01-13378. Science Advisory Board to the National Center for Toxicological Research; 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: Science Advisory Board to the National Center for Toxicological Research (NCTR).

General Function of the Committee: The board advises the Director, NCTR, in establishing, implementing, and evaluating the research programs that assist the Commissioner of Food and Drugs (the Commissioner) in fulfilling regulatory responsibilities. The board provides an extra-agency review in ensuring that the research programs at NCTR are scientifically sound and pertinent.

Date and Time: The meeting will be held on June 11, 2001, 1 p.m. to 5:30 p.m., and June 12, 2001, 8:30 a.m. to 1 p.m.

Location: NCTR, Bldg. #12, Conference Center, Jefferson, AR.

Contact: Leonard M. Schechtman, NCTR (HFT-10), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-6696, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 12559. Please call the Information Line for up-to-date information on this meeting.

Agenda: The board will be presented with progress reports on the implementation of recommendations made by the board at its last meeting on NCTR's research programs in endocrine disrupter knowledge base and microbiology. The NCTR director will provide a center update and a discussion of future research directions. A proposal will be made to the board that it consider establishing a subcommittee on scientific opportunities to improve regulatory science through collaboration with external stakeholders. A report will be provided to the board on the activities of an existing subcommittee with a similar focus (Advisory Committee for Pharmaceutical Science, Nonclinical Studies Subcommittee) NCTR division directors will discuss the accomplishments and future directions for their divisions.

Procedure: On June 11, 2001, from 1 p.m. to 5:30 p.m., and June 12, 2001, from 8:30 a.m. to 12 noon, 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 May 18, 2001. Oral presentations from the public will be scheduled between approximately 11 a.m. and 12 noon on June 12, 2001. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before May 18, 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.

Closed Committee Deliberations: On June 12, 2001, from 12 noon to 1 p.m., the meeting will be closed to permit discussion where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)). This portion of the meeting will be closed to permit discussion of information concerning individuals associated with the research programs at NCTR.

The Commissioner approves the scheduling of meetings at locations outside the Washington, DC area on the basis of the criteria of 21 CFR 14.22 of FDA's regulations relating to public advisory committees.

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

Dated: May 22, 2001.

Linda A. Suydam,

Senior Associate Commissioner.