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| Center | Date | Time | Location |
|---|---|---|---|
| CBER | July 17, 2003 |
8:00 a.m. - 6:00
p.m. 8:00 a.m. - 4:30 p.m. |
Holiday Inn Select |
Agenda:
On July 17, 2003, the Committee will discuss the safety of bovine bone gelatin
in oral and topical drugs, food and cosmetics. The Committee will then discuss
bovine spongiform encephalopathy in Canada and potential implications for FDA-regulated
products. In the afternoon, the Committee will hear presentations on transmissible
spongiform encephalopathies (TSEs) and decontamination of medical equipment
and facilities.
On Friday, July 18, 2003, the Committee will discuss designing, interpreting, and validating studies to evaluate reprocessing methods for removing TSE contamination from medical devices. In the afternoon, the Committee will discuss methods to decontaminate facilities and equipment used to prepare human cellular and tissue products, and human blood products, including plasma derivatives, to reduce the theoretical risk of transmitting TSE agents.
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 July 10, 2003. Oral presentations from the public will be
scheduled between approximately 11:35 a.m. and 11:55 a.m., and 1:55 p.m. and
2:25 p.m. on July 17, 2003; and between approximately 9:50 a.m. and 10:20 a.m.,
and 1:30 p.m. and 2:00 p.m. on July 18, 2003. Time allotted for each presentation
may be limited. Those desiring to make formal oral presentations should notify
the contact person before July 11, 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,
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.