FOOD AND DRUG ADMINISTRATION

CENTER FOR BIOLOGICS EVALUATION AND RESEARCH

VACCINES AND RELATED BIOLOGICAL PRODUCTS ADVISORY COMMITTEE

MEETING BY TELECONFERENCE

AGENDA

September 22, 2005

Food and Drug Administration, NIH campus

* FDA Building 29B, Conference Room C

8800 Rockville Pike, Bethesda, MD

1:30 PM EST

1:30 p.m. Call to Order and Opening Remarks Dr. Gary Overturf, Chair

1:35 Announcements/Administrative Matters Christine Walsh, R.N., FDA

Open Session – Presentation on Laboratory of Retroviruses and Laboratory of

Immunoregulation, Division of Viral Products; Laboratory of Respiratory &

Special Pathogens and Laboratory of Methods Development & Quality Control,

Division of Bacterial Parasitic & Allergenic Products

1:40 p.m. Laboratory of Retroviruses, Division of Viral Products

Overview of Laboratory Dr. Hana Golding, FDA

2:00 Laboratory of Immunoregulation, Division of Viral Products

Overview of Laboratory Dr. Ira Berkower, FDA

2:20 Laboratory of Respiratory & Special Pathogens, Division of Bacterial

Parasitic & Allergenic Products

Overview of Laboratory Dr. Drusilla L. Burns, FDA

2:40 Laboratory of Methods Development & Quality Control, Division

of Bacterial Parasitic & Allergenic Products

Overview of Laboratory Dr. Bruce D. Meade, FDA

3:00 p.m. Open Public Hearing (If needed, otherwise will move directly to

closed session)

4:00 p.m. Break (Prepare for closed session)

4:05 p.m. Closed Session

5:05 p.m. Adjourn Meeting

* The public may attend the meeting at the above location where equipment will be provided to allow public participation in the meeting.