Three important principles color the issues in public health and medical preparedness and response. First, preparedness and response are different functions. At each level of government, they involve different leadership roles, legal authorities, organizational structures, and funding mechanisms. Generally, during an incident, certain conditions must be met before a jurisdiction can implement response activities, or access funds reserved for that purpose. Second, states and localities, rather than the federal government, are the seats of authority and responsibility for the oversight of both health care and emergency management. For example, state laws generally authorize governors to order and enforce the evacuation of residents in emergency situations. Except under extraordinary circumstances, the federal government generally does not dictate the conduct of health care or emergency management activities to state or local officials, or to health care providers. Finally, most public health functions—broad, population-based programs, such as restaurant inspections to assure food safety—are inherently governmental. In contrast, the nation's health care system—which delivers professional health care services to individuals—is primarily private and for-profit. Providers and facilities operate in an increasingly competitive marketplace in which emergency planning is not always seen as a necessary expense. The 2001 terrorist attacks, the flawed response to Hurricane Katrina, and concerns about an influenza ("flu") pandemic sharpened congressional interest in the nation's ability to track and respond to health threats. The 109 th Congress established or reauthorized relevant programs and activities in the Departments of Health and Human Services (HHS) and Homeland Security (DHS). The 110 th Congress focused on oversight of these activities, in particular (1) the fitness of HHS and DHS—in terms of authority, funding, policies, and workforce—to respond to health emergencies; (2) the effectiveness of federal agency coordination; and (3) the status of major initiatives such as pandemic flu preparedness and disaster planning for at-risk populations. The 111 th Congress is likely to remain engaged in oversight of the nation's readiness for health threats. It faces a different and dynamic landscape, however. The Obama Administration will likely usher in some shifts in preparedness priorities, in direction and degree yet to be shown. The nation's health care system is the subject of a vigorous reform debate. Although emergency management is not the focus of that debate, significant system reforms, if enacted, would likely affect emergency planning needs and system response capacity. And the nation's unsettled economy poses a dilemma for policy makers. Future spending for public programs may be significantly constrained, unless a program were seen as a means for job creation, or some other engine of economic stimulus. It remains to be seen where federal programs to address health emergencies will fit into this complex picture. This report, which will be updated as needed, summarizes key issues in domestic public health and medical preparedness and response, citing other CRS Reports and sources of additional information. The 109 th Congress enacted two comprehensive laws affecting public health and medical preparedness and response. The Pandemic and All-Hazards Preparedness Act (PAHPA, P.L. 109-417 ), passed in 2006, established or extended programs for public health emergency preparedness and response activities in HHS, and established a Biomedical Advanced Research and Development Authority (BARDA) in HHS to oversee the development and procurement of medical countermeasures (e.g., diagnostic tests, drugs, and vaccines). The Post-Katrina Emergency Management Reform Act of 2006 (PKA, Title VI of P.L. 109-295 ) reorganized DHS and, within it, the Federal Emergency Management Agency (FEMA). The PKA also codified the position of DHS Chief Medical Officer, with primary responsibility within DHS for medical issues related to natural and man-made disasters and terrorism. The Obama Administration may reconsider any number of homeland security objectives, and its priorities are likely to differ, at least somewhat, from those of the George W. Bush Administration. For example, the Bush Administration placed considerable emphasis on the detection of and response to a large-scale biological attack. Among other things, it established the BioWatch system of air monitors in major cities, and redirected federal funds from states to these cities to bolster planning for mass dispensing of antibiotics in response to an attack. These efforts were widely critiqued. Some said they were excessive, draining resources from routine public health and biomedical research needs. Others said they were insufficient to protect the public in a timely manner. Still others questioned the basic effectiveness of the programs. Critiques are likely to continue, whether or not the Obama Administration maintains its predecessors' priorities. The transition also marks the first transfer of presidential authority for the Department of Homeland Security (DHS), and for a number of homeland security positions and programs established since 2001. These positions include the Assistant Secretary for Health Affairs and Chief Medical Officer at DHS (DHS CMO), the Assistant Secretary for Preparedness and Response (ASPR) in the Department of Health and Human Services (HHS), and their corresponding offices and activities. Shifts in doctrine or priority in the new Administration, if any, may manifest when key positions are filled, or when the budget proposal for FY2010 is unveiled. The 111 th Congress may consider removing FEMA from DHS and re-establishing it as a separate agency, as it was in the Clinton Administration. Other substantial reorganizations of federal homeland security agencies do not appear to be under debate at this time. Congress may consider relocating certain programs, however. (See, for example, the subsequent section " Select Agent Program .") Also, President Obama may consider reorganizing certain homeland security functions, such as those of the Homeland Security Council (HSC). President George W. Bush established the HSC in the Executive Office of the President shortly after the 2001 terrorist attacks. From 2005 through 2008, the HSC served as the hub of federal preparedness activities for pandemic flu, involving HHS, DHS, the State Department, and other federal departments and agencies. Some have called for a merger of the HSC with the larger National Security Council (NSC), citing a number of responsibilities shared by the two. It is reported that President Obama has called for a comprehensive review of the functions of the NSC. For public health and medical preparedness and response, the roles and responsibilities of principals in HHS and DHS have shifted in past years. The 109 th Congress provided some clarity, but refinement of these roles and responsibilities is likely to continue for some time to come. Pursuant to the PAHPA and the PKA, applicable activities in DHS are led by the DHS CMO, and in HHS by the HHS ASPR. The PKA provided that the DHS CMO "shall have the primary responsibility within the Department for medical issues related to natural disasters, acts of terrorism, and other man-made disasters," while the PAHPA provided that the "Secretary of [HHS] shall lead all Federal public health and medical response to public health emergencies and incidents.... " (Emphasis added.) Hence, the Secretary of Homeland Security leads all federal emergency and disaster response activities; the DHS CMO leads both preparedness and response activities for public health and medical care, but only within DHS; and the Secretary of HHS, through the ASPR, leads all federal public health and medical response activities, under the overall leadership of the Secretary of Homeland Security. The Government Accountability Office (GAO) noted, in the context of pandemic flu planning, that " ... these leadership roles involve shared responsibilities, and it is not clear how these would work in practice." GAO recommended that DHS and HHS conduct training and exercises to ensure that federal leadership roles are clearly defined and understood. In February 2009, GAO reported that although some recommended activities have been undertaken, it is unclear whether these exercises rigorously tested federal leadership roles in a pandemic. Federal incident response activities are coordinated according to the National Response Framework (NRF), and "all-hazards" blueprint published by DHS. Public health and medical response activities (under the leadership of HHS) are laid out in an annex called Emergency Support Function #8 , or ESF-8. These activities, at the federal, state, and local levels, are commonly referred to as ESF-8 activities. The NRF replaced the earlier National Response Plan, incorporating lessons from the flawed response to Hurricane Katrina. Nonetheless, some leadership gaps and conflicts remain in ESF-8. In addition to the inter-related roles of the HHS ASPR and the DHS CMO discussed above, there are concerns about a lack of leadership clarity for responder health and safety (see " The Health and Safety of Disaster Responders "); emergency sheltering; mass fatality management; and mental health services, among others. On January 28, 2009, DHS Secretary Janet Napolitano announced an action directive to review the Department's plans for the response to a large-scale medical incident. The directive required specific DHS offices and components, working with state and local partners, to review and assess current plans (including ESF-8 in the NRF), relevant homeland security grant programs, and other matters. DHS components were to report to the Secretary by February 24, 2009. The PAHPA requires the HHS Secretary to publish a comprehensive, all-hazards national public health and medical response strategy and implementation plan (the "National Health Security Strategy," or NHSS), beginning in 2009, and quadrennially thereafter. The NHSS is to include a process for achieving a number of preparedness goals enumerated in the statute. In 2007, the Bush Administration published a homeland security directive to establish a "national strategy for public health and medical preparedness," including implementation steps. The directive stated that the principles and actions it contained were to be incorporated into the NHSS, and serve as a foundation to address the preparedness goals prescribed by the PAHPA.