FOOD AND DRUG ADMINISTRATION

CENTER FOR BIOLOGICS EVALUATION AND RESEARCH

VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE

MEETING ON CBER LABORATORY SITE VISITS

LABORATORY OF MYCOBACTERIAL DISEASES & CELLULAR IMMUNOLOGY

LABORATORY OF METHOD DEVELOPMENT

MEETING BY TELECONFERENCE

May 8, 2003

BUILDING 29B, CONFERENCE ROOM A

Bethesda, Maryland

1:30 PM EST

AGENDA

DRAFT as of 4/04/03

1:30 p.m. Call to Order David Stephens, M.D.

VRBPAC Chair

1:35 p.m. Announcements Jody Sachs, D.P.M.

VRBPAC Exec. Sec., FDA

1:45 p.m. Open Session

Overview of Division of Bacterial, Parasitic & Allergenic Products

Richard Walker, Ph.D.

Division Director, FDA

1:55 p.m. Overview of Division of Viral Products Jerry Weir, Ph.D.

Division Director, FDA

Laboratory of Mycobacterial Diseases & Cellular Immunology:

2:10 p.m. Overview of Research Activities Sheldon Morris, Ph.D.

Chief LMDCI, FDA

Laboratory of Method Development:

2:20 p.m. Overview of Research Activities Konstantin Chumakov, Ph.D.

Chief LMD, FDA

2:30 p.m. Open Public Hearing

3:30 p.m. Closed Session

Discussion and Committee Recommendations

4:00 p.m. Adjournment