[Federal Register: May 9, 2003 (Volume 68, Number 90)]
[Notices]
[Page 25050-25051]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr09my03-96]
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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 (SAB) 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 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 June 19, 2003, from 9
a.m. to 4:45 p.m. and on June 20, 2003, from 9 a.m. to 12:15 p.m.
Location: NCTR, Building [numsign]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 Biometry. The draft report is the product
of a site visit team that conducted an onsite review of the Division in
May. Division staffers will provide a preliminary response to the
issues raised and recommendations made.
The establishment of a Pharmaceutical Safety Working Group and the
background and history of two Expert Working Groups (EWG) will be
discussed. A proposal to move oversight for the EWGs from the Center
for Drug Evaluation and Research (CDER) to NCTR will also be reviewed.
Representatives from CDER and industry will present perspectives on the
proposed change in oversight. An earlier version of this proposal was
discussed at the June 2001 and August 2002 meetings of the SAB. The
Board will also receive updates on the activities of the Cardiotoxicity
and Vascular Injury EWGs.
Procedure: On June 19, 2003, from 9 a.m. to 4:45 p.m., and June 20,
2003, from 9 a.m. to 11:45 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 June 6, 2003. Oral presentations
from the public will be scheduled between approximately 10:45 a.m. and
11:45 a.m., on June 20, 2003. Time allotted for each presentation may
be limited. Those desiring to make formal oral presentations should
notify the contact person before June 6, 2003, 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 20, 2003, from 11:45 a.m.
to 12:15 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
[[Page 25051]]
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 14 days in advance of the meeting.
Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).
Dated: May 3, 2003.
Peter J. Pitts
Associate Commissioner for External Relations.
[FR Doc. 03-11605 Filed 5-8-03; 8:45 am]
BILLING CODE 4160-01-S