• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Advisory Committees

  • Print
  • Share
  • E-mail

August 2, 2013 Blood Products Advisory Committee Meeting Summary Minutes

Food and Drug Administration
Center for Biologics Evaluation and Review

SUMMARY MINUTES
BLOOD PRODUCTS ADVISORY COMMITTEE

August 2, 2013
National Institute of Health, Building 29B, Conference Rooms A&B

Committee Members FDA Participants
Participants
Dr. Jay Brooks Jackson##
Dr. Francisco A. Bonilla
Dr. Demetrios Demetriades
Dr. Donna DiMichele
Dr. Valerie  Durkalski-Mauldin
Dr. Ronald Gilcher
Dr. Nigel Key
Dr. Jennifer Kuzma
Dr. Matthew Kuehnert
Dr. Jeanne Linden
Dr. James Maguire
Dr. Steven Pipe
Dr. Peter Rhee #
Dr. Katherine Schexneider
Dr. Christopher Stowell
Mr. Corey Dubin* 
Dr. Topy Simon#
Dr. Carolyn Wilson
Dr. Hira Nakhasi
Dr. Indira Hewlett
Dr. Peter Marks
Dr. Paul Mied
Dr. C.D. Atreya
Designated Federal Official
Emery Bryan, R.N., LCDR, USPHS
Committee Management Specialist
Pearline Muckelvene
Rosanna Harvey
Joanne Lipkind
*  Consumer Representative
** Industry Representative
# Did not attend
## Chair

The summary minutes for the August 2, 2013 meeting of the Blood Products Advisory Committee were approved on September, 16 2013.

I certify that I participated in the August 2, 2013 meeting of the Blood Products Advisory Committee and that the minutes accurately reflect what transpired.

/signature/ /signature/
Emery Bryan, R.N., LCDR, USPHS
Designated Federal Officer
Jay B. Jackson, M.D.
Chair

Dr. J. Brooks Jackson, Chair, called the meeting of the Blood Products Advisory Committee to order at 10:00 a.m. EST on August 2, 2013.  In open session, the Committee discussed the Review of the Research Programs in the Laboratory of Molecular Virology (LMV), Division of Emerging and Transfusion Transmitted Diseases (DETTD), Office of Blood Research and Review (OBRR), Center for Biologics Evaluation and Research (CBER).

The Committee members participated in the meeting by telephone conference call. The public attended the open session of the meeting at the Food and Drug Administration, Building 29B, Conference Rooms A and B in Bethesda, MD. A speakerphone was provided at the specified location for public participation.

An Open Public Hearing was announced.  No public comment was offered.

The Committee then met in closed session to discuss the Site Visit Report. 

Following is a summary of the discussion.  Additional information and specific details may be obtained from the transcript of the meeting.  The transcript may be viewed on the World Wide Web at August 2, 2013 Blood Products Advisory Committee Meeting Transcript.

Open Session
The Committee discussed the intramural research programs of the Laboratory of Molecular Virology in the Division of Emerging and Transfusion Transmitted Diseases, Office of Blood Research and Review.  The committee heard the following presentations:  Overview of CBER and OBRR Research Programs from Dr. Carolyn Wilson; Overview of the Division of Emerging and Transfusion Transmitted Diseases Research Program from Dr. Hira Nakhasi; and Overview of the Laboratory of Molecular Virology by Dr. Indira Hewlett.
An Open Public Hearing was announced.  No public comments were made. The Committee then went into closed session.