Influenza Pandemic: Further Efforts Are Needed to Ensure Clearer 
Federal Leadership Roles and an Effective National Strategy	 
(14-AUG-07, GAO-07-781).					 
                                                                 
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. 				 
-------------------------Indexing Terms------------------------- 
REPORTNUM:   GAO-07-781 					        
    ACCNO:   A74347						        
  TITLE:     Influenza Pandemic: Further Efforts Are Needed to Ensure 
Clearer Federal Leadership Roles and an Effective National	 
Strategy							 
     DATE:   08/14/2007 
  SUBJECT:   Critical infrastructure				 
	     Emergency management				 
	     Emergency preparedness				 
	     Emergency response plans				 
	     Federal/state relations				 
	     Homeland security					 
	     Infectious diseases				 
	     Influenza						 
	     Pandemic						 
	     Program evaluation 				 
	     Public health					 
	     Strategic planning 				 
	     National Response Plan				 

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GAO-07-781

   

     * [1]Results in Brief
     * [2]Background

          * [3]All-Hazards Emergency Management Policies Provide the Overar
          * [4]The Executive Branch Has Taken Other Steps to Prepare for a

     * [5]Federal Government Leadership Roles and Responsibilities Nee

          * [6]The Strategy and Plan Do Not Clarify Leadership Roles and Re
          * [7]Additional Key Leadership Roles and Responsibilities Are Evo
          * [8]Recent Congressional Actions Addressed Leadership Roles and

               * [9]Pandemic and All-Hazards Preparedness Act and Its
                 Implementa
               * [10]Post-Katrina Reform Act and Its Implementation

          * [11]Rigorous and Robust Exercises Are Important for Testing Fede

     * [12]The National Strategy and Its Implementation Plan Do Not Add

          * [13]The Strategy and Plan Partially Address Purpose, Scope, and
          * [14]Strategy and Plan Address Problem Definition and Risk Assess
          * [15]The Strategy and Plan Partially Address Goals, Objectives, A
          * [16]The Strategy and Plan Do Not Address Resources, Investments,
          * [17]The Strategy and Plan Partially Address Organizational Roles
          * [18]The Strategy and Plan Partially Address Integration and Impl

     * [19]Conclusions
     * [20]Recommendations for Executive Action
     * [21]Agency Comments and Our Evaluation
     * [22]GAO Contact
     * [23]Acknowledgments
     * [24]GAO's Mission
     * [25]Obtaining Copies of GAO Reports and Testimony

          * [26]Order by Mail or Phone

     * [27]To Report Fraud, Waste, and Abuse in Federal Programs
     * [28]Congressional Relations
     * [29]Public Affairs

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

GAO-07-781

Contents

Letter 1

Results in Brief 5
Background 9
Federal Government Leadership Roles and Responsibilities Need
Clarification and Testing 15
The National Strategy and Its Implementation Plan Do Not Address All the
Characteristics of an Effective Strategy, Thus Limiting Their Usefulness
as Planning Tools 23
Conclusions 37
Recommendations for Executive Action 39
Agency Comments and Our Evaluation 40
Appendix I Scope and Methodology 42
Appendix II Comments from the Department of Homeland Security 46
Appendix III GAO Contact and Staff Acknowledgments 48
Related GAO Products 49

Tables

Table 1: Summary of Desirable Characteristics for a National Strategy 4
Table 2: Extent to Which the Strategy and Plan Address GAO's Desirable
Characteristics of an Effective National Strategy 7
Table 3: Extent to Which the Strategy and Plan Address GAO's Desirable
Characteristics of an Effective National Strategy 23
Table 4: GAO Desirable Characteristics for a National Strategy 43

Figures

Figure 1: National Strategy and Implementation Plan's Goals, Pillars,
Functional Areas, and Action Items 28
Figure 2: Related National Preparedness Strategies, Initiatives, and Plans
35

Abbreviations

CBO Congressional Budget Office
COOP Continuity of Operations
CRS Congressional Research Service
DHS Department of Homeland Security
DOD Department of Defense DOT Department of Transportation
ESF Emergency Support Function
FCO Federal Coordinating Officer
FEMA Federal Emergency Management Agency
HHS Department of Health and Human Services
HSC Homeland Security Council
NIMS National Incident Management System
NRP National Response Plan
PFO Principal Federal Official
USDA Department of
Agriculture

This is a work of the U.S. government and is not subject to copyright
protection in the United States. It may be reproduced and distributed in
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separately.

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. An influenza pandemic is a real
and significant threat facing the United States and the world. Pandemics
occur when a novel virus emerges that infects and can be effectively
transmitted between humans who have little immunity to it. Although the
timing and severity of the next pandemic is unpredictable, there is
widespread agreement that a pandemic will occur at some point. Three
influenza pandemics occurred in the 20th century. Notable among these was
the influenza pandemic of 1918, called the "Spanish flu," which killed
over 50 million people worldwide, including over 675,000 in the United
States. Pandemics have spread worldwide within months, and a future
pandemic is expected to spread even more quickly given modern travel
patterns. While health experts cannot predict with certainty which strain
of influenza virus will be involved in the next pandemic, the avian
influenza virus that began in Hong Kong in 1997, known as H5N1, could lead
to a pandemic if it acquires the genetic ability to spread efficiently
from person to person.

Unlike incidents that are discretely bounded in space or time (e.g., most
natural or man-made disasters), a pandemic is not a singular event, but is
likely to come in waves, each lasting weeks or months, and pass through
communities of all sizes across the nation and the world simultaneously.
An influenza pandemic could result in 200,000 to 2 million deaths in the
United States, depending on its severity. Further, an influenza pandemic
Unlike incidents that are discretely bounded in space or time (e.g., most
natural or man-made disasters), a pandemic is not a singular event, but is
likely to come in waves, each lasting weeks or months, and pass through
communities of all sizes across the nation and the world simultaneously.
An influenza pandemic could result in 200,000 to 2 million deaths in the
United States, depending on its severity. Further, an influenza pandemic
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.^1 National strategies that address these
characteristics offer policymakers and implementing agencies a management
tool that can help ensure accountability and more effective results. Table
1 provides the desirable characteristics and a brief description of each
characteristic.

^1 See GAO, Combating Terrorism: Evaluation of Selected Characteristics in
National Strategies Related to Terrorism, [30]GAO-04-408T (Washington,
D.C.: Feb. 3, 2004); Rebuilding Iraq: More Comprehensive National Strategy
Needed to Help Achieve U.S. Goals, [31]GAO-06-788 (Washington, D.C.: July
11, 2006); and Financial Literacy and Education Commission: Further
Progress Needed to Ensure an Effective National Strategy, [32]GAO-07-100
(Washington, D.C.: Dec. 4, 2006).

Table 1: Summary of Desirable Characteristics for a National Strategy

Desirable characteristic         Brief description                         
Purpose, scope, and methodology  Addresses why the strategy was produced,  
                                    the scope of its coverage, and the        
                                    process by which it was developed.        
Problem definition and risk      Addresses the particular national         
assessment                       problems and threats the strategy is      
                                    directed toward.                          
Goals, subordinate objectives,   Addresses what the strategy is trying to  
activities, and performance      achieve; steps to achieve those results;  
measures                         as well as the priorities, milestones,    
                                    and performance measures to gauge         
                                    results.                                  
Resources, investments, and risk Addresses what the strategy will cost,    
management                       the sources and types of resources and    
                                    investments needed, and where resources   
                                    and investments should be targeted by     
                                    balancing risk reductions and costs.      
Organizational roles,            Addresses who will be implementing the    
responsibilities, and            strategy, what their roles will be        
coordination                     compared to others, and mechanisms for    
                                    them to coordinate their efforts.         
Integration and implementation   Addresses how a national strategy relates 
                                    to other strategies' goals, objectives,   
                                    and activities--and to subordinate levels 
                                    of government and their plans to          
                                    implement the strategy.                   

Source: GAO.

We rated the Strategy and Plan on each of the characteristics, giving a
rating of "addresses," "partially addresses," or "does not address."
According to our methodology, a strategy "addresses" a characteristic when
it explicitly cites all, or nearly all, elements of the characteristic,
and has sufficient specificity and detail. A strategy "partially
addresses" a characteristic when it explicitly cites one or a few of the
elements of a characteristic, and the documents have sufficient
specificity and detail. It should be noted that the "partially addresses"
category includes a range that varies from explicitly citing most of the
elements to citing as few as one of the elements of a characteristic. A
strategy "does not address" a characteristic when it does not explicitly
cite or discuss any elements of a characteristic, any references are
either too vague or general to be useful, or both. The elements are
provided in appendix I.

We conducted our review from May 2006 through June 2007 in accordance with
generally accepted government auditing standards. Further details on our
scope and methodology are in appendix I. A list of other related GAO
reports on pandemic preparedness, emergency preparedness, and other
related topics is included at the end of this report.^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.

^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.

In addition to these positions, the NRP includes leadership roles for
Principal Federal Officials (PFO) and Federal Coordinating Officers (FCO).
To assist in planning and coordinating efforts to respond to a pandemic,
in December 2006 the Secretary predesignated a national PFO, and
established five pandemic regions each with a regional PFO and FCO. PFOs
are responsible for facilitating federal domestic incident planning and
coordination, and FCOs are responsible for coordinating federal resource
support in a presidentially declared major disaster or emergency. However,
the relationship of these roles to each other as well as with other
leadership roles in a pandemic is unclear.

Most of these leadership roles and responsibilities have not been tested
under pandemic scenarios, leaving unclear how all of these new and
developing relationships would work. According to a 2007 CRS report,
although pandemic influenza scenarios have been used to exercise specific
response elements, such as the distribution of stockpiled medications at
specific locations or jurisdictions, there have been no national exercises
to test a multisector, multijurisdictional response or any exercises to
test the new national leadership structure for pandemic influenza.^3 The
only national multisector pandemic exercise to date was a tabletop
simulation conducted by members of the cabinet in December 2005--prior to
the release of the Plan in May 2006 and the establishment of PFO and FCO
positions for a pandemic.

The Strategy and Plan represent an important first step in guiding the
nation's preparedness and response activities, calling for a series of
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.

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

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

                                                           Partially Does not 
Desirable characteristic                      Addresses addresses address  
Clear purpose, scope, and methodology                   X                  
Problem definition and risk assessment        X                            
Goals, subordinate objectives, activities,              X                  
and performance measures                                                   
Resources, investments, and risk management                       X        
Organizational roles, responsibilities, and             X                  
coordination                                                               
Integration and implementation                          X                  

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

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

           o 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.
           o 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.
           o 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.
           o 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.^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.
			  
^4 Pub. L. No. 107-296, 116 Stat. 2135 (2002).

           States may need federal assistance in the event of a pandemic to
           maintain essential services. Upon receiving such requests, the
           President may issue emergency or major disaster declarations
           pursuant to the Robert T. Stafford Disaster Relief and Emergency
           Assistance Act of 1974 (the Stafford Act).^5 The Stafford Act
           primarily establishes the programs and processes for the federal
           government to provide major disaster and emergency assistance to
           state and local governments and tribal nations, individuals, and
           qualified private nonprofit organizations. Federal assistance may
           include technical assistance, the provision of goods and services,
           and financial assistance, including direct payments, grants, and
           loans. FEMA is responsible for carrying out the functions and
           authorities of the Stafford Act.

           The Secretary of Health and Human Services also has authority,
           under the Public Health Service Act, to declare a public health
           emergency and to take actions necessary to respond to that
           emergency consistent with his/her authorities.^6 These actions may
           include making grants, entering into contracts, and conducting and
           supporting investigations into the cause, treatment, or prevention
           of the disease or disorder that caused the emergency. The
           Secretary's declaration may also initiate the authorization of
           emergency use of unapproved products or approved products for
           unapproved uses as well as waiving of certain HHS regulatory
           requirements.

           The NRP, as revised in May 2006, applies to all incidents
           requiring a coordinated federal response. The most severe of these
           incidents, termed Incidents of National Significance, must be
           personally declared and managed by the Secretary of Homeland
           Security. According to the Plan, the Secretary of Homeland
           Security may declare a pandemic an Incident of National
           Significance, perhaps as early as when an outbreak occurs in
           foreign countries but before the disease reaches the United
           States. In addition to the base response plan, the NRP has 31
           annexes consisting of 15 Emergency Support Function (ESF) annexes,
           9 support annexes, and 7 incident annexes. The ESFs are the
           primary means through which the federal government provides
           support to state, local, and tribal governments, and the ESF
           structure provides a mechanism for interagency coordination during
           all phases of an incident--some departments and 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.
			  
^5 The Robert T. Stafford Disaster Relief and Emergency Assistance Act of
1974 is codified, as amended, at 42 U.S.C. S 5121-5207.

^6 The Public Health Service Act is codified, as amended, at 42 U.S.C. S
201-300ii-4.

           Of the 15 ESF annexes, ESF-8, the public health and medical
           services ESF, would be the primary ESF used for the public health
           and medical care aspects of a pandemic involving humans.^7
           Although HHS is the lead agency for ESF-8, the ESFs are carried
           out through a "unified command" approach and several other federal
           agencies, including the Departments of Agriculture, Defense,
           Energy, Homeland Security (and the U.S. Coast Guard), Justice, and
           Labor, are specifically supporting agencies.

           ESF-11 pertains to agriculture and natural resources, and its
           purpose includes control and eradication of an outbreak of a
           highly contagious or economically devastating animal/zoonotic
           disease including avian influenza. The purpose of ESF-11 is to
           ensure, in coordination with ESF-8, that
           animal/veterinary/wildlife issues in natural disasters are
           supported. The Departments of Agriculture and the Interior share
           responsibilities as primary agencies for this ESF.^8

           FEMA has or shares lead responsibility for several of the ESFs,
           including those that would be applicable during a pandemic. For
           example, FEMA is the lead agency for ESF-5 (emergency management),
           ESF-6 (mass care, housing, and human services), and ESF-14
           (long-term community recovery and mitigation) and is the primary
           agency for ESF-15 (external affairs). Additionally, FEMA is
           responsible for carrying out the functions and authorities of the
           Stafford Act.

           The incident annexes describe the policies, situations, concept of
           operations, and responsibilities pertinent to the type of incident
           in question. Included among the seven incident annexes within the
           NRP is the Catastrophic Incident Annex.^9 The Catastrophic
           Incident Annex could be applicable to a pandemic influenza as it
           applies to any incident that results in extraordinary levels of
           mass casualties, damage, or disruption severely affecting the
           population, infrastructure, environment, economy, national morale,
           and/or government functions.
			  
^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.

           The NRP also addresses two key leadership positions in the event
           of a Stafford Act emergency or major disaster. One official, the
           FCO, who can be appointed by the Secretary of Homeland Security on
           behalf of the President, manages and coordinates federal resource
           support activities related to Stafford Act disasters and
           emergencies.^10 The other official, the PFO, is designated by the
           Secretary of Homeland Security to facilitate federal support to
           established incident command structures and to coordinate overall
           federal incident management and assistance activities across the
           spectrum of prevention, preparedness, response, and recovery. The
           PFO is to provide a primary point of contact and situational
           awareness for the Secretary of Homeland Security. While the PFO is
           supposed to work closely with the FCO during an incident, the PFO
           has no operational authority over the FCO.
			  
			  The Executive Branch Has 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:

           o A Web site, [33]www.pandemicflu.gov , to provide one-stop access
           to U.S. government avian and pandemic influenza information. This
           site is managed by HHS.
           o 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.^11 
			  
^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.
			  
           o 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.
           o In March 2006, FEMA issued guidance for federal agencies to
           revise their Continuity of Operations (COOP) Plans to address
           pandemic threats. COOP plans are intended to ensure that essential
           government services are available in emergencies. We testified in
           May 2006, on the need for agencies to adequately prepare their
           telework capabilities for use during a COOP event.^12 
           o In September 2006, DHS issued guidance to assist owners and
           operators of critical infrastructure and key resources to prepare
           for a localized outbreak, as well as a broader influenza
           pandemic.^13

           In addition to these tools and guidance, other actions included
           HHS grant awards totaling $350 million to state and local
           governments for pandemic planning and more than $1 billion to
           accelerate development and production of new technologies for
           influenza vaccines within the United States.

^12 GAO, Continuity of Operations: Agencies Could Improve Planning for
Telework during Disruptions, [34]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).

           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.^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.
			  
^14 Congressional Research Service, Pandemic Influenza.			  

           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.^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.^16 The extent to which this would
           be considered a medical response with the Secretary of Health and
           Human Services in the lead, or when it would be under the
           Secretary of Homeland Security's leadership as part of his/her
           responsibility for ensuring that critical infrastructure is
           protected, is unclear. According to HHS officials we interviewed,
           resolving this ambiguity will depend on several factors, including
           how the outbreak occurs and the severity of the pandemic.

           Officials from other agencies also need greater clarity about
           these roles and responsibilities. For example, USDA is not
           planning for DHS to assume the lead coordinating role if an
           outbreak of avian flu among poultry occurs sufficient in scope to
           warrant a presidential declaration of an emergency or major
           disaster.^17 The federal response may be slowed as agencies
           resolve their roles and responsibilities following the onset of a
           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.
			  
^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, [35]GAO-07-652
(Washington, D.C.: June 11, 2007).
			  
			  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.^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.

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

           The national PFO for pandemic influenza said that a draft charter
           has also been developed to establish a Pandemic Influenza PFO
           Working Group to help identify and address many policy and
           operational issues before a pandemic. According to a FEMA
           official, some of these issues include staff availability,
           protective measures for staff, and how to ensure that the
           assistance to be provided under the Stafford Act is implemented
           and coordinated in a unified and consistent manner across the
           country during a pandemic. As of June 7, 2007, the draft charter
           was undergoing some revisions and was expected to be sent to the
           Secretary of Homeland Security for review and approval around the
           end of June. Additionally, there are plans to identify related
           exercises, within and outside of the federal government, to create
           a consolidated schedule of exercises for the national PFO for
           pandemic influenza and regional PFOs and FCOs to participate in by
           leveraging existing exercise plans. DHS officials said that they
           expect FEMA would retain responsibility for maintaining this
           consolidated schedule.

           It is unclear whether the newly established national and regional
           positions for a pandemic will further clarify leadership roles.
           For example, in 2006, DHS made revisions to the NRP and released a
           Supplement to the Catastrophic Incident Annex--both designed to
           further clarify federal roles and responsibilities and
           relationships among federal, state, and local governments and
           responders. However, we reported in February 2007 that these
           revisions had not been tested and there was little information
           available on the extent to which these and other actions DHS was
           taking to improve readiness were operational.^19 Additionally, DHS
           is currently coordinating a comprehensive review of the NRP and
           NIMS to assess their effectiveness, identify improvements, and
           recommend modifications. One of the issues expected to be
           addressed during this review is clarifying of roles and
           responsibilities of key structures, positions, and levels of
           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.

^19 GAO, Homeland Security: Management and Programmatic Challenges Facing
the Department of Homeland Security, [36]GAO-07-398T (Washington, D.C.:
Feb. 6, 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^20 and the Post-Katrina Emergency
           Management Reform Act of 2006^21--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.^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.
			  
^20 Pub. L. No. 109-417.

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

           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.^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.

			  ^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.

           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 ex ercise program to
           expose weaknesses in plans and allow planners to refine them.
           Exercises--particularly for the type and magnitude of emergency
           incidents such as a severe influenza pandemic for which there is
           little actual experience--are essential for developing skills and
           identifying what works well and what needs further improvement.
           Our prior work examining the preparation for and response to
           Hurricane Katrina highlighted the importance of realistic
           exercises to test and refine assumptions, capabilities, and
           operational procedures; and build upon strengths.^24 In response
           to the experiences during Hurricane Katrina, the Post-Katrina
           Reform Act called for a national exercise program to evaluate
           preparedness of a national response to natural and man-made
           disasters.

           While pandemic influenza scenarios have been used to exercise
           specific response elements and locations, such as for distributing
           stockpiled medications, there has been no national exercise to
           test a multisector, multijurisdictional response or any exercises
           to test the working and operational relationships of the national
           PFO and the five regional PFOs and FCOs for pandemic influenza.
           According to a CRS report, the only national multisector pandemic
           exercise to date was a tabletop simulation involving members of
           the federal cabinet in December 2005.^25 This tabletop exercise
           was prior to the release of the Plan in May 2006, the
           establishment of a national PFO and regional PFO and FCO positions
           for a pandemic, and enactment of the Pandemic and All-Hazards
           Preparedness Act in December 2006 and the Post-Katrina Reform Act
           in October 2006.
			  
^24 GAO, Hurricane Katrina: GAO's Preliminary Observations Regarding
Preparedness, Response, and Recovery, [37]GAO-06-442T (Washington, D.C.:
Mar. 8, 2006).

^25 Congressional Research Service, Pandemic Influenza.

           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
			  
                                                           Partially Does not 
Desirable characteristic                      Addresses addresses address  
Clear purpose, scope, and methodology                   X                  
Problem definition and risk assessment        X                            
Goals, subordinate objectives, activities,              X                  
and performance measures                                                   
Resources, investments, and risk management                       X        
Organizational roles, responsibilities, and             X                  
coordination                                                               
Integration and implementation                          X       				  

           Source: GAO analysis of the National Strategy for Pandemic
           Influenza and Implementation Plan for the National Strategy for
           Pandemic Influenza.
			  
			  The Strategy and Plan Partially Address 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^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.

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

           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.^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.

^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.

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

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

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.^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.

^28 GAO, Influenza Pandemic: Efforts to Forestall Onset Are Under Way;
Identifying Countries at Greatest Risk Entails Challenges, [38]GAO-07-604
(Washington, D.C.: June 20, 2007).

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

A national strategy needs to describe what the strategy will cost;
identify where resources will be targeted to achieve the maximum results;
and describe how the strategy balances benefits, risks, and costs.
Guidance on costs and resources needed using a risk management approach
helps implementing parties allocate resources according to priorities,
track costs and performance, and shift resources, as appropriate. We found
that neither the Strategy nor Plan contain these elements.

While neither document addresses the overall cost to implement the Plan,
the Plan refers to the administration's budget request of $7.1 billion and
a congressional appropriation of $3.8 billion to support the objectives of
the Strategy. In November 2005, the administration requested $7.1 billion
in emergency supplemental funding over 3 years to support the
implementation of the Strategy. In December 2005, Congress appropriated
$3.8 billion to support budget requirements to help address pandemic
influenza issues.^29 The Plan states that much of this funding would be
directed toward domestic preparedness and the establishment of
countermeasure stockpile and production capacity, with $400 million
directed to bilateral and multilateral international efforts. However, the
3-year $7.1 billion budget proposal does not coincide with the period of
the Plan. Additionally, whereas the Plan does not allocate funds to
specific action items, our analysis of budget documents indicates that the
funds were allocated primarily toward those action items related to
vaccines and antivirals.

Developing and sustaining the capabilities stipulated in the Plan would
require the effective use of federal, state, and local funds. Given that
funding needs may not be readily addressed through existing mechanisms 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.

^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).

Despite the numerous action items and specific implementing directives and
guidance directed toward federal agencies, states, organizations, and
businesses, neither document addresses what it would cost to complete the
actions that are stipulated. Rather, the Plan states that the local
communities would have to address the medical and nonmedical effects of
the pandemic with available resources, and also that pandemic influenza
response activities may exceed the budgetary resources of responding
federal and state government agencies.

The overall uncertainty of funding to complete action items stipulated in
the Plan has been problematic. For example, there were more than 50
actions in the Plan that were to be completed before the end of 2006 for
which DOD was either a lead or support agency. We reported that because
DOD had not yet requested funding, it was unclear whether DOD could
address the tasks assigned to it in the Plan and pursue its own
preparedness efforts for its workforce departmentwide within current
resources.^30

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

A national strategy should address which organizations would implement the
strategy, their roles and responsibilities, and mechanisms for
coordinating their efforts. It helps to answer the fundamental question
about who is in charge, not only during times of crisis, but also during
all phases of emergency management, as well as the organizations that will
provide the overall framework for accountability and oversight. This
characteristic entails identifying the specific federal departments,
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.

^30 GAO, Influenza Pandemic: DOD Has Taken Important Actions to Prepare,
but Accountability, Funding, and Communications Need to be Clearer and
Focused Departmentwide, [39]GAO-06-1042 (Washington, D.C.: Sept. 21,
2006).

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.^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.

^31 GAO, Influenza Pandemic: DOD Combatant Commands' Preparedness Efforts
Could Benefit from More Clearly Defined Roles, Resources, and Risk
Mitigation, [40]GAO-07-696 (Washington, D.C.: June 20, 2007).

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

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.^32
The current interim Goal is particularly important for determining what
capabilities are needed for a catastrophic disaster. It defines 36 major
capabilities that first responders should possess to prevent, protect
from, respond to, and recover from a wide range of incidents and the most
critical tasks associated with these capabilities. An inability to
effectively perform these critical tasks would, by definition, have a
detrimental effect on protection, prevention, response, and recovery
capabilities. The interim Goal also includes 15 planning scenarios,
including one for pandemic influenza that outlines universal and critical
tasks to be undertaken for planning for an influenza pandemic and target
capabilities, such as search and rescue and economic and community
recovery. Yet, the Strategy and Plan do not integrate this
already-developed planning scenario and related tasks and capabilities.
One federal agency official who assisted in drafting the Plan told us that
the Goal and its pandemic influenza scenario had been considered but
omitted because the Goal's pandemic influenza scenario is geared to a less
severe pandemic--such as those that occurred in 1957 and 1968--while the
Plan is based on the more severe 1918-level mortality and morbidity rates.

Further, the Strategy and Plan do not provide sufficient detail about how
the Strategy, action items, and proposed set of independent plans are to
be integrated with other national strategies and framework. Without
clearly providing this linkage, the Plan may limit a common understanding
of the overarching framework, thereby hindering the nation's ability to
effectively prepare for, respond to, and recover from a pandemic. For
example, the Plan contains 39 action items that are response related
(i.e., specific actions are to be taken within a prescribed number of
hours or days after an outbreak). However, these action items are
interspersed among the 324 action items, and the Plan does not describe
the linkages of these response-related action items with the NRP or other
response related plans. Further, DHS officials have recognized the need
for a common understanding across federal agencies and better integration
of agencies plans to prepare for and respond to a pandemic. DHS officials
are developing a Federal Concept Plan for Pandemic Influenza to enhance
interagency preparedness, response, and recovery efforts.

^32 The Goal establishes the national vision and priorities to guide the
nation's efforts to set measurable readiness benchmarks and targets to
strengthen the nation's preparedness, and attempts to provide a
comprehensive preparedness effort.

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:

           o the cost, sources, and types of resources and investments needed
           to complete the action items and where they should be targeted;
           o a process and schedule for monitoring and publicly reporting on
           progress made on completing the actions;
           o clearer linkages with other strategies and plans; and
           o clearer descriptions of relationships or priorities among action
           items and greater use of outcome-focused performance measures.
			  
			  Agency Comments and Our Evaluation

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

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

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

           If you or your staff have any questions regarding this report,
           please contact me at (202) 512-6543 or [41][email protected] .
           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.

           Bernice Steinhardt
			  Director
			  Strategic Issues
			  
			  Appendix I: Scope and Methodology

           Our reporting objectives were to review the extent to which (1)
           federal leadership roles and responsibilities for preparing for
           and responding to a pandemic are clearly defined and (2) the
           National Strategy for Pandemic Influenza (Strategy) and the
           Implementation Plan for the National Strategy for Pandemic
           Influenza (Plan) address the characteristics of an effective
           national strategy.

           To determine to what extent federal leadership roles and
           responsibilities for preparing for and responding to a pandemic
           are clearly defined, we drew upon our extensive body of work on
           the federal government's response to hurricanes Katrina and Rita
           as well as our prior work on pandemic influenza. We also studied
           the findings in reports issued by Congress, the Department of
           Homeland Security's Office of the Inspector General, the Homeland
           Security Council (HSC), and the Congressional Research Service.
           Additionally, we reviewed the Strategy and Plan and a variety of
           federal emergency documents, including the National Response
           Plan's base plan and supporting annexes and the implementation
           plans developed by the Departments of Homeland Security and Health
           and Human Services. HSC officials declined to meet with us,
           stating that we should rely upon information provided by agency
           officials. We interviewed officials in the departments of
           Agriculture, Defense, Health and Human Services, Homeland
           Security, Transportation, and State and the Federal Emergency
           Management Agency and the U.S. Coast Guard. Some of these
           officials were involved in the development of the Plan.

           To review the extent to which the Strategy and Plan address the
           characteristics of an effective national strategy, we analyzed the
           Strategy and Plan; reviewed key relevant sections of major
           statutes, regulations, directives, national strategies, and plans
           discussed in the Plan; and interviewed officials in agencies that
           the Strategy and Plan identified as lead agencies in preparing for
           and responding to a pandemic.

           We assessed the extent to which the Strategy and Plan jointly
           addressed the six desirable characteristics, and the related
           elements under each characteristic, of an effective national
           strategy by using the six characteristics developed in previous
           GAO work.^1 Table 4 provides the desirable characteristics and
           examples of their elements.
			  
^1 [42]GAO-04-408T .			  

Table 4: GAO Desirable Characteristics for a National Strategy

Desirable                                                                  
characteristic         Brief description        Examples of elements       
Purpose, scope, and    Addresses why the           o Statement of broad or 
methodology            strategy was produced,      narrow purpose, as      
                          the scope of its            appropriate.            
                          coverage, and the           o How it compares and   
                          process by which it was     contrasts with other    
                          developed.                  national strategies.    
                                                      o What major functions, 
                                                      mission areas, or       
                                                      activities it covers.   
                                                      o Principles or         
                                                      theories that guided    
                                                      its development.        
                                                      o Impetus for strategy, 
                                                      for example, statutory  
                                                      requirement or event.   
                                                      o Process to produce    
                                                      strategy, for example,  
                                                      interagency task force  
                                                      or state, local, or     
                                                      private input.          
                                                      o Definition of key     
                                                      terms.                  
Problem definition and Addresses the particular    o Discussion or         
risk assessment        national problems and       definition of problems, 
                          threats the strategy is     their causes, and       
                          directed toward.            operating environment.  
                                                      o Risk assessment,      
                                                      including an analysis   
                                                      of threats and          
                                                      vulnerabilities.        
                                                      o Quality of data       
                                                      available, for example, 
                                                      constraints,            
                                                      deficiencies, and       
                                                      "unknowns."             
Goals, subordinate     Addresses what the          o Overall results       
objectives,            strategy is trying to       desired, that is, "end  
activities, and        achieve; steps to           state."                 
performance measures   achieve those results;      o Hierarchy of          
                          as well as the              strategic goals and     
                          priorities, milestones,     subordinate objectives. 
                          and performance measures    o Specific activities   
                          to gauge results.           to achieve results.     
                                                      o Priorities,           
                                                      milestones, and         
                                                      outcome-related         
                                                      performance measures.   
                                                      o Specific performance  
                                                      measures.               
                                                      o Process for           
                                                      monitoring and          
                                                      reporting on progress.  
                                                      o Limitations on        
                                                      progress indicators.    
Resources,             Addresses what the          o Resources and         
investments, and risk  strategy will cost, the     investments associated  
management             sources and types of        with the strategy.      
                          resources and               o Types of resources    
                          investments needed, and     required, such as       
                          where resources and         budgetary, human        
                          investments should be       capital, information    
                          targeted by balancing       technology, research    
                          risk reductions and         and development, and    
                          costs.                      contracts.              
                                                      o Sources of resources, 
                                                      for example, federal,   
                                                      state, local, and       
                                                      private.                
                                                      o Economic principles,  
                                                      such as balancing       
                                                      benefits and costs.     
                                                      o Resource allocation   
                                                      mechanisms, such as     
                                                      grants, in-kind         
                                                      services, loans, or     
                                                      user fees.              
                                                      o "Tools of             
                                                      government," for        
                                                      example, mandates or    
                                                      incentives to spur      
                                                      action.                 
                                                      o Importance of fiscal  
                                                      discipline.             
                                                      o Linkage to other      
                                                      resource documents, for 
                                                      example, federal        
                                                      budget.                 
                                                      o Risk management       
                                                      principles.             
Organizational roles,  Addresses who will be       o Roles and             
responsibilities, and  implementing the            responsibilities of     
coordination           strategy, what their        specific federal        
                          roles will be compared      agencies, departments,  
                          to others, and              or offices.             
                          mechanisms for them to      o Roles and             
                          coordinate their            responsibilities of     
                          efforts.                    state, local, private,  
                                                      and international       
                                                      sectors.                
                                                      o Lead, support, and    
                                                      partner roles and       
                                                      responsibilities.       
                                                      o Accountability and    
                                                      oversight framework.    
                                                      o Potential changes to  
                                                      current organizational  
                                                      structure.              
                                                      o Specific processes    
                                                      for coordination and    
                                                      collaboration.          
                                                      o How conflicts will be 
                                                      resolved.               
Integration and        Addresses how a national    o Integration with      
implementation         strategy relates to         other national          
                          other strategies' goals,    strategies              
                          objectives, and             (horizontal).           
                          activities--and to          o Integration with      
                          subordinate levels of       relevant documents from 
                          government and their        implementing            
                          plans to implement the      organizations           
                          strategy.                   (vertical).             
                                                      o Details on specific   
                                                      federal, state, local,  
                                                      or private strategies   
                                                      and plans.              
                                                      o Implementation        
                                                      guidance.               
                                                      o Details on            
                                                      subordinate strategies  
                                                      and plans for           
                                                      implementation, for     
                                                      example, human capital  
                                                      and enterprise          
                                                      architecture.           

Source: GAO.

National strategies with these characteristics offer policymakers and
implementing agencies a management tool that can help ensure
accountability and more effective results. We have used this methodology
to assess and report on the administration's strategies relating to
terrorism, rebuilding of Iraq, and financial literacy.^2

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

^2 [43]GAO-04-408T , [44]GAO-06-788 , and [45]GAO-07-100 .

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

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

Appendix II: Comments from the Department of Homeland Security

Appendix III: GAO Contact and Staff Acknowledgments

GAO Contact

Bernice Steinhardt, (202) 512-6543 or [46][email protected]

Acknowledgments

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

Related GAO Products

Homeland Security: Observations on DHS and FEMA Efforts to Prepare for and
Respond to Major and Catastrophic Disasters and Address Related
Recommendations and Legislation. [47]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.
[48]GAO-07-854 . Washington, D.C.: June 29, 2007.

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Benefit from More Clearly Defined Roles, Resources, and Risk Mitigation.
[49]GAO-07-696 . Washington, D.C.: June 20, 2007.

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but Better Planning Could Improve Response. [51]GAO-07-652 . Washington,
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The Federal Workforce: Additional Steps Needed to Take Advantage of
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[52]GAO-07-515 . Washington, D.C.: May 4, 2007.

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[55]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. [56]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. [57]GAO-06-643 .
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Continuity of Operations: Agencies Could Improve Planning for Telework
during Disruptions. [58]GAO-06-740T . Washington, D.C.: May 11, 2006.

Hurricane Katrina: GAO's Preliminary Observations Regarding Preparedness,
Response, and Recovery. [59]GAO-06-442T . Washington, D.C.: March 8, 2006.

Emergency Preparedness and Response: Some Issues and Challenges Associated
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February 23, 2006.

Statement by Comptroller General David M. Walker on GAO's Preliminary
Observations Regarding Preparedness and Response to Hurricanes Katrina and
Rita. [61]GAO-06-365R . Washington, D.C.: February 1, 2006.

Influenza Pandemic: Applying Lessons Learned from the 2004-05 Influenza
Vaccine Shortage. [62]GAO-06-221T . Washington, D.C.: November 4, 2005.

Influenza Vaccine: Shortages in 2004-05 Season Underscore Need for Better
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Washington, D.C.: May 26, 2005.

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2004.

Infectious Disease Preparedness: Federal Challenges in Responding to
Influenza Outbreaks. [68]GAO-04-1100T . Washington, D.C.: September 28,
2004.

Emerging Infectious Diseases: Asian SARS Outbreak Challenged International
and National Responses. [69]GAO-04-564 . Washington, D.C.: April 28, 2004.

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. Washington, D.C.: April 9, 2003.

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Global Health: Framework for Infectious Disease Surveillance.
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(450450)

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

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Highlights of [87]GAO-07-781 , a report to congressional requesters

August 2007

INFLUENZA PANDEMIC

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

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.

[88]What GAO Recommends

GAO recommends that (1) DHS and HHS develop rigorous testing, training,
and exercises for pandemic influenza to ensure that federal leadership
roles and responsibilities are clearly defined, understood, and work
effectively and (2) the HSC set a time frame to update the Plan, involve
key nonfederal stakeholders, and more fully address the characteristics of
an effective national strategy. DHS and HHS concurred with the report. HSC
did not comment.

The executive branch has taken an active approach to help address this
potential threat, including establishing an online information
clearinghouse, developing planning guidance and checklists, awarding
grants to accelerate development and production of new technologies for
influenza vaccines within the United States, and assisting state and local
government pandemic planning efforts. However, federal government
leadership roles and responsibilities for preparing for and responding to
a pandemic continue to evolve, and will require further clarification and
testing before the relationships of the many leadership positions are well
understood. The Strategy and Plan do not specify how the leadership roles
and responsibilities will work in addressing the unique characteristics of
an influenza pandemic, which could occur simultaneously in multiple
locations and over a long period. A pandemic could extend well beyond
health and medical boundaries, affecting critical infrastructure, the
movement of goods and services across the nation and the globe, the
economy, and security. Although the Department of Health and Human
Services' (HHS) Secretary is to lead the public health and medical
response and the Department of Homeland Security's (DHS) Secretary is to
lead overall nonmedical support and response actions, the Plan does not
clearly address these simultaneous responsibilities or how these roles are
to work together, particularly over an extended period and at multiple
locations across the country. In addition, the Secretary of DHS has
predesignated a national Principal Federal Official (PFO) to facilitate
pandemic coordination as well as five regional PFOs and five regional
Federal Coordinating Officers. Most of these leadership roles and
responsibilities have not been tested under pandemic scenarios, leaving it
unclear how they will work. Because initial actions may help limit the
spread of an influenza virus, the effective exercise of shared leadership
roles and responsibilities could have substantial consequences. However,
only one national multisector pandemic-related exercise has been held and
that was prior to the issuance of the Plan.

While the Strategy and Plan are an important first step in guiding
national preparedness, they do not fully address all six characteristics
of an effective national strategy. Specifically, they fully address only
one of the six characteristics, by reflecting a clear description and
understanding of problems to be addressed, and do not address one
characteristic because the documents do not describe the financial
resources needed to implement actions. Although the other characteristics
are partially addressed, important gaps exist that could hinder the
ability of key stakeholders to effectively execute their responsibilities,
including state and local jurisdictions that will play crucial roles in
preparing for and responding to a pandemic were not directly involved in
developing the Plan, relationships and priorities among actions were not
clearly described, performance measures focused on activities that are not
always linked to results, insufficient information is provided about how
the documents are integrated with other key related plans, and no process
is provided for monitoring and reporting on progress.

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  85. mailto:[email protected]
  86. http://www.gao.gov/cgi-bin/getrpt?GAO-07-781
  87. http://www.gao.gov/cgi-bin/getrpt?GAO-07-781
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