September 20, 2011: Vaccines and Related Biological Products Advisory Committee Meeting Agenda

AGENDA
Food and Drug Administration
Center for Biologics Evaluation and Research
Vaccines and Related Biological Products Advisory Committee
127th Meeting via Teleconference
National Institutes of Health
Bldg. 29B, Conference Room C
September 20, 2011

Open Session

1:00 p.m.	Call to Order and Opening Remarks	Jose Romero, M.D., Chair
	Conflict of Interest Statement	Donald Jehn, M.S., FDA

Topic I

Presentation of Laboratory of Enteric and Sexually Transmitted Diseases, Division of Bacterial, Parasitic, and Allergenic Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research

1:15	Overview of Research/Site Visit Process, Center Biologics Evaluation and Research (CBER)	Carolyn Wilson, Ph.D., FDA
1:30	Overview Office of Vaccines Research and Review (OVRR), CBER	Konstantin Chumakov, Ph.D., FDA
1:45	Overview Division of Bacterial, Parasitic, And Allergenic Products, OVRR	Jay Slater, M.D., FDA
2:00	Overview Laboratory of Laboratory of Enteric And Sexually Transmitted Diseases	Scott Stibitz, Ph.D., FDA
2:30	Open Public Hearing (if no speakers, will move directly to closed session)
3:30	Closed Session
4:00	Adjourn Meeting