[Federal Register Volume 66, Number 62 (Friday, March 30, 2001)]
[Notices]
[Pages 17430-17431]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-7878]


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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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[[Page 17431]]

SUMMARY: 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 April 26, 2001, 8 a.m. 
to 6 p.m., and on April 27, 2001, 8:30 a.m. to 12 noon.
    Location: Holiday Inn, The Ballrooms, 8120 Wisconsin Ave., 
Bethesda, 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: [email protected], 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 April 26, 2001, the committee will consider the safety 
and efficacy of new drug application (NDA) 21-144, KetekTM 
(telithromycin) tablets, Aventis Pharmaceuticals, Inc., for the 
treatment of bacterial respiratory infections.
    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 April 18, 
2001. Oral presentations from the public will be scheduled on April 26, 
2001, between approximately 2 p.m. and 3 p.m. Time allotted for each 
presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before April 18, 2001, 
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 April 27, 2001, from 8:30 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)).
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: March 22, 2001.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 01-7878 Filed 3-29-01; 8:45 am]
BILLING CODE 4160-01-S