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| Center | Date | Time | Location |
|---|---|---|---|
| CBER | February 20, 2003 | 8:00 a.m. - 5:30 p.m. | Holiday Inn |
Agenda:
On February 20, 2003, the committee will listen to updates on: Implementation
of the variant Creutzfeldt-Jakob Disease (vCJD) guidance (``Guidance for Industry:
Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob
Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood
Products''; this guidance can be accessed at /cber/guidelines.htm)
and its affect on blood supply, and an update on bovine spongiform encephalopathy
epidemiology and food chain controls. The committee will then discuss consideration
of labeling claims for transmissible spongiform encephalopathy (TSE) agent clearance
in plasma derivatives.
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 13, 2003. Oral presentations from the public will
be scheduled between approximately 10:10 a.m. to 10:30 a.m. and between approximately
3 p.m. to 3:40 p.m. on February 20, 2003. Time allotted for each presentation
may be limited. Those desiring to make formal oral presentations should notify
the contact person before February 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 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 20852-1449,
301-827-0314, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572
in the Washington, DC area), code 12392. Please call the Information Line for
up-to-date information on this meeting.}
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