[Federal Register Volume 65, Number 249 (Wednesday, December 27, 2000)]
[Notices]
[Page 81874]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-33020]



[[Page 81874]]

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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 January 29, 2001, 8 a.m. 
to 6 p.m. and January 30, 2001, 8 a.m. to 4:30 p.m.
    Location: Holiday Inn, The Ballrooms, Two Montgomery Ave., 
Gaithersburg, MD.
    Contact Person: 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 January 29, 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 community-acquired pneumonia, acute exacerbation of 
chronic bronchitis, acute sinusitis, and tonsillitis/pharyngitis. On 
January 30, 2001, the committee will consider the safety and efficacy 
of NDA 50-755, Augmentin ESTM (amoxicillin/clavulanate) 90 
milligrams per kilogram per day, SmithKline Beecham Pharmaceuticals, 
for the treatment of pediatric patients with acute otitis media due to 
penicillin resistant Streptococcus pneumoniae.
    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 January 22, 
2001. Oral presentations from the public will be scheduled on January 
29, 2001, between approximately 2 p.m. and 3 p.m., and on January 30, 
2001, between approximately 2:45 p.m. to 3:45 p.m. Time allotted for 
each presentation may be limited. Those desiring to make formal oral 
presentations should notify the contact person before January 22, 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.
    Notice of this meeting is given under the Federal Advisory 
Committee Act (5 U.S.C. app. 2).

    Dated: December 18, 2000.
Linda A. Suydam,
 Senior Associate Commissioner.
[FR Doc. 00-33020 Filed 12-26-01; 8:45 am]
BILLING CODE 4160-01-S