On December 19, 2006, President George W. Bush signed S. 3678 , the Pandemic and All-Hazards Preparedness Act ( P.L. 109-417 ), which authorizes appropriations through FY2011 to improve bioterrorism and other public health emergency preparedness and response activities, and establishes the Biomedical Advanced Research and Development Authority (BARDA) within the Department of Health and Human Services (HHS) for the advanced research and development of medical countermeasures. The Pandemic and All-Hazards Preparedness Act effected the second comprehensive reauthorization of federal programs designed to improve the nation's readiness for public health threats such as bioterrorism or pandemic influenza. Many of these authorities, found principally in the Public Health Service Act and implemented by the Secretary of Health and Human Services (HHS), were first explicitly authorized in 2000 ( P.L. 106-505 ), amid growing concerns about global terrorist activity and emerging infectious diseases. Congress reviewed, extended and expanded many of these authorities following the terrorist attacks of 2001 ( P.L. 107-188 ). The anthrax attacks, in particular, had put a harsh spotlight on a public health system that was poorly coordinated and otherwise unfit for 21 st century challenges. As the 109 th Congress began its consideration of the Pandemic and All-Hazards Preparedness Act in 2005, Hurricane Katrina slammed into the Gulf Coast, while a new strain of avian flu, on a steady march across Europe and Asia, threatened a global pandemic. In this context, Members of Congress considered the challenges of bolstering a public health system that is based largely in state authority, and a healthcare system that is largely in private hands. Congress grappled, on the federal level, with integrating the new Department of Homeland Security (DHS) into the nation's preparedness and response activities. The challenges of building effective, coordinated systems across federal agencies, with state and local governments, with private industry, with citizens, and with foreign nations, were formidable as well. The 110 th Congress will likely be interested in the implementation of provisions in P.L. 109-417 , and in the continued evolution of relationships between HHS, DHS, the states, and others among whom coordination is essential in a time of heightened concern about national security. Members of the 110 th Congress may wish to consider legislation to address additional expiring public health authorities, such as the Select Agent program to control access to pathogens that could be used for bioterrorism, which expires at the end of FY2007. Congress may also wish to examine certain permanent emergency response and funding authorities of the Secretary of HHS. This report discusses some key provisions in the Pandemic and All-Hazards Preparedness Act ( P.L. 109-417 ), and provides a history of prior public health and medical preparedness and response legislation. A comparison of provisions in P.L. 109-417 with preexisting law is provided in Table 1 later in this report. In July 2006, Senator Burr introduced S. 3678 , the Pandemic and All-Hazards Preparedness Act. This bill proposed a comprehensive reauthorization of health preparedness and response programs in Title I of P.L. 107-188 , the Public Health Security and Bioterrorism Preparedness and Response Act of 2002. In addition, several bills were introduced in the 109 th Congress to enhance Project BioShield, the HHS program to develop and procure specific countermeasures (such as drugs and vaccines for victims of bioterrorism) for the Strategic National Stockpile. These included S. 3 (Gregg), S. 975 (Lieberman), S. 1873 (Burr), S. 1880 (Kennedy), S. 2564 (Burr), and H.R. 5533 (Rogers). The two legislative initiatives proceeded along parallel tracks until December 2006, when BioShield provisions were attached to S. 3678 as a new Title IV, and the amended bill passed in both chambers. The bill was signed by the President on December 19, 2006, and became P.L. 109-417 . Some key provisions of this law are discussed below. A comparison of provisions in P.L. 109-417 with preexisting law is provided in Table 1 later in this report. One of the most difficult challenges faced by Congress and other policymakers following the 2001 terror attacks was to envision those catastrophic threats for which the nation must be prepared, define the capabilities needed to assure national preparedness, and determine the appropriate federal activities and incentives needed to achieve these goals among federal, state, and local governments, and the private sector. Both of the earlier bioterrorism laws, P.L. 106-505 and P.L. 107-188 , had called on the Secretary of HHS, in collaboration with other stakeholders, to define core national capacities for preparedness and response for public health and medical emergencies. The process has been a challenge. However, recent efforts at DHS, to develop national preparedness goals and target capabilities, have helped to define certain large-scale public health and medical capabilities—such as rapid disease detection, mass prophylaxis, and medical surge—that would be required for an effective response to mass casualty incidents, and that would require a substantial federal coordinating effort. The Pandemic and All-Hazards Preparedness Act would require the Secretary of HHS to prepare a quadrennial National Health Security Strategy and implementation plan, to include preparedness goals for federal, state, and local governments in harmony with national preparedness and response efforts at DHS. In October 2006, the President signed P.L. 109-295 , the Post-Katrina Emergency Management Reform Act of 2006 (called the "Post-Katrina Act," included in DHS appropriations for FY2007). The act reauthorized and reorganized programs in the Federal Emergency Management Agency (FEMA, in DHS). Among other things, the law also codified the position of Chief Medical Officer (CMO) at DHS, the individual who coordinates all departmental activities regarding medical and public health aspects of disasters. Since the Secretary of DHS serves as the federal lead for a coordinated national response to disasters, including terrorism, Members of Congress were interested in clarifying the relationship between the CMO and the Secretary of HHS in disaster preparedness and response. The Post-Katrina Act provides that the CMO "shall have the primary responsibility within the Department for medical issues related to natural disasters, acts of terrorism, and other man-made disasters." (Emphasis added.) The Pandemic and All-Hazards Preparedness Act provides that "The Secretary of Health and Human Services shall lead all Federal public health and medical response to public health emergencies and incidents covered by the National Response Plan...." (Emphasis added.) Members of Congress will likely be interested in how this statutory division of authority is implemented by the two departments. The 109 th Congress considered several measures to improve Project BioShield, a program to encourage the development of promising chemical, biological, radiological, or nuclear countermeasures that the private sector might not otherwise develop. The 108 th Congress launched the program in the Project BioShield Act of 2004 ( P.L. 108-276 ), providing $5.6 billion for the program over 10 years. Project BioShield allows the government to guarantee a market for specified amounts of particular countermeasures. Under this program, HHS can solicit bids for specific countermeasures and execute contracts for the delivery of countermeasures at guaranteed prices even if the countermeasure has up to eight more years of development. The government only pays for the countermeasure on delivery. As time has passed with little perceived progress on some major identified countermeasure targets, criticism of this program has mounted. The cancellation of the next-generation anthrax vaccine contract, the largest BioShield contract to date, has highlighted these criticisms. The 109 th Congress considered several measures to improve Project BioShield results, including S. 3 (Gregg), S. 975 (Lieberman), S. 1873 (Burr), S. 1880 (Kennedy), S. 2564 (Burr), and H.R. 5533 (Rogers). Congress incorporated some of the proposals in these bills into the Pandemic and All-Hazards Preparedness Act, Title IV. This law requires the HHS Secretary to develop and make public a strategic plan to guide HHS research and development and procurement of countermeasures. It also creates the Biodefense Advanced Research and Development Authority (BARDA) in HHS. This office is to help implement the strategic plan, directly support countermeasure advanced development, and facilitate communication between the government and countermeasure developers. This law allows HHS to make milestone-based payments for Project BioShield contracts which do not have to be repaid even if the product is never delivered. It also permits the HHS Secretary to hold meetings and execute specific agreements with multiple potential countermeasure developers that would otherwise violate antitrust laws, contingent on prior approval of the Attorney General and the Chairman of the Federal Trade Commission. Since FY2002, Congress has provided approximately $7 billion in grants to states to build public health and hospital preparedness for public health threats. Presumably due to national security concerns and other sensitivities, HHS has not published comprehensive or state-specific information regarding states' performance toward meeting the objectives for these grant programs. Congress has been keenly interested in the management of these grants, on topics ranging from the relevance of broad program goals in achieving national preparedness, to the rigor of fiscal accounting mechanisms, to the balance of federal vs. state funding shares, to issues of program transparency.