00-16123. 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). 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 July 28, 2000, 8:30 a.m. to 5:30 p.m.

Location: Parklawn Bldg., conference rooms G and H, 5600 Fishers Lane, and CDER Advisory Committee conference room 1066, 5630 Fishers Lane, Rockville, 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: [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: The committee will discuss supplemental new drug applications (NDA's) 19-537/S038, 19-847/S024, 19-857/S027, 19-858/S021, 20-780/S008 for Cipro® (ciprofloxacin), Bayer Corp. Pharmaceutical Division, for post-exposure prophylaxis of clinical disease from inhaled Bacillus anthracis.

Registration: Persons interested in attending the meeting are required to register by July 14, 2000. You may register by submitting your name, affiliation, telephone and fax number, and e-mail address to Thomas Perez, FAX [phone], or e-mail: [e-mail]. Registration confirmation will be sent by e-mail or facsimile on July 21, 2000.

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 July 19, 2000. Oral presentations from the public will be scheduled between approximately 1:30 p.m. and 2:30 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before July 19, 2000, 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: June 19, 2000.

Linda A. Suydam,

Senior Associate Commissioner.