[Federal Register Volume 66, Number 9 (Friday, January 12, 2001)]
[Notices]
[Pages 2911-2912]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-1056]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Anti-Infective Drugs Advisory Committee; Amendment of Notice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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Summary: The Food and Drug Administration (FDA) is announcing an 
amendment to the notice of meeting of the Anti-Infective Drugs Advisory 
Committee. This meeting was announced in the Federal Register of 
December 27, 2000 (65 FR 81874). The amendment is being made to cancel 
the entire session on January 29, 2001. This meeting will be open to 
the public. There are no other changes.

For Further Information 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: 
<a href="/cdn-cgi/l/email-protection#95c5f0e7f0efc1d5f6f1f0e7bbf3f1f4bbf2fae3"><span class="__cf_email__" data-cfemail="f4a49186918ea0b497909186da929095da939b82">[email protected]</span></a>, 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.

Supplementary Information: In the Federal Register of December 27, 2000 
(65 FR 81874), FDA announced that a meeting of the Anti-Infective Drugs 
Advisory Committee would be held on January 29 and 30, 2001. On page 
81874, beginning in the first column, the Date and Time, Location, 
Agenda, and Procedure portions of this meeting are amended to read as 
follows:

[[Page 2912]]

    Date and Time: The meeting will be held on January 30, 2001, 8 a.m. 
to 6 p.m.
    Location: Holiday Inn, The Ballrooms, Two Montgomery Ave., 
Gaithersburg, MD.
    Agenda: The committee will consider the safety and efficacy of a 
new drug application (NDA) 50-755, Augmentin ES<SUP>TM</SUP> 
(amoxicillin/clavulanate) 90 milligrams per kilograms 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 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: January 5, 2001.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 01-1056 Filed 1-11-01; 8:45 am]
BILLING CODE 4160-01-S


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