[Federal Register: May 9, 2003 (Volume 68, Number 90)]
[Page 25050-25051]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



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.


    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 
    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]