Meeting of the Blood Products Advisory Committee
| Center | Date | Time | Location |
|---|---|---|---|
| CBER | April 1-2, 2009 | April 1, 2009 from 8:00 a.m. to 6:00 p.m. |
Hilton Washington DC North/Gaithersburg, Grand Ballroom, 620 Perry Parkway, Gaithersburg, Maryland 20877 |
Agenda
On April 1, 2009, the Committee will hear updates on the following topics: National Biovigilance Data Collection and Analysis Program; a summary of the December 16-17, 2008, meeting of the Department of Health and Human Services Advisory Committee on Blood Safety and Availability; and a summary of the September 12, 2008, FDA Workshop on Approaches to Minimize the Risk of Transfusion-Transmitted Babesiosis in the United States. The Committee will then discuss blood donor screening, and testing donors of human cells, tissues, and cellular and tissue-based products (HCT/Ps) for hepatitis B virus infection by nucleic acid testing. In the afternoon the Committee will discuss potential testing strategies for Trypanosoma cruzi infection in blood donors. On April 2, 2009, the Committee will discuss FDA’s current considerations on plasma obtained from a Whole Blood donor for further manufacturing use, and in the afternoon will review the research programs in the Laboratory of Molecular Virology, Division of Emerging and Transfusion Transmitted Diseases, CBER Site Visit held on October 22, 2008.
Meeting Materials
Materials for this meeting are available at http://www.fda.gov/ohrms/dockets/ac/cber09.html.
Public Participation Information
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 on or before March 25, 2009 .
- Oral presentations from the public will be scheduled between approximately 11:30 a.m. and 12:00 p.m. and between approximately 4:15 p.m. and 4:45 p.m. on April 1, 2009, and between approximately 10:45 a.m. and 11:45 a.m. and between 3:15 p.m. and 3:45 p.m. on April 2, 2009. Those desiring to make formal oral presentations should notify the contact person 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 on or before March 23, 2009. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by March 24, 2009 .
Closed Committee Deliberations
On April 2, between 4:00 p.m. and 4:45 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)). The Committee will discuss reports of intramural research programs and make recommendations regarding personnel staffing decisions.
Contact Information
- William Freas, Ph.D.
1401 Rockville Pike, HFM-71, Rockville, MD 20852
301-827-1295
FAX: 301-827-0294
e-mail: william.freas@fda.hhs.gov - FDA Advisory Committee Information Line
1-800-741-8138 (301-443-0572 in the Washington, DC, area)
code 3014519516
Please call the Information Line for up-to-date information on this meeting.
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting.
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Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).