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U.S. Department of Health and Human Services

Advisory Committees

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August 2-3, 2011: Blood Products Advisory Committee Meeting: Final Agenda

Tuesday, August 2, 2011

1:30 p.m.

Opening Remarks, Blaine Hollinger, M.D., Chair

Statement of Conflicts of Interest, Announcements

1:40 p.m.

Topic I: T. cruzi Incidence Study in Blood Donors and Its Implications for Selective Testing of Blood Donors

  1. Introduction and Background, Robert Duncan, Ph.D., DETTD, OBRR, FDA (15’)
  2. Presentation of Study Results, Susan Stramer, Ph.D., American Red Cross (45’)
  3. Estimated Frequency of Travel to Endemic Areas, Brian Custer, Ph.D., M.P.H., Blood Systems Research Institute (20’)
  4. Summary and Questions for the Committee, Robert Duncan, Ph.D. (5’)
3:15 p.m.Break
3:30 p.m.Open Public Hearing
4:00 p.m.

Open Committee Discussion

Questions for the Committee

5:00 p.m.Adjournment

Wednesday, August 3, 2011

8:00 a.m.

Opening Remarks, Blaine Hollinger, M.D., Chair

Statement of Conflicts of Interest, Announcements

8:10 a.m.

Topic II: Maintaining a Safe and Adequate Supply of Donated Blood During a Severe Emergency

  1. Introduction and FDA’s Considerations, Alan Williams, Ph.D., OBRR, FDA (30’)
  2. History of Blood Utilization in Emergency Situations, John Hess, M.D., M.P.H., University of Maryland School of Medicine (20’)
  3. Overview of Current Emergency Response Systems to Ensure Blood Availability
    1. Department of Health and Human Services Responsibilities under Emergency Support Function # 8, Jerry Holmberg, Ph.D., Senior Advisor for Blood, Office of the Assistant Secretary for Health, HHS (20’)
    2. Role of the AABB Interorganizational Task Force on Domestic Disasters and Acts of Terrorism, Jamie Blietz, M.B.A., CAE, AABB (15’)
    3. Practical Aspects of Emergency Response in Blood Establishments, Louis Katz, M.D., Mississippi Valley Regional Blood Center (15’)
  4. Physiology of Blood Loss/Donor Response to Reduced Interdonation Intervals, John Feiner, M.D., University of California, San Francisco (35’)
  5. Blood Center Experience with Double Red Cell Collections by Apheresis, Peter Tomasulo, M.D., Blood Systems, Inc. (15’)
  6. Questions for the Committee, Alan Williams, Ph.D., OBRR, FDA (5’)
10:50 a.m.Break
11:00 a.m.Open Public Hearing
11:30 a.m.

Open Committee Discussion

Questions for the Committee

12:30 p.m.Break
12:45 p.m.

Committee Updates

  • Update from the HHS Advisory Committee on Blood Safety and Availability and Summary of June 7-8, 2011 Meeting, Jerry Holmberg, Ph.D., Office of the Assistance Secretary for Health (15’)
  • Summary of May 17-18, 2011 Workshop on Risk Mitigation Strategies to Address Procoagulant Activity in Immune Globulin Products, Dorothy Scott, M.D., DH, OBRR, FDA (15’)
  • Summary of August 1, 2011 Transmissible Spongiform Encephalopathies Advisory Committee, David Asher, M.D., DETTD, OBRR, FDA (15’)
1:30 p.m.Adjournment