
Administration, 5600 Fishers Lane, rm. 6-30, Rockville, MD 20857,
approximately 15 working days after the meeting at a cost of 10 cents
per page.
Dated: March 14, 2007.
Randall W. Lutter,
Associate Commissioner for Policy and Planning.
[FR Doc. E7-5153 Filed 3-20-07; 8:45 am]
BILLING CODE 4160-01-S