Thursday, October 14, 2004

8:00 a.m. Administrative Remarks,

William Freas, PhD, Executive Secretary

8:10 a.m. Opening Remarks

Suzette Priola, PhD, Chairperson

Introduction

Jesse L. Goodman, MD, MPH,

Director, Center for Biologics Evaluation and Research

Presentation of Plaques to Retiring Committee Members

Jesse Goodman, MD, MPH

8:20 a.m. Informational Presentation #1: USDA BSE Licensed Tests and Enhanced Surveillance Program, Lawrence Elsken, DVM, USDA

Informational Presentation #2: USDA Review of Worldwide BSE Situation and USDA Responses, Lisa Ferguson, DVM, USDA

Informational Presentation #3: Update on Animal Feed Rulemaking, Burt Pritchett, DVM, CVM

9:05 a.m. Questions for Presenters

9:15 a.m. OPEN PUBLIC HEARING

10:05 Informational Presentation #4: Labeling Claims for TSE Clearance Studies for Plasma Derivative Products,

Dorothy Scott, MD, OBRR, FDA

10:15 Informational Presentation # 5: Industry-Wide Data on TSE Clearance from Plasma Products, Henry Baron, MD, Senior Director- Prion Research, ZLB Behring (Speaking on behalf of the Plasma Protein Therapeutics Association)

10:30 BREAK

TSEAC AGENDA (page 2)

10:50 a.m. Topic – Presumptive Transfusion Transmissions of Variant CJD (vCJD): Consideration of Current FDA-Recommended Safeguards

A. FDA Introduction, David Asher, MD, OBRR/FDA

B. Presumptive Transfusion Transmission of vCJD (review of CJD and vCJD: UK and EU epidemiology, case reports, surveillance and projections, potential public health implications, and responses), Professor Robert G. Will, MD, UK CJD Surveillance Unit

C. Comparison of the Transfusion Risk for CJD vs. vCJD, Steven Anderson, PhD, OBE/FDA

D. Leukoreduction and Its Failure to Remove Most Infectivity from Blood, Luisa Gregori, PhD, VA Medical Center

12:10 p.m. Questions for Speakers

12:25 LUNCH

1:25 E. Changes in Canadian CJD/vCJD Blood Safety Policies,

Peter Ganz, PhD, HealthCanada

F. Current Safeguards for Blood Products Recommended by FDA, Dorothy Scott, MD, OBRR/CBER

G. Possible Effects of Prior CJD-Related Blood Donor Deferrals on Blood Supply, Alan Williams, PhD, OBRR/CBER

2:30 Questions for Speakers

2:45 OPEN PUBLIC HEARING

3:15 BREAK

3:35 Questions to the Committee

3:45 Committee Discussion and Vote

5:00 p.m. ADJOURN