[Federal Register: October 18, 2001 (Volume 66, Number 202)]
[Notices]               
[Page 52924-52925]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18oc01-73]                         

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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). The meeting will 
be open 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 November 7, 2001, from 8 
a.m. to 5 p.m.
    Location: Holiday Inn, Kennedy Ballroom, 8777 Georgia Ave., Silver 
Spring, MD.
    Contact: Thomas H. Perez, Center for Drug Evaluation and Research 
(HFD-21), Food and Drug Administration, 5600 Fishers Lane, Rockville, 
MD 20857, 301-827-6758, e-mail: PerezT@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: The committee will consider the safety and efficacy of a 
new drug application (NDA) 50-710, Pfizer, Inc., for 1-day and 3-day 
dosing regimens of azithromycin suspension for the treatment of otitis 
media.
    Procedure: 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 30, 
2001. Oral presentations from the public will be scheduled between 
approximately 1 p.m. and 2 p.m. Time allotted for each presentation may 
be limited. Those desiring to make formal oral presentations should 
notify the contact person before October 30, 2001, and submit a brief 
statement of the general

[[Page 52925]]

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.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: October 11, 2001.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 01-26276 Filed 10-17-01; 8:45 am]
BILLING CODE 4160-01-S