[Federal Register: January 12, 2001 (Volume 66, Number 9)]
[Notices]
[Page 2911-2912]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12ja01-97]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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:
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.
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 ESTM
(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