Draft Agenda:09/12/03

 

BLOOD  PRODUCTS ADVISORY COMMITTEE

77^th 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