Topic I: Review of FDA’s Risk Assessment for Potential Exposure to Variant Creutzfeldt-Jakob Disease in U.S.-licensed Plasma-Derived Factor VIII

1. Introduction, Steven Anderson, Ph.D., OBE, FDA (30’)
2. Presentation of FDA Risk Assessment, Hong Yang, Ph.D., OBE, FDA (40’)
3. Summary and Questions for the Committee, Steven Anderson, Ph.D., OBE, FDA (20’)

Open Committee Discussion

Questions for the Committee

Topic II: Labeling of Plasma-derived Products, including Plasma-derived Albumin and Products Containing Plasma-derived Albumin to Address the Possible Risk of Transmission of V ariant Creutzfeldt-Jakob Disease

1. Introduction and Rationale for Proposed Labeling Change for Plasma Derivatives to Reflect Possible vCJD Risk Dorothy Scott, M.D., DH, OBRR, FDA (15’)
2. TSE Clearance in Manufacturing of Plasma Derivatives, PPTA (25’)
3. Summary and Questions for the Committee Dorothy Scott, M.D., DH, OBRR, FDA (20’)

Open Committee Discussion

Questions for the Committee

Opening Remarks, Chair, TSEAC

Statement of Conflicts of Interest, Announcements

Informational Presentations: FDA’s Geographic Donor Deferral Policy to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products and Human Cells, Tissues and Cellular and Tissue-based Products

• Review of Current FDA Policies
  • David Asher, M.D., DETTD, OBRR, FDA (30’)
  • Elizabeth Lybarger, M.F.S., M.S. LT USPHS, DHT, OCTGT, FDA (15’)
• Variant CJD in the UK and Worldwide, Robert Will, M.D., UK CJD Surveillance Unit, Edinburgh (30’)
• BSE in the USA and Worldwide, Linda Detwiler, D.V.M., University of Mississippi (15’)
• USDA Updates
  • Christopher Robinson, D.V.M., National Center for Import and Export, APHIS, USDA (15’)
  • Troy Bigelow, D.V.M, National Center for Animal Health Programs, APHIS, USDA (15’)
• Questions to Speakers (10’)

Committee Updates

1. Recent Advances in Development of Devices to Remove TSE Agents from Blood Components.
   1. Steven J. Burton, Ph.D., Prometric BioSciences, Ltd. (15’)
   2. Sam Coker, Ph.D., Pall Medical Corporation (15’)
   3. Tomo Yokomizo, M.Sc., Asahi-Kasei Medical (15’)
2. Questions to Speakers (10’)