03-24926. Anti-Infective Drugs Advisory Committee; Notice of Meeting

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

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 October 28, 2003, from 8 a.m. to 5:30 p.m., and on October 29, 2003, from 8:30 a.m. to 4:30 p.m.

Location: Holiday Inn, The Ballrooms, 2 Montgomery Village Ave., Gaithersburg, MD.

Contact Person: Tara P. Turner, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane (for express delivery, 5630 Fishers Lane, rm. 1093) Rockville, MD 20857, 301-827-7001, 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.

Agenda: On October 28, 2003, the committee will begin with a closed session from 8 a.m. to 12 noon. Following the closed session, from 1 p.m. to 5:30 p.m., the committee will discuss clinical trial design issues for demonstrating the safety and efficacy of antimicrobials in the treatment of diabetic foot infections. On October 29, 2003, the committee will discuss clinical trial design issues for demonstrating the safety and efficacy of antimicrobials in the treatment of acute bacterial sinusitis.

Procedure: On October 28, 2003, from 1 p.m. to 5:30 p.m., and on October 29, 2003, from 8:30 a.m. to 4:30 p.m., the meeting is open to the public. 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 October 21, 2003. Oral presentations from the public will be scheduled between approximately 3:15 p.m. and 3:45 p.m. on October 28, 2003, and between approximately 1 p.m. and 1:30 p.m. on October 29, 2003. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before October 21, 2003, 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 October 28, 2003, from 8 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)).

Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets.

FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Tara Turner at least 7 days in advance of the meeting.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).

Dated: September 25, 2003.

Peter J. Pitts,

Associate Commissioner for External Relations.