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| Center | Date | Time | Location |
|---|---|---|---|
| CBER | February 12, 2004 February 13, 2004 |
8 a.m. - 5:30 p.m. 8 a.m. - 3:30 p.m. |
Holiday Inn |
Agenda:
On February 12, 2004, the committee will hear an informational presentation
on a presumptive transfusion-transmitted case of variant Creutzfeldt-Jakob Disease
(vCJD) reported recently in the United Kingdom, and hear updates on related
experimental studies in animals on transmission of TSE agents by blood, and
relevant epidemiology of human TSEs. In the afternoon, the committee will receive
an update on the case of bovine spongiform encephalopathy (BSE) recently recognized
in the United States, and will have a general discussion about potential models
of risk-based approaches to sourcing of bovine materials used to make medical
products.
On February 13, 2004, the committee will have a preliminary discussion about FDA's current recommendations on measures to minimize risk from TSE agents in various types of medical products.
Background material and meeting information will become available no later than the day before the meeting (Simply select the appropriate 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 February 5, 2004. Oral presentations from the public will
be scheduled between approximately 11:30 a.m. and 12 noon, and 3 p.m. and 3:30
p.m. on February 12, 2004; and between 11 a.m. and 12 noon on February 13, 2004.
Time allotted for each presentation may be limited. Those desiring to make formal
oral presentations should notify the contact person before February 9, 2004,
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 William Freas or Sheila D. Langford at least 7 days in advance
of the meeting.
Contact Person:
William Freas or Sheila D. Langford, Center for Biologics
Evaluation and Research (HFM-71), Food and Drug Administration, 1401 Rockville
Pike, Rockville, MD 20852-1448, 301-827-0314, or FDA Advisory Committee Information
Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512392.
Please call the Information Line for up-to-date information on this meeting.
[ Full FR Notice ]