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entitled 'Influenza Pandemic: Further Efforts Are Needed to Ensure 
Clearer Federal Leadership Roles and Effective National Strategy' which 
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Report to Congressional Requesters: 

United States Government Accountability Office: 

GAO: 

August 2007: 

Influenza Pandemic: 

Further Efforts Are Needed to Ensure Clearer Federal Leadership Roles 
and an Effective National Strategy: 

Leadership and Planning for a Pandemic: 

GAO-07-781: 

GAO Highlights: 

Highlights of GAO-07-781, a report to congressional requesters. 

Why GAO Did This Study: 

An influenza pandemic is a real and significant potential threat facing 
the United States and the world. Pandemics occur when a novel virus 
emerges that can easily be transmitted among humans who have little 
immunity. In 2005, the Homeland Security Council (HSC) issued a 
National Strategy for Pandemic Influenza and, in 2006, an 
Implementation Plan. 

Congress and others are concerned about the federal government’s 
preparedness to lead a response to an influenza pandemic. This report 
assesses how clearly federal leadership roles and responsibilities are 
defined and the extent to which the Strategy and Plan address six 
characteristics of an effective national strategy. To do this, GAO 
analyzed key emergency and pandemic-specific plans, interviewed agency 
officials, and compared the Strategy and Plan with the six 
characteristics GAO identified. 

What GAO Found: 

The executive branch has taken an active approach to help address this 
potential threat, including establishing an online information 
clearinghouse, developing planning guidance and checklists, awarding 
grants to accelerate development and production of new technologies for 
influenza vaccines within the United States, and assisting state and 
local government pandemic planning efforts. However, federal government 
leadership roles and responsibilities for preparing for and responding 
to a pandemic continue to evolve, and will require further 
clarification and testing before the relationships of the many 
leadership positions are well understood. The Strategy and Plan do not 
specify how the leadership roles and responsibilities will work in 
addressing the unique characteristics of an influenza pandemic, which 
could occur simultaneously in multiple locations and over a long 
period. A pandemic could extend well beyond health and medical 
boundaries, affecting critical infrastructure, the movement of goods 
and services across the nation and the globe, 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. 

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.

[hyperlink, http://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. 

[End of section] 

Contents: 

Letter: 

Results in Brief: 

Background: 

Federal Government Leadership Roles and Responsibilities Need 
Clarification and Testing: 

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

Conclusions: 

Recommendations for Executive Action: 

Agency Comments and Our Evaluation: 

Appendix I: Scope and Methodology: 

Appendix II: Comments from the Department of Homeland Security: 

Appendix II: IGAO Contact and Staff Acknowledgments: 

Related GAO Products: 

Tables: 

Table 1: Summary of Desirable Characteristics for a National Strategy: 

Table 2: Extent to Which the Strategy and Plan Address GAO's Desirable 
Characteristics of an Effective National Strategy: 

Table 3: Extent to Which the Strategy and Plan Address GAO's Desirable 
Characteristics of an Effective National Strategy: 

Table 4: GAO Desirable Characteristics for a National Strategy: 

Figures: 

Figure 1: National Strategy and Implementation Plan's Goals, Pillars, 
Functional Areas, and Action Items: 

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

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: 

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 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. 

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 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 
high-level overview of the approach that the federal government will 
take to prepare for and respond to an influenza pandemic. It also 
articulates expectations for nonfederal entities--including state, 
local, and tribal governments; the private sector; international 
partners; and individuals--to prepare themselves and their communities. 
The 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. 

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.[Footnote 
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. 

Table 1: Summary of Desirable Characteristics for a National Strategy: 

Desirable characteristic: Purpose, scope, and methodology; 
Brief description: Addresses why the strategy was produced, the scope 
of its coverage, and the process by which it was developed. 

Desirable characteristic: Problem definition and risk assessment; 
Brief description: Addresses the particular national problems and 
threats the strategy is directed toward. 

Desirable characteristic: Goals, subordinate objectives, activities, 
and performance measures; 
Brief description: 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. 

Desirable characteristic: Resources, investments, and risk management; 
Brief description: 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. 

Desirable characteristic: Organizational roles, responsibilities, and 
coordination; 
Brief description: Addresses who will be implementing the strategy, 
what their roles will be compared to others, and mechanisms for them to 
coordinate their efforts. 

Desirable characteristic: Integration and implementation; 
Brief description: 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. 

[End of table] 

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 reports on pandemic preparedness, emergency preparedness, and other 
related topics is included at the end of this report.[Footnote 2] 

Results in Brief: 

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. 

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 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.[Footnote 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 
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: Clear purpose, scope, and methodology; 
Addresses: [Empty]; 
Partially addresses: X; 
Does not address: [Empty]. 

Desirable characteristic: Problem definition and risk assessment; 
Addresses: X; 
Partially addresses: [Empty]; 
Does not address: [Empty]. 

Desirable characteristic: Goals, subordinate objectives, activities, 
and performance measures; 
Addresses: [Empty]; 
Partially addresses: X; 
Does not address: [Empty]. 

Desirable characteristic: Resources, investments, and risk management; 
Addresses: [Empty]; 
Partially addresses: [Empty]; 
Does not address: X. 

Desirable characteristic: Organizational roles, responsibilities, and 
coordination; 
Addresses: [Empty]; 
Partially addresses: X; 
Does not address: [Empty]. 

Desirable characteristic: Integration and implementation; 
Addresses: [Empty]; 
Partially addresses: X; 
Does not address: [Empty]. 

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

[End of table] 

The Strategy and Plan partially address the remaining four 
characteristics. Some of the gaps we found include the following: 

* 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 response-related 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 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. 

Background: 

The Strategy lays out three high-level goals to prepare for and respond 
to an influenza pandemic: (1) stop, slow, or otherwise limit the spread 
of a pandemic to the United States; (2) limit the domestic spread of a 
pandemic and mitigate disease, suffering, and death; and (3) sustain 
infrastructure and mitigate impact on the economy and the functioning 
of society. These goals are underpinned by three pillars that are 
intended to guide the federal government's approach to a pandemic 
threat: (1) preparedness and communication, (2) surveillance and 
detection, and (3) response and containment. Each pillar describes 
domestic and international efforts, animal and human health efforts, 
and efforts that would need to be undertaken at all levels of 
government and in communities to prepare for and respond to a pandemic. 

The Plan is intended to support the broad framework and goals 
articulated in the Strategy by outlining specific steps that federal 
departments and agencies should take to achieve these goals. It also 
describes expectations regarding preparedness and response efforts of 
state and local governments and tribal entities and the private sector. 
The Plan's chapters cover categories of actions that are intended to 
address major considerations raised by a pandemic, including protecting 
human and animal health; transportation and borders; and international, 
security, and institutional considerations. The Plan is not intended to 
describe the operational details of how federal departments and 
agencies would accomplish their objectives to support the Strategy. 
Rather, these operational details are supposed to be included in the 
departments' and agencies' pandemic implementation plans along with 
additional considerations raised during a pandemic involving (1) 
protection of employees, (2) maintenance of essential functions and 
services, and (3) the manner in which departments and agencies would 
communicate messages about pandemic planning and respond to their 
stakeholders. 

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

The Homeland Security Act of 2002 required the newly established DHS to 
develop a comprehensive National Incident Management System (NIMS) and 
a comprehensive NRP.[Footnote 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. 

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).[Footnote 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.[Footnote 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 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.[Footnote 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.[Footnote 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 
the Catastrophic Incident Annex.[Footnote 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.[Footnote 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 Taken Other Steps to Prepare for a Pandemic: 

The executive branch has also developed tools and guidance to aid in 
preparing for and responding to a pandemic influenza. Among these are 
the following: 

* A Web site, [hyperlink, http://www.pandemicflu.gov], to provide one-
stop access to U.S. government avian and pandemic influenza 
information. This site is managed by HHS. 

* Planning checklists for state and local governments, businesses, 
schools, community organizations, health care providers, and 
individuals and families. As of July 2007, there were 16 checklists 
included on the Web site.[Footnote 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.[Footnote 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.[Footnote 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. 

Federal Government Leadership Roles and Responsibilities Need 
Clarification and Testing: 

While the Strategy and Plan describe the broad roles and 
responsibilities for preparing for and responding to a pandemic 
influenza, they do little to clarify existing emergency response roles 
and responsibilities. Instead, the documents restate the shared roles 
and responsibilities of the Secretaries of Health and Human Services 
and Homeland Security already prescribed by the NRP and related annexes 
and plans. These and other leadership roles and responsibilities 
continue to evolve, such as with the establishment of a national PFO 
and regional PFOs and FCOs and potential changes from ongoing efforts 
to revise the NRP. Congress has also passed legislation to address 
prior problems that emerged regarding federal leadership roles and 
responsibilities for emergency management that have ramifications for 
pandemic influenza. Although pandemic influenza scenarios have been 
used to exercise specific response elements, such as the distribution 
of stockpiled medications at specific locations or jurisdictions, no 
national exercises have tested the new federal leadership structure for 
pandemic influenza.[Footnote 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 Leadership Roles and 
Responsibilities: 

The Strategy and Plan do not clarify the specific leadership roles and 
responsibilities for a pandemic. Instead, they restate the existing 
leadership roles and responsibilities, particularly for the Secretaries 
of Homeland Security and Health and Human Services, prescribed in the 
NRP--an all-hazards plan for emergencies ranging from hurricanes to 
wildfires to terrorist attacks. However, the leadership roles and 
responsibilities prescribed under the NRP may need to operate somewhat 
differently because of the characteristics of a pandemic that 
distinguish it from other emergency incidents. For example, because a 
pandemic influenza is likely to occur in successive waves, planning has 
to consider how to sustain response mechanisms for several months to 
over a year--issues that are not clearly addressed in the Plan. In 
addition, the distributed nature of a pandemic, as well as the sheer 
burden of disease across the nation, means that the support states, 
localities, and tribal entities can expect from the federal government 
would be limited in comparison to the aid it mobilizes for 
geographically and temporarily bounded disasters like earthquakes and 
hurricanes. Consequently, legal authorities, roles and 
responsibilities, and lines of authority at all levels of government 
must be clearly defined, effectively communicated, and well-understood 
to facilitate rapid and effective decision making. This is also 
important for public and private sector organizations and international 
partners so everyone can better understand what is expected of them 
before and during a pandemic. 

The Strategy and Plan describe the Secretary of Health and Human 
Services as being responsible for leading the medical response in a 
pandemic, while the Secretary of Homeland Security is responsible for 
overall domestic incident management and federal coordination. However, 
since a pandemic extends well beyond health and medical boundaries, to 
include sustaining critical infrastructure, private sector activities, 
the movement of goods and services across the nation and the globe, and 
economic and security considerations, it is not clear when, in a 
pandemic, the Secretary of Health and Human Services would be in the 
lead and when the Secretary of Homeland Security would lead. 

Specifically, the Plan states that the Secretary of Health and Human 
Services, consistent with his/her role under the NRP as the coordinator 
for ESF-8, would be responsible for the overall coordination of the 
public health and medical emergency response during a pandemic, 
including coordinating all federal medical support to communities; 
providing guidance on infection control and treatment strategies to 
state, local, and tribal entities and the public; maintaining, 
prioritizing, and distributing countermeasures in the Strategic 
National Stockpile; conducting ongoing epidemiologic assessment and 
modeling of the outbreak; and researching the influenza virus, novel 
countermeasures, and rapid diagnostics. The Plan calls for the 
Secretary to be the principal federal spokesperson for public health 
issues, coordinating closely with DHS on public messaging pertaining to 
the pandemic. 

Also similar to the NRP, the Plan states that the Secretary of Homeland 
Security, as the principal federal official for domestic incident 
management, would be responsible for coordinating federal operations 
and resources; establishing reporting requirements; and conducting 
ongoing communications with federal, state, local, and tribal 
governments, the private sector, and nongovernmental organizations. It 
also states that in the context of response to a pandemic, the 
Secretary of Homeland Security would coordinate overall nonmedical 
support and response actions, sustain critical infrastructure, and 
ensure necessary support to the Secretary of Health and Human Services' 
coordination of public health and medical emergency response efforts. 
Additionally, the Plan states that the Secretary of Homeland Security 
would be responsible for coordinating the overall response to the 
pandemic; implementing policies that facilitate compliance with 
recommended social distancing measures; providing for a common 
operating picture for all departments and agencies of the federal 
government; and ensuring the integrity of the nation's infrastructure, 
domestic security, and entry and exit screening for influenza at the 
borders.[Footnote 15] 

Other DHS responsibilities include operating and maintaining the 
National Biosurveillance Integration System, which is intended to 
provide an all-source biosurveillance common operating picture to 
improve early warning capabilities and facilitate national response 
activities through better situational awareness. This responsibility, 
however, appears to be both a public health issue and an overall 
incident management issue, raising similar issues about the 
interrelationship of DHS and HHS roles and responsibilities. In 
addition, a pandemic could threaten our critical infrastructure, such 
as the capability to deliver electricity or food, by removing essential 
personnel from the workplace for weeks or months.[Footnote 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.[Footnote 17] The federal 
response may be slowed as agencies resolve their roles and 
responsibilities following the onset of a significant outbreak. In 
addition, although DHS and HHS officials emphasize that they are 
working together on a frequent basis, these roles and responsibilities 
have not been thoroughly tested and exercised. 

Additional Key Leadership Roles and Responsibilities Are Evolving and 
Untested: 

The executive branch has several efforts, some completed and others 
under way, to strengthen and clarify leadership roles and 
responsibilities for preparing for and responding to a pandemic 
influenza. However, many of these efforts are new, untested through 
exercises, or both. For example, on December 11, 2006, the Secretary of 
Homeland Security predesignated the Vice Commandant of the U.S. Coast 
Guard as the national PFO for pandemic influenza, and also established 
five pandemic regions, each with a regional PFO.[Footnote 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 
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.[Footnote 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 
government, including the role of the PFO and that position's current 
lack of operational authority during an emergency. The review is 
expected to be done, and a revised NRP and NIMS issued, by the summer 
of 2007. 

Recent Congressional Actions Addressed Leadership Roles and 
Responsibilities: 

In 2006, Congress passed two acts addressing leadership roles and 
responsibilities for emergency management--the Pandemic and All- 
Hazards Preparedness Act[Footnote 20] and the Post-Katrina Emergency 
Management Reform Act of 2006[Footnote 21]--which were enacted into law 
on December 19, 2006 and October 4, 2006, respectively. 

Pandemic and All-Hazards Preparedness Act and Its Implementation: 

The Pandemic and All-Hazards Preparedness Act codifies preparedness and 
response federal leadership roles and responsibilities for public 
health and medical emergencies that are now in the NRP by designating 
the Secretary of Health and Human Services as the lead federal official 
for public health and medical preparedness and response, consistent 
with the NRP. The act also requires the Secretary to establish an 
interagency agreement, in collaboration with DOD, DHS, DOT, the 
Department of Veterans Affairs, and other relevant federal agencies, 
prescribing that consistent with the NRP, HHS would assume operational 
control of emergency public health and medical response assets in the 
event of a public health emergency. Further, the act requires that the 
Secretary develop a coordinated National Health Security Strategy and 
accompanying implementation plan for public health emergency 
preparedness and response. This health security strategy and 
accompanying implementation plan are to be completed by 2009 and 
updated every 4 years. 

The act also prescribes several new preparedness responsibilities for 
HHS. For example, the Secretary must develop and disseminate criteria 
for an effective state plan for responding to a pandemic influenza. 
Additionally, the Secretary is required to develop and require the 
application of measurable evidence-based benchmarks and objective 
standards that measure the levels of preparedness in such areas as 
hospitals and state and local public health security. 

The act seeks to further strengthen HHS's public health leadership role 
by transferring the National Disaster Medical System from DHS back to 
HHS, thus placing these public health resources within HHS.[Footnote 
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. 

Post-Katrina Reform Act and Its Implementation: 

In response to the findings and recommendations from several reports, 
the Post-Katrina Emergency Management Reform Act (referred to as the 
Post-Katrina Reform Act in this report) designated the FEMA 
Administrator as the principal domestic emergency management advisor to 
the President, the HSC, and the Secretary of Homeland Security. 
Therefore, the FEMA Administrator also has a leadership role in 
preparing for and responding to an influenza pandemic, including key 
areas such as planning and exercising. For example, under the Post- 
Katrina Reform Act, the FEMA Administrator is responsible for carrying 
out a national exercise program to test and evaluate preparedness for a 
national response to natural and man-made disasters. 

The act made FEMA a distinct entity within DHS for leading and 
supporting the nation in a risk-based, comprehensive emergency 
management system of preparedness, protection, response, recovery, and 
mitigation. As part of the reorganization, DHS transferred several 
offices and divisions of its National Preparedness Directorate to FEMA, 
including the Offices of Grants and Training and National Capital 
Region Coordination.[Footnote 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 Administration. The reorganization took effect on March 31, 
2007, and it will likely take some time before it is fully implemented 
and key leadership positions within FEMA are filled. 

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

Disaster planning, including for a pandemic influenza, needs to be 
tested and refined with a rigorous and robust exercise program to 
expose weaknesses in plans and allow planners to refine them. 
Exercises--particularly for the type and magnitude of emergency 
incidents such as a severe influenza pandemic for which there is little 
actual experience--are essential for developing skills and identifying 
what works well and what needs further improvement. Our prior work 
examining the preparation for and response to Hurricane Katrina 
highlighted the importance of realistic exercises to test and refine 
assumptions, capabilities, and operational procedures; and build upon 
strengths.[Footnote 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.[Footnote 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. 

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

The Strategy and Plan represent important efforts to guide the nation's 
preparedness and response activities, setting forth actions to be taken 
by federal agencies and expectations for a wide range of actors, 
including states and communities, the private sector, global partners, 
and individuals. However, the Strategy and Plan do not address all of 
the characteristics of an effective national strategy as we identified 
in our prior work. While national strategies necessarily vary in 
content, the six characteristics we identified apply to all such 
planning documents and can help ensure that they are effective 
management tools. Gaps and deficiencies in these documents are 
particularly troubling in that a pandemic represents a complex 
challenge that will require the full understanding and collaboration of 
a multitude of entities and individuals. The extent to which these 
documents, that are to provide an overall framework to ensure 
preparedness and response to a pandemic influenza, fail to adequately 
address key areas, could have critical impact on whether the public and 
key stakeholders have a clear understanding and can effectively execute 
their roles and responsibilities. 

As shown in table 3, the Strategy and its Plan address one of the six 
characteristics of an effective national strategy. However, they only 
partially address four and do not address one of the characteristics at 
all. As a result, the Strategy and Plan fall short as an effective 
national strategy in important areas. 

Table 3: Extent to Which the Strategy and Plan Address GAO's Desirable 
Characteristics of an Effective National Strategy: 

Desirable characteristic: Clear purpose, scope, and methodology; 
Addresses: [Empty]; 
Partially addresses: X; 
Does not address: [Empty]. 

Desirable characteristic: Problem definition and risk assessment; 
Addresses: X; 
Partially addresses: [Empty]; 
Does not address: [Empty]. 

Desirable characteristic: Goals, subordinate objectives, activities, 
and performance measures; 
Addresses: [Empty]; 
Partially addresses: X; 
Does not address: [Empty]. 

Desirable characteristic: Resources, investments, and risk management; 
Addresses: [Empty]; 
Partially addresses: [Empty]; 
Does not address: X. 

Desirable characteristic: Organizational roles, responsibilities, and 
coordination; 
Addresses: [Empty]; 
Partially addresses: X; 
Does not address: [Empty]. 

Desirable characteristic: Integration and implementation; 
Addresses: [Empty]; 
Partially addresses: X; 
Does not address: [Empty]. 

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

[End of table] 

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

A national strategy should address its purpose, scope, and methodology, 
including the process by which it was developed, stakeholder 
involvement, and how it compares and contrasts with other national 
strategies. Addressing this characteristic helps make a strategy more 
useful to organizations responsible for implementing the strategy, as 
well as those responsible for oversight. We found that the Strategy and 
Plan partially address this characteristic by describing their purpose 
and scope. However, neither document described in adequate detail their 
methodology for involving key stakeholders, how they relate to other 
national strategies, or a process for updating the Plan. 

In describing its purpose, the Strategy states that it was developed to 
provide strategic direction for the departments and agencies of the 
U.S. government and guide the U.S. preparedness and response activities 
to mitigate the impact of a pandemic. In support of the Strategy, the 
Plan states that its purpose is to translate the Strategy into tangible 
action and direct federal departments and agencies to take specific, 
coordinated steps to achieve the goals of the Strategy and outline 
expectations for state, local, and tribal entities; businesses; schools 
and universities; communities; nongovernmental organizations; and 
international partners. 

As a part of its scope, the Plan identifies six major functions: (1) 
protecting human health, (2) protecting animal health, (3) 
international considerations, (4) transportation and borders, (5) 
security considerations, and (6) institutional considerations. The Plan 
proposes that departments and agencies undertake a series of actions in 
support of these functional areas with operational details on how 
departments would accomplish these objectives to be provided by 
separate departmental plans. Additionally, the Strategy and Plan 
describe the principles and planning assumptions that guided their 
development. The Strategy's guiding principles include recognition of 
the private sector's integral role and leveraging global partnerships. 
The Plan's principles are more expansive, listing 12 planning 
assumptions that it identifies as facilitating its planning efforts. 
For example, 1 of the assumptions is that illness rates would be 
highest among school-aged children (about 40 percent). 

Another element under this characteristic is the involvement of key 
stakeholders in the development of the strategy. Neither the Strategy 
nor Plan described the involvement of key stakeholders, such as state, 
local, and tribal entities, in the development of the Strategy or Plan, 
even though they would be on the front lines in a pandemic and the Plan 
identifies actions they should complete. The Plan contains 17 actions 
calling for state, local, and tribal governments to lead national and 
subnational efforts, and identifies another 64 actions where their 
involvement is needed. Officials told us that federal stakeholders had 
opportunities to review and comment on the Plan but that state, local, 
and tribal entities were not directly involved, although the drafters 
of the Plan were generally aware of their concerns. Stakeholder 
involvement during the planning process is important to ensure that the 
federal government's and nonfederal entities' responsibilities and 
resource requirements are clearly understood and agreed upon. 
Therefore, the Strategy and Plan may not fully reflect a national 
perspective on this critical national issue since nonfederal 
stakeholders were not involved in the process to develop the actions 
where their leadership, support, or both would be needed. Further, 
these nonfederal stakeholders need to understand their critical roles 
in order to be prepared to work effectively under difficult and 
challenging circumstances. 

Both documents address the scope of their coverage and include several 
important elements in their discussions, but do not address how they 
compare and contrast to other national strategies. The Strategy 
recognizes that preparing for a pandemic is more than a purely federal 
responsibility, and that the nation must have a system of plans at all 
levels of government and in all sectors outside of government that can 
be integrated to address the pandemic threat. It also extends its scope 
to include the development of an international effort as a central 
component of overall capacity. The Strategy lays out the major 
functions, mission areas, and activities considered under the extent of 
its coverage. For example, the Strategy's scope is defined as extending 
well beyond health and medical boundaries, to include sustaining 
critical infrastructure, private sector activities, the movement of 
goods and services across the nation and the globe, and economic and 
security considerations. Although the Strategy states that it will be 
consistent with the National Security Strategy and the Strategy for 
Homeland Security, it does not specify how they are related. The Plan 
mentions the NRP and states that it will guide the federal pandemic 
response. Because a pandemic would affect all facets of our society, 
including the nation's security, it is important to recognize and 
reflect an understanding of how these national strategies relate to one 
another. 

The Plan does not describe a mechanism for updating it to reflect 
policy decisions, such as clarifications in leadership roles and 
responsibilities and other lessons learned from exercising and testing 
or other changes. Although the Plan was developed with the intent of 
being initial guidance and being updated and expanded over time, 
officials in several agencies told us that specific processes or time 
frames for updating and revising it have not been established. In 
addition to incorporating lessons learned, such updates are important 
in ensuring that the Plan accurately reflects entities' capabilities 
and a clear understanding of roles and responsibilities. Additionally, 
an update would also provide the opportunity for input from nonfederal 
entities that have not had an opportunity to directly provide input to 
the Strategy and Plan. 

Strategy and Plan Address Problem Definition and Risk Assessment: 

National strategies need to reflect a clear description and 
understanding of the problems to be addressed, their causes, and 
operating environment. In addition, the strategy should include a risk 
assessment, including an analysis of the threats to and vulnerabilities 
of critical assets and operations. We found that the Strategy and Plan 
address this characteristic by describing the potential problems 
associated with a pandemic as well as potential threats and 
vulnerabilities. 

In defining the problem, both documents provide information on what a 
pandemic is and how influenza viruses are transmitted, and explain that 
a threat stems from an unprecedented outbreak of avian influenza in 
Asia and Europe, caused by the H5N1 strain of the influenza A virus. 
The President, in releasing the Strategy, stated that it presented an 
approach to address the threat of pandemic influenza, whether it 
results from the strain currently in birds in Asia or another influenza 
virus. Additionally, the problem definition includes a historical 
perspective of other pandemics in the United States. 

The Plan used the severity of the 1918 influenza pandemic as the basis 
for its risk assessment. A CBO study[Footnote 26] was used to describe 
the possible economic consequences of such a severe pandemic on the 
U.S. economy today. While the Plan did not discuss the likelihood of a 
severe pandemic or analyze the possibility of whether the H5N1 strain 
would be the specific virus strain to cause a pandemic, it stated that 
history suggests that a pandemic would occur some time in the future. 
As a result, it recognizes the importance of preparing for an outbreak. 

The Strategy and Plan included discussions of the constraints and 
challenges involved in a pandemic. For example, the Plan included 
challenges such as severe shortfalls in surge capacity in the nation's 
health care facilities, limited vaccine production capabilities, the 
lack of real-time surveillance among most of the systems, and the 
inability to quantify the value of many infection control strategies. 

In acknowledging the challenges involved in pandemic preparedness, the 
Plan also describes a series of circumstances to enable preparedness, 
such as viewing pandemic preparedness as a national security issue, 
connectivity between communities, and communicating risk and 
responsibility. In this regard, the Plan recognizes that one of the 
nation's greatest vulnerabilities is the lack of connectivity between 
communities responsible for pandemic preparedness. The Plan 
specifically cites vulnerabilities in coordination of efforts between 
the animal and human health communities, as well as between the public 
health and medical communities. In the case of public health and 
medical communities, the public health community has responsibility for 
communitywide health promotion and disease prevention and mitigation 
efforts, and the medical community is largely focused on actions at the 
individual level. 

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

A national strategy should describe its goals and the steps needed to 
achieve those results, as well as the priorities, milestones, and 
outcome-related performance measures to gauge results. Identifying 
goals, objectives, and outcome-related performance measures aids 
implementing parties in achieving results and enables more effective 
oversight and accountability. We found that the Strategy and Plan 
partially address this characteristic by identifying the overarching 
goals and objectives for pandemic planning. However, the documents did 
not describe relationships or priorities among the action items, and 
some of the action items lacked a responsible entity for ensuring their 
completion. The Plan also did not describe a process for monitoring and 
reporting on the action items. Further, many of the performance 
measures associated with action items were not clearly linked with 
results nor assigned clear priorities.[Footnote 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. 

Figure 1: National Strategy and Implementation Plan's Goals, Pillars, 
Functional Areas, and Action Items: 

[See PDF for image] 

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

[End of figure] 

The Plan uses the Strategy's three major goals that are underpinned by 
three pillars as its framework and expands on this organizing structure 
by presenting chapters on six functional areas with various objectives, 
action items, and performance measures. For example, pillar 2, 
surveillance and detection, under the transportation and borders 
functional area, includes an objective to develop and exercise 
mechanisms to provide active and passive surveillance during an 
outbreak, both within and outside our borders. Under this objective is 
an action item for HHS, in coordination with other specific federal 
agencies, to develop policy recommendations for transportation and 
borders entry and exit protocols, screening, or both and to review the 
need to develop domestic response protocols and screening within 6 
months. The item's performance measure is policy recommendations for 
response protocols, screening, or both. 

While some action items depend on other action items, these linkages 
are not always apparent in the Plan. For example, one action item, 
concerning the development of a joint strategy for deploying federal 
health care and public health assets and personnel, is under the 
preparedness and communication pillar. However, another action item 
concerning the development of strategic principles for deployment of 
federal medical assets is under the response and containment pillar 
within the same chapter. While these two action items are clearly 
related, the plan does not make a connection between the two or discuss 
their relationship. An HHS official who helped draft the Plan 
acknowledged that while an effort was made to ensure linkages among 
action items, there may be gaps in the linkages among interdependent 
action items within and across the Plan's chapters on the six 
functional areas (i.e., the chapters that contain action items). 

Some action items, particularly those that are to be completed by 
state, local, and tribal governments or the private sector, do not 
identify an entity responsible for carrying out the action. Although 
the plan specifies actions to be carried out by states, local 
jurisdictions, and other entities, including the private sector, it 
gives no indication of how these actions will be monitored and how 
their completion will be ensured. For example, one such action item 
states that "all health care facilities should develop and test 
infectious disease surge capacity plans that address challenges 
including: increased demand for services, staff shortages, infectious 
disease isolation protocols, supply shortages, and security." 
Similarly, another action item states that "all Federal, State, local, 
tribal, and private sector medical facilities should ensure that 
protocols for transporting influenza specimens to appropriate reference 
laboratories are in place within 3 months." Yet the plan does not make 
clear who will be responsible for making sure that these actions are 
completed. 

While most of the action items have deadlines for completion, ranging 
from 3 months to 3 years, the Plan does not identify a process to 
monitor and report on the progress of the action items nor does it 
include a schedule for reporting progress. Agency officials told us 
that they had identified individuals to act as overall coordinators to 
monitor the action items for which their agencies have lead 
responsibility and provide periodic progress reports to the HSC. 
However, we could not identify a similar mechanism to monitor the 
progress of the action items that fall to state and local governments 
or the private sector. The first public reporting on the status of the 
action items occurred in December 2006 when the HSC reported on the 
status of the action items that were to have been completed by November 
3, 2006--6 months after the release of the Plan. Of the 119 action 
items that were to be completed by that time, we found that the HSC 
omitted the status of 16 action items. Two of the action items that 
were omitted from the report were to (1) establish an interagency 
transportation and border preparedness working group and (2) engage in 
contingency planning and related exercises to ensure preparedness to 
maintain essential operations and conduct missions. 

Additionally, we found that several of the action items that were 
reported by the HSC as being completed were still in progress. For 
example, DHS, in coordination with the Department of State (State), 
HHS, the Department of the Treasury (Treasury), and the travel and 
trade industry, was to tailor existing automated screening programs and 
extended border programs to increase scrutiny of travelers and cargo 
based on potential risk factors within 6 months. The measure of 
performance was to implement enhanced risk-based screening protocols. 
Although this action item was reported as complete, the HSC reported 
that DHS was still developing risk-based screening protocols, a major 
component of this action. A DHS official, responsible for coordinating 
the completion of DHS-led action items, acknowledged that all action 
items are a work in progress and that they would continue to be 
improved, including those items that were listed as completed in the 
report. The HSC's report included a statement that a determination of 
"complete" does not necessarily mean that work has ended; in many cases 
work is ongoing. Instead, the complete determination means that the 
measure of performance associated with an action item was met. It 
appears that this determination has not been consistently or accurately 
applied for all items. Our recent report on U.S. agencies' 
international efforts to forestall a pandemic influenza also reported 
that eight of the Plan's international-related action items included in 
the HSC's report either did not directly address the associated 
performance measure or did not indicate that the completion deadline 
had been met.[Footnote 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 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.[Footnote 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 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.[Footnote 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, agencies, and offices involved and, where appropriate, the 
different sectors, such as state, local, private, and international 
sectors. We found that the Strategy and Plan partially address this 
characteristic by containing broad information on roles and 
responsibilities. But, as we noted earlier, while the Plan describes 
coordination mechanisms for responding to a pandemic, it does not 
clarify how responsible officials would share leadership 
responsibilities. In addition, it does not describe mechanisms for 
coordinating preparations and completing the action items, nor does it 
describe an overall accountability and oversight framework. 

The Strategy identifies lead agencies for preparedness and response. 
Specifically, HHS is the lead agency for medical response; USDA for 
veterinary response; State for international activities; and DHS for 
overall domestic incident management, sustainment of critical 
infrastructure and key resources, and federal coordination. The Plan 
also briefly describes the preparedness and response roles and 
responsibilities of DOD, the Department of Labor, DOT, and Treasury. 
The Plan states that these and all federal cabinet agencies are 
responsible for their respective sectors and developing pandemic 
response plans. In addition, the Strategy and Plan broadly describe the 
expected roles and responsibilities of state, local, and tribal 
governments; international partners; the private and nonprofit sectors; 
and individuals and families. For example, in the functional area of 
transportation and borders, the Plan states that it expects state and 
local communities to involve transportation and health professionals to 
identify transportation options, consequences, and implications in the 
event of a pandemic. 

The Plan states that the primary mechanism for coordinating the federal 
government's response to a pandemic is the NRP. In this regard, the 
Plan acknowledges that sustaining mechanisms for several months to over 
a year will present unique challenges, and thus day-to-day monitoring 
of the response to a pandemic influenza would occur through the 
national operations center with an interagency body composed of senior 
decision makers from across the government and chaired by the White 
House. Additionally, the Plan states that policy issues that cannot be 
resolved at the department level would be addressed through the HSC- 
National Security Council policy coordination process. As stipulated in 
the Plan, the specifics of this policy coordination mechanism were 
included in the May 2006 revisions to the NRP. 

The Plan also generally identifies lead and support roles for the 
action items federal agencies are responsible for completing, but it is 
not explicit in defining these roles or processes for coordination and 
collaboration. While it identifies which federal agencies have lead and 
support roles for completing 305 action items, the Plan does not define 
the roles of the lead and support agencies. Rather, it leaves it to the 
agencies to interpret and negotiate their roles. According to DOT 
officials we met with, this lack of clarity, coupled with staff 
turnover, left them unclear about their roles and responsibilities in 
completing action items. Thus, they had to seek clarification from DHS 
and HHS officials to assist them in defining what it meant to be the 
lead agency for an action item. Additionally, the Plan does not 
describe specific processes for coordination and collaboration between 
federal and nonfederal organizations and sectors for completing the 
action items. 

Related to this issue, we recently reported that some of DOD's 
combatant commands, tasked with providing support in the event of a 
pandemic, had received limited detailed guidance from the lead agencies 
about what support they may be asked to provide during a 
pandemic.[Footnote 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 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: 

[See PDF for image] 

Source: GAO. 

[End of figure] 

Whereas the Plan states that it supports Homeland Security Presidential 
Directive 8, which required the development of a domestic all-hazards 
preparedness goal--the National Preparedness Goal (Goal)--it does not 
describe how it supports the directive or its relationship to the 
Goal.[Footnote 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. 

The Plan also requires the federal departments and agencies to develop 
their own pandemic plans that describe the operational details related 
to the respective action items and cover the following areas: (1) 
protection of their employees; (2) maintenance of their essential 
functions and services; (3) how they would support both the federal 
response to a pandemic and those of states, localities, and tribal 
entities; and (4) the manner in which they would communicate messages 
about pandemic planning and response to their stakeholders. Further, it 
is unclear whether all the departments will share some or all of the 
information in their plans with nonfederal entities. While some 
agencies-such as HHS, DOD, and the Department of Veterans Affairs-have 
publicly released their pandemic plans, at least one agency, DHS, has 
indicated that it does not intend to publicly release its plan. Since 
DHS is a lead agency for planning for and responding to a pandemic, 
this gap may make it more challenging to fully advance joint and 
integrated planning across all levels of government and the private 
sector. 

The Plan recognizes and discusses the need for integrating planning 
across all levels of government and the private sector to ensure that 
the plans and response actions are complementary, compatible, and 
coordinated. In this regard, the Plan provides initial planning 
guidance for state, local, and tribal entities; businesses; schools and 
universities; and nongovernmental organizations for a pandemic. It also 
includes various action items that when completed, would produce 
additional planning guidance and materials for these entities. However, 
the Plan is unclear as to how the existing guidance relates to broad 
federal and specific departmental and agency plans as well as how the 
additional guidance would be integrated and how any gaps or conflicts 
that exist would be identified and addressed. 

Conclusions: 

Although it is likely that an influenza pandemic will occur in the 
future, there is a high level of uncertainty about when a pandemic 
might occur and its level of severity. The administration has taken an 
active approach to this potential disaster by establishing an 
information clearinghouse for pandemic information; developing numerous 
planning guidelines for governments, businesses, nongovernmental 
organizations, and individuals; issuing the Strategy and Plan; 
completing many action items contained in the Plan; and continuing 
efforts to complete the remaining action items. 

A pandemic poses some unique challenges. Other disasters, such as 
hurricanes, earthquakes, or terrorist attacks, generally occur within a 
short period and the immediate effects are experienced in specific 
locations. By contrast, a pandemic would likely occur in multiple 
waves, each lasting weeks or months and affecting communities across 
the nation. Initial actions may help limit the spread of an influenza 
virus, reflecting the importance of a swift and effective response. 
Therefore, the effective exercise of shared leadership roles and 
responsibilities could have substantial consequences, both in the short 
and long term. However, these roles and responsibilities continue to 
evolve, leaving uncertainty about how the federal government would lead 
preparations for and response to a pandemic. Since the release of the 
Plan in May 2006, no national pandemic exercises of federal leadership 
roles and responsibilities have been conducted. Without rigorous 
testing, training, and exercising, the administration lacks information 
to determine whether current and evolving leadership roles and 
responsibilities are clear and clearly understood or if more changes 
are needed to ensure clarity. 

The Strategy and Plan are important because they broadly describe the 
federal government's approach and planned actions to prepare for and 
respond to a pandemic, as well as expectations for states and 
communities, the private sector, and global partners. Although they 
contain a number of important characteristics, the documents lack 
several key elements. As a result, their usefulness as a management 
tool for ensuring accountability and achieving results is limited. For 
example, because the Strategy and Plan do not address the resources and 
investments needed to implement the actions called for, it is unclear 
what resources are needed to build capacity and whether they would be 
available. Further, because they did not include stakeholders that are 
expected to be the primary responders to a pandemic in the development 
of the Strategy and Plan, these documents may not fully reflect a 
national perspective on this critical national issue, and stakeholders 
and the public may not have a full understanding of their critical 
roles. In addition, the linkages among pandemic planning efforts and 
with all-hazards plans and initiatives need to be clear so that the 
numerous parties involved can operate in an integrated manner. Finally, 
because many of the performance measures do not provide information 
about the impacts of proposed actions, it will be difficult to assess 
the extent to which we are better prepared or to identify areas needing 
additional attention. Opportunities exist to improve the usefulness of 
the Plan because it is viewed as an evolving document and is intended 
to be updated on a regular basis to reflect ongoing policy decisions, 
as well as improvements in domestic preparedness. Currently, however, 
time frames or mechanisms for updating the Plan are undefined. 

While the HSC publicly reported on the status of approximately 100 
action items that were to have been completed by November 2006, the 
Plan lacks a prescribed process for monitoring and reporting on the 
progress of the action items or what has been accomplished as a result. 
Therefore, it is unclear when the next report will be issued or how 
much information will be released. In addition, some of the information 
reported was incorrect. This lack of transparency makes it difficult to 
inform a national dialogue on the progress made to date or what further 
steps are needed. It also inhibits congressional oversight of 
strategies, funding priorities, and critical efforts to enhance the 
nation's level of preparedness. 

DHS officials believe that their efforts to develop a Federal Concept 
Plan for Pandemic Influenza may help to more fully address some of the 
characteristics that we found the Strategy and Plan lack. According to 
those officials, the proposed Concept Plan may help, for example, 
better integrate the organizational roles, responsibilities, and 
coordination of interagency partners. They recognized, however, that 
the Concept Plan would not fully address all of the gaps we have 
identified. For example, they told us that the Concept Plan may not 
address actual or estimated costs or investments of the resources that 
will be required. Overall, they agreed that more needs to be done, 
especially in view of the long time requirements and challenging issues 
presented by a potential pandemic influenza. 

Recommendations for Executive Action: 

To enhance preparedness efforts for a possible pandemic, we are making 
the following two recommendations: 

We recommend that the Secretaries of Homeland Security and Health and 
Human Services work together to develop and conduct rigorous testing, 
training, and exercises for pandemic influenza to ensure that federal 
leadership roles are clearly defined and understood and that leaders 
are able to effectively execute shared responsibilities to address 
emerging challenges. Once the leadership roles have been clarified 
through testing, training, and exercising, the Secretaries of Homeland 
Security and Health and Human Services should ensure that these roles 
are clearly understood by state, local, and tribal governments; the 
private and nonprofit sectors; and the international community. 

We also recommend that the Homeland Security Council establish a 
specific process and time frame for updating the Implementation Plan 
for the National Strategy for Pandemic Influenza. The process for 
updating the Plan should involve key nonfederal stakeholders and 
incorporate lessons learned from exercises and other sources. The Plan 
should also be improved by including the following information in the 
next update: 

* the cost, sources, and types of resources and investments needed to 
complete the action items and where they should be targeted; 

* a process and schedule for monitoring and publicly reporting on 
progress made on completing the actions; 

* clearer linkages with other strategies and plans; and: 

* clearer descriptions of relationships or priorities among action 
items and greater use of outcome-focused performance measures. 

Agency Comments and Our Evaluation: 

We provided a draft of this report to DHS, HHS, and the HSC for review 
and comment. DHS provided written comments, which are reprinted in 
appendix II. In commenting on the draft report, DHS concurred with the 
first recommendation and stated that DHS is taking action on many of 
the shortfalls identified in the report. For example, DHS stated that 
it is working closely with HHS and other interagency partners to 
develop and implement a series of coordinated interagency pandemic 
exercises and will include all levels of government as well as the 
international community and the private and nonprofit sectors. 
Additionally, DHS stated that its Incident Management Planning Team 
intends to use our list of desirable characteristics of an effective 
national strategy as one of the review metrics for all future plans. 
DHS also provided us with technical comments, which we incorporated in 
the report as appropriate. 

HHS informed us that it had no comments and concurred with the draft 
report. The HSC did not comment on the draft report. 

As agreed with your offices, unless you publicly announce the contents 
of this report earlier, we plan no further distribution of it until 30 
days from its date. We will then send copies of this report to the 
appropriate congressional committees and to the Assistant to the 
President for Homeland Security; the Secretaries of HHS, DHS, USDA, 
DOD, State, and DOT; and other interested parties. We will also make 
copies available to others upon request. In addition, this report will 
be available at no charge on the GAO Web site at [hyperlink, 
http://www.gao.gov]. 

If you or your staff have any questions regarding this report, please 
contact me at (202) 512-6543 or steinhardtb@gao.gov. Contact points for 
our Offices of Congressional Relations and Public Affairs may be found 
on the last page of this report. GAO staff who made major contributions 
to this report are listed in appendix III. 

Signed by: 

Bernice Steinhardt: 
Director Strategic Issues: 

[End of section] 

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.[Footnote 33] Table 4 
provides the desirable characteristics and examples of their elements. 

Table 4: GAO Desirable Characteristics for a National Strategy: 

Desirable characteristic: Purpose, scope, and methodology; 
Brief description: Addresses why the strategy was produced, the scope 
of its coverage, and the process by which it was developed; 
Examples of elements: 
* 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. 

Desirable characteristic: Problem definition and risk assessment; 
Brief description: Addresses the particular national problems and 
threats the strategy is directed toward; 
Examples of elements: 
* 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.". 

Desirable characteristic: Goals, subordinate objectives, activities, 
and performance measures; 
Brief description: 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; 
Examples of elements: 
* 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. 

Desirable characteristic: Resources, investments, and risk management; 
Brief description: 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; 
Examples of elements: 
* 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. 

Desirable characteristic: Organizational roles, responsibilities, and 
coordination; 
Brief description: Addresses who will be implementing the strategy, 
what their roles will be compared to others, and mechanisms for them to 
coordinate their efforts; 
Examples of elements: 
* 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. 

Desirable characteristic: Integration and implementation; 
Brief description: 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; 
Examples of elements: 
* 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. 

[End of table] 

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.[Footnote 34] 

To assess whether the documents addressed these desirable 
characteristics, two analysts independently assessed both documents 
against each of the elements of a characteristic. If the analysts did 
not agree, a third party reviewed, discussed, and made the final 
determination to rate that element. Each characteristic was given a 
rating of either "addresses," "partially addresses," or "does not 
address." According to our methodology, a strategy "addresses" a 
characteristic when it explicitly cites all, or nearly all, elements of 
the characteristic and has sufficient specificity and detail. A 
strategy "partially addresses" a characteristic when it explicitly 
cites one or a few of the elements of a characteristic and has 
sufficient specificity and detail. It should be noted that the 
"partially addresses" category includes a range that varies from 
explicitly citing most of the elements to citing as few as one of the 
elements of a characteristic. A strategy "does not address" a 
characteristic when it does not explicitly cite or discuss any elements 
of a characteristic, any references are either too vague or general to 
be useful, or both. 

We reviewed relevant sections of major statutes, regulations, 
directives, and plans discussed in the Plan to better understand if and 
how they were related. Specifically, our review included Homeland 
Security Presidential Directive 5 on the Management of Domestic 
Incidents; the National Response Plan; and the Robert T. Stafford 
Disaster Relief and Emergency Assistance Act of 1974 (as amended) as 
well as other national strategies. 

We conducted our review from May 2006 through June 2007 in accordance 
with generally accepted government auditing standards. 

[End of section] 

Appendix II: Comments from the Department of Homeland Security: 

U.S. Department of Homeland Security: 
Washington, DC 20528: 

Homeland Security: 

July 10, 2007: 

Mr. Norman J. Rabkin: 
Managing Director: 
Homeland Security and Justice Issues: 
U.S. Government Accountability Office: 
441 G Street, NW: 
Washington, DC 20548: 

Dear Mr. Rabkin: 

The Department of Homeland Security (DHS) appreciates the opportunity 
to review and respond to the Government Accountability Office's (GAO) 
draft report entitled, "Influenza Pandemic: Further Efforts Are Needed 
to Ensure Clearer Federal Leadership Roles and Effective National 
Strategy," (GAO-07-81). 

The Department appreciates the work done in this engagement to identify 
any issues that hinder the effectiveness of the National Strategy for 
Pandemic Influenza and Implementation Plan, both designed to minimize 
the negative effects of pandemic influenza. Although we feel the report 
offers an accurate depiction of the current pandemic preparedness 
issues from a broad and strategic perspective, the scope of the report 
does not address the significant planning efforts occurring at the 
operational and tactical levels among Federal, State, Tribal, Local, 
and private sector stakeholders. Over the last year, the Federal 
Government has conducted an extensive outreach effort to the private 
sector, particularly critical infrastructure businesses. In the last 
year, over 150 presentations, workshops, and forums have been conducted 
and have been attended by thousands of key stakeholders from critical 
infrastructure entities (e.g., healthcare operations, banking and 
finance entities, operations centers, retail operations, transportation 
and trucking operations, supply warehousing operations, grocery and 
food suppliers, and supply distributors) as well as businesses of all 
types. These information sharing sessions have provided practical 
action- oriented information to identify essential functions and 
critical planning elements, and to assist businesses in protecting the 
health of employees and in maintaining continuity of business 
operations during a pandemic. 

We concur with the recommendation that the Secretaries of the DHS and 
Health and Human Services (HHS) work together to develop and conduct 
rigorous testing, training, and exercises for pandemic influenza, 
ensuring that not only federal leadership roles, but the roles of all 
involved parties are clearly defined and understood, and that leaders 
are able to effectively execute shared responsibilities to address 
emerging challenges. DHS has identified and through the Incident 
Management Planning Team (IMPT), is already taking action on many of 
the shortfalls identified in this report. The IMPT now intends to use 
the GAO planning review methodology as one of our review metrics for 
all future IMPT plans. DHS is also working closely with the Department 
of Health and Human Services (HHS) and other interagency partners to 
develop and implement a series of coordinated interagency pandemic 
exercises that will include all levels of the Federal, State, Local, 
Tribal and Territorial governments. These exercises will include the 
private sector, volunteer, faith based organizations, and the 
international community. The Planning, Training, Exercises and 
Evaluations (PTEE-PCC) will coordinate these efforts to ensure 
interagency collaboration. 

Thank you again for the opportunity to provide comments on this draft 
report and we look forward to working with you again on future homeland 
security and justice issues. Technical comments will be provided under 
a separate cover. 

Sincerely, 

Signed by: 

Steven J. Pecinovsky: 
Director: 
Departmental GAO/OIG Liaison Office: 

[End of section] 

Appendix III: GAO Contact and Staff Acknowledgments: 

GAO Contact: 

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

Acknowledgments: 

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

[End of section] 

Related GAO Products: 

Homeland Security: Observations on DHS and FEMA Efforts to Prepare for 
and Respond to Major and Catastrophic Disasters and Address Related 
Recommendations and Legislation. GAO-07-1142T. Washington, D.C.: July 
31, 2007. 

Emergency Management Assistance Compact: Enhancing EMAC's Collaborative 
and Administrative Capacity Should Improve National Disaster Response. 
GAO-07-854. Washington, D.C.: June 29, 2007. 

Influenza Pandemic: DOD Combatant Commands' Preparedness Efforts Could 
Benefit from More Clearly Defined Roles, Resources, and Risk 
Mitigation. GAO-07-696. Washington, D.C.: June 20, 2007. 

Influenza Pandemic: Efforts to Forestall Onset Are Under Way; 
Identifying Countries at Greatest Risk Entails Challenges. GAO-07-604. 
Washington, D.C.: June 20, 2007. 

Avian Influenza: USDA Has Taken Important Steps to Prepare for 
Outbreaks, but Better Planning Could Improve Response. GAO-07-652. 
Washington, D.C.: June 11, 2007. 

The Federal Workforce: Additional Steps Needed to Take Advantage of 
Federal Executive Boards' Ability to Contribute to Emergency 
Operations. GAO-07-515. Washington, D.C.: May 4, 2007. 

Financial Market Preparedness: Significant Progress Has Been Made, but 
Pandemic Planning and Other Challenges Remain. GAO-07-399. Washington, 
D.C.: March 29, 2007. 

Public Health and Hospital Emergency Preparedness Programs: Evolution 
of Performance Measurement Systems to Measure Progress. GAO-07-485R. 
Washington, D.C.: March 23, 2007. 

Homeland Security: Preparing for and Responding to Disasters. GAO-07- 
395T. Washington, D.C.: March 9, 2007. 

Influenza Pandemic: DOD Has Taken Important Actions to Prepare, but 
Accountability, Funding, and Communications Need to be Clearer and 
Focused Departmentwide. GAO-06-1042. Washington, D.C.: September 21, 
2006. 

Hurricane Katrina: Better Plans and Exercises Needed to Guide the 
Military's Response to Catastrophic Natural Disasters. GAO-06-643. 
Washington, D.C.: May 15, 2006. 

Continuity of Operations: Agencies Could Improve Planning for Telework 
during Disruptions. GAO-06-740T. Washington, D.C.: May 11, 2006. 

Hurricane Katrina: GAO's Preliminary Observations Regarding 
Preparedness, Response, and Recovery. GAO-06-442T. Washington, D.C.: 
March 8, 2006. 

Emergency Preparedness and Response: Some Issues and Challenges 
Associated with Major Emergency Incidents. GAO-06-467T. Washington, 
D.C.: February 23, 2006. 

Statement by Comptroller General David M. Walker on GAO's Preliminary 
Observations Regarding Preparedness and Response to Hurricanes Katrina 
and Rita. GAO-06-365R. Washington, D.C.: February 1, 2006. 

Influenza Pandemic: Applying Lessons Learned from the 2004-05 Influenza 
Vaccine Shortage. GAO-06-221T. Washington, D.C.: November 4, 2005. 

Influenza Vaccine: Shortages in 2004-05 Season Underscore Need for 
Better Preparation. GAO-05-984. Washington, D.C.: September 30, 2005. 

Influenza Pandemic: Challenges in Preparedness and Response. GAO-05- 
863T. Washington, D.C.: June 30, 2005. 

Influenza Pandemic: Challenges Remain in Preparedness. GAO-05-760T. 
Washington, D.C.: May 26, 2005. 

Flu Vaccine: Recent Supply Shortages Underscore Ongoing Challenges. GAO-
05-177T. Washington, D.C.: November 18, 2004. 

Emerging Infectious Diseases: Review of State and Federal Disease 
Surveillance Efforts. GAO-04-877. Washington, D.C.: September 30, 2004. 

Infectious Disease Preparedness: Federal Challenges in Responding to 
Influenza Outbreaks. GAO-04-1100T. Washington, D.C.: September 28, 
2004. 

Emerging Infectious Diseases: Asian SARS Outbreak Challenged 
International and National Responses. GAO-04-564. Washington, D.C.: 
April 28, 2004. 

Public Health Preparedness: Response Capacity Improving but Much 
Remains to Be Accomplished. GAO-04-458T. Washington, D.C.: February 12, 
2004. 

HHS Bioterrorism Preparedness Programs: States Reported Progress but 
Fell Short of Program Goals for 2002. GAO-04-360R. Washington, D.C.: 
February 10, 2004. 

Hospital Preparedness: Most Urban Hospitals Have Emergency Plans but 
Lack Certain Capacities for Bioterrorism Response. GAO-03-924. 
Washington, D.C.: August 6, 2003. 

Severe Acute Respiratory Syndrome: Established Infectious Disease 
Control Measures Helped Contain Spread, But a Large-Scale Resurgence 
May Pose Challenges. GAO-03-1058T. Washington, D.C.: July 30, 2003. 

SARS Outbreak: Improvements to Public Health Capacity Are Needed for 
Responding to Bioterrorism and Emerging Infectious Diseases. GAO-03- 
769T. Washington, D.C.: May 7, 2003. 

Infectious Disease Outbreaks: Bioterrorism Preparedness Efforts Have 
Improved Public Health Response Capacity, but Gaps Remain. GAO-03-654T. 
Washington, D.C.: April 9, 2003. 

Flu Vaccine: Steps Are Needed to Better Prepare for Possible Future 
Shortages. GAO-01-786T. Washington, D.C.: May 30, 2001. 

Flu Vaccine: Supply Problems Heighten Need to Ensure Access for High- 
Risk People. GAO-01-624. Washington, D.C.: May 15, 2001. 

Influenza Pandemic: Plan Needed for Federal and State Response. GAO-01- 
4. Washington, D.C.: October 27, 2000. 

Global Health: Framework for Infectious Disease Surveillance. GAO/ 
NSIAD-00-205R. Washington, D.C.: July 20, 2000. 

Footnotes: 

[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). 

[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. 

[3] Congressional Research Service, Pandemic Influenza: Domestic 
Preparedness Efforts, RL 33145 (Washington, D.C.: Feb. 20, 2007). 

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

[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. 

[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. 

[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. 

[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). 

[14] Congressional Research Service, Pandemic Influenza. 

[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). 

[18] The Secretary of Homeland Security combined the jurisdictions 
covered by FEMA's 10 regional offices into 5 pandemic regions. 

[19] GAO, Homeland Security: Management and Programmatic Challenges 
Facing the Department of Homeland Security, GAO-07-398T (Washington, 
D.C.: Feb. 6, 2007). 

[20] Pub. L. No. 109-417. 

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

[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 Post-Katrina Reform Act reorganization 
requirements and additional organizational changes made under the 
Homeland Security Act of 2002. 

[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. 

[26] Congressional Budget Office, A Potential Influenza Pandemic: 
Possible Macroeconomic Effects and Policy Issues (Washington, D.C.: 
Dec. 8, 2005). 

[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. 

[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). 

[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). 

[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). 

[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). 

[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. 

[33] GAO-04-408T. 

[34] GAO-04-408T, GAO-06-788, and GAO-07-100. 

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