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May 8, 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

May 8, 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. Carolyn Wilson
Dr. Konstantin Chumakov
Dr. Robin Levis
Dr. Keith Peden
Dr. Philip Krause
Dr. Peter Marks
Designated Federal Official
Donald Jehn, M.S.
Committee Management Specialist
Denise Royster
Joanne Lipkind

These summary minutes for the May 8, 2013 Meeting of the Vaccines and Related Biological Products Advisory Committee were approved on May 13, 2013.

I certify that I participated in the May 8, 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

*Did not attend meeting
**Chair for Site Visit Review of Laboratory of DNA Viruses
# Industry Representative (only open session)

The Chair, Dr. Robert Daum, called the Meeting of the Vaccines and Related Biological Products Advisory Committee to order at 1:00 p.m. EDT on May 8, 2013.  The meeting addressed the February 22, 2013 site visit of the intramural research programs of the Laboratory of DNA Viruses (LDNAV), 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 page.

Proceedings were adjourned at approximately 2:40 p.m. EDT on May 8, 2013.

Open Session
The telephone conference meeting focused on the intramural research programs of the Laboratory of DNA Viruses, 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. Robin Levis, and an overview of the Laboratory of DNA Viruses from Dr. Keith Peden. 

Closed Session
The committee discussed the site visit report of February 22, 2013 with Dr. Durbin giving an overview of the report.  The committee approved this report without modifications.