Food and Drug Administration

Center for Biologics Evaluation and Research

Vaccines and Related Biological Products Advisory Committee

Teleconference Meeting

November 20, 2008

National Institutes of Health

Building 29B/Conference Room C

DRAFT AGENDA

Open Session

1:00 p.m. Call to Order John Modlin, M.D., Acting Chair

Administrative Matters Christine Walsh R.N., FDA

Presentation of Laboratory of DNA Viruses, Division of Viral Products, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research

1:10 Overview of Research/Site Visit Process, Carolyn Wilson, Ph.D., FDA

Center Biologics Evaluation and Research (CBER)

1:20 Overview Office of Vaccines Research Konstantin Chumakov, Ph.D., FDA

and Review (OVRR), CBER

1:30 Overview Division of Viral Products (DVP), Jerry Weir, Ph.D., FDA

OVRR

1:40 Overview Laboratory of DNA Viruses Philip Krause, Ph.D., FDA

2:15 Q&A

2:30 Open Public Hearing (if no speakers, will move directly to closed session)

3:30 Closed Session

4:00 Adjourn Meeting