Agenda:On December 14, 2010, in the morning, the committee will discuss the risk of dengue virus infection in blood donors. In the afternoon, the committee will discuss murine leukemia virus-related human retroviruses and blood safety. On December 15, 2010, in the morning, the committee will hear updates on the following topics: (1) November 4 and 5, 2010, meeting of the Health and Human Services Advisory Committee on Blood Safety and Availability and (2) December 9 and 10, 2010, FDA workshop entitled "Product Development Program for Interventions in Patients With Severe Bleeding Due to Trauma and Other Causes," and (3) Research programs in the Laboratories of Hemostasis and Plasma Derivatives, Division of Hematology, Office of Blood Research and Review, Center for Biologics Evaluation and Research.
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. Background material is available athttp://www.fda.gov/AdvisoryCommittees/Calendar/default.htm.Scroll down to the appropriate advisory committee link.
Procedure:On December 14, from 8 a.m. to 5:30 p.m. the meeting is open to the public. On December 15, from 8 a.m. to 12 noon the meeting is open to the public. 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 December 7, 2010. Oral presentations from the public will be scheduled between approximately 10:15 a.m. and 11 a.m. and between 3:45 p.m. and 4:15 p.m. on December 14, 2010, and between approximately 11:30 a.m. and 12 noon on December 15, 2010. Those individuals interested in making 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 November 29, 2010. 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 November 30, 2010.
Closed Committee Deliberations:On December 15, from 12 noon to 12:45 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 programsand make recommendations regarding personnel staffing decisions.
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 Bryan Emery at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site athttp://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htmfor procedures on public conduct during advisory committee meetings.
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).