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entitled 'Influenza Pandemic: Sustaining Focus on the Nation's Planning 
and Preparedness' which was released on March 6, 2009. 

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Report to the Chairman, Committee on Homeland Security, House of 
Representatives: 

United States Government Accountability Office: 

GAO: 

February 2009: 

Influenza Pandemic: 

Sustaining Focus on the Nation's Planning and Preparedness Efforts: 

Pandemic Planning and Preparedness Efforts: 

GAO-09-334: 

GAO Highlights: 

Highlights of GAO-09-334, a report to the Chairman, Committee on 
Homeland Security, House of Representatives. 

Why GAO Did This Study: 

GAO has conducted a body of work over the past several years to help 
the nation better prepare for, respond to, and recover from a possible 
influenza pandemic, which could result from a novel strain of influenza 
virus for which there is little resistance and which therefore is 
highly transmissible among humans. GAO’s work has pointed out that 
while the previous administration had taken a number of actions to plan 
for a pandemic, including developing a national strategy and 
implementation plan, much more needs to be done. However, national 
priorities are shifting as a pandemic has yet to occur, and other 
national issues have become more immediate and pressing. Nevertheless, 
an influenza pandemic remains a real threat to our nation and the 
world. 

For this report, GAO synthesized the results of 11 reports and two 
testimonies issued over the past 3 years using six key thematic areas: 
(1) leadership, authority, and coordination; (2) detecting threats and 
managing risks; (3) planning, training, and exercising; (4) capacity to 
respond and recover; (5) information sharing and communication; and (6) 
performance and accountability. GAO also updated the status of 
recommendations in these reports. 

What GAO Found: 

Leadership roles and responsibilities need to be clarified and tested, 
and coordination mechanisms could be better utilized. Shared leadership 
roles and responsibilities between the Departments of Health and Human 
Services (HHS) and Homeland Security (DHS) and other entities are 
evolving, and will require further testing and exercising before they 
are well understood. Although there are mechanisms in place to 
facilitate coordination between federal, state, and local governments 
and the private sector to prepare for an influenza pandemic, these 
could be more fully utilized. 

Efforts are underway to improve the surveillance and detection of 
pandemic-related threats, but targeting assistance to countries at the 
greatest risk has been based on incomplete information. Steps have been 
taken to improve international disease surveillance and detection 
efforts. However, information gaps limit the capacity for comprehensive 
comparisons of risk levels by country. 

Pandemic planning and exercising has occurred, but planning gaps 
remain. The United States and other countries, as well as states and 
localities, have developed influenza pandemic plans. Yet, additional 
planning needs still exist. For example, the national strategy and 
implementation plan omitted some key elements, and HHS found many major 
gaps in states’ pandemic plans. 

Further actions are needed to address the capacity to respond to and 
recover from an influenza pandemic. An outbreak will require additional 
capacity in many areas, including the procurement of additional patient 
treatment space and the acquisition and distribution of medical and 
other critical supplies, such as antivirals and vaccines for an 
influenza pandemic. 

Federal agencies have provided considerable guidance and pandemic-
related information, but could augment their efforts. Federal agencies, 
such as HHS and DHS, have shared information in a number of ways, such 
as through Web sites and guidance, but state and local governments and 
private sector representatives would welcome additional information on 
vaccine distribution and other topics. 

Performance monitoring and accountability for pandemic preparedness 
needs strengthening. Although certain performance measures have been 
established in the National Pandemic Implementation Plan to prepare for 
an influenza pandemic, these measures are not always linked to results. 
Further, the plan does not contain information on the financial 
resources needed to implement it. 

GAO has made 23 recommendations in its reports—13 of these have been 
implemented and 10 remain outstanding. Continued leadership focus on 
pandemic preparedness remains vital, as the threat has not diminished. 

What GAO Recommends: 

This report does not make new recommendations. However, the report 
discusses the status of GAO’s prior recommendations on the nation’s 
planning and preparedness for a pandemic. 

To view the full product, including the scope and methodology, click on 
[hyperlink, http://www.gao.gov/cgi-bin/getrpt?GAO-09-334]. For more 
information, contact Bernice Steinhardt at (202) 512-6543 or 
steinhardtb@gao.gov. 

[End of section] 

Contents: 

Letter: 

Results in Brief: 

Background: 

Leadership Roles and Responsibilities Need to Be Clarified and Tested, 
and Coordination Mechanisms Could Be Better Utilized: 

Efforts Are Underway to Improve the Surveillance and Detection of 
Pandemic-Related Threats in Humans and Animals, but Targeting 
Assistance to Countries at the Greatest Risk Has Been Based on 
Incomplete Information: 

Pandemic Planning and Exercising Has Occurred in the United States and 
Other Countries, but Planning Gaps Remain: 

Further Actions Are Needed to Address the Capacity to Respond to and 
Recover from an Influenza Pandemic: 

Federal Agencies Have Provided Considerable Guidance and Pandemic- 
Related Information, but Could Augment Their Efforts: 

Performance Monitoring and Accountability for Pandemic Preparedness 
Needs Strengthening: 

Concluding Observations: 

Appendix I: Open Recommendations from GAO's Work on an Influenza 
Pandemic as of February 2009: 

Appendix II: Implemented Recommendations from GAO's Work on an 
Influenza Pandemic as of February 2009: 

Appendix III: GAO Contact and Staff Acknowledgments: 

Related GAO Products: 

Figures: 

Figure 1: Key Themes of GAO's Pandemic Strategy: 

Figure 2: WHO Global Pandemic Phases: 

Figure 3: Top 15 Recipients of Committed, Country-Specific 
International Avian and Influenza Pandemic Funding as of December 2006: 

Figure 4: HHS Influenza Pandemic Supplemental Appropriations, Fiscal 
Year 2006: 

Abbreviations: 

APHIS: Animal and Plant Health Inspection Service: 
CBO: Congressional Budget Office: 
CDC: Centers for Disease Control and Prevention: 
DHS: Department of Homeland Security: 
DOD: Department of Defense: 
EMAC: Emergency Management Assistance Compact: 
FAO: Food and Agriculture Organization: 
FCO: Federal Coordinating Officer: 
FEB: federal executive board: 
FEMA: Federal Emergency Management Agency: 
HHS: Department of Health and Human Services: 
HSC: Homeland Security Council: 
NGA: National Governors Association: 
National Pandemic Implementation Plan: National Strategy for Pandemic 
Influenza Implementation Plan: 
National Pandemic Strategy: National Strategy for Pandemic Influenza: 
NRF: National Response Framework: 
OIE: World Organisation for Animal Health: 
OPM: Office of Personnel Management: 
PFO: Principal Federal Official: 
SEC: Securities and Exchange Commission: 
UNSIC: United Nations System Influenza Coordinator: 
USAID: United States Agency for International Development: 
USDA: United States Department of Agriculture: 
WHO: World Health Organization: 

[End of section] 

United States Government Accountability Office: 

Washington, DC 20548: 

February 26, 2009: 

The Honorable Bennie G. Thompson: 
Chairman: 
Committee on Homeland Security: 
House of Representatives: 

Dear Mr. Chairman: 

As you know, we conducted a body of work over the past several years to 
help the nation better prepare for, respond to, and recover from a 
possible influenza pandemic. Our work has pointed out that while the 
previous administration had taken a number of actions to plan for a 
pandemic, including developing a national strategy and implementation 
plan, much more needs to be done. At the same time, however, national 
priorities are shifting as a pandemic has yet to occur, and the 
nation's financial crisis and other national issues have become more 
immediate and pressing. Nevertheless, an influenza pandemic remains a 
real threat to our nation and to the world. Strengthening preparedness 
for large-scale public health emergencies, such as an influenza 
pandemic, is one of the 13 urgent issues that we identified as among 
those needing the immediate attention of the new administration and 
Congress during this transition period.[Footnote 1] As your Committee 
also recently reported, there are opportunities to renew federal 
efforts to protect our country against influenza pandemic in the new 
administration.[Footnote 2] 

Given the consequences of a severe influenza pandemic, in 2006 we 
developed a strategy for our work that would help support Congress's 
decision making and oversight related to pandemic planning. Our 
strategy was built on a large body of work spanning two decades, 
including reviews of government responses to prior disasters such as 
Hurricanes Andrew and Katrina, the devastation caused by the 9/11 
terror attacks, efforts to address the Year 2000 (Y2K) computer 
challenges, and assessments of public health capacities in the face of 
bioterrorism and emerging infectious diseases such as Severe Acute 
Respiratory Syndrome (SARS). The strategy was built around six key 
themes as shown in figure 1. While all of these themes are 
interrelated, our earlier work underscored the importance of 
leadership, authority, and coordination, a theme that touches on all 
aspects of preparing for, responding to, and recovering from an 
influenza pandemic. 

Figure 1: Key Themes of GAO's Pandemic Strategy: 

This figure is an illustration of the key themes of GAO's Pandemic 
Strategy as puzzle pieces. The themes are as follows: 

[Refer to PDF for image] 

Performance and accountability; 
Leadership, authority, and coordination; 
Detecting threats and managing risks; 
Information sharing and communication; 
Capacity to respond and recover; 
Planning, training, and exercising. 

Source: GAO. 

[End of figure] 

At your request, this report synthesizes the work thus far completed 
under this strategy. In the past 3 years, we have issued 11 reports and 
two testimonies on influenza pandemic planning, which address these key 
themes. We have made 23 recommendations based on the findings from many 
of these reports and testimonies. Thirteen of these recommendations 
have been acted upon by the responsible federal agencies, but while the 
responsible federal agencies have generally agreed with our 
recommendations, 10 recommendations have not yet been implemented. We 
also have three pandemic-related reviews underway on the following 
topics: (1) the status of implementing the National Strategy for 
Pandemic Influenza Implementation Plan (National Pandemic 
Implementation Plan); (2) plans to protect the federal workforce in a 
pandemic; and (3) the effect of a pandemic on the telecommunications 
capacity needed to sustain critical financial market activities. A list 
of our open and implemented recommendations can be found in appendices 
I and II. While this report makes no new recommendations, we have 
updated the status of recommendations that have not yet been 
implemented. A list of our related GAO products that are referenced 
throughout this report is located after appendix III. 

We also collaborated with several state and local audit offices on 
coordinated audits of state and local pandemic planning and consulted 
with audit offices from a number of countries on pandemic-related 
activities through our external partnerships. These countries include 
Austria, Belgium, Cambodia, Canada, Germany, Indonesia, Japan, 
Kazakhstan, Sweden, the United Kingdom, and Vietnam. We have also drawn 
from audits of pandemic planning and exercising conducted by audit 
officials in Portland, Oregon; Kansas City, Missouri; and New York 
state. Finally, we have incorporated recent studies conducted by the 
Congressional Budget Office (CBO), National Governors Association 
(NGA), United Nations System Influenza Coordinator (UNSIC), and the 
World Bank. 

This report is largely based on our prior work, which was conducted in 
accordance with generally accepted government auditing standards. Those 
standards require that we plan and perform the audit to obtain 
sufficient, appropriate evidence to provide a reasonable basis for our 
findings and conclusions based on our audit objectives. We believe that 
the evidence obtained provides a reasonable basis for our findings and 
conclusions based on our audit objectives. 

Results in Brief: 

We have synthesized the results from our pandemic work over the past 
few years by the six key themes in our pandemic strategy, as follows: 

Leadership roles and responsibilities need to be clarified and tested, 
and coordination mechanisms could be better utilized. Federal 
government leadership roles and responsibilities for pandemic 
preparedness and response are evolving, and will require further 
testing before the relationships among the many federal leadership 
positions are well understood. Such clarity in leadership is even more 
crucial now given the change in administration and the associated 
transition of senior federal officials. Although there are mechanisms 
in place to facilitate coordination between federal, state, and local 
governments and the private sector to prepare for an influenza 
pandemic, these could be more fully utilized. For example, a system of 
coordinating councils that facilitates planning between government and 
the private sector for critical infrastructure protection could be 
better used to help resolve key challenges to public and private sector 
coordination. In addition, some federal executive boards (FEB), which 
bring together federal agencies and community leaders outside of 
Washington, D.C., have established relationships with state and local 
governments and community organizations that could be useful in 
pandemic preparedness and response. As a result of our recommendations, 
FEBs were included in the National Response Framework (NRF)[Footnote 3] 
in January 2008 as one of the regional support structures that have the 
potential to contribute to the development of situational awareness 
during an emergency. 

Efforts are underway to improve the surveillance and detection of 
pandemic-related threats in humans and animals, but targeting 
assistance to countries at the greatest risk has been based on 
incomplete information. International disease surveillance and 
detection efforts serve as an early warning system that could prevent 
the spread of an influenza pandemic outbreak. The United States and its 
international partners are involved in efforts to improve pandemic 
surveillance, including diagnostic capabilities, so that outbreaks can 
be quickly detected. Yet, international capacity for surveillance has 
many weaknesses, particularly in developing countries. Animal 
surveillance is also a key part of this early warning system. 
Controlling an outbreak in poultry would be instrumental to reducing 
the risk of a human pandemic. While the U.S. Department of Agriculture 
(USDA) has created a National Avian Influenza Surveillance System to 
link existing avian influenza surveillance data from USDA, other 
federal and state agencies, and industry, federal and state officials 
generally do not know the numbers and locations of backyard birds so 
controlling an outbreak of avian influenza among these birds remains 
particularly difficult. Finally, at the time of our 2007 review, 
assessments by U.S. agencies and international organizations were used 
to target assistance to countries at risk, but the information on which 
those assessments were based was not sufficiently detailed or was 
incomplete, limiting their value for comprehensive comparisons of risk 
levels by country. 

Pandemic planning and exercising has occurred in the United States and 
other countries, but planning gaps remain. The U.S. government has 
worked with its international partners to develop an overall global 
strategy that is compatible with the U.S. approach. Other countries, 
including Belgium, Japan, Sweden, and the United Kingdom, have also 
developed influenza pandemic plans and frameworks. While the National 
Strategy for Pandemic Influenza (National Pandemic Strategy) and 
National Pandemic Implementation Plan are important first steps in 
guiding national preparedness, important gaps exist that could hinder 
the ability of key stakeholders to effectively execute their 
responsibilities. For example, state and local jurisdictions that will 
play crucial roles in preparing for and responding to a pandemic were 
not directly involved in developing the National Pandemic 
Implementation Plan, even though it relies on these stakeholders' 
efforts. Further, USDA response plans did not identify entities 
responsible for carrying out tasks associated with an outbreak 
scenario. At the state level, we found that each state has developed a 
pandemic plan and conducted pandemic exercises as required by federal 
pandemic funding guidance. However, according to an interagency 
assessment, on average, states had "many major gaps" in their plans, 
and the Department of Health and Human Services (HHS) has recently 
reported that most states continue to have major gaps in their pandemic 
plans. Officials in states and localities reported that they would 
welcome additional guidance from the federal government to help them 
better plan and exercise for an influenza pandemic, for example, on how 
to implement community interventions such as closing schools. In the 
private sector, in response to our recommendation, financial market 
organizations were directed by their federal regulators to ensure that 
the pandemic plans they have in place are adequate to maintain critical 
operations during a severe outbreak. 

Further actions are needed to address the capacity to respond to and 
recover from an influenza pandemic. Improving the nation's response 
capability to catastrophic disasters, such as an influenza pandemic, is 
essential. Following a mass casualty event, health care systems would 
need the ability to adequately care for a large number of patients or 
patients with unusual or highly specialized medical needs. The ability 
of local or regional health care systems to deliver services could be 
compromised, at least in the short term, because the volume of patients 
would far exceed the available hospital beds, medical personnel, 
pharmaceuticals, equipment, and supplies. Further, in natural and man- 
made disasters, assistance from other states may be used to increase 
capacity, but in a pandemic, states would likely be reluctant to 
provide assistance to each other due to scarce resources and fears of 
infection. The federal government has provided some guidance and 
funding to help states plan for additional capacity. For example, the 
federal government provided guidance for states to use when preparing 
for medical surge and on prioritizing target groups for an influenza 
pandemic vaccine. However, an outbreak will require additional capacity 
in many areas, including the procurement of additional patient 
treatment space and the acquisition and distribution of medical and 
other critical supplies, such as antivirals and vaccines for an 
influenza pandemic.[Footnote 4] In a severe pandemic, the demand would 
exceed the available hospital bed capacity, which would be further 
challenged by the existing shortages of health care providers and their 
potential high rates of absenteeism. In addition, the availability of 
antivirals and vaccines could be inadequate to meet demand due to 
limited production, distribution, and administration capacity. 

Federal agencies have provided considerable guidance and pandemic- 
related information, but could augment their efforts. Federal agencies, 
including HHS and the Department of Homeland Security (DHS), have 
shared pandemic-related information in a number of ways, such as 
through Web sites, guidance, and state summits and meetings, and are 
using established networks, including the FEBs and coordinating 
councils for critical infrastructure protection, to share information 
about pandemic preparedness, response, and recovery. Federal agencies 
have established an influenza pandemic Web site [hyperlink, 
http://www.pandemicflu.gov] and disseminated pandemic preparedness 
checklists for workplaces, individuals and families, schools, health 
care, community organizations, and state and local governments. 
However, private sector and state and local government officials 
continue to look for additional guidance and clarification from the 
federal government for specific topics, such as state border closures 
and fatality management. 

Performance monitoring and accountability for pandemic preparedness 
needs strengthening. While the National Pandemic Strategy and 
Implementation Plan identify overarching goals and objectives for 
pandemic planning, the documents are not altogether clear on the roles, 
responsibilities, and requirements to carry out the plan. Some of the 
action items in the National Pandemic Implementation Plan, 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. Moreover, the National Pandemic Strategy and 
Implementation Plan do not provide information on the financial 
resources needed to implement them, which is one of six characteristics 
of an effective national strategy that we have identified.[Footnote 5] 
As a result, the documents do not provide a picture of priorities or 
how adjustments might be made in view of resource constraints. In the 
case of the Department of Defense (DOD), although it had instituted 
reporting requirements for its components responsible for implementing 
action items tasked to DOD in the National Pandemic Implementation 
Plan, there were not similar oversight mechanisms in place for other 
pandemic-related tasks. For example, DOD did not require its components 
to report on their development or revision of their continuity of 
operations plans in preparation for an influenza pandemic. 

Strengthening preparedness for large-scale public health emergencies, 
including the possibility of an influenza pandemic, is one of the 
urgent issues that we identified as among those needing the immediate 
attention of the new administration and Congress during this transition 
period. Although much has been done, many challenges remain, with 
almost half the recommendations that we have made over the past 3 years 
still not fully implemented. It will be essential for the 
administration to test the shared leadership roles that have been 
established between HHS and DHS, as these roles and responsibilities 
continue to evolve, as well as the relative roles, responsibilities and 
authorities for an influenza pandemic among the federal government, 
state and local governments, and the private sector. DHS and HHS 
should, in coordination with other federal agencies, continue to work 
with states and local governments to help them address identified gaps 
in their pandemic planning, as well as with the private sector through 
the critical infrastructure coordinating councils. Despite other more 
immediate national priorities, the threat of a severe influenza 
pandemic remains, and the administration should maintain momentum in 
preparing the nation. 

Background: 

Influenza pandemic--caused by a novel strain of influenza virus for 
which there is little resistance and which therefore is highly 
transmissible among humans--continues to be a real and significant 
threat facing the United States and the world. While some scientists 
and public health experts believe that the next influenza pandemic 
could be caused by a highly pathogenic strain of the H5N1 avian 
influenza virus (also known as "bird flu")[Footnote 6] that is 
currently circulating in parts of Asia, Europe, and Africa, it is 
unknown when an influenza pandemic will occur, where it will begin, or 
whether an H5N1 virus or another strain would be the cause. Influenza 
pandemic poses a grave threat to global public health at a time when 
the United Nations' World Health Organization (WHO) has said that 
infectious diseases are spreading faster than at any time in history. 
Influenza pandemics have spread worldwide within months, and a future 
pandemic is expected to spread even more quickly given modern travel 
patterns. 

Unlike incidents that are discretely bounded in space or time (e.g., 
most natural or man-made disasters), an influenza 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. While a pandemic will not directly damage 
physical infrastructure such as power lines or computer systems, it 
threatens the operation of critical systems by potentially removing the 
essential personnel needed to operate them from the workplace for weeks 
or months. In a severe pandemic, absences attributable to illnesses, 
the need to care for ill family members, and fear of infection may, 
according to the Centers for Disease Control and Prevention (CDC), 
reach a projected 40 percent during the peak weeks of a community 
outbreak, with lower rates of absence during the weeks before and after 
the peak.[Footnote 7] In addition, an influenza pandemic could result 
in 200,000 to 2 million deaths in the United States, depending on its 
severity. 

In addition to the profound human costs in terms of illnesses and 
deaths, the economic and societal repercussions of a pandemic could be 
significant. In its December 2005 report on possible macroeconomic 
effects and policy issues related to a potential influenza pandemic, 
CBO stated that a severe influenza pandemic, similar to the 1918-1919 
pandemic, might cause a decline in U.S. gross domestic product of about 
4.25 percent.[Footnote 8] CBO updated its report in July 2006 to 
include some estimates from medical experts that suggest that CBO may 
have initially underestimated the economic impact.[Footnote 9] The 
report also noted that these medical experts stressed the uncertainty 
about the exact characteristics of the potential virus and suggested 
that the worst-case scenario could be much worse than the severe 
scenario that CBO considered, especially if the H5N1 virus acquires the 
ability to spread efficiently among humans without losing its extreme 
virulence. In addition, in September 2008, the World Bank reported that 
a severe pandemic could cause a 4.8 percent drop in world economic 
activity, which would cost the world economy more than $3 
trillion.[Footnote 10] 

WHO has developed six phases of pandemic alert, each divided into three 
periods, as a system of informing the world of the seriousness of the 
pandemic threat. As seen in figure 2, according to WHO the world is 
currently in Phase 3 where a new influenza virus subtype is causing 
disease in humans, but is not yet spreading efficiently and sustainably 
among humans. 

Figure 2: WHO Global Pandemic Phases: 

[Refer to PDF for image] 

Inter-pandemic phase: New virus in animals, no human cases: Low risk of 
human cases: 1; 
Inter-pandemic phase: New virus in animals, no human cases: Higher risk 
of human cases: 2. 

Pandemic alert: New virus causes no human cases: No or very limited 
human-to-human transmission: 3(circled); 
Pandemic alert: New virus causes no human cases: Evidence of increased 
human-to-human transmission: 4; 
Pandemic alert: New virus causes no human cases: Evidence of increased 
human-to-human transmission: 5. 

Pandemic: Efficient and sustained human-to-human transmission: 6. 

Source: WHO. 

Note: Circle indicates WHO assessment of current global phase. 

[End of figure] 

The Homeland Security Council (HSC) took an active approach to this 
potential disaster by, among other things, issuing the National 
Pandemic Strategy in November 2005, and the National Pandemic 
Implementation Plan in May 2006. The National Pandemic Strategy 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 provides expectations for nonfederal entities-- 
including state, local, and tribal governments; the private sector; 
international partners; and individuals--to prepare themselves and 
their communities. The National Pandemic Implementation Plan is 
intended to lay out broad implementation requirements and 
responsibilities among the appropriate federal agencies and clearly 
define expectations for nonfederal entities. The National Pandemic 
Implementation Plan contains 324 action items related to these 
requirements, responsibilities, and expectations, most of which are to 
be completed before or by May 2009. HSC publicly reported on the status 
of the action items that were to be completed by 6 months, 1 year and 2 
years in December 2006, July 2007, and October 2008 respectively. HSC 
indicated in its October 2008 progress report that 75 percent of the 
action items have been completed. As previously mentioned, we have 
ongoing work assessing the status of implementing this plan. 

Leadership Roles and Responsibilities Need to Be Clarified and Tested, 
and Coordination Mechanisms Could Be Better Utilized: 

Our prior work evaluating catastrophic event preparedness, response, 
and recovery has shown that in the event of a catastrophic disaster, 
the leadership roles, responsibilities, and lines of authority for the 
response at all levels must be clearly defined and effectively 
communicated to facilitate rapid and effective decision making, 
especially in preparing for and in the early hours and days after the 
event.[Footnote 11] 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.[Footnote 12] Such clarity in leadership is even more 
crucial now given the change in administration and the associated 
transition of senior federal officials. 

Most of these federal leadership roles involve shared responsibilities 
between HHS and DHS, and it is not clear how these would work in 
practice. According to the National Pandemic Strategy and Plan, the 
Secretary of Health and Human Services is to lead the federal medical 
response to a pandemic, and the Secretary of Homeland Security will 
lead the overall domestic incident management and federal coordination. 
In addition, under the Post-Katrina Emergency Management Reform Act of 
2006, the Administrator of the Federal Emergency Management Agency 
(FEMA) was designated as 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.[Footnote 13] To assist in planning and coordinating 
efforts to respond to a pandemic, in December 2006 the Secretary of 
Homeland Security predesignated a national Principal Federal Official 
(PFO) for influenza pandemic and established five pandemic regions each 
with a regional PFO and Federal Coordinating Officers (FCO) for 
influenza pandemic. PFOs are responsible for facilitating federal 
domestic incident planning and coordination, and FCOs are responsible 
for coordinating federal resources 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. Moreover, as we 
testified in July 2007, state and local first responders were still 
uncertain about the need for both FCOs and PFOs and how they would work 
together in disaster response.[Footnote 14] Accordingly, we recommended 
in our August 2007 report on federal leadership roles and the National 
Pandemic Strategy that DHS and HHS develop rigorous testing, training, 
and exercises for influenza pandemic to ensure that federal leadership 
roles and responsibilities for a pandemic are clearly defined and 
understood and that leaders are able to effectively execute shared 
responsibilities to address emerging challenges.[Footnote 15] In 
response to our recommendation, HHS and DHS officials stated in January 
2009 that several influenza pandemic exercises had been conducted since 
November 2007 that involved both agencies and other federal officials, 
but it is unclear whether these exercises rigorously tested federal 
leadership roles in a pandemic. 

With respect to control of an outbreak in poultry, which would be 
instrumental to reducing the risk of a human pandemic, both USDA and 
DHS may become involved, depending on the level of the outbreak. USDA 
is responsible for acting to prevent, control, and eradicate foreign 
animal diseases in domestic livestock and poultry, in coordination with 
a number of other entities, including states. The Secretary of Homeland 
Security assumes responsibility for coordinating the federal response 
under certain circumstances, such as an outbreak serious enough for the 
President to declare an emergency or a major disaster. In a June 2007 
report on USDA's planning for avian influenza, we found that USDA was 
not planning for DHS to assume the lead coordinating role if an 
outbreak among poultry occurred that is sufficient in scope to warrant 
these declarations. To address challenges that limit the national 
ability to quickly and effectively respond to highly pathogenic avian 
influenza, we recommended that the Secretaries of Agriculture and 
Homeland Security clarify their respective roles and how they will work 
together in the event of a declared presidential emergency or major 
disaster, and test the effectiveness of this coordination during 
exercises.[Footnote 16] Both USDA and DHS agreed that they should 
develop additional clarity and better define their coordination roles 
in these circumstances, and have taken preliminary steps to do so. For 
example, according to USDA and DHS officials, the two agencies meet on 
a regular basis to discuss such coordination issues. 

Roles and responsibilities for influenza pandemic preparedness can also 
be unclear within individual federal agencies. In two reports on DOD 
and its combatant commands' pandemic preparedness efforts, we noted 
that while DOD and the combatant commands had taken numerous actions to 
prepare for a pandemic, roles and responsibilities for pandemic 
preparedness within the department and the commands had not been 
clearly defined or communicated.[Footnote 17] Our September 2006 report 
on DOD's pandemic preparedness noted that neither the Secretary nor the 
Deputy Secretary of Defense had clearly and fully defined and 
communicated lead and supporting roles and responsibilities with clear 
lines of authority for DOD's influenza pandemic planning, and we 
recommended that DOD do so. In response, DOD communicated 
departmentwide that the Deputy Secretary of Defense had designated the 
Assistant Secretary of Defense for Homeland Defense and Americas' 
Security Affairs, working with the Assistant Secretary of Defense for 
Health Affairs, to lead DOD's pandemic efforts. Similarly, in a June 
2007 report, we recommended that DOD take steps to clarify U.S. 
Northern Command's roles and responsibilities for pandemic planning and 
preparedness efforts.[Footnote 18] In response, DOD clarified U.S. 
Northern Command's roles and responsibilities in guidance and plans. 

In addition to concerns about clarifying federal roles and 
responsibilities for a pandemic and how shared leadership roles would 
work in practice, private sector officials have told us that they are 
unclear about the respective roles and responsibilities of the federal 
and state governments during a pandemic emergency. The National 
Pandemic Implementation Plan states that in the event of an influenza 
pandemic, the distributed nature and sheer burden of the disease across 
the nation would mean that the federal government's support to any 
particular community is likely to be limited, with the primary response 
to a pandemic coming from states and local communities. Further, 
federal and private sector representatives we interviewed at the time 
of our October 2007 report identified several key challenges they face 
in coordinating federal and private sector efforts to protect the 
nation's critical infrastructure in the event of an influenza 
pandemic.[Footnote 19] One of these was a lack of clarity regarding the 
roles and responsibilities of federal and state governments on issues 
such as state border closures and influenza pandemic vaccine 
distribution. 

Coordination Mechanisms: 

Mechanisms and networks for collaboration and coordination on pandemic 
preparedness between federal and state governments and the private 
sector exist, but they could be better utilized. In some instances, the 
federal and private sectors are working together through a set of 
coordinating councils, including sector-specific and cross-sector 
councils. To help protect the nation's critical infrastructure, DHS 
created these coordinating councils as the primary means of 
coordinating government and private sector efforts for industry sectors 
such as energy, food and agriculture, telecommunications, 
transportation and water.[Footnote 20] Our October 2007 report found 
that DHS has used these critical infrastructure coordinating councils 
primarily to share pandemic information across sectors and government 
levels rather than to address many of the challenges identified by 
sector representatives, such as clarifying the roles and 
responsibilities between federal and state governments.[Footnote 21] We 
recommended in the October 2007 report that DHS encourage the councils 
to consider and address the range of coordination challenges in a 
potential influenza pandemic between the public and private sectors for 
critical infrastructure. DHS concurred with our recommendation and DHS 
officials informed us in February 2009 that the department is working 
on initiatives to address it, such as developing pandemic contingency 
plan guidance tailored to each of the critical infrastructure sectors, 
and holding a series of "webinars" with a number of the 
sectors.[Footnote 22] 

Federal executive boards (FEB) bring together federal agency and 
community leaders in major metropolitan areas outside of Washington, 
D.C., to discuss issues of common interest, including an influenza 
pandemic. The Office of Personnel Management (OPM), which provides 
direction to the FEBs, and the FEBs have designated emergency 
preparedness, security, and safety as an FEB core function. The FEB's 
emergency support role with its regional focus may make the boards a 
valuable asset in pandemic preparedness and response. As a natural 
outgrowth of their general civic activities and through activities such 
as hosting emergency preparedness training, some of the boards have 
established relationships with, for example, federal, state, and local 
governments; emergency management officials; first responders; and 
health officials in their communities. In a May 2007 report on the 
FEBs' ability to contribute to emergency operations, we found that many 
of the selected FEBs included in our review were building capacity for 
influenza pandemic response within their member agencies and community 
organizations by hosting influenza pandemic training and 
exercises.[Footnote 23] We recommended that, since FEBs are well 
positioned within local communities to bring together federal agency 
and community leaders, the Director of OPM work with FEMA to formally 
define the FEBs' role in emergency planning and response. As a result 
of our recommendation, FEBs were included in the National Response 
Framework (NRF) in January 2008 as one of the regional support 
structures that have the potential to contribute to development of 
situational awareness during an emergency. OPM and FEMA also signed a 
memorandum of understanding in August 2008 in which FEBs and FEMA 
agreed to work collaboratively in carrying out their respective roles 
in the promotion of the national emergency response system. 

Efforts Are Underway to Improve the Surveillance and Detection of 
Pandemic-Related Threats in Humans and Animals, but Targeting 
Assistance to Countries at the Greatest Risk Has Been Based on 
Incomplete Information: 

International disease surveillance and detection efforts serve to 
address the threat posed by infectious diseases, such as an influenza 
pandemic, before they develop into widespread outbreaks. Such efforts 
also provide national and international public health authorities with 
information for planning and managing efforts to control diseases such 
as an influenza pandemic. However, as we have reported in the past, 
domestic and international disease surveillance efforts need 
improvement.[Footnote 24] For example, some state public health 
departments' initiatives to enhance disease reporting have been 
incomplete, and there is a need for national standards and 
interoperability in information collection and sharing to detect 
outbreaks. Globally, in December 2007 we reported that the United 
States and its international partners are involved in efforts to 
improve global influenza surveillance, including diagnostic 
capabilities, so that pandemic strains can be quickly 
detected.[Footnote 25] Yet, international capacity for influenza 
surveillance still has many weaknesses, particularly in developing 
countries. For example, some countries experiencing H5N1 human 
influenza outbreaks, like Indonesia, had at times not promptly shared 
human virus samples with the international community, thus further 
weakening international surveillance efforts. 

Efforts are also being made both within the United States and 
internationally to improve surveillance and detection for highly 
pathogenic avian influenza. As stated earlier, controlling an outbreak 
in poultry would be instrumental to reducing the risk of a human 
pandemic. Within the United States, USDA is taking many important 
measures to help the nation prepare for outbreaks of highly pathogenic 
avian influenza. In a June 2007 report on avian influenza, we stated 
that USDA had developed several surveillance programs to detect highly 
pathogenic avian influenza, including a long-standing voluntary program 
that systematically tests samples of birds from participating poultry 
operators' flocks for the virus.[Footnote 26] Further, we also stated 
that USDA's Animal and Plant Health Inspection Service (APHIS) is 
working with the Department of the Interior, state wildlife agencies, 
and others to increase surveillance of wild birds in Alaska and the 48 
contiguous states in addition to working with states and industry to 
conduct surveillance of birds at auctions, swap meets, flea markets, 
and public exhibitions. APHIS has also formed the National Avian 
Influenza Surveillance System, designed to link existing avian 
influenza surveillance data from USDA, other federal and state 
agencies, and industry. 

However, in the United States, federal and state officials generally do 
not know the numbers and locations of backyard birds so controlling an 
outbreak of highly pathogenic avian influenza among these birds remains 
particularly difficult. We recommended that the Secretary of 
Agriculture work with states to determine how to overcome potential 
problems associated with unresolved issues, such as the difficulty in 
locating backyard birds and disposing of carcasses and materials. USDA 
agreed with our recommendation and efforts are underway. For example, 
according to USDA officials, the agency has developed online tools to 
help states make effective decisions about carcass disposal. In 
addition, USDA has created a secure Internet site that contains draft 
guidance for disease response, including highly pathogenic avian 
influenza, and it includes a discussion about many of the unresolved 
issues. 

International surveillance networks for influenza in birds and other 
animals have also been established and efforts are under way to improve 
data sharing among scientists.[Footnote 27] However, global 
surveillance of the disease among domestic animals has serious 
shortfalls. The World Organisation for Animal Health (OIE) and the Food 
and Agriculture Organization (FAO) collaborate to obtain and confirm 
information on suspected highly pathogenic H5N1 cases. According to the 
October 2008 report by the UNSIC and the World Bank on the state of 
pandemic readiness,[Footnote 28] data obtained from national 
authorities indicate that 75 percent of countries[Footnote 29] report 
having a surveillance system that is operational and capable of 
detecting highly pathogenic avian influenza. In addition, estimates of 
risk for disease transmission from one country to another, as well as 
among regions within countries, are difficult to make because of 
uncertainties about how factors such as trade in poultry and other 
birds and wild bird migration affect the movement of the disease. 

Risk-Based Targeting of Assistance to Priority Countries: 

Assessments by U.S. agencies and international organizations identified 
widespread risks of the emergence of influenza pandemic, and the United 
States identified priority countries for assistance. Our June 2007 
report on international efforts to assess and respond to an influenza 
pandemic risk noted that the bulk of U.S. and other donors' country- 
specific commitments had been made to countries that the United States 
had designated as priorities, with funding concentrated among certain 
of these countries. We reported that through 2006, the United States 
had committed about $377 million to improve global preparedness for 
avian and influenza pandemic, 27 percent of the $1.4 billion committed 
by all donors, which is the greatest share of funds of all donors. 
Since we issued our June 2007 report, the UNSIC and the World Bank 
reported that as of April 2008, the United States had committed $629 
million, which is approximately 31 percent of the $2.05 billion 
committed by all donors, for avian and pandemic influenza efforts. 

Figure 3 shows the distribution of committed global and U.S. funding 
across major recipient countries as of December 2006. Of the top 15 
recipients of committed international funds, 11 were U.S. priority 
countries. More recent data on U.S. funding patterns show similar 
focuses on certain countries, with Indonesia the largest recipient, 
followed by Vietnam and Cambodia. 

Figure 3: Top 15 Recipients of Committed, Country-Specific 
International Avian and Influenza Pandemic Funding as of December 2006: 

[Refer to PDF for image] 
		
U.S. Priority Countries: Vietnam; 
U.S. total: 13.37; 
All other donors: 74.44. 

U.S. Priority Countries: Indonesia; 
U.S. total: 24.65; 
All other donors: 42.38. 

U.S. Priority Countries: Nigeria; 
U.S. total: 2.36; 
All other donors: 56.51. 

U.S. Priority Countries: Turkey; 
U.S. total: 1.41; 
All other donors: 44.99. 

U.S. Priority Countries: Romania; 
U.S. total: 3.06; 
All other donors: 38.52. 

U.S. Priority Countries: Cambodia; 
U.S. total: 9.56; 
All other donors: 17.8. 

U.S. Priority Countries: Laos; 
U.S. total: 7.69; 
All other donors: 19.6. 

U.S. Priority Countries: China; 
U.S. total: 8.14; 
All other donors: 3.07. 

U.S. Priority Countries: Georgia; 
U.S. total: 1.19; 
All other donors: 10. 

U.S. Priority Countries: Thailand; 
U.S. total: 8.68; 
All other donors: 0.1. 

U.S. Priority Countries: Mexico; 
U.S. total: 6.45; 
All other donors: 0. 

U.S. Priority Countries: Azerbaijan; 
U.S. total: 0.75; 
All other donors: 5.69. 

Non-U.S. Priority Countries: Armenia; 
U.S. total: 2.94; 
All other donors: 7.59. 

Non-U.S. Priority Countries: Moldova; 
U.S. total: 0.86; 
All other donors: 9.04. 

Non-U.S. Priority Countries: West Bank Gaza; 
U.S. total: 0.5; 
All other donors: 13. 

Source: GAO analysis of data compiled by the World Bank. 

Notes: More recent data reported by the UNSIC and the World Bank on the 
distribution of U.S. commitments, as of April 30, 2008, show a similar 
focus on certain countries, with Indonesia the largest recipient of 
U.S. country-specific commitments (about $48 million), followed by 
Vietnam (about $21 million), and Cambodia (about $14 million). 

The World Bank defines a commitment as the result of an agreement 
between the donor and recipient for designated purposes or a firm 
decision, such as a legislative appropriation, that prevents the use of 
an allocated amount for other purposes. 

Totals include funds from donor countries, international organizations, 
and the World Bank administered Avian and Human Influenza Facility. 

[End of figure] 

However, we reported that gaps in available information from other 
countries limited the capacity for comprehensive, well-informed 
comparisons of risk levels by country.[Footnote 30] For example, in 
2007 we reported that the United States Agency for International 
Development's (USAID) environmental risk assessment of areas at 
greatest risk for avian influenza outbreaks included a limited 
understanding of the role of poultry trade or wild birds. USAID, the 
Department of State, and the United Nations had also gathered 
information that was not sufficiently detailed or complete enough to 
permit well-informed country comparisons. Despite these limitations, 
the HSC has used available information to designate priority countries 
for assistance. The UNSIC and the World Bank stated in the 2008 report 
that reports from national authorities responding to a UNSIC survey 
indicate that 68 percent of countries[Footnote 31] had conducted a risk 
assessment. As we previously reported in June 2007, adopting a risk 
management approach can help manage the uncertainties in an influenza 
pandemic and identify the most appropriate course of action.[Footnote 
32] However, the FAO's detailed evaluation concluded that very few 
countries have a surveillance plan that is based on an "elaborated" 
risk-analysis. 

Pandemic Planning and Exercising Has Occurred in the United States and 
Other Countries, but Planning Gaps Remain: 

By their very nature, catastrophic events involve extraordinary levels 
of mass casualties, damage, or disruption that can overwhelm state and 
local responders--making sound planning for catastrophic events 
crucial. Strong advance planning, both within and among federal, state, 
and local governments and other organizations, as well as robust 
training and exercise programs to test these plans in advance of a real 
disaster, are essential to best position the nation to prepare for, 
respond to, and recover from major catastrophes such as an influenza 
pandemic. Capabilities are built upon the appropriate combination of 
people, skills, processes, and assets. Ensuring that needed 
capabilities are available requires effective planning and coordination 
as well as training and exercises in which the capabilities are 
realistically tested, problems identified and lessons learned, and 
subsequently addressed in partnership with other federal, state, and 
local stakeholders. We have also noted that an incomplete understanding 
of roles and responsibilities under the National Response Plan has 
often led to misunderstandings, problems, and delays--an area where 
training could be helpful. Key officials must actively and personally 
participate so that they are better prepared to deal with real life 
situations. In addition, as we previously reported on the federal 
response to Hurricane Katrina, lessons learned from exercises must be 
incorporated and used to improve emergency plans.[Footnote 33] 

Pandemic Planning and Exercising in Other Countries: 

A number of countries in addition to the United States have developed 
pandemic plans, along with state and local governments, and the private 
sector. We reported in June 2007 that the U.S. government has worked 
with its international partners to develop an overall global strategy 
that is compatible with the U.S. approach. These steps included the 
appointment of a UNSIC and periodic global conferences to review 
progress and refine the strategy. 

Other countries, including Belgium, Japan, Sweden, and the United 
Kingdom, have developed influenza pandemic plans and frameworks. In 
July 2006, Belgium issued the Belgian pandemic flu preparedness plan 
which provides basic information on various topics such as leadership, 
antivirals, vaccines, surveillance, logistics, and public 
communication.[Footnote 34] Similar to Belgium's pandemic plan, Japan 
used WHO's six influenza pandemic phases in drafting government 
policies and response efforts in its Pandemic Influenza Preparedness 
Action Plan of the Japanese Government issued in November 
2005.[Footnote 35] Sweden's National Audit Office reported in its 
February 2008 audit that Sweden's Preparedness planning for pandemic 
influenza - National Actions is focused only on infection control 
services and the health sector and does not cover the rest of 
society.[Footnote 36] To address this, the government of Sweden agreed 
to further develop its plan by March 2010. Further, the Sweden's 
National Audit Office found that there is very limited knowledge of the 
extent to which municipalities can provide essential services in the 
event of an influenza pandemic. Within the United Kingdom, the 
government issued The National Framework for Responding to an Influenza 
Pandemic and the Scottish National Framework for Responding to an 
Influenza Pandemic in November 2007 and March 2007, respectively. Both 
frameworks provide information and guidance to assist and support 
public and private organizations across all sectors in understanding 
the nature of the challenges and in making the appropriate preparations 
for an influenza pandemic.[Footnote 37] 

According to a UNSIC global survey, 141 countries, or 97 percent of 
those that responded, have pandemic preparedness plans.[Footnote 38] 
However, further analysis conducted by the UNSIC's Pandemic Influenza 
Contingency Team and other institutions suggested that the quality and 
comprehensiveness of these plans continue to vary significantly between 
countries. UNSIC and the World Bank also found that there had been a 
moderate increase in the number of countries that have undertaken 
simulation exercises.[Footnote 39] Specifically, where testing has 
occurred, 25 percent of respondents (37 of 145 countries), reported 
that testing took place at both the national and local levels. In 
addition, 37 percent of respondents (45 of 120 countries) have 
incorporated the lessons learned from simulations into plan revisions. 

Federal, State, and Local Government Pandemic Planning and Exercising: 

In our August 2007 report on the National Pandemic Strategy and 
Implementation Plan, we found that while these documents are an 
important first step in guiding national preparedness, they do not 
fully address all six characteristics of an effective national 
strategy, as identified in our work.[Footnote 40] The documents fully 
address only one of the six characteristics, by reflecting a clear 
description and understanding of problems to be addressed. Further, the 
National Pandemic Strategy and Implementation Plan do not address one 
characteristic at all, containing no discussion of what it will cost, 
where resources will be targeted to achieve the maximum benefits, and 
how it will balance benefits, risks, and costs. Moreover, the documents 
do not provide a picture of priorities or how adjustments might be made 
in view of resource constraints. Although the remaining four 
characteristics are partially addressed, important gaps exist that 
could hinder the ability of key stakeholders to effectively execute 
their responsibilities. For example, state and local jurisdictions that 
will play crucial roles in preparing for and responding to a pandemic 
were not directly involved in developing the National Pandemic 
Implementation Plan, even though it relies on these stakeholders' 
efforts. Stakeholder involvement during the planning process is 
important to ensure that the federal government's and nonfederal 
entities' responsibilities are clearly understood and agreed upon. 
Further, relationships and priorities among actions were not clearly 
described, performance measures were not always linked to results, and 
insufficient information was provided about how the documents are 
integrated with other response related plans, such as the NRF. We 
recommended that the HSC establish a process for updating the National 
Pandemic Implementation Plan and that the updated plan should address 
these and other gaps. HSC did not comment on our recommendation and has 
not indicated if it plans to implement it. 

Concerning federal government planning for an outbreak in animals, we 
reported in 2007 that although USDA had also taken important steps to 
prepare for outbreaks of highly pathogenic avian influenza, there were 
still gaps in its planning. We noted that USDA was drafting response 
plans for highly pathogenic avian influenza and was also working with 
the HSC and other key federal agencies to produce an "interagency 
playbook" intended to clarify how primary federal responders would 
initially interact to respond to six scenarios of detection of highly 
pathogenic H5N1. USDA had also begun preliminary exercises to test 
aspects of these plans with federal, state, local, and industry 
partners. However, USDA response plans did not identify the 
capabilities needed to carry out the tasks associated with an outbreak 
scenario--that is, the entities responsible for carrying them out, the 
resources needed, and the source of those resources. To address these 
gaps, we recommended that the Secretary of Agriculture identify these 
capabilities, use this information to develop a response plan that 
identifies the critical tasks for responding to the selected outbreak 
scenario and, for each task, identifies the responsible entities, the 
location of resources needed, time frames, and completion status, and 
test these capabilities in ongoing exercises to identify gaps and ways 
to overcome those gaps. USDA concurred, and officials told us that it 
has created a draft preparedness and response plan that identifies 
federal, state, and local actions, timelines, and responsibilities for 
responding to highly pathogenic avian influenza, but the plan has not 
been issued yet. 

At the state and local levels, we reported in June 2008 that, according 
to CDC, all 50 states and the 3 localities that received federal 
pandemic funds have developed influenza pandemic plans and conducted 
pandemic exercises in accordance with federal funding guidance. All of 
the 10 localities that we reviewed had also developed plans and 
conducted exercises. Further, all of the 10 localities and the five 
states that we reviewed had incorporated lessons learned from pandemic 
exercises into their planning.[Footnote 41] However, an HHS-led 
interagency assessment of states' plans found on average that states 
had "many major gaps" in their influenza pandemic plans in 16 of 22 
priority areas, such as school closure policies and community 
containment, which are community-level interventions designed to reduce 
the transmission of a pandemic virus. The remaining 6 priority areas 
were rated as having "a few major gaps." Since we issued our report in 
June 2008, HHS led another interagency assessment of state influenza 
pandemic plans. HHS reported in January 2009 that, based on this 
assessment, although states have made important progress toward 
preparing for combating an influenza pandemic, most states still have 
major gaps in their pandemic plans.[Footnote 42] As we had reported in 
June 2008, HHS, in coordination with DHS and other federal agencies, 
had convened a series of regional workshops for states in five 
influenza pandemic regions across the country. Because these workshops 
could be a useful model for sharing information and building 
relationships, we recommended that HHS and DHS, in coordination with 
other federal agencies, convene additional meetings with states to 
address the gaps in the states' pandemic plans. HHS and DHS generally 
concurred with our recommendation, but have not yet held these 
additional meetings. HHS and DHS recently indicated that while no 
additional meetings are planned at this time, states will have to 
continuously update their pandemic plans and submit them for review. 

We have also reported on the need for more guidance from the federal 
government to help states and localities in their planning. In June 
2008, we reported that although the federal government has provided a 
variety of guidance, officials of the states and localities we reviewed 
told us that they would welcome additional guidance from the federal 
government in a number of areas, such as community containment, to help 
them to better plan and exercise for an influenza pandemic. State and 
local officials have identified similar concerns. An October 2007 
Kansas City Auditor's Office report on influenza pandemic preparedness 
in the city noted that Kansas City Health Department officials would 
like the federal government to provide additional guidance on some of 
the same issues we found, including clarifying community interventions 
such as school closings.[Footnote 43] In addition, according to the 
National Governors Association's (NGA) September 2008 issue brief on 
states' pandemic preparedness, states are concerned about a wide range 
of school-related issues, including when to close schools or dismiss 
students, how to maintain curriculum continuity during closures, and 
how to identify the appropriate time at which classes could 
resume.[Footnote 44] In addition, NGA reported that states generally 
have very little awareness of the status of disease outbreaks, either 
in real time or in near real time, to allow them to know precisely when 
to recommend a school closure or reopening in a particular area. NGA 
reported that states wanted more guidance in the following areas: (1) 
workforce policies for the health care, public safety, and private 
sectors; (2) schools; (3) situational awareness such as information on 
the arrival or departure of a disease in a particular state, county, or 
community; (4) public involvement; and (5) public-private sector 
engagement. 

Private Sector Pandemic Planning: 

The private sector has also been planning for an influenza pandemic, 
but many challenges remain. To better protect critical infrastructure, 
federal agencies and the private sector have worked together across a 
number of sectors to plan for a pandemic, including developing general 
pandemic preparedness guidance, such as checklists for continuity of 
business operations during a pandemic. However, federal and private 
sector representatives have acknowledged that sustaining preparedness 
and readiness efforts for an influenza pandemic is a major challenge, 
primarily because of the uncertainty associated with a pandemic, 
limited financial and human resources, and the need to balance pandemic 
preparedness with other, more immediate, priorities, such as responding 
to outbreaks of foodborne illnesses in the food sector and, now, the 
effects of the financial crisis. 

In our March 2007 report on preparedness for an influenza pandemic in 
one of these critical infrastructure sectors--financial markets--we 
found that despite significant progress in preparing markets to 
withstand potential disease pandemics, securities and banking 
regulators could take additional steps to improve the readiness of the 
securities markets.[Footnote 45] Although the seven organizations that 
we reviewed--which included exchanges, clearing organizations, and 
payment-system processors--were working on planning and preparation 
efforts to reduce the likelihood that a worldwide influenza pandemic 
would disrupt their critical operations, only one of the seven had 
completed a formal plan. To increase the likelihood that the securities 
markets will be able to function during a pandemic, we recommended that 
the Chairman, Federal Reserve; the Comptroller of the Currency; and the 
Chairman, Securities and Exchange Commission (SEC), consider taking 
additional actions to ensure that market participants adequately 
prepare for a pandemic outbreak. In response to our recommendation, the 
Federal Reserve and the Office of the Comptroller of the Currency, in 
conjunction with the Federal Financial Institutions Examination 
Council, and the SEC directed all banking organizations under their 
supervision to ensure that the pandemic plans the financial 
institutions have in place are adequate to maintain critical operations 
during a severe outbreak. SEC issued similar requirements to the major 
securities industry market organizations. 

Further Actions Are Needed to Address the Capacity to Respond to and 
Recover from an Influenza Pandemic: 

Improving the nation's response capability to catastrophic disasters, 
such as an influenza pandemic, is essential. Following a mass casualty 
event of injured or ill victims, health care systems would need the 
ability to adequately care for a large number of patients or patients 
with unusual or highly specialized medical needs. The ability of local 
or regional health care systems to deliver services consistent with 
established standards of care[Footnote 46] could be compromised, at 
least in the short term, because the volume of patients would far 
exceed the available hospital beds, medical personnel, pharmaceuticals, 
equipment, and supplies. Providing such care would require the 
allocation of scarce resources. 

Medical Surge Capacity: 

In contrast to discrete events such as hurricanes and most terrorist 
attacks, the widespread and iterative nature of a pandemic--likely to 
occur in waves as it spreads simultaneously through different 
communities and regions--presents continuing challenges in preparing 
for a medical surge in a mass casualty event such as a pandemic. Under 
such conditions, emergency management approaches that have been used in 
the past to increase capacity when responding to other types of 
disasters, such as assistance from other states or the deployment of 
military resources, may not be viable options since these groups may 
need to hold onto resources in order to meet their own needs should 
they be affected by the disease. We reported in June 2007 that state 
officials informed us that the Emergency Management Assistance Compact 
(EMAC), a collaborative arrangement among member states that provides a 
legal framework for requesting resources and that has been used in 
emergencies such as Hurricane Katrina, would not work in an influenza 
pandemic.[Footnote 47] State officials reported their reluctance to 
send personnel into an infected area, expressed their concern that 
resources would not be available, and believed that personnel would be 
reluctant to volunteer to go to another state. Further, NGA reported in 
its September 2008 issue brief on state pandemic preparedness that EMAC 
is seen as unreliable during a pandemic because states would likely be 
unwilling to share scarce resources or deploy personnel into a location 
where the disease is active and thus expose those individuals to a high-
risk environment. 

HHS estimates that in a severe influenza pandemic, almost 10 million 
people would require hospitalization, which would exceed the current 
capacity of U.S. hospitals and necessitate difficult choices regarding 
rationing of resources. HHS also estimates that almost 1.5 million of 
these people would require care in an intensive care unit and about 
740,000 people would require mechanical ventilation. In our September 
2008 report on HHS's influenza pandemic planning efforts, we reported 
that although HHS has initiated efforts to improve the surge capacity 
of health care providers, these efforts will be challenged during a 
severe pandemic because of the widespread nature of such an event, the 
existing shortages of health care providers, and the potential high 
absentee rate of providers. Given the uncertain effectiveness of 
efforts to increase surge capacity, HHS has developed guidance to 
assist health care facilities in planning for altered standards of 
care; that is, for providing care while allocating scarce equipment, 
supplies, and personnel in a way that saves the largest number of lives 
in mass casualty events.[Footnote 48] As we reported in June 2008, 7 
out of 20 states reviewed had adopted or were drafting altered 
standards of care for specific medical issues. Three of the 7 states 
had adopted some altered standards of care guidelines.[Footnote 49] We 
also found that 18 of the 20 states reviewed were selecting alternate 
care sites, which deliver medical care outside of a hospital setting 
for patients who would normally be treated as inpatients. 

In addition, we reported that the federal government has provided 
funding, guidance, and other assistance to help states prepare for 
medical surge in a mass casualty event, such as an influenza pandemic. 
Further, the federal government has provided guidance for states to use 
when preparing for medical surge, including Reopening Shuttered 
Hospitals to Expand Surge Capacity, which contains a checklist that 
states can use to identify entities that could provide more resources 
in preparing for a medical surge and also provided other assistance 
such as conferences and electronic bulletin boards for states to use in 
preparing for medical surge. Some state officials reported, however, 
that they had not begun work on altered standards of care guidelines, 
or had not completed drafting guidelines, because of the difficulty of 
addressing the medical, ethical, and legal issues involved. We 
recommended that HHS serve as a clearinghouse for sharing among the 
states altered standards of care guidelines developed by individual 
states or medical experts. HHS did not comment on the recommendation, 
and it has not indicated if it plans to implement it.[Footnote 50] 
Further, in our June 2008 report on state and local planning and 
exercising efforts for an influenza pandemic, we found that state and 
local officials reported that they wanted federal influenza pandemic 
guidance on facilitating medical surge, which was also one of the areas 
that the HHS-led assessment rated as having "many major gaps" 
nationally among states' influenza pandemic plans.[Footnote 51] 

Antivirals and Vaccine Capacity: 

In fiscal year 2006, Congress appropriated $5.62 billion in 
supplemental funding to HHS for, among other things, (1) monitoring 
disease spread to support rapid response, (2) developing vaccines and 
vaccine production capacity, (3) stockpiling antivirals and other 
countermeasures, (4) upgrading state and local capacity, and (5) 
upgrading laboratories and research at CDC. Figure 4 shows that the 
majority of this supplemental funding--about 77 percent--was allocated 
for developing antivirals and vaccines for a pandemic, and purchasing 
medical supplies. Also, a portion of the funding for state and local 
preparedness--$170 million--was allocated for state antiviral purchases 
for their state stockpiles. 

Figure 4: HHS Influenza Pandemic Supplemental Appropriations, Fiscal 
Year 2006: 

[Refer to PDF for image] 

Pie graph: 

Vaccine: $3,233: 58%; 
Antivirals[C]: $911: 16%; 
State and local preparedness[C]: $770: 14%; 
Other domestic [B]: $276: 5%; 
International activities: $179: 3%; 
Medical supplies (personal protective equipment, ventilators, etc.): 
$170: 3%; 
Risk communications: $51: 1%. 

Source: GAO, HHS. 

Notes: Data are from the Department of Health and Human Services, 
Pandemic Planning Update III: A Report from Secretary Michael O. 
Leavitt (Washington, D.C.: Nov. 13, 2006). 

[A] International activities includes: international preparedness, 
surveillance, response, and research. 

[B] Other domestic includes: surveillance, quarantine, lab capacity, 
rapid tests. 

[C] State and local preparedness includes funding for state subsidies 
of antiviral drugs. 

[D] This chart does not include $30 million in supplemental funding 
that was transferred to the U.S. Agency for International Development. 

[End of figure] 

According to HHS's Pandemic Influenza Implementation Plan, HHS seeks to 
ensure the availability of antiviral treatment courses for at least 25 
percent of the U.S. population or at least 81 million treatment 
courses.[Footnote 52] As of May 2008, both HHS and states had 
stockpiled a total of 72 million treatment courses. Specifically, HHS 
had stockpiled 44 million courses of antivirals for treatment in the 
HHS-managed Strategic National Stockpile, which is a national 
repository of medical supplies that is designed to supplement 
stockpiles from state and local jurisdictions in the event of a public 
health emergency, and had reserved an additional 6 million courses from 
its federally stockpiled antivirals for containment of an initial 
outbreak. HHS also subsidized the purchase of 31 million treatment 
courses by state and local jurisdictions for storage in their own 
stockpiles, of which 22 million treatment courses had been stockpiled. 

In our December 2007 report on using antivirals and vaccines to 
forestall a pandemic, we found that the availability of antivirals and 
vaccines in a pandemic could be inadequate to meet demand due to 
limited production, distribution, and administration capacity.[Footnote 
53] As we reported, WHO estimated that the quantity of antivirals 
required to forestall a pandemic would be enough treatment courses for 
25 percent of the population. In addition, there would need to be 
enough preventative courses to last 20 days for the remaining 75 
percent of the population in the outbreak contamination zone. Further, 
due to the time required to detect the virus and develop and 
manufacture a targeted vaccine for a pandemic, pandemic vaccines are 
likely to play little or no role in efforts to stop or contain a 
pandemic at least in its initial phases. According to a September 2008 
CBO report on the United States' policy regarding pandemic vaccines, if 
an influenza pandemic were to occur today, it would be impossible to 
vaccinate the entire population of about 300 million people within the 
following 6 months because current capacity for domestic production 
would be completely inadequate.[Footnote 54] 

The United States, its international partners, and the pharmaceutical 
industry are investing substantial resources to address constraints on 
the availability and effectiveness of antivirals and vaccines, but some 
of these efforts face limitations. We reported in September 2008 that 
HHS was making large investments in domestic vaccine manufacturing 
capacity by supporting vaccine research with contracts that require 
manufacturers to establish vaccine-producing facilities within U.S. 
borders.[Footnote 55] Through these contracts, one U.S. facility has 
expanded its manufacturing capacity and a second facility was recently 
established in the United States. Further, according to a January 2009 
report by HHS, the department awarded $120 million to vaccine 
manufacturers to retrofit their existing U.S. vaccine manufacturing 
facilities for egg-based vaccines[Footnote 56] while also planning to 
build domestic cell-based vaccine[Footnote 57] production facilities 
within the U.S. by awarding approximately $500 million in contracts in 
fiscal year 2009.[Footnote 58] 

CBO also reported that HHS is not only encouraging the expansion and 
refurbishing of existing facilities but also funding the development of 
new adjuvants, substances that can be added to influenza vaccines to 
reduce the amount of active ingredient (also called antigen) needed per 
dose of vaccine. By using adjuvants for egg-based and cell-based 
vaccines, domestic manufacturers could produce more doses in existing 
facilities, which means that fewer new facilities would be needed to 
manufacture cell-based formulations and smaller stockpiles could be 
used to protect a larger population.[Footnote 59] 

However, increasing production capacity of vaccines and antivirals will 
take several years, as new facilities are built and necessary materials 
acquired. Also, weaknesses within the international influenza 
surveillance system impede the detection of strains, which could limit 
the ability to promptly administer or develop effective antivirals and 
vaccines to treat and prevent cases of infection to prevent its spread. 
The delayed use of antivirals and the emergence of antiviral resistance 
in influenza strains could limit their effectiveness. In addition, 
limited support for clinical trials could hinder their ability to 
improve understanding of the use of antivirals and vaccines against a 
pandemic strain. 

In light of this anticipated limitation in supply, HHS released 
guidance on prioritizing target groups for a pandemic vaccine. Because 
of the uncertainties surrounding the availability of a pandemic 
vaccine, in September 2008, we recommended that the Secretary of Health 
and Human Services expeditiously finalize guidance to assist state and 
local jurisdictions to determine how to effectively use limited 
supplies of antivirals, and the pre-pandemic vaccine, which is 
developed prior to an outbreak using strains that have the potential to 
cause an influenza pandemic.[Footnote 60] In December 2008, HHS 
released final guidance on antiviral drug use during an influenza 
pandemic.[Footnote 61] In addition, HHS officials informed us in 
February 2009 that it is drafting guidance on pre-pandemic influenza 
vaccination. 

In addition to antiviral and vaccine stockpiles for an influenza 
pandemic for the general population, our June 2007 report on avian 
influenza planning concluded that USDA had significant gaps in its 
planning for providing antivirals to individuals responsible for 
responding to an outbreak of highly pathogenic avian 
influenza.[Footnote 62] USDA has coordinated with DHS and other federal 
agencies to create a National Veterinary Stockpile. This stockpile is 
intended to be the nation's repository of animal vaccines, personal 
protective equipment, and other critical veterinary products to respond 
to the most dangerous foreign animal diseases, including highly 
pathogenic avian influenza. However, at the time of the report, USDA 
had not yet estimated the amount of antiviral medication that it would 
need in the event of a highly pathogenic avian outbreak or resolved how 
to provide such supplies within the first 24 hours of an outbreak. 
According to Occupational Safety and Health Administration guidelines, 
poultry workers responding to an outbreak of highly pathogenic avian 
influenza should take antiviral medication daily. Further, the National 
Veterinary Stockpile is required to contain sufficient amounts of 
antiviral medication to respond to the most damaging animal diseases 
that affect human health and the economy and has not yet obtained any 
antiviral medication for highly pathogenic avian influenza. However, 
HHS officials told National Veterinary Stockpile officials that the 
antiviral medication in the Strategic National Stockpile was reserved 
only for use during a human pandemic. We therefore recommended that the 
Secretary of Agriculture determine the amount of antiviral medication 
that USDA would need in order to protect animal health responders, 
given various highly pathogenic avian influenza scenarios, and 
determine how to obtain and provide supplies within 24 hours of an 
outbreak. In commenting on our recommendation, USDA officials told us 
that the National Veterinary Stockpile now contains enough antiviral 
medication to protect 3,000 animal health responders for 40 days. 
However, USDA officials told us that they have yet to determine the 
number of individuals that would need medicine based on a calculation 
of those exposed to the virus under a specific scenario. Further, USDA 
officials said that a contract for additional medication for the 
stockpile has not yet been secured, which would better ensure that 
medications are available in the event of an outbreak of highly 
pathogenic avian influenza. 

Federal Agencies Have Provided Considerable Guidance and Pandemic- 
Related Information, but Could Augment Their Efforts: 

Our work evaluating public health and natural disaster catastrophe 
preparedness, response, and recovery has shown that insufficient 
collaboration among federal, state, and local governments created 
challenges for sharing public health information and developing 
interoperable communications for first responders. In 2005, we 
designated establishing appropriate and effective information-sharing 
mechanisms to improve homeland security as a high-risk area. Over the 
past several years, we have identified potential information-sharing 
barriers, critical success factors, and other key management issues 
that should be considered to facilitate information sharing among and 
between government entities and the private sector. 

Citizens should be given an accurate portrayal of risk, without 
overstating the threat or providing false assurances of security. Risk 
communication principles have been used in a variety of public warning 
contexts, from alerting the public to severe weather, to less 
commonplace warnings of infectious disease outbreaks. In general, these 
principles seek to maximize public safety by ensuring the public has 
sufficient information to determine what actions to take to prevent or 
respond to emergencies. Appropriately warning the public of threats can 
help save lives and reduce costs of disasters. Federal, state and local 
officials and risk management experts who participated in an April 2008 
Comptroller General's forum on strengthening the use of risk management 
principles in homeland security identified and ranked the challenges in 
applying these principles. Improving risk communication to the public 
was one of the top three challenges identified by the forum 
participants.[Footnote 63] 

Our prior work identified several instances when risk communication 
proved less than effective. For example, during the 2004-2005 flu 
season, demand for the flu vaccine exceeded supply, and information 
about future vaccine availability was uncertain (as could happen in a 
future pandemic). Although CDC communicated regularly through a variety 
of media as the situation evolved, state and local officials identified 
several communications lessons. These included the need for consistency 
among federal, state, and local communications, the importance of using 
diverse media to reach different audiences, and the importance of 
disseminating clear, updated information when responding to changing 
circumstances.[Footnote 64] Another example, from our October 1999 
report on DOD's anthrax vaccine immunization program, illustrated the 
importance of providing accurate and sufficient information to 
personnel. Although DOD and the military services used a variety of 
measures to educate military personnel about the program, military 
personnel wanted more information on the program, and over one-half of 
respondents that participated in our survey said that the information 
they received was less than moderately helpful or that they did not 
receive any information.[Footnote 65] 

The National Pandemic Implementation Plan emphasizes that government 
and public health officials must communicate clearly and continuously 
with the public throughout a pandemic. The plan recognizes that timely, 
accurate, credible, and coordinated messages will be necessary. The 
federal government has undertaken a number of communications efforts to 
provide information on a possible pandemic and how to prepare for it. 
HHS (including CDC), DHS, and other federal agencies have provided a 
variety of influenza pandemic information and guidance for states and 
local communities through Web sites and meetings with states. These 
efforts included: 

* establishing an influenza pandemic Web site [hyperlink, 
http://www.pandemicflu.gov]; 

* including pandemic information on another Web site, Lessons Learned 
Information Sharing System (LLIS) [hyperlink, http://www.llis.dhs.gov], 
which is a national network of lessons learned and best practices for 
emergency responders and homeland security officials; 

* sponsoring state pandemic summits with all 50 states and additional 
regional state workshops; 

* disseminating pandemic preparedness checklists for workplaces, 
individuals and families, schools, health care, community 
organizations, and state and local governments; and: 

* providing additional guidance for the public, such as on pandemic 
vaccine targeting and allocation and pre-pandemic community 
planning.[Footnote 66] 

There are established coordination networks that are being used to 
provide information to state and local governments and to the private 
sector about pandemic planning and preparedness. For example, the FEBs 
are charged with providing timely and relevant information to support 
emergency preparedness and response coordination, and OPM expects the 
boards to establish notification networks and communications plans to 
be used in emergency and nonemergency situations. The boards are also 
expected to disseminate relevant information received from OPM and 
other agencies regarding emergency preparedness information and to 
relay local emergency situation information to parties such as OPM, FEB 
members, media, and state and local government authorities. FEB 
representatives generally viewed the boards as an important 
communications link between Washington and the field and among field 
agencies. Each of the selected boards we reviewed reported conducting 
communications activities as a key part of its emergency support 
service. In addition, critical infrastructure coordinating councils 
have been also primarily used as a means to share information and 
develop pandemic-specific guidance across the industry sectors, such as 
banking and finance and telecommunications, and across levels of 
government. 

However, as noted earlier, state and local officials from all of the 
states and localities we interviewed wanted additional federal 
influenza pandemic guidance from the federal government on specific 
topics, such as implementing community interventions, fatality 
management, and facilitating medical surge. Although the federal 
government has issued some guidance, it may not have reached state and 
local officials or may not have addressed the particular concerns or 
circumstances of the state and local officials we interviewed. In 
addition, private sector officials have told us that they would like 
clarification about the respective roles and responsibilities of the 
federal and state governments during an influenza pandemic emergency, 
such as in state border closures and influenza pandemic vaccine 
distribution. 

Performance Monitoring and Accountability for Pandemic Preparedness 
Needs Strengthening: 

As indicated earlier, in August 2007 we reported that although the 
National Pandemic Strategy and Implementation Plan identified the 
overarching goals and objectives for pandemic planning, the documents 
had some gaps. Most of the implementation plan's performance measures 
consist of actions to be completed, 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 National Pandemic Strategy and 
Implementation Plan. 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. For example, most of the action 
items' performance measures consist of actions to be completed, such as 
guidance developed and disseminated. Further, 18 of the action items 
have no measure of performance associated with them. In addition, the 
National Pandemic Implementation 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. 
This is further complicated by the lack of a description of the 
financial resources needed to implement the action items, which is one 
of six characteristics of an effective national strategy. 

We also found that 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, 
how their completion will be ensured, or who will be responsible for 
making sure that these actions are completed. Also, it appears that 
HSC's determination of completeness has not been accurately applied for 
all of the action items. Several of the action items that were reported 
by the HSC as being completed were still in progress. For example, our 
June 2007 report on U.S. agencies' international efforts to forestall 
an influenza pandemic found that eight of the plan's international- 
related action items included in the HSC's progress report as completed 
either did not directly address the associated performance measure or 
did not indicate that the completion deadline had been met.[Footnote 
67] As stated earlier, we are currently assessing the implementation of 
the plan. 

We have also reported that, although DOD instituted reporting 
requirements for its components responsible for implementing 31 action 
items tasked to DOD in the National Pandemic Implementation Plan, there 
were not similar oversight mechanisms in place for pandemic-related 
tasks that were not specifically part of the National Plan.[Footnote 
68] For example, DOD did not require DOD components to report on their 
development or revision of their continuity of operations plans in 
preparation for an influenza pandemic. Over time, a lack of clear lines 
of authority, oversight mechanisms, and goals and performance measures 
could hamper the leadership's abilities to ensure that planning efforts 
across the department are progressing as intended as DOD continues its 
influenza pandemic planning and preparedness efforts. Additionally, 
without clear departmentwide goals, it would be difficult for all DOD 
components to develop effective plans and guidance. In response to our 
recommendation, DOD designated an official to lead DOD's pandemic 
efforts, established a Pandemic Influenza Task Force, and communicated 
this information throughout the department. DOD also assigned 
responsibility to the U.S. Northern Command for directing, planning, 
and synchronizing DOD's global response to an influenza pandemic and 
disseminated this information throughout the department. 

There have been some other instances where performance and 
accountability has been strengthened. The FEBs have recently 
established performance measures for their emergency support role. In 
our May 2007 report, we recommended that OPM continue its efforts to 
establish performance measures and accountability for the emergency 
support responsibilities of the FEBs before, during, and after an 
emergency event that affects the federal workforce outside Washington, 
D.C.[Footnote 69] In response to our recommendation, the FEB strategic 
plan for fiscal years 2008 through 2012 includes operational goals with 
associated measures for its emergency preparedness, security, and 
employee safety line of business. The data intended to support these 
measures include methods such as stakeholder and participant surveys, 
participant lists, and emergency preparedness test results. 

In providing funding to states and certain localities to help them to 
prepare for a pandemic, HHS has instituted a number of accountability 
requirements. As described above, HHS received $5.62 billion in 
supplemental appropriations specifically available for pandemic 
influenza-related purposes in fiscal year 2006. As shown in figure 4, a 
total of $770 million, or about 14 percent of the supplemental 
appropriations, went to states and localities for preparedness 
activities. Of the $770 million, $600 million was specifically provided 
by Congress for state and local planning and exercising. The HHS 
pandemic funding was administered by CDC and required all 50 states and 
3 localities to, among other things, develop influenza pandemic plans 
and conduct influenza pandemic exercises. According to CDC officials, 
all 50 states and the localities that received direct funding have met 
these requirements. 

Concluding Observations: 

Strengthening preparedness for large-scale public health emergencies, 
including the possibility of an influenza pandemic, is one of the 
issues that we identified as among those needing the urgent attention 
of the new administration and Congress during this transition period. 
Although much has been done, many challenges remain, as is evidenced by 
the fact that almost half of the recommendations that we have made over 
the past 3 years have still not been fully implemented. Given the 
change in administration and the associated transition of senior 
federal officials, it will be essential for this administration to 
continue to exercise and test the shared leadership roles that have 
been established between HHS and DHS, as well as the relative roles, 
responsibilities, and authorities for a pandemic among the federal 
government, state and local governments and the private sector. In the 
area of critical infrastructure protection, DHS should continue to work 
with other federal agencies and private sector members of the critical 
infrastructure coordinating councils to help address the challenges 
required to coordinate between the federal and private sectors before 
and during a pandemic. These challenges include clarifying roles and 
responsibilities of federal and state governments. DHS and HHS should 
also, in coordination with other federal agencies, continue to work 
with states and local governments to help them address identified gaps 
in their pandemic planning. To help improve international disease 
surveillance and detection efforts, the United States should continue 
to work with international organizations and other countries to help 
address gaps in available information, which limit the capacity for 
comprehensive, well-informed comparisons of risk levels by countries. 

Continued leadership focus on pandemic preparedness is particularly 
crucial now as the attention on influenza pandemic may be waning as 
attention shifts to other more immediate national priorities. In 
addition, as leadership changes across the executive branch, the new 
administration should recognize that the threat of an influenza 
pandemic remains unchanged and should therefore continue to maintain 
momentum in preparing the nation for a possible influenza pandemic. 

As agreed with your office, we plan no further distribution of this 
report until 30 days from its date, unless you publicly announce its 
contents earlier. At that time, we will send copies to other interested 
parties. In addition, this report is available at no charge on GAO's 
Web site at [hyperlink, http://www.gao.gov]. 

If you or your staff have any further questions about this report, 
please contact me at (202) 512-6543 or steinhardtb@gao.gov, or Sarah 
Veale, Assistant Director, at (202) 512-6890 or veales@gao.gov. Contact 
points for our Offices of Congressional Relations and Public Affairs 
may be found on the last page of this report. Major contributors to 
this report are listed in appendix III. 

Sincerely yours, 

Signed by: 

Bernice Steinhardt: 
Director, Strategic Issues: 

[End of section] 

Appendix I: Open Recommendations from GAO's Work on an Influenza 
Pandemic as of February 2009: 

Title and GAO product number: Influenza Pandemic: HHS Needs to Continue 
Its Actions and Finalize Guidance for Pharmaceutical Interventions, GAO-
08-671, September 30, 2008; 
Summary of open recommendations: The Secretary of Health and Human 
Services should expeditiously finalize guidance to assist state and 
local jurisdictions to determine how to effectively use limited 
supplies of antivirals and pre-pandemic vaccine in a pandemic, 
including prioritizing target groups for pre-pandemic vaccine; 
Status: In December 2008, HHS released final guidance on antiviral drug 
use during an influenza pandemic. HHS officials informed us that they 
are drafting the guidance on pre-pandemic influenza vaccination. 

Title and GAO product number: Influenza Pandemic: Federal Agencies 
Should Continue to Assist States to Address Gaps in Pandemic Planning,; 
GAO-08-539, June 19, 2008; 
Summary of open recommendations: The Secretaries of Health and Human 
Services and Homeland Security should, in coordination with other 
federal agencies, convene additional meetings of the states in the five 
federal influenza pandemic regions to help them address identified gaps 
in their planning; 
Status: HHS and DHS officials indicated that while no additional 
meetings are planned at this time, states will have to continuously 
update their pandemic plans and submit them for review. 

Title and GAO product number: Influenza Pandemic: Opportunities Exist 
to Address Critical Infrastructure Protection Challenges That Require 
Federal and Private Sector Coordination, GAO-08-36, October 31, 2007; 
Summary of open recommendations: The Secretary of Homeland Security 
should work with sector-specific agencies and lead efforts to encourage 
the government and private sector members of the councils to consider 
and help address the challenges that will require coordination between 
the federal and private sectors involved with critical infrastructure 
and within the various sectors, in advance of, as well as during, a 
pandemic; 
Status: DHS officials informed us that the department is working on 
initiatives, such as developing pandemic contingency plan guidance 
tailored to each of the critical infrastructure sectors, and holding a 
series of "webinars" with a number of the sectors. 

Title and GAO product number: Influenza Pandemic: Further Efforts Are 
Needed to Ensure Clearer Federal Leadership Roles and an Effective 
National Strategy, GAO-07-781; , August 14, 2007; 
Influenza Pandemic: Opportunities Exist to Clarify Federal Leadership 
Roles and Improve Pandemic Planning, GAO-07-1257T, September 26, 2007; 
Summary of open recommendations: (1) The Secretaries of Homeland 
Security and Health and Human Services should work together to develop 
and conduct rigorous testing, training, and exercises for an influenza 
pandemic 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. 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; 
Status: (1) HHS and DHS officials stated that several influenza 
pandemic exercises had been conducted since November 2007 that involved 
both agencies and other federal officials, but it is unclear whether 
these exercises rigorously tested federal leadership roles in a 
pandemic. 

Summary of open recommendations: (2) The Homeland Security Council 
should establish a specific process and time frame for updating the 
National Pandemic Implementation Plan. The process should involve key 
nonfederal stakeholders and incorporate lessons learned from exercises 
and other sources. The National Pandemic Implementation Plan should 
also be improved by including the following information in the next 
update: (A) resources and investments needed to complete the action 
items and where they should be targeted, (B) a process and schedule for 
monitoring and publicly reporting on progress made on completing the 
action items, (C) clearer linkages with other strategies and plans, and 
(D) clearer descriptions of relationships or priorities among action 
items and greater use of outcome-focused performance measures; 
Status: (2) HSC did not comment on the recommendation and has not 
indicated if it plans to implement it. 

Title and GAO product number: Avian Influenza: USDA Has Taken Important 
Steps to Prepare for Outbreaks, but Better Planning Could Improve 
Response, GAO-07-652, June 11, 2007; 
Summary of open recommendations: (1) The Secretaries of Agriculture and 
Homeland Security should develop a memorandum of understanding that 
describes how USDA and DHS will work together in the event of a 
declared presidential emergency or major disaster, or an Incident of 
National Significance, and test the effectiveness of this coordination 
during exercises; 
Status: (1) Both USDA and DHS officials told us that they have taken 
preliminary steps to develop additional clarity and better define their 
coordination roles. For example the two agencies meet on a regular 
basis to discuss such coordination. 

Summary of open recommendations: (2) The Secretary of Agriculture 
should, in consultation with other federal agencies, states, and the 
poultry industry identify the capabilities necessary to respond to a 
probable scenario or scenarios for an outbreak of highly pathogenic 
avian influenza. The Secretary of Agriculture should also use this 
information to develop a response plan that identifies the critical 
tasks for responding to the selected outbreak scenario and, for each 
task, identifies the responsible entities, the location of resources 
needed, time frames, and completion status. Finally, the Secretary of 
Agriculture should test these capabilities in ongoing exercises to 
identify gaps and ways to overcome those gaps; 
Status: (2) USDA officials told us that it has created a draft 
preparedness and response plan that identifies federal, state, and 
local actions, timelines, and responsibilities for responding to highly 
pathogenic avian influenza, but the plan has not been issued yet. 

Summary of open recommendations: (3) The Secretary of Agriculture 
should develop standard criteria for the components of state response 
plans for highly pathogenic avian influenza, enabling states to develop 
more complete plans and enabling USDA officials to more effectively 
review them; 
Status: (3) USDA told us that it has drafted large volumes of guidance 
documents that are available on a secure Web site. However, the 
guidance is still under review and it is not clear what standard 
criteria from these documents USDA officials and states should apply 
when developing and reviewing plans. 

Summary of open recommendations: (4) The Secretary of Agriculture 
should focus additional work with states on how to overcome potential 
problems associated with unresolved issues, such as the difficulty in 
locating backyard birds and disposing of carcasses and materials; 
Status: (4) USDA officials have told us that the agency has developed 
online tools to help states make effective decisions about carcass 
disposal. In addition, USDA has created a secure Internet site that 
contains draft guidance for disease response, including highly 
pathogenic avian influenza, and it includes a discussion about many of 
the unresolved issues. 

Summary of open recommendations: (5) The Secretary of Agriculture 
should determine the amount of antiviral medication that USDA would 
need in order to protect animal health responders, given various highly 
pathogenic avian influenza scenarios. The Secretary of Agriculture 
should also determine how to obtain and provide supplies within 24 
hours of an outbreak; 
Status: (5) USDA officials told us that the National Veterinary 
Stockpile now contains enough antiviral medication to protect 3,000 
animal health responders for 40 days. However, USDA has yet to 
determine the number of individuals that would need medicine based on a 
calculation of those exposed to the virus under a specific scenario. 
Further, USDA officials told us that a contract for additional 
medication for the stockpile has not yet been secured, which would 
better ensure that medications are available in the event of an 
outbreak of highly pathogenic avian influenza. 

Source: GAO. 

[End of table] 

[End of section] 

Appendix II: Implemented Recommendations from GAO's Work on an 
Influenza Pandemic as of February 2009: 

GAO report: Influenza Pandemic: DOD Combatant Commands' Preparedness 
Efforts Could Benefit from More Clearly Defined Roles, Resources, and 
Risk Mitigation, GAO-07-696, June 20, 2007; 
Recommendation: (1) The Secretary of Defense should instruct the 
Assistant Secretary of Defense for Homeland Defense and Americas' 
Security Affairs to issue guidance that specifies which of the tasks 
assigned to DOD in the plan and other pandemic planning tasks apply to 
the individual combatant commands, military services, and other 
organizations within DOD, as well as what constitutes fulfillment of 
these actions; 
Actions taken: (1) The 14 national implementation plan tasks assigned 
to the Joint Staff as the lead organization within DOD, which includes 
tasks to be performed by the combatant commands, have been completed. 
According to DOD, the department's Global Pandemic Influenza Planning 
Team developed recommendations for the division of responsibilities, 
which were included in U.S. Northern Command's global synchronization 
plan for pandemic influenza. Additionally, DOD assigned pandemic 
influenza- related tasks to the combatant commands in its 2008 Joint 
Strategic Capabilities Plan. 

Recommendation: (2) The Secretary of Defense should instruct the 
Assistant Secretary of Defense for Homeland Defense and Americas' 
Security Affairs to issue guidance that specifies U.S. Northern 
Command's roles and responsibilities as global synchronizer relative to 
the roles and responsibilities of the various organizations leading and 
supporting the department's influenza pandemic planning; 
Actions taken: (2) Revisions to DOD's 2008 Joint Strategic Capabilities 
Plan, as well as guidance from the Secretary of Defense during a 
periodic review of U.S. Northern Command's pandemic influenza global 
synchronization plan, clarified and better defined U.S. Northern 
Command's role as global synchronizer. 

Recommendation: (3) The Secretary of Defense should instruct the 
Assistant Secretary of Defense for Homeland Defense and Americas' 
Security Affairs to work with the Under Secretary of Defense 
(Comptroller) to identify the sources and types of resources combatant 
commands need to accomplish their influenza pandemic planning and 
preparedness activities; 
Actions taken: GAO report: (3) DOD, through U.S. Northern Command as 
the global synchronizer for pandemic influenza planning, collected 
information from the combatant commands on funding requirements related 
to pandemic influenza preparedness and submitted this information 
through DOD's formal budget and funding process. Through this process, 
five of the combatant commands (U.S. Northern Command, U.S. European 
Command, U.S. Pacific Command, U.S. Central Command, and U.S. 
Transportation Command) obtained about $25 million for fiscal years 
2009 through 2013 for pandemic influenza planning and exercises. Future 
pandemic influenza-related funding requirements will be addressed 
through DOD's established budget process. 

Recommendation: (4) The Secretary of Defense should instruct the Joint 
Staff to work with the combatant commands to develop options to 
mitigate the effects of factors that are beyond the combatant commands' 
control; 
Actions taken: (4) The combatant commands are increasingly inviting 
representatives from the United Nations, including the World Health 
Organization and the Food and Agriculture Organization; host and 
neighboring nations; and other federal government agencies to exercises 
and conferences to share information and fill information gaps. 
Additionally, U.S. Northern Command and U.S. Pacific Command, along 
with the military services and installations, are increasingly working 
and planning with state, local, and tribal representatives. DOD views 
updating and reviewing plans to ensure that they are current as a 
continuous process driven by changes in policy, science, and 
environmental factors. 

GAO report: Financial Market Preparedness: Significant Progress Has 
Been Made, but Pandemic Planning and Other Challenges Remain, GAO-07-
399, March 29, 2007; 
Recommendation: The Chairman, Federal Reserve, the Comptroller of the 
Currency, and the Chairman, Securities and Exchange Commission, should 
consider taking additional actions to ensure that market participants 
adequately prepare for an outbreak, including issuing formal 
expectations that business continuity plans for a pandemic should 
include measures likely to be effective even during severe outbreaks, 
and setting a date by which market participants should have such plans; 
Actions taken: In December 2007, the Federal Reserve, in conjunction 
with the Federal Financial Institutions Examination Council, issued an 
Interagency Statement on Pandemic Planning to each Federal Reserve Bank 
and to all banking organizations supervised by the Federal Reserve. The 
statement directed those banks to ensure the pandemic plans they have 
in place are adequate to maintain critical operations during a severe 
outbreak. In December 2007, the Office of the Comptroller of the 
Currency, in conjunction with the Federal Financial Institutions 
Examination Council, also issued an Interagency Statement on Pandemic 
Planning to the national banks, outlining the same requirements for 
pandemic plans as the guidance issued by the Federal Reserve. In July 
and August of 2007, the Securities and Exchange Commission's Market 
Regulation Division issued letters to the major clearing organizations 
and exchanges--those covered by the Commission's 2003 Policy Statement 
on Business Continuity Planning for Trading Markets--that directed 
these organizations to confirm by year-end 2007 that their pandemic 
plans are adequate to maintain critical operations during a severe 
outbreak. 

GAO report: The Federal Workforce: Additional Steps Needed to Take 
Advantage of Federal Executive Boards' Ability to Contribute to 
Emergency Operations, GAO-07-515, May 4, 2007; 
Recommendation: (1) OPM should initiate discussion with the Department 
of Homeland Security and other responsible stakeholders to consider the 
feasibility of integrating the federal executive board's (FEB) 
emergency support responsibilities into the established emergency 
response framework, such as the National Response Plan; 
Actions taken: (1) In January 2008, the FEBs were included in the 
National Response Framework section on regional support structures that 
have the potential to contribute to development of situational 
awareness during an emergency. In addition, in August 2007, the FEBs 
were integrated into the National Continuity Policy Implementation Plan 
issued by the White House Homeland Security Council. 

Recommendation: 2) OPM should continue its efforts to establish 
performance measures and accountability for the emergency support 
responsibilities of the FEBs before, during, and after an emergency 
event that affects the federal workforce outside Washington, D.C; 
Actions taken: (2) The FEB strategic plan for fiscal years 2008 through 
2012 includes operational goals with associated measures for its 
emergency preparedness, security, and employee safety line of business. 
The data intended to support these measures includes methods such as 
stakeholder and participant surveys, participant lists, and emergency 
preparedness test results. 

Recommendation: (3) OPM, as part of its strategic planning process for 
the FEBs, should develop a proposal for an alternative to the current 
voluntary contribution mechanism that would address the uncertainty of 
funding sources for the boards; 
Actions taken: (3) In November 2008, OPM submitted a legislative 
proposal to provide for interagency funding of FEB operations 
nationwide. 

Recommendation:  (4) OPM should work with FEMA to develop a memorandum 
of understanding, or some similar mechanism that formally defines the 
FEB role in emergency planning and response; 
Actions taken: (4) In addition to integrating the FEBs into national 
emergency plans, FEMA and OPM signed a memorandum of agreement on 
August 1, 2008. Among other things, the memorandum states that the 
federal executive boards and FEMA will work together in carrying out 
their respective roles in the promotion of the National Incident 
Management System and the National Response Framework. 

GAO report: Influenza Pandemic: DOD Has Taken Important Actions to 
Prepare, but Accountability, Funding, and Communications Need to be 
Clearer and Focused Departmentwide, GAO-06-1042, September 21, 2006; 
Recommendation: (1) The Secretary of Defense should instruct the 
Assistant Secretary of Defense for Homeland Defense, as the individual 
accountable for DOD's influenza pandemic planning and preparedness 
efforts, to clearly and fully define and communicate departmentwide the 
roles and responsibilities of the organizations that will be involved 
in DOD's efforts, with clear lines of authority; the oversight 
mechanisms, including reporting requirements, for all aspects of DOD's 
influenza pandemic planning efforts, to include those tasks that are 
outside of the national implementation plan; and the goals and 
performance measures for DOD's planning and preparedness efforts; 
Actions taken: (1) The Deputy Secretary of Defense verbally designated 
the Assistant Secretary of Defense for Homeland Defense, working with 
the Assistant Secretary of Defense for Health Affairs, to lead DOD's 
pandemic influenza efforts and established a Pandemic Influenza Task 
Force. This information was communicated throughout the department when 
the Principal Deputy to the Assistant Secretary of Defense for Homeland 
Defense and Americas' Security Affairs issued DOD's Implementation Plan 
for Pandemic Influenza within the department in a July 2006 memo. 
Additionally, U.S. Northern Command was designated as the lead 
combatant command for directing, planning, and synchronizing DOD's 
global response to an influenza pandemic; this information was 
disseminated throughout the department in November 2006. 

Recommendation: (2) The Secretary of Defense should instruct the 
Assistant Secretary of Defense for Homeland Defense to work with the 
Under Secretary of Defense (Comptroller) to establish a framework for 
requesting funding for the department's preparedness efforts. The 
framework should include the appropriate funding mechanism and controls 
to ensure that needed funding for DOD's influenza pandemic preparedness 
efforts is tied to the department's goals; 
Actions taken: (2) The Office of the Under Secretary of Defense 
(Comptroller) is utilizing established protocols for programming funds 
related to pandemic influenza preparedness for DOD. Funding requests 
for preparedness efforts were submitted as part of the department's 
fiscal year 2009 integrated program and budget review, and long-term 
funding requests will be included in future budget requests. 

Recommendation: (3) The Secretary of Defense should instruct the 
Assistant Secretary of Defense for Health Affairs to clarify DOD's 
guidance to explicitly define whether or how all types of personnel--
including DOD's military and civilian personnel, contractors, 
dependents, and beneficiaries--would be included in DOD's distribution 
of vaccines and antivirals, and communicate this information 
departmentwide; 
Actions taken: (3) In August 2007, DOD issued additional guidance 
related to the distribution of its vaccine and antiviral stockpiles in 
the event of an influenza pandemic. 

Recommendation: (4) The Secretary of Defense should instruct the 
Assistant Secretary of Defense for Public Affairs to implement a 
comprehensive and effective communications strategy departmentwide that 
is transparent as to what actions each group of personnel should take 
and the limitations of the efficacy, risks, and potential side effects 
of vaccines and antivirals; 
Actions taken: (4) DOD has updated its publicly available pandemic 
influenza Web site, to include links to the Military Vaccine Agency, 
which provides information on the risks and side effects of vaccines. 

Source: GAO. 

[End of table] 

[End of section] 

Appendix III: GAO Contact and Staff Acknowledgments: 

GAO Contact: 

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

Staff Acknowledgments: 

In addition to the contact named above, major contributors to this 
report include Sarah Veale, Assistant Director; Maya Chakko; Susan 
Sato; Mark Ryan; Kara Marshall; and members of GAO's Pandemic Working 
Group. 

[End of section] 

Related GAO Products: 

Veterinarian Workforce: Actions Are Needed to Ensure Sufficient 
Capacity for Protecting Public and Animal Health. [hyperlink, 
http://www.gao.gov/products/GAO-09-178]. Washington, D.C.: February 4, 
2009. 

Influenza Pandemic: HHS Needs to Continue Its Actions and Finalize 
Guidance for Pharmaceutical Interventions. [hyperlink, 
http://www.gao.gov/products/GAO-08-671]. Washington, D.C.: September 
30, 2008. 

Influenza Pandemic: Federal Agencies Should Continue to Assist States 
to Address Gaps in Pandemic Planning. GAO-08-539. Washington, D.C.: 
June 19, 2008. 

Emergency Preparedness: States Are Planning for Medical Surge, but 
Could Benefit from Shared Guidance for Allocating Scarce Medical 
Resources. [hyperlink, http://www.gao.gov/products/GAO-08-668]. 
Washington, D.C.: June 13, 2008. 

Influenza Pandemic: Efforts Under Way to Address Constraints on Using 
Antivirals and Vaccines to Forestall a Pandemic. [hyperlink, 
http://www.gao.gov/products/GAO-08-92]. Washington, D.C.: December 21, 
2007. 

Influenza Pandemic: Opportunities Exist to Address Critical 
Infrastructure Protection Challenges That Require Federal and Private 
Sector Coordination. [hyperlink, http://www.gao.gov/products/GAO-08-
36]. Washington, D.C.: October 31, 2007. 

Influenza Pandemic: Federal Executive Boards' Ability to Contribute to 
Pandemic Preparedness. [hyperlink, http://www.gao.gov/products/GAO-07-
1259T]. Washington, D.C.: September 28, 2007. 

Influenza Pandemic: Opportunities Exist to Clarify Federal Leadership 
Roles and Improve Pandemic Planning. [hyperlink, 
http://www.gao.gov/products/GAO-07-1257T]. Washington, D.C.: September 
26, 2007. 

Influenza Pandemic: Further Efforts Are Needed to Ensure Clearer 
Federal Leadership Roles and an Effective National Strategy. 
[hyperlink, http://www.gao.gov/products/GAO-07-781]. Washington, D.C.: 
August 14, 2007. 

Emergency Management Assistance Compact: Enhancing EMAC's Collaborative 
and Administrative Capacity Should Improve National Disaster Response. 
[hyperlink, http://www.gao.gov/products/GAO-07-854]. Washington, D.C.: 
June 29, 2007. 

Influenza Pandemic: DOD Combatant Commands' Preparedness Efforts Could 
Benefit from More Clearly Defined Roles, Resources, and Risk 
Mitigation. [hyperlink, http://www.gao.gov/products/GAO-07-696]. 
Washington, D.C.: June 20, 2007. 

Influenza Pandemic: Efforts to Forestall Onset Are Under Way; 
Identifying Countries at Greatest Risk Entails Challenges. [hyperlink, 
http://www.gao.gov/products/GAO-07-604]. Washington, D.C.: June 20, 
2007. 

Avian Influenza: USDA Has Taken Important Steps to Prepare for 
Outbreaks, but Better Planning Could Improve Response. [hyperlink, 
http://www.gao.gov/products/GAO-07-652]. Washington, D.C.: June 11, 
2007. 

The Federal Workforce: Additional Steps Needed to Take Advantage of 
Federal Executive Boards' Ability to Contribute to Emergency 
Operations. [hyperlink, http://www.gao.gov/products/GAO-07-515]. 
Washington, D.C.: May 4, 2007. 

Financial Market Preparedness: Significant Progress Has Been Made, but 
Pandemic Planning and Other Challenges Remain. [hyperlink, 
http://www.gao.gov/products/GAO-07-399]. Washington, D.C.: March 29, 
2007. 

Influenza Pandemic: DOD Has Taken Important Actions to Prepare, but 
Accountability, Funding, and Communications Need to be Clearer and 
Focused Departmentwide. [hyperlink, http://www.gao.gov/products/GAO-06-
1042]. Washington, D.C.: September 21, 2006. 

Catastrophic Disasters: Enhanced Leadership, Capabilities, and 
Accountability Controls Will Improve the Effectiveness of the Nation's 
Preparedness, Response, and Recovery System. [hyperlink, 
http://www.gao.gov/products/GAO-06-618]. Washington, D.C.: September 6, 
2006. 

Footnotes: 

[1] GAO's 2009 Congressional and Presidential Transition Web site: 
http://www.gao.gov/transition_2009. 

[2] House Committee on Homeland Security,Getting Beyond Getting Ready 
for Pandemic Influenza, a report prepared by the majority staff, 111th 
Cong., 1st sess., January 2009. 

[3] Issued in January 2008 by the Department of Homeland Security (DHS) 
and effective in March 2008, the NRF is a guide to how the nation 
conducts all-hazards incident response and replaces the National 
Response Plan. It focuses on how the federal government is organized to 
support communities and states in catastrophic incidents. The NRF 
builds upon the National Incident Management System, which provides a 
national template for managing incidents. 

[4] Antivirals can prevent or reduce the severity of a viral infection, 
such as influenza. Vaccines are used to stimulate the production of an 
immune system response to protect the body from disease. 

[5] The six characteristics of an effective national strategy include: 
(1) purpose, scope, and methodology, (2) problem definition and risk 
assessment, (3) goals, subordinate objectives, activities, and 
performance measures, (4) resources, investments, and risk management, 
(5) organizational roles, responsibilities, and coordination, and (6) 
integration and implementation. 

[6] Avian influenza viruses are classified as either "low pathogenic" 
or "highly pathogenic" based on their genetic features and the severity 
of the disease they cause in poultry. Highly pathogenic avian influenza 
viruses are associated with high morbidity and mortality in poultry. 
Health experts are concerned that should highly pathogenic H5N1 or 
another subtype, to which humans have no immunity, develop the capacity 
to spread easily from person to person, an influenza pandemic could 
occur in humans. 

[7] GAO, Influenza Pandemic: Further Efforts Are Needed to Ensure 
Clearer Federal Leadership Roles and an Effective National Strategy, 
[hyperlink, http://www.gao.gov/products/GAO-07-781] (Washington, D.C.: 
August 14, 2007). 

[8] Congressional Budget Office, A Potential Influenza Pandemic: 
Possible Macroeconomic Effects and Policy Issues (Washington, D.C., 
December 8, 2005; rev. July 27, 2006). 

[9] Congressional Budget Office, A Potential Influenza Pandemic: An 
Update on Possible Macroeconomic Effects and Policy Issues (Washington, 
D.C., May 22, 2006; rev. July 27, 2006). 

[10] Andrew Burns, Dominique van der Mensbrugghe, and Hans Timmer, 
Evaluating the Economic Consequences of Avian Influenza (Washington 
D.C.: World Bank, September 2008). 

[11] GAO, Hurricane Katrina: GAO's Preliminary Observations Regarding 
Preparedness, Response, and Recovery, [hyperlink, 
http://www.gao.gov/products/GAO-06-442T] (Washington, D.C.: Mar. 8, 
2006). 

[12] GAO, Influenza Pandemic: Opportunities Exist to Clarify Federal 
Leadership Roles and Improve Pandemic Planning, [hyperlink, 
http://www.gao.gov/products/GAO-07-1257T] (Washington, D.C.: Sept. 26, 
2007). 

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

[14] GAO, Homeland Security: Observations on DHS and FEMA Efforts to 
Prepare for and Respond to Major and Catastrophic Disasters and Address 
Related Recommendations and Legislation, [hyperlink, 
http://www.gao.gov/products/GAO-07-1142T] (Washington, D.C.: July 31, 
2007). 

[15] [hyperlink, http://www.gao.gov/products/GAO-07-781]. 

[16] GAO, Avian Influenza: USDA Has Taken Important Steps to Prepare 
for Outbreaks, but Better Planning Could Improve Response, [hyperlink, 
http://www.gao.gov/products/GAO-07-652] (Washington, D.C.: June 11, 
2007). 

[17] GAO, Influenza Pandemic: DOD Has Taken Important Actions to 
Prepare, but Accountability, Funding, and Communications Need to be 
Clearer and Focused Departmentwide, [hyperlink, 
http://www.gao.gov/products/GAO-06-1042] (Washington, D.C.: Sept, 21, 
2006); and GAO, Influenza Pandemic: DOD Combatant Command's 
Preparedness Efforts Could Benefit from More Clearly Defined Roles, 
Resources, and Risk Mitigation, [hyperlink, 
http://www.gao.gov/products/GAO-07-696] (Washington, D.C.: June 20, 
2007). 

[18] As operational commanders, DOD's unified combatant commands are an 
essential part of the department's influenza pandemic planning. There 
are currently nine combatant commands--five with geographical 
responsibilities and four with functional responsibilities. A sixth 
geographical combatant command--the U.S. Africa Command--became 
operational in October 2008. 

[19] GAO, Influenza Pandemic: Opportunities Exist to Address Critical 
Infrastructure Protection Challenges That Require Federal and Private 
Sector Coordination, [hyperlink, http://www.gao.gov/products/GAO-08-36] 
(Washington, D.C.: Oct. 31, 2007). 

[20] The 18 critical infrastructure and key resource sectors are: food 
and agriculture; banking and finance; chemical; commercial facilities; 
commercial nuclear reactors, materials, and water; dams; defense 
industrial base; drinking water and water treatment systems; emergency 
services; energy; governmental facilities; information technology; 
national monuments and icons; postal and shipping; public health and 
healthcare; telecommunications; transportation systems; and critical 
manufacturing. Critical infrastructure are systems and assets, whether 
physical or virtual, so vital to the United States that their 
incapacity or destruction would have a debilitating effect on national 
security, national economic security, and national public health or 
safety, or any combination of those matters. Key resources are publicly 
or privately controlled resources essential to minimal operations of 
the economy or government, including individual targets whose 
destruction would not endanger vital systems but could create a local 
disaster or profoundly damage the nation's morale or confidence. 

[21] [hyperlink, http://www.gao.gov/products/GAO-08-36]. 

[22] [hyperlink, http://www.gao.gov/products/GAO-08-36]. 

[23] GAO, The Federal Workforce: Additional Steps Needed to Take 
Advantage of Federal Executive Boards' Ability to Contribute to 
Emergency Operations, [hyperlink, http://www.gao.gov/products/GAO-07-
515] (Washington, D.C.: May 4, 2007). 

[24] GAO, Emerging Infectious Diseases: Review of State and Federal 
Disease Surveillance Efforts, [hyperlink, 
http://www.gao.gov/products/GAO-04-877] (Washington, D.C.: Sept. 30, 
2004) and GAO, Information Technology: Federal Agencies Face Challenges 
in Implementing Initiatives to Improve Public Health Infrastructure, 
[hyperlink, http://www.gao.gov/products/GAO-05-308] (Washington, D.C.: 
June 10, 2005). 

[25] GAO, Influenza Pandemic: Efforts Under Way to Address Constraints 
on Using Antivirals and Vaccines to Forestall a Pandemic, [hyperlink, 
http://www.gao.gov/products/GAO-08-92] (Washington, D.C.: Dec. 21, 
2007). 

[26] [hyperlink, http://www.gao.gov/products/GAO-07-652]. 

[27] [hyperlink, http://www.gao.gov/products/GAO-08-92]. 

[28] United Nations System Influenza Coordinator and the World Bank, 
Responses to Avian Influenza and State of Pandemic Readiness, Fourth 
Global Progress Report, (New York, N.Y., and Washington, D.C., October 
2008). 

[29] Of the 178 countries that UNSIC surveyed, 148 of those surveyed 
responded to the entire survey for an overall response rate of 
approximately 83 percent, whereas 30 of those surveyed did not respond. 
105 countries, or 75 percent of 140 respondents addressing surveillance 
systems, reported having an operational surveillance system capable of 
detecting highly pathogenic avian influenza. 

[30] GAO, Influenza Pandemic: Efforts to Forestall Onset Are Under Way; 
Identifying Countries at Greatest Risk Entails Challenges, [hyperlink, 
http://www.gao.gov/products/GAO-07-604] (Washington, D.C.: June 20, 
2007). 

[31] Of the 178 countries that UNSIC surveyed, 148 of those surveyed 
responded to the entire survey for an overall response rate of 
approximately 83 percent, whereas 30 of those surveyed did not respond. 
95 countries, or approximately 68 percent of 139 respondents addressing 
surveillance systems, had actually conducted a risk assessment. 

[32] [hyperlink, http://www.gao.gov/products/GAO-07-604]. 

[33] GAO, Catastrophic Disasters: Enhanced Leadership, Capabilities, 
and Accountability Controls Will Improve the Effectiveness of the 
Nation's Preparedness, Response, and Recovery System, [hyperlink, 
http://www.gao.gov/products/GAO-06-618] (Washington, D.C.: Sept 6, 
2006). 

[34] Interministerial Influenza Commission, Belgian pandemic flu 
preparedness plan, Version 1 (Belgium: July 2006). 

[35] Inter-ministerial Avian Influenza Committee, Pandemic Influenza 
Preparedness Action Plan of the Japanese Government (Japan: rev. 
October 2007). 

[36] Riksrevisionen, Swedish National Audit Office, Pandemics-- 
Managing Threats to Human Health (Sweden: February 2008). 

[37] United Kingdom Cabinet Office, National Risk Register (London, 
U.K.: 2008). 

[38] Of the 178 countries that UNSIC surveyed, 148 of those surveyed 
responded to the entire survey for an overall response rate of 
approximately 83 percent, whereas 30 of those surveyed did not respond. 
Of 145 respondents addressing pandemic planning 141 countries, or 97 
percent, said that they had a pandemic plan in place. Four respondents 
from Africa indicated that they did not have a pandemic plan. 

[39] A comparison of countries that replied to UNSIC's surveys in 2007 
and 2008 showed that 34 of 69 respondents reported having conducted a 
simulation in 2008 that had not done so in 2007. 

[40] The six characteristics of an effective national strategy include: 
(1) purpose, scope, and methodology, (2) problem definition and risk 
assessment, (3) goals, subordinate objectives, activities, and 
performance measures, (4) resources, investments, and risk management, 
(5) organizational roles, responsibilities, and coordination, and (6) 
integration and implementation. GAO, Combating Terrorism: Evaluation of 
Selected Characteristics in National Strategies Related to Terrorism, 
[hyperlink, http://www.gao.gov/products/GAO-04-408T] (Washington, D.C.: 
Feb. 3, 2004). 

[41] We conducted site visits to the five most populous states 
including California, Florida, Illinois, New York, and Texas for a 
number of reasons, including that these states constituted over one- 
third of the United States population, received over one-third of the 
total funding from HHS and DHS that could be used for planning and 
exercising efforts, and were likely entry points for individuals coming 
from another country given that the states either bordered Mexico or 
Canada or contained major ports, or both. Within each state, we also 
interviewed officials at 10 localities, which consisted of five urban 
areas and five rural counties. 

[42] Departments of Health and Human Services and Homeland Security and 
other agencies, Assessment of States' Operating Plans to Combat 
Pandemic Influenza: Report to Homeland Security Council, (Washington, 
D.C.: January 2009). 

[43] City Auditor's Office, City of Kansas City, Missouri, Performance 
Audit: Pandemic Flu Preparedness (October 2007). 

[44] National Governors Association Center for Best Practices, Issue 
Brief: Pandemic Preparedness in the States--An Assessment of Progress 
and Opportunity (September 2008). 

[45] GAO, Financial Market Preparedness: Significant Progress Has Been 
Made, but Pandemic Planning and Other Challenges Remain, [hyperlink, 
http://www.gao.gov/products/GAO-07-399] (Washington, D.C.: March 29, 
2007). 

[46] A standard of care is the diagnostic and treatment process that a 
provider should follow for a certain type of patient or illness, or 
certain clinical circumstances. It is how similarly qualified health 
care providers would manage the patient's care under the same or 
similar circumstances. 

[47] GAO, Emergency Management Assistance Compact: Enhancing EMAC's 
Collaborative and Administrative Capacity Should Improve National 
Disaster Response, [hyperlink, http://www.gao.gov/products/GAO-07-854] 
(Washington, D.C.: June 29, 2007). 

[48] GAO, Influenza Pandemic: HHS Needs to Continue Its Actions and 
Finalize Guidance for Pharmaceutical Interventions, [hyperlink, 
http://www.gao.gov/products/GAO-08-671] (Washington, D.C.: Sept. 30, 
2008). 

[49] GAO, Emergency Preparedness: States Are Planning for Medical 
Surge, but Could Benefit from Shared Guidance for Allocating Scarce 
Medical Resources, [hyperlink, http://www.gao.gov/products/GAO-08-668] 
(Washington, D.C.: June 13, 2008). 

[50] [hyperlink, http://www.gao.gov/products/GAO-08-668]. 

[51] [hyperlink, http://www.gao.gov/products/GAO-08-539]. 

[52] Department of Health and Human Services, Pandemic Influenza 
Implementation Plan (November 2006). 

[53] [hyperlink, http://www.gao.gov/products/GAO-08-92]. 

[54] Congressional Budget Office, U.S. Policy Regarding Pandemic- 
Influenza Vaccines (Washington, D.C.: September 2008). 

[55] [hyperlink, http://www.gao.gov/products/GAO-08-671]. 

[56] The standard egg-based technology is essentially the same, whether 
producing seasonal or influenza pandemic vaccines. However, with egg- 
based technology, an influenza pandemic vaccine would require at least 
6 months to produce. 

[57] Cell-based vaccines hold the potential to shorten the time between 
the identification of a pandemic virus and full-scale production of the 
vaccine for the U.S. population. In place of eggs, cell-based vaccine 
production uses laboratory-grown cell lines that can host a growing 
virus. 

[58] HHS, Pandemic Planning Update VI: A Report from Secretary Michael 
O. Leavitt, (Washington, D.C.: Jan. 8, 2009). 

[59] Congressional Budget Office, U.S. Policy Regarding Pandemic- 
Influenza Vaccines. 

[60] HHS has launched studies to determine how long the stockpiled pre- 
pandemic vaccines remain safe and effective, but in the meanwhile it 
assumes a 2-year shelf life. 

[61] HHS, Guidance on Antiviral Drug Use during an Influenza Pandemic 
(Washington, D.C.: Dec. 16, 2008). 

[62] [hyperlink, http://www.gao.gov/products/GAO-07-652]. 

[63] GAO, Highlights of a Forum: Strengthening the Use of Risk 
Management Principles in Homeland Security, [hyperlink, 
http://www.gao.gov/products/GAO-08-627SP] (Washington, D.C.: April 
2008). 

[64] GAO, Influenza Vaccine: Shortages in 2004-05 Season Underscore 
Need for Better Preparation, [hyperlink, 
http://www.gao.gov/products/GAO-05-984] (Washington, D.C.: Sept. 30, 
2005). 

[65] GAO, Medical Readiness: DOD Continues to Face Challenges in 
Implementing Its Anthrax Vaccine Immunization Program, [hyperlink, 
http://www.gao.gov/products/GAO/T-NSIAD-00-157] (Washington, D.C.: Apr. 
13, 2000). 

[66] Department of Health and Human Services and Department of Homeland 
Security, Guidance on Allocating and Targeting Pandemic Influenza 
Vaccine (July 23, 2008) and Department of Health and Human Services and 
Centers for Disease Control and Prevention, Interim Pre-Pandemic 
Planning Guidance: Community Strategy for Pandemic Influenza Mitigation 
in the United States (February 2007). 

[67] [hyperlink, http://www.gao.gov/products/GAO-07-604]. 

[68] [hyperlink, http://www.gao.gov/products/GAO-06-1042]. 

[69] [hyperlink, http://www.gao.gov/products/GAO-07-515]. 

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