Revised:11/30/01 1:52 PM
BLOOD PRODUCTS ADVISORY COMMITTEE
70th Meeting - December 13-14, 2001
Hilton Silver Spring Hotel
8727 Colesville Road Silver Spring, MD
Thursday, December 13, 2001
8:00 a.m. Statement of Conflict of Interest
8:05 a.m. Welcome and Opening Remarks
8:30 a.m. Committee Updates
10:00 a.m. BREAK
10:30 a.m. Open Committee Discussion
I. Potential Concerns for Simian Foamy Virus Transmission by Blood and Blood Products
A. Introduction and Background - Hira Nakhasi, Ph.D., Director, DETTD, OBRR, CBER,FDA
B. Review of SFV Biology and Pathogenesis - Arifa Khan, Ph.D., OVRR, CBER,FDA
C. Review of CDC Investigation on Human Infections with SFV - Louisa Chapman, M.D., CDC
D. Review of Health Canada Study: Risk Assessment - Paul Sandstrom, Ph.D., Health Canada
E
. FDA Proposed Animal Study on SFV Transmission by Blood - Arifa Khan, Ph.D.12:00 NOON OPEN PUBLIC HEARING
12:30 p.m. Open Committee Discussion
F. Questions for the Committee
G. Committee Discussion and Recommendations
1:30 p.m. LUNCH
2:30 p.m. Open Committee Discussion
II. Discussion on Leukocyte Reduction Guidance
A. Introduction and Background - Alan Williams, Ph.D., Director, DBA, OBRR, CBER, FDA
B. Review of Filter Performance Data - Betsy Poindexter, DH, OBRR, CBER, FDA
C. Establishing the Appropriate QC Cut-off for Contaminating Leukocytes
- Edward Snyder, M.D., Yale-New Haven Hospital
- Linda Kline,M.D., American Red Cross
D. QC Strategy - Alan Williams, Ph.D.
3:30 p.m. BREAK
3:45 p.m. OPEN PUBLIC HEARING
Manufacturer Presentation - Baxter IMAGN
Manufacturer Presentation - Blood mixing devices
4:45 p.m. Open Committee Discussion
E. Questions for the Committee - Alan Williams, Ph.D.
F. Committee Discussion and Recommendations
5:30 p.m. RECESS (until 8:00 a.m., Friday, September 21, 2001)
Friday, December 14,2001
8:00 a.m. Open Committee Discussion
III. Human Cells, Tissues and Cellular and Tissue-Based Products: Risk Factors for Semen Donation
A. Introduction and Background - Antonio Pereira, M.D., Human Tissue Staff, OBRR, CBER, FDA
B. Current Practices in Semen Banking - Charles Sims, M.D. Los Angeles, CA
C. Incidence and Prevalence of HIV, HBV, HCV and Other STDs among High Risk Groups - Linda A. Valleroy, Ph.D., Division of HIV/AIDS Prevention, NCHSTP, CDC
D. Risk of and Actual Transmission of HIV, Hepatitis, and Other STDs by Semen - Deborah Anderson, Ph.D., Brigham & Women’s Hospital, Boston, MA
E. HHV-8 as an Emerging Pathogen - Michael Cannon, Ph.D., Epidemiologist, Division of Viral and Rickettsial Diseases, CDC
10:15 a.m. BREAK
10:45 a.m. Open Committee Discussion
F. Benefits of Semen Quarantine and Donor Retesting - George Schreiber, Ph.D., Westast G. Cryopreservation of Semen - TBD
H. Achieving Pregnancy Using Fresh vs. Cryopreserved Semen for Semen Insemination - Emmet J. Lamb, M.D., Professor Emeritus, OB-GYN, Stanford University, Stanford, CA
11:30 a.m. OPEN PUBLIC HEARING
Industry Presentations
1:00 p.m. LUNCH
2:00 p.m. Open Committee Discussion
I. Questions for the Committee - Antonio Periera, M.D.
J. Committee Discussion and Recommendations
3:30 p.m. ADJOURNMENT