01-7184. Science Board to the Food and Drug Administration 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: Science Board to the Food and Drug Administration.

General Function of the Committee: The board shall provide advice primarily to the agency’s Senior Advisor for Science, and as needed, to the Commissioner of Food and Drugs and other appropriate officials on specific complex and technical issues as well as emerging issues within the scientific community in industry and academia. Additionally, the board will provide advice to the agency on keeping pace with technical and scientific evolutions in the fields of regulatory science, formulating an appropriate research agenda, and upgrading its scientific and research facilities to keep pace with these changes. It will also provide the means for critical review of agency-sponsored intramural and extramural scientific research programs.

Date and Time: The meeting will be held on April 13, 2001, 9 a.m. to 4:30 p.m.

Location: 5630 Fishers Lane, rm. 1066, Rockville, MD.

Contact: Susan M. Bond, Office of Science Coordination and Communication (HF-33), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-6687, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 12603. Please call the Information Line for up-to-date information on this meeting.

Agenda: Open committee discussion, 8:30 a.m. to 1 p.m.; open public hearing, 1 p.m. to l:30 p.m.; open committee discussion, 1:30 p.m. to 4:30 p.m. The board will hear and discuss programmatic peer review for the FDA’s Center for Devices and Radiological Health. The committee will also discuss: (1) The FDA’s Office of Women’s Health research plan; (2) an overview of tissue and tissue engineered products; and (3) strategies to meet scientific workforce challenges.

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 April 6, 2001. Oral presentations from the public will be scheduled between approximately 1 p.m. and 1:30 p.m. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before April 6, 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: March 16, 2001.

Linda A. Suydam,

Senior Associate Commissioner.