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Notice

Science Advisory Board to the National Center for Toxicological Research; Notice of Meeting

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Information about this document as published in the Federal Register.

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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 (SAB) to the National Center for Toxicological Research (NCTR).

General Function of the Committee: The Board advises the Director, NCTR, on establishing, implementing, and evaluating the research programs that assist the Commissioner of Food and Drugs in fulfilling his 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 August 8, 2002, from 1 p.m. to 5 p.m. and August 9, 2002, from 8 a.m. to 1 p.m.

Location: NCTR, Building #12, Conference Center, 3900 NCTR Dr., Jefferson, AR 72079.

Contact Person: 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 a draft report on the evaluation of the Division of Chemistry. The draft report is the product of a site visit team that conducted an onsite review of the Division in January. Division staffers will provide a preliminary response to the issues raised and recommendations made. The NCTR Director will provide a Center update and discuss the development of five newly established centers of excellence at the NCTR. These are the: Functional Genomics Center, Structural Genomics Center, Toxicoinformatics Center, Hepatotoxicity Center, and Phototoxicity Center. The Directors of each of these Centers will provide a presentation on the development and future of their respective center. A proposal presented to the Board at the June 2001 meeting regarding the establishment of a subcommittee on scientific opportunities to improve regulatory science through collaborations with external stakeholders will be revisited. The Board will receive an update on activities of an existing subcommittee with a similar focus (Advisory Committee for Pharmaceutical Science, Nonclinical Studies Subcommittee).

Procedure: On August 8, 2002, from 1 p.m. to 5 p.m., and August 9, 2002, from 8 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 July 31, 2002. Oral presentations from the public will be scheduled between approximately 11 a.m. and 12 noon, on August 9, 2002. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person before July 31, 2002, 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 August 9, 2002, 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.

Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets.

FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Leonard M. Schechtman at least 7 days in advance of the meeting.

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

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Dated: June 24, 2002.

William K. Hubbard,

Senior Associate Commissioner for Policy, Planning, and Legislation.

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[FR Doc. 02-16588 Filed 7-1-02; 8:45 am]

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