|
|
|
FDA Home Page | Search FDA Site | A-Z Index | Contact FDA
| Center | Date | Time | Location |
|---|---|---|---|
| CBER | June 19, 2003 June 20, 2003 |
8:00 a.m. - 4:30
p.m. 8:30 a.m. - 3:00 p.m. |
Hilton Gaithersburg |
Agenda:
On June 19, 2003, the committee will hear updates on the following tentative
topics: Medical Device User Fee and Modernization Act, secure e-mail and electronic
submissions, white particulate matter in blood bags, and safety reporting requirements
for human drug and biological products. The committee will further hear informational
presentations on Severe Acute Respiratory Syndrome and West Nile Virus.
On June 20, 2003, the committee will hear presentations, discuss and provide
recommendations on the topic of recovered plasma. In the afternoon, the committee
will hear an informational presentation on the current thinking and indications
for use on vaccinia immune globulin intravenous.
Background material will become available no later than the day before the
meeting and will be posted under the Dockets Management Branch site at http://www.fda.gov/ohrms/dockets/ac/03acdocs.htm.
(Scroll down and select the appropriate advisory committee link.)
Procedure:
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 13, 2003. Oral presentations from the
public will be scheduled between approximately 10:45 a.m. and 11:30 a.m. and
2:30 p.m. and 3:30 p.m. on June 19, 2003; and between approximately 9:30 a.m.
and 10:30 a.m. and 2:00 p.m. and 2:30 p.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 13, 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 Linda A. Smallwood at (301) 827-3514 or Pearline K. Muckelvene
at (301) 827-1281 at least 7 days in advance of the meeting.
Contact Person:
Linda A. Smallwood, Ph.D., Center for Biologics Evaluation and Research (HFM-302),
Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448,
301-827-3514, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572
in the Washington, DC area), code 19516. Please call the Information Line for
up-to-date information on this meeting.