Food and Drug Administration

Blood Products Advisory Committee

December 13, 2001

Briefing Information

Committee Updates

Summary: Revised Preventive Measures to Reduce the Possible Risk of Transmission of CJD and Variant CJD by Blood and Blood Products, Dorothy Scott, MD  [pdf version] [htm version] [Word version]

Consent Decree Update, Cecily Kodis Kaufman, FDA   [ppt version] [htm version]

Topic I. Simian Foamy Virus

Potential concerns for simian foamy virus (SFV) transmission by blood and blood products, Hira Nakhasi, Ph.D., FDA   [ppt version] [htm version]

FDA seeks advice on its approach to assessing the possible transfusion risk from SFV, Hira Nakhasi, PhD, FDA  [pdf version] [htm version] [Word version]

Emergency meeting called for 81 Tunney's Pasture workers; 'Virus in search of a disease' strikes fear into employees of Health Canada [rtf version]

CDC Investigations Relevant to Potential for Simian Foamy Virus Transmission by Transfusion, Louisa Chapman, MD, National Center for Infectious Diseases, Centers for Disease Control and Prevention (CDC)  [ppt version] [htm version]

Simian Foamy Virus Infection Among Individuals Occupationally Exposed to Non Human Primates, James Brooks, Paul Sandstrom, Health Canada   [ppt version] [htm version]

Simian Foamy Viruses (SFV), Arifa S. Khan, PhD, FDA  [ppt version] [htm version]

Proposed Animal Study to Evaluate Simian Foamy Virus (SFV) Transmission by Blood, Arifa S. Khan, PhD, FDA   [ppt  version] [htm version]

Statement of the American Association of Blood Banks, Kay R Gregory MS MT(ASCP)SBB  [pdf version] [htm version] [Word version]

Bibliography  Topic I [pdf version] [htm version] [Word version]

Topic II.  Discussion on Leukocyte Reduction Guidance

Summary, Alan Williams, PhD   [pdf version] [htm version] [Word version]

Guidance Modification Table, Alan Williams, PhD   [pdf version] [htm version] [Word version]

Statement of the American Association of Blood Banks, Kay R Gregory MS MT(ASCP)SBB  [pdf version] [htm version] [Word version]

Bibliography  Topic II [pdf version] [htm version] [Word version]

Open Public Hearing

Whole Blood Mixing, A Synopsis of an Evaluation Performed by The Montreal Centre of Canadian Blood Transfusion, Dr. Giles Roy, Dr. Mindy Goldman, and Suzanne Remy-Prince, July, 1992, SEBRA   [pdf version] [htm version] [Word version]

Haemonetics Corporation, Mark A. Popovsky, MD   [pdf version] [htm version] [Word version]