Subcommittee meeting of the

Blood Products Advisory Committee

for Office Site Visit Review of the

Office of Blood Research and Review

July 22, 2005

DRAFT AGENDA

Open Session

8:00 a.m. Welcome and Introduction of Committee

OSV Chair

Conflict of Interest Statement

8:10 Introduction/Charge to Committee

Dr. Karen Midthun

Deputy Director, Center for Biologics Evaluation and Research

CBER Mission

CBER Program Structure

8:35 Overview of CBER Research Programs

Kathryn Carbone, M.D.

Associate Director for Research

8:55 Overview Office of Blood Research and Review (OBRR)

Jay S. Epstein, M.D. Director, OBRR

Office Mission and Structure

Regulatory Activities and Priorities

Research Program Introduction

9:20 Q & A for Deputy Director, CBER, Associate Director for Research, CBER & Office Director, OBRR

9:30 Break

9:45 Overview of the Research Program of the Division of Emerging and Transfusion Transmitted Diseases

Hira L. Nakhasi, Ph.D., Director, DETTD

Scope/Mission/Regulatory Relevance/Public Health Impact

Division Research Program Structure & Research

Accomplishments

Regulatory and Product Contributions/Relevance/Expertise

Five-year Objectives

10:40 Q&A

Subcommittee meeting of the

Blood Products Advisory Committee

Draft agenda (Continued)

10:50 Overview of the Research Program of the Division of Hematology

Basil Golding, M.D. Director, DH

Scope/Mission/Regulatory Relevance/Public Health Impact

Division Research Program Structure & Research Programs

Accomplishments

Regulatory and product contributions/relevance/expertise

Five-year Objectives

Q and A (10’)

11:45 Overview of the Research Program of the Division of Blood Applications

Alan Williams, Ph.D., Director DBA

12:05 p.m. Q&A

12:15 Open Public Hearing

1:15 Lunch

Closed Session

2:15 p.m. Discussion of Regulatory/Personnel Issues

Introduction of CBER Panel and Questions to Panel by committee (Drs. Epstein, Nakhasi, Golding, Williams, Scott, Vostal, Alayash, Mied, Asher, Hewlett, Kaplan, Biswas, Cowan, Abbondanzo, Silverman, Lozier

3:30 Closed Executive Session of Committee

4:45 Oral Summary (Deputy Director, Assoc. Dir. Research, CBER, Office Director and Division Directors, OBRR)

5:00 Adjourn

Presentation of finalized Sub-Committee Report at next full meeting of the Full Blood Products Advisory Committee and discussion/vote by full committee.