Joint Meeting of the Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee and the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee; Notice of Meeting

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

This notice announces a forthcoming meeting of public advisory subcommittees of the Food and Drug Administration (FDA). The meeting will be open to the public.

Name of Committee: The Pediatric Subcommittee of the Anti-Infective Drugs Advisory Committee and the Pediatric Oncology Subcommittee of the Oncologic Drugs Advisory Committee.

General Function of the Committees: To provide advice and recommendations to the agency on FDA's regulatory issues.

Date and Time: The meeting will be held on September 12, 2000, 8 a.m. to 12 noon.

Location: Hyatt Regency, Baccarat/Haverford Rooms, One Bethesda Metro Center, Bethesda, MD.

Contact Person: Jayne E. Peterson or Karen M. Templeton-Somers, Center for Drug Evaluation and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7001, or e-mail: at PetersonJ@cder.fda.gov or SomersK@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.

Agenda: The subcommittees will meet jointly to discuss the approaches and processes used in pediatric oncology for the development of drugs to treat serious and life threatening diseases with limited patient populations.

Procedure: Interested persons may present data, information, or views, orally or in writing, on issues pending before the subcommittees. Written submissions may be made to the contact persons by September 6, 2000. Oral presentations from the public will be scheduled between approximately 10 a.m. and 11 a.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact persons before September 6, 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. After the scientific presentations, a 30-minute open public session may be conducted for interested persons who have submitted their request to speak by September 6, 2000, to address issues specific to the topic before the subcommittees.

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