To address the potential threat of an influenza pandemic, the President and his HSC issued two planning documents. The Strategy was issued in November 2005 and is intended to provide a high-level overview of the approach that the federal government will take to prepare for and respond to an influenza pandemic. It also articulates expectations for nonfederal entities—including state, local, and tribal governments; the private sector; international partners; and individuals—to prepare themselves and their communities. The Plan was issued in May 2006 and is intended to lay out broad implementation requirements and responsibilities among the appropriate federal agencies and clearly define expectations for nonfederal entities. The Plan includes 324 action items related to these requirements, responsibilities, and expectations and most of them are to be completed before or by May 2009. It is intended to support the broad framework and goals articulated in the Strategy by outlining specific steps that federal departments and agencies should take to achieve these goals. It also describes expectations regarding preparedness and response efforts of state and local governments, tribal entities, the private sector, global partners, and individuals. The Plan’s chapters cover categories of actions that are intended to address major considerations raised by a pandemic, including protecting human and animal health; transportation and borders; and international, security, and institutional considerations. Several federal leadership roles involve shared responsibilities for preparing for and responding to an influenza pandemic, including the Secretaries of Health and Human Services and Homeland Security, the Administrator of the Federal Emergency Management Agency (FEMA), a national Principal Federal Official (PFO), and regional PFOs and Federal Coordinating Officers (FCO). Many of these leadership roles and responsibilities have not been tested under pandemic scenarios, leaving unclear how all of these new and developing relationships would work. The Strategy and Plan do not clarify the specific leadership roles and responsibilities for a pandemic. Instead, they restate the existing leadership roles and responsibilities, particularly for the Secretaries of Homeland Security and Health and Human Services, prescribed in the National Response Plan (NRP)—an all-hazards plan for emergencies ranging from hurricanes to wildfires to terrorist attacks. However, the leadership roles and responsibilities prescribed under the NRP need to operate somewhat differently because of the characteristics of a pandemic that distinguish it from other emergency incidents. For example, because a pandemic influenza is likely to occur in successive waves, planning has to consider how to sustain response mechanisms for several months to over a year—issues that are not clearly addressed in the Plan. In addition, the distributed nature of a pandemic, as well as the sheer burden of disease across the nation, means that the support states, localities, and tribal entities can expect from the federal government would be limited in comparison to the aid it mobilizes for geographically and temporarily bounded disasters like earthquakes and hurricanes. Consequently, legal authorities, roles and responsibilities, and lines of authority at all levels of government must be clearly defined, effectively communicated, and well understood to facilitate rapid and effective decision making. This is also important for public and private sector organizations and international partners so everyone can better understand what is expected of them before and during a pandemic. The Strategy and Plan state that the Secretary of Health and Human Services is responsible for leading the medical response in a pandemic, while the Secretary of Homeland Security is responsible for overall domestic incident management and federal coordination. However, since a pandemic extends well beyond health and medical boundaries, to include sustaining critical infrastructure, private sector activities, the movement of goods and services across the nation and the globe, and economic and security considerations, it is not clear when, in a pandemic, the Secretary of Health and Human Services would be in the lead and when the Secretary of Homeland Security would lead. A pandemic could threaten our critical infrastructure, such as the capability to deliver electricity or food, by removing essential personnel from the workplace for weeks or months. The extent to which this would be considered a medical response with the Secretary of Health and Human Services in the lead, or when it would be under the Secretary of Homeland Security’s leadership as part of his/her responsibility for ensuring that critical infrastructure is protected, is unclear. According to HHS officials we interviewed, resolving this ambiguity will depend on several factors, including how the outbreak occurs and the severity of the pandemic. Although DHS and HHS officials emphasize that they are working together on a frequent basis, these roles and responsibilities have not been thoroughly tested and exercised. Moreover, under the Post-Katrina Emergency Management Reform Act of 2006 (referred to as the Post-Katrina Reform Act in this testimony), the FEMA Administrator was designated the principal domestic emergency management advisor to the President, the HSC, and the Secretary of Homeland Security, adding further complexity to the leadership structure in the case of a pandemic. The act also gives the Administrator responsibility for carrying out a national exercise program to test and evaluate national preparedness for responding to all-hazards, including an influenza pandemic. Other evolving federal leadership roles include those of PFOs and FCOs. To assist in planning and coordinating efforts to respond to a pandemic, in December 2006 the Secretary of Homeland Security predesignated a national PFO and established five pandemic regions each with a regional PFO and FCO. PFOs are responsible for facilitating federal domestic incident planning and coordination, and FCOs are responsible for coordinating federal resources support in a presidentially declared major disaster or emergency. However, the relationship of these roles to each other as well as with other leadership roles in a pandemic is unclear. U.S. Coast Guard and FEMA officials we met with recognized that planning for and responding to a pandemic would require different operational leadership roles and responsibilities than for most other emergencies. For example, a FEMA official said that given the number of people who would be involved in responding to a pandemic, collaboration between HHS, DHS, and FEMA would need to be greater than for any other past emergencies. Officials are starting to build on these relationships. For example, some of the federal officials with leadership roles for an influenza pandemic met during the week of March 19, 2007, to continue to identify issues and begin developing solutions. One of the participants told us that although additional coordination meetings are needed, it may be challenging since there is no dedicated funding for the staff working on pandemic issues to participate in these and other related meetings. It is also unclear whether the newly established national and regional positions for a pandemic will further clarify leadership roles in light of existing and newly emerging plans and issues. For example, in 2006, DHS made revisions to the NRP and released a Supplement to the Catastrophic Incident Annex—both designed to further clarify federal roles and responsibilities and relationships among federal, state, and local governments and responders. However, we reported in February 2007 that these revisions had not been tested and there was little information available on the extent to which these and other actions DHS was taking to improve readiness were operational. We also reported in May 2007 that FEMA has predesignated five teams of FCOs and PFOs in the Gulf Coast and eastern seaboard states at risk of hurricanes. However, there is still some question among state and local first responders about the need for both positions and how they will work together in disaster response. More recently, DHS reviewed the NRP and its supplemental documents. One of the issues this review intended to address was clarifying roles and responsibilities of key structures, positions, and levels of government, including the role of the PFO and that position’s current lack of operational authority over the FCO during an emergency. On September 10, 2007, DHS released a draft National Response Framework to replace the NRP, for public comment. Comments on the framework are due October 11, 2007, and comments on the supplemental documents, such as revised Emergency Support Function specifications, are due by November 9, 2007. Disaster planning, including for a pandemic influenza, needs to be tested and refined with a rigorous and robust exercise program to expose weaknesses in plans and allow planners to refine them. Exercises— particularly for the type and magnitude of emergency incidents such as a severe influenza pandemic for which there is little actual experience—are essential for developing skills and identifying what works well and what needs further improvement. Our prior work examining the preparation for and response to Hurricane Katrina highlighted the importance of realistic exercises to test and refine assumptions, capabilities, and operational procedures, and build upon strengths. While pandemic influenza scenarios have been used to exercise specific response elements, such as the distribution of stockpiled medications at specific locations or jurisdictions, no national exercises have tested the new federal leadership structure for pandemic influenza. The only national multisector pandemic exercise to date was a tabletop simulation conducted by members of the cabinet in December 2005. This tabletop exercise was prior to the release of the Plan in May 2006, the establishment of a national PFO and regional PFO and FCO positions for a pandemic, and enactment of the Post-Katrina Reform Act. Our work found that the Strategy and Plan do not address all of the characteristics of an effective national strategy as identified in our prior work. While national strategies necessarily vary in content, the six characteristics we identified apply to all such planning documents and can help ensure that they are effective management tools. Gaps and deficiencies in these documents are particularly troubling in that a pandemic represents a complex challenge that will require the full understanding and collaboration of a multitude of entities and individuals. The extent to which these documents, that are to provide an overall framework to ensure preparedness and response to a pandemic influenza, fail to adequately address key areas could have critical impact on whether the public and key stakeholders have a clear understanding and can effectively execute their roles and responsibilities. Specifically, we found that the documents fully address only one of the six characteristics of an effective national strategy—problem definition and risk assessment—because they identified the potential problems associated with a pandemic as well as potential threats, challenges, and vulnerabilities.