01-1056. 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: [e-mail], 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:

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.