Congressional comment on the study charge

Mr. Robert Neal, Legislative Assistant, Office of Representative George Nethercutt, Jr.

9:15

Concerns Regarding the Safety or Efficacy of Anthrax Vaccine

Dr. Meryl Nass

Dr. George Robertson

10:00

Break

10:15

Anthrax the Disease, and Anthrax Vaccine Development and History

LTC John D. Grabenstein, Deputy Director for Clinical Operations, Anthrax Vaccine Immunization Program

LTC Mark G. Kortepeter, Chief, Education and Training, Operational Medicine Division, U.S. Army Medical Research Institute of Infectious Diseases

11:00

The DoD Anthrax Vaccine Immunization Program (AVIP) Status and Projected Future

LTC John D. Grabenstein, Deputy Director for Clinical Operations, Anthrax Vaccine Immunization Program

11:45

Working lunch

12:30 p.m.

How Are Safety and Efficacy Determined by FDA?

Dr. Juli Clifford, Division of Vaccines and Related Products Applications, Center for Biologics Evaluation and Research, FDA

Dr. Karen Midthun, Director, Office of Vaccines Research and Review, Center for Biologics Evaluation and Research, FDA

1:15

The Vaccine Adverse Events Reporting System (VAERS)

Dr. Gina Mootrey, VAERS Project Officer, National Immunization Program, CDC

2:00

The Anthrax Vaccine Expert Committee (AVEC)

Dr. Vito Caserta, Health Resources and Services Administration, DHHS

2:30

Adjourn Open Session