|
|
|
FDA Home | Search FDA Site | A-Z Index | Contact FDA
| Center | Date | Time | Location |
|---|---|---|---|
| NCTR | June 19, 2003 |
9:00 a.m. - 4:45
p.m. |
NCTR Building
#12 |
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.
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.
Procedure:
On June 19, 2003, from 9:00 a.m. and 4:45 p.m., and June 20, 2003, from 9:00
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. 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 14 days in advance of the meeting.
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.