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U.S. Department of Health and Human Services

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March 18, 2014: Blood Products Advisory Committee Meeting Draft Agenda

FOOD AND DRUG ADMINISTRATION
Center for Biologics Evaluation and Research
109th Meeting of the Blood Products Advisory Committee
Great Room, Building 31
FDA White Oak Campus
10903 New Hampshire Avenue
Silver Spring, MD 20993
March 18-19, 2014

Tuesday, March 18, 2014: DRAFT AGENDA
8:30 a.m. Call to Order and Opening Remarks
Introduction of Committee
Christopher Stowell, Ph.D., M.D.
Acting Chair, BPAC
Conflicts of Interest Statement Bryan Emery, LCDR
Designated Federal Officer, BPAC
Topic I: Evaluation of the Safety and Effectiveness of the Immucor PreciseType™ HEA Molecular BeadChip Assay, manufactured by BioArray Solutions Limited
8:40 a.m. Introduction Orieji Illoh, M.D.
OBRR, FDA
9:00 a.m. BioArray Presentations      Joanne Spadoro, Ph.D. 
9:05 a.m. Immucor PreciseTypeTM HEA Molecular BeadChip Test Sukanta Banerjee, Ph.D.
10:00 a.m. Red Cell Typing with the BioArray System Connie Westhoff, Ph.D.
10:30 a.m. Questions for Speakers
10:45 a.m. Break
11:00 a.m. FDA Review of Performance Studies Annette Ragosta
OBRR, FDA
11:20 a.m. FDA Statistical Analysis Renee Rees, Ph.D.
OBE, FDA
11:50 a.m. FDA Resolution of Discrepancies and Conclusions Annette Ragosta
OBRR, FDA
12:00 p.m. Questions for Speakers
12:10 p.m. Red Blood Cell Genotype Assays: Clinical Experience Ellen Klapper, M.D.
Cedars Sinai Medical Center
12:30 p.m. Lunch
1:30 p.m. Open Public Hearing
2:00 p.m. Open Committee Discussion
Questions for the Committee
3:15 p.m. Break
Committee Updates
3:30 p.m. Presidential Commission for the Study of Bioethical Issues: Ethical Implications of Incidental Findings Lisa Lee, Ph.D.
Presidential Commission for the Study of Bioethical Issues
4:00 p.m. Summary of January 28-29, 2014 FDA Public Workshop on Immune globulin-associated Hemolysis Dorothy Scott, M.D.
OBRR, FDA
4:15 p.m. Summary of Dec 4-5, 2013 HHS Advisory Committee on Blood and Tissue Safety and Availability James Berger
OASH, HHS
4:30 p.m. Adjournment