Food and Drug Administration
Center for Biologics Evaluation and Research
SUMMARY MINUTES
VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE
Meeting # 115: November 20, 2008
Teleconference Meeting
Committee Members FDA Participants
Dr. John Modlin,
Dr. Vicky DeBold* Dr. Jerry Weir
Dr. Pablo Sanchez Dr. Norman Baylor
Dr. Frank DeStefano
Dr. Peter Gilbert
Dr. Seth Hetherington**
Dr. Lisa Jackson***
Designated Federal Officer Committee Management
Specialist
Christine Walsh, R.N. Denise Royster
These summary minutes for the November 20, 2008 Meeting of the Vaccines and Related Biological Products Advisory Committee were approved on ___November 26, 2008____.
I certify that I participated in the November 20, 2008 Meeting of the Vaccines and Related Biological Products Advisory Committee and that these minutes accurately reflect what transpired.
______/s/________________ _________/s/_______________
Christine Walsh, R.N. John Modlin, M.D.
Designated Federal Officer Acting Chair
* Consumer Representative
** Industry Representative
*** Absent November 20, 2008 Meeting
The Acting Chair, Dr. John Modlin called the one hundred and fifteenth Meeting of the Vaccines and Related Biological Products Advisory Committee to order at 1:05 p.m. ET on November 20, 2008. The meeting addressed the April 3, 2008 site visit of the intramural research programs of the Laboratory of DNA Viruses, Division of Viral Products, Office of Vaccines Research and Review (OVRR), Center for Biologics Evaluation 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 National Institutes of Health, Building 29B,
Conference Room C,
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: http://www.fda.gov/ohrms/dockets/ac/cber08.html#VaccinesandRelatedBiological.
Proceedings were adjourned at approximately 3:30 p.m. ET on November 20, 2008.
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 (OVRR). The committee heard presentations on the overview of the Laboratory Site Visit process from Dr. Carolyn Wilson, FDA, an overview of the Office of Vaccines Research and Review from Dr. Konstantin Chumakov, FDA, an overview of the Division of Viral Products from Dr. Jerry Weir, FDA, and an overview of the Laboratory of DNA Viruses from Dr. Philip Krause, FDA.
Closed Session
The committee discussed the site visit report from the April 3, 2008, Laboratory of DNA Viruses. The committee approved the site visit report.