FOOD AND DRUG ADMINISTRATION

CENTER FOR BIOLOGICS EVALUATION AND RESEARCH

VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE

MEETING ON CBER LABORATORY SITE VISIT

LABORATORY OF ENTERIC AND SEXUALLY TRANSMITTED DISEASES

MEETING BY TELECONFERENCE

NOVEMBER 18, 2002

BUILDING 29B, CONF. ROOM C

Bethesda, Maryland

1:00 PM EST

1:00 p.m. Call to Order Robert Daum, M.D.

VRBPAC Chair

1:15 p.m. Announcements Jody Sachs, D.P.M.

VRBPAC Exec. Sec., FDA

1:20 p.m. Open Session

Overview of Division of Bacterial, Parasitic & Allergenic Products

Richard Walker, Ph.D.

Division Director, FDA

1:30 p.m. Overview of Laboratory of Enteric and Sexually Transmitted Diseases (LESTD)

Dennis Kopecko, Ph.D.

Laboratory Chief, FDA

1:40 p.m. Overview of Research Activities Scott Stibitz, Ph.D.

LESTD, FDA

1:50 p.m. Overview of Research Activities Philip Boucher, Ph.D.

LESTD, FDA

2:00 p.m. Open Public Hearing

3:00 p.m. Closed Session

Discussion and Committee Recommendations

3:30 p.m. Adjournment