[Federal Register Volume 64, Number 68 (Friday, April 9, 1999)]
[Notices]
[Page 17399]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-8938]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Science Advisory Board to the National Center for Toxicological
Research; Notice of Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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: To provide advice and
recommendations to the agency on FDA's regulatory issues.
Date and Time: The meeting will be held on April 26, 1999, 12 noon
to 5:30 p.m., and April 27, 1999, 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 three of NCTR's programs in Biochemical Toxicology,
Genetic Toxicology, and Molecular Epidemiology, for their review,
discussion, and approval. The draft reports are the products of three
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. Two progress reports will be
presented to the board on the recommendations it made at its last
meeting on NCTR's Neurotoxicology Program and Biometry and Risk
Assessment Program. The NCTR Director will also provide a center
update.
Procedure: On April 26, 1999, from 12 noon to 5:30 p.m., and April
27, 1999, 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 board. Written submissions may
be made to the contact person by April 15, 1999. Oral presentations
from the public will be scheduled between approximately 11 a.m. and 12
noon on April 27, 1999. Time allotted for each presentation may be
limited. Those desiring to make formal oral presentations should notify
the contact person before April 15, 1999, 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 April 27, 1999, 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: April 1, 1999.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 99-8938 Filed 4-8-99; 8:45 am]
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