Food and Drug Administration

Center for Biologics Evaluation and Research

 

SUMMARY MINUTES

VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE

 

 

Meeting # 103: September 22, 2005

Teleconference Meeting

 

Committee Members FDA Participants

Dr. Gary D. Overturf, Chair Dr. Hana Golding

Dr. Walter Royal III Dr. Bruce D. Meade

Dr. Ruth A. Karron Dr. Drusilla L. Burns

Dr. David Markovitz Dr. Ira Berkower

Dr. Monica M. Farley Dr. Kathryn Carbone

Dr. Philip S. LaRussa Dr. Norman Baylor

Dr. Steven Self Dr. Jerry Weir

Ms. Cindy Lyn Province, R.N., M.S.N.* Dr. Richard Walker

Dr. Philip Krause

Dr. Michael Brennan

 

Absent:

Dr. Bonnie M. Word

 

Executive Secretary Committee Management Specialist

Christine Walsh, R.N. Denise Royster

 

 

These summary minutes for the September 22, 2005 Meeting of the Vaccines and Related Biological products Advisory Committee were approved on _______________________.

 

I certify that I participated in the September 22, 2005 Meeting of the Vaccines and Related Biological Products Advisory Committee and that these minutes accurately reflect what transpired.

 

 

 

____________________________ ______________________________

Christine Walsh, R.N. Gary D. Overturf, M.D.

Executive Secretary Chair

 

 

*Consumer Representative

 

 

The Chair, Dr. Gary D. Overturf, called the one hundred and third Meeting of the Vaccines and Related Biological Products Advisory Committee to order at 1:35 p.m. ET on September 22, 2005. The meeting addressed the April 18 19, 2005 site visit of the intramural research programs of the Laboratory of Retroviruses and the Laboratory of Immunoregulation, Division of Viral Products, and the June 16, 2005 site visit of the Laboratory of Respiratory & Special Pathogens and the Laboratory of Methods Development & Quality Control, Division of Bacterial Parasitic & Allergenic Products, Office of Vaccines Research and Review (OVRR), Center for Biologics and Research (CBER).

 

The meeting was held by telephone conference call. The public was welcome to attend the open session of the meeting at the Food and Drug Administration, Building 29B, Conference Room C, Bethesda, MD. A speakerphone was provided at the specified location for public participation.

 

An Open Public Hearing was announced. Public comment was offered via an electronic message from B. Sachau. Copies of the comment were provided to committee members, displayed in the public notebook at the meeting, and posted on the FDA website. No other 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: http://www.fda.gov/ohrms/dockets/ac/cber05.html#VaccinesandRelatedBiological.

 

Proceedings were adjourned at approximately 4:00 p.m. ET on September 22, 2005.

 

Open Session

 

The telephone conference meeting focused on the intramural research programs of the Laboratory of Retroviruses and the Laboratory of Immunoregulation, Division of Viral Products, and the Laboratory of Respiratory & Special Pathogens and the Laboratory of Methods Development & Quality Control, Division of Bacterial Parasitic & Allergenic Products, Office of Vaccines Research and Review (OVRR). The committee heard presentations, to include overviews of each research laboratory, from Dr. Hana Golding, Laboratory of Retroviruses; Dr. Ira Berkower, Laboratory of Immunoregulation; Dr. Drusilla L. Burns, Laboratory of Respiratory & Special Pathogens; and Dr. Bruce D. Meade, Laboratory of Methods Development & Quality Control.

 

Closed Session

 

The committee discussed the site visit reports from the April 18 -19, 2005 Laboratory of Retroviruses and Laboratory of Immunoregulation and the June 16, 2005 Laboratory of Respiratory and Special Pathogens and Laboratory of Methods Development & Quality Control site visits.