[Federal Register Volume 63, Number 76 (Tuesday, April 21, 1998)]
[Notices]
[Pages 19735-19736]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-10406]
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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 regulatory issues.
Date and Time: The meeting will be held on May 6, 1998, 9 a.m. to 5
p.m., and May 7, 1998, 9 a.m. to 11 a.m.
Location: NCTR, 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 Information Technology,
Biometry and Risk Assessment, and Neurotoxicology for their review,
discussion, and approval. The draft reports are the products of three
site visit teams who conducted onsite reviews over the last 9 months.
The staff from these programs will provide a preliminary response to
the issues raised and recommendations made. A progress report will be
presented to the board on the recommendations it made at its last
meeting on NCTR's Estrogen Knowledge Base project. Also, there will be
a Center Director's update.
Procedure: On May 6, 1998, from 9 a.m. to 5 p.m., and May 7, 1998,
from 9 a.m. to 11 a.m., 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 April 17, 1998. Oral presentations from the
public will be scheduled between approximately 11 a.m. and 12 m., on
May 7, 1998. Time allotted for each presentation may be limited. Those
desiring to make formal oral presentations should notify the contact
person before April 17, 1998, 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 May 7, 1998, from 1 p.m. to 2:30
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 of the Washington, DC, area on the basis of the criteria of 21
CFR 14.22 of FDA's regulations relating to public advisory committees.
[[Page 19736]]
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: April 14, 1998.
Michael A. Friedman,
Deputy Commissioner for Operations.
[FR Doc. 98-10406 Filed 4-20-98; 8:45 am]
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