Background

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.

		All-Hazards Emergency Management Policies Provide the Overarching Context for the Strategy and Plan

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 Taken Other Steps to Prepare for a Pandemic

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.

	Federal Government Leadership Roles and Responsibilities Need Clarification and Testing

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. Instead, the  documents restate the shared roles and responsibilities of the Secretaries  of Health and Human Services and Homeland Security already prescribed  by the NRP and related annexes and plans. These and other leadership  roles and responsibilities continue to evolve, such as with the  establishment of a national PFO and regional PFOs and FCOs and  potential changes from ongoing efforts to revise the NRP. Congress has  also passed legislation to address prior problems that emerged regarding  federal leadership roles and responsibilities for emergency management  that have ramifications for pandemic influenza. Although 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, which was prior to the release of the Plan and  the establishment of the PFO and FCO positions for a pandemic.

		The Strategy and Plan Do Not Clarify Leadership Roles and Responsibilities

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  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 may 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 describe the Secretary of Health and Human  Services as being 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.
Specifically, the Plan states that the Secretary of Health and Human  Services, consistent with his/her role under the NRP as the coordinator for  ESF-8, would be responsible for the overall coordination of the public  health and medical emergency response during a pandemic, including  coordinating all federal medical support to communities; providing  guidance on infection control and treatment strategies to state, local, and  tribal entities and the public; maintaining, prioritizing, and distributing  countermeasures in the Strategic National Stockpile; conducting ongoing  epidemiologic assessment and modeling of the outbreak; and researching  the influenza virus, novel countermeasures, and rapid diagnostics. The  Plan calls for the Secretary to be the principal federal spokesperson for  public health issues, coordinating closely with DHS on public messaging  pertaining to the pandemic.
Also similar to the NRP, the Plan states that the Secretary of Homeland  Security, as the principal federal official for domestic incident  management, would be responsible for coordinating federal operations  and resources; establishing reporting requirements; and conducting  ongoing communications with federal, state, local, and tribal governments,  the private sector, and nongovernmental organizations. It also states that  in the context of response to a pandemic, the Secretary of Homeland  Security would coordinate overall nonmedical support and response  actions, sustain critical infrastructure, and ensure necessary support to the  Secretary of Health and Human Services’ coordination of public health and  medical emergency response efforts. Additionally, the Plan states that the  Secretary of Homeland Security would be responsible for coordinating the  overall response to the pandemic; implementing policies that facilitate  compliance with recommended social distancing measures; providing for a  common operating picture for all departments and agencies of the federal  government; and ensuring the integrity of the nation’s infrastructure,  domestic security, and entry and exit screening for influenza at the  borders.
Other DHS responsibilities include operating and maintaining the National  Biosurveillance Integration System, which is intended to provide an all- source biosurveillance common operating picture to improve early  warning capabilities and facilitate national response activities through  better situational awareness. This responsibility, however, appears to be  both a public health issue and an overall incident management issue,  raising similar issues about the interrelationship of DHS and HHS roles  and responsibilities. In addition, 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.
Officials from other agencies also need greater clarity about these roles  and responsibilities. For example, USDA is not planning for DHS to  assume the lead coordinating role if an outbreak of avian flu among  poultry occurs sufficient in scope to warrant a presidential declaration of  an emergency or major disaster. The federal response may be slowed as  agencies resolve their roles and responsibilities following the onset of a  significant outbreak. In addition, 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.

		Additional Key Leadership Roles and Responsibilities Are Evolving and Untested

The executive branch has several efforts, some completed and others  under way, to strengthen and clarify leadership roles and responsibilities  for preparing for and responding to a pandemic influenza. However, many  of these efforts are new, untested through exercises, or both. For example,  on December 11, 2006, the Secretary of Homeland Security predesignated  the Vice Commandant of the U.S. Coast Guard as the national PFO for  pandemic influenza, and also established five pandemic regions, each with  a regional PFO. Also, FCOs were predesignated for each of the regions. In  addition to the five regional FCOs, a FEMA official with significant FCO  experience has been selected to serve as the senior advisor to the national  PFO. DOD has selected Defense Coordination Officers and HHS has  selected senior health officials to work together within this national  pandemic influenza preparedness and response structure.
DHS is taking steps to further clarify federal leadership roles and  responsibilities. Specifically, it is developing a Federal Concept Plan for  Pandemic Influenza, which is intended to identify specific federal  response roles and responsibilities for each stage of an outbreak.  According to DHS, the Concept Plan, which is based on the  Implementation Plan and other related documents, would also identify  “seams and gaps that must be addressed to ensure integration of all federal  departments and agencies prior to, during, and after a pandemic outbreak  in the U.S.” According to DHS officials, they sent a draft to federal  agencies in May for comment and have not yet determined when the  Concept Plan will be issued.
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 relationships among  the federal actors for a pandemic. 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, however, 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.
The national PFO for pandemic influenza said that a draft charter has also  been developed to establish a Pandemic Influenza PFO Working Group to  help identify and address many policy and operational issues before a  pandemic. According to a FEMA official, some of these issues include staff  availability, protective measures for staff, and how to ensure that the  assistance to be provided under the Stafford Act is implemented and  coordinated in a unified and consistent manner across the country during  a pandemic. As of June 7, 2007, the draft charter was undergoing some  revisions and was expected to be sent to the Secretary of Homeland  Security for review and approval around the end of June. Additionally,  there are plans to identify related exercises, within and outside of the  federal government, to create a consolidated schedule of exercises for the  national PFO for pandemic influenza and regional PFOs and FCOs to  participate in by leveraging existing exercise plans. DHS officials said that  they expect FEMA would retain responsibility for maintaining this  consolidated schedule.
It is unclear whether the newly established national and regional positions  for a pandemic will further clarify leadership roles. 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. Additionally, DHS is currently  coordinating a comprehensive review of the NRP and NIMS to assess their  effectiveness, identify improvements, and recommend modifications. One  of the issues expected to be addressed during this review is clarifying of  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 during an emergency. The review is expected to  be done, and a revised NRP and NIMS issued, by the summer of 2007.

		Recent Congressional Actions Addressed Leadership Roles and Responsibilities

In 2006, Congress passed two acts addressing leadership roles and  responsibilities for emergency management—the Pandemic and All- Hazards Preparedness Act and the Post-Katrina Emergency Management  Reform Act of 2006—which were enacted into law on December 19, 2006  and October 4, 2006, respectively.

			Pandemic and All-Hazards Preparedness Act and Its Implementation

The Pandemic and All-Hazards Preparedness Act codifies preparedness  and response federal leadership roles and responsibilities for public health  and medical emergencies that are now in the NRP by designating the  Secretary of Health and Human Services as the lead federal official for  public health and medical preparedness and response, consistent with the  NRP. The act also requires the Secretary to establish an interagency  agreement, in collaboration with DOD, DHS, DOT, the Department of  Veterans Affairs, and other relevant federal agencies, prescribing that  consistent with the NRP, HHS would assume operational control of  emergency public health and medical response assets in the event of a  public health emergency. Further, the act requires that the Secretary  develop a coordinated National Health Security Strategy and  accompanying implementation plan for public health emergency  preparedness and response. This health security strategy and  accompanying implementation plan are to be completed by 2009 and  updated every 4 years.
The act also prescribes several new preparedness responsibilities for HHS.  For example, the Secretary must develop and disseminate criteria for an  effective state plan for responding to a pandemic influenza. Additionally,  the Secretary is required to develop and require the application of  measurable evidence-based benchmarks and objective standards that  measure the levels of preparedness in such areas as hospitals and state  and local public health security.
The act seeks to further strengthen HHS’s public health leadership role by  transferring the National Disaster Medical System from DHS back to HHS,  thus placing these public health resources within HHS. It also creates the  Office of the Assistant Secretary for Preparedness and Response  (replacing the Office of the Assistant Secretary for Public Health  Emergency Preparedness) and consolidates other preparedness and  response functions within HHS in the new Assistant Secretary’s office.
HHS has set up an implementation team involving over 200 HHS staff to  implement the provisions of this act. According to a HHS official, an  interim implementation plan is expected to be made available for public  comment sometime during the summer of 2007.

			Post-Katrina Reform Act and Its Implementation

In response to the findings and recommendations from several reports, the  Post-Katrina Emergency Management Reform Act (referred to as the Post- Katrina Reform Act in this report) designated the FEMA Administrator as  the principal domestic emergency management advisor to the President,  the HSC, and the Secretary of Homeland Security. Therefore, the FEMA  Administrator also has a leadership role in preparing for and responding to  an influenza pandemic, including key areas such as planning and  exercising. For example, under the Post-Katrina Reform Act, the FEMA  Administrator is responsible for carrying out a national exercise program  to test and evaluate preparedness for a national response to natural and  man-made disasters.
The act made FEMA a distinct entity within DHS for leading and  supporting the nation in a risk-based, comprehensive emergency  management system of preparedness, protection, response, recovery, and  mitigation. As part of the reorganization, DHS transferred several offices  and divisions of its National Preparedness Directorate to FEMA, including  the Offices of Grants and Training and National Capital Region  Coordination. FEMA’s National Preparedness Directorate contains  functions related to preparedness doctrine, policy, and contingency  planning and includes DHS’s exercise coordination and evaluation  program and emergency management training. Other transfers included  the Chemical Stockpile Emergency Preparedness Division, Radiological  Emergency Preparedness Program, and the United States Fire  Administration. The reorganization took effect on March 31, 2007, and it  will likely take some time before it is fully implemented and key  leadership positions within FEMA are filled.

		Rigorous and Robust Exercises Are Important for Testing Federal Leadership for a Pandemic

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. In response to the experiences  during Hurricane Katrina, the Post-Katrina Reform Act called for a  national exercise program to evaluate preparedness of a national response  to natural and man-made disasters.
While pandemic influenza scenarios have been used to exercise specific  response elements and locations, such as for distributing stockpiled  medications, there has been no national exercise to test a multisector,  multijurisdictional response or any exercises to test the working and  operational relationships of the national PFO and the five regional PFOs  and FCOs for pandemic influenza. According to a CRS report, the only  national multisector pandemic exercise to date was a tabletop simulation  involving members of the federal 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 Pandemic and All-Hazards Preparedness  Act in December 2006 and the Post-Katrina Reform Act in October 2006.

	The National Strategy and Its Implementation Plan Do Not Address All the Characteristics of an Effective Strategy, Thus Limiting Their Usefulness as Planning Tools

The Strategy and Plan represent important efforts to guide the nation’s  preparedness and response activities, setting forth actions to be taken by  federal agencies and expectations for a wide range of actors, including  states and communities, the private sector, global partners, and  individuals. However, the Strategy and Plan do not address all of the  characteristics of an effective national strategy as we 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.
As shown in table 3, the Strategy and its Plan address one of the six  characteristics of an effective national strategy. However, they only  partially address four and do not address one of the characteristics at all.  As a result, the Strategy and Plan fall short as an effective national strategy  in important areas.

		The Strategy and Plan Partially Address Purpose, Scope, and Methodology

A national strategy should address its purpose, scope, and methodology,  including the process by which it was developed, stakeholder involvement,  and how it compares and contrasts with other national strategies.  Addressing this characteristic helps make a strategy more useful to  organizations responsible for implementing the strategy, as well as those  responsible for oversight. We found that the Strategy and Plan partially  address this characteristic by describing their purpose and scope.  However, neither document described in adequate detail their  methodology for involving key stakeholders, how they relate to other  national strategies, or a process for updating the Plan.
In describing its purpose, the Strategy states that it was developed to  provide strategic direction for the departments and agencies of the U.S.  government and guide the U.S. preparedness and response activities to  mitigate the impact of a pandemic. In support of the Strategy, the Plan  states that its purpose is to translate the Strategy into tangible action and  direct federal departments and agencies to take specific, coordinated steps  to achieve the goals of the Strategy and outline expectations for state,  local, and tribal entities; businesses; schools and universities;  communities; nongovernmental organizations; and international partners.
As a part of its scope, the Plan identifies six major functions:                     (1) protecting human health, (2) protecting animal health, (3) international  considerations, (4) transportation and borders, (5) security  considerations, and (6) institutional considerations. The Plan proposes  that departments and agencies undertake a series of actions in support of  these functional areas with operational details on how departments would  accomplish these objectives to be provided by separate departmental  plans. Additionally, the Strategy and Plan describe the principles and  planning assumptions that guided their development. The Strategy’s  guiding principles include recognition of the private sector’s integral role  and leveraging global partnerships. The Plan’s principles are more  expansive, listing 12 planning assumptions that it identifies as facilitating  its planning efforts. For example, 1 of the assumptions is that illness rates  would be highest among school-aged children (about 40 percent).
Another element under this characteristic is the involvement of key  stakeholders in the development of the strategy. Neither the Strategy nor  Plan described the involvement of key stakeholders, such as state, local,  and tribal entities, in the development of the Strategy or Plan, even though  they would be on the front lines in a pandemic and the Plan identifies  actions they should complete. The Plan contains 17 actions calling for  state, local, and tribal governments to lead national and subnational  efforts, and identifies another 64 actions where their involvement is  needed. Officials told us that federal stakeholders had opportunities to  review and comment on the Plan but that state, local, and tribal entities  were not directly involved, although the drafters of the Plan were  generally aware of their concerns. Stakeholder involvement during the  planning process is important to ensure that the federal government’s and  nonfederal entities’ responsibilities and resource requirements are clearly  understood and agreed upon. Therefore, the Strategy and Plan may not  fully reflect a national perspective on this critical national issue since  nonfederal stakeholders were not involved in the process to develop the  actions where their leadership, support, or both would be needed. Further,  these nonfederal stakeholders need to understand their critical roles in  order to be prepared to work effectively under difficult and challenging  circumstances.
Both documents address the scope of their coverage and include several  important elements in their discussions, but do not address how they  compare and contrast to other national strategies. The Strategy recognizes  that preparing for a pandemic is more than a purely federal responsibility,  and that the nation must have a system of plans at all levels of government  and in all sectors outside of government that can be integrated to address  the pandemic threat. It also extends its scope to include the development  of an international effort as a central component of overall capacity. The  Strategy lays out the major functions, mission areas, and activities  considered under the extent of its coverage. For example, the Strategy’s  scope is defined as extending 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. Although the Strategy states that it  will be consistent with the National Security Strategy and the Strategy for  Homeland Security, it does not specify how they are related. The Plan  mentions the NRP and states that it will guide the federal pandemic  response. Because a pandemic would affect all facets of our society,  including the nation’s security, it is important to recognize and reflect an  understanding of how these national strategies relate to one another.
The Plan does not describe a mechanism for updating it to reflect policy  decisions, such as clarifications in leadership roles and responsibilities  and other lessons learned from exercising and testing or other changes.  Although the Plan was developed with the intent of being initial guidance  and being updated and expanded over time, officials in several agencies  told us that specific processes or time frames for updating and revising it  have not been established. In addition to incorporating lessons learned,  such updates are important in ensuring that the Plan accurately reflects  entities’ capabilities and a clear understanding of roles and  responsibilities. Additionally, an update would also provide the  opportunity for input from nonfederal entities that have not had an  opportunity to directly provide input to the Strategy and Plan.

		Strategy and Plan Address Problem Definition and Risk Assessment

National strategies need to reflect a clear description and understanding of  the problems to be addressed, their causes, and operating environment. In  addition, the strategy should include a risk assessment, including an  analysis of the threats to and vulnerabilities of critical assets and  operations. We found that the Strategy and Plan address this characteristic  by describing the potential problems associated with a pandemic as well  as potential threats and vulnerabilities.
In defining the problem, both documents provide information on what a  pandemic is and how influenza viruses are transmitted, and explain that a  threat stems from an unprecedented outbreak of avian influenza in Asia  and Europe, caused by the H5N1 strain of the influenza A virus. The  President, in releasing the Strategy, stated that it presented an approach to  address the threat of pandemic influenza, whether it results from the strain  currently in birds in Asia or another influenza virus. Additionally, the  problem definition includes a historical perspective of other pandemics in  the United States.
The Plan used the severity of the 1918 influenza pandemic as the basis for  its risk assessment. A CBO study was used to describe the possible  economic consequences of such a severe pandemic on the U.S. economy  today. While the Plan did not discuss the likelihood of a severe pandemic  or analyze the possibility of whether the H5N1 strain would be the specific  virus strain to cause a pandemic, it stated that history suggests that a  pandemic would occur some time in the future. As a result, it recognizes  the importance of preparing for an outbreak.
The Strategy and Plan included discussions of the constraints and  challenges involved in a pandemic. For example, the Plan included  challenges such as severe shortfalls in surge capacity in the nation’s health  care facilities, limited vaccine production capabilities, the lack of real-time  surveillance among most of the systems, and the inability to quantify the  value of many infection control strategies.
In acknowledging the challenges involved in pandemic preparedness, the  Plan also describes a series of circumstances to enable preparedness, such  as viewing pandemic preparedness as a national security issue,  connectivity between communities, and communicating risk and  responsibility. In this regard, the Plan recognizes that one of the nation’s  greatest vulnerabilities is the lack of connectivity between communities  responsible for pandemic preparedness. The Plan specifically cites  vulnerabilities in coordination of efforts between the animal and human  health communities, as well as between the public health and medical  communities. In the case of public health and medical communities, the  public health community has responsibility for communitywide health  promotion and disease prevention and mitigation efforts, and the medical  community is largely focused on actions at the individual level.

		The Strategy and Plan Partially Address Goals, Objectives, Activities, and Performance Measures

A national strategy should describe its goals and the steps needed to  achieve those results, as well as the priorities, milestones, and outcome- related performance measures to gauge results. Identifying goals,  objectives, and outcome-related performance measures aids implementing  parties in achieving results and enables more effective oversight and  accountability. We found that the Strategy and Plan partially address this  characteristic by identifying the overarching goals and objectives for  pandemic planning. However, the documents did not describe  relationships or priorities among the action items, and some of the action  items lacked a responsible entity for ensuring their completion. The Plan  also did not describe a process for monitoring and reporting on the action  items. Further, many of the performance measures associated with action  items were not clearly linked with results nor assigned clear priorities.
The Strategy and Plan identify a hierarchy of major goals, pillars,  functional areas, and specific activities (i.e., action items), as shown in  figure 1. The Plan includes and expands upon the Strategy’s framework by  including 324 action items.
The Plan uses the Strategy’s three major goals that are underpinned by  three pillars as its framework and expands on this organizing structure by  presenting chapters on six functional areas with various objectives, action  items, and performance measures. For example, pillar 2, surveillance and  detection, under the transportation and borders functional area, includes  an objective to develop and exercise mechanisms to provide active and  passive surveillance during an outbreak, both within and outside our  borders. Under this objective is an action item for HHS, in coordination  with other specific federal agencies, to develop policy recommendations  for transportation and borders entry and exit protocols, screening, or both  and to review the need to develop domestic response protocols and  screening within 6 months. The item’s performance measure is policy  recommendations for response protocols, screening, or both.
While some action items depend on other action items, these linkages are  not always apparent in the Plan. For example, one action item, concerning  the development of a joint strategy for deploying federal health care and  public health assets and personnel, is under the preparedness and  communication pillar. However, another action item concerning the  development of strategic principles for deployment of federal medical  assets is under the response and containment pillar within the same  chapter. While these two action items are clearly related, the plan does not  make a connection between the two or discuss their relationship. An HHS  official who helped draft the Plan acknowledged that while an effort was  made to ensure linkages among action items, there may be gaps in the  linkages among interdependent action items within and across the Plan’s  chapters on the six functional areas (i.e., the chapters that contain action  items).
Some action items, particularly those that are to be completed by state,  local, and tribal governments or the private sector, do not identify an  entity responsible for carrying out the action. Although the plan specifies  actions to be carried out by states, local jurisdictions, and other entities,  including the private sector, it gives no indication of how these actions will  be monitored and how their completion will be ensured. For example, one  such action item states that “all health care facilities should develop and  test infectious disease surge capacity plans that address challenges  including: increased demand for services, staff shortages, infectious  disease isolation protocols, supply shortages, and security.” Similarly,  another action item states that “all Federal, State, local, tribal, and private  sector medical facilities should ensure that protocols for transporting  influenza specimens to appropriate reference laboratories are in place  within 3 months.” Yet the plan does not make clear who will be  responsible for making sure that these actions are completed.
While most of the action items have deadlines for completion, ranging  from 3 months to 3 years, the Plan does not identify a process to monitor  and report on the progress of the action items nor does it include a  schedule for reporting progress. Agency officials told us that they had  identified individuals to act as overall coordinators to monitor the action  items for which their agencies have lead responsibility and provide  periodic progress reports to the HSC. However, we could not identify a  similar mechanism to monitor the progress of the action items that fall to  state and local governments or the private sector. The first public  reporting on the status of the action items occurred in December 2006  when the HSC reported on the status of the action items that were to have  been completed by November 3, 2006—6 months after the release of the  Plan. Of the 119 action items that were to be completed by that time, we  found that the HSC omitted the status of 16 action items. Two of the action  items that were omitted from the report were to (1) establish an  interagency transportation and border preparedness working group and  (2) engage in contingency planning and related exercises to ensure  preparedness to maintain essential operations and conduct missions.
Additionally, we found that several of the action items that were reported  by the HSC as being completed were still in progress. For example, DHS,  in coordination with the Department of State (State), HHS, the Department  of the Treasury (Treasury), and the travel and trade industry, was to tailor  existing automated screening programs and extended border programs to  increase scrutiny of travelers and cargo based on potential risk factors  within 6 months. The measure of performance was to implement enhanced  risk-based screening protocols. Although this action item was reported as  complete, the HSC reported that DHS was still developing risk-based  screening protocols, a major component of this action. A DHS official,  responsible for coordinating the completion of DHS-led action items,  acknowledged that all action items are a work in progress and that they  would continue to be improved, including those items that were listed as  completed in the report. The HSC’s report included a statement that a  determination of “complete” does not necessarily mean that work has  ended; in many cases work is ongoing. Instead, the complete  determination means that the measure of performance associated with an  action item was met. It appears that this determination has not been  consistently or accurately applied for all items. Our recent report on U.S.  agencies’ international efforts to forestall a pandemic influenza also  reported that eight of the Plan’s international-related action items included  in the HSC’s report either did not directly address the associated  performance measure or did not indicate that the completion deadline had  been met.
Most of the Plan’s performance measures are focused on activities such as  disseminating guidance, but the measures are not always clearly linked  with intended results. This lack of clear linkages makes it difficult to  ascertain whether progress has in fact been made toward achieving the  national goals and objectives described in the Strategy and Plan. Most of  the Plan’s performance measures consist of actions to be completed, such  as guidance developed and disseminated. Without a clear linkage to  anticipated results, these measures of activities do not give an indication  of whether the purpose of the activity is achieved. Further, 18 of the action  items have no measure of performance associated with them. In addition,  the plan does not establish priorities among its 324 action items, which  becomes especially important as agencies and other parties strive to  effectively manage scarce resources and ensure that the most important  steps are accomplished.

		The Strategy and Plan Do Not Address Resources, Investments, and Risk Management

A national strategy needs to describe what the strategy will cost; identify  where resources will be targeted to achieve the maximum results; and  describe how the strategy balances benefits, risks, and costs. Guidance on  costs and resources needed using a risk management approach helps  implementing parties allocate resources according to priorities, track  costs and performance, and shift resources, as appropriate. We found that  neither the Strategy nor Plan contain these elements.
While neither document addresses the overall cost to implement the Plan,  the Plan refers to the administration’s budget request of $7.1 billion and a  congressional appropriation of $3.8 billion to support the objectives of the  Strategy. In November 2005, the administration requested $7.1 billion in  emergency supplemental funding over 3 years to support the  implementation of the Strategy. In December 2005, Congress appropriated  $3.8 billion to support budget requirements to help address pandemic  influenza issues. The Plan states that much of this funding would be  directed toward domestic preparedness and the establishment of  countermeasure stockpile and production capacity, with $400 million  directed to bilateral and multilateral international efforts. However, the 3- year $7.1 billion budget proposal does not coincide with the period of the  Plan. Additionally, whereas the Plan does not allocate funds to specific  action items, our analysis of budget documents indicates that the funds  were allocated primarily toward those action items related to vaccines and  antivirals.
Developing and sustaining the capabilities stipulated in the Plan would  require the effective use of federal, state, and local funds. Given that  funding needs may not be readily addressed through existing mechanisms  and could stress existing government and private resources, it is critical  for the Plan to lay out funding requirements. For example, the Plan states  that one of the primary objectives of domestic vaccine production  capacity would be for domestic manufacturers to produce enough vaccine  for the entire U.S. population within 6 months. However, it states that  production capacity would depend on the availability of future  appropriations. Despite the fact that the production of enough vaccine for  the population would be critical if a pandemic were to occur, the Plan  does not provide even a rough estimate of how much the vaccine could  cost for consideration in future appropriations.
Despite the numerous action items and specific implementing directives  and guidance directed toward federal agencies, states, organizations, and  businesses, neither document addresses what it would cost to complete  the actions that are stipulated. Rather, the Plan states that the local  communities would have to address the medical and nonmedical effects of  the pandemic with available resources, and also that pandemic influenza  response activities may exceed the budgetary resources of responding  federal and state government agencies.
The overall uncertainty of funding to complete action items stipulated in  the Plan has been problematic. For example, there were more than 50  actions in the Plan that were to be completed before the end of 2006 for  which DOD was either a lead or support agency. We reported that because  DOD had not yet requested funding, it was unclear whether DOD could  address the tasks assigned to it in the Plan and pursue its own  preparedness efforts for its workforce departmentwide within current  resources.

		The Strategy and Plan Partially Address Organizational Roles, Responsibilities, and Coordination

A national strategy should address which organizations would implement  the strategy, their roles and responsibilities, and mechanisms for  coordinating their efforts. It helps to answer the fundamental question  about who is in charge, not only during times of crisis, but also during all  phases of emergency management, as well as the organizations that will  provide the overall framework for accountability and oversight. This  characteristic entails identifying the specific federal departments,  agencies, and offices involved and, where appropriate, the different  sectors, such as state, local, private, and international sectors. We found  that the Strategy and Plan partially address this characteristic by  containing broad information on roles and responsibilities. But, as we  noted earlier, while the Plan describes coordination mechanisms for  responding to a pandemic, it does not clarify how responsible officials  would share leadership responsibilities. In addition, it does not describe  mechanisms for coordinating preparations and completing the action  items, nor does it describe an overall accountability and oversight  framework.
The Strategy identifies lead agencies for preparedness and response.  Specifically, HHS is the lead agency for medical response; USDA for  veterinary response; State for international activities; and DHS for overall  domestic incident management, sustainment of critical infrastructure and  key resources, and federal coordination. The Plan also briefly describes  the preparedness and response roles and responsibilities of DOD, the  Department of Labor, DOT, and Treasury. The Plan states that these and  all federal cabinet agencies are responsible for their respective sectors and  developing pandemic response plans. In addition, the Strategy and Plan  broadly describe the expected roles and responsibilities of state, local, and  tribal governments; international partners; the private and nonprofit  sectors; and individuals and families. For example, in the functional area  of transportation and borders, the Plan states that it expects state and  local communities to involve transportation and health professionals to  identify transportation options, consequences, and implications in the  event of a pandemic.
The Plan states that the primary mechanism for coordinating the federal  government’s response to a pandemic is the NRP. In this regard, the Plan  acknowledges that sustaining mechanisms for several months to over a  year will present unique challenges, and thus day-to-day monitoring of the  response to a pandemic influenza would occur through the national  operations center with an interagency body composed of senior decision  makers from across the government and chaired by the White House.  Additionally, the Plan states that policy issues that cannot be resolved at  the department level would be addressed through the HSC-National  Security Council policy coordination process. As stipulated in the Plan, the  specifics of this policy coordination mechanism were included in the May  2006 revisions to the NRP.
The Plan also generally identifies lead and support roles for the action  items federal agencies are responsible for completing, but it is not explicit  in defining these roles or processes for coordination and collaboration.  While it identifies which federal agencies have lead and support roles for  completing 305 action items, the Plan does not define the roles of the lead  and support agencies. Rather, it leaves it to the agencies to interpret and  negotiate their roles. According to DOT officials we met with, this lack of  clarity, coupled with staff turnover, left them unclear about their roles and  responsibilities in completing action items. Thus, they had to seek  clarification from DHS and HHS officials to assist them in defining what it  meant to be the lead agency for an action item. Additionally, the Plan does  not describe specific processes for coordination and collaboration  between federal and nonfederal organizations and sectors for completing  the action items.
Related to this issue, we recently reported that some of DOD’s combatant  commands, tasked with providing support in the event of a pandemic, had  received limited detailed guidance from the lead agencies about what  support they may be asked to provide during a pandemic. This has  hindered these commands’ ability to plan to provide support to lead  federal agencies domestically and abroad during a pandemic.
The Plan also does not describe the role played by organizations that are  to provide the overall framework for accountability and oversight, such as  the HSC. According to agency officials, the HSC is monitoring executive  branch agencies’ efforts to complete the action items. However, there is no  specific documentation describing this process or institutionalizing it. This  is important since some of the action items are not expected to be  completed during this administration. Also, a similar oversight process for  those actions items for which nonfederal entities have the lead  responsibility does not appear to exist.

		The Strategy and Plan Partially Address Integration and Implementation

A national strategy should make clear how it relates to the goals,  objectives, and activities of other strategies and to subordinate levels of  government and their plans to implement the strategy. A strategy might  also discuss, as appropriate, various strategies and plans produced by  state, local, private, and international sectors. A clear relationship between  the strategy and other critical implementing documents helps agencies and  other entities understand their roles and responsibilities, foster effective  implementation, and promote accountability. We found that the Strategy  and Plan partially address this characteristic. Although the documents  mention other related national strategies and plans, they do not provide  sufficient detail describing the relationships among these strategies and  plans nor do they describe how subordinate levels of government and  independent plans proposed by the Plan would be integrated to implement  the Strategy.
Since September 11, 2001, various national strategies, presidential  directives, and national initiatives have been developed to better prepare  the nation to respond to incidents of national significance, such as a  pandemic influenza. As noted in figure 2, these include the National  Security Strategy and the NRP. However, although the Strategy states that  it is consistent with the National Security Strategy and the National  Strategy for Homeland Security, it does not state how it is consistent or  describe its relationship with these two strategies. In addition, the Plan  does not specifically address how the Strategy or other related pandemic  plans should be integrated with the goals, objectives, and activities of the  national initiatives already in place.
Whereas the Plan states that it supports Homeland Security Presidential  Directive 8, which required the development of a domestic all-hazards  preparedness goal—the National Preparedness Goal (Goal)—it does not  describe how it supports the directive or its relationship to the Goal. The  current interim Goal is particularly important for determining what  capabilities are needed for a catastrophic disaster. It defines 36 major  capabilities that first responders should possess to prevent, protect from,  respond to, and recover from a wide range of incidents and the most  critical tasks associated with these capabilities. An inability to effectively  perform these critical tasks would, by definition, have a detrimental effect  on protection, prevention, response, and recovery capabilities. The interim  Goal also includes 15 planning scenarios, including one for pandemic  influenza that outlines universal and critical tasks to be undertaken for  planning for an influenza pandemic and target capabilities, such as search  and rescue and economic and community recovery. Yet, the Strategy and  Plan do not integrate this already-developed planning scenario and related  tasks and capabilities. One federal agency official who assisted in drafting  the Plan told us that the Goal and its pandemic influenza scenario had  been considered but omitted because the Goal’s pandemic influenza  scenario is geared to a less severe pandemic—such as those that occurred  in 1957 and 1968—while the Plan is based on the more severe 1918-level  mortality and morbidity rates.
Further, the Strategy and Plan do not provide sufficient detail about how  the Strategy, action items, and proposed set of independent plans are to be  integrated with other national strategies and framework. Without clearly  providing this linkage, the Plan may limit a common understanding of the  overarching framework, thereby hindering the nation’s ability to  effectively prepare for, respond to, and recover from a pandemic. For  example, the Plan contains 39 action items that are response related (i.e.,  specific actions are to be taken within a prescribed number of hours or  days after an outbreak). However, these action items are interspersed  among the 324 action items, and the Plan does not describe the linkages of  these response-related action items with the NRP or other response  related plans. Further, DHS officials have recognized the need for a  common understanding across federal agencies and better integration of  agencies plans to prepare for and respond to a pandemic. DHS officials are  developing a Federal Concept Plan for Pandemic Influenza to enhance  interagency preparedness, response, and recovery efforts.
The Plan also requires the federal departments and agencies to develop  their own pandemic plans that describe the operational details related to  the respective action items and cover the following areas: (1) protection of  their employees; (2) maintenance of their essential functions and services;  (3) how they would support both the federal response to a pandemic and  those of states, localities, and tribal entities; and (4) the manner in which  they would communicate messages about pandemic planning and  response to their stakeholders. Further, it is unclear whether all the  departments will share some or all of the information in their plans with  nonfederal entities. While some agencies-such as HHS, DOD, and the  Department of Veterans Affairs-have publicly released their pandemic  plans, at least one agency, DHS, has indicated that it does not intend to  publicly release its plan. Since DHS is a lead agency for planning for and  responding to a pandemic, this gap may make it more challenging to fully  advance joint and integrated planning across all levels of government and  the private sector.
The Plan recognizes and discusses the need for integrating planning across  all levels of government and the private sector to ensure that the plans and  response actions are complementary, compatible, and coordinated. In this  regard, the Plan provides initial planning guidance for state, local, and  tribal entities; businesses; schools and universities; and nongovernmental  organizations for a pandemic. It also includes various action items that  when completed, would produce additional planning guidance and  materials for these entities. However, the Plan is unclear as to how the  existing guidance relates to broad federal and specific departmental and  agency plans as well as how the additional guidance would be integrated  and how any gaps or conflicts that exist would be identified and  addressed.

	Conclusions

Although it is likely that an influenza pandemic will occur in the future,  there is a high level of uncertainty about when a pandemic might occur  and its level of severity. The administration has taken an active approach  to this potential disaster by establishing an information clearinghouse for  pandemic information; developing numerous planning guidelines for  governments, businesses, nongovernmental organizations, and individuals;  issuing the Strategy and Plan; completing many action items contained in  the Plan; and continuing efforts to complete the remaining action items.
A pandemic poses some unique challenges. Other disasters, such as  hurricanes, earthquakes, or terrorist attacks, generally occur within a  short period and the immediate effects are experienced in specific  locations. By contrast, a pandemic would likely occur in multiple waves,  each lasting weeks or months and affecting communities across the  nation. Initial actions may help limit the spread of an influenza virus,  reflecting the importance of a swift and effective response. Therefore, the  effective exercise of shared leadership roles and responsibilities could  have substantial consequences, both in the short and long term. However,  these roles and responsibilities continue to evolve, leaving uncertainty  about how the federal government would lead preparations for and  response to a pandemic. Since the release of the Plan in May 2006, no  national pandemic exercises of federal leadership roles and  responsibilities have been conducted. Without rigorous testing, training,  and exercising, the administration lacks information to determine whether  current and evolving leadership roles and responsibilities are clear and  clearly understood or if more changes are needed to ensure clarity.
The Strategy and Plan are important because they broadly describe the  federal government’s approach and planned actions to prepare for and  respond to a pandemic, as well as expectations for states and  communities, the private sector, and global partners. Although they  contain a number of important characteristics, the documents lack several  key elements. As a result, their usefulness as a management tool for  ensuring accountability and achieving results is limited. For example,  because the Strategy and Plan do not address the resources and  investments needed to implement the actions called for, it is unclear what  resources are needed to build capacity and whether they would be  available. Further, because they did not include stakeholders that are  expected to be the primary responders to a pandemic in the development  of the Strategy and Plan, these documents may not fully reflect a national  perspective on this critical national issue, and stakeholders and the public  may not have a full understanding of their critical roles. In addition, the  linkages among pandemic planning efforts and with all-hazards plans and  initiatives need to be clear so that the numerous parties involved can  operate in an integrated manner. Finally, because many of the  performance measures do not provide information about the impacts of  proposed actions, it will be difficult to assess the extent to which we are  better prepared or to identify areas needing additional attention.  Opportunities exist to improve the usefulness of the Plan because it is  viewed as an evolving document and is intended to be updated on a  regular basis to reflect ongoing policy decisions, as well as improvements  in domestic preparedness. Currently, however, time frames or  mechanisms for updating the Plan are undefined.
While the HSC publicly reported on the status of approximately 100 action  items that were to have been completed by November 2006, the Plan lacks  a prescribed process for monitoring and reporting on the progress of the  action items or what has been accomplished as a result. Therefore, it is  unclear when the next report will be issued or how much information will  be released. In addition, some of the information reported was incorrect.  This lack of transparency makes it difficult to inform a national dialogue  on the progress made to date or what further steps are needed. It also  inhibits congressional oversight of strategies, funding priorities, and  critical efforts to enhance the nation’s level of preparedness.
DHS officials believe that their efforts to develop a Federal Concept Plan  for Pandemic Influenza may help to more fully address some of the  characteristics that we found the Strategy and Plan lack. According to  those officials, the proposed Concept Plan may help, for example, better  integrate the organizational roles, responsibilities, and coordination of  interagency partners. They recognized, however, that the Concept Plan  would not fully address all of the gaps we have identified. For example,  they told us that the Concept Plan may not address actual or estimated  costs or investments of the resources that will be required. Overall, they  agreed that more needs to be done, especially in view of the long time  requirements and challenging issues presented by a potential pandemic  influenza.

	Recommendations for Executive Action

To enhance preparedness efforts for a possible pandemic, we are making  the following two recommendations:  We recommend that the Secretaries of Homeland Security and Health and  Human Services work together to develop and conduct rigorous testing,  training, and exercises for pandemic influenza to ensure that federal  leadership roles are clearly defined and understood and that leaders are  able to effectively execute shared responsibilities to address emerging  challenges. Once the leadership roles have been clarified through testing,  training, and exercising, the Secretaries of Homeland Security and Health  and Human Services should ensure that these roles are clearly understood  by state, local, and tribal governments; the private and nonprofit sectors;  and the international community.
We also recommend that the Homeland Security Council establish a  specific process and time frame for updating the Implementation Plan for  the National Strategy for Pandemic Influenza. The process for updating  the Plan should involve key nonfederal stakeholders and incorporate  lessons learned from exercises and other sources. The Plan should also be  improved by including the following information in the next update:  the cost, sources, and types of resources and investments needed to  complete the action items and where they should be targeted;    a process and schedule for monitoring and publicly reporting on progress  made on completing the actions;    clearer linkages with other strategies and plans; and    clearer descriptions of relationships or priorities among action items and  greater use of outcome-focused performance measures.

	Agency Comments and Our Evaluation

We provided a draft of this report to DHS, HHS, and the HSC for review  and comment. DHS provided written comments, which are reprinted in  appendix II. In commenting on the draft report, DHS concurred with the  first recommendation and stated that DHS is taking action on many of the  shortfalls identified in the report. For example, DHS stated that it is  working closely with HHS and other interagency partners to develop and  implement a series of coordinated interagency pandemic exercises and  will include all levels of government as well as the international  community and the private and nonprofit sectors. Additionally, DHS stated  that its Incident Management Planning Team intends to use our list of  desirable characteristics of an effective national strategy as one of the  review metrics for all future plans. DHS also provided us with technical  comments, which we incorporated in the report as appropriate.
HHS informed us that it had no comments and concurred with the draft  report. The HSC did not comment on the draft report.
As agreed with your offices, unless you publicly announce the contents of  this report earlier, we plan no further distribution of it until 30 days from  its date. We will then send copies of this report to the appropriate  congressional committees and to the Assistant to the President for  Homeland Security; the Secretaries of HHS, DHS, USDA, DOD, State, and  DOT; and other interested parties. We will also make copies available to  others upon request. In addition, this report will be available at no charge  on the GAO Web site at http:/www.gao.gov.
If you or your staff have any questions regarding this report, please  contact me at (202) 512-6543 or steinhardtb@gao.gov. Contact points for  our Offices of Congressional Relations and Public Affairs may be found on  the last page of this report. GAO staff who made major contributions to  this report are listed in appendix III.

Appendix I: Scope and Methodology

Our reporting objectives were to review the extent to which (1) federal  leadership roles and responsibilities for preparing for and responding to a  pandemic are clearly defined and (2) the National Strategy for Pandemic  Influenza (Strategy) and the Implementation Plan for the National  Strategy for Pandemic Influenza (Plan) address the characteristics of an  effective national strategy.
To determine to what extent federal leadership roles and responsibilities  for preparing for and responding to a pandemic are clearly defined, we  drew upon our extensive body of work on the federal government’s  response to hurricanes Katrina and Rita as well as our prior work on  pandemic influenza. We also studied the findings in reports issued by  Congress, the Department of Homeland Security’s Office of the Inspector  General, the Homeland Security Council (HSC), and the Congressional  Research Service. Additionally, we reviewed the Strategy and Plan and a  variety of federal emergency documents, including the National Response  Plan’s base plan and supporting annexes and the implementation plans  developed by the Departments of Homeland Security and Health and  Human Services. HSC officials declined to meet with us, stating that we  should rely upon information provided by agency officials. We interviewed  officials in the departments of Agriculture, Defense, Health and Human  Services, Homeland Security, Transportation, and State and the Federal  Emergency Management Agency and the U.S. Coast Guard. Some of these  officials were involved in the development of the Plan.
To review the extent to which the Strategy and Plan address the  characteristics of an effective national strategy, we analyzed the Strategy  and Plan; reviewed key relevant sections of major statutes, regulations,  directives, national strategies, and plans discussed in the Plan; and  interviewed officials in agencies that the Strategy and Plan identified as  lead agencies in preparing for and responding to a pandemic.
We assessed the extent to which the Strategy and Plan jointly addressed  the six desirable characteristics, and the related elements under each  characteristic, of an effective national strategy by using the six  characteristics developed in previous GAO work. Table 4 provides the  desirable characteristics and examples of their elements.
National strategies with these characteristics offer policymakers and  implementing agencies a management tool that can help ensure  accountability and more effective results. We have used this methodology  to assess and report on the administration’s strategies relating to  terrorism, rebuilding of Iraq, and financial literacy.
To assess whether the documents addressed these desirable  characteristics, two analysts independently assessed both documents  against each of the elements of a characteristic. If the analysts did not  agree, a third party reviewed, discussed, and made the final determination  to rate that element. Each characteristic was given a rating of either  “addresses,” “partially addresses,” or “does not address.” According to our  methodology, a strategy “addresses” a characteristic when it explicitly  cites all, or nearly all, elements of the characteristic and has sufficient  specificity and detail. A strategy “partially addresses” a characteristic  when it explicitly cites one or a few of the elements of a characteristic and  has sufficient specificity and detail. It should be noted that the “partially  addresses” category includes a range that varies from explicitly citing most  of the elements to citing as few as one of the elements of a characteristic.
A strategy “does not address” a characteristic when it does not explicitly  cite or discuss any elements of a characteristic, any references are either  too vague or general to be useful, or both.
We reviewed relevant sections of major statutes, regulations, directives,  and plans discussed in the Plan to better understand if and how they were  related. Specifically, our review included Homeland Security Presidential  Directive 5 on the Management of Domestic Incidents; the National  Response Plan; and the Robert T. Stafford Disaster Relief and Emergency  Assistance Act of 1974 (as amended) as well as other national strategies.
We conducted our review from May 2006 through June 2007 in accordance  with generally accepted government auditing standards.

Appendix II: Comments from the Department of Homeland Security

Appendix III: GAO Contact and Staff Acknowledgments

	GAO Contact

	Acknowledgments

In addition to the contact named above, Susan Ragland, Assistant Director;  Allen Lomax; David Dornisch; Donna Miller; Catherine Myrick; and  members of GAO’s Pandemic Working Group made key contributions to  this report.

Related GAO Products

Homeland Security: Observations on DHS and FEMA Efforts to Prepare  for and Respond to Major and Catastrophic Disasters and Address  Related Recommendations and Legislation. GAO-07-1142T. Washington,  D.C.: July 31, 2007.
Emergency Management Assistance Compact: Enhancing EMAC’s  Collaborative and Administrative Capacity Should Improve National  Disaster Response. GAO-07-854. Washington, D.C.: June 29, 2007.
Influenza Pandemic: DOD Combatant Commands’ Preparedness Efforts  Could Benefit from More Clearly Defined Roles, Resources, and Risk  Mitigation. GAO-07-696. Washington, D.C.: June 20, 2007.
Influenza Pandemic: Efforts to Forestall Onset Are Under Way;  Identifying Countries at Greatest Risk Entails Challenges. GAO-07-604.  Washington, D.C.: June 20, 2007.
Avian Influenza: USDA Has Taken Important Steps to Prepare for  Outbreaks, but Better Planning Could Improve Response. GAO-07-652.  Washington, D.C.: June 11, 2007.
The Federal Workforce: Additional Steps Needed to Take Advantage of  Federal Executive Boards’ Ability to Contribute to Emergency  Operations.  GAO-07-515. Washington, D.C.: May 4, 2007.
Financial Market Preparedness: Significant Progress Has Been Made,  but Pandemic Planning and Other Challenges Remain. GAO-07-399.  Washington, D.C.: March 29, 2007.
Public Health and Hospital Emergency Preparedness Programs:  Evolution of Performance Measurement Systems to Measure Progress.  GAO-07-485R. Washington, D.C.: March 23, 2007.
Homeland Security: Preparing for and Responding to Disasters. GAO-07- 395T. Washington, D.C.: March 9, 2007.
Influenza Pandemic: DOD Has Taken Important Actions to Prepare, but  Accountability, Funding, and Communications Need to be Clearer and  Focused Departmentwide. GAO-06-1042. Washington, D.C.: September 21,  2006.
Hurricane Katrina: Better Plans and Exercises Needed to Guide the  Military’s Response to Catastrophic Natural Disasters. GAO-06-643.  Washington, D.C.: May 15, 2006.
Continuity of Operations: Agencies Could Improve Planning for  Telework during Disruptions. GAO-06-740T. Washington, D.C.: May 11,  2006.
Hurricane Katrina: GAO’s Preliminary Observations Regarding  Preparedness, Response, and Recovery. GAO-06-442T. Washington, D.C.:  March 8, 2006.
Emergency Preparedness and Response: Some Issues and Challenges  Associated with Major Emergency Incidents. GAO-06-467T. Washington,  D.C.: February 23, 2006.
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Influenza Pandemic: Challenges in Preparedness and Response. GAO-05- 863T. Washington, D.C.: June 30, 2005.
Influenza Pandemic: Challenges Remain in Preparedness. GAO-05-760T.  Washington, D.C.: May 26, 2005.
Flu Vaccine: Recent Supply Shortages Underscore Ongoing Challenges.  GAO-05-177T. Washington, D.C.: November 18, 2004.
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Summary:
Why GAO Did This Study

An influenza pandemic is a real and significant potential threat facing the United States and the world. Pandemics occur when a novel virus emerges that can easily be transmitted among humans who have little immunity. In 2005, the Homeland Security Council (HSC) issued a National Strategy for Pandemic Influenza and, in 2006, an Implementation Plan. Congress and others are concerned about the federal government's preparedness to lead a response to an influenza pandemic. This report assesses how clearly federal leadership roles and responsibilities are defined and the extent to which the Strategy and Plan address six characteristics of an effective national strategy. To do this, GAO analyzed key emergency and pandemic-specific plans, interviewed agency officials, and compared the Strategy and Plan with the six characteristics GAO identified.

What GAO Found

The executive branch has taken an active approach to help address this potential threat, including establishing an online information clearinghouse, developing planning guidance and checklists, awarding grants to accelerate development and production of new technologies for influenza vaccines within the United States, and assisting state and local government pandemic planning efforts. However, federal government leadership roles and responsibilities for preparing for and responding to a pandemic continue to evolve, and will require further clarification and testing before the relationships of the many leadership positions are well understood. The Strategy and Plan do not specify how the leadership roles and responsibilities will work in addressing the unique characteristics of an influenza pandemic, which could occur simultaneously in multiple locations and over a long period. A pandemic could extend well beyond health and medical boundaries, affecting critical infrastructure, the movement of goods and services across the nation and the globe, and economic and security considerations. Although the Department of Health and Human Services' (HHS) Secretary is to lead the public health and medical response and the Department of Homeland Security's (DHS) Secretary is to lead overall nonmedical support and response actions, the Plan does not clearly address these simultaneous responsibilities or how these roles are to work together, particularly over an extended period and at multiple locations across the country. In addition, the Secretary of DHS has designated a national Principal Federal Official (PFO) to facilitate pandemic coordination as well as five regional PFOs and five regional Federal Coordinating Officers. Most of these leadership roles and responsibilities have not been tested under pandemic scenarios, leaving it unclear how they will work. Because initial actions may help limit the spread of an influenza virus, the effective exercise of shared leadership roles and responsibilities could have substantial consequences. However, only one national multisector pandemic-related exercise has been held and that was prior to the issuance of the Plan. While the Strategy and Plan are an important first step in guiding national preparedness, they do not fully address all six characteristics of an effective national strategy. Specifically, they fully address only one of the six characteristics, by reflecting a clear description and understanding of problems to be addressed, and do not address one characteristic because the documents do not describe the financial resources needed to implement actions. Although the other characteristics are partially addressed, important gaps exist that could hinder the ability of key stakeholders to effectively execute their responsibilities, including state and local jurisdictions that will play crucial roles in preparing for and responding to a pandemic were not directly involved in developing the Plan, relationships and priorities among actions were not clearly described, performance measures focused on activities that are not always linked to results; insufficient information is provided about how the documents are integrated with other key related plans, and no process is provided for monitoring and reporting on progress.