Emergency Preparedness and Response
Federal, State, and Local Public Health Preparedness Legal and Regulatory Meeting (December 14-15, 2010)
The 2009-2010 H1N1 influenza pandemic highlighted regulatory, legal, and policy challenges and successes related to distributing and dispensing medical countermeasures at the state and local levels during a public health emergency. In December 2010, FDA’s Office of Counterterrorism and Emerging Threats convened a meeting in Baltimore, MD, to bring together local, state, and federal public health stakeholders, including legal counsel, to discuss these experiences. The meeting provided state public health preparedness officials with federal perspectives on the latest legal, regulatory, and policy issues at the time. It was also intended to provide a forum for state and local public health stakeholders to inform federal partners about their public health emergency preparedness and response experiences.
NOTE: The information provided below, including presentations and questions and answers, was developed and presented before the enactment of the Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA). The statutory authority discussed in some of these materials has been amended by PAHPRA.
Public Health Preparedness Meeting Materials (2010)
Q's and A's on Public Health Preparedness Meeting[ARCHIVED] FDA Regulation of Medical Products(PDF - 143KB) [ARCHIVED] Public Health Emergency Authorities: Determinations and Declarations(PDF - 164KB) [ARCHIVED] Shelf Life Extension Program (SLEP)(PDF - 325KB) [ARCHIVED] EUA: CDC's Roles and Responsibilities(PDF - 828KB) [ARCHIVED]