FOOD AND DRUG ADMINISTRATION
Center for Biologics Evaluation and Research
111th Meeting of the Blood Products Advisory Committee
Great Room, Building 31
FDA White Oak Campus
10903 New Hampshire Avenue
Silver Spring, MD 20993
December 2-3, 2014
|8:30 a.m.||Call to Order and Opening Remarks
Introduction of Committee
Brooks Jackson, M.D., MBA
|Conflict of Interest Statement
Bryan Emery, LCDR
Designated Federal Officer, BPAC
|Topic I: Scientific Considerations Related to Reconsideration of the Current Blood Donor Deferral Policy for Men Who Have Had Sex with Another Man (MSM) Even One Time Since 1977|
|8:40 a.m.||Introduction and Overview of Data Presented at the November 13, 2014 HHS Advisory Committee on Blood and Tissue Safety and Availability (ACBTSA)
Alan Williams, Ph.D.
|9:20 a.m.||Recommendations of the November 13, 2014 Meeting of the HHS ACBTSA
|9:30 a.m.||U.S. Donor Marker and Risk Factor Monitoring Program: Building on the REDS-II Transfusion-Transmitted Retrovirus and Hepatitis Virus Rates and Risk Factors Study
Simone Glynn, M.D., M.Sc.,
|10:15 a.m.||Strategies to Monitor HIV Incidence and Recency in Blood Donors
Don Brambilla, Ph.D.
Research Triangle Institute International
Michele Owen, Ph.D.
|11:15 a.m.||Questions for Speakers|
|11:30 a.m.||Open Public Hearing|
|1:30 p.m.||Open Committee Discussion
Questions for the Committee
|2:45 p.m.||Ebola Virus and Potential Implications for Blood Safety
Gerardo Kaplan, Ph.D.