Revised:11/30/01 1:52 PM


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.


12:30 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


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


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