United States Government Accountability Office

GAO Report to Congressional Requesters

INFLUENZA 

PANDEMIC 

Further Efforts Are 

Needed to Ensure 

Clearer Federal 

Leadership Roles and 

an Effective National 

Strategy 

August 2007 

 

GAO-07-781 
What GAO Found

United States Government Accountability Office

Why GAO Did This Study

Highlights

Accountability Integrity Reliability

August 2007

INFLUENZA PANDEMIC

Further Efforts Are Needed to Ensure 

Clearer Federal Leadership Roles and an 

Effective National Strategy 

Highlights of GAO-07-781, a report to 

congressional requesters 

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 Recommends

GAO recommends that (1) DHS 

and HHS develop rigorous testing,

training, and exercises for

pandemic influenza to ensure that

federal leadership roles and 

responsibilities are clearly defined, 

understood, and work effectively 

and (2) the HSC set a time frame to

update the Plan, involve key 

nonfederal stakeholders, and more 

fully address the characteristics of 

an effective national strategy. DHS 

and HHS concurred with the

report. HSC did not comment. 

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, the economy, and security. 

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 predesignated 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. 

www.gao.gov/cgi-bin/getrpt?GAO-07-781.

To view the full product, including the scope 

and methodology, click on the link above. 

For more information, contact Bernice 

Steinhardt at (202) 512-6543 or 

steinhardtb@gao.gov. 
Contents 

Letter 1

Results in Brief 5

Background 9

Federal Government Leadership Roles and Responsibilities Need 

Clarification and Testing 15 

The National Strategy and Its Implementation Plan Do Not Address 

All the Characteristics of an Effective Strategy, Thus Limiting 

Their Usefulness as Planning Tools 23 

Conclusions 37

Recommendations for Executive Action 39 

Agency Comments and Our Evaluation 40 

Appendix I Scope and Methodology 42 

Appendix II Comments from the Department of Homeland 

Security 46 

Appendix III GAO Contact and Staff Acknowledgments 48 

Related GAO Products 49 

Tables 

Table 1: Summary of Desirable Characteristics for a National 

Strategy 4

Table 2: Extent to Which the Strategy and Plan Address GAO’s 

Desirable Characteristics of an Effective National Strategy 7 

Table 3: Extent to Which the Strategy and Plan Address GAO’s 

Desirable Characteristics of an Effective National Strategy 23 

Table 4: GAO Desirable Characteristics for a National Strategy 43 

Figures 

Figure 1: National Strategy and Implementation Plan’s Goals, 

Pillars, Functional Areas, and Action Items 28 

Page i GAO-07-781 Leadership and Planning for a Pandemic
Figure 2: Related National Preparedness Strategies, Initiatives, and 

Plans 35

Abbreviations 

CBO Congressional Budget Office 

COOP Continuity of Operations 

CRS Congressional Research Service 

DHS Department of Homeland Security 

DOD Department of Defense 

DOT Department of Transportation 

ESF Emergency Support Function 

FCO Federal Coordinating Officer 

FEMA Federal Emergency Management Agency 

HHS Department of Health and Human Services 

HSC Homeland Security Council 

NIMS National Incident Management System 

NRP National Response Plan 

PFO Principal Federal Official 

USDA Department of Agriculture 

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Page ii GAO-07-781 Leadership and Planning for a Pandemic
United States Government Accountability Office

Washington, DC 20548 

August 14, 2007 

The Honorable Judd Gregg 

Ranking Member 

Committee on the Budget 

United States Senate 

The Honorable Henry A. Waxman 

Chairman 

The Honorable Tom Davis 

Ranking Member 

Committee on Oversight and Government Reform 

House of Representatives 

The Honorable Henry A. Waxman 

Chairman 

The Honorable Tom Davis 

Ranking Member 

Committee on Oversight and Government Reform 

House of Representatives 

The Honorable Bennie G. Thompson

Chairman 

Committee on Homeland Security 

House of Representatives 

The Honorable Bennie G. Thompson

Chairman 

Committee on Homeland Security 

House of Representatives 

An influenza pandemic is a real and significant threat facing the United 

States and the world. Pandemics occur when a novel virus emerges that 

infects and can be effectively transmitted between humans who have little 

immunity to it. Although the timing and severity of the next pandemic is 

unpredictable, there is widespread agreement that a pandemic will occur 

at some point. Three influenza pandemics occurred in the 20th century. 

Notable among these was the influenza pandemic of 1918, called the 

“Spanish flu,” which killed over 50 million people worldwide, including 

over 675,000 in the United States. Pandemics have spread worldwide 

within months, and a future pandemic is expected to spread even more 

quickly given modern travel patterns. While health experts cannot predict 

with certainty which strain of influenza virus will be involved in the next

pandemic, the avian influenza virus that began in Hong Kong in 1997, 

known as H5N1, could lead to a pandemic if it acquires the genetic ability 

to spread efficiently from person to person. 

An influenza pandemic is a real and significant threat facing the United 

States and the world. Pandemics occur when a novel virus emerges that 

infects and can be effectively transmitted between humans who have little 

immunity to it. Although the timing and severity of the next pandemic is 

unpredictable, there is widespread agreement that a pandemic will occur 

at some point. Three influenza pandemics occurred in the 20th century. 

Notable among these was the influenza pandemic of 1918, called the 

“Spanish flu,” which killed over 50 million people worldwide, including 

over 675,000 in the United States. Pandemics have spread worldwide 

within months, and a future pandemic is expected to spread even more 

quickly given modern travel patterns. While health experts cannot predict 

with certainty which strain of influenza virus will be involved in the next

pandemic, the avian influenza virus that began in Hong Kong in 1997, 

known as H5N1, could lead to a pandemic if it acquires the genetic ability 

to spread efficiently from person to person. 

Unlike incidents that are discretely bounded in space or time (e.g., most 

natural or man-made disasters), a pandemic is not a singular event, but is 

likely to come in waves, each lasting weeks or months, and pass through 

communities of all sizes across the nation and the world simultaneously. 

An influenza pandemic could result in 200,000 to 2 million deaths in the 

United States, depending on its severity. Further, an influenza pandemic 

Unlike incidents that are discretely bounded in space or time (e.g., most 

natural or man-made disasters), a pandemic is not a singular event, but is 

likely to come in waves, each lasting weeks or months, and pass through 

communities of all sizes across the nation and the world simultaneously. 

An influenza pandemic could result in 200,000 to 2 million deaths in the 

United States, depending on its severity. Further, an influenza pandemic 

Page 1 GAO-07-781 Leadership and Planning for a Pan for a Pandemic
could have major impacts on society and the economy. According to a 

study by the Congressional Budget Office (CBO), a severe pandemic 

(similar to the 1918 pandemic) could result in a 5 percent reduction of the 

gross domestic product in the United States over the subsequent year. 

Further, an influenza pandemic could cause high rates of absences in 

schools and workplaces. According to the Centers for Disease Control and 

Prevention, in a severe pandemic, absences attributable to illness, the 

need to care for ill family members, and fear of infection may reach 40 

percent during the peak weeks of a community outbreak, with lower rates 

of absence during the weeks before and after the peak. 

To date, the H5N1 virus has been confirmed in birds in 60 nations, up from 

16 nations reported in May 2005. There have been numerous cases where 

the virus has been transmitted from birds to humans, and although there 

have been isolated instances of human-to-human transmission, the virus 

has not yet transmitted efficiently from person to person. From January 

2003 through July 25, 2007, the World Health Organization reported more 

than 300 confirmed human cases, and more than 190 of these people in 12 

countries have died. 

To address the potential threat of an influenza pandemic, the President 

and his Homeland Security Council (HSC) issued two planning documents. 

The first of these, the National Strategy for Pandemic Influenza

(Strategy), was issued in November 2005 and is intended to provide a highlevel overview of the approach that the federal government will take to 

prepare for and respond to an influenza pandemic. It also articulates 

expectations for nonfederal entities—including state, local, and tribal 

governments; the private sector; international partners; and individuals—

to prepare themselves and their communities. The Implementation Plan 

for the National Strategy for Pandemic Influenza (Plan) was issued in 

May 2006. It is intended to lay out broad implementation requirements and 

responsibilities among the appropriate federal agencies and clearly define 

expectations for nonfederal entities. The Plan includes 324 action items 

related to these requirements, responsibilities, and expectations. 

In light of the problems experienced during prior disasters, such as 

Hurricane Katrina, members of Congress and others have expressed 

concern about whether the federal government is adequately prepared to

lead the nation in planning for and responding to an influenza pandemic. 

In response to your request, this report examines the clarity of federal 

leadership roles and responsibilities for preparing for and responding to a 

pandemic influenza and provides a detailed review of the Strategy and 

Plan. 

Page 2 GAO-07-781 Leadership and Planning for a Pandemic
The objectives of this report are to address the extent to which (1) federal 

leadership roles and responsibilities for preparing for and responding to a 

pandemic are clearly defined and documented and (2) the Strategy and the 

Plan address the characteristics of an effective national strategy. To

address the first objective, we analyzed the Strategy and Plan and 

reviewed a variety of federal emergency documents, including the 

National Response Plan’s (NRP) base plan and annexes, the draft 

implementation plan developed by the Department of Homeland Security 

(DHS), and the implementation plan developed by the Department of 

Health and Human Services (HHS). We interviewed officials from DHS 

(including the Federal Emergency Management Agency (FEMA)), HHS, 

and others with federal leadership roles in preparing for and responding to 

a pandemic, including the Departments of Agriculture (USDA), Defense 

(DOD), Transportation (DOT), and State. Some of these officials were 

involved in the development of the Plan. We also interviewed the Vice

Commandant of the U.S. Coast Guard who has been predesignated as the 

national Principal Federal Official for pandemic influenza. Additionally, 

we studied the findings in prior GAO products as well as reports issued by 

Congress, the Congressional Research Service (CRS), CBO, the HSC, 

DHS’s Office of the Inspector General, and other experts. 

For the second objective, we assessed the Strategy and Plan to determine 

how well they jointly addressed the six desirable characteristics of an 

effective national strategy that we developed in previous work, including 

reviewing several elements related to each characteristic. We have used

this methodology to assess and report on the administration’s strategies 

relating to combating terrorism, rebuilding Iraq, and improving citizens’ 

financial literacy.1

 National strategies that address these characteristics 

offer policymakers and implementing agencies a management tool that 

can help ensure accountability and more effective results. Table 1 provides 

the desirable characteristics and a brief description of each characteristic. 

 1

 See GAO, Combating Terrorism: Evaluation of Selected Characteristics in National

Strategies Related to Terrorism, GAO-04-408T (Washington, D.C.: Feb. 3, 2004); 

Rebuilding Iraq: More Comprehensive National Strategy Needed to Help Achieve U.S.

Goals, GAO-06-788 (Washington, D.C.: July 11, 2006); and Financial Literacy and

Education Commission: Further Progress Needed to Ensure an Effective National

Strategy, GAO-07-100 (Washington, D.C.: Dec. 4, 2006). 

Page 3 GAO-07-781 Leadership and Planning for a Pandemic
Table 1: Summary of Desirable Characteristics for a National Strategy 

Desirable characteristic Brief description

Purpose, scope, and methodology Addresses why the strategy was produced, 

the scope of its coverage, and the process 

by which it was developed. 

Problem definition and risk assessment Addresses the particular national problems 

and threats the strategy is directed toward. 

Goals, subordinate objectives, activities, 

and performance measures 

Addresses what the strategy is trying to 

achieve; steps to achieve those results; as 

well as the priorities, milestones, and 

performance measures to gauge results. 

Resources, investments, and risk 

management 

Addresses what the strategy will cost, the 

sources and types of resources and 

investments needed, and where resources 

and investments should be targeted by 

balancing risk reductions and costs. 

Organizational roles, responsibilities, and 

coordination 

Addresses who will be implementing the 

strategy, what their roles will be compared 

to others, and mechanisms for them to 

coordinate their efforts. 

Integration and implementation Addresses how a national strategy relates 

to other strategies’ goals, objectives, and 

activities—and to subordinate levels of 

government and their plans to implement 

the strategy. 

Source: GAO.

We rated the Strategy and Plan on each of the characteristics, giving a 

rating of “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 the documents have 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. The elements are provided in appendix I.

We conducted our review from May 2006 through June 2007 in accordance 

with generally accepted government auditing standards. Further details on

our scope and methodology are in appendix I. A list of other related GAO 

Page 4 GAO-07-781 Leadership and Planning for a Pandemic
reports on pandemic preparedness, emergency preparedness, and other 

related topics is included at the end of this report.2

While an influenza pandemic will most likely 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 developing a Strategy and Plan and has taken a 

number of other actions. These include establishing an information 

clearinghouse for pandemic information; developing planning guidance 

and checklists for governments, businesses, nongovernmental 

organizations, and individuals; issuing the Strategy and Plan; and starting 

work on completing the action items contained in the Plan. In addition to

these actions, HHS has awarded grants 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 these approaches have been 

significant, considerably more work needs to be done. 

Results in Brief 

To begin with, 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 the Plan

do not specify how the leadership roles and responsibilities would work in 

addressing the unique characteristics of a pandemic influenza, which 

could occur simultaneously in multiple locations and over a long period, 

coming in waves, each lasting weeks or months. A pandemic necessitates 

a strategy that 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. The Strategy and Plan indicate that 

both the Secretary of Health and Human Services and the Secretary of 

Homeland Security will have leadership responsibilities that are consistent 

with the NRP—the former for leading the federal medical response to a 

pandemic and the latter for overall domestic incident management and 

federal coordination. However, it is not clear how, in a pandemic, the 

Secretaries of Health and Human Services and Homeland Security would 

 2

 In addition to these published reports, GAO has engagements under way to examine other 

aspects of preparing for and responding to a pandemic, including efforts by DHS, HHS, and

state and local governments. 

Page 5 GAO-07-781 Leadership and Planning for a Pandemic
share leadership responsibilities in practice. For example, a pandemic 

could threaten critical infrastructure, a DHS responsibility, by removing 

essential personnel from the workplace for weeks or months, requiring 

both a medical response as well as actions to protect and sustain critical

infrastructure. Yet, 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. 

Moreover, under recent legislation, the FEMA Administrator was 

designated the principal domestic emergency management advisor to the

President, the HSC, and the Secretary of Homeland Security, adding 

further complexity to the leadership structure in the case of a pandemic. 

In addition to these positions, the NRP includes leadership roles for 

Principal Federal Officials (PFO) and Federal Coordinating Officers 

(FCO). To assist in planning and coordinating efforts to respond to a 

pandemic, in December 2006 the Secretary predesignated a national PFO,

and established five pandemic regions each with a regional PFO and FCO. 

PFOs are responsible for facilitating federal domestic incident planning 

and coordination, and FCOs are responsible for coordinating federal 

resource support in a presidentially declared major disaster or emergency. 

However, the relationship of these roles to each other as well as with other 

leadership roles in a pandemic is unclear. 

Most of these leadership roles and responsibilities have not been tested 

under pandemic scenarios, leaving unclear how all of these new and 

developing relationships would work. According to a 2007 CRS report, 

although pandemic influenza scenarios have been used to exercise specific 

response elements, such as the distribution of stockpiled medications at 

specific locations or jurisdictions, there have been no national exercises to 

test a multisector, multijurisdictional response or any exercises to test the 

new national leadership structure for pandemic influenza.3

 The only 

national multisector pandemic exercise to date was a tabletop simulation 

conducted by members of the cabinet in December 2005—prior to the 

release of the Plan in May 2006 and the establishment of PFO and FCO 

positions for a pandemic. 

The Strategy and Plan represent an important first step in guiding the 

nation’s preparedness and response activities, calling for a series of 

 3

 Congressional Research Service, Pandemic Influenza: Domestic Preparedness Efforts, 

RL 33145 (Washington, D.C.: Feb. 20, 2007). 

Page 6 GAO-07-781 Leadership and Planning for a Pandemic
actions by federal agencies and expectations for states and communities, 

the private sector, global partners, and individuals. However, when viewed 

together, the Strategy and Plan do not fully address the six characteristics 

of an effective national strategy. Gaps and deficiencies in these documents

are particularly troubling because they can affect the usefulness of the 

planning documents to those with key roles to play and affect their ability 

to effectively carry out their responsibilities. 

As shown in table 2, while the Strategy and Plan address one of the 

desirable characteristics of an effective national strategy, they do not 

address another characteristic and partially address the remaining four 

characteristics. For example, the documents address the problem 

definition and risk assessment characteristic by identifying the potential 

problems associated with a pandemic as well as potential threats, 

challenges, and vulnerabilities. However, they did not address the 

resources, investments, and risk management characteristic because they

do not discuss the financial resources and investments needed to 

implement the actions called for. Therefore, they do not provide a picture 

of priorities or how adjustments might be made in view of resource 

constraints. 

Table 2: Extent to Which the Strategy and Plan Address GAO’s Desirable 

Characteristics of an Effective National Strategy 

Desirable characteristic Addresses 

Partially 

addresses 

Does not

address 

Clear purpose, scope, and 

methodology 

X

Problem definition and risk 

assessment 

X

Goals, subordinate objectives,

activities, and performance measures 

X

Resources, investments, and risk 

management 

X

Organizational roles, responsibilities, 

and coordination 

X

Integration and implementation X 

Source: GAO analysis of the National Strategy for Pandemic Influenza and Implementation Plan for the National Strategy for Pandemic

Influenza. 

The Strategy and Plan partially address the remaining four characteristics. 

Some of the gaps we found include the following: 

Page 7 GAO-07-781 Leadership and Planning for a Pandemic
• Purpose, scope and methodology: Key stakeholders, such as state, local, 

and tribal governments, were not directly involved in developing actions 

and the performance measures that are to assess progress, even though 

the Strategy and Plan rely on these stakeholders’ efforts. The Plan contains

17 actions in which state, local, and tribal governments should lead 

national and subnational efforts and identifies another 64 actions where 

their involvement is needed. 

• Integration and implementation: The Strategy and Plan provide little detail 

about how the set of pandemic plans they propose, such as the individual 

agencies’ pandemic plans, are to be integrated with other existing national

strategies that are to provide an overall all-hazards framework. For 

example, although the Strategy and Plan’s leadership framework is 

consistent with provisions of the NRP, there are no linkages between the 

39 response action items in the plan and the NRP or other responserelated plans. 

• Goals, objectives, activities, and performance measures: Most of the Plan’s

performance measures are focused on activities, such as disseminating 

guidance, and are not always clearly linked to the goals and objectives 

described in the Strategy and Plan. This lack of a clear linkage between 

the performance measures and intended results makes it difficult to 

ascertain whether any progress beyond the completion of activities has in

fact been made. Also, the Plan does not establish priorities among the 324 

actions it calls for, and although the intent expressed in the Plan is that it 

will be updated, there are no mechanisms provided in the Plan to do so. 

Further, while officials told us they periodically report to the HSC the 

status of the action items for which their agencies have lead responsibility, 

there is no prescribed process for publicly reporting nor is there a process 

for monitoring actions led by other entities, such as states and local 

governments. In December 2006, the HSC publicly reported on the status

of most of the actions that were to have been completed within 6 months 

of the Plan’s release. However, some of the actions the HSC reported as 

complete are actually still under way, and other actions that were 

supposed to be completed were omitted from the report. 

• Organizational roles, responsibilities, and coordination: As noted earlier, 

the Strategy and Plan did not clarify how responsible officials will share 

leadership responsibilities. 

This report contains two recommendations to enhance preparedness 

efforts for a possible pandemic. First, 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 the federal leadership roles are clearly defined and 

understood and that leaders are able to effectively execute shared 

responsibilities to address emerging challenges. The second 

Page 8 GAO-07-781 Leadership and Planning for a Pandemic
recommendation is that the HSC establish a specific process and time 

frame for updating the Plan. The process should involve key nonfederal 

stakeholders and incorporate lessons learned from exercises and other 

sources. The Plan can also be improved by including the following 

information in the next update: (1) resources and investments needed to

complete the action items and where they should be targeted, (2) a 

process and schedule for monitoring and publicly reporting on progress 

made on completing the action items, (3) clearer linkages with other 

strategies and plans, and (4) clearer descriptions of relationships or 

priorities among actions items and greater use of outcome-focused 

performance measures. 

DHS officials we met with said that they are developing a Federal Concept

Plan for Pandemic Influenza that focuses on federal interagency tasks 

and is intended to help ensure coordinated federal preparation, response, 

and recovery operations if there is an outbreak. In May 2007, DHS 

provided a draft to federal agencies for review and comment, and officials

think it may help address some of the gaps we identified in the Plan. DHS 

had not determined when the Concept Plan would be issued.

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 it is taking action on many of the 

shortfalls identified in the report. 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. 

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. 

Background 

Page 9 GAO-07-781 Leadership and Planning for 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.4

 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. 

All-Hazards Emergency 

Management Policies 

Provide the Overarching 

Context for the Strategy 

and Plan 

 4

 Pub. L. No. 107-296, 116 Stat. 2135 (2002). 

Page 10 GAO-07-781 Leadership and Planning for a Pandemic
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).5

 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.6

 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 

 5

 The Robert T. Stafford Disaster Relief and Emergency Assistance Act of 1974 is codified, 

as amended, at 42 U.S.C. § 5121-5207. 

6

 The Public Health Service Act is codified, as amended, at 42 U.S.C. § 201-300ii-4. 

Page 11 GAO-07-781 Leadership and Planning for a Pandemic
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.7

 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.8

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 

 7

 The 15 ESF annexes are in (1) transportation; (2) communications; (3) public works and 

engineering; (4) firefighting; (5) emergency management; (6) mass care, housing, and 

human services; (7) resource support; (8) public health and medical services; (9) urban

search and rescue; (10) oil and hazardous materials response; (11) agriculture and natural 

resources; (12) energy; (13) public safety and security; (14) long-term community recovery 

and mitigation; and (15) external affairs. 

8

 ESF-11 supporting agencies include the Departments of Commerce, Defense, Energy, 

Justice, and Labor. 

Page 12 GAO-07-781 Leadership and Planning for a Pandemic
the Catastrophic Incident Annex.9

 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.

10 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: 

The Executive Branch Has 

Taken Other Steps to 

Prepare for a Pandemic 

• 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 

 9

 The NRP includes the seven incident annexes: biological, catastrophic, cyber, food and 

agriculture, nuclear/radiological, oil and hazardous materials, and terrorism incident law 

enforcement and investigation. 

10 For non-Stafford Act incidents, the NRP refers to Federal Resource Coordinators. 

Page 13 GAO-07-781 Leadership and Planning for a Pandemic
families. As of July 2007, there were 16 checklists included on the Web 

site.11

• 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.12

• 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.13

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. 

 11 As of July 25, 2007, the checklists included State and Local Pandemic Influenza Planning 

Checklist, Pandemic Preparedness Planning for United States Businesses with Overseas 

Operations, Business Pandemic Influenza Planning Checklist, Health Insurer Pandemic 

Influenza Planning Checklist, Travel Industry Pandemic Influenza Planning Checklist, Child 

Care and Preschool Pandemic Influenza Planning Checklist, School District (K-12) 

Pandemic Influenza Planning Checklist, Colleges and Universities Pandemic Influenza 

Planning Checklist, Faith-Based and Community Organizations Pandemic Influenza 

Planning Checklist, Home Health Care Services Pandemic Influenza Planning Checklist, 

Medical Offices and Clinics Checklist, Emergency Medical Services and Medical Transport 

Checklist, Hospital Preparedness Checklist, Long-term Care and Other Residential 

Facilities Pandemic Influenza Planning Checklist, and Pandemic Flu Planning Checklist for 

Individuals and Families.

12 GAO, Continuity of Operations: Agencies Could Improve Planning for Telework during

Disruptions, GAO-06-740T (Washington, D.C.: May 11, 2006). 

13 Department of Homeland Security, Pandemic Influenza Preparedness, Response, and

Recovery Guide for Critical Infrastructure and Key Resources, (Washington, D.C.: Sept.

19, 2006). 

Page 14 GAO-07-781 Leadership and Planning for a Pandemic
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.14 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 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 

Federal Government 

Leadership Roles and 

Responsibilities Need 

Clarification and 

Testing

The Strategy and Plan Do 

Not Clarify Leadership 

Roles and Responsibilities 

 14 Congressional Research Service, Pandemic Influenza. 

Page 15 GAO-07-781 Leadership and Planning for a Pandemic
government must be clearly defined, effectively communicated, and wellunderstood 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 

Page 16 GAO-07-781 Leadership and Planning for a Pandemic
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.15

Other DHS responsibilities include operating and maintaining the National 

Biosurveillance Integration System, which is intended to provide an allsource 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.16

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.17 The federal response may be slowed as 

agencies resolve their roles and responsibilities following the onset of a 

 15 Social distancing includes measures such as limiting public gatherings or closing 

buildings to help people avoid exposure to infectious diseases. 

16 Critical infrastructure and key resource sectors include agriculture and food; banking 

and finance; chemical; commercial facilities; dams; defense industrial base; drinking water 

and water treatment systems; emergency services; energy; government facilities; 

information technology; national monuments and icons; nuclear reactors, materials, and

waste; postal and shipping; public health and health care; telecommunications; and 

transportation systems. 

17 GAO, 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).

Page 17 GAO-07-781 Leadership and Planning for a Pandemic
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. 

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.18 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 

Additional Key Leadership 

Roles and Responsibilities 

Are Evolving and Untested 

 18 The Secretary of Homeland Security combined the jurisdictions covered by FEMA’s 10 

regional offices into 5 pandemic regions. 

Page 18 GAO-07-781 Leadership and Planning for a Pandemic
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.19 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 

 19 GAO, Homeland Security: Management and Programmatic Challenges Facing the 

Department of Homeland Security, GAO-07-398T (Washington, D.C.: Feb. 6, 2007). 

Page 19 GAO-07-781 Leadership and Planning for a Pandemic
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. 

In 2006, Congress passed two acts addressing leadership roles and 

responsibilities for emergency management—the Pandemic and AllHazards Preparedness Act20 and the Post-Katrina Emergency Management 

Reform Act of 200621—which were enacted into law on December 19, 2006 

and October 4, 2006, respectively. 

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, 

Recent Congressional 

Actions Addressed 

Leadership Roles and 

Responsibilities 

Pandemic and All-Hazards 

Preparedness Act and Its 

Implementation 

 20 Pub. L. No. 109-417. 

21 Pub. L. No. 109-295, Title VI. 

Page 20 GAO-07-781 Leadership and Planning for a Pandemic
thus placing these public health resources within HHS.22 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.

In response to the findings and recommendations from several reports, the 

Post-Katrina Emergency Management Reform Act (referred to as the PostKatrina 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.23 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

Post-Katrina Reform Act and 

Its Implementation 

 22 The National Disaster Medical System was transferred to DHS from HHS as part of the

Homeland Security Act of 2002 establishing DHS. 

23 On January 18, 2007, DHS provided Congress with a notice of implementation of the PostKatrina Reform Act reorganization requirements and additional organizational changes

made under the Homeland Security Act of 2002. 

Page 21 GAO-07-781 Leadership and Planning for a Pandemic
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. 

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.24 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 2005.25 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. 

Rigorous and Robust 

Exercises Are Important 

for Testing Federal 

Leadership for a Pandemic 

 24 GAO, Hurricane Katrina: GAO’s Preliminary Observations Regarding Preparedness, 

Response, and Recovery, GAO-06-442T (Washington, D.C.: Mar. 8, 2006). 

25 Congressional Research Service, Pandemic Influenza. 

Page 22 GAO-07-781 Leadership and Planning for a Pandemic
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. 

Table 3: Extent to Which the Strategy and Plan Address GAO’s Desirable 

Characteristics of an Effective National Strategy 

The National Strategy 

and Its 

Implementation Plan 

Do Not Address All 

the Characteristics of 

an Effective Strategy, 

Thus Limiting Their 

Usefulness as 

Planning Tools 

Desirable characteristic Addresses 

Partially 

addresses 

Does not

address 

Clear purpose, scope, and 

methodology 

X

Problem definition and risk 

assessment 

X

Goals, subordinate objectives,

activities, and performance measures 

X

Resources, investments, and risk 

management 

X

Organizational roles, responsibilities, 

and coordination 

X

Integration and implementation X 

Source: GAO analysis of the National Strategy for Pandemic Influenza and Implementation Plan for the National Strategy for Pandemic

Influenza. 

Page 23 GAO-07-781 Leadership and Planning for a Pandemic
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 

The Strategy and Plan 

Partially Address Purpose, 

Scope, and Methodology 

Page 24 GAO-07-781 Leadership and Planning for a Pandemic
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, 

Page 25 GAO-07-781 Leadership and Planning for a Pandemic
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.

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 study26 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 

Strategy and Plan Address 

Problem Definition and 

Risk Assessment 

 26 Congressional Budget Office, A Potential Influenza Pandemic: Possible Macroeconomic 

Effects and Policy Issues (Washington, D.C.: Dec. 8, 2005).

Page 26 GAO-07-781 Leadership and Planning for a Pandemic
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. 

A national strategy should describe its goals and the steps needed to 

achieve those results, as well as the priorities, milestones, and outcomerelated 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.27

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 Strategy and Plan 

Partially Address Goals, 

Objectives, Activities, and 

Performance Measures 

 27 Of the 324 action items, 39 were response related with performance measures requiring 

certain efforts within a prescribed time frame after an outbreak and thus not included in 

the universe of action items assessed for this purpose. Additionally, there were no 

performance measures associated with 18 action items. 

Page 27 GAO-07-781 Leadership and Planning for a Pandemic
Figure 1: National Strategy and Implementation Plan’s Goals, Pillars, Functional Areas, and 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. 

Page 28 GAO-07-781 Leadership and Planning for a Pandemic
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

Page 29 GAO-07-781 Leadership and Planning for a Pandemic
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.28

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 

 28 GAO, 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). 

Page 30 GAO-07-781 Leadership and Planning for a Pandemic
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.29 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 

 29 Emergency Supplemental Appropriations to Address Hurricanes in the Gulf of Mexico 

and Pandemic Influenza Act of 2006, Division B of Pub.L. No. 109-148 (2005).

Page 31 GAO-07-781 Leadership and Planning for a Pandemic
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.30

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, 

 30 GAO, 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.: Sept. 21, 2006). 

Page 32 GAO-07-781 Leadership and Planning for a Pandemic
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 

Page 33 GAO-07-781 Leadership and Planning for a Pandemic
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.31 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 

 31 GAO, 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). 

Page 34 GAO-07-781 Leadership and Planning for a Pandemic
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. 

Figure 2: Related National Preparedness Strategies, Initiatives, and Plans 

National strategies

and initiatives Pandemic influenza strategy and plans

National Security Strategy

National Strategy for 

Homeland Security

National Incident 

Management System

National Response Plan

• Emergency support 

 functions

• Catastrophic Incident 

 Annex

Interim National

Preparedness Goal

• Planning scenarios

State pandemic plans

Local pandemic plans

Tribal nations’

pandemic plans

Private sector

pandemic plans

International

pandemic plans

National Strategy for 

Pandemic Influenza

Implementation Plan for

the National Strategy for 

Pandemic Influenza

Individual federal agency 

pandemic influenza plans

Source: GAO.

Whereas the Plan states that it supports Homeland Security Presidential 

Directive 8, which required the development of a domestic all-hazards 

Page 35 GAO-07-781 Leadership and Planning for a Pandemic
preparedness goal—the National Preparedness Goal (Goal)—it does not 

describe how it supports the directive or its relationship to the Goal.32 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. 

 32 The Goal establishes the national vision and priorities to guide the nation’s efforts to set 

measurable readiness benchmarks and targets to strengthen the nation’s preparedness, and 

attempts to provide a comprehensive preparedness effort. 

Page 36 GAO-07-781 Leadership and Planning for a Pandemic
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. 

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. 

Conclusions 

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 

Page 37 GAO-07-781 Leadership and Planning for a Pandemic
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.

Page 38 GAO-07-781 Leadership and Planning for a Pandemic
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. 

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. 

Recommendations for 

Executive Action 

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 

Page 39 GAO-07-781 Leadership and Planning for a Pandemic
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. 

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

Agency Comments 

and Our Evaluation 

Page 40 GAO-07-781 Leadership and Planning for a Pandemic
the last page of this report. GAO staff who made major contributions to 

this report are listed in appendix III. 

Bernice Steinhardt 

Director 

Strategic Issues 

Page 41 GAO-07-781 Leadership and Planning for a Pandemic
Appendix I: Scope and Methodology 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.1

 Table 4 provides the 

desirable characteristics and examples of their elements. 

 1 GAO-04-408T. 

Page 42 GAO-07-781 Leadership and Planning for a Pandemic
Appendix I: Scope and Methodology 

Table 4: GAO Desirable Characteristics for a National Strategy 

Desirable characteristic Brief description Examples of elements 

Purpose, scope, and 

methodology 

Addresses why the strategy was 

produced, the scope of its 

coverage, and the process by 

which it was developed. 

• Statement of broad or narrow purpose, as appropriate. 

• How it compares and contrasts with other national strategies. 

• What major functions, mission areas, or activities it covers. 

• Principles or theories that guided its development. 

• Impetus for strategy, for example, statutory requirement or

event. 

• Process to produce strategy, for example, interagency task 

force or state, local, or private input. 

• Definition of key terms. 

Problem definition and risk 

assessment 

Addresses the particular national 

problems and threats the strategy 

is directed toward. 

• Discussion or definition of problems, their causes, and 

operating environment. 

• Risk assessment, including an analysis of threats and 

vulnerabilities.

• Quality of data available, for example, constraints, 

deficiencies, and “unknowns.” 

Goals, subordinate objectives,

activities, and performance 

measures 

Addresses what the strategy is 

trying to achieve; steps to achieve 

those results; as well as the 

priorities, milestones, and 

performance measures to gauge 

results. 

• Overall results desired, that is, “end state.” 

• Hierarchy of strategic goals and subordinate objectives. 

• Specific activities to achieve results. 

• Priorities, milestones, and outcome-related performance 

measures. 

• Specific performance measures. 

• Process for monitoring and reporting on progress. 

• Limitations on progress indicators. 

Resources, investments, and 

risk management 

Addresses what the strategy will 

cost, the sources and types of 

resources and investments 

needed, and where resources and 

investments should be targeted by 

balancing risk reductions and 

costs. 

• Resources and investments associated with the strategy. 

• Types of resources required, such as budgetary, human 

capital, information technology, research and development, 

and contracts. 

• Sources of resources, for example, federal, state, local, and 

private. 

• Economic principles, such as balancing benefits and costs. 

• Resource allocation mechanisms, such as grants, in-kind

services, loans, or user fees. 

• “Tools of government,” for example, mandates or incentives to 

spur action. 

• Importance of fiscal discipline.

• Linkage to other resource documents, for example, federal 

budget. 

• Risk management principles. 

Page 43 GAO-07-781 Leadership and Planning for a Pandemic
Appendix I: Scope and Methodology 

Desirable characteristic Brief description Examples of elements 

Organizational roles, 

responsibilities, and 

coordination 

Addresses who will be

implementing the strategy, what 

their roles will be compared to

others, and mechanisms for them 

to coordinate their efforts. 

• Roles and responsibilities of specific federal agencies, 

departments, or offices. 

• Roles and responsibilities of state, local, private, and 

international sectors. 

• Lead, support, and partner roles and responsibilities. 

• Accountability and oversight framework. 

• Potential changes to current organizational structure. 

• Specific processes for coordination and collaboration. 

• How conflicts will be resolved. 

Integration and

implementation

Addresses how a national strategy 

relates to other strategies’ goals, 

objectives, and activities—and to 

subordinate levels of government 

and their plans to implement the 

strategy. 

• Integration with other national strategies (horizontal). 

• Integration with relevant documents from implementing

organizations (vertical). 

• Details on specific federal, state, local, or private strategies

and plans. 

• Implementation guidance. 

• Details on subordinate strategies and plans for 

implementation, for example, human capital and enterprise

architecture. 

Source: GAO.

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.2

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.

 2 GAO-04-408T, GAO-06-788, and GAO-07-100. 

Page 44 GAO-07-781 Leadership and Planning for a Pandemic
Appendix I: Scope and Methodology 

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. 

Page 45 GAO-07-781 Leadership and Planning for a Pandemic
Appendix II: Comments from the Department Appendix II: Comments from the Department of Homeland Security

of Homeland Security 

Page 46 GAO-07-781 Leadership and Planning for a Pandemic
Appendix II: Comments from the Department 

of Homeland Security

Page 47 GAO-07-781 Leadership and Planning for a Pandemic
Appendix III: GAO

A

 Contact and Staff 

cknowledgments 

Page 48 GAO-07-781

Appendix III: GAO Contact and Staff 

Acknowledgments 

Bernice Steinhardt, (202) 512-6543 or steinhardtb@gao.gov

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. 

GAO Contact 

Acknowledgments 

Leadership and Planning for a Pandemic
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(450450) Page 51 GAO-07-781 Leadership and Planning for a Pandemic
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