Advisory Committee

on
Blood Safety and Availability
Department of Health and Human Services
Thirty-eighth Meeting
June 10 &11, 2010

The Universities at Shady Grove

9630 Gudelsky Drive
Rockville, MD 20850
Phone: (301) 738-6000

Thursday, June 10, 2010

08:00 Doors Open Open to the Public

08:30 Call to Order Jerry A. Holmberg, PhD

Roll Call/Conflict of Interest Executive Secretary
Designated Federal Official

08:40 Charge to the Committee on Current High Risk Howard K. Koh, MD, MPH
Behavior Deferral Policy for Blood Donors Assistant Secretary for Health

Scientific Rationale for the Current Policy on Donor Deferral for Men who have
had Sex with another Man (MSM)

09:15 FDA’s Policy on Blood Donor Deferral for MSM Jay S. Epstein, M.D.
Director, Office of Blood Research
and Evaluation, FDA

09:45 Human cell, tissue, and cellular and tissue- Melissa Greenwald, M.D.
based product (HCT/P) Policy Office of Cellular Tissue, and Gene
Therapies
CBER, FDA

Epidemiology of Transfusion Transmitted Diseases in Individuals Practicing High

Risk Behavior compared to the General Population

10:00 A review of the current epidemiology of HIV Amy Lansky, Ph.D., MPH
Deputy Director for Surveillance,
Epidemiology, and Laboratory
Science
Division of HIV/AIDS Prevention
National Center for HIV, STD, and TB
Prevention CDC
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10:30 Break
10:45 Transfusion-associated transmissions of HIV
11:15 Behaviors and other risk factors associated
with viral hepatitis B and C
11:45 Other Sexually Transmitted Disease (STD):
Association with Risk Behavior
12:00 Lunch
1:00 Status of Current Transfusion Transmitted
Disease Testing: Sensitivity, Cost, Window
Period and Residual Risk
Risk Assessments in US and other Countries
1:30 Formal Risk Assessment in the US
2:00 Current Review of MSM Policy in Canada
2:30 Current review of donor deferral rules including
MSM by the transfusion committee of the
European Directorate for the Quality of
Medicines (EDQM), Council of Europe (CoE)
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Bernard M. Branson, M.D.
Associate Director for Laboratory
Diagnostics
CDC - Division of HIV/AIDS
Prevention
Scott D. Holmberg, MD, MPH
Chief, Epidemiology and Surveillance
Branch,
Division of Viral Hepatitis,
NCHHSTP, CDC
John M. Douglas, Jr, M.D.
Chief Medical Officer
National Center for HIV, Viral
Hepatitis, STD, and TB Prevention
CDC
Michael Busch, M.D., Ph.D.
Director, Blood Systems Research
Institute
Vice President, Research/Scientific
Affairs, Blood Systems
Andrew Dayton, M.D., Ph.D.
Medical Officer, Research
FDA/CBER/DETTD/LMV
Peter Ganz, Ph.D.
Director, Centre for Blood and
Tissues Evaluation, Biologics &
Genetic Therapies Directorate
Health Canada
Rut Norda, M.D., Ph.D.
Uppsala University Hospital
Coordinator of National Statistics,
Swedish Society for Transfusion
medicine (SFTM)
Board member of the Swedish Blood
Alliance (SweBA)
Chair Transfusion Committee of the
EDQM, Council of Europe
6/3/2010
 3:00 Break

Computerized Inventory Management in Blood Collection Establishments

3:15 Current Status of Computerized Inventory AABB and Blood Industry

Management in Blood Collection
Establishments (National, Community-based,
and Hospital-based)
3:30 Quarantine Release Errors Sharon O’Callaghan
Program Surveillance Branch
FDA, CBER, OCBQ

Reliability of Donor Questionnaires to Address High Risk Sexual Behavior

3:50 Historical Data on Donor Question Alan Williams, Ph.D.

Development and Validation FDA/CBER/OBRR

4:20 Risk Behavior, Recall and Accuracy TBD

5:00 Adjournment for the Evening

Friday, June 11, 2010

08:00 Doors Open Open to the Public

08:30 Call to Order Jerry A. Holmberg, PhD

Roll Call/Conflict of Interest Executive Secretary and Designated
Federal Official

Hemovigilance and Data Sets

08:40 Potential Data Sources for identification of low Robert Reinhard, M.A.
risk MSM Subsets

08:50 Risk Factor Interviews and Infectious Marker Brian Custer, Ph.D., MPH
Surveillance Associate Investigator
Blood Systems Research Institute

Societal Considerations of MSM Deferral Policy

09:20 Medical Ethics Consideration Lori P. Knowles LLB BCL MA LLM

Health Law Institute, University of
Alberta Consultant, Biotechnology
Policy, Law & Ethics

09:50 Gay Men’s Health Crisis Nathan Schaefer, MSSA

Director, Public Policy
Sean Cahill
Gay Men's Health Crisis
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10:20 Consumers’ Consideration Mark Skinner, J.D.
American Plasma User Coalition
(A-Plus)
10:50 Break

11:05 Open Public Comment Richard Vogel, Hemophilia

Association of New Jersey
Carl Schmid, The AIDS Institute
Andrea Weddle, HIV Medicine
Association
Lee Storrow
Charlene Galareau, Ph.D. Wellesley
College
Ruth M Jacobs, M.D. Rockville, MD
Cliff Kincaid, America’s Survival, Inc.

12:00 Analysis of Policy Options by the PHS Working Richard Davey, M.D.
Group FDA, CBER, OBRR

12:30 Lunch

1:30 Committee Discussion Committee

5:00 Adjournment

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