Food and Drug Administration, HHS.
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 (the Board) to the National Center for Toxicological Research (NCTR).
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 June 5, 2000, 1 p.m. to 4:30 p.m., and June 6, 2000, 8:30 a.m. to 1 p.m.
Location: NCTR, Bldg. #12, Conference Center, Jefferson, AR.
Contact Person: Ronald F. Coene, 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 draft reports on evaluations of NCTR's research programs in Endocrine Disrupter Knowledge Base, and Microbiology, for their review, discussion, and approval. The draft reports are the products of two site visit teams who conducted on site reviews over the last year. The staff from these programs will provide a preliminary response to the issues raised and recommendations made. Three progress reports will be presented to the Board on the recommendations it made at its last meeting, as a result of earlier site visits, on NCTR's programs in BioChem Toxicology, Genetic Toxicology and Molecular Epidemiology. The NCTR Acting Director will also provide a Center update and a discussion of future research directions.
Procedure: On June 5, 2000, from 1 p.m. to 4:30 p.m., and June 6, 2000, 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 23, 2000. Oral presentations from the public will be scheduled between approximately 11 a.m. and 12 noon on June 6, 2000. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before May 23, 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.
Closed Committee Deliberations: On June 6, 2000, 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 of Food and Drugs 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).Start Signature
Dated: May 5, 2000.
Linda A. Suydam,
Senior Associate Commissioner.
[FR Doc. 00-12180 Filed 5-15-00; 8:45 am]
BILLING CODE 4160-01-F