Implementation of the Pandemic and All-Hazards Preparedness Act Briefing for National Vaccine Advisory Commitee February 5, 2007 By: Brian Kamoie Acting Director Office of Policy & Strategic Planning ASPR

2 Outline Brief Overview of Statute Implementation Plan and Structure Next steps

3 Brief Overview of Act Extensive 137-page bill affects all aspects of the Department’s preparedness and response functions. Codifies HHS as lead of Federal public health and medical response to public health emergencies and National Response Plan (NRP) incidents. Directs HHS to enter into an interagency agreement with DHS, VA, DoT to assume operational control of Federal public health and medical personnel and assets during incidents (except Department of Defense (DOD)). Creates a new Assistant Secretary for Preparedness and Response (ASPR): –Senate confirmed position –Principal advisor to the Secretary on public health and medical preparedness and response –Deployment authority for Federal personnel (including National Disaster Medical System) –Oversee advanced research, development, and procurement of qualified countermeasures –Coordinate public health and medical response systems with Federal, State, local, Tribal and EMAC –All functions of ASPHEP

4 Brief Overview of Act (continued) ASPR has “authority over and responsibility for”: –NDMS (transferred to HHS as of January 1, 2007) –Hospital Preparedness Cooperative Agreement Program (transferred from HRSA) ASPR shall “exercise the responsibilities and authorities of the Secretary with respect to the coordination of”: –Medical Reserve Corps (currently coordinated by the Assistant Secretary for Health); –ESAR-VHP (currently coordinated by HRSA); –Strategic National Stockpile (currently coordinated by CDC and ASPR); –Cities Readiness Initiative (currently coordinated by CDC and ASPR); and –Other duties as the Secretary determines appropriate. ASPR shall carry out other duties as the Secretary determines appropriate ASPR leads in international preparedness and response initiatives and activities Requires evidence-based benchmarks and standards that measure levels of preparedness. Starting in 2009 and every four years, the Secretary shall submit the National Health Security Strategy and implementation plan for public health emergency preparedness and response, to include an evaluation of progress of Federal, State, local, and Tribal entities based on the evidence-based benchmarks and objective performance standards.

5 Brief Overview of Act (continued) Establishes the Biomedical Advanced Research and Development Authority (BARDA) within HHS, led by a Director appointed by the Secretary Requires Secretary to publish a strategic plan to integrate biodefense requirements with advanced research and development, strategic initiatives for innovation, and the procurement of qualified countermeasures. Secretary may use advanced and milestone payments in awarding contracts, grants, and cooperative agreements for medical countermeasure development. Advanced payment can be up to 10% of total award, and additional milestone payments of 5% each may be used up to a total of 50% of the total award amount. Requires the Secretary to convene meetings with representatives from relevant industries, academia, other Federal agencies, and stakeholders at least annually. Provides antitrust protection for industry meetings and activities undertaken pursuant to written agreements approved by the Attorney General and Federal Trade Commission Chairman. Provides additional streamlined transaction and direct hiring authorities.

6 Brief Overview of Act (continued) HHS to establish a near real-time electronic nationwide public health surveillance system through a network of interoperable systems. Directs improvement in force management and readiness of the Commissioned Corps, including training requirements. HHS to conduct a joint review of NDMS with DHS, DOD, and VA within 180 days of enactment, including an evaluation of medical surge capacity and mobile medical units. Enhances VA’s support of the Secretary of HHS during incidents (including directive to train and equip staff and centers and provide supplies and logistical support)

7 Implementation Plan Draft plan specifies actions called for in the statute with: –Timeline –Measure of Performance –Lead for activity Organized by chapters that align with workgroups Similar to large-scale implementation plans (e.g., National Strategy for Pandemic Influenza Implementation Plan) To be circulated internally for comment this week

8 Implementation Structure Secretary Deputy Secretary Senior Steering Committee Coordinated by ASPR Implementation Team Surveillance System/ Information Technology ESF #8 Public Health and Medical Response At-Risk Individuals Grants Medical Countermeasures (BARDA) National Health Security Strategy Education and Training International Programs Assistant Secretary- Agency Head Level Senior Staff Level

9 Next Steps Circulate draft Implementation Plan Present program recommendations to the Secretary for Decision Convene Implementation Team and Workgroups