Draft Agenda:09/12/03

 

BLOOD PRODUCTS ADVISORY COMMITTEE

77th Meeting September 18, 2003

Hilton Gaithersburg, 620 Perry Parkway

Gaithersburg, MD 20877

 

Thursday, September 18, 2003

8:00 a.m. Welcome, Statement of Conflict of Interest, Announcements

8:15 a.m. Committee Updates

 

        Summary of PHS Blood Safety and Availability Advisory Committee Meeting Lawrence McMurtry 20

        Approval of HIV-1 Group "O" Sensitive Assays Paul Mied, PhD 5

        Revised Guidance on Severe Acute Respiratory Syndrome (SARS) Sharyn Orton, PhD 5

        Current Thinking on Use of Chlorhexidine as an Arm Preparation for Donor Phlebotomy Leslie Holness, MD 5

        Labeling and Storage: Blood and Blood Components (Proposed Regulation) Elizabeth Callaghan 5

        Overview of Counterterrorism Exercise (TOPOFF II) Richard Lewis, PhD 5

 

9:00 a.m. Open Public Hearing

 

9:20 a.m. Open Committee Discussion

9:35 a.m. BREAK

 

10:00 a.m. Open Committee Discussion

 

I. West Nile Virus (WNV) Informational

A. Introduction and Background Hira Nakhasi, PhD, Director, Division of Emerging and Transmitted Diseases, OBRR 15

B. Epidemiology and Surveillance

Anthony Marfin, MD, CDC 15

C. Plasma and Plasma Derivatives Safety 45

- FDA Current Thinking Mahmood Farsid, PhD, DH, OBRR 15

- Presentation PPTA 30

 

11:30 a.m. OPEN PUBLIC HEARING 60

Industry Presentations

12:30 NOON Open Committee Discussion

D. Committee Discussion

 

1:30 p.m. LUNCH

 

2:30 p.m. Open Committee Discussion

 

II. Supplemental Testing for HIV and HCV

A.                        Introduction and Background 20

- Robin Biswas, MD/Indira Hewlett, PhD, DETTD, OBRR

 

B.                        Performance of HIV and HCV Supplemental Assays

1. Miriam Alter, PhD, CDC 15

2. Steve McDougal, MD, CDC 15

3. Michael Busch, MD, PhD, Blood Centers of the Pacific 15

4. Susan Stramer, PhD, ARC 15

4:00 p.m. BREAK

 

4:15 p.m. OPEN PUBLIC HEARING

 

4:45 p.m. Open Committee Discussion

C. Questions for the Committee

D. Committee Discussion and Recommendations

 

6:00 p.m. ADJOURNMENT