[Federal Register: October 2, 2003 (Volume 68, Number 191)]
[Notices]               
[Page 56845]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02oc03-72]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 
Anti-Infective Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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    This notice announces a forthcoming meeting of a public advisory 
committee of the Food and Drug Administration (FDA). At least one 
portion of the meeting will be closed to the public.

    Name of Committee: Anti-Infective Drugs Advisory Committee.
    General Function of the Committee: To provide advice and 
recommendations to the agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on October 28, 2003, 
from 8 a.m. to 5:30 p.m., and on October 29, 2003, from 8:30 a.m. to 
4:30 p.m.
    Location: Holiday Inn, The Ballrooms, 2 Montgomery Village Ave., 
Gaithersburg, MD.
    Contact Person: Tara P. Turner, Center for Drug Evaluation and 
Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane 
(for express delivery, 5630 Fishers Lane, rm. 1093) Rockville, MD 20857, 301-827-7001, e-mail: TurnerT@cder.fda.gov, or FDA Advisory 
Committee Information Line, 1-800-741-8138 (301-443-0572 in the 
Washington, DC area), code 12530. Please call the Information Line 
for up to date information on this meeting.
    Agenda: On October 28, 2003, the committee will begin with a 
closed session from 8 a.m. to 12 noon. Following the closed session, 
from 1 p.m. to 5:30 p.m., the committee will discuss clinical trial 
design issues for demonstrating the safety and efficacy of 
antimicrobials in the treatment of diabetic foot infections. On 
October 29, 2003, the committee will discuss clinical trial design 
issues for demonstrating the safety and efficacy of antimicrobials 
in the treatment of acute bacterial sinusitis.
    Procedure: On October 28, 2003, from 1 p.m. to 5:30 p.m., and on 
October 29, 2003, from 8:30 a.m. to 4:30 p.m., the meeting is open 
to the public. Interested persons may present data, information, or 
views, orally or in writing, on issues pending before the committee. 
Written submissions may be made to the contact person by October 21, 
2003. Oral presentations from the public will be scheduled between 
approximately 3:15 p.m. and 3:45 p.m. on October 28, 2003, and 
between approximately 1 p.m. and 1:30 p.m. on October 29, 2003. Time 
allotted for each presentation may be limited. Those desiring to 
make formal oral presentations should notify the contact person 
before October 21, 2003, 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.
    Closed Committee Deliberations: On October 28, 2003, from 8 a.m. 
to 12 noon, the meeting will be closed to permit discussion and 
review of trade secret and/or confidential information (5 U.S.C. 
552b(c)(4)).
    Persons attending FDA's advisory committee meetings are advised 
that the agency is not responsible for providing access to 
electrical outlets.
    FDA welcomes the attendance of the public at its advisory 
committee meetings and will make every effort to accommodate persons 
with physical disabilities or special needs. If you require special 
accommodations due to a disability, please contact Tara Turner at 
least 7 days in advance of the meeting.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: September 25, 2003.
Peter J. Pitts,
Associate Commissioner for External Relations.
[FR Doc. 03-24926 Filed 10-1-03; 8:45 am]

BILLING CODE 4160-01-S