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November 13, 2013: Vaccines and Related Biological Products Advisory Committee Meeting Summary Minutes

Food and Drug Administration
Center for Biologics Evaluation and Review

SUMMARY MINUTES
VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE

November 13, 2013
Teleconference Meeting

Committee MembersFDA Participants
Dr. Robert Daum, Chair
Dr. Gillian Air
Dr. Michael Hudgens
Dr. Pedro Piedra
Dr. Ambrose Cheung
Dr. Anna Durbin #
Dr. Gregory Gray 
Dr. Gary Schoolnik
Dr. Carol Tacket
Dr. Edgar Marcuse
Dr. Kent Kester +
Dr. Theordore Tsai **+
Dr. Stephanie Christner *
Dr. Carolyn Wilson
Dr. Konstantin Chumakov
Dr. Jerry Weir
Dr. Hana Golding
Dr. Carol Weiss
Dr. Ira Berkower
Dr. Marion Gruber
Designated Federal Official  Committee Management Specialist
Donald Jehn, M.S.Rosanna Harvey
Joanne Lipkind

These summary minutes for the November 13, 2013 Meeting of the Vaccines and Related Biological Products Advisory Committee were approved on November 19, 2013.

I certify that I participated in the November 13, 2013 Meeting of the Vaccines and Related Biological Products Advisory Committee and that these minutes accurately reflect what transpired.

/// original signed////// original signed///
Donald Jehn, M.S.  
Designated Federal Official
Robert Daum, M.D.
Chair

*Consumer Representative
# Chair for Site Visit Review of Laboratory of Retrovirus Research and Laboratory of Immunoregulation
** Industry Representative
+ Did not attend

The Chair, Dr. Robert Daum, called the Meeting of the Vaccines and Related Biological Products Advisory Committee to order at 12:30 p.m. EST on November 13, 2013.  The meeting addressed the June 4, 2013 site visit of the intramural research programs of the Laboratory of Retrovirus Research (LRR) and Laboratory of Immunoregulation (LIR), Division of Viral Products (DVP), Office of Vaccines Research and Review (OVRR), Center for Biologics Evaluation and Research (CBER).

The meeting was held by telephone conference call and adobe connect.  The public was welcome to attend the open session of the meeting at the Food and Drug Administration, Rockwall II Bldg, Conference Room 1033, 5515 Security Lane, Rockville, MD.  A speakerphone was provided at the specified location for public participation.

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

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 the   2013 Vaccines and Related Biological Products Advisory Committee Meetings main page.
Proceedings were adjourned at approximately 3:30 p.m. EST on November 13, 2013.

Open Session
The telephone conference meeting focused on the intramural research programs of the Laboratory of Retrovirus Research and Laboratory of Immunoregulation, Division of Viral Products, Office of Vaccines Research and Review.  The committee heard presentations of an overview of the Research Site Visit Process and OVRR’s research programs from Dr. Carolyn Wilson, an overview of the Division of Viral Products from Dr. Jerry Weir, an overview of the Laboratory of Retrovirus Research from Dr. Hana Golding and an overview of the Laboratory of Immunoregulation from Carol Weiss. 

Closed Session
The committee discussed the site visit report of June 4, 2013 with Dr. Durbin giving an overview of the report.  The committee approved this report with minor administrative modifications.