The Strategy lays out three high-level goals to prepare for and respond to an influenza pandemic: (1) stop, slow, or otherwise limit the spread of a pandemic to the United States; (2) limit the domestic spread of a pandemic and mitigate disease, suffering, and death; and (3) sustain infrastructure and mitigate impact on the economy and the functioning of society. These goals are underpinned by three pillars that are intended to guide the federal government’s approach to a pandemic threat: (1) preparedness and communication, (2) surveillance and detection, and (3) response and containment. Each pillar describes domestic and international efforts, animal and human health efforts, and efforts that would need to be undertaken at all levels of government and in communities to prepare for and respond to a pandemic. The Plan 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 and tribal entities and the private sector. 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. The Plan is not intended to describe the operational details of how federal departments and agencies would accomplish their objectives to support the Strategy. Rather, these operational details are supposed to be included in the departments’ and agencies’ pandemic implementation plans along with additional considerations raised during a pandemic involving (1) protection of employees, (2) maintenance of essential functions and services, and (3) the manner in which departments and agencies would communicate messages about pandemic planning and respond to their stakeholders. The Homeland Security Act of 2002 required the newly established DHS to develop a comprehensive National Incident Management System (NIMS) and a comprehensive NRP. NIMS and the NRP are intended to provide an integrated all-hazards approach to emergency incident management. As such, they are expected to form the basis of the federal response to a pandemic. NIMS defines “how” to manage an emergency incident. It defines roles and responsibilities of federal, state, and local responders for emergency incidents regardless of the cause, size, or complexity of the situation. Its intent is to establish a core set of concepts, principles, terminology, and organizational processes to enable effective, efficient, and collaborative emergency incident management at all levels. The NRP, on the other hand, defines “what” needs to be done to manage an emergency incident. It is designed to integrate federal government domestic prevention, protection, response, and recovery plans into a single operational plan for all hazards and all emergency response disciplines. Using the framework provided by NIMS, the NRP is intended to provide the structure and mechanisms for national-level policy and operational direction for domestic incident management where federal support is necessary. States may need federal assistance in the event of a pandemic to maintain essential services. Upon receiving such requests, the President may issue emergency or major disaster declarations pursuant to the Robert T. Stafford Disaster Relief and Emergency Assistance Act of 1974 (the Stafford Act). The Stafford Act primarily establishes the programs and processes for the federal government to provide major disaster and emergency assistance to state and local governments and tribal nations, individuals, and qualified private nonprofit organizations. Federal assistance may include technical assistance, the provision of goods and services, and financial assistance, including direct payments, grants, and loans. FEMA is responsible for carrying out the functions and authorities of the Stafford Act. The Secretary of Health and Human Services also has authority, under the Public Health Service Act, to declare a public health emergency and to take actions necessary to respond to that emergency consistent with his/her authorities. These actions may include making grants, entering into contracts, and conducting and supporting investigations into the cause, treatment, or prevention of the disease or disorder that caused the emergency. The Secretary’s declaration may also initiate the authorization of emergency use of unapproved products or approved products for unapproved uses as well as waiving of certain HHS regulatory requirements. The NRP, as revised in May 2006, applies to all incidents requiring a coordinated federal response. The most severe of these incidents, termed Incidents of National Significance, must be personally declared and managed by the Secretary of Homeland Security. According to the Plan, the Secretary of Homeland Security may declare a pandemic an Incident of National Significance, perhaps as early as when an outbreak occurs in foreign countries but before the disease reaches the United States. In addition to the base response plan, the NRP has 31 annexes consisting of 15 Emergency Support Function (ESF) annexes, 9 support annexes, and 7 incident annexes. The ESFs are the primary means through which the federal government provides support to state, local, and tribal governments, and the ESF structure provides a mechanism for interagency coordination during all phases of an incident—some departments and agencies may provide resources during the early stages, while others would be more prominent in supporting recovery efforts. The ESFs group capabilities and resources into the functions that are most likely needed during actual or potential incidents where coordinated federal response is required. Of the 15 ESF annexes, ESF-8, the public health and medical services ESF, would be the primary ESF used for the public health and medical care aspects of a pandemic involving humans. Although HHS is the lead agency for ESF-8, the ESFs are carried out through a “unified command” approach and several other federal agencies, including the Departments of Agriculture, Defense, Energy, Homeland Security (and the U.S. Coast Guard), Justice, and Labor, are specifically supporting agencies. ESF-11 pertains to agriculture and natural resources, and its purpose includes control and eradication of an outbreak of a highly contagious or economically devastating animal/zoonotic disease including avian influenza. The purpose of ESF-11 is to ensure, in coordination with ESF-8, that animal/veterinary/wildlife issues in natural disasters are supported. The Departments of Agriculture and the Interior share responsibilities as primary agencies for this ESF. FEMA has or shares lead responsibility for several of the ESFs, including those that would be applicable during a pandemic. For example, FEMA is the lead agency for ESF-5 (emergency management), ESF-6 (mass care, housing, and human services), and ESF-14 (long-term community recovery and mitigation) and is the primary agency for ESF-15 (external affairs). Additionally, FEMA is responsible for carrying out the functions and authorities of the Stafford Act. The incident annexes describe the policies, situations, concept of operations, and responsibilities pertinent to the type of incident in question. Included among the seven incident annexes within the NRP is the Catastrophic Incident Annex. The Catastrophic Incident Annex could be applicable to a pandemic influenza as it applies to any incident that results in extraordinary levels of mass casualties, damage, or disruption severely affecting the population, infrastructure, environment, economy, national morale, and/or government functions. The NRP also addresses two key leadership positions in the event of a Stafford Act emergency or major disaster. One official, the FCO, who can be appointed by the Secretary of Homeland Security on behalf of the President, manages and coordinates federal resource support activities related to Stafford Act disasters and emergencies. The other official, the PFO, is designated by the Secretary of Homeland Security to facilitate federal support to established incident command structures and to coordinate overall federal incident management and assistance activities across the spectrum of prevention, preparedness, response, and recovery. The PFO is to provide a primary point of contact and situational awareness for the Secretary of Homeland Security. While the PFO is supposed to work closely with the FCO during an incident, the PFO has no operational authority over the FCO. The executive branch has also developed tools and guidance to aid in preparing for and responding to a pandemic influenza. Among these are the following: A Web site, www.pandemicflu.gov, to provide one-stop access to U.S. government avian and pandemic influenza information. This site is managed by HHS. Planning checklists for state and local governments, businesses, schools, community organizations, health care providers, and individuals and families. As of July 2007, there were 16 checklists included on the Web site. Interim planning guidance for state, local, tribal, and territorial communities on nonpharmaceutical interventions (i.e., other than vaccines and drug treatment) to mitigate an influenza pandemic. This guidance, called the Interim Pre-pandemic Planning Guidance: Community Strategy for Pandemic Influenza Mitigation in the United States, includes a Pandemic Severity Index to characterize the severity of a pandemic, provides planning recommendations for specific interventions for a given level of pandemic severity, and suggests when those interventions should be started and how long they should be used. In March 2006, FEMA issued guidance for federal agencies to revise their Continuity of Operations (COOP) Plans to address pandemic threats. COOP plans are intended to ensure that essential government services are available in emergencies. We testified in May 2006, on the need for agencies to adequately prepare their telework capabilities for use during a COOP event. In September 2006, DHS issued guidance to assist owners and operators of critical infrastructure and key resources to prepare for a localized outbreak, as well as a broader influenza pandemic. In addition to these tools and guidance, other actions included HHS grant awards totaling $350 million to state and local governments for pandemic planning and more than $1 billion to accelerate development and production of new technologies for influenza vaccines within the United States. While the Strategy and Plan describe the broad roles and responsibilities for preparing for and responding to a pandemic influenza, they do little to clarify existing emergency response roles and responsibilities.