[House Hearing, 111 Congress]
[From the U.S. Government Publishing Office]



   BEYOND READINESS: AN EXAMINATION OF THE CURRENT STATUS AND FUTURE 
             OUTLOOK OF THE NATIONAL RESPONSE TO PANDEMIC 
                               INFLUENZA

=======================================================================

                                HEARING

                     COMMITTEE ON HOMELAND SECURITY

                        HOUSE OF REPRESENTATIVES

                     ONE HUNDRED ELEVENTH CONGRESS

                             FIRST SESSION

                               __________

                             JULY 29, 2009

                               __________

                           Serial No. 111-32

                               __________

       Printed for the use of the Committee on Homeland Security

                                     

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  Available via the World Wide Web: http://www.gpoaccess.gov/congress/
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                     COMMITTEE ON HOMELAND SECURITY

               Bennie G. Thompson, Mississippi, Chairman
Loretta Sanchez, California          Peter T. King, New York
Jane Harman, California              Lamar Smith, Texas
Peter A. DeFazio, Oregon             Mark E. Souder, Indiana
Eleanor Holmes Norton, District of   Daniel E. Lungren, California
    Columbia                         Mike Rogers, Alabama
Zoe Lofgren, California              Michael T. McCaul, Texas
Sheila Jackson Lee, Texas            Charles W. Dent, Pennsylvania
Henry Cuellar, Texas                 Gus M. Bilirakis, Florida
Christopher P. Carney, Pennsylvania  Paul C. Broun, Georgia
Yvette D. Clarke, New York           Candice S. Miller, Michigan
Laura Richardson, California         Pete Olson, Texas
Ann Kirkpatrick, Arizona             Anh ``Joseph'' Cao, Louisiana
Ben Ray Lujan, New Mexico            Steve Austria, Ohio
Bill Pascrell, Jr., New Jersey
Emanuel Cleaver, Missouri
Al Green, Texas
James A. Himes, Connecticut
Mary Jo Kilroy, Ohio
Eric J.J. Massa, New York
Dina Titus, Nevada
Vacancy
                    I. Lanier Avant, Staff Director
                     Rosaline Cohen, Chief Counsel
                     Michael Twinchek, Chief Clerk
                Robert O'Connor, Minority Staff Director








                            C O N T E N T S

                              ----------                              
                                                                   Page

                               STATEMENTS

The Honorable Bennie G. Thompson, a Representative in Congress 
  From the State of Mississippi, and Chairman, Committee on 
  Homeland Security:
  Oral Statement.................................................     1
  Prepared Statement.............................................     2
The Honorable Peter T. King, a Representative in Congress From 
  the State of New York, and Ranking Member, Committee on 
  Homeland Security:
  Oral Statement.................................................     3
The Honorable Paul C. Broun, a Representative in Congress From 
  the State of Georgia:
  Prepared Statement.............................................     3
The Honorable Stephen F. Lynch, a Representative in Congress From 
  the State of Massachusetts:
  Prepared Statement.............................................     4

                               WITNESSES
                                Panel I

Ms. Jane Holl Lute, Deputy Secretary, Department of Homeland 
  Security:
  Oral Statement.................................................     5
  Prepared Statement.............................................     7
Mr. William Corr, Deputy Secretary, Department of Health and 
  Human Services:
  Oral Statement.................................................    10
  Prepared Statement.............................................    12
Ms. Bernice Steinhardt, Director, Strategic Issues, Government 
  Accountability Office:
  Oral Statement.................................................    16
  Prepared Statement.............................................    17

                                Panel II

Ms. Colleen M. Kelley, President, National Treasury Employees 
  Union:
  Oral Statement.................................................    46
  Prepared Statement.............................................    48
Mr. Richard G. Muth, Executive Director, Maryland Emergency 
  Management Agency:
  Oral Statement.................................................    51
  Prepared Statement.............................................    54
Dr. Mark B. Horton, M.D., M.S.P.H., Director, California 
  Department of Public Health, and State Health Officer:
  Oral Statement.................................................    60
  Prepared Statement.............................................    62
Dr. Thomas A. Farley, M.D., New York City Department of Health 
  and Mental Hygiene:
  Oral Statement.................................................    68
  Prepared Statement.............................................    70

                                APPENDIX

Questions From Chairman Bennie G. Thompson of Mississippi for Ms. 
  Jane Holl Lute, Deputy Secretary, Department of Homeland 
  Security.......................................................    85
Questions From Chairman Bennie G. Thompson of Mississippi for 
  William Corr, Deputy Secretary, Department of Health and Human 
  Services.......................................................    98
Questions From Ranking Member Peter T. King of New York for 
  William Corr, Deputy Secretary, Department of Health and Human 
  Services.......................................................   101
Questions From the Honorable Michael T. McCaul of Texas for 
  William Corr, Deputy Secretary, Department of Health and Human 
  Services.......................................................   101
Questions From Chairman Bennie G. Thompson of Mississippi for Ms. 
  Bernice Steinhardt, Director, Strategic Issues, Government 
  Accountability Office..........................................   102
Questions From Ranking Member Peter T. King of New York for Ms. 
  Bernice Steinhardt, Director, Strategic Issues, Government 
  Accountability Office..........................................   102
Question From Chairman Bennie G. Thompson of Mississippi for Ms. 
  Colleen M. Kelley, National President, National Treasury 
  Employees Union................................................   103
Questions From Chairman Bennie G. Thompson of Mississippi for Mr. 
  Richard G. Muth, Executive Director, Maryland Emergency 
  Management Agency..............................................   103
Questions From Chairman Bennie G. Thompson of Mississippi for Dr. 
  Mark B. Horton, Director, California Department of Public 
  Health.........................................................   103
Questions From Chairman Bennie G. Thompson of Mississippi for Dr. 
  Thomas A. Farley, New York City Department of Health and Mental 
  Hygiene........................................................   104

 
   BEYOND READINESS: AN EXAMINATION OF THE CURRENT STATUS AND FUTURE 
         OUTLOOK OF THE NATIONAL RESPONSE TO PANDEMIC INFLUENZA

                              ----------                              


                        Wednesday, July 29, 2009

                     U.S. House of Representatives,
                            Committee on Homeland Security,
                                                    Washington, DC.
    The committee met, pursuant to call, at 2:00 p.m., in Room 
311, Cannon House Office Building, Hon. Bennie G. Thompson 
[Chairman of the committee] presiding.
    Present: Representatives Thompson, Harman, Jackson Lee, 
Cuellar, Carney, Richardson, Kirkpatrick, Lujan, Pascrell, 
Cleaver, Green, Himes, King, Rogers, McCaul, Dent, Bilirakis, 
Olson, and Cao.
    Chairman Thompson. The committee on Homeland Security will 
come to order.
    As a matter of housekeeping, our reporter is in a building 
where a suspicious package has been identified and security 
will not let anyone out of the building. But they are watching 
us on an in-house station doing the reporting and unless they 
have to evacuate the building, rest assured, a transcript of 
this hearing will take place. But you can understand the 
sensitivity of the security, and that is why our recorder is 
not present at this point. However, as indicated, we will 
continue with the hearing.
    The committee is meeting today to receive testimony on 
``Beyond Readiness: An Examination of the Current Status and 
Future Outlook of the National Response to Pandemic 
Influenza.''
    I would like to thank our witnesses for appearing before us 
today. Today's hearing will review this Nation's state of 
preparedness for an influenza pandemic.
    In April 2009, the Centers for Disease Control and 
Prevention reported two cases of respiratory illness in 
children caused by a virus. Those two cases, which occurred 
less that 4 months ago, were the first confirmed instances of 
H1N1 flu within the United States.
    By late June, U.S. health officials estimated that there 
had been more than 1 million infections in the United States. 
According to the World Health Organization, this virus is 
travelling the world with unprecedented speed. There have been 
confirmed cases on every continent except Antarctica. While 
this may be troubling, there is no need to panic in the face of 
this pandemic.
    So far, the disease has been mild in most people and 
treatments are available. But many scientists and public health 
officials are predicting that the virus will surge in the fall. 
It is that resurgence which we must be ready to meet. The 
Centers for Disease Control and Prevention estimates that as 
many as 40 percent of the U.S. population could become infected 
with H1N1 over the next 2 years.
    The good news is that a vaccine is currently under 
development, and over the last 4 years, Congress has provided 
approximately $8.6 billion for pandemic planning efforts. But 
unfortunately, despite this amount of funding, according to GAO 
there are still major gaps in pandemic planning and 
preparedness efforts. Among the major gaps is the failure to 
plan for additional bed space and medical supplies.
    Additionally, GAO determined that leadership roles and 
responsibilities for an influenza pandemic need to be further 
clarified, tested, and exercised. Given this country's recent 
experience with disasters, it is hard to believe that there are 
those who underestimate the importance of plans and drills. Our 
children are taught in school what to do in a fire drill. They 
are not taught to wait until a fire starts, yell instructions, 
and hope everybody makes it to the exit. We teach them that 
planning and practice increases their chance of survival. That 
elementary school lesson still applies.
    Finally, we need to understand that the emergency 
preparedness and response community and the health care 
community have always shared resources during crises and 
disasters. These formal and informal partnerships may be 
strained during a pandemic. Increased drills and exercises will 
strengthen these relationships, decrease uncertainty, and 
improve response and recovery.
    I want to thank our witnesses and look forward to their 
testimony today. The Chair now recognizes the Ranking Member of 
the full committee, the gentleman from New York, Mr. King, for 
an opening statement.
    [The statement of Chairman Thompson follows:]
           Prepared Statement of Chairman Bennie G. Thompson
                             July 29, 2009
    In April 2009, the Centers for Disease Control and Prevention (CDC) 
reported two cases of respiratory illness in children caused by a 
virus. Those two cases, which occurred less than 4 months ago, were the 
first confirmed instances of H1N1 flu within the United States. By late 
June, U.S. health officials estimated that there had been more than 1 
million infections in the United States.
    According to the World Health Organization, this virus is 
travelling the world with ``unprecedented speed''. There have been 
confirmed cases on every continent except Antarctica.
    And while this may be troubling, there is no need to panic in the 
face of this pandemic. So far, the disease has been mild in most people 
and treatments are available. But many scientists and public health 
officials are predicting that the virus will resurge in the fall. And 
it is that resurgence which we must be ready to meet.
    The Centers for Disease Control and Prevention estimates that as 
many as 40 percent of the U.S. population could become infected with 
H1N1 over the next 2 years. The good news is that a vaccine is 
currently under development and over the last 4 years Congress has 
provided approximately $8.6 billion for pandemic planning efforts. But 
unfortunately, despite this amount of funding, according to GAO there 
are still major gaps in pandemic planning and preparedness efforts.
    Among the major gaps, is the failure to plan for additional bed 
space and medical supplies. Additionally, GAO determined that 
leadership roles and responsibilities for an influenza pandemic need to 
be further clarified, tested, and exercised. Given this country`s 
recent experience with disasters, it is hard to believe that there are 
those who underestimate the importance of plans and drills.
    Our children are taught in school what to do in a fire drill. They 
are not taught to wait until a fire starts, yell instructions, and hope 
everybody makes it to the exit. We teach them that planning and 
practice increases their chance of survival. That elementary school 
lesson still applies. Finally, we need to understand that the emergency 
preparedness and response community and the health care community have 
always shared resources during crises and disasters. These formal and 
informal partnerships may be strained during a pandemic.
    Increased drills and exercises will strengthen these relationships, 
decrease uncertainty, and improve response and recovery.

    Mr. King. Thank you, Mr. Chairman. Thank you for holding 
this hearing. As you indicated, this is a very serious issue.
    Apparently, the consensus is that the H1N1 flu is going to 
return, and possibly it could be more severe than the first go-
around. I don't have a very long opening statement, but one, I 
would like to acknowledge the presence of Dr. Tom Farley, who 
is the newly-appointed commissioner of the New York City Health 
Department and congratulate him for the job he has done in less 
than 2 months, coming in right at the peak of the flu season in 
New York.
    I also would like to stress some questions I will be asking 
during the question-and-answer session.
    One is on the issue of the vaccine. I met with Secretary 
Lute the other day on this as to what the prospects are for 
having a vaccine. Almost as importantly is the educational 
process that will go to the public. Already there are rumors 
going around that the vaccine could be more harmful and that it 
is dangerous to kids, and what is going to be done to stop 
those rumors when they start and what can be done to convince 
the public that, in fact, this vaccine is expected to work and 
certainly will not be dangerous, especially to young children.
    Also, the issue, since DHS is obviously a new Department, 
and as far as I know, this is the first health crisis that has 
affected the country since DHS was started. Secretary Lute, 
have you looked back to see lessons learned, how effective the 
Department was, how close the coordination was with HHS, 
whether or not it was synchronized, and what, if any, 
improvements are necessary for the future. Also on the issue 
for our employees, TSA, CBP in particular, and what will be 
done to protect them as they are doing their job. What are the 
appropriate procedures for them?
    With that, I look forward to the testimony, Mr. Chairman. 
Thank you for the hearing.
    Chairman Thompson. Thank you.
    Other Members of the committee are reminded that under 
committee rules, opening statements may be submitted for the 
record.
    [The statement of Hon. Broun follows:]
           Prepared Statement of the Honorable Paul C. Broun
                             July 29, 2009
    Thank you, Mr. Chairman.
    I'd like to welcome our witnesses here today. I'm pleased the 
committee is meeting to review and assess the status of H1N1 readiness 
efforts to prepare for and respond to pandemic influenza.
    As a doctor, I am particularly troubled with the Federal 
Government's lack of concern for the protection of Federal employees' 
health. I'm sure that you know that I offered amendment earlier this 
year that would have allowed any TSA employee to wear a protective 
facemask in the event of a pandemic or public health emergency. I was 
disappointed that this important amendment was defeated on a party line 
vote.
    I am particularly concerned by what seems to be a lack of progress 
in this area, due in part because of the defeat of my amendment. I 
believe that it is absolutely essential that the employees on the front 
lines be able to protect themselves by taking extra precautions if they 
feel it is in the best interest of their personal health. The 
Department needs to adopt a policy immediately to permit its employees 
to take precautionary measures to protect their own health.
    I am specifically interested in hearing our witnesses' thoughts on 
protective equipment measures such as face masks, and what the strategy 
is to protect screeners and other personnel at the border and around 
the country. I'd like to quote my colleague Congressman Stephen Lynch 
who said, ``In my opinion it is unconscionable that our workers have 
been denied the use of certain PPE [personal protective equipment] 
items--such as N-95 and surgical masks, gloves, and hand sanitizer--and 
even threatened for attempting to protect themselves from a 
communicable disease.''
    I hope our witnesses can convince my colleagues of the importance 
and seriousness of this issue and that we can work together in a 
bipartisan manner to fix it soon.
    Thank you, Mr. Chairman. I yield back the balance of my time.

    Chairman Thompson. Without objection, a statement provided 
to the committee by Representative Lynch of Massachusetts 
addressing the subject matter covered by today's hearing will 
be inserted into the record at the appropriate point.
    [The statement of Hon. Lynch follows:]
          Prepared Statement of the Honorable Stephen F. Lynch
                             July 30, 2009
    I'd like to thank Chairman Thompson for allowing me to submit a 
statement for the record for today's hearing.
    As Chair of the House's Federal Workforce Subcommittee, I have 
monitored closely the Department of Homeland Security's (DHS) response 
to the outbreak of the H1N1 virus. DHS employs approximately 225,000 
Federal workers who are charged with the tremendous job of keeping the 
American public safe, including 52,000 Customs and Border Patrol (CBP) 
employees, 50,000 Transportation Security Administration (TSA) 
employees, and 17,200 Immigration and Customs Enforcement (ICE) 
employees. I feel it is my responsibility to ensure the health and 
safety of these Federal employees--especially those on the front-line.
    In addition to the on-going emergency preparedness efforts to 
secure the public's safety, it is essential that Federal agencies 
implement adequate and uniform worker policies that protect the very 
employees who will be called upon to respond in the event of an 
emergency. Without such policies, not only is the health of front-line 
employees being put at risk, but the health of their families and the 
general welfare of the public are also placed at risk. In short, the 
Federal Government cannot ably respond to emergencies if the very 
personnel needed as part of that response are themselves compromised.
    I have been troubled by the apparent reluctance on the part of DHS 
to address the voluntary use of personal protective equipment (PPE) 
amidst the H1N1 flu outbreak. In my opinion it is unconscionable that 
our workers have been denied the use of certain PPE items--such as N-95 
and surgical masks, gloves, and hand sanitizer--and even threatened for 
attempting to protect themselves from a communicable disease. Further, 
it is alarming that DHS has not yet distributed written guidance on the 
voluntary usage of protective gear to its own employees during a public 
health emergency.
    These front-line Federal workers--many of whom work well within 6 
feet of individuals who could be known or suspected to have the H1N1 
virus--deserve to be reassured that their employer--which in this case 
is the Federal Government--has done everything possible to guarantee 
their health while on the job.
    Mr. Chairman, I thank you for holding this timely hearing, and look 
forward to working with you to ensure that our Federal workforce's 
needs are addressed as our Government prepares for the possibility of a 
larger influenza outbreak this fall and winter.

    Chairman Thompson. I welcome our first panel of witnesses. 
Our first witness is Dr. Jane Holl Lute, Deputy Secretary of 
the Department of Homeland Security. As Deputy Secretary, she 
is responsible for the operation of our newest Federal 
department and the operational coordination of Federal, non-
Federal, and private sector agencies when the Nation is 
confronted with events that threaten our homeland. She was 
confirmed by the Senate in January 2009 and brings to the 
Department over 30 years of military and senior executive 
experience in the U.S. Government.
    Welcome, Dr. Lute.
    Our second witness is Mr. William Corr, the Deputy 
Secretary of the Department of Health and Human Services. As 
Deputy Secretary, he is responsible for the operations of the 
largest civilian department in the Federal Government. Mr. Corr 
has extensive management and health care policy experience, 
including work for Congress. I welcome him back to the Hill 
today.
    Our third witness is Ms. Bernice Steinhardt, Director of 
Strategic Issues at the Government Accountability Office. She 
has studied a number of different health policies and strategic 
issues, and has been responsible for producing many of the 
reports about pandemic influenza and related issues for our 
committee.
    We thank all of you for being our witnesses and for your 
service to the Nation and for being here today.
    Without objection, the witness' full statements will be 
inserted in the record. I now ask each witness to summarize 
their statement for 5 minutes beginning with Secretary Lute.

 STATEMENT OF JANE HOLL LUTE, DEPUTY SECRETARY, DEPARTMENT OF 
                       HOMELAND SECURITY

    Ms. Lute. Mr. Chairman, Ranking Member King, distinguished 
Members of the committee, it is an honor to appear before you 
this afternoon with my colleagues to discuss the Department of 
Homeland Security's preparation for a possible resurgence of 
H1N1 this fall.
    I have to say it is nice to appear before Congress to 
discuss something other than myself. As fun as that 
confirmation process was, I am happier to be on these sides of 
the issue.
    In the months since I have been in office, it has been 
readily apparent how important the relationship between this 
committee and the Department of Homeland Security is. Like all 
important relationships, we won't always get it quite right. 
But, Mr. Chairman and Ranking Member King, Members of the 
committee, I hope you all know that Secretary Napolitano and I 
are committed to collaborating with you as we work to make the 
United States of America a safer place. We want and need your 
support, your ideas, your direction, and the American people 
deserve your oversight.
    While I recognize that this proceeding is focused on H1N1, 
I think it is important to contextualize H1N1 within the 
spectrum of threats that Department of Homeland Security 
negotiates and navigates every day.
    Secretary Napolitano and I often think about our jobs in 
the context of managing the supply chain of trouble. Now, I am 
sure there is a more sophisticated way to express it, but I am 
from New York, so it seems to be a vivid representation of the 
challenges we face. Trouble, it will come as no surprise to 
this committee, comes in many forms; whether it is a time bomb, 
or tornado, a computer virus created by man, or a pandemic 
virus created by Mother Nature. Trouble has suppliers, 
facilitators, purchasers, producers, distributors, and 
customers. These perilous products move through multiple 
channels before they reach our shore, and it is the job of the 
Department of Homeland Security to understand the supply chain 
of trouble and identify opportunities along the way to gather 
information, intelligence, interdict, redirect, and stop 
trouble before it reaches our shores and our communities, and 
to do this in a way that is not only consistent with but that 
honors our cherished principles of civil rights, executive 
authority, and the important laws that guide our privacy and 
liberty.
    Just as threats have multiplied and evolved, the Department 
of Homeland Security's mission to lead the American effort to 
protect itself must adapt to the new supply chains of trouble 
that deliver, not just bombs and bullets, but botnets, and now 
we know, pandemics.
    Nontraditional threats like H1N1 cannot be stopped by 
magnetometers or guns or fences. Indeed, H1N1, as the Chairman 
has noted, is already here. In fact, it is ever present around 
the world.
    While we lack a complete understanding of what this fall 
will look like, we are planning for the worst. The outbreak of 
H1N1 this spring offered an unparalleled window into the state 
of our critical pandemic response capabilities and readiness. 
In some areas we excel. In other areas, frankly, as this 
committee has noted, we still have work to do.
    As with all aspects of the Department's work, Secretary 
Napolitano has asked me to supervise the staff members 
responsible for coordinating lessons learned and ensure that 
the Department is ready for whatever the fall may bring. While 
the Secretary may be the principal Federal official for 
domestic incident management, she is not the sole Federal 
official.
    The Department of Health and Human Services, I am deeply 
honored to be testifying with my HHS colleague, Deputy 
Secretary Corr this afternoon, who has a leading role to play 
in mounting a response to H1N1, as does the Department of 
Education and others, as does Congress.
    Indeed, congressional leadership on this issue has been of 
particular importance. The $47 million Congress provided to DHS 
for pandemic influenza preparedness in fiscal year 2006 has 
already proven its worth. With that funding, we have been able 
to build the foundation of our pandemic preparedness, including 
stockpiling of personal protective equipment and antiviral 
drugs for DHS employees and supporting pandemic influenza 
workshops.
    Our role is to coordinate and assist the larger Federal 
response. We are working with the White House, National 
security staff and our Federal interagency partners to finalize 
the Federal strategic implementation plan for the 2009 H1N1 
flu. This plan is being revised to reflect the lessons that we 
learned this spring.
    Internally, we are finalizing our own operational plans to 
provide direction to DHS components to ensure that our mission-
essential functions are maintained while protecting our 
workforce in the face of a sustained or worsening outbreak.
    While final touches to formal plans are being made, the 
overall coordination for this incident began months ago. At the 
start of the current outbreak of H1N1, the National Operations 
Center was fully activated to fulfill its role on interagency 
coordination, and they were assisted in this by the Office of 
Health Affairs which coordinated with HHS to help manage 
requests for information from a variety of stakeholders.
    We have been actively engaged with our Federal, State, and 
local and Tribal partners throughout the H1N1 outbreak, and we 
are working with others under the direction of President Obama 
who hosted a H1N1 summit 3 weeks ago for State and local 
leaders and stakeholders. This summit focused on lessons 
learned from the response so far. We are helping the private 
sector to plan for a pandemic. DHS began providing extensive 
guidance to private sector partners several years ago. 
Challenges have arisen and we are adapting in view of the 
experience gained.
    The health and safety of our workforce is one of our 
highest priorities, and we will continue to ensure that our 
front-line employees receive guidance on personal protection 
that is based on the best science available. We learned from 
the H1N1 flu that we have to have more guidance in place, and 
we have worked in that direction.
    There are a number of other efforts throughout the 
Department that I detailed in my statement for the record.
    Every day, Secretary Napolitano and I wake up thinking 
about how we can find new points on the supply chain of trouble 
and to interdict that trouble before it makes its way to the 
United States. H1N1 is no different. We will be prepared and we 
will be ready.
    Thank you again for this opportunity to testify. I will be 
happy to answer your questions.
    [The statement of Ms. Lute follows:]
                  Prepared Statement of Jane Holl Lute
                             July 29, 2009
    Chairman Thompson, Ranking Member King, and Members of the 
committee: Thank you for this opportunity to discuss National efforts 
to respond to the H1N1 flu outbreak, and what the Department of 
Homeland Security (DHS) is doing to prepare Americans for the effects 
of pandemic influenza in the future.
    The outbreak of H1N1 this past spring presented us with an early 
opportunity to evaluate our capacity to respond to a potential pandemic 
influenza. As we ready for the possibility that the H1N1 influenza may 
worsen, we must take advantage of what we learned from our earlier 
experience with this flu.
    Secretary Napolitano has asked me to lead internal coordination of 
the Department's response to H1N1. Our efforts within DHS are many, but 
we work in close coordination with the Department of Health and Human 
Services, the Department of Education, and the many other agencies that 
are contributing to the preparedness of our Nation. I am pleased to 
testify alongside my colleague, Deputy Secretary Corr, from HHS. We 
must, and are, acting in unison to ensure the entire Nation has the 
highest level of preparedness possible.
       overview of pandemic preparedness and planning within dhs
    Before speaking about current and future activities of DHS, I would 
like to touch briefly on the past leadership that has allowed us to 
reach our current readiness state.
    Specifically, I would like to acknowledge the $47.3 million that 
Congress allocated to DHS for pandemic influenza preparedness in fiscal 
year 2006. The recent outbreak of H1N1 made the importance of this 
funding even more evident. With that funding, the Department was able 
to build the basis of our pandemic preparedness foundation. For 
example, DHS conducted exercises (including intradepartmental pandemic 
influenza tabletops and workshops), purchased personal protective 
equipment (PPE) for DHS employees, and stockpiled antiviral medications 
for employees.
    DHS is currently working with White House National Security Staff 
and our Federal interagency partners to finalize the Federal Strategic 
Implementation Plan for the 2009 H1N1 flu. The draft H1N1 
Implementation Plan is being revised to reflect the many policy and 
strategic decisions that have been made, lessons learned from the 
initial response, and an overarching goal to mitigate the impact of 
H1N1 on society and the economy.
    At the same time, the Department is finalizing the DHS 2009 H1N1 
Operational Plan, which will be completed within the coming weeks. This 
plan will provide the necessary direction to DHS components to ensure 
that the Department's mission-essential functions are maintained while 
protecting our workforce in the face of a sustained or worsening 
outbreak.
    The Secretary and I are committed to the timely finalization of 
both the inter- and intra-agency pandemic flu plans.
                         incident coordination
    While final touches to formal plans are being made, overall 
coordination for this incident began immediately as Secretary 
Napolitano carried out her responsibilities as the Principal Federal 
Official.
    At the start of the current outbreak of H1N1, the Department's 
National Operations Center (NOC) was fully activated in order to 
provide direct support to the Secretary as well as to fulfill its role 
of interagency coordination. The NOC was ably assisted by the Office of 
Health Affairs (OHA), which coordinated with HHS and helped to manage 
requests for information from a variety of stakeholders, including our 
own DHS components, Federal interagency partners, State and local 
officials, the private sector, and Congress.
    To further facilitate incident coordination, DHS recently 
established Regional Coordination Teams to serve as an additional 
resource for the Federal Government, States, and local communities. The 
teams are designed to provide a regional link to our Federal partners; 
identify and respond to critical needs; identify and help reconcile 
regional issues; and coordinate with safety and health officials to 
protect Federal workers. The teams are charged with facilitating 
Federal interaction with our State and local partners in a pandemic 
where, unlike in many site-specific natural disasters, the affected 
population is spread across the entire Nation.
             state, local, tribal, and territorial outreach
    The Department of Homeland Security has been actively engaged with 
our Federal, State, local, territorial, and Tribal partners to prepare 
for our national response to an influenza pandemic. DHS offices and 
components have worked closely with partners to share information that 
is most critical to preparedness plans. During the initial H1N1 
outbreak in the spring, DHS' Office of Intergovernmental Programs held 
daily information calls and posted daily status updates to fusion 
centers through the Homeland Security State and Local Intelligence 
Community (HS-SLIC) network. Given the overwhelmingly positive response 
that this outreach and engagement received, DHS will continue to use 
all mechanisms at hand come this fall, including, but not limited to, 
the Homeland Security Information Network, and the Homeland Security 
State and local intelligence community, in order to distribute critical 
information.
    Three weeks ago, following President Obama's direction and 
leadership, DHS, HHS, and the Department of Education hosted a summit 
for State and local leaders and stakeholders. The summit discussions 
focused on lessons learned from the initial wave, including DHS areas 
of focus such as continuity of operations planning, front-line employee 
protection, and public and private sector roles in the national 
response. The summit's multiagency approach was very well-received. It 
allowed the Federal Government to convene key leaders and underscore 
how critical it is for local communities to coordinate activities among 
and between officials from the public health, emergency management, 
education, and public and private sectors.
        critical infrastructure and private sector preparedness
    This history of past efforts and coordination proved beneficial 
during the H1N1 outbreak. Prior to the outbreak, DHS had published the 
``Pandemic Influenza Preparedness, Response and Recovery, Guide for 
Critical Infrastructures and Key Resources'' to provide guidance to our 
Critical Infrastructure and Key Resource (CIKR) partners. In addition, 
with the help of our interagency partners, DHS completed specific 
pandemic influenza plans for all 18 of the CIKR sectors. Important 
components of the final plans and overall pandemic preparedness issues 
were highlighted, and will continue to be highlighted, in a series of 
web seminars led by DHS representatives. DHS is also coordinating with 
CIKR partners through the Government Coordinating Councils (GCC) and 
Sector Coordinating Councils (SCC).
    Across DHS, we are engaged with various private sector 
organizations, associations, and businesses to more broadly ensure 
their access to, and understanding of, pandemic preparation tools, 
resources, and guidance.
    While this guidance has been useful to our stakeholders, challenges 
arose because the H1N1 virus presented itself in a way that differed 
from some assumptions made in previous pandemic flu planning materials. 
Because of this, DHS and the Centers for Disease Control and Prevention 
(CDC) continue to work together to provide updated guidance that can 
best help CIKR and private sector partners maintain operations through 
the trials of a pandemic influenza.
    For example, our CIKR and Private Sector Offices are jointly 
participating in outreach with CDC, bringing together representatives 
from several major international corporations. The initial workshop 
focused on efforts to help private sector partners better prepare to 
meet their essential functions in a pandemic environment. Additional 
outreach is planned by both the National Protection and Programs 
Directorate and the Private Sector Office.
    Furthermore, to anticipate the impact of H1N1 on critical 
infrastructure and private sector businesses and organizations, the DHS 
National Biosurveillance Integration Center has partnered with the 
National Infrastructure Simulation and Analysis Center within the DHS 
Office of Infrastructure Protection to present mathematical modeling of 
the virus' expected spread and infrastructure impact informed by the 
best available epidemiological information about the virus. We will use 
this data to help guide our policy decisions as well as our 
preparedness and planning activities.
                      protecting the dhs workforce
    As I mentioned earlier, DHS had personal protective equipment on 
hand for use by employees, specifically those who perform certain tasks 
that may place them at increased risk of exposure. Components with 
employees who may be at risk include the U.S. Coast Guard (USCG), U.S. 
Immigration and Customs Enforcement (ICE), U.S. Customs and Border 
Protection (CBP), and the Transportation Security Administration (TSA). 
For example, TSA has shipped PPE to every airport hub, to Federal Air 
Marshal Special Agent in Charge offices, and to Office of Inspection 
field locations. Additionally, PPE is pre-positioned at 120 DHS 
locations and field offices Nation-wide.
    The Department has also stockpiled two types of antivirals, 
oseltamivir (Tamiflu) and zanamivir (Relenza), dedicated to DHS 
workforce protection. These medications are stored in a pharmaceutical 
warehouse, fielded across the Operational Workforce sites, and are 
prepared to be deployed as necessary. In addition, the USCG purchased 
courses of antivirals through Department of Defense stockpile channels. 
Overall, DHS has on hand approximately 540,000 courses of antivirals 
targeted for its mission-essential workforce.
    The health and safety of our workforce is one of Secretary 
Napolitano's and my top priorities, and we will continue to ensure that 
our front-line employees receive workforce protection guidance based on 
the best science available. DHS follows CDC guidance and OSHA standards 
on personal protective equipment, including when to use masks and 
respirators, and updates that guidance as new guidance is released. We 
learned from the H1N1 flu emergence that we needed to have more 
guidance in place. Looking forward, we are involved in intra-agency and 
interagency efforts to develop coordinated workforce protection 
guidance. There is no question that this continues to be a priority 
area for DHS.
               other current and on-going h1n1 activities
    The Department will continue to conduct stakeholder outreach, 
strategize and plan, and work with our interagency partners to help the 
Nation become as prepared as possible for any future pandemic. 
Additional on-going activities of DHS offices and components include 
the following:
   OHA is working with the CDC, HHS, and the Department of 
        Veterans Affairs on guidance to Federal departments on 
        prioritizing their employees for vaccines as well as on vaccine 
        distribution strategies for Federal employees.
   OHA continues to stockpile antivirals and PPE. OHA is also 
        developing policies and guidance for the use of antivirals and 
        PPE by DHS employees, based on CDC guidance, as well as working 
        with all components on communication programs, education, and 
        training in order to protect our workforce.
   The Office of Public Affairs is working with the White 
        House, HHS, and other agencies on overall pandemic 
        communication strategies.
   The Regional Coordination Teams are beginning training and 
        outreach to State and local officials.
   Department leadership, under my supervision, meets weekly to 
        review key preparedness timelines and strategies, identify 
        gaps, and design solutions.
   FEMA, in coordination with HHS, has drafted a Comprehensive 
        Preparedness Guide (CPG) specifically for pandemic influenza. 
        This CPG will be published in the next few weeks to provide 
        operational direction to State, local, and Tribal jurisdictions 
        relating to their pandemic planning.
   NBIC is maintaining constant, real-time, dynamic 
        biosurveillance.
   The NOC is coordinating efforts that will allow the U.S. 
        Government to maintain a common operating picture of the 
        current status of H1N1 influenza outbreaks during the fall 
        waves.
    Again, thank you for the invitation to discuss these important 
issues and for your continued willingness to work alongside the 
Department to provide leadership in protecting and ensuring the 
security of our homeland.

    Chairman Thompson. Thank you for your testimony.
    I now recognize Deputy Secretary Corr to summarize his 
statement for 5 minutes.

  STATEMENT OF WILLIAM CORR, DEPUTY SECRETARY, DEPARTMENT OF 
                   HEALTH AND HUMAN SERVICES

    Mr. Corr. Thank you, Mr. Chairman, Congressman King, and 
Members of the committee, it is a pleasure to be here today to 
give you an update on the activities of the Department of 
Health and Human Services. It is certainly a pleasure to appear 
with Deputy Secretary Lute, my colleague with DHS, and 
certainly with Ms. Steinhardt, we have great respect for the 
work that GAO does and take it very, very seriously.
    Secretary Sebelius and all of us at HHS deeply appreciate 
the leadership that the Congress has shown in providing the 
resources in the supplemental appropriations bill to give us 
the flexibility to begin targeting our resources as we need to 
for this H1N1 outbreak.
    While the headlines and the 24-hour news updates may have 
quieted down, this virus has not gone away and we cannot let up 
for one moment. In concert with our partners at Homeland 
Security and throughout the administration, we are doing 
everything possible to monitor and respond to this virus. The 
Department's concentrated and considerable efforts are not 
about raising alarms, they are about being being prepared. This 
is a very serious virus capable of causing severe disease and 
death, and it is essential that we have a coordinated and clear 
strategy to combat it.
    Going forward, we will work closely with the White House, 
with the Department of Homeland Security, and all of our 
Federal interagency partners to focus our health efforts around 
four areas.
    First is surveillance, to learn as much as we can about the 
virus, how it is changing and how it is spreading.
    Second, mitigation to encourage people to do what they can 
do. Each citizen has things that they can do in home and in 
their schools and their neighborhoods, to deal with the 
potential surge on our medical infrastructure, and to provide 
appropriate medical countermeasures.
    Immunization is the third leg which involves laying the 
groundwork for a potentially large-scale campaign to distribute 
vaccine.
    Last is communication, providing clear and accurate 
information to State and local governments and to the public.
    I would like to, Mr. Chairman, very quickly try to 
summarize some of the main activities. There are many, but I 
will highlight them and then be available for any questions 
that the committee might ask.
    As noted, the virus has now reached every State in the 
United States. As of July 24, there were over 43,000 confirmed 
cases; 5,000 hospitalizations; and 302 deaths. Going forward, 
CDC will be reporting in a different way, reporting on the 
number of hospitalizations and deaths and a good deal of 
information about the virus itself, how we are tracking it, 
where the flu is occurring and what the impact is on disease 
and on hospitalization.
    This virus usually causes a self-limited disease that gets 
better without treatment, but it also can cause severe illness 
and even death. Infants, children, and those with underlying 
health conditions appear to be most vulnerable to severe 
disease.
    The CDC is working closely with the World Health 
Organization and the Pan American Health Organization and 
ministries of health from around the world to continue 
characterizing the virus as it spreads. To today, we have 
observed rapid, early season increases in flu cases in the 
southern hemisphere, evidence of increased burden on the health 
care system, and extended school closures in some locations. We 
are working aggressively to monitor for evidence of change in 
the virus and whether it is becoming more virulent and 
transmittal.
    All of this information will allow us to make decisions as 
we go forward here in the United States.
    On May 22, Secretary Sebelius announced $1.1 billion of 
funds for vaccine development and manufacturing that includes 
clinical trials that will give us further information about 
safety and the optimal dose that is needed for the protective 
immune response that we desire. She also has announced $884 
million to secure ingredients, including the antigens which are 
the key components of vaccine and adjuvant so that we will have 
vaccine available, if needed.
    The studies are underway now with the vaccine, and we 
anticipate limited quantities of the vaccine in the next 
several months. Today, a special meeting of the CDC's advisory 
committee on immunization practices is occurring, and they will 
be considering many subjects and are one of our many advisory 
committees that we are relying upon for scientific and public 
health expertise.
    One of the recommendations will be on the age and risk 
groups that are recommended for vaccination. To help 
communities prepare for an increase in cases this fall, HHS, 
Homeland Security, and the Department of Education conducted a 
summit on July 9 involving State, local, Tribal, and Federal 
officials to discuss lessons learned, best practices, and to 
discuss preparedness priorities. At the summit, Secretary 
Sebelius announced the availability of $350 million in 
supplemental funding that will be made available both to State, 
local, and territorial health departments as well as to 
hospitals for preparedness.
    At the summit, we sent a strong message to our partners 
that they must be ready to begin an immunization program this 
fall when the licensed vaccine is anticipated to be available, 
but the decision to do a vaccination program has not been made 
yet and will be made in the near future.
    Before an immunization campaign begins, our scientific and 
public health experts will learn everything we can about the 
vaccine, its safety and efficacy, as well as the status of the 
spread of the virus as we make decisions. We have also 
purchased antivirals and other needed products. We have begun 
our effort to educate the public as, Congressman King pointed 
out, and I know that all of the Members of the committee are 
deeply concerned about so that the public has as much 
information as possible on how they can protect themselves.
    We have provided some school guidance, and will be 
providing extensive guidance to schools about how they should 
consider their activities as they enter into the school year.
    We are working with Federal, State, local, and Tribal 
partners to develop a community-based set of interventions. Mr. 
Chairman, if I may say in closing, we will also make every 
endeavor to keep this committee and other key committees of the 
Congress fully informed about our actions, what we know, as 
well as what we do not know. Thank you, Mr. Chairman.
    [The statement of Mr. Corr follows:]
                   Prepared Statement of William Corr
                             July 29, 2009
    Good afternoon Chairman Thompson, Ranking Member King, and Members 
of the committee. I am Bill Corr, Deputy Secretary at the U.S. 
Department of Health and Human Services (HHS). I am pleased to have 
this opportunity to update the committee on HHS' activities related to 
the 2009-H1N1 influenza outbreak. Several HHS agencies, including the 
Office of the Assistant Secretary for Preparedness and Response (ASPR), 
the Centers for Disease Control and Prevention (CDC), the National 
Institutes of Health (NIH) and the Food and Drug Administration (FDA), 
play key roles in our preparations for and response to pandemic 
influenza.
    We appreciate the quick action of Congress in recently providing 
$1.85 billion in immediately available resources and an additional $5.8 
billion contingency emergency appropriation for pandemic influenza 
preparedness and response, of which we have notified you that we plan 
to immediately access $1.825 billion. The Congress has provided 
sufficient flexibility within the appropriation for HHS to target its 
responses and resources as the situation evolves. Immediate activities 
will include providing funding to States for important planning 
necessary if a 2009-H1N1 immunization program is implemented this fall; 
funding to hospitals for preparation activities given a likely surge in 
patients during the flu season; purchasing additional vaccines, 
syringes, and needles; and providing support for monitoring, 
diagnostics, and public health response capabilities.
    Mr. Chairman, we at the Department are proud of what we've done so 
far to protect the American people. While the headlines and 24-hour 
news updates may have quieted down, this virus has not gone away, and 
we have not let up. In concert with our partners at the Department of 
Homeland Security and throughout the administration, we are doing 
everything possible to monitor and respond to this virus.
    It has been our goal to build the national infrastructure necessary 
to mount a scalable and flexible response to a novel influenza virus. 
This has included developing pre-pandemic vaccines for viruses with 
pandemic potential; Federal and State stockpiling of key medical 
countermeasures, such as antiviral drugs; and conducting exercises to 
practice accessing and distributing materiel from the stockpiles.
    With the strong support of Congress, and working with Governors, 
mayors, Tribes, State and local health departments, the medical 
community, and our private sector partners, the administration has been 
actively building on the preparations that have been underway for 
several years for an anticipated influenza pandemic to ensure the 
Nation is ready for the H1N1 virus scenarios that may develop over the 
next few months. From the outset, we have said that medical science 
will lead the way, and we are preparing action plans based on the best 
scientific information available.
    I want to be clear: The Department's efforts are not about raising 
alarms or stoking fears. They are about being prepared. This is a 
serious virus capable of causing severe disease and death, and it is 
essential that we have a clear and coordinated strategy to combat it.
    With that in mind, HHS is currently working with the White House 
and our Federal interagency partners to focus and galvanize our efforts 
around a National Framework for 2009-H1N1 Influenza Preparedness and 
Response that is based on four pillars: Surveillance, mitigation, 
immunization, and communication.
    Surveillance entails learning as much as we can about whether and 
how the virus is changing and spreading in the rest of the world, so 
that we have a clearer idea of how the virus will present in the United 
States during the fall flu season. Mitigation means encouraging people 
to do basic things at work, at home, in schools, and in their 
neighborhoods to help stop the spread of the virus; managing a 
potential surge in demands on our medical infrastructure; and providing 
appropriate medical countermeasures to infection. Immunization involves 
laying the groundwork for a potentially large-scale campaign to 
distribute an H1N1 vaccine and prioritize its use. And communication 
means providing clear and accurate information to State and local 
governments and to the public, which is essential during an outbreak.
    Each of the efforts I will describe this morning fits into this 
framework.
    Since the first 2009-H1N1 influenza patient in the United States 
was confirmed by laboratory testing at CDC on April 15, 2009, the virus 
has reached every State in the United States. On April 26, 2009 HHS 
issued a Nation-wide Public Health Emergency Declaration and declared 
that the emergency justified emergency use of several products. On that 
and the following day FDA issued four Emergency Use Authorizations 
(EUAs) in response to requests by CDC. An EUA allows the use of an 
unapproved product or use of an approved product for an unapproved use 
in an emergency declared as justifying such use. These authorizations 
allowed for the emergency use of certain antiviral medications, in 
vitro diagnostic devices, and respiratory protection products. A fifth 
EUA for a diagnostic panel for laboratory screening followed.
    As of July 24, 2009 CDC reported 43,771 confirmed and probable 
cases in the United States, with 5,011 hospitalizations and 302 deaths. 
However, most cases are not tested and confirmed and CDC estimates that 
there have been more than 1 million cases of novel H1N1 flu in the 
United States to date. Since the exact number of persons ill with 2009-
H1N1 flu is likely to be much higher than individual case counts 
indicate, Friday, July 24, 2009, was the last day that CDC is providing 
individual confirmed and probable cases of novel H1N1 influenza. CDC 
will continue to report the total number of hospitalizations and deaths 
each week, and to use its traditional surveillance systems to track the 
progress of the novel H1N1 flu outbreak. These systems work to 
determine when and where flu activity is occurring, track flu-related 
illness, determine what flu viruses are circulating, detect changes in 
flu viruses and measure the impact of flu on hospitalizations and 
deaths in the United States. The World Health Organization (WHO) 
reported 94,512 confirmed cases on July 6, 2009. For similar reasons, 
earlier in July the World Health Organization announced that it would 
stop issuing its global tables showing the numbers of confirmed novel 
H1N1 flu cases for all countries.
    This virus usually causes a self-limited disease that gets better 
without treatment, but it can also cause severe illness and even death. 
Infants, children, and those with underlying health conditions appear 
to be most vulnerable to severe disease.
    CDC staff worldwide are collaborating with WHO, the Pan American 
Health Organization (PAHO) and ministries of health to study 
characteristics of the 2009-H1N1 virus, including: The severity and 
transmissibility of H1N1 illness; population-based rates of mild and 
severe illness; risk factors for severe disease; impact on the health 
care infrastructure; and rates of transmission in households and 
communities in the Southern Hemisphere. These activities will better 
prepare the Nation and other Northern Hemisphere countries when we 
enter flu season in the fall.
    To date, we have observed rapid early season increase in flu cases 
in the Southern Hemisphere, evidence of increased burden on health care 
systems and extended school closures in several locations. We also are 
working aggressively to monitor for evidence of changes in the 2009-
H1N1 virus itself, whether the virus is becoming more virulent or 
transmittable.
    Efforts are underway to develop a vaccine against this new virus. 
NIH plans to invest more than $200 million in influenza research, 
including research on the 2009-H1N1, this fiscal year. Over the years, 
NIH has built a substantial infrastructure of research centers, 
intramural and NIH-supported extramural laboratories, highly trained 
personnel, and clinical research networks to rapidly conduct research 
on new pandemic viruses, such as 2009-H1N1 influenza. This established 
infrastructure enabled intramural researchers on the NIH campus, 
researchers at medical centers throughout the country in pre-existing 
NIH research networks, such as the Centers of Excellence in Influenza 
Research and Surveillance (CEIRS) and Regional Centers of Excellence 
for Biodefense and Emerging Infectious Diseases (RCEs), as well as 
industry partners and individual NIH grantees to act quickly to study 
the 2009-H1N1 influenza virus. In addition, NIH has been working with 
the biotechnology and pharmaceutical industries to speed development of 
new influenza vaccines, diagnostic tools, and anti-influenza drugs.
    On May 22, 2009 HHS Secretary Sebelius announced that $1.1 billion 
of funds previously appropriated for such purposes would be used for 
vaccine development and manufacturing. This includes resources for the 
clinical trials that are being carried out through NIH and through the 
manufacturers in collaboration with the FDA, CDC, and ASPR. On July 13, 
Secretary Sebelius announced that the Department will commit an 
additional $884 million to secure additional ingredients, including 
antigens and adjuvants, needed to manufacture the H1N1 vaccines. The 
Biomedical Advanced Research and Development Authority (BARDA) within 
ASPR has contracted with five vaccine manufacturers for the purchase of 
these bulk vaccine components. In addition to clinical trials conducted 
by the manufacturers, NIH will use its longstanding vaccine clinical 
trials infrastructure, notably the network of Vaccine and Treatment 
Evaluation Units, to conduct clinical studies to confirm safety and 
determine the optimal dose needed to induce a protective immune 
response. The five manufacturers who already produce U.S.-licensed 
seasonal vaccine are also conducting their own 2009-H1N1 influenza 
vaccine trials under contract with HHS. These studies are just 
beginning to get under way and will be carried out over the next 
several months. We anticipate that limited quantities of a vaccine may 
be available by mid-October.
    NIH and its industry partners have been developing several other 
kinds of influenza vaccines, for example, DNA vaccines, in which 
harmless influenza genetic sequences are injected directly into a 
person to stimulate an immune response against the proteins coded for 
by these genetic sequences. Studies are underway to evaluate how well 
these candidate antiviral drugs block the 2009-H1N1 influenza strain 
and to screen other compounds for activity against the virus. However, 
because these ``next-generation'' vaccines will require additional 
safety and efficacy testing before they can be deployed, they are 
unlikely to reach the public before the vaccines that are currently 
being produced.
    Today a special meeting of CDC's Advisory Committee on Immunization 
Practices (ACIP) will take place in Atlanta to follow up on issues 
related to planning for a 2009-H1N1 immunization campaign should it 
become necessary. Meeting topics include 2009-H1N1 epidemiology in the 
United States and internationally; implementation planning; vaccine 
development and formulations; communications; and ACIP Workgroup 
recommendations on age/risk groups recommended for vaccination.
    To help communities prepare for an increase in 2009-H1N1 influenza 
cases in the fall, HHS, the Department of Homeland Security, the 
Department of Education and the White House held the H1N1 Influenza 
Preparedness Summit at NIH on July 9, 2009 for Federal, State, local, 
and Tribal officials to build on and tailor States' existing pandemic 
plans, share lessons learned and best practices, and discuss 
preparedness priorities.
    At the summit, Secretary Sebelius announced the availability of 
$350 million in supplemental funding. These funds will be available to 
State, local, and territorial health departments to bolster their 
response activities to the 2009-H1N1 influenza pandemic, including: 
Addressing planning gaps; preparing for a potential mass vaccination 
campaign; meeting the information needs of the public, health, and 
educational professionals to support their decision-making; 
implementing strategies to reduce people's exposure to the 2009-H1N1 
virus; supporting laboratory testing; preparing hospitals and the 
health care community; and improving influenza surveillance and 
investigations.
    At the summit we sent a strong message to our State, tribal, and 
local partners that they must be ready to begin an immunization program 
by mid-October, when the first licensed vaccine is anticipated to be 
available. Before an immunization campaign begins, we will review what 
we know about the vaccine, its safety and efficacy, as well as the 
status of the pandemic to determine if an immunization program should 
proceed.
    Vaccines are not the only tools we have in our response 
armamentarium. Other 2009-H1N1 response efforts include the use of 
antiviral drugs and mitigation efforts, such as social distancing.
    The 2009-H1N1 influenza virus is currently sensitive to the 
antiviral drugs oseltamivir (Tamiflu) and zanamivir (Relenza). 
(Although cases of resistance to oseltamivir have been detected in some 
2009-H1N1 virus isolates, they are currently rare.) When it became 
apparent that 2009-H1N1 was spreading within the United States, HHS 
released 25 percent of the States' pro rata share of antiviral drugs 
and personal protective equipment. to help the States prepare to 
respond to the outbreak. Thirteen million regimens of antiviral drugs 
have been purchased and are scheduled to be delivered to replenish the 
CDC's Strategic National Stockpile (SNS) by the end of September 2009. 
An additional 400,000 regimens of antiviral drugs from the SNS were 
delivered to Mexico in response to an official request for assistance 
in combating the 2009-H1N1 influenza outbreak. Additionally, HHS 
recently announced plans to provide 420,000 treatment courses of 
oseltamavir to PAHO to fight the 2009-H1N1 virus in Latin America and 
the Caribbean.
    CDC and other HHS agencies continue to educate the public on ways 
to prevent infection, including frequent hand washing, staying home 
from school or work if ill, and coughing and sneezing into your elbow 
instead of your hands.
    School guidance is an area of particular concern because children 
are one of the groups at greatest risk of illness with this particular 
strain of influenza and are transmitting the virus at high rates. HHS 
is working with Federal, State, local, and Tribal partners to develop a 
comprehensive public health guidance package to inform decisions about 
a range of interventions applicable to school settings. Our goal, if 
possible, is to keep schools open and safe for students, faculty, and 
staff, but we will also advise communities to be prepared for the 
possibility of school closures, particularly if the virus were to 
change or become more severe. It will include decision-making guidance 
about how to choose combinations of interventions most applicable to 
the local situation and acceptable to the community.
    HHS is also working with Federal, State, local, and Tribal partners 
to develop a more general set of community-based interventions 
applicable in a wide range of settings. HHS will develop tools and 
materials to make the recommendations specific to various settings, and 
is establishing a technical assistance cadre to provide one-on-one 
consulting.
    To assist in preparing communities for increased health care 
demand, HHS is increasing the level of engagement with health care 
providers by convening stakeholder meetings to develop guidance and/or 
tools; providing tools and templates for local community planners; 
facilitating or supporting the development of clinical and triage 
protocols; and providing other technical assistance to partners and 
Federal agencies.
    Additionally, HHS will continue to evaluate community mitigation 
guidelines. As the outbreak progresses, we will continue to assess all 
guidelines to ensure that they are appropriately based upon the 
available science.
    Please be assured that we will continue to communicate with you. We 
will tell you what we know when we know it, and we will also inform you 
when we don't know. To that end, we continue to work with our State, 
local, territorial, and Tribal partners to best prepare our communities 
to respond effectively to the formidable public health and medical 
challenge that 2009-H1N1 influenza presents to us all.
    I would like to conclude by making two important points. First, we 
are all in this together. While the steps the Department and other 
agencies have taken will help engage the American people and ensure 
they are prepared, it's important for every family, business, and 
school to prepare its own household and business plan and think through 
the steps they will take if a family member, co-worker, or student 
contracts the H1N1 flu. This is a responsibility that we all share as 
parents, neighbors, co-workers, and community members.
    The second point is that, while the H1N1 pandemic presents a 
tremendous challenge, it has also brought a valuable opportunity that 
has helped us accelerate our work to improve the entire public health 
system; raise awareness about the basic steps people can take to stop 
the spread of germs and disease and the value of seasonal flu vaccine; 
and identify the strengths and weaknesses in our prevention and 
preparedness systems. The application of these lessons will be 
invaluable.
    We have made tremendous progress over the years in preparing for a 
flu pandemic. Congress has provided strong leadership and support for 
these efforts. We look forward to working with you to continue the 
progress we have made to ensure that our Nation is prepared for any 
public health threat.
    I would be happy to answer any questions.

    Chairman Thompson. Thank you for your testimony. We will 
get into some of the meat of it after opening statements.
    I now recognize Director Steinhardt to summarize her 
statement for 5 minutes.

 STATEMENT OF BERNICE STEINHARDT, DIRECTOR, STRATEGIC ISSUES, 
                GOVERNMENT ACCOUNTABILITY OFFICE

    Ms. Steinhardt. Thank you, Mr. Chairman, Mr. King, and 
other Members of the committee. We appreciate the opportunity 
to be here today to talk about the work that we have done at 
your request over the last 3 years, to assess the Federal 
Government's planning and preparedness for a pandemic 
influenza. When we started, a pandemic was a possibility. 
Today, it is a reality. As it has turned out, we have been 
fortunate so far that the pandemic has not been severe. The big 
question that we face is whether it will stay that way or 
whether the virus will become more virulent this fall or 
winter. In any case, we know we have to be prepared for that.
    So how well-prepared are we? Clearly we are benefiting from 
the groundwork that has been laid over the last few years. We 
have a National pandemic strategy and implementation plan 
developed by the Federal Government. All 50 States and the 
District of Columbia, as well as many local governments and 
private companies have their own pandemic plans as well. But 
the work we have done suggests that there is more that the 
Federal Government can and should do to fill in the gaps in the 
Nation's readiness.
    This afternoon I would like to focus on the most important 
of these gaps that our work has shown.
    First, the leadership roles in the pandemic, the who-is-in-
charge question, have not been clearly worked out and tested, 
as you pointed out earlier, Mr. Chairman. Under the National 
plan, the Secretaries of Homeland Security and Health and Human 
Services are supposed to share leadership responsibilities 
along with the system of Federal coordinating officials, 
principal Federal officials, and the FEMA administrator. But 
there has never been a National exercise to test how these 
roles will work together, a point of particular importance now 
that we have new leaders in these positions. In 2007, we 
recommended that the two Departments undertake this kind of 
exercise, but that has not been done.
    Second, the National plan, which was intended to be a 3-
year plan, is now over 3 years old and it needs to be updated, 
particularly in light of the experiences of the last few 
months. But there are no provisions for updating the plan or 
even reporting on its progress. Two years ago we recommended 
that the Homeland Security Council establish a process for 
updating the plan that would also involve key stakeholders, 
like State and local governments, and would incorporate lessons 
learned from exercises and other sources. That still has not 
been acted on.
    Third, the Federal Government could be doing a better job 
of sharing its expertise and coordinating its decisions with 
other levels of government and the private sector. There have 
been a number of mechanisms developed for this purpose, but 
they could be used even more. The critical infrastructure 
coordinating councils, for example, bring together private 
sector leaders from the 18 critical infrastructure sectors with 
officials from DHS and other Federal and State agencies to 
develop plans to protect critical infrastructure in major 
emergencies, including a pandemic flu.
    But at the time of our 2007 review, private sector members 
told us they were still looking for clarification about the 
respective roles and responsibilities of the Federal and State 
governments in areas like State border closures and vaccine 
distribution. We recommended then that DHS make greater use of 
the coordinating councils to have these kinds of discussions 
and help resolve some of these issues, but it is not clear to 
us that this has been happening.
    Finally, there needs to be a greater degree of 
accountability to ensure that Federal workers are protected in 
the event of a pandemic.
    Under the National pandemic plan, agencies are supposed to 
develop operational plans to protect their employees and to 
maintain essential operations and services. But based on our 
survey of the major agencies, progress on these plans appear to 
be very uneven with several agencies reporting that they were 
still in the early stages of planning. Yet there is no 
mechanism to monitor agency planning and no provision for 
agencies to report on their progress. As a result, we 
recommended that the Homeland Security Council ask DHS to take 
on this monitoring and reporting role, and we suggested that 
the Congress might want to consider requiring DHS to report to 
the Congress as well as to the White House.
    In closing, I want to observe that the last few months have 
given us real-life experience with some of the issues that are 
raised by a pandemic flu, but all of this experience will be 
for naught if we don't incorporate its lessons into our 
planning for the future. As our work suggests, there are still 
significant gaps and we should be addressing them now while 
time is still on our side.
    Thank you very much.
    [The statement of Ms. Steinhardt follows:]
         Prepared Statement of Statement of Bernice Steinhardt
                             July 29, 2009
                             gao highlights
    Highlights of GAO-09-909T, a testimony before the Committee on 
Homeland Security, House of Representatives.
Why GAO Did This Study
    As the current H1N1 outbreak underscores, an influenza pandemic 
remains a real threat to our Nation. Over the past 3 years, GAO 
conducted a body of work, consisting of 12 reports and 4 testimonies, 
to help the Nation better prepare for a possible pandemic. In February 
2009, GAO synthesized the results of most of this work and, in June 
2009, GAO issued an additional report on agency accountability for 
protecting the Federal workforce in the event of a pandemic. GAO's work 
points out that while a number of actions have been taken to plan for a 
pandemic, including developing a national strategy and implementation 
plan, many gaps in pandemic planning and preparedness still remain.
    This statement covers six 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.
What GAO Recommends
    This statement discusses the status of GAO's prior recommendations 
on the Nation's planning and preparedness for a pandemic. Key open 
recommendations concern the need to exercise the shared Federal 
leadership roles for a pandemic, address planning gaps at all levels of 
government and in the private sector, and monitor and report on 
agencies' plans to protect their workers.
influenza pandemic.--gaps in pandemic planning and preparedness need to 
                              be addressed
What GAO Found
   Leadership roles and responsibilities for an influenza 
        pandemic need to be clarified, tested, and exercised, and 
        existing coordination mechanisms, such as critical 
        infrastructure coordinating councils, could be better utilized 
        to address challenges in coordination between the Federal, 
        State, and local governments and the private sector in 
        preparing for a pandemic.
   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, particularly from developing countries.
   Pandemic planning and exercising has occurred at the 
        Federal, State, and local government levels, but important 
        planning gaps remain at all levels of government. At the 
        Federal level, agency planning to maintain essential operations 
        and services while protecting their employees in the event of a 
        pandemic is uneven.
   Further actions are needed to address the capacity to 
        respond to and recover from an influenza pandemic, which will 
        require additional capacity in patient treatment space, and the 
        acquisition and distribution of medical and other critical 
        supplies, such as antivirals and vaccines.
   Federal agencies have provided considerable guidance and 
        pandemic-related information to State and local governments, 
        but could augment their efforts with additional information on 
        school closures, State border closures, and other topics.
   Performance monitoring and accountability for pandemic 
        preparedness needs strengthening. For example, the May 2006 
        National Strategy for Pandemic Influenza Implementation Plan 
        does not establish priorities among its 324 action items and 
        does not provide information on the financial resources needed 
        to implement them. Also, greater agency accountability is 
        needed to protect Federal workers in the event of a pandemic 
        because there is no mechanism in place to monitor and report on 
        agencies' progress in developing workforce pandemic plans.
    The current H1N1 pandemic should serve as a powerful reminder that 
the threat of a pandemic influenza, which seemed to fade from public 
awareness in recent years, never really disappeared. While Federal 
agencies have taken action on 13 of GAO's 24 recommendations, 11 of the 
recommendations that GAO has made over the past 3 years have not been 
fully implemented. With the possibility that the H1N1 virus could 
become more virulent this fall or winter, the administration and 
Federal agencies should use this time to turn their attention to 
filling in the planning and preparedness gaps GAO's work has pointed 
out.
    Mr. Chairman and Members of the committee: I am pleased to be here 
today to discuss key themes from the body of work GAO has developed 
over the past several years to help the Nation better prepare for, 
respond to, and recover from a possible influenza pandemic. An 
influenza pandemic remains a real threat to our Nation and to the 
world, as we are witnessing during the current H1N1 pandemic. The 
previous administration took a number of actions to plan for a 
pandemic, including developing a national strategy and implementation 
plan. However, much more needs to be done, and many gaps in planning 
and preparedness still remain. Strengthening preparedness for large-
scale public health emergencies, such as an influenza pandemic, is one 
of 13 urgent issues that we identified earlier this year as among those 
needing the immediate attention of the new administration and 
Congress.\1\
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    \1\ GAO's 2009 Congressional and Presidential Transition website: 
http://www.gao.gov/transition_2009.
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    In the past 3 years, GAO has issued 12 reports and 4 testimonies on 
influenza pandemic planning.\2\ We synthesized the results of most of 
our work in a February 2009 report, which I will discuss in more detail 
today.\3\ In addition, I will discuss key results from our recent 
report on protecting the Federal workforce in the event of a 
pandemic.\4\ We have made 24 recommendations based on the findings from 
these reports, 13 of which have been acted upon by the responsible 
Federal agencies. The responsible Federal agencies have generally 
agreed with our recommendations and some actions are underway to 
address them. However, 11 recommendations have not yet been fully 
implemented. While our February 2009 report made no new 
recommendations, it reflects the status of those recommendations that 
were made prior to our June 2009 report that had not yet been 
implemented. Many of the recommendations that remain unimplemented have 
become even more pressing in light of the very real possibility of the 
return of a more severe form of the H1N1 virus later this year. Lists 
of our open recommendations and related GAO products that are 
referenced throughout this statement are located in attachments I and 
II.*
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    \2\ We also have two 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); and (2) the effect of a pandemic on the 
telecommunications capacity needed to sustain critical financial market 
activities.
    \3\ GAO, Influenza Pandemic: Sustaining Focus on the Nation's 
Planning and Preparedness Efforts, GAO-09-334 (Washington, DC: Feb. 26, 
2009).
    \4\ GAO, Influenza Pandemic: Increased Agency Accountability Could 
Help Protect Federal Employees Serving the Public in the Event of a 
Pandemic, GAO-09-404 (Washington, DC: June 12, 2009).
    * The information has been retained in committee files.
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    In summary, my statement will address the following issues which 
were drawn from the key themes of GAO's pandemic work:
   Leadership roles and responsibilities for an influenza 
        pandemic need to be clarified, tested, and exercised, and 
        existing coordination mechanisms, such as critical 
        infrastructure coordinating councils, could be better utilized 
        to address challenges in coordination between the Federal, 
        State, and local governments and the private sector in 
        preparing for a pandemic.
   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, particularly from 
        developing countries.
   Pandemic planning and exercising have occurred at the 
        Federal, State, and local government levels, but important 
        planning gaps remain at all levels of government. At the 
        Federal level, agency planning to maintain essential operations 
        and services while protecting their employees in the event of a 
        pandemic is uneven.
   Further actions are needed to address the capacity to 
        respond to and recover from an influenza pandemic, which will 
        require additional capacity in patient treatment space, and the 
        acquisition and distribution of medical and other critical 
        supplies, such as antivirals and vaccines.
   Federal agencies have provided considerable guidance and 
        pandemic-related information to State and local governments, 
        but could augment their efforts with additional information on 
        school closures, State border closures, and other topics.
   Performance monitoring and accountability for pandemic 
        preparedness needs strengthening. For example, the May 2006 
        National Strategy for Pandemic Influenza Implementation Plan 
        (National Pandemic Implementation Plan) does not establish 
        priorities among its 324 action items and does not provide 
        information on the financial resources needed to implement 
        them. Also, greater agency accountability is needed to protect 
        Federal workers in the event of a pandemic because there is no 
        mechanism in place to monitor and report on agencies' progress 
        in developing workforce pandemic plans that provide the 
        operational details of how agencies will protect their 
        employees and maintain essential operations and services.
    As noted earlier, this statement is 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.
                               background
    Given the consequences of a severe influenza pandemic, in 2006, GAO 
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. 


    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. 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. However, the current H1N1 pandemic seems to be 
relatively mild, although widespread. The history of an influenza 
pandemic suggests it could return in a second wave this fall or winter 
in a more virulent form.\5\ 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.\6\ In addition, an influenza pandemic could result in 200,000 
to 2 million deaths in the United States, depending on its severity.
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    \5\ On June 11, 2009, the World Health Organization (WHO) raised 
its influenza pandemic alert level from phase 5 to the highest phase, 
phase 6, signaling the widespread human infection associated with a 
pandemic for the H1N1 virus.
    \6\ GAO, Influenza Pandemic: Further Efforts Are Needed to Ensure 
Clearer Federal Leadership Roles and an Effective National Strategy, 
GAO-07-781 (Washington, DC: Aug. 14, 2007).
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    The President's Homeland Security Council (HSC) took an active 
approach to this potential disaster by, among other things, issuing the 
National Strategy for Pandemic Influenza (National Pandemic Strategy) 
in November 2005, and the National Pandemic Implementation Plan in May 
2006.\7\ 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 non-Federal 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 non-Federal 
entities. The Plan contains 324 action items related to these 
requirements, responsibilities, and expectations, most of which were 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. We have on-going work for this 
committee assessing the status of implementing this plan which we 
expect to report on in the fall of 2009.
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    \7\ On May 26, 2009, the President announced the full integration 
of White House staff supporting national security and homeland 
security. The Homeland Security Council will be maintained as the 
principal venue for interagency deliberations on issues that affect the 
security of the homeland, such as influenza pandemic.
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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. Most of these 
Federal leadership roles involve shared responsibilities between the 
Department of Health and Human Services (HHS) and the Department of 
Homeland Security (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.\8\ 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.
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    \8\ Pub. L. No. 109-295, Title VI.
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    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.\9\ 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.\10\ 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.
---------------------------------------------------------------------------
    \9\ 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, GAO-07-1142T (Washington, DC: 
July 31, 2007).
    \10\ GAO-07-781.
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    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 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.\11\ 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.
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    \11\ GAO, Influenza Pandemic: Opportunities Exist to Address 
Critical Infrastructure Protection Challenges That Require Federal and 
Private Sector Coordination, GAO-08-36 (Washington, DC: Oct. 31, 2007).
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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.\12\ 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.\13\ 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 at the time of our February 2009 report that the department 
was 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.
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    \12\ 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 health care; 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.
    \13\ GAO-08-36.
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    Federal executive boards (FEB) bring together Federal agency and 
community leaders in major metropolitan areas outside of Washington, 
DC, 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.\14\ 
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) \15\ 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.
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    \14\ GAO, The Federal Workforce: Additional Steps Needed to Take 
Advantage of Federal Executive Boards' Ability to Contribute to 
Emergency Operations, GAO-07-515 (Washington, DC: May 4, 2007).
    \15\ Issued in January 2008 by 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.
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   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
    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, as reported in 2007, international capacity for surveillance has 
many weaknesses, particularly in developing countries.\16\ As a result, 
assessments of the risks of the emergence of influenza pandemic by U.S. 
agencies and international organizations, which were used to target 
assistance to countries at risk, were based on insufficiently detailed 
or incomplete information, limiting their value for comprehensive 
comparisons of risk levels by country.
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    \16\ GAO, Influenza Pandemic: Efforts Under Way to Address 
Constraints on Using Antivirals and Vaccines to Forestall a Pandemic, 
GAO-08-92 (Washington, DC: Dec. 21, 2007).
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pandemic planning and exercising has occurred, but planning gaps remain
    The National Pandemic Strategy and National Pandemic Implementation 
Plan are important first steps in guiding national preparedness. 
However, important gaps exist that could hinder the ability of key 
stakeholders to effectively execute their responsibilities. 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.\17\ 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 non-Federal 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.
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    \17\ 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, 
GAO-04-408T (Washington, DC: Feb. 3, 2004).
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Federal Workforce Pandemic Planning
    The National Pandemic Implementation Plan required Federal agencies 
to develop operational plans for protecting their employees and 
maintaining essential operations and services in the event of a 
pandemic. In our June 2009 report, we found that Federal agency 
progress in pandemic planning is uneven.\18\ We surveyed the pandemic 
coordinators from the 24 agencies covered by the Chief Financial 
Officers Act of 1990, which we supplemented with a case study approach 
of 3 agencies.\19\ We used the survey to get an overview of Government-
wide pandemic influenza preparedness efforts. The survey questions 
asked about pandemic plans; essential functions other than first 
response that employees cannot perform remotely; protective measures, 
such as procuring pharmaceutical interventions; social distancing 
strategies;\20\ information technology testing; and communication of 
human capital pandemic policies. Although all of the surveyed agencies 
reported being engaged in planning for pandemic influenza to some 
degree, several agencies reported that they were still in the early 
stages of developing their pandemic plans and their measures to protect 
their workforce. For example, several agencies responded that they had 
yet to identify essential functions during a pandemic that cannot be 
performed remotely. And, although many of the agencies' pandemic plans 
rely on telework to carry out their functions, 5 agencies reported 
testing their information technology capability to little or no extent.
---------------------------------------------------------------------------
    \18\ GAO-09-404.
    \19\ The survey was conducted from May through July 2008, and the 
results were confirmed or updated in early 2009.
    \20\ Social distancing is a technique used to minimize close 
contact among persons in public places, such as work sites and public 
areas.
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    The three case study agencies also showed differences in the degree 
to which their individual facilities had operational pandemic plans. 
The Bureau of Prisons' correctional workers had only recently been 
required to develop pandemic plans for their correctional facilities. 
The Department of Treasury's Financial Management Service, which has 
production staff involved in disbursing Federal payments such as Social 
Security checks, had pandemic plans for its four regional centers and 
had stockpiled personal protective equipment. By contrast, the Federal 
Aviation Administration's air traffic control management facilities, 
where air traffic controllers work, had not yet developed facility 
pandemic plans or incorporated pandemic plans into their all-hazards 
contingency plans.
State and Local Pandemic Planning
    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.\21\ A portion of the $5.62 billion that 
Congress appropriated in supplemental funding to HHS for pandemic 
preparedness in 2006--$600 million--was specifically provided for State 
and local planning and exercising. All 10 localities that we reviewed 
in depth had also developed plans and conducted exercises, and had 
incorporated lessons learned from pandemic exercises into their 
planning.\22\ 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.'' Subsequently, HHS led another interagency assessment of State 
influenza pandemic plans and reported in January 2009 that although 
they had made important progress, most States still had major gaps in 
their pandemic plans.\23\
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    \21\ GAO, Influenza Pandemic: Federal Agencies Should Continue to 
Assist States to Address Gaps in Pandemic Planning, GAO-08-539, 
(Washington, DC: June 19, 2008).
    \22\ 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 U.S. 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 5 urban 
areas and 5 rural counties.
    \23\ DHS and HHS and other agencies, Assessment of States' 
Operating Plans to Combat Pandemic Influenza: Report to Homeland 
Security Council (Washington, DC: January 2009).
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    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.\24\ 
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. As 
reported in February 2009, HHS and DHS generally concurred with our 
recommendation, but have not yet held these additional meetings.\25\ 
HHS and DHS indicated at the time of our February 2009 report that 
while no additional meetings had been planned, States will have to 
continuously update their pandemic plans and submit them for review.
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    \24\ GAO-08-539.
    \25\ GAO-09-334.
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    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.\26\ Other State and local officials have identified similar 
concerns. 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.\27\ NGA also 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.
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    \26\ GAO-08-539.
    \27\ National Governors Association Center for Best Practices, 
Issue Brief: Pandemic Preparedness in the States--An Assessment of 
Progress and Opportunity (September 2008).
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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.\28\ 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. However, 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.
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    \28\ GAO, Financial Market Preparedness: Significant Progress Has 
Been Made, but Pandemic Planning and Other Challenges Remain, GAO-07-
399 (Washington, DC: Mar. 29, 2007).
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 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.
    Over the last few years, Congress has provided over $13 billion in 
supplemental funding for pandemic preparedness. The $5.62 billion that 
Congress provided in supplemental funding to HHS in 2006 was 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.\29\ 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 that 
went to States and localities for preparedness activities--$170 
million--was allocated for State antiviral purchases for their State 
stockpiles. In June 2009, Congress approved and the President signed a 
supplemental appropriations act that included $7.7 billion for pandemic 
flu preparedness, including the development and purchase of vaccine, 
antivirals, necessary medical supplies, diagnostics, and other 
surveillance tools and to assist international efforts and respond to 
international needs relating to the 2009-H1N1 influenza outbreak.\30\ 
This amount included $1.85 billion to be available immediately and $5.8 
billion to be available subsequently in the amounts designated by the 
President as emergency funding requirements. On July 10, 2009, HHS 
announced its plans to use the $350 million designated for upgrading 
State and local capacity for additional grants to States and 
territories to prepare for the H1N1 pandemic and seasonal influenza. 
State public health departments will receive $260 million, and 
hospitals will receive $90 million of these grant funds.
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    \29\ Pub. L. No. 109-148 and Pub. L. No. 109-234.
    \30\ Pub. L. No. 111-32.
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    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.\31\ 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.
---------------------------------------------------------------------------
    \31\ 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.
---------------------------------------------------------------------------
    The Federal Government has provided some guidance in addition to 
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. Some State officials reported, however, that they had 
not begun work on altered standards of care guidelines, 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 event, 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.\32\ 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.\33\
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    \32\ GAO, Emergency Preparedness: States Are Planning for Medical 
Surge, but Could Benefit From Shared Guidance for Allocating Scarce 
Medical Resources, GAO-08-668, (Washington, DC: June 13, 2008).
    \33\ GAO-08-539.
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   federal agencies have provided considerable guidance and pandemic-
          related information, but could augment their efforts
    The National Pandemic Implementation Plan emphasizes that 
Government and public health officials must communicate clearly and 
continuously with the public throughout a pandemic. Accordingly, HHS, 
DHS, and other Federal agencies have shared pandemic-related 
information in a number of ways, such as through websites, guidance, 
and State summits and meetings, and are using established networks, 
including coordinating councils for critical infrastructure protection, 
to share information about pandemic preparedness, response, and 
recovery. Federal agencies have established an influenza pandemic 
website (www.pandemicflu.gov) and disseminated pandemic preparedness 
checklists for workplaces, individuals and families, schools, health 
care, community organizations, and State and local governments.
    However, State and local officials from all of the States and 
localities we interviewed for our June 2008 report on State and local 
pandemic planning and exercising, wanted additional influenza pandemic 
guidance from the Federal Government on specific topics, on how to 
implement community interventions such as closing schools, fatality 
management, and facilitating medical surge. Although the Federal 
Government had issued some guidance at the time of our review, 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. More recently, CDC has issued additional 
guidance on a number of topics related to responding to the H1N1 
outbreak. CDC issued interim guidance on school closures which 
originally recommended that schools with confirmed H1N1 influenza 
close. Once it became more clear that the disease severity of H1N1 was 
similar to that of seasonal influenza and that the virus had already 
spread within communities, CDC determined that school closure would be 
less effective as a measure of control and issued updated guidance 
recommending that schools not close for suspected or confirmed cases of 
influenza.\34\ However, the change in guidance caused confusion, 
underscoring the importance of clear and continuous communication with 
the public throughout a pandemic. 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.
---------------------------------------------------------------------------
    \34\ Centers for Disease Control and Prevention, Update on School 
(K-12) and Child Care Programs: Interim CDC Guidance in Response to 
Human Infections with the Novel Influenza A (H1N1) Virus (Updated May 
22, 2009).
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  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. 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.
    For example, one action item asked that all HHS-, Department of 
Defense-, and Veterans Administration-funded hospitals and health 
facilities develop, test, and be prepared to implement infection 
control campaigns for pandemic influenza within 3 months. However, the 
associated performance measure is not clearly linked to the intended 
result. This performance measure states that infection control guidance 
should be developed and disseminated on www.pandemicflu.gov and other 
channels.\35\ This action would not directly result in developing, 
testing, and preparing to implement infection control campaigns. This 
lack of clear linkage 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. In addition, as discussed earlier, 
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. 
Moreover, the National Pandemic Strategy and its 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. As a result, the documents do not 
provide a picture of priorities or how adjustments might be made in 
view of resource constraints.
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    \35\ Homeland Security Council, National Strategy for Pandemic 
Influenza Implementation Plan (Washington, DC: May 2006).
---------------------------------------------------------------------------
    As discussed earlier, the National Pandemic Implementation Plan 
also required Federal agencies to develop operational pandemic plans to 
describe, among other requirements, how each agency will protect its 
workforce and maintain essential operations and services in the event 
of a pandemic.\36\ We recently reported, however, that there is no 
mechanism in place to monitor and report on agencies' progress in 
developing these plans. Under the Implementation Plan, DHS was charged 
with this responsibility, but instead the HSC simply requested that 
agencies certify to the council that they were addressing in their 
plans the applicable elements of a pandemic checklist. The 
certification process did not provide for monitoring and reporting on 
agencies' abilities to continue operations in the event of a pandemic 
while protecting their employees. Moreover, even as envisioned under 
the Implementation Plan, the report was to be directed to the Executive 
Office of the President with no provision for the report to be made 
available to Congress.
---------------------------------------------------------------------------
    \36\ GAO-09-404.
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    As noted earlier, given agencies' uneven progress in developing 
their pandemic plans, monitoring, and reporting would enhance agencies' 
accountability to protect their employees during a pandemic. We 
therefore recommended that the HSC request that the Secretary of 
Homeland Security monitor and report to the Executive Office of the 
President on the readiness of agencies to continue their operations 
while protecting their employees in the event of a pandemic. We also 
suggested that to help support its oversight responsibilities, Congress 
may want to consider requiring DHS to report to it on agencies' 
progress in developing and implementing their plans, including any key 
challenges and gaps in the plans. The HSC noted that it will give 
serious consideration to the report findings and recommendations, and 
DHS said the report findings and recommendations will contribute to its 
efforts to ensure that Government entities are well-prepared for what 
may come next.
                        concluding observations
    The current H1N1 influenza pandemic should serve as a powerful 
reminder that the threat of a more virulent pandemic, which seemed to 
fade from public awareness in recent years, never really disappeared. 
While Federal agencies have taken action on many of our 
recommendations, about half the recommendations that we have made over 
the past 3 years are still not fully implemented. It is essential, 
given the change in administration and the associated transition of 
senior Federal officials, that the shared leadership roles that have 
been established between HHS and DHS, along with other responsible 
Federal officials, are tested in rigorous tests and exercises. 
Likewise, DHS should continue to work with other Federal agencies and 
private sector members of the critical infrastructure coordinating 
councils to help address the challenges of coordination and clarify 
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. Moreover, the 3-year period 
covered by the National Pandemic Implementation Plan is now over and it 
will be important for HSC to establish a process for updating the 
National Pandemic Implementation Plan so that the updated plan can 
address the gaps we have identified, as well as lessons learned from 
the current H1N1 outbreak. Finally, greater monitoring and reporting of 
agencies' progress in plans to protect their workers during a pandemic 
are needed to insure the readiness of agencies to continue operations 
while protecting their employees in the event of a pandemic.
    Pandemic influenzas, as I noted earlier, differ from other types of 
disasters in that they are not necessarily discrete events. While the 
current H1N1 pandemic seems to be relatively mild, the virus could 
become more virulent this fall or winter. Given this risk, the 
administration and Federal agencies should use this opportunity to turn 
their attention to filling in some of the planning and preparedness 
gaps our work has pointed out, while time is still on our side.
    Chairman Thompson and Members of the committee, this concludes my 
prepared statement. I would be happy to respond to any questions you 
may have.

    Chairman Thompson. Thank you very much for your testimony.
    I now recognize myself for 5 minutes of questioning.
    Mr. Corr, if we had an outbreak of H1N1 tomorrow, do we 
have enough vaccine on hand now to address it or are we still 
short?
    Mr. Corr. Mr. Chairman, we are taking all of the necessary 
steps to develop the vaccine, but it will not be available for 
use for several more months. Clinical trials at the National 
Institutes of Health and among the vaccine manufacturers are 
now underway. We need the results of those trials to understand 
the level of dosing and the immune response, whether we are 
getting sufficient immune response. We also need further 
information about the virus itself which we are collecting in 
the southern hemisphere as well as in the States.
    So we expect that we will be in a position to do a 
vaccination campaign if the decision is made to proceed with 
one in the September/October time frame.
    Chairman Thompson. Thank you.
    Dr. Lute, given the fact that we don't at this point have 
enough of the vaccine on hand, what plans has DHS put into 
place in the interim to address any potential outbreak?
    Ms. Lute. Mr. Chairman, as I mentioned in my opening 
remarks, there is a Federal plan for 2009 H1N1 that is in final 
stages of completion, as well as a Departmental plan within 
DHS. As was noted, all of the Federal agencies are themselves 
responsible for developing plans to continue to execute their 
mission responsibilities in the event of an outbreak.
    Equally, State and local authorities, municipalities, have 
been engaged in planning and we have been providing them 
through FEMA planning templates and planning training and 
assistance to prepare for the coming fall.
    Chairman Thompson. Thank you.
    Now Ms. Steinhardt, in your review, you indicated that some 
of these National plans probably needed updating or, in some 
instances, were outdated. Did you make some suggestions to 
either DHS or HHS that they do this? If so, do you have any 
knowledge as to whether or not they have updated those plans?
    Ms. Steinhardt. Thank you, Mr. Chairman for your question. 
To our knowledge, they have not updated the plans. I am 
interested in Secretary Lute's comments about a Federal 
implementation plan that is in draft stage. We haven't seen 
that yet and so can't comment on it.
    But I would say in the past when we have looked at the 
current version of the implementation plan and National 
strategy, we noted a number of gaps in what is included there.
    But I would say that the most significant one was the fact 
that many of the action items in the plan were assigned to 
State and local governments, but there had been no consultation 
with State and local governments in the drafting of that plan. 
When we talked to some of them, some of the State and local 
governments, particularly at the local level, they weren't even 
aware that they had responsibility for any of the action items.
    Chairman Thompson. Dr. Lute, could you provide the 
committee with a copy of this draft plan you talked about?
    Ms. Lute. Mr. Chairman, we will certainly share with this 
committee all of the preparations that we are undertaking. Let 
me just use this opportunity, if I might, to reflect on Ranking 
Member King's questions on lessons learned from the spring.
    What we learned over the past several months is that 
several principles are operating here:
    No. 1, rest on the science.
    No. 2, planning is key.
    No. 3, consistent communication across the Federal 
Government and between the Federal Government and State and 
local municipal authorities across public health sectors, 
public policy sectors, governmental sectors as well is also 
key. While we are not satisfied with progress to date, we can 
say with great conviction that a good deal of progress has 
occurred and we now have an elaborated matrix of action 
requirements across the Federal Government and between us and 
the State and locals to ensure that we are prepared for the 
fall.
    Chairman Thompson. Thank you.
    Mr. Corr, I am not certain, are you aware of some 
information that we have that some pages might have come down 
with H1N1-like symptoms?
    Mr. Corr. I read that in the paper this morning, yes.
    Chairman Thompson. But you don't have any knowledge beyond 
what you read in the paper?
    Mr. Corr. I do not.
    Chairman Thompson. Dr. Lute.
    Ms. Lute. Equally.
    Chairman Thompson. Well, part of our dilemma as Members of 
Congress is we have been involved and potentially in contact 
with some of the people, and we have no knowledge of it other 
than reading it in the paper. I think part of the issue that 
Ms. Steinhardt's report goes to is we don't have a plan of 
informing people when potential situations like this exist.
    Ms. Steinhardt, do you have any comments on what you think 
people in a situation like this at a minimum should be informed 
of?
    Ms. Steinhardt. Well, I can't speak, Mr. Chairman, to the 
specifics of this situation. But I do think it underscores the 
importance of having operational plans, plans at a sufficient 
level of detail so that when these kinds of situations arise, 
organizations, people within the organization know exactly what 
they need to do to follow up on that situation. It is not 
enough to just have something that is very high level.
    Chairman Thompson. Again, this was brought to my attention 
in the newspaper, too. I thought it was kind of interesting 
that Members of Congress didn't have any way of being told of 
the situation or the Senate or what have you. The gentleman 
from New York for 5 minutes.
    Mr. King. Thank you, Mr. Chairman.
    Secretary Corr, you said right now you are evaluating the 
virus. Is it too early to say how virulent it might be, to make 
estimates if it is going to be more severe than last spring?
    Mr. Corr. Congressman, the experts at CDC are continuing to 
watch what happens in this country with regard to the spread 
and the virulence of the virus. We are watching very closely in 
the southern hemisphere, and so far it appears to have a 
similar pattern. In some places the disease has had a serious 
effect on individuals. In other places it has been mild, as it 
has been in the United States. The virus itself does not appear 
to be mutating which is important information.
    But again, we are collecting information. We are just 
reaching the height of the southern hemisphere's flu season. So 
the short answer is that there is a great deal of information 
that we will continue to collect that will inform the decision 
about whether to do a vaccination campaign here in the United 
States.
    In the mean time, there is a great deal that every 
individual can do. One of the most important messages that I 
think we need to get out to the American people is that every 
individual, every family, every business, every school, has a 
responsibility to understand what they can do to mitigate the 
spread of the disease. It certainly is an issue for Members. As 
many people as you shake hands with and see every day, there is 
some very basic information that we need in everyone's 
knowledge base, which is wash your hands frequently, cover your 
nose and mouth with your arm and not with your hand when you 
sneeze or cough. If you have a fever or flu-like symptoms, stay 
home.
    We need to get this message out. We are working daily with 
State and local health departments. We are developing 
communication plans that will continue to spread this word. 
There is a great deal of public information.
    Mr. King. Secretary Corr, along those lines, if and when a 
vaccine is being used, are you going to have rapid response 
teams ready to answer the questions that the public will have 
because I am sure we can expect rumors, some true, some false, 
conspiracy theories, and everything else. Are you going to be 
able to go after them right away and have answers for the 
public?
    Mr. Corr. As best we can. We understand that it is critical 
for the public to trust the vaccines and the public health 
experts who are recommending them. We will do everything that 
we can to make sure that we have accurate information available 
for everyone.
    Mr. King. As far as lessons learned, as far as your two 
departments are concerned, do you feel that the level of 
coordination was sufficient? Can that be improved on? After, 
Ms. Steinhardt, I would ask if you would comment on what you 
think of the level of coordination during the last crisis, if 
you will?
    Ms. Lute. Thank you. From our point of view, the spring was 
an excellent example of very tight and close coordination from 
the leading public health agency in the Federal Government and 
the leading National incident management agency. From the very 
outset of the outbreak of H1N1 in the spring, we closely 
liaised with HHS to establish what the science was. Our aim 
jointly that we pursued at every level from the Secretaries on 
down to the working level was designed to create empowered 
individuals, capable communities, and a responsive Federal 
system to identify where the gaps were in our knowledge, to 
understand what were the responsible messages to be sending 
out, and to engage State and local tribal authorities at times 
on multiple times a day during the spring. So from our point of 
view, this coordination was important. It was emblematic. We 
have built on it over the intervening weeks to prepare 
ourselves for the fall.
    Mr. Corr. I certainly agree with that. Given the speed with 
which the virus came upon us, we felt like at HHS, that there 
was outstanding leadership from DHS in coordinating all of our 
activities and integrating our science and public health 
experts into the decision-making process. Our two Secretaries 
were leaders in terms of talking to the American people about 
what to expect. We felt like it was an excellent working 
relationship. We need to always build on it and we need to 
incorporate, as GAO has pointed out, our State and local and 
territorial and tribal partners. We need to incorporate the 
business communities in all of our plans going forward, and are 
attempting to do that.
    I urge you to take a look at the CDC website at Flu.gov. 
There are extensive guidelines that are for different provider 
groups, businesses, individuals. We are trying to provide as 
much information as rapidly as we can. It is evolving as we 
learn more. But we are trying to provide guidance to the 
Department of Education. Our Departments are working very 
closely with the Department of Education so we give good 
guidance for schools for the fall.
    Ms. Steinhardt. I would say certainly looking at it from 
the outside, the coordination seemed to work very well at the 
beginning of the H1N1 outbreak. But I would point out that at 
the time, Secretary Sebelius hadn't been confirmed yet in her 
position so we just had at the beginning Secretary Napolitano 
leading the effort, as it were, along with obviously others in 
the two departments.
    The pandemic itself, it hadn't reached pandemic proportions 
yet. It was not yet a severe outbreak, and so it didn't call on 
all of the resources that might be called on in a more severe 
pandemic situation. We still haven't tested that kind of 
scenario, and that still remains to be done.
    Mr. King. Thank you very much. Thank you, Mr. Chairman.
    Chairman Thompson. Thank you very much.
    Mr. Corr, for the sake of the information, once the vaccine 
is available, do you plan to make it available to the public 
free of charge?
    Mr. Corr. The short answer is, yes; but let me just back 
up, Mr. Chairman, to say one of the big differences in this 
effort with this virus is that the decision to make a vaccine 
and the decision to use it have been separated. We are doing 
everything in our power to get a vaccine ready; and in the 
coming months, we will make the decision whether we should have 
a vaccination campaign. We expect there will be one, but that 
decision hasn't been made. It would be distributed free of 
charge. We hope in the distribution system, if there is 
insurance coverage--Mr. Chairman, let me back up and correct 
myself just a little bit.
    There are still some key decisions like the feasibility of 
having private insurance that already covers vaccines to cover 
it. We are moving very quickly on trying to develop a 
distribution system since we will need a mixed distribution 
system, some through the private system and some publicly if we 
have to vaccinate a large number of Americans. So the 
feasibility of some aspects of the distribution system still 
have to be determined.
    Chairman Thompson. Thank you very much.
    The gentleman from Texas, Mr. Green, for 5 minutes.
    Mr. Green. Thank you, Mr. Chairman. I thank the witnesses. 
I especially thank the staff members for the excellent material 
that has been accorded us. I have found it to be fascinating. I 
am moved by an indication and perhaps I should ask a question 
rather than make a statement.
    Is it true that the United States of America has more cases 
recorded than any other country? Is this true?
    According to what I am looking at, we have 40,556, and that 
makes us about 40 percent of all of the known cases on record.
    Mr. Corr. Congressman Green, between the United States and 
Mexico, you have the vast majority of confirmed cases. But let 
me point out that the CDC estimates that there may have been a 
million Americans exposed to H1N1. So the number of confirmed 
cases is a fraction of what we actually expect has happened.
    Mr. Green. With 40,000, that gives us about 40 percent of 
the known cases, and it appears, and I would be tempted to ask 
a question, is it true that we have the most deaths reported? 
My intelligence indicates that we have 263 which appears to be 
half of all of the known deaths; is this true?
    Mr. Corr. The latest CDC numbers are 302 deaths in the 
United States as of July 24. Let me just ask. This is Dr. 
Nicole Lurie, who is the Assistant Secretary for Preparedness 
and Response and has some of the individual numbers. We will 
get that for you.
    Mr. Green. Listen, let me just say this to you, I have been 
where you are, and I have had to look back too, and I 
appreciate that.
    Mr. Corr. Thank you. I want to get you accurate 
information.
    Mr. Green. I am asking because while we have more 
population, we don't have more than China or India. We don't 
have more than a lot of other places in the world, and when we 
are 40 percent of all of the known cases in the world and half 
of all of the known deaths in the world, that causes me to 
pause and ask what is happening here in the United States?
    Mr. Corr. Congressman Green, we also have the finest 
surveillance system in the world, and I think we have a great 
deal more knowledge about what is happening among our citizens.
    Let me point out to you that in a normal flu season, 36,000 
Americans die from seasonal flu, including 500 to 1,000 
children. So the regular seasonal flu takes a huge impact on 
our population. That is why we are so concerned about H1N1, 
because it is a novel virus and could potentially do greater 
harm.
    Mr. Green. I would assume that we are concerned because of 
the possibility of simultaneous infections that will lead to 
mutations?
    Mr. Corr. That is the reason we are doing enhanced 
surveillance in the southern hemisphere. What can happen with a 
virus, as it moves to the southern hemisphere during their flu 
season is it can mutate and come back to the United States in a 
more virulent form. We are tracking it as carefully as we can 
to understand whether that is happening. So far it doesn't 
appear that it is, but we won't have final conclusion until we 
get further into the southern hemisphere's flu season.
    Mr. Green. Just one final question. The magnitude of this, 
we don't want to overexaggerate. We want to make sure that we 
maintain a level of understanding such that the public won't 
panic. It is important not to panic. But by the same token, it 
is important to understand the magnitude of what we may be 
confronting. I have a little bit of concern when I read the 
report that I have about the possibility of mutation and the 
impact of a mutated virus and also when I look at how we have 
handled this thus far. Just do this for me, when do you think 
we will know, have some idea as to whether the current vaccines 
that we have will be efficacious as opposed to having to deal 
with a mutation that may create another dynamic that we need 
not discuss?
    Mr. Corr. I will correct this for the record if I need to, 
but I think the clinical trials will occur over the next 2 
months. But I think in the next month, we will have additional 
information about the type of vaccine that we would use. Within 
the next 2 months, we will have a great deal more information 
about the actual virus itself and whether it has mutated as it 
had moved from the southern hemisphere back to the United 
States.
    Mr. Green. Thank you. I yield back the balance of my time.
    Chairman Thompson. I recognize Mr. McCaul from Texas for 5 
minutes.
    Mr. McCaul. Thank you, Mr. Chairman.
    So the strain we see today when seasonal flu season hits, 
it more likely than not will be a different type of influenza; 
is that correct?
    Mr. Corr. That is correct.
    Mr. McCaul. So the challenge will be to predict what the 
mutations will be, like you do with the influenza vaccines 
every year; is that correct?
    Mr. Corr. That is precisely the case.
    Mr. McCaul. I am concerned about this going into even a 
more deadly strain and what DHS and HHS has planned to deal 
with that. One is obviously the vaccine, trying to predict 
that, and the other issue would be the antivirals. Would the 
antivirals we have today be effective on a mutated strain?
    Mr. Corr. Well, we know that the antivirals we have today 
are effective against H1N1. I am not probably in the best 
position to answer the question about if there are mutations, 
but we can certainly get that information for you.
    Mr. McCaul. Just hypothetically, if it mutates into a 
strain that the vaccine cannot deal with or cover, we obviously 
would be looking at another vaccine and then the reliance on 
these antivirals would increase; is that fair?
    Mr. Corr. Yes. We would have to rely also upon community 
mitigation practices. It would involve encouraging people not 
to form in large groups. It may involve closing schools. The 
guidance as to when to consider closing schools is being 
written and will be available. Individual practices are so 
important under those circumstances. Businesses will have to 
plan. All of these things need to happen if we go forward with 
H1N1; and certainly if there is a variation on H1N1 as it comes 
back, it would be even more important for those practices to be 
followed.
    Mr. McCaul. Where are we right now with the stockpiling of 
these antivirals? I know that the National strategy relies on 
the States to purchase these, and maybe 31 million courses of 
treatment. The States have not purchased that amount yet; have 
they?
    Mr. Corr. My understanding is that we have roughly 35 
million courses of treatment which is a full course among the 
States now. An additional--the total is somewhere between 75 
and 100 million total courses available through the Federal 
Government and the State governments.
    Mr. McCaul. Do you feel that we have an adequate supply 
stockpiled to deal with this if the vaccine is not successful?
    Mr. Corr. Our public health experts believe that for the 
virus as we now project it, that we have sufficient antivirals. 
We have the manufacturers working full speed on antivirals, and 
we have purchased the capacity to develop the vaccine so we 
have moved ahead to make contracts to be sure that we have the 
manufacturing capacity committed to us to make the necessary 
medicines and vaccines.
    Mr. McCaul. When you look at mutations, and I am not an 
expert in this area but you are, but as we look at mutations, 
is it typical to look at, say, Latin America as they are 
dealing with their different change of seasons from ours and 
then it moves up north?
    Mr. Corr. It is across the entire southern hemisphere, in 
South America. We are looking in South Africa and Australia. 
Basically it is the flu season in the southern part of the 
world where we are looking because the virus moves to the 
colder climate, and then as it turns colder here, it is back in 
the United States.
    Mr. McCaul. So it is safe to say that when we hit the fall, 
we will have an increase in cases of H1N1?
    Mr. Corr. We expect we will; and we expect we will also 
have seasonal flu circulating at the same time.
    Mr. McCaul. What we have seen happen in terms of the colder 
climates, this influence of virus has not mutated in any 
significant way?
    Mr. Corr. So far.
    Mr. McCaul. That is the good news.
    Mr. Corr. It certainly is.
    Chairman Thompson. The gentleman from Pennsylvania for 5 
minutes.
    Mr. Carney. Thank you, Mr. Chairman.
    My question goes back to the planning aspect also. How are 
you employing the universities for the regional bio labs that 
exist, or are you for this?
    Mr. Corr. There is a network of universities that work with 
the NIH in our clinical studies, and the NIH has extensive 
experience in vaccine research and they are employing all of 
the resources that we have across the country to conduct the 
necessary trials and to collect as much information as we can 
as we go forward to make the decision about a vaccination 
program.
    Mr. Carney. Are those research labs, biocontainment labs 
part of a surge capacity? Ms. Lute.
    Ms. Lute. We are relying on the National labs for modeling 
information, and I think it is fair to say that we are jointly 
with HHS and with the other parts of the Federal family working 
very hard to mobilize the very best resources this country has 
to offer in order to fully anticipate how this virus will 
reoccur in the United States and be attentive and responsive if 
it does mutate. We are anticipating a number of scenarios. 
Again, we are in constant touch across the Federal agencies 
with State and local authorities with these sources of 
expertise to be sure that the very best knowledge is deployed 
to keep Americans safe.
    Mr. Carney. Respectfully, we spent $250 million on these 
regional biocontainment labs, and the upkeep hasn't been there. 
Are they going to be ready to go if we need them? Is there a 
way to make sure that we can continue to fund them because the 
upkeep hasn't been there? Are you planning on doing an 
investigation into their levels of readiness should they have 
to surge? Are you talking about perhaps a competitive grant 
program for them to ensure that they can meet the standards 
that we expect, that were intended?
    Ms. Lute. A process of readiness and preparedness for the 
fall, it ranges across all of the capabilities that will be 
required. We know that facilities are important, a important 
component of that.
    Mr. Carney. That is not the question.
    Ms. Lute. We are doing everything that we can to ensure 
that we will be ready for the fall.
    Mr. Carney. Okay. Thank you, Mr. Chairman.
    Chairman Thompson. Thank you very much.
    The gentleman from Louisiana, Mr. Cao for 5 minutes.
    Mr. Cao. Thank you, Mr. Chairman.
    This is a question to the panel. Besides incapacitating the 
work force, what other Homeland Security issues do you 
anticipate from the H1N1 virus?
    Ms. Lute. Among the issues that we are looking at is how 
State and local authorities, municipal authorities, are able to 
respond to the challenges that they face across public health, 
emergency response. Are there medical centers that they have 
and the critical infrastructure that sustains those medical 
centers? Have they done adequate planning? Are they doing 
adequate cross communication and talk? Are we aware of what 
weaknesses and gaps may exist? Are we taking appropriate action 
to fill them?
    Secretary Corr mentioned the importance of schools. Schools 
are a particular source of incubation and transmission for 
H1N1. We know that. We are working very closely with the 
Department of Education and CDC to ensure that responsible 
guidance is formulated and disseminated in a timely way.
    So in every dimension of public health, Secretary Corr can 
speak to, but emergency management and public policy response, 
we are paying attention.
    Mr. Cao. Is there a possibility that the H1N1 virus can be 
turned into a weapon?
    Ms. Lute. There are scenarios under which biological agents 
naturally occurring or occurring through man-made processes can 
be weaponized; but we have no indication in the current 
circumstance that anything regarding the H1N1 outbreak in the 
United States, or as it has unfolded in the hemisphere is, in 
any way, associated with that.
    Mr. Cao. Are the amounts of funding that you have received, 
are they sufficient to help your agencies coordinate with the 
State and local governments in connection with the H1N1 virus?
    Mr. Corr. Congressman, the supplemental funds that we have 
received, as I mentioned in my opening statement, a portion of 
those, $350 million have been granted to State and local 
government as well as to hospitals for preparedness planning. 
So that is the initial sources of funding that are going out. 
CDC is providing extensive guidance to State and local and 
territorial health departments, as well as Tribal governments, 
and we are working closely with them.
    Mr. Cao. A district like mine, 80 percent of the city post-
Katrina lacks a health care system and possibly medical 
providers to address a pandemic. How would Homeland Security 
and the different agencies address areas that are in tremendous 
need like New Orleans?
    Mr. Corr. May I just say initially in terms of the 
distribution of a vaccine if we were to conduct a vaccination 
campaign, one of the reasons for a mixed distribution system is 
to provide public health department sites so that individuals 
who don't have a regular provider, or if there is an inadequate 
number of medical providers, there is a place where all 
individuals would be able to go to get vaccinated.
    Mr. Cao. Thank you very much.
    Chairman Thompson. Thank you very much.
    The gentleman from New Mexico, Mr. Lujan, for 5 minutes.
    Mr. Lujan. Thank you, Mr. Chairman.
    Mr. Chairman, before I begin with my questions, in regards 
to the committee markup of H.R. 1881, the Transportation 
Security Workforce Enhancement Act of 2009, I ask unanimous 
consent that the record for the markup reflect that I would 
have voted ``yea'' on the question of adoption had I been 
present.
    Chairman Thompson. Hearing no objection, so ordered.
    Mr. Lujan. Mr. Chairman, thank you very much for this very 
important hearing.
    Mr. Corr, did I hear correctly that as we are preparing for 
this, that one of the things that has been looked at on how we 
will deliver some of the antiviral medication necessary to be 
distributed to people will be if their health insurance allows 
for it to be paid for?
    Mr. Corr. The question involved the vaccine distribution 
system. If we were to do a vaccination campaign that covers 
hundreds of millions of Americans, which is one possibility, 
the question is how we do that in a timely fashion? The 
expectation is that we would want to distribute it to 
providers, but also through public sites so that we can be sure 
that the priority groups that need the vaccine first receive 
it; and, secondly, so we actually reach the Americans that we 
need to.
    One of the issues we will have to deal with is we have the 
funds to pay for that vaccine, but to the extent that private 
insurance covers it, the decision would have to be made about 
whether to have the insurance companies cover that particular 
shot. The first and most important aspect of this is to get 
people vaccinated. If people go without vaccination, they may 
be exposed to H1N1 and become sick and expose others. So it is 
first and most important that we have a vaccination campaign, 
and those decisions will be made in that context.
    Mr. Lujan. So in that situation, Mr. Corr, it sounds like 
the more people we have covered, the better off we will be?
    Mr. Corr. I think that is always the case when it comes to 
health care.
    Mr. Lujan. Interesting.
    My next question is for Dr. Lute. In regards to H1N1, 
earlier in the year there was attention brought to the fact 
that Los Alamos National Laboratory and Sandia National 
Laboratory have in place a National Infrastructure Simulation 
and Analysis Center. I know some work was done in order to 
collaborate with them from a modeling perspective and 
preparation for what we could anticipate with this pandemic. 
What is the Department doing to work with our laboratories in 
utilizing NISAC and other resources to allow us to get out in 
front of this and continue to see what we can do from a 
preparedness perspective?
    Ms. Lute. Preparedness, as I mentioned, is a key concern of 
ours. To the extent planning and good modeling can inform 
planning, not only for how the virus will unfold and 
potentially spread in a community, there is a certain degree of 
unpredictability to this. This virus has a degree of virulence 
which is uneven, as we have come to understand it. So working 
very closely with the labs on the modeling and the entire 
environment of biosurveillance is key. As I mentioned earlier, 
we will rest on the science in making policy recommendations to 
State and locals.
    Mr. Lujan. In regards to preparation, getting the word out, 
coming from a border State, I hope that we are preparing in 
multiple languages, including Spanish. The district I represent 
represents many native nations, and so I hope that is being 
considered as we prepare in that regard.
    Speaking to that specifically with our tribal nations, what 
is being done to specifically coordinate with them and how can 
that be improved?
    Ms. Lute. From the perspective of the Department of 
Homeland Security, we have engaged in extensive coordination. 
We have had weekly conference calls continuing from the spring 
experience that we have had. We send out e-mail updates. The 
flu summit, as I mentioned earlier, involved State and local 
authorities, and urging them to put the word out. There will be 
webcasts in August. FEMA is engaging at a regional level to 
provide additional information and guidance for State and local 
plans. In addition, we are putting out teams specifically 
focused on pandemic preparedness to ensure that we are aware of 
gaps or problems that exist at the earliest opportunity.
    Mr. Lujan. Mr. Chairman, I would just close bringing our 
attention to one of the points that staff put in our report, 
which is that we need to drive to make every effort to do what 
we can now to save as many lives as possible in the future, and 
I think that should include now and in the future, Mr. 
Chairman. I think that it is important that we keep our eye on 
that ball.
    Chairman Thompson. I agree with you. The gentleman from New 
Jersey for 5 minutes.
    Mr. Pascrell. Mr. Chairman, may I simply start by saying 
that I think our committee should ask, and I am asking and if 
you think it is not in order----
    Chairman Thompson. Excuse me, Mr. Pascrell. Mr. Olson is 
next for 5 minutes. I hope the gentleman from New Jersey 
forgives me for that.
    Mr. Olson. Thank you all for coming today. I have a 
question for both Secretary Lute and Secretary Corr. About this 
time last year in September, my region was hit by Hurricane Ike 
which devastated much of the region and had a particular impact 
on some of the health care aspects, particularly the University 
of Texas, Galveston's medical branch. It basically was lost. 
They opened up their level 3 trauma center just this past week. 
They had been a level 1 before. We are under siege again. 
August and September are historically the big months when the 
strong hurricanes come through.
    If we had the misfortune of having a category 3, 4, or 5 
hurricane come hit the Texas Gulf Coast while we are in the 
middle of some sort of pandemic, H1N1, have you done the 
planning and do you have the resources to make sure that you 
can respond to both of those so that the pandemic doesn't run 
out of control?
    Mr. Corr. Congressman, you raise a very, very important 
question which we have asked ourselves. What the Department has 
done is go through our hurricane preparedness planning in every 
aspect and ask ourselves the question if we are in the middle 
of an H1N1 outbreak, how does it change what we need to do? How 
do we move patients? Where do we put individuals?
    The one thing you don't want to do in an H1N1 outbreak is 
collect lots of people in a small room, but that may be all we 
can do to move people out of the way of a hurricane. All 
aspects are being gone through thoroughly. We meet regularly 
with our State preparedness and emergency manager coordinators. 
So we will be working closely with them. We will be discussing 
this very situation, and we will provide extensive guidance 
before we get to flu season here again so we are in a 
comfortable position that we know how to act in the case we 
have an outbreak at the same time.
    Mr. Olson. Secretary Lute.
    Ms. Lute. What I would say is that the health and safety of 
citizens in a circumstance where we would have multiple issues 
to deal with of a significant traumatic nature for a community 
are very much on both of our minds. This is part of the 
contingency planning that we are doing. FEMA, at the outset of 
the hurricane season, convened a meeting of governors of States 
where hurricanes routinely hit during the hurricane season to 
advise them of preparedness measures, changes from procedures 
and issues to make them more aware of the hurricane dimension 
of that. In the context of that meeting, which I attended, and 
the Secretary did as well, the H1N1 virus and its reappearance 
was raised as well. As I mentioned, we have been in weekly 
contact, sometimes daily contact on these issues, to ensure 
preparedness, and we are thinking about the contingencies that 
you have raised.
    Mr. Olson. Thank you very much for that answer.
    One question about the liability, and that is for you, 
Secretary Corr: Can HHS ensure us that the liability issues are 
being addressed concerning the administration of a new vaccine 
so the health care workers are provided the coverage and will 
participate in the vaccination programs and won't be worried 
about the liability?
    Mr. Corr. My understanding is that current law protects 
them.
    Mr. Olson. Thank you very much, Mr. Chairman. I yield back 
the balance of my time.
    Chairman Thompson. Now the gentleman from New Jersey, Mr. 
Pascrell. We have about 4 minutes left on the vote.
    Mr. Pascrell. No problem, Mr. Chairman.
    Mr. Chairman, I am going to be asking for unanimous consent 
from both sides. We have heard some very startling testimony 
today from GAO. Every time you come here it is startling.
    I think that we should ask both Departments, who I have a 
great deal of respect for, that they respond to all of the 
concerns and recommendations laid before us today within the 
next 3 months. I ask unanimous consent for that request, Mr. 
Chairman?
    Chairman Thompson. Without objection.
    Mr. Pascrell. Thank you.
    Mr. Chairman, there are some concerns about whether 
Stafford Act disaster assistance is applicable here. Will the 
Department retain the FEMA disaster assistance policy on 
influenza pandemic which was issued in 2007?
    Ms. Lute. Congressman, what I can say is that the Stafford 
Act may be invoked under certain contingencies, and as may 
arise in the fall with the pandemic, and we plan for those 
contingencies and are prepared to respond appropriately.
    Mr. Pascrell. I just wanted to get you on the record for 
that. I think that is very critical to what we are talking 
about today.
    My next question is to both you, Dr. Lute, and Mr. Corr. 
Can you tell me, the replenishing of the 11 million antivirals 
in the Strategic National Stockpile, was that a one-time act or 
do you view it as the standard operating procedure as the 
Federal Government moves forward in facing the threat of H1N1 
in the coming months?
    Chairman Thompson. We have 2 minutes left in the vote.
    Ms. Lute. Certainly from the perspective of the Department 
of Homeland Security, maintaining a current and effective 
stockpile is essential. That is an on-going process.
    Mr. Pascrell. So this is going to be a regular practice?
    Mr. Corr. Certainly the purpose of the stockpile is to have 
it ready and available in the event it is needed.
    Mr. Pascrell. That may be the purpose. But I want to hear 
from you that this is going to be regular procedure and that 
this is not simply a one-shot deal. That is my concern.
    Mr. Corr. The Department of Health and Human Services 
certainly values the Strategic National Stockpile and hopes 
that it will stay full.
    Mr. Pascrell. My final question is what do you tell mothers 
and fathers about what they should be telling their kids about 
this particular virus we are talking about today?
    Mr. Corr. They should make getting the vaccination, if it 
happens, something that children view as, and I have got 
children and I am not sure how you make it fun to do, but you 
have to impress upon them the importance of it. Because I think 
they are going to hear about it in school. They are going to 
hear about the things they need to do depending upon their age, 
so I think we need to have a broad public discussion about this 
if we are going to succeed in our efforts.
    Chairman Thompson. Thank you very much. The committee will 
recess to take three votes. It should be about 20 minutes.
    [Recess.]
    Chairman Thompson. We would like to reconvene our recessed 
meeting. We have been told that we have about an hour before 
the next series of votes.
    At this point, our gentlelady from New York, if she has any 
questions, while she is getting ready, a comment came to mind 
for the panel relative to the vaccine that we talked about a 
little earlier and the question continues to be, when we have 
reached the critical number that the Department is comfortable 
with, will the Department look at some distribution process 
that would allow the immunization to occur; or is your 
testimony, Mr. Corr, that that is still being looked at?
    Mr. Corr. Mr. Chairman, one of the important lessons 
learned in 1976 with the previous swine flu vaccination program 
is that it is important to separate the decision to make a 
vaccine from the decision to use it. We have made the decision 
because we have to in order to have the vaccine manufactured as 
quickly as possible, to go forward with the manufacturing.
    But the decision to start the vaccination campaign will 
benefit from the additional information we can collect. If you 
ask us--Do we expect there will be a vaccination campaign?--I 
think the answer is yes. But the decision needs to await 
additional information that we will collect in the Southern 
Hemisphere and in the United States. That decision will be made 
soon.
    Chairman Thompson. Thank you very much.
    I hope the point Mr. Pascrell made was not overlooked. It 
is the committee's intention, based on GAO recommendations, for 
some 3-month period of time, if at all possible, for you to 
fully implement the recommendation. If not, the expectation is 
you would indicate back to the committee which ones you are 
unable to accomplish.
    The gentlelady from New York for 5 minutes.
    Ms. Clarke. Thank you very much, Mr. Chairman.
    Thank you, Ranking Member.
    This examination of the current status of H1N1 is so very 
important right now. We are still hearing of occurrences not 
only in our Nation, but around the world; and so it is very 
timely that we address this now, particularly before we go into 
our recess and come back towards the fall.
    My question to both you, Mr. Corr, and to you, Dr. Lute, 
has to do with the sale and movement actually of counterfeit 
pharmaceuticals across our borders.
    As you know, the sale and movement of counterfeit 
pharmaceuticals across our borders into the United States is a 
growing problem, and both of your agencies have been involved 
in investigating cases involving these counterfeits, the FDA 
under HHS and ICE of the DHS.
    Can you talk about what the FDA and ICE, as well as CBP, 
are doing to address counterfeit vaccine for H1N1 as well as 
counterfeit antivirals and other medications that make 
unsubstantiated claims to treat H1N1 influenza illness?
    Ms. Lute. I might just begin by underscoring what you know 
already to be true about the role of ICE in investigating any 
suspected cross-border engagement of counterfeit 
pharmaceuticals. This is very much a contingency that we are 
aware of.
    We recognize that there are certain incentives for groups 
to profit from what we expect to be a major national incident, 
come the fall; and we are very vigilant on that and working 
together with our colleagues throughout the system to be sure 
that we have complete--as complete as possible surveillance and 
detection and interdiction and disruption and proper law 
enforcement accountability, should that circumstance arise.
    Mr. Corr. Congresswoman, I think that is a complete answer 
certainly as far as the Food and Drug Administration and HHS 
are concerned.
    Ms. Clarke. I think that our vigilance is really going to 
be important here, and unfortunately, there are those out there 
who would exploit a situation like this. We already know that 
in many instances, there is a big profit to be gained from 
counterfeiting, and we just want to make sure that our 
population is well-protected.
    So we look forward to any finding that you may have about 
any developments, any cooperation that you would be getting 
from any of our partners across the border about any instances 
that they may have encountered as they are beginning to deal 
with the flu season in their respective areas.
    My next question is about science and technology 
challenges.
    The committee is always on the lookout for new technologies 
that will help us address the threats facing this Nation. But I 
am kind of disappointed to see that we have not made further 
progress in getting beyond the use of egg-based technologies 
for vaccine production, still depending on that technology for 
the H1N1 vaccine this time around. However, I am heartened that 
the administration is supporting the development of new 
technologies to create new vaccines, diagnostic tests, et 
cetera.
    Mr. Corr, could you tell us about the contract that HHS has 
with Protein Sciences Corporation to develop its technique for 
making influenza vaccines by growing flu virus proteins in 
insect cells?
    Dr. Lute, please discuss what DHS is doing to support 
information via its Science and Technology Directorate.
    Mr. Corr. Congresswoman, as you point out, the resources of 
the Department, our advanced research resources, have focused 
on developing new methods of making vaccines and other 
products. I can't speak to you off the top of my head about 
that particular methodology. We will get that information for 
you.
    But rest assured that we recognize that using egg-based 
technology is not as efficient and as productive as we need. As 
we move forward with this, it is a very important aspect of our 
advanced development program to find other development 
technologies that will produce more vaccine and at lower 
prices.
    Ms. Clarke. Thank you.
    Ms. Lute. I would only add, Congresswoman, that we work 
very closely with HHS and Science and Technology, along with 
personnel and partnerships, forms the backbone of the 
Department of Homeland Security's response to all risks and 
hazards that the country faces.
    While HHS has the lead on the medical side and the 
scientific side, we are certainly attentive and alert to 
technologies that enhance our ability to understand how risks 
are approaching our shores, how we can more effectively 
communicate the necessary actions people need to take. We will 
stay in close coordination with our other colleagues, 
especially HHS, as this season unfolds.
    Ms. Clarke. Thank you very much.
    Thank you, Mr. Chairman. I yield back.
    Chairman Thompson. Thank you very much.
    The Chair now recognizes the gentleman from Florida, Mr. 
Bilirakis, for 5 minutes.
    Mr. Bilirakis. Thank you very much, Mr. Chairman. This 
question is to for Deputy Secretary Lute, Deputy Secretary 
Corr.
    In his written testimony, Mr. Farley, New York City's 
Health Commissioner, stated the majority of individuals who die 
each year in New York City from influenza are over the age of 
65. As you may know, my district in Florida is home to a 
significant elderly population, and the H1N1 strain of 
influenza is particularly virulent.
    How are you, how are your Departments working with the 
State and local governments to provide outreach and information 
to elderly and other special needs populations? What 
recommendations are you making to State and local governments 
as they work to prepare these populations? Who should be 
vaccinated?
    That is the question for the two of you. Thank you.
    Ms. Lute. Mr. Chairman, with your permission, perhaps I 
will begin as reaching out to State and local authorities and 
municipalities.
    From the very beginning, in the spring when this virus 
presented itself, this was recognized by the Department, by the 
Federal Government, as an important aspect of mobilizing any 
national response to this virus; in other words, that we needed 
to have the Federal Government tightly connected to State and 
local authorities to ensure that the best information based on 
the best science was put out in as timely a way as possible, 
and that we had plain language guidelines that people could 
follow. CDC and HHS have worked tirelessly to improve the 
websites and to improve the content of the information and the 
substance that is being put out to the public.
    As I mentioned earlier, we have been giving daily e-mail 
updates, twice weekly conference calls to the private sector, 
which represents an important component of community life, we 
recognize; weekly conference calls, e-mails, updates to State 
and local authorities, a flu summit that was conducted so that 
people were aware of the best knowledge that we had at the 
time. A webcast is planned for August, and FEMA has been making 
available planning templates and planning training as well.
    Mr. Corr. Congressman, I would just add that one of the 
challenges this flu season is going to be that we expect 
seasonal flu to be circulating at the same time that H1N1 is. 
From an elderly person's or a senior citizen's perspective, 
H1N1, at least so far, appears to be more severe among younger 
people, among children and younger people that have other 
underlying conditions. It doesn't seem to be as severe in 
senior citizens. It may be because of some partial immunity 
developed from the swine flu in 1976 or earlier flus that they 
were exposed to.
    This just points up, though, the incredible importance of 
communicating clearly to the public through our work with the 
State and local and Tribal and territorial health departments, 
as Secretary Lute was saying, so that people understand how 
important it is to get their seasonal flu shot and to get their 
H1N1 shot.
    So we will be endeavoring to make sure the public 
understands what they need to do.
    Mr. Bilirakis. With regard to the younger people, my 
State's acting epidemiologist has said that as many as 5 
million Floridians could contract the H1N1 virus within the 
year if the virus follows the pattern of previous pandemics. 
There have been at least 22 deaths in my State of individuals 
who had the H1N1 virus. I am especially concerned that the 
number of cases in Florida will skyrocket when schools begin in 
the fall.
    Since this virus has disproportionately, as you said, 
affected school-age children, would each of you please comment 
on the following questions:
    What recommendations should we provide parents of school-
age children in my district about how to protect their children 
from this virus;
    Should children with this virus stay home from school;
    Should school administrators close schools;
    Which schools have become infected with this virus; and,
    Are there uniform recommendations about how long schools 
should remain closed under such circumstances?
    If you could address those--one more--what Federal 
Department or Agency is the lead authority when it comes to 
such guidance?
    Thank you very much.
    Ms. Lute. Again, Mr. Chairman, with your permission, I 
might just begin in response.
    The issue of schools and school closures was one of the 
things that we learned during the spring. This is, as you 
rightly point out, a source of quickly spreading the disease 
among--the virus among young people. So we are very aware of 
the importance of getting good guidance out, again, based on 
the principle of the best scientific knowledge and evidence.
    We are in the process of formulating, with the Department 
of Education and our colleagues from CDC and Health and Human 
Services, that guidance, so that it can be promulgated and that 
school administrators can have a plain-language--access to 
plain-language instructions for making those decisions on a 
school-by-school and municipality basis.
    Mr. Corr. Congressman, I would just add that it is very 
important for parents to explain to their children some basic 
steps they can take that will protect them. It is the same 
instructions, really, for all of us, which is that if you are 
coughing or sneezing, you cough into your arm; that if you are 
sick, you stay home, that you wash your hands frequently; do 
not touch your eyes, nose or mouth. Those basic steps can make 
a huge difference in the transmission of the virus.
    Having said that, the guidance that Secretary Lute talked 
about and worked with the school systems are very important for 
them to understand what steps they should take as the exposure 
to the virus spreads.
    Chairman Thompson. The gentleman's time has expired.
    The gentleman from Texas, Mr. Cuellar, for 5 minutes.
    Mr. Cuellar. Thank you, Mr. Chairman. This question is to 
Dr. Lute and Mr. Corr.
    How has the pandemic influenza National planning scenario 
informed you of your plans and response efforts, question No. 
1? The second part is, have your agencies considered how a 
pandemic could be taken advantage of by terrorists and how do 
you respond under that particular scenario?
    Ms. Lute. With your permission, Mr. Chairman, I will begin.
    The National scenarios provide a basis and a foundation for 
understanding how to approach with best planning needs and 
understanding the gaps that exist in the state of our National 
preparedness to deal with this.
    We have learned a lot, I would like to underscore, Mr. 
Chairman, about this pandemic and how we could--we should 
respond to it, the state of readiness that exists in the 
Federal Government, at the State and local level, what 
knowledge gaps exist and what tools are necessary so that 
individuals can be empowered, communities can be capable of 
dealing with the scenarios that may unfold, and the Federal 
Government is responsive to meet their needs.
    We have also--in the Department of Homeland Security we 
remain vigilant every single day about the potential for 
terrorists to exploit any set of circumstances which they may 
perceive as a vulnerability. This virus will not represent a 
vulnerability for terrorists to exploit. This is a 
circumstance, it is a public health circumstance; it is Nation-
wide.
    It is unique; we are taking, in some cases, unique 
measures. For example. We are deploying regional coordination 
teams which will focus on pandemic preparedness and response to 
allow the other elements of the Homeland Security family to be 
able to focus on their responsibilities in maintaining 
vigilance and leading the American effort to protect ourselves.
    Mr. Corr. Congressman, I would just add that looking back 
at the preparedness planning that has gone on, as the GAO did, 
is very helpful in recognizing where we still have gaps. But we 
are learning first-hand a great deal about how to prepare for 
and implement our plans. I think that as we work our way 
through this, we are going to be able to substantially enhance 
and improve our long-term planning for pandemics of other 
types.
    Mr. Cuellar. Thank you.
    Dr. Lute, let me focus on Customs Border Protection folks, 
which are the men and women in blue, as you know, on the border 
area. If they don't have a sufficient--well, let me ask you, 
let me put it this way.
    Are they sufficiently qualified to determine who might 
display symptoms of a particular illness, No. 1?
    No. 2 is, what protection are we giving to those men and 
women at the border?
    Ms. Lute. Congressman, these extraordinary men and women 
who police our borders and provide the protection and the 
secure borders that the American people have a right to expect 
conduct screening of individuals every day as they cross. They 
are not medical doctors, equipped with the expertise that 
doctors do have to be able to specifically identify symptoms 
and the underlying condition which may give rise to those 
symptoms. But we have a very close working relationship with 
CDC, as you know, so that when individuals are identified that 
may present particular symptoms and conditions, they can be 
referred for additional screening and appropriate action as 
necessary.
    Mr. Cuellar. I do understand that they are not M.D.s. I do 
understand that you have got resources. But I guess my question 
is, what sort of training have they gotten to identify those 
symptoms?
    Ms. Lute. We have conducted training of the Customs Border 
as well as our Transportation Security officers on H1N1, the 
symptoms that present themselves. It is important to recognize 
that the virus can be present and a person can be asymptomatic 
for a period of time. Again, we rely on medical advice and 
assistance for this purpose.
    But we screen every day, and we are adding this information 
to their skill set as they perform their duty.
    Mr. Cuellar. Thank you, Dr. Lute.
    Mr. Corr and Ms. Steinhardt, I appreciate what you do at 
the GAO with the strategic work. Thank you.
    Thank you, Mr. Chairman.
    Chairman Thompson. Thank you very much.
    I would like to thank our first panel of witnesses for 
their valuable testimony and Members for their questions. 
Before being dismissed, I would remind our first panel of 
witnesses that the Members of the committee may have additional 
questions for you, and we ask that you respond expeditiously in 
writing to those questions.
    I would like to ask the clerk to prepare the witness table 
for our second panel of witnesses; and again, thank our first 
panel of witnesses for their very valuable testimony.
    We have been told that we have another series of votes, and 
I am going to try to get through the witness statements first, 
and then we will come back to questions and we will go right 
into the questions.
    I would like to welcome our second panel of witnesses. Our 
first witness, Ms. Colleen Kelley, is president of the National 
Treasury Employees Union.
    Our second witness is Mr. Richard Muth. Mr. Muth is 
director of the Maryland Emergency Management Agency.
    Our third witness is Dr. Mark Horton. He serves as the 
California State health officer and as the director of the 
California Department of Health.
    The fourth witness is Dr. Thomas Farley. Dr. Farley is 
health commissioner for New York City.
    We thank our witnesses for their service to their States 
and to the Nation and for being here today. As previously 
stated, each witness's full statement will be inserted in the 
record. I now ask each witness to summarize his or her 
statement for 5 minutes, beginning with Ms. Kelley.

 STATEMENT OF COLLEEN M. KELLEY, PRESIDENT, NATIONAL TREASURY 
                        EMPLOYEES UNION

    Ms. Kelley. Thank you very much, Chairman Thompson and 
Ranking Member King and committee Members. I appreciate the 
opportunity to testify on behalf of thousands of employees 
represented by NTEU, who work every day to protect our country 
from threats and who have continued to do their critical work 
diligently during the on-going H1N1 flu outbreak.
    This outbreak has raised serious concerns about how the 
Federal Government creates and communicates policies to protect 
the health of front-line Federal personnel. Most troubling to 
NTEU is that key stakeholders, including Federal employees and 
their employee representatives, are not consulted in the 
development of pandemic response strategies. We have not had 
the opportunity to participate in the development of or comment 
on the November, 2005 National Strategy for Pandemic Influenza 
and the May 2006 Implementation Plan.
    NTEU commends you, Mr. Chairman, for recognizing this 
glaring weakness in the committee's January 2009 report Getting 
Beyond Getting Ready for Pandemic Influenza and for calling on 
the new administration to address this shortcoming.
    The NTEU members at the Department of Homeland Security 
most affected by the outbreak of the H1N1 influenza are Customs 
and Border Protection officers and agriculture specialists who 
work at the land, sea, and air ports of entry and 
Transportation Security officers who work at the airports. Both 
groups of employees interact with thousands of travelers in a 
single shift. Their work includes reviewing immigration 
documents, wanding passengers, questioning them and sometimes 
patting them down or detaining them. It requires them to be 
within 6 feet of the travelers that they process.
    The CDC's general guidelines of avoiding crowds and 
maintaining a distance of 6 feet from those exhibiting illness 
is clearly not possible for these DHS employees who are at 
increased risk of exposure. Specific guidance must be developed 
and communicated clearly and in writing to them.
    For the past 3 months, NTEU has repeatedly requested clear, 
written guidance from DHS with respect to the voluntary use of 
personal protection equipment, including N95 masks for these 
front-line employees at CDC and TSA. Because of the Agency's 
reluctance to issue clear and written voluntary use guidance, 
NTEU worked with Congress on this critical subject. On June 4, 
the full House approved an NTEU-supported amendment to the TSA 
Authorization Act that requires TSA to allow personnel to 
voluntarily wear PPE during an emergency.
    House appropriators also added NTEU-supported language to 
the fiscal year 2010 DHS appropriations bill, which ensures 
that DHS personnel may voluntarily use PPE, including masks, 
without being subject to discipline. We appreciate this 
committee's support on these efforts and its continued focus on 
pandemic preparedness, particularly with regard to the impact 
on the Federal workforce.
    NTEU believes that congressional involvement has helped to 
move Homeland Security to begin to clarify and communicate its 
guidance. On May 29, TSA issued policy guidance on PPE that is 
clear and allows TSA's discretionary use of the N95 masks; but 
the May 29 TSA guidance was not initially shared with TSA 
employees, and according to our Members, was only recently 
distributed to TSA personnel, just 10 days ago. This delay in 
publicizing the TSA PPE voluntary use guidance is very 
troubling.
    With respect to PPE guidance at CBP, after initially 
prohibiting voluntary use, I am pleased to report that just a 
few hours ago, NTEU signed an agreement with CBP to permit 
employees the option, at their discretion, of donning 
protective masks including the N95 respirators. NTEU's 
experience with Homeland Security during the initial and 
continuing outbreak of H1N1 influenza highlights the need for 
open and frank communication between all Federal agencies, 
their employees and their employee representatives.
    A resurgence of the H1N1 flu is expected in the fall, as we 
know, and important issues must be addressed now that will 
impact all Federal workers, but especially those on the front 
line who, by the very nature of their jobs, work in close 
contact with huge numbers of travelers who may be infected. 
Therefore, NTEU makes the following recommendations:
    No. 1, that a determination must be made as to whether some 
Federal workers should receive priority in a vaccination 
distribution;
    No. 2, that Federal leave policies must be clear, 
especially in the case of working parents who may have a sick 
or quarantined child or a child whose school or day care is 
closed;
    No. 3, social distancing is a key factor in preventing the 
spread of the flu, and for this reason Federal telework 
programs must be up and running to facilitate continuity of 
operations;
    No. 4, in the case of substantial reduction of personnel 
due to illness, shifting of job location and duties of Federal 
personnel may be necessary to maintain operational control; 
shift extensions, overtime, cancellation of leave and travel 
requirements will be critical in order to address a pandemic-
induced reduction in the Federal workforce; and
    No. 5, clear written personnel policies must be in place to 
address these contingencies, and frequent, updated 
communication with the Federal workforce and Federal employee 
representatives is absolutely essential.
    Thank you again for the opportunity to testify, and I look 
forward to any questions.
    [The statement of Ms. Kelley follows:]
                Prepared Statement of Colleen M. Kelley
                             july 29, 2009
    Chairman Thompson, Ranking Member King, distinguished members of 
the Committee: I would like to thank the committee for the opportunity 
to provide this testimony. As President of the National Treasury 
Employees Union (NTEU), I have the honor of leading a union that 
represents hundreds of thousands of Federal worker including thousands 
of Transportation Security Officers (TSOs) at the Department of 
Homeland Security's (DHS) Transportation Security Administration (TSA) 
and 22,000 Customs and Border Protection (CBP) Officers, Agriculture 
Specialists (CBP AS) and trade enforcement specialists who are 
stationed at 327 land, sea, and air ports of entry (POEs) across the 
United States. TSOs, CBP Officers and CBP AS make up our Nation's first 
line of defense in the wars on terrorism, drugs, contraband smuggling, 
human trafficking, agricultural pests, and animal disease while at the 
same time facilitating legitimate trade and travel.
    Employees on the frontlines of our Nation's borders and airports 
are exposed to many threats, the newest being exposure to the H1N1 
influenza. On Wednesday, April 22, 2009, the first reports of H1N1 flu 
exposure in the United States became public and the press began 
reporting on a swine flu outbreak originating in Mexico. To date, it is 
suspected that there have been as many as 2 million H1N1 flu cases in 
the United States. H1N1 flu outbreaks are documented daily. Currently, 
at the U.S. Coast Guard Academy in New London, Connecticut, over 10 
percent of the freshman class has H1N1 flu.
    This outbreak has raised serious concerns about how the Federal 
Government creates and communicates policies to protect the health of 
key frontline Federal personnel. Most troubling to NTEU, is that key 
stakeholders, including Federal employees and their employee 
representatives, are not being consulted in the development of pandemic 
response strategies and had not been afforded the opportunity to 
participate in the development of or comment on the November 2005 
National Strategy for Pandemic Influenza and the May 2006 
Implementation Plan. NTEU commends the Chairman for recognizing this 
glaring weakness in the committee's January 2009 report entitled, 
``Getting Beyond Getting Ready for Pandemic Influenza'' and for calling 
the new administration to address this shortcoming. I applaud the 
Homeland Security Committee for holding this timely hearing.
    Policies to mitigate health risks for Federal employees should vary 
according to the type of work being done and the potential for 
exposure. The general guidelines, which include staying out of crowds, 
do not adequately address situations where an employee's entire work 
shift requires him or her to be in close contact (within 6 feet) of 
literally thousands of travelers, which is the case for Transportation 
Security Officers, Customs and Border Protection Officers, and 
Agriculture Specialists.
    Specific guidance must be developed and communicated clearly and in 
writing to these employees who are at increased risk of exposure. It is 
unacceptable and shocking that more than 3 months after the initial 
onset of H1N1 flu in the United States and despite repeated urging from 
NTEU and others, there is still no comprehensive guidance in place to 
protect the health of these frontline employees.
    The September 2007 CBP Operations Plan for Pandemic Response states 
that ``CBP is the first line of our Nation's defense against a 
pandemic, both overseas and along our border.'' This plan was 
formulated in response to the possible outbreak H5N1 avian flu 
pandemic. According to this plan, ``CBP could experience a substantial 
reduction of personnel due to illness (approximately 30% to 50%), 
potentially having a substantial impact on sustaining continuity of CBP 
operations . . . Once a pandemic begins to spread, significant numbers 
of infected travelers at and between the POEs may be searched, 
detained, transported, and housed by CBP pending removal or transfer 
into the custody of medical authorities, impacting CBP's ability to 
perform its mission . . . In spite of this, CBP must continue to carry 
out its priority mission to prevent the entry of terrorists and their 
weapons, regardless of the circumstances. To accomplish this, CBP will 
need to protect its workforce . . . ''.
    It was therefore extremely troubling to NTEU that DHS issued 
conflicting and confusing guidance to frontline CBP Officers and TSOs 
during the initial H1N1 spring outbreak. Shortly after the swine flu 
outbreak became public in late April 2009, NTEU started receiving 
questions from our members at ports of entry around the country. In 
numerous locations, personal protection equipment (PPE), including 
gloves and N-95 respirators, was distributed to employees. At JFK 
Airport in New York, for example, distribution to CBP employees began 
on April 25 and continued through April 26 with little guidance. In the 
afternoon of the 26th employees were initially told they were only to 
wear the respirators if in contact with an ill individual. Later they 
were told they were not to wear the respirators at all, so as not to 
alarm the public or offend passengers.
    On April 26 Homeland Security Secretary Napolitano sent a message 
to DHS employees working near the Southwest border. That message 
stated: ``CDC recommends that a distance of 6 feet should be maintained 
between all employees and someone who appears ill. The use of N95 masks 
is suggested if an employee must maintain closer contact than the 6 
feet of distance.''
    On April 28, a CBP spokesperson was quoted in CNSNews.com saying, 
``CBP officers and Border Patrol agents are provided personal 
protection gear which they may utilize at their discretion.''
    On April 30 a DHS spokesperson was quoted in a media report saying, 
``the Department of Homeland Security has not issued an order saying 
our employees cannot wear masks.''
    Transportation Security Officers at Dallas/Fort Worth Airport were 
issued masks on April 26 and on the 28th told they could not wear them 
unless they were dealing with a traveler exhibiting swine flu symptoms.
    According to a press report in the Washington Times on May 2, a TSA 
PowerPoint presentation was distributed to TSA employees on April 29 
that stated: `` . . . the routine wearing of protective masks by TSA 
personnel in the workplace is not authorized . . . In addition to not 
being medically necessary, the masks interfere with normal 
[transportation security operation] duties and hold the potential for 
unnecessarily alarming the public . . . ''.
    NTEU requested a copy of the PowerPoint presentation, but was told 
it was not available for public distribution.
    As soon as questions began coming in to NTEU from our members 
around the country as to whether they could wear respirators or masks, 
NTEU began trying to find out what the current policy was and urged 
that these employees be allowed to wear the masks if they felt their 
health was at risk. We contacted CBP, TSA, and DHS. DHS was saying it 
had not issued a Department-wide order prohibiting the voluntary 
wearing of masks, but CBP and TSA were clearly enforcing such a 
prohibition.
    Some statements from DHS that appeared in the press indicated that 
managers who were preventing the wearing of masks were misinformed 
about the actual policy. The idea that a few managers were misinformed 
is clearly not accurate. NTEU heard from many, many employees from 
around the country and attached to this testimony are affidavits from 
some of them relating instances of supervisors demanding that they 
remove respirator masks.* Many of them are disturbingly threatening and 
many include comments indicating the reason was fear of alarming the 
public. I trust this committee will ensure that the employees providing 
these affidavits will be free from any negative impact.
---------------------------------------------------------------------------
    * The information has been retained in committee files.
---------------------------------------------------------------------------
    On April 30, DHS issued Interim Guidance stating that: ``Employees 
who work closely with (either in contact with or within 6 feet of) 
people specifically known or suspected to be infected with the H1N1 
virus must wear respiratory protection.'' The guidance did not address 
the question of the voluntary donning of masks. In addition, the 
Interim Guidance noted it was being released ``as an interim measure 
until the Office of Personnel Management provides comprehensive 
guidance for all Federal employees.'' OPM has since indicated it does 
not intend to provide such Government-wide guidance, stating that on 
questions such as this, affecting narrow segments of the workforce, 
decisions are up to the individual agency.
    On May 1, I wrote to DHS Secretary Napolitano and OPM Director 
Berry urging that written guidance be issued immediately clarifying 
that these frontline employees would be allowed to wear masks at their 
discretion. On May 5, CBP Acting Commissioner Ahern sent out an 
employee message reiterating the mandatory use of respirators when 
employees were in close contact with people known or suspected to be 
infected with the H1N1 virus. The message included no reference to the 
voluntary wearing of respirators despite NTEU's repeated requests to 
CBP for such guidance.
    On May 8, I sent a second letter to Acting TSA Administrator 
Rossides and a letter to Acting CBP Commissioner Jayson Ahern asking 
again for written guidance that these employees be allowed to wear 
respirators/masks at their discretion.
    On May 14, 2009, I testified before the House Committee on 
Oversight and Government Reform Subcommittee on the Federal Workforce, 
Postal Service and District of Columbia about the Department of 
Homeland Security's (DHS) refusal to allow Customs and Border 
Protection (CBP) and Transportation Security Administration (TSA) 
employees to wear a respiratory mask, if they so choose, to help 
protect them from infection from the swine flu virus.
    At the hearing, Subcommittee Chairman Stephen Lynch (D-MA) offered 
to work with NTEU on legislation if this situation was not quickly 
corrected by the Department. On Friday, May 29, the Department of 
Homeland Security Under Secretary for Management, Elaine Duke, issued 
an updated guidance regarding the use of Personal Protective Equipment 
(PPE), as it applies to working in close proximity to persons 
exhibiting symptoms of the H1N1 virus. But again, the guidance failed 
to provide a clear and reasonable policy allowing for the donning of a 
mask at your discretion in situations not involving close contact with 
an apparently infected person. On June 1, I sent a letter to DHS Under 
Secretary Duke seeking clarification of the May 29 guidance.
    On June 4, the House of Representatives passed H.R. 2200, the TSA 
Authorization Act. On the House floor, Representative Lynch offered an 
amendment to provide that any TSA personnel may voluntarily wear 
personal protective equipment (including surgical and N95 masks, 
gloves, and hand sanitizer) during any emergency. NTEU worked closely 
with Representative Lynch and strongly supported this amendment. The 
Lynch amendment was passed by voice vote and became part of the bill. 
The bill now goes to the Senate for consideration.
    Unfortunately, H.R. 2200 was limited to TSA-related provisions; 
therefore, the amendment does not address the discretionary use of PPE 
by CBP Officers and CBP Agriculture Specialists at the ports of entry 
that also daily come into close contact with thousands of travelers 
transiting into the United States.
    On June 16, NTEU testified before the Senate Homeland Security and 
Governmental Affairs Subcommittee on Oversight of Government 
Management, the Federal Workforce, and the District of Columbia on this 
issue. NTEU asked the committee to include similar language to the 
Lynch amendment in any upcoming legislation that includes CBP 
jurisdiction.
    Working with House Appropriators and Representative Lynch, NTEU got 
language in H.R. 2892, the fiscal year 2010 DHS House appropriations 
bill that would allow DHS personnel the discretionary use of masks 
without being subject to discipline.
    Also, NTEU serves on the Federal Advisory Committee on Occupational 
Safety and Health (FACOSH). NTEU believes that the Occupational Safety 
and Health Administration has the expertise to formulate the pandemic 
flu workplace health and safety response and submitted a resolution to 
that effect at their scheduled meeting in June. As a result, a FACOSH 
work group was established to address emerging worker health and safety 
issues, including the voluntary use of PPE by Federal workers, 
surrounding the H1N1 flu.
    Despite these continued efforts, CBP issued a new guidance on June 
17, 2009 that stated that ``employees may use the personal protective 
equipment (PPE) in situations where they believe it is needed to safely 
carry out their duties.'' This guidance, however, was followed by 
management guidance on June 19 that stated ``Any employee who feels it 
is necessary to don PPE to perform their normal duties, must first 
contact their immediate supervisor . . . If after consultation with 
their supervisor the employee still has concerns, the employee will be 
allowed to wear PPE . . . Each request to don PPE must be considered on 
a case by case basis by CBP management.''
    NTEU met with DHS and CBP officials on July 14 and raised this 
contradictory language and asked them to agree to a Memorandum of 
Understanding (MOU) with us that is clear and unambiguous. On July 23, 
NTEU received a proposal that we believe will be acceptable to our 
members. As of the submission of this testimony, NTEU and CBP appear 
close to an agreement.
    Unlike the June 19 CBP guidance, on May 29, 2009, TSA issued Policy 
Guidance on Personnel Protective Equipment that is clear and allows 
TSOs discretionary use of N95 masks. But the May 29 TSA guidance was 
not shared with TSA employees and, according to TSOs, was only just 
distributed to TSA personnel after the reported H1N1 flu-related death 
of a TSO at the San Juan Airport on July 19.
    These experiences with DHS during the initial and continuing 
outbreak of H1N1 influenza highlights the need for open and frank 
communication between Federal agencies, their employees, and their 
employee representatives. The U.S. Government expects a resurgence of 
the H1N1 flu strain in the fall and continues to prepare for the 
upcoming 2009-2010 winter flu season. The timing, severity, and the 
geographic location of the resurgent H1N1 influenza remains unknown, 
but important issues must be addressed now for all Federal workers, 
especially those on the frontline who are responsible for keeping our 
air, sea, and land ports open to trade and travel. Those issues 
include:
    (1) Clear guidance is needed as to whether some Federal workers 
        should receive priority when a vaccination is approved and 
        distributed to the public.
    (2) Federal leave policy must be clear, especially in the case of 
        working parents who may have a sick or quarantined child or a 
        child whose school or daycare is closed.
    (3) Social distancing is a key factor is preventing the spread of 
        flu. For this reason, Federal telework programs must be up and 
        running to facilitate continuity of operations.
    (4) In the case of substantial reduction of personnel due to 
        illness, shifting of job location and duties of Federal 
        personnel may be necessary to maintain operational control. 
        Shift extensions, overtime, cancellation of leave, and travel 
        requirements will be critical in order to address a pandemic-
        induced reduction in the Federal workforce.
    (5) Clear written personnel policies must be in place to address 
        these contingencies and frequent, updated communication with 
        the Federal workforce and Federal employees' representatives is 
        absolutely essential.
    NTEU appreciates the committee's continued focus on pandemic 
preparedness and its insistence on common-sense guidance with respect 
to protecting frontline DHS personnel and the entire Federal workforce. 
NTEU pledges to work with Congress and our agency partners to address 
the personnel challenges of a potentially severe pandemic and help to 
ensure the continuity of Federal services.
    Thank you again for holding this important hearing.

    Chairman Thompson. Thank you very much for your testimony.
    We now recognize Mr. Muth for 5 minutes.

  STATEMENT OF RICHARD G. MUTH, EXECUTIVE DIRECTOR, MARYLAND 
                  EMERGENCY MANAGEMENT AGENCY

    Mr. Muth. Good afternoon, Chairman Thompson, Ranking Member 
King and Members of this committee. Before being appointed to 
my current position, I served in the Baltimore County Fire 
Department for over 30 years, including 15 years as the 
county's Emergency Manager. I thought that was important to 
say, because I come here today representing both the State 
government but also with much experience at the local level.
    It is an honor to be invited here today to discuss 
Maryland's current preparedness and response activities for the 
H1N1 and the critical issues that remain a challenge for the 
future.
    A pandemic flu response presents a set of challenges are 
that different from other emergencies. Since the last severe 
pandemic in the United States happened about 90 years ago, we 
don't have any hands-on experience dealing with one; and unlike 
most emergencies, especially declared disasters, it does not 
have a well-defined beginning and ending. It does not have 
geographic limitations and potentially lasts much longer.
    We have experienced a relatively mild spring outbreak, but 
experts tell us the fall flu season will be much worse. 
Maryland is committed to using all available resources and 
personnel to address the situation.
    This committee's majority staff report identified four 
major categories of action items to strengthen: Establish 
effective management, address and meet key medical 
requirements, evaluate update plans, and improve early warning 
and detection. Here are some of Maryland's accomplishments in 
these areas, or plans in our areas that we are still working 
on:
    First, Governor Martin O'Malley instructed the Maryland 
Department of Health and Mental Hygiene in my agency to lead an 
H1N1 leadership task force to address some of these issues, 
determine who is in charge, integrate the response in the 
incident command system and improve communications among 
various State and local agencies and with the public.
    Next, the Governor mandated State agencies' Continuity of 
Operations Plans to be updated and completed by October 1, 
along with updated pandemic flu operational plans and our 
Strategic National Stockpile plan. Just 2 days ago, we hosted 
the H1N1 summit to ensure open dialogue between public health 
and school officials, emergency medical providers, and local 
emergency managers.
    While we are working diligently to prepare for a possible 
pandemic as schools return to session next month and as the 
traditional flu season hits later in the fall, we have 
identified several issues that must be addressed at the Federal 
level either by Congress or the administration.
    First, leadership and coordination issues must be resolved 
at the Federal level, which will give the States more 
confidence in the guidance we receive from the Department of 
Health and Human Services and the Department of Homeland 
Security and other Federal partners. There may have been 
legitimate political and logistical reasons for having HHS and 
DHS as the Federal voices of H1N1, but that may have confused 
the public, and while the leadership issue may have been 
resolved at the Federal level, that resolution need to be 
communicated to the States.
    I had the opportunity to speak to some of my peers across 
the country, and they all had the same concerns that we had; so 
this communication certainly needs to be worked on.
    It is vital that all agencies use the incident command 
system. Failure to use this consistent common language in 
commands can delay the coordination of resources and may 
endanger both responders and the general public.
    It is important that the public receive timely, credible, 
and definitive guidance from the Centers for Disease Control. 
For example, the radical change in school closing guidance 
several days into the spring pandemic clearly colored the 
public's perception of Government decisions.
    Second, as was shown with both the inaugural activities 
last January and the spring H1N1 outbreak, it may be time for 
legislative review of the Stafford Act to help make sure it is 
appropriate to deal with today's events and their potential 
enormous cost. The Stafford Act was designed to deal with 
disasters like tornadoes and hurricanes, but it does not work 
so well with emergencies that don't have a definitive ending 
date or may have a lull of several months between activities, 
such as we are seeing now with the pandemic.
    We need Federal guidance about what types of disaster 
assistance might be available for responding to a pandemic and 
what thresholds are required for a disaster declaration. In 
this economic climate, States cannot afford to guess at what 
may or may not qualify for assistance.
    Third, State and local governments need greater flexibility 
to use various Federal grants to help with H1N1 prevention and 
response. Protection for first responders and workers in the 
medical field needs to be one of the top priorities. I am 
asking that Congress and the administration develop a new 
funding source so that these front-line workers can be supplied 
with appropriate personal protective equipment.
    It is also vital that these grants allow States the 
flexibilities to manage their own need. One-size-fits-all does 
not always fit all.
    Finally, we must have consistency between public health and 
emergency management planning guidance so that the various 
agencies can work together seamlessly. Not only is the current 
guidance inconsistent with established emergency management 
guidance, it does not allow for the needed flexibility or 
scalability for each State or situation. The spring outbreak, 
for example, while it was a fast-spreading, novel virus, it did 
not seem to have the high mortality of previous pandemics. 
However, much of the planning guidance was based on the high 
mortality pandemics in 1918 and 1919.
    In addition, I would like to mention one other area of 
concern. I sit on a subcommittee of National Children and 
Disasters, and one area they have is that the children not be 
forgotten in all areas, including planning and any type of 
inoculation.
    So I thank you for giving me the opportunity to discuss 
these important issues today.
    [The statement of Mr. Muth follows:]
                 Prepared Statement of Richard G. Muth
                             July 29, 2009
                              introduction
    Chairman Thompson, Ranking Member King, and Members of the 
committee, my name is Richard Muth and I am the Executive Director of 
the Maryland Emergency Management Agency. It is an honor to be invited 
here today to discuss Maryland's current preparedness and response 
activities for the H1N1 pandemic influenza and the critical issues that 
remain a challenge for the future.
What is the Maryland Emergency Management Agency?
    The Maryland Emergency Management Agency (MEMA) is mandated under 
State law to ensure that the State is prepared to deal with all 
emergencies, especially those that exceed the capabilities of the local 
jurisdictions, and to coordinate the overall State's response in a 
declared emergency or major disaster. In addition to supporting the 
local governments, MEMA coordinates assistance with the Federal 
Emergency Management Agency (FEMA) and other Federal partners when the 
Governor declares a state of emergency and receives a Presidential 
disaster declaration. While MEMA is part of the Maryland Military 
Department and under the authority of the Adjutant General, during 
emergencies the Governor assumes direct authority over the Agency and 
the Executive Director of MEMA reports directly to the Governor.
    A key element within MEMA is the Maryland Joint Operations Center 
(MJOC). Operated round-the-clock by National Guard and MEMA employees, 
it is a joint civilian-military watch center. In addition to serving as 
a communications hub for emergency responders State-wide and supporting 
local emergency management, the MJOC monitors local, State, national, 
and international events, including weather, and advises decision-
makers in Maryland when a situation warrants.
    MEMA coordinates the States' response to an emergency at the State 
Emergency Operations Center (SEOC) in Reisterstown, Maryland. When the 
SEOC is fully activated, each State agency, as well as some Federal 
agencies, private sector, and volunteer organizations sends a 
representative to the SEOC with authority to make decisions and 
allocate needed resources and funds to response efforts on behalf of 
their agency.
    MEMA also serves as the State administrative agent for all homeland 
security grants received from the Federal Government.
    Pandemic flu response presents challenges distinguishable from most 
emergencies.--There are a few aspects of pandemic flu that distinguish 
it from other emergencies that States and localities are accustomed to 
handling. The nature of this type of event is new and unfamiliar to 
almost all Americans because the United States has not experienced nor 
witnessed a severe flu pandemic since 1918-1919. With little to no past 
experience to guide us outside of history books, aspects of our 
response efforts have to be revised and reconsidered. The unknown 
duration and potentially long-term nature of this novel event also 
creates enormous resource strains, especially in an environment of 
budget deficits.
    As we approach the fall, States and localities will have to balance 
competing priorities: Meeting the demands of a flu of unknown duration 
and severity, ensuring the ability to manage the needs of other 
emergencies (such as a possible hurricane), and continuing to provide 
basic and essential Government services to the public. The response and 
implications of pandemic influenza are not simply a public health or 
individual medical issue. The health response will require an increase 
in resources, coordination, and support from all levels and sectors of 
government while at the same time will create a severe reduction in the 
available government and private workforce. Pandemic influenza has the 
potential to severely impact every aspect of our economy.
    The Committee on Homeland Security Majority Staff Report, ``Getting 
Beyond Getting Ready for Pandemic Influenza'' identified four major 
categories of action items to strengthen response: (1) Establishing 
effective management and coordination; (2) addressing and meeting key 
medical requirements; (3) evaluating and updating plans; and (4) 
improving early warning and detection. Maryland strongly agrees with 
these recommendations and is currently taking steps to complete these 
actions. I will highlight some of our accomplishments, future 
intentions, and remaining gaps in these four areas.
         1. establishing effective management and coordination
    On June 24, 2009, Maryland Governor Martin O'Malley hosted a State 
after-action meeting to discuss and evaluate Maryland's initial 
response to the H1N1 outbreak. As a result of the information gleaned 
from this meeting, Governor O'Malley immediately established an H1N1 
Leadership Task Force. This Task Force is co-chaired by the Secretary 
of the Department of Health and Mental Hygiene (DHMH) and me and 
includes executive level personnel from all relevant State agencies. To 
ensure that Maryland is prepared to respond effectively to H1N1 this 
fall, the Task Force has been assigned specific action items and a 45-
day timeline to report back to the Governor on the ways in which it has 
corrected gaps and resolved issues. This Task Force has been charged 
with the following deliverables:
    1. Resolve any issues involving implementation of the unified 
        command/incident command system during public health 
        emergencies; the number, location, and staffing of operations 
        centers; and the use and implementation of a Joint Information 
        Center.
    2. Ensuring that the States' Pandemic Flu, Strategic National 
        Stockpile (SNS), and Mass Vaccination plans are completed and 
        have been reviewed and signed by all agencies to ensure they 
        understand and can execute their roles during an emergency.
    3. Identifying a date within 60 days to convene meetings among 
        State and local leadership such as local public health 
        officials and emergency managers, school officials, emergency 
        medical service providers, and/or hospital leadership and local 
        elected officials to ensure a two-way dialogue and discussion 
        regarding communications and response to fall H1N1 operations.
    4. Determine whether reconsideration of State-wide human resource 
        and personnel policies (leave, tele-work, and on-call 
        situations) for public health emergencies is needed, and as 
        appropriate, develop and implement these policies.
    5. Pre-identify trigger points and guidance for State agencies to 
        activate their pandemic influenza Continuity of Operations 
        Plans (COOP).
    6. Pre-identify optimal procedures, combinations, and sequences for 
        requesting a Stafford Act emergency, public health emergency, 
        and authoring emergency powers in conjunction with H1N1.
    7. Develop a streamlined system to ensure comprehensive and 
        consistent internal communications across State agencies and 
        externally with local partners which can be applied to all-
        hazard situations.
    8. Conduct an exercise of the State's plan for mass distribution of 
        an H1N1 vaccine, as well as any other aspects of the State's 
        pandemic influenza plan deemed in need of exercise by the 
        taskforce.
    9. Provide an assessment of local jurisdictions and private sector 
        partners' readiness.
    By identifying and demanding timely action on these issues, 
Maryland will increase its ability to respond to a potentially more 
severe wave of H1N1 this fall. Many of these action items will address 
critical components of effective management and coordination for future 
response. However, there is additional assistance and clarity that 
could be provided by the Federal Government to assist us with our 
efforts.
    All Federal Government Agencies must use the Incident Command 
System (ICS) and provide a consistent message to the States regarding 
who is in charge during a public health emergency:
    It is the State's policy to coordinate, to the extent possible, all 
emergency management functions of the State with the comparable 
functions of the Federal Government. Despite State mandates to use the 
incident command system (ICS), it does not appear to the States that 
all Federal agencies have fully adopted or institutionalized its use, 
particularly within the Department of Health and Human Services (HHS). 
Traditionally, first responders, fire, police, Emergency Medical 
Services, etc. understand and use ICS every day. There appears to be 
confusion with other agencies as to the use of and fully understanding 
of this system. One of our first lessons learned from the event last 
spring was that, in the future, we must use the ICS standard as soon as 
practical because failure to use it can cause inconsistent commands 
across government, can delay the coordination of resources and 
information, and may endanger responders and the safety of the public.
    We know that moving forward, it must be clear to all stakeholders 
that DHMH is the lead response agency in a public health emergency and 
MEMA is the lead coordinating agency. The roles are analogous to that 
of an airline pilot and air traffic control tower. An airplane pilot is 
responsible for the safe takeoff, flight, and landing of an aircraft. 
To successfully accomplish these tasks, an airplane pilot needs to 
receive a steady stream of information on weather conditions and other 
traffic in the area to make appropriate decisions on how to fly the 
plane. The air traffic control tower is responsible for maintaining 
situational awareness, coordinating any needed resources, and providing 
the pilot with the information required to fly the plane in a skillful 
manner. These roles are similar to that of DHMH and MEMA in a public 
health emergency. MEMA will maintain situational awareness of the 
conditions of the emergency throughout the State and coordinate this 
information with DHMH so it can use its subject matter expertise to 
make effective decisions on responding to the emergency. This division 
of roles must be the same at the Federal level between HHS and DHS.
    There continue to remain questions and inconsistent messages about 
whether HHS or DHS is in charge of the response to a public health 
emergency at the Federal level. In July, the DHS Secretary Napolitano 
and HHS Secretary Sebellius held a H1N1 Summit with the States. Even at 
this event, it was not clear to participants about the differences in 
roles and responsibilities between HHS and DHS in pandemic influenza. 
For example, DHS has a new initiative of H1N1 Field Response Teams and 
the States would like to know how these will be used in the most 
effective manner.
    During the spring incident, guidance and information from the 
Centers for Disease Control (CDC) was disparate, sometimes confusing, 
and constantly changing, especially as it applied to recommendations on 
school closings. When guidance from the Federal Government changes 
frequently, it affects the public's perception of the Government's 
control of the event and impacts the likelihood that the public will 
comply with Government's decisions and recommended advice. While the 
constantly changing decisions were only somewhat understood this past 
spring due to the new and unknown nature of H1N1, it is critical this 
fall that States receive timely, definitive guidance from the Federal 
Government, especially on recommendations for school closings. The 
authority to close schools within Maryland depends on the nature of the 
emergency. To avoid delay and confusion during times of emergency, the 
Maryland State Department of Education (MSDE) and DHMH recently signed 
a Memorandum of Understanding to clarify their respective roles when an 
emergency requires the closing of public and non-public schools.
    It is extremely important that the public perceive that governments 
are relying on the same credible information before making decisions. 
This is of particular importance in Maryland, due to its proximity to 
the District of Columbia and the Commonwealth of Virginia. It would be 
very difficult for a parent who lives in the District of Columbia, 
works in Virginia, and possibly has a child attending school in 
Maryland to understand why each jurisdiction has different policies on 
social distancing measures such as school closings or tele-work 
policies. The local governments in the National Capital Region are 
meeting to find ways to coordinate school closing decisions so that 
each government is informed of the decisions and justifications before 
they are announced to the public.
    2. addressing and meeting key medical requirements and resources
    States and Localities Need Flexibility with the Use of Grant 
Funding for H1N1.--As noted in the February 2009 GAO report on pandemic 
influenza, the usual emergency management approaches to increasing 
resource capacity during disasters, such as requesting assistance from 
other States through the Emergency Management Assistance Compact 
(EMAC), may not be viable options during a pandemic because other 
States may want to hold onto resources in order to meet their own needs 
or may not wish to expose their staff to the disease. EMAC still will 
play a role in flu response but the amount of resources available from 
other States will depend on the extent of cases and the severity of 
illness in other States.
    Workforce protection is an issue of key concern for States and 
localities. While some funding for EMS protection is included in the 
recent supplemental HHS Healthcare Preparedness Program grant, the 
level is not sufficient to cover Personal Protective Equipment for all 
EMS responders and does not offer any protection for law enforcement 
and other public safety responders who may be at risk during a pandemic 
in the line of duty. Public safety agencies have not been included in 
these grants but will need to provide support to the health and medical 
response. They will need the resources to protect their workforce and 
also to ensure the ability to continue providing services with a 
reduced workforce. Recent Congressional appropriations for pandemic 
influenza only appear to provide funds to States and localities through 
grant awards to public health departments and hospitals.
    I ask that Congress and the administration introduce new funding 
for PPE. In the absence of new funding, flexibility in the usage of 
current grants would address these issues. Each State and locality will 
have different needs that will not fit into ``a one size fits all'' 
box.
    As for medical resources, Maryland knows it has gaps in surge 
capacity that will require tough policy decisions this fall. The State 
has insufficient knowledge of private antiviral inventories and needs 
to encourage partnerships and communications with the private medical 
sector. CDC has indicated it will assist States with a better 
understanding of the commercial pipeline for critical pharmaceuticals 
and medical supplies by developing a ``supply chain dashboard'' using 
aggregated proprietary data from the manufacturers and distributors. 
States look forward to access to such a dashboard to support resource 
allocation and SNS decisions. While we cannot address everything this 
fall, Maryland is in the process of developing forward-thinking 
approaches to potential resource shortages through the use of 
volunteers and by using health care workers in non-traditional roles to 
assist with response. These efforts are described in detail below:
    The Emergency System for Advance Registration of Volunteer Health 
Professionals (ESAR-VHP).--ESAR-VHP is a Federal program that 
establishes and implements guidelines and standards for registering, 
credentialing, and deploying medical professionals in the event of a 
large-scale national emergency. Maryland purchased a web-based, fully 
compliant ESAR-VHP system in June 2009 from Collaborative Fusion, Inc., 
called CORES. After multiple phases of testing, it is anticipated that 
the system will go ``live'' August 24, 2009 and will be available for 
volunteers to register the following month. This system will allow 
Maryland to register volunteers through a website, with volunteers able 
to log into the system with a password at any time to update their 
information. The CORES system will directly access State licensing and 
National credentialing agencies to ensure volunteers are practicing 
professionals in good standing. The system has a messaging and 
notification component that will send messages through a variety of 
methods (e-mail, pager, cell phone, etc). It also has a mission manager 
component that will allow volunteers to view a detailed description of 
missions as they arise.
    Maryland Civic Guard.--Maryland's Civic Guard, launched July 16, 
2009 by Governor O'Malley, is a coordinated effort between MEMA and the 
University of Maryland's Center for Health and Homeland Security (CHHS) 
that will engage local governments, private groups, businesses, 
corporations, and nonprofit organizations to enhance the system of 
cooperative volunteering during emergencies. The Civic Guard seeks to 
build on the strength of current partnerships between local 
governments, volunteer organizations, private businesses, and Maryland 
State government. Under the first phase of the initiative, supported in 
part by a FEMA Regional Catastrophic Preparedness Grant, MEMA and CHHS 
will work with local government, the private sector, and non-profit 
entities to identify resource needs and potential opportunities for 
private sector and non-profit entities to create or expand 
partnerships. The Civic Guard initiative will seek to share information 
on needs and resources and, where possible, create agreements and 
memoranda of understanding--before disaster strikes--with business and 
non-profit partners.
    Broadening scope of practice and use of non-traditional 
professionals to assist with mass vaccination.--The State is developing 
procedures that would have the Governor modify State regulations on a 
temporary basis under a declared state of emergency to broaden scope of 
practice standards among various trained health care providers and also 
use trained health care providers in non-traditional roles to assist 
with a mass vaccination this fall. Under this plan, the State would 
consider using veterinarians, pharmacists, dentists, emergency medical 
technicians, and other auxiliary providers to meet the personnel 
requirements associated with a State-wide vaccination campaign.
                    3. evaluating and updating plans
    Continuity of Operations Plans (COOP).--The recent H1N1 influenza 
situation highlighted the need for up-to-date and comprehensive COOP 
plans within State government to ensure the ability to maintain vital 
operations and services for our citizens, especially in the face of 
possible reduced workforce availability due to illness.
    By request of the Governor, MEMA and DHMH are leading an initiative 
to ensure that all executive agencies have viable, operational, and up-
to-date Pandemic COOP plans by September 1, 2009 and full COOP plans by 
October 1, 2009. As part of this initiative, MEMA, in coordination with 
DHMH, provided a series of free training sessions on developing a COOP 
plan to State employees, locals, and non-profit agencies in July. In 
addition, the Governor is requiring executive level personnel from all 
State agencies and departments to participate in a 1-day COOP tabletop 
exercise and is scheduling a State-wide COOP drill for late summer/
early fall. MEMA will begin a peer review process of all COOP plans 
submitted October 1, 2009 or before.
    Even with free training for local governments, it will be difficult 
for some local agencies to complete or update their COOP plans because 
of budget and staff shortages. The State is aware, but cannot currently 
assist, in addressing known gaps in COOP planning within many private 
businesses.
    Coordinating Emergency Management and Public Health Planning.--On 
July 27, Maryland initiated a meeting among each locality's public 
health officers and emergency managers to share their experiences from 
H1N1 and address communication gaps. This was an important first step 
in bringing together two disciplines that, in the past, have not had a 
great deal of experience working together and not always understood the 
others roles and responsibilities. In the future, it will be critical 
to have these disciplines integrate and coordinate their planning 
efforts, especially for the myriad of issues in an influenza pandemic 
that implicate both disciplines, such as mass fatality and special 
needs populations planning. One way to assist with this task is to 
ensure that public health and emergency management planning guidance at 
all levels of government must be consistent. Unfortunately, the Federal 
Government has created barriers to accomplishing this task because 
public health planning guidance released by HHS is often inconsistent 
with established emergency management planning guidance that is 
released by FEMA. The States would like to see emergency planning 
guidance come from DHS in coordination and conjunction with appropriate 
subject matter experts, to ensure that all planning guidance provided 
to the States is consistent.
    CDC Pandemic Influenza Planning Guidance.--One area of public 
health planning guidance in need of serious revision is the Centers for 
Disease Control's (CDC) guidance to States on pandemic influenza 
planning. In addition to being inconsistent with established emergency 
management planning guidance, it does not sufficiently allow for 
necessary flexibility or scalability to the specific needs of a State. 
Maryland's pandemic influenza plan closely corresponds to the template 
provided by the CDC, which ended up not being easily understood in an 
operational context this past spring. DHMH is currently reviewing and 
revising the State plan to address these issues in time for fall.
    State Strategic National Stockpile Plan.--Maryland's SNS plan was 
developed and exercised with the assumption that all of the available 
resources would be deployed to the State, rather than the 25% that was 
distributed in May. This demonstrates a flaw in the CDC's planning 
requirements established for State plans. State SNS plans are rigidly 
reviewed annually using a tool developed by the CDC. Under Federal 
requirements, a State SNS plan is required to be written under the 
assumption of receiving a 100% deployment of SNS assets. The CDC has 
already recognized this gap and is actively working to develop the 
scalable concept at the Federal level to provide to the States.
    The Federal planning assumption was that a State's SNS shipment 
would follow a request from the Governor, an assumption which proved to 
be inaccurate in May 2009. Upon announcement that the State was to 
receive 25% of its antiviral allocation, DHMH made arrangements for 
receipt at the designated RSS site, and upon arrival, the shipment was 
immediately inventoried by type, lot number, and expiration dates. A 
long-term lease for secure, temperature-controlled storage was obtained 
through an emergency procurement and the assets transported and 
secured. Since then, the CDC and FDA have successfully worked out a 
protocol for the extension of the shelf life of those antiviral 
medications and soon-to-expire dates.
    This effort to safely maximize the shelf life and therefore the 
economic utility of these anti-virals should be replicated for the FDA 
for other medication caches purchased by the States with Federal 
funding.
         4. improving early warning and detection of influenza
    Maryland uses the Electronic Surveillance System for the Early 
Notification of Community-based Epidemics (ESSENCE). This is a web-
based syndromic surveillance system designed for the early detection of 
disease outbreaks, suspicious patterns of illness, and public health 
emergencies. It automatically categorizes data such as chief complaints 
from 46 acute care hospitals, over the counter medication sales from 
two large pharmacy chains (approximately 300 total stores), and call 
data from two State poison control centers into syndromes to detect 
aberrations in the expected level of disease. ESSENCE runs automated 
statistical algorithms on each syndrome and generates alerts when the 
observed counts are higher than expected. To our knowledge, Maryland is 
the only State with 100% connectivity to all acute hospitals, 
reflecting achievement of a priority goal of Governor O'Malley.
    DHMH epidemiologists review ESSENCE alerts daily and determine if 
follow-up is necessary. Follow-up investigation of alerts includes 
contacting local health departments and the hospital infection control 
staff to obtain more information. In addition, DHMH epidemiologists 
notify the DHMH Physician On-Call and State Epidemiologist for alerts 
determined to have public health significance and initiate an active 
investigation.
    ESSENCE provides situational awareness on the health of Maryland 
residents, detects disease clusters and exposures to allow for a more 
rapid response to disease prevention and mitigation, and provides early 
indication of increased influenza activity before cases are confirmed. 
This analysis provides a critical tool for planning and resource 
allocation. Maryland will continue sustained year-round flu 
surveillance and is currently working with the State Superintendant of 
Schools to assess what is needed to add school absenteeism data to the 
system.
        challenges in applying the stafford act to pandemic flu
    Recent events, such as the 2009 Presidential Inauguration, have 
demonstrated the need for Congress to review the Stafford Act 
declaration process and regulations, particularly to ensure relevancy 
to post-9/11 threats and emergencies. The Stafford Act was designed to 
deal with disasters like tornados and hurricanes. The time has come for 
Congress and the administration to revisit the Stafford Act, 
particularly as it might apply to pandemic influenza and other public 
health threats.
    Under 42 U.S.C.  5121(b), the purpose of the Stafford Act is to 
provide an orderly and continuing means of assistance by the Federal 
Government to States and localities in carrying out their 
responsibilities to alleviate the suffering and damage from disasters.
    There are two major types of declarations:
    1. Emergencies.--Any assistance for which, in the determination of 
        the President, Federal assistance is needed to supplement State 
        and local efforts and capabilities to save lives and to protect 
        property and public health and safety, or to lessen or avert 
        the threat of catastrophe in any part of the United States. 42 
        U.S.C.  5122(1)
    2. Major Disasters.--Include any natural catastrophe, which in the 
        determination of the President cause damage of sufficient 
        severity and magnitude to warrant major disaster assistance 
        under the Act to supplement the efforts and available resources 
        of States, local governments, and disaster relief 
        organizations. 42 U.S.C.  5122(2)
    There are two main types of assistance that correspond with these 
declarations: Major disaster assistance and emergency declaration 
assistance. Significantly less assistance is available under an 
emergency declaration than under a major disaster declaration. 
Expenditures made under an emergency declaration, unlike under a major 
disaster declaration, are limited to $5 million per declaration, unless 
the President determines that there is a continuing need for immediate 
emergency assistance.
    To qualify for Federal assistance, the Governor must:
    (1) Certify that the situation or disaster is of such severity and 
        magnitude that effective response is beyond the capabilities of 
        the State and local governments;
    (2) Direct execution of the State's emergency plan;
    (3) Describe the State and local efforts and resources which have 
        been or will be used to alleviate the emergency;
    (4) For emergencies, define the type and extent of Federal aid 
        required; and
    (5) For major disasters, certify that State and local government 
        obligations and expenditures will comply will all applicable 
        cost-sharing requirements of the Act. See 42 U.S.C.  5170,  
        5191.
    There are at least two challenges with applying the Stafford Act to 
pandemic influenza. First, the Stafford Act requires that a State 
describe the nature of the emergency or disaster and certify that it is 
beyond the capacity of the State to respond. While this process is 
relatively straightforward in the context of a storm or flood, it is 
more difficult in a lengthy event of unknown duration without a well-
defined start and end date/time attached it, such as pandemic 
influenza. FEMA has noted that a pandemic influenza will last longer 
than other public health emergencies and may include waves of activity 
separated by months. See FEMA Disaster Assistance Policy, DAP9523.17 
(March 17, 2007). Unlike a request to rebuild a bridge, human service 
needs are more difficult to quantify, especially with regard to a 
State's capacity to handle the issue.
    Given the unique characteristics of pandemic influenza, States need 
specific guidance from the Federal Government on when this event would 
be considered of such severity and magnitude that effective response is 
beyond the capabilities of the State and local governments. In 
addition, States need guidance on the level of specificity that would 
be required in the declaration request with regard to available State 
and local resources and the type and extent of Federal aid required.
    Second, there is ambiguity in the law concerning whether the 
Stafford Act would cover an influenza pandemic under a major disaster 
declaration or just under a declaration of emergency. This legal 
uncertainty has been noted in several recent congressional reports. See 
e.g., CRS Report RL34724, Would an Influenza Pandemic Qualify as a 
Major Disaster under the Stafford Act?, by Edward C. Liu, at 6-10 (Oct. 
20, 2008.)
    This ambiguity is significant for a number of reasons. Assistance 
for declared emergencies is generally capped at $5 million while major 
disaster assistance does not have this cap. A declaration of a major 
disaster also expands the types of aid that are available to States, 
localities, and individuals. For example, a major disaster declaration 
permits the distribution of aid directly to individuals and households 
to meet disaster-related medical and other expenses. 42 U.S.C.  5174.
    States need guidance from the Federal Government on whether and 
what type of major disaster assistance is potentially available for 
responding to pandemic flu outbreaks and what thresholds would have to 
be met for pandemic flu to be considered a major disaster, as opposed 
to an emergency. Maryland is not the only State looking for this 
advice. We are aware of the States of California and Oregon also 
raising this issue.
    Effective response to a pandemic flu requires a closely coordinated 
effort among Federal, State, and local partners. Disaster assistance 
should be clearly defined. States should not be left to guess and 
debate what might or might not qualify for assistance. In light of 
recent and emerging threats, it is time not only to provide guidance on 
these issues, but to revisit the Stafford Act to make sure it is 
relevant to 21st century threats and disasters.
                               conclusion
    The State requests the following actions by the Federal Government 
to help close gaps in preparedness and response for pandemic influenza:
    1. We request guidance from FEMA on whether and what type of major 
        disaster assistance will potentially be available for 
        responding to pandemic influenza and what thresholds would have 
        to be met for pandemic influenza to be considered a major 
        disaster, as opposed to an emergency. We also ask that the 
        Stafford Act be revisited for its relevance and applicability 
        to post-9/11 threats and incidents like pandemic influenza.
    2. We are concerned about leadership, coordination, and 
        communication at the Federal level. States need to understand 
        who is in charge at the Federal level and the difference in 
        roles and responsibilities between DHS/HHS. We need assurance 
        that all Federal agencies are using the incident command 
        system. We need to ensure we have timely, credible, definitive 
        guidance from HHS on issues such as school closings.
    3. We ask for expansion and or flexibility on use of grant funds 
        for H1N1 and also ask that you consider providing funds to 
        other public safety disciplines outside of public health and 
        hospitals.
    4. We ask that the Federal Government revise pandemic flu planning 
        guidance for the States and ensure that all public health 
        planning guidance is consistent with established emergency 
        management planning guidance.

    Chairman Thompson. Thank you very much. We will have some 
time for the explanation on the question.
    We have 10 minutes left on this vote, and we have two 5-
minute witnesses.
    Dr. Horton.

    STATEMENT OF MARK B. HORTON, M.D., M.S.P.H., DIRECTOR, 
   CALIFORNIA DEPARTMENT OF PUBLIC HEALTH, AND STATE HEALTH 
                            OFFICER

    Dr. Horton. Thank you, Honorable Chairman Thompson and 
Ranking Member King and other Members. It is a pleasure to be 
here to speak and give a State health officer's perspective on 
what has worked to date, what we have learned to date going 
forward, and what are our major challenges.
    As I begin, though, I wanted to reiterate points that have 
been made about this virus. First of all, it is a novel virus, 
and we don't have a vaccine. This means that there are huge 
numbers of susceptible individuals still in our population. We 
can fully expect a lot of sick people through the summer and 
into the fall, a lot of hospitalizations and, yes, a lot of 
deaths. We can, I think, fully expect that.
    Second, this virus is acting very differently than seasonal 
flu. The fact that we are seeing still growing activity in many 
States right now today--we talk about a resurgence, but the 
fact of the matter is, it with us right now and it is affecting 
different populations; and it is mutable, which means we have 
to maintain full capacity in our epidemiology in laboratories 
in order to adequately monitor this and give us the information 
to make the correct public health decisions.
    What worked well: I want to congratulate the Centers for 
Disease Control in taking the lead and ensuring that there was 
good vertical collaboration and communication connecting the 
State health officers with the local health officers throughout 
the first wave of this pandemic. Some of the manifestations of 
that were, for example, within days of the first identification 
of the first cases in southern California, there were teams of 
epidemiologists on the ground that included CDC 
epidemiologists, State epidemiologists, and local 
epidemiologists to ask the right questions to help us better 
characterize the seriousness of the illness it was causing and 
the transmissibility.
    Second, laboratory capacity: Certainly, in California, the 
coordination between the 24 local laboratories, the State 
laboratory, and the California laboratories allowed us to test 
fully 14,000 specimens within a period of 6 to 8 weeks--
unprecedented capacity--so it was good working together.
    Similarly, with the Strategic National Stockpile, each 
State received 25 percent of its allotment of antiviral 
medications and masks. We were able to receive those and 
redistribute those to 51 local jurisdictions in California 
within a matter of days. We think this is a huge success and 
speaks to the excellent planning and resources that have been 
provided to us for putting things together.
    What are the lessons that we have learned? First of all, as 
I can congratulate the epidemiological and laboratory capacity, 
I should also state that they were stretched to the limit. We--
no way could we have sustained the effort that we put forward 
in the first weeks of this campaign. I am very concerned about 
our ability to continue to monitor this pandemic adequately as 
we move through the summer into the fall, into the regular 
season.
    Second, I think previous mention was made about the supply 
chain for critical materials. We detected some serious 
vulnerabilities there. Laboratories in the State of California 
were telling me that we were within hours of having to stop 
testing for influenza because we didn't have the proper 
laboratory reagents. Similar problems were occurring about the 
availability of antiviral medications and masks.
    We need to rethink and reconfirm the consistency of the 
manufacturers, the distributing systems to ensure that we can 
continue to supply those materials to local and State health 
departments that need them.
    Third, we have inadequate data systems. Now, in the 
epidemiology area, I think we have good systems in place to 
gather epidemiological information at the local, State, and 
Federal level, to be able to collate that data and tell us what 
is going on.
    We don't have similar effective data systems in the health 
care system. At the local level, local health officers, and 
emergency medical technicians can tell you what is available, 
what is happening in their emergency rooms and in their 
hospitals, but we have no way consistently to collate that 
information regionally and at the State level so that I, as 
State Health Officer, have a heck of a time telling my Governor 
what is happening broadly in the health care system throughout 
California.
    What are our challenges moving forward? I think there are 
three big ones, I think. The ones I will reiterate:
    Maintaining epidemiological and laboratory capacity at the 
State, local, and Federal level to be able to give us the 
information we need on an on-going basis to make the right 
public health decisions is of vital importance and is a major 
challenge for us.
    Mass vaccination, it has been mentioned before, but what I 
want to emphasize in my comments is that I think we have the 
capacity, if we decide to do this, to get the vaccine delivered 
from the Federal Government to the State to the locals. The 
real challenge is administering that vaccine to individuals. 
That is going to be left up to the locals. The State and the 
Federal Government and agencies need to be prepared to support 
local agencies that are going to be responsible for actually 
administering that vaccine.
    Then one final comment is on surge capacity. There is no 
question in my mind that our health care system is going to be 
stretched to the limit if not overwhelmed. We need to take 
major steps forward to assist the health care system in 
preparing for this overwhelming increase in sick people that we 
are likely to see later on this year, and I have further 
details on how we can do that.
    Thank you for the opportunity to testify.
    Chairman Thompson. Thank you very much.
    [The statement of Dr. Horton follows:]
                  Prepared Statement of Mark B. Horton
                             July 29, 2009
    Good afternoon Chairman Thompson, Ranking Member King and 
distinguished Members of the committee. I am Dr. Mark Horton, Director 
of the California Department of Public Health (CDPH) and California's 
State Health Officer. CDPH, in partnership with the Centers for Disease 
Control (CDC), local health departments (LHDs), the California 
Emergency Medical Services Authority (EMSA) \1\ and the California 
Emergency Management Agency (CalEMA),\2\ responded to the recent 
outbreak of a novel influenza virus (H1N1) which has resulted in over 
3,200 reported cases of illness, 537 hospitalizations and 60 deaths in 
California.
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    \1\ The California Emergency Medical Services Authority is 
responsible to ensure quality patient care by administering an 
effective, State-wide system of coordinated emergency medical care, 
injury prevention, and disaster medical response.
    \2\ In 2009 the California Office of Emergency Services and the 
California Department of Homeland Security were combined in the 
California Emergency Management Agency, CalEMA.
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    Thank you for asking me here today to discuss our response to this 
outbreak, activities underway to address on-going illness, and our 
continued preparations to respond to future pandemic influenza, most 
urgently for the upcoming the influenza season. In my testimony I will 
briefly outline our experience with the H1N1 outbreak this spring, 
including lessons learned, but will focus on our activities to confront 
the next pandemic influenza outbreak by highlighting:
   Disease surveillance;
   Public health interventions, including mass vaccination 
        campaigns;
   Health care surge capacity;
   Social disruption; and
   Communications.
    The California Department of Public Health operates more than 150 
discrete programs \3\ ranging from communicable disease control, to 
food, drug and radiation safety; drinking water management; hospital 
and clinic inspections; chronic disease and injury control; maternal, 
child and adolescent health; and, most pertinent to today's hearing, 
public health emergency response. We employ more than 3,500 staff and 
our current budget is approximately $3.7 billion to serve California's 
38 million residents.
---------------------------------------------------------------------------
    \3\ http://www.cdph.ca.gov.
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                              introduction
    California was the first State to identify the H1N1 virus. On April 
17, 2009, the CDC, through laboratory data supplied by the Federal 
Border Infectious Disease Surveillance (BIDs) program office located in 
San Diego, determined that two California influenza cases had a unique 
combination of gene segments not previously reported among swine or 
human influenza viruses in the United States or elsewhere. Within days 
CDC epidemiologists were on the ground in these counties to augment 
local and State investigative resources.
    By June 11, 2009, the World Health Organization categorized H1N1 as 
Phase 6, indicating a global pandemic was underway. At that time, 74 
countries on five continents reported more than 28,000 illnesses and 
144 deaths due to H1N1. We continue to experience significant H1N1 
activity worldwide and there is much that remains unknown about this 
virus. Therefore, although our comprehensive public health surveillance 
allowed California to be the first to recognize the circulation of 
pandemic H1N1 and mount an aggressive response, we cannot relax our 
vigilance.
                               background
    The delivery of public health services in California, including 
public health emergency response, is accomplished through a partnership 
of Federal, State, and local agencies. In California local public 
health departments have primary responsibility for responding to 
outbreaks in their jurisdiction. In outbreaks involving multiple 
jurisdictions, the State public health department, in conjunction with 
CDC, and our State and local emergency management and homeland security 
agencies, takes the lead to provide additional laboratory capacity, 
confirmatory testing, coordinate distribution of stockpiled equipment 
and supplies, develop State-wide policy guidance for public and private 
agencies and assist with development and dissemination of public 
information campaigns and provide resources when local needs exceed 
available capacity. In California, public health follows incident 
command system principles and county and State emergency management 
agencies coordinate closely with public health during all responses. In 
H1N1, CalEMA, in recognition that this is a public health emergency, 
designated CDPH as the lead agency while serving as a close and 
supportive partner.
    Since 2002, the State of California has provided $470 million in 
Federal grant funds to local health departments to build local health 
department preparedness capacity for all-hazard and specific public 
health emergencies. This funding included the fiscal year 2006 
Congressional investment in State and local pandemic influenza 
preparedness activities ($600 million allocated nationally).
    Additionally, since 2004, California has invested more than $170 
million in State funds to support activities to increase medical surge 
capacity. These funds were used to purchase all available antivirals to 
supplement the Federal investment in the Strategic National Stockpile. 
California purchased three mobile field hospitals, alternate care site 
caches, ventilators, respirators, and funded preparation of Standards 
and Guidelines for clinics, long-term care facilities, and health 
professionals.
    Those resources were put to use when on April 21, in response to 
growing numbers of cases of this pandemic H1N1, CDPH, and EMSA 
activated the Joint Emergency Operations Center (JEOC), the State's 
health operational center that coordinates and provides 
multijurisdictional response support for our Federal, State, and local 
partners. In addition, our 500,000-square-foot laboratory complex in 
Richmond, California activated its emergency response function, the 
Richmond Campus Coordinating Center (RCCC) to assist with 
identification of cases which could be ``probable'' H1N1, which were 
then sent to CDC for verification. Shortly thereafter, our Richmond 
laboratories received equipment, training, and CDC certification to 
conduct the confirmatory tests leading to a more rapid collection of 
surveillance data. California was the first State in the Nation to 
receive this certification for H1N1.
    The JEOC and RCCC conducted numerous daily policy and operational 
meetings/briefings that included congressional staff, our State 
legislature, local health departments, sister agencies and departments, 
and media (daily briefings for up to 200 media outlets). We established 
a multi-lingual hotline available 7 days per week, and developed public 
information materials (flyers, public service announcements, blogs, 
Facebook, and Twitter outreach).
    CDPH, through a State General Fund allocation, had already 
purchased 3.7 million treatment courses of antivirals and CDC shipped 
an additional 1.325 million courses of antivirals to California from 
the Strategic National Stockpile for distribution to local communities. 
During the course of this outbreak, CDPH received requests for 
antivirals from 51 local health departments, 100 percent of which were 
shipped within 24 hours. The California Highway Patrol provided 24-hour 
security for the stored materials and escorts for all antiviral 
shipments.
    Governor Arnold Schwarzenegger declared a state of public health 
emergency clearing the way for redirection of resources from other 
departments, relief from administrative procedures, and pursuit of 
Federal resources.
    As we continue to monitor H1N1 activity our JEOC and RCCC remain at 
a moderate level of activation. The State laboratory and the California 
network of 26 local public health laboratories continue to test 
hundreds of hospitalized and fatal cases each week; since the start of 
the pandemic 4 months ago these labs have collectively tested over 
14,500 specimens, compared to a typical volume of 2,000 in a regular 
influenza season.
    The data provided by this testing has enabled CDPH to have 
continuous, timely, and reliable data on the pandemic and who is being 
affected, allowing CDPH to better prepare for the 2009-10 respiratory 
season and planning for antiviral and vaccination priority needs. Data 
from the CDPH influenza surveillance has had a major impact Nation-
wide, including providing the first description of the clinical and 
epidemiologic profile of hospitalized cases, identifying obesity as a 
possible risk factor for death, and actively monitoring and providing 
important data on the rare occurrence of antiviral resistant viruses 
following the identification of the first U.S. case in San Francisco.
    California led the way with the identification of this new virus 
and with an aggressive multiagency response. We appreciate the Federal 
investment which has taken place up to this point. Without it, our 
capacity would have been significantly diminished.
                            lessons learned
    Planning Assumptions.--As we prepare to respond to future 
outbreaks, mindful not only of the experiences of the past few months, 
but of more than 100 years of public health science and service to 
inform us, we must stress that planning for pandemic illness, or any 
emergency, requires certain assumptions which during an actual event 
may be realized, or not. The test of those assumptions through the 
course of an actual event becomes the basis for adjustments in the next 
phase of planning. For example, as you may know, the planning models 
assumed the initial outbreak of pandemic influenza would occur 
somewhere within the Asian countries and would then take approximately 
6 weeks to arrive in North America. H1N1 did not follow that model. 
With the information available to us now, we believe it started in 
North America, dramatically reducing the amount of time to organize the 
response.
    Decision-making Process.--Certain technical and operational 
questions can be resolved relatively quickly and do not need to be 
revisited, allowing attention and resources to be directed to emerging 
or more complex issues. CalEMA and our California Department of 
Forestry and Fire (CalFire) embedded incident response experts in our 
State health operations center and laboratory operations center to 
assist with application of incident command strategies. More extensive 
use of the incident command structure will benefit future responses and 
the CDPH is using experts from CalEMA to conduct incident command 
structure training to strengthen the depth of that expertise within 
CDPH.
    Communications.--Because public health emergency response involves 
a system of Federal, State, and local partners it is critical to ensure 
that information flows efficiently among all parties. CDC and the 
Federal Department of Homeland Security laid the groundwork for robust 
and integrated interagency communications.
    Yet it is critical to coordinate timing and frequency of 
information exchange among relevant parties. The numerous daily 
conference calls hosted by various Federal and State actors often 
conflicted, forcing officials to choose between calls or redirect other 
staff to participate in order to stay informed of new information. 
Often the same officials who conduct the briefings are also the 
officials who must be engaged in urgent policy decisions. Using 
incident command strategies, California revised its briefing strategies 
to avoid duplication and scheduling conflicts and smooth the timely 
flow of relevant information to affected Federal, State, and local 
officials.
    Supply Chain.--We experienced an early and inexplicable collapse of 
the private industry pipeline for antivirals and masks which, if not 
resolved, would have rapidly depleted our stockpiles. The resolution 
required Federal intervention as the suppliers were national companies. 
Because the public sector relies so heavily on the private sector for a 
range of goods and services, including the emergency response supplies, 
Government will need to work more closely with the private sector to 
ensure supply chain reliability.
    Public Health Continuity of Operations.--Despite a compressed 
timeline for response, the system responded appropriately and 
effectively to the H1N1 outbreak. However, had the event been more 
prolonged or more severe in its intensity, the public health systems, 
most likely, and the health care delivery system, certainly, would have 
been stretched to the limit. Our workforce of epidemiologists and 
microbiologists were redirected from other disease investigations to 
support the emergency response. If pandemic H1N1 becomes more severe or 
if there is another pandemic outbreak, we could not sustain core public 
health service levels, the continuity of our business operations would 
be affected. As we look ahead to the start of seasonal influenza 
activities we recognize the most optimistic scenario will find us 
confronted with the demands of the seasonal influenza, with H1N1 
response as an additional pressure on our public health and health care 
delivery systems.
    In order to support the State health and laboratory operations 
centers' response to a more sustained or severe epidemic, California 
has organized three additional response teams composed of staffs from 
within and outside of the Department who are already receiving training 
in the public health emergency response functions--everything from 
epidemiologic emergency response to support functions such as 
accounting and administrative support.
    The new strategies must also take into account that the public 
health workforce will also be stricken with influenza, resulting in a 
high degree of absenteeism. In addition, we must commit to close 
collaboration with the private sector to enhance their planning for 
continuity of operations to ensure continued availability of essential 
goods and services.
                            looking forward
    CDPH and CalEMA have been working together to plan for further 
escalation of the disease and the rollout of a vaccination campaign 
this coming fall and winter. While CDPH focuses on some of the core 
public health functions that must be in place, CalEMA is working with 
CDPH on triggers for activation of the overall emergency response 
structure, use of its business operations center to address resource 
shortages in the supply chain and other issues.
    H1N1 Surveillance/Monitoring and Laboratory.--Preparation for 
surveillance to monitor for increasing pandemic activity, and possibly 
increased morbidity and mortality, is under way. These active 
surveillance activities include:
   Continuing and expanding current surveillance components to 
        measure severity of the pandemic in different populations at 
        risk;
   Laboratory testing to perform numerous activities including 
        detecting the emergence of new strains that may cause more 
        severe disease, identifying new strains that may be poorly 
        matched to the vaccine, and developing antiviral resistance; 
        and
   Continuing to monitor for morbidity and mortality associated 
        with seasonal influenza.
    Further, the emphasis on laboratory diagnosis is the key to strong 
surveillance. Because H1N1 is a laboratory-based diagnosis, without 
laboratory testing and results, there can be no H1N1 diagnosis. The 
laboratory is the cornerstone of influenza diagnosis. As such, 
laboratory monitoring of the pandemic and seasonal viruses in the 
following populations will be the cornerstone of the surveillance 
activities for the upcoming respiratory season:
   Severely ill cases hospitalized in intensive care;
   Fatal cases;
   Sampling of hospitalized cases from Kaiser Permanente and 
        other academic and community hospitals State-wide;
   Outbreaks in institutions, including hospitals, prisons, 
        schools, long-term care facilities; and
   Outpatient specimens from over 150 volunteer sentinel 
        providers State-wide.
    The CDPH Viral and Rickettsial Disease Laboratory (VRDL) is 
prepared to test over 16,000 specimens in the upcoming respiratory 
season to accomplish the above goals (the normal volume is a typical 
season is 1,000 specimens). Approximately 15-20% of specimens will be 
tested for antiviral resistance to continue to monitor for the 
emergence of antiviral resistance. A subset of fatal and severely ill 
cases will undergo genetic analysis to monitor for the emergence of new 
strains that may not respond to a pandemic vaccine. Surveillance will 
also monitor changes in the circulating seasonal influenza virus in 
order to determine the formulation for the season influenza vaccine in 
the subsequent 2010-11 season.
    In addition, the laboratory surveillance data will be used so that 
CDPH can monitor clinical and epidemiologic data associated with 
severely ill and fatal cases and from outbreak settings for populations 
at increased risk for morbidity and mortality. CPDH receives 
surveillance data from many different sources, including electronic 
hospitalization and outpatient data (Kaiser Permanente), influenza-like 
illness (ILI) data from a group of sentinel providers who voluntarily 
report ILA data to CDPH and from hospitals about severely ill cases 
hospitalized in ICUs. The data will allow CDPH to provide guidance on 
outbreak management, including in schools, and recommendations on 
antiviral prophylaxis and treatment for hospitalized patients and 
patients at high-risk, and vaccine prioritization strategies.
    Public Health Interventions/Medical Countermeasures.--In planning 
for the large task of providing pandemic influenza vaccine, it is 
helpful to review the capacity to produce and deliver the seasonal 
influenza vaccine. Influenza vaccine production has increased 
dramatically over recent years, resulting in over 100 million doses of 
licensed vaccine available in the United States every autumn. 
Meanwhile, the public health system's capacity for vaccine 
administration health has diminished since 1976, when it delivered 40 
million doses of swine flu vaccine. As a result of increased vaccine 
and decreased public infrastructure, public health departments provide 
less than 10% of flu shots each year in California.
    Just as in 1976, public health is needed in 2009-10 to coordinate 
the delivery of pandemic influenza vaccine. However, instead of 40 
million doses, the public health system is being asked to oversee the 
administration of many times this amount, up to hundreds of millions of 
doses of vaccine, with approximately one-eighth of this total going to 
California.
    While we are awaiting final information about the decision to 
vaccinate and the amount and timing of vaccine production, California 
is working quickly to:
   Identify as many current private and public vaccinators who 
        can also administer pandemic vaccine;
   Identify additional vaccinators who can fill in gaps in 
        services and map vaccinators to the prioritized populations 
        they serve;
   Identify or build systems to distribute vaccine to 
        potentially thousands of vaccinators;
   Establish or strengthen systems to share information with 
        vaccinators and receive and validate vaccine orders;
   Track administration of vaccine; and
   Monitor the safety of pandemic vaccines.
    These vaccination program activities will require substantial 
resources beyond what is already available. Public health will have to 
allocate, distribute, and administer a two-dose vaccine for the entire 
population in addition to the separate administration of the seasonal 
influenza vaccine.
    CDPH continues to work closely with LHDs, health care providers and 
other State organizations such as the Board of Pharmacy to ensure that 
mass vaccination campaigns and antiviral dispensing plans are able to 
meet the needs of providing such medical countermeasures to all 
affected persons in California. CDPH has developed an allocation and 
distribution plan for shipping State and Federal stockpiles of 
antivirals to local jurisdictions utilizing the Standardized Emergency 
Management System. In addition, State-wide distribution plans for 
vaccines is currently under development and we continually communicate 
with local pandemic planning partners.
    Surge Capacity\4\.--CDPH will continue to work with LHDs and health 
care providers to ensure that California can respond to a surge in the 
need for patient care.
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    \4\ Surge capacity is defined as a ``health care systems' ability 
to rapidly expand beyond normal services to meet the increased demand 
for qualified personnel, medical care, and public health in the event 
of bioterrorism or other large-scale public health emergencies or 
disasters''. (Addressing Surge Capacity in a Mass Casualty Event, AHRQ, 
2004)
---------------------------------------------------------------------------
    At the local level, LHDs, and health care facilities are building 
partnerships and planning for patient distribution across the continuum 
of care from home health to expansion of existing health care 
facilities to Government-authorized alternate care sites to respond to 
an otherwise overloaded health care system. LHDs have purchased 
supplies to implement their plans and CDPH has stockpiled supplies and 
equipment for 21,000 alternate care site beds.
    CDPH has stockpiled 50.9 million N95 respirators and 2,400 
ventilators (estimated to supply hospital works for 6 months) to ensure 
the protection of health care workers. CDPH has allocated these on a 
population based share and is packaging county allocations to enable 
quick distribution.
    CDPH has provided LHDs, hospitals, and other health care facilities 
with standards and guidelines for emergency planning and operation of 
alternate care sites, expansion of existing facilities, and tools to 
move from individual to population-based care.
    Social Disruption.--As Secretary Napolitano expressed many times 
during the initial stages of the H1N1 outbreak, the potential for 
social disruption during a pandemic is one of the most compelling 
arguments for interagency communication and collaboration. As the 
Director of Public Health and the State Health Officer one of my major 
concerns is the lack of widespread emergency planning for continuity of 
operations in the private sector and the potential for a disruption of 
public and private sector goods and services. During the H1N1 response 
we experienced a breakdown in the supply chain for antivirals. Without 
adequate planning we can also experience collapse of the supply chains 
for gasoline, food, and water. There must be a concerted and 
coordinated effort between and among all levels of Government to 
engender and support the necessary planning.
    Communications.--As previously mentioned, under the leadership of 
CDC and Homeland Security, the flow of information from the local to 
the State to the Federal level and back again was nearly constant, even 
at the initial stages of the outbreak. But we need to recognize that it 
is communication with the public that will play a critical role in our 
efforts to reduce the illnesses and deaths from pandemic influenza. As 
history demonstrated during the 1918 influenza pandemic, communities in 
which public officials made a commitment to sharing timely information 
about self-protective measures reported a lower level of social 
disruption from the flu. The public must be involved in our 
preparedness efforts. They will need advice on non-pharmaceutical 
interventions, such as staying home when sick. They will need advice on 
the appropriate use of available health services otherwise the health 
care delivery system will be quickly overwhelmed. These messages will 
need to be repeated often and shared widely.
    Public communication must be coordinated and emphasize the actions 
that families, schools, and businesses must take to reduce the toll of 
influenza. New tools, such as Web-based videos, text messaging, 
Facebook, Twitter, and other social media will be employed. Community-
based organizations, faith-based organizations, and neighborhood groups 
will be messengers, too, disseminating life-saving information. We must 
motivate people to action without causing them alarm.
                            closing remarks
    A mantra of emergency preparedness is that we are most ready for a 
disaster right after we have experienced the last one and that is true 
of our experience with the H1N1 outbreak this spring. But this type of 
readiness can deteriorate quickly unless adequate resources are 
provided to build and maintain the public health infrastructure.
    There have been enormous efforts in California, the United States, 
and globally to prepare for pandemic influenza. Congress has provided 
significant support for these efforts, as have State and local 
governments. Our detection of H1N1 came as a result of the investments 
made in enhanced surveillance and laboratory capacity. Our ability to 
maintain an effective response to this relatively mild pandemic also 
came as a result of previous investments. A severe epidemic would 
require mobilization of the public health work force for a period of 
many months and has the potential to cause serious social disruption of 
both public and private sector services.
    I will return to my initial outline to suggest specific actions 
which could strengthen our efforts to achieve readiness for pandemic 
influenza:
Surveillance
   Additional investment in the public health workforce 
        including epidemiologists, microbiologists, and laboratorians 
        to ensure enough scientists are on the ground to identity and 
        monitor the spread of disease;
   Continued investment in epidemiologic and laboratory 
        physical capacity including expanding the network of sentinel 
        physicians;
   Providing investment to enhance surveillance systems within 
        emergency rooms and hospitals to build capacity to monitor 
        prevalence of disease in real time; and
   Investment in standardized electronic reporting systems and 
        centralized databases (such as automated laboratory information 
        management systems to connect hospital and private laboratory 
        data systems to local and State health departments).
Public Health Interventions
   Investment in resources to ensure rapid development, re-
        evaluation, and distribution of clear guidelines related to 
        social distancing strategies for schools and workplace;
   Investment in supplies and guidelines for use of personal 
        protective equipment such as masks and the prophylactic use of 
        antivirals; and
   Investment in supplies and distribution for mass 
        vaccinations.
Health Care Surge Capacity
   Continue investment in the Strategic National Stockpile to 
        ensure adequate supplies antivirals, vaccines, and medical 
        supplies as well as the resources to distribute them;
   Restore investment in medical surge capacity to prevent the 
        overload of the health care delivery system including 
        guidelines for patient triage, infection control in health 
        facilities, and vaccination of health care workers; and
   Provide resources for an aggressive public information 
        campaign on the appropriate use of health care services.
Social Disruption
   Dedicate Government resources to lead a multiagency 
        initiative to increase public and private sector development of 
        plans for continuity of operations and continuity of 
        Government. This is a critical undertaking in part because it 
        is the least developed segment of emergency preparedness and 
        the potential consequences could exacerbate any emergency 
        beyond all of our ability to respond.
Communications
   Maintain the resources needed to support the flow of 
        information through the levels of Government and provide 
        resources for sharing among States. The excellent communication 
        spearheaded by CDC and the Department of Homeland Security was 
        well executed and adding the ability for communications across 
        State governments will further enhance information exchange; 
        and
   Invest in development of traditional and new media materials 
        and messages for vaccinators, other medical providers, local, 
        State, and Federal health agencies and the public.
    The H1N1 outbreak has demonstrated the unique and essential public 
health skills and services that are provided for less than 1 percent of 
health care expenditures. Let me repeat, less than 1 percent of each 
dollar spent on health care goes to support the public health services 
which would be required in an emergency response. Core public health 
functions and the public health emergency response system deserve and 
require our Nation's support.
    The stronger the foundation of the public health system, the better 
the system is able to respond. Continued Federal support of public 
health infrastructure and emergency preparedness and response will be 
vital to our ability to protect public health and safety when the next 
pandemic influenza strikes.
    Thank you for this opportunity to appear before you today. I am 
pleased to answer any questions you may have.

    Chairman Thompson. Dr. Farley, I think we are running out 
of time. We have to go vote. We have about 20 minutes of votes 
and we will come back to hear your presentation and Members 
will ask questions.
    The committee stands in recess.
    [Recess.]
    Ms. Clarke. [Presiding.] I now recognize Dr. Farley to 
summarize his statement for 5 minutes.

 STATEMENT OF THOMAS A. FARLEY, M.D., NEW YORK CITY DEPARTMENT 
                  OF HEALTH AND MENTAL HYGIENE

    Dr. Farley. I would like to thank the Chair, Congressman 
Thompson, Ranking Member King and the committee for convening 
this hearing.
    Large, densely populated urban areas like New York City 
face unique challenges when combating highly contagious viruses 
such as influenza. The city has a population of over 8 million, 
and the population grows to nearly 12 million on weekdays. More 
than 1 million students attend about 1,500 public schools in 
the city. These are ideal conditions for easy transmission of 
influenza.
    We know that we will not be able to prevent pandemic 
influenza from entering New York City once it emerges anywhere 
in the world; and that once it arrives, we can try to slow its 
transmission, but will not be able to halt it. When H1N1 
arrived in New York City in late April, we knew little about 
how easily the virus might be transmitted, the severity of the 
illness it might cause and who in New York City was at risk for 
infection or severe illness. Through CDC we quickly acquired 
the technology necessary to begin performing confirmatory tests 
for the new H1N1 in our own laboratory, vastly improving our 
ability to obtain timely information about the virus. The 
development and distribution of such a test in such a short 
period of time is a remarkable feat, and we appreciate the 
support we received from our partners at the CDC.
    From reports of severe illness, it appears that H1N1 
community transmission in New York City was more widespread 
than elsewhere in the United States. We estimate that at least 
several hundred thousand and perhaps at many as 1 million 
people in the city became ill with H1N1. With 47 recorded 
deaths from H1N1, the case fatality ratio was approximately 1 
per 10,000 cases, roughly the same as or lower than the case 
fatality ratio for seasonal influenza.
    During the outbreak, the Health Department recommended 
closing 57 schools for 5 days to protect those at highest risk 
of complications. School closures were not expected to 
interrupt the spread of influenza in the city as a whole.
    Our plans for the expected return of H1N1 in the fall or 
winter are focused on assessment of current resources, 
addressing gaps, and implementing enhancements. This process 
will be greatly aided by the supplemental funding that Congress 
recently approved, and we would like to express our thanks for 
that support.
    The best tool we have to prevent influenza infection and 
severe disease is vaccination. We are hopeful that a vaccine 
against H1N1 will be available before the virus returns. If 
ample supplies are available, we will provide it to people in 
ways that will protect those most at risk for severe infection.
    However, because we do not yet know how much vaccine will 
be available, we must prepare for a range of options. These 
include vaccination by private medical providers, vaccination 
in public clinics, mass vaccination in schools, and vaccination 
using point-of-distribution, or POD, sites. If an H1N1 vaccine 
is not available in ample supply before the virus returns, we 
will have to rely more on antiviral medications to protect 
persons at risk for severe disease. We are developing 
contingency plans for use of antivirals that will rely on 
distribution to hospitals and community health centers.
    A significant challenge for public health departments will 
be responding to an H1N1 outbreak while we are also promoting 
vaccination against seasonal influenza. The overlap of these 
activities will further strain private providers, health care 
facilities, long-term care facilities and the health 
department.
    During the peak of the pandemic this past spring, some 
hospital emergency departments were severely strained. Some 
hospitals created additional space by setting up tents outside 
of their emergency departments or used outpatient clinic space 
to quickly separate influenza patients from others. To avoid 
this overcrowding this coming season, we are working to develop 
better ways to guide people's decision-making about when it is 
necessary to seek medical assistance. We plan to publicize up-
to-date guidance on our website and disseminate it through 
community and faith-based organizations, as well as schools.
    To provide alternatives to hospital emergency departments, 
the health department is working with community health centers 
to expand their operations. We will also encourage hospitals to 
develop specialized influenza clinics or alternate emergency 
departments so they can handle patient load and reduce exposure 
of influenza to other emergency room patients.
    Our current thinking regarding school closure policy is 
that if the virus does not increase in severity, we are 
unlikely to recommend widespread or prolonged school closures. 
Because the disease has been mild in nearly all children, such 
closures would not stop the spread of the virus, and the 
economic and social disruption caused by school closures is 
substantial.
    We will recommend that children and staff with symptoms 
stay home and that children or staff at risk of severe disease 
who come in contact with ill persons consult with their medical 
provider about taking antiviral medications. On the other hand, 
if there is evidence to suggest that the virus is more severe 
or the disease incidence increases significantly, school 
closures and other measures to reduce contact among large 
numbers of persons may be considered.
    To date, the cost of the H1N1 response for the health 
department activities alone has been approximately $4 million. 
City-wide costs are estimated to exceed $12 million. While the 
funding has been very much appreciated, the funding that will 
be needed to respond to a more severe return of this virus 
would be substantially more.
    I would like to thank, again, the committee for our 
opportunity to testify; and I will be happy to answer any 
questions you have.
    [The statement of Dr. Farley follows:]
                 Prepared Statement of Thomas A. Farley
                             July 29, 2009
    I want to thank Chairman Thompson, Ranking Member King, and the 
other distinguished Members of the committee for convening this hearing 
about the current status and future outlook of the national response to 
pandemic influenza.
    As you know, influenza is a serious viral disease. In New York 
City, on average 1,000 people die of seasonal influenza each year, the 
vast majority of whom are over the age of 65. Large densely-populated 
urban areas like New York City face unique challenges when combating 
highly contagious viruses such as influenza. The vast majority of New 
York City commuters travel by public transportation--each day there are 
between 7 and 8 million trips on the subway, and the population of the 
city grows to nearly 12 million during the weekday. There are 1.2 
million public school students attending about 1,500 public schools in 
the city. These are ideal conditions for easy transmission of a virus 
such as influenza.
    The new strain of the influenza virus, H1N1, arrived in New York 
City in late April, when a large number of students from a high school 
became ill over a few days. At that time we knew little about how 
easily the virus would be transmitted, the severity of the illness it 
might cause, and who among the New York City population was most at 
risk for infection or for severe illness.
    Under the Citywide Incident Management System, the New York City 
Department of Health and Mental Hygiene (DOHMH) is a lead agency in 
responding to public health emergencies, including pandemics, along 
with the Police and Fire Departments. In preparation for such an event, 
the Department had developed a Pandemic Influenza Preparedness and 
Response Plan. The plan is grounded in the reality that we will not be 
able to prevent pandemic influenza from entering New York City once it 
emerges anywhere in the world, and that once it arrives we can try to 
slow its transmission, but will not be able to halt it. A key priority 
in our plan, which is very relevant in our current response, is 
minimizing severe illness and death by identifying and treating those 
New Yorkers who are most at risk as early as possible in the pandemic.
    In response to the initial H1N1 outbreak at the high school, the 
Department activated its Incident Command System (ICS), drawing on all 
needed agency resources and providing the highest level of coordinated 
response during emergencies. Our response utilized the preparedness 
infrastructure capacity and capabilities that DOHMH has been building 
and enhancing since 2001, largely with the support of Federal funding. 
The Department's preparedness infrastructure enabled the agency to 
sustain an effective response over an 8-week period, with over 200 
Health Department staff working on response activities at the height of 
the outbreak.
    The New York City Health Department constantly monitors influenza-
like illnesses (ILI) activity in community and health care settings 
using a variety of surveillance methods. We routinely track hospital 
emergency department visits, pharmacy sales of antiviral and other 
medications, and influenza virus specimens taken from a network of 
sentinel physicians, among other indicators, to monitor trends and 
identify clusters of influenza-like illness.
    Because H1N1 was a new virus and we had little information on its 
clinical and epidemiologic characteristics, our priority for 
surveillance was monitoring for more severe illness and death, which 
required scaling up our efforts. In partnership with the health care 
community and New York City's Chief Medical Examiner, we established 
enhanced surveillance to track the number of persons who were 
hospitalized or had died with influenza-like symptoms. We actively 
worked with the health care providers reporting these suspect cases to 
arrange testing for H1N1 in our laboratory.
    The Department's Public Health Laboratory provides a wide range of 
public health laboratory testing services. During the early period of 
the outbreak, the Laboratory was able to determine that the ILI at this 
high school was probably H1N1. We quickly acquired the technology 
necessary from CDC and were able to begin performing confirmatory tests 
for the new H1N1 by May 11. Our laboratory was one of the first 
nationally to receive this test. Having this capacity locally improved 
our ability to obtain timely information about the virus. The 
development and distribution of such a test in such a short period of 
time is a remarkable feat, and we appreciate the support we've received 
from our partners at the CDC.
    We observed some important patterns about this new H1N1 influenza 
virus from our early investigations. First, the virus appeared to 
spread rapidly among children. In contrast to seasonal influenza, the 
elderly were generally spared. Second, nearly all of the younger people 
who did become ill had mild symptoms, with most recovering completely 
in 5-6 days.
    The Health Department continued to survey New Yorkers to determine 
what proportion of the city's population has experienced influenza-like 
illness since late April, and what types of symptoms people have 
experienced. The Health Department conducted two population-based 
telephone surveys, asking about influenza-like illness from early May 
through mid-June. These surveys were designed to be representative of 
all New Yorkers, and from these data we estimate that at least several 
hundred thousand and perhaps as many as 1 million people in the city 
became ill from H1N1. With 47 recorded deaths from H1N1, the case-
fatality ratio is approximately one per 10,000 cases, which is roughly 
the same as or lower than the case-fatality ratio for seasonal 
influenza.
    The H1N1 community transmission in New York City appears to have 
been more widespread than elsewhere in the United States. As of July 1, 
909 people diagnosed with H1N1 have been hospitalized in New York City. 
An analysis of H1N1 hospitalization data found that the most common 
risk factor for complications due to H1N1 in New York City thus far has 
been asthma. We also observed that individuals who are younger than 2, 
pregnant, or have a weakened immune system, diabetes or cardiovascular 
disease were at elevated risk during the current outbreak
    As with seasonal influenza, the H1N1 influenza has claimed lives, 
47 so far in New York City since the outbreak began. While most of 
these deaths have involved people with underlying risk factors for 
influenza complications, some occurred in otherwise healthy people. 
These deaths are tragic, but not unexpected. An important part of our 
response is educating New Yorkers about why it is important for 
individuals with these risk factors or chronic underlying health 
problems to consult a health care provider when experiencing influenza-
like illness. We also urged all New Yorkers to take measures to protect 
themselves from influenza, including avoiding close contact with people 
who have influenza-like illness, and washing hands often with soap and 
water.
    During the outbreak, DOHMH recommended closing 57 schools for 5 
days. The main goal of school closures was to protect those at highest 
risk of complications from influenza by slowing transmission in that 
particular school community and reducing exposures among those with 
underlying conditions. School closures were not expected to interrupt 
the spread of influenza in the city as a whole.
    One of the greatest challenges facing the city during a pandemic is 
to provide quick, clear, consistent, and frequent emergency information 
to the public. Central to our communications strategy is the use of the 
news media to keep New Yorkers well-informed about the progress of the 
outbreak and about what measures they can take to protect themselves.
    Information was made widely available through Mayor Bloomberg's 
almost daily press briefings, and the Mayor's leadership in addressing 
the issue routinely played a significant role in educating the public 
about H1N1. The health department issued 25 press releases and held 
eleven press conferences and briefings, generating thousands of media 
stories. This method of communication is effective and efficient, and 
allows us to reach the maximum number of people with the latest and 
most up-to-date information.
    The department also issued a wide variety of fact sheets, 
brochures, posters, and pamphlets targeting various populations, 
including the school community, employers, and faith and community 
leaders. We translated these documents into 12 languages, and developed 
low literacy materials. All of these materials were made available on a 
dedicated page on the DOHMH website.
    Equally important to our public communications is our ability to 
distribute important clinical information to health care providers. 
With approximately 29,000 subscribers, our Health Alert Network 
provides an opportunity to get clinical recommendations and treatment 
guidance directly into the hands of providers with the click of a 
button; we sent out health alerts, as well as multiple clinical 
guidance documents and treatment recommendations during the course of 
the outbreak, providing physicians with the latest information on H1N1 
activity in New York City. Our Provider Access Line, staffed by Health 
Department and Medical Reserve Corp personnel, fielded nearly 5,000 
requests for assistance. We also conducted numerous conference calls 
with providers to review our guidance.
    Importantly, regular teleconferences and communications with the 
Centers for Disease Control provided invaluable assistance and guidance 
to our efforts.
                    planning for recurrence of h1n1
    We are now planning for the expected return of H1N1 in the fall or 
winter, when influenza virus transmission traditionally peaks. We are 
focusing on assessment of current resources, addressing gaps, and 
implementing enhancements. DOHMH has established formal planning 
workgroups, many of which have interagency participation, tasked with 
implementing solutions to gaps and weaknesses identified. This process 
will be greatly enhanced by the additional supplemental funding that 
Congress recently approved and we would like to express our thanks for 
that support.
                   surveillance & laboratory capacity
    Perhaps the greatest challenge we face--one that is common to 
pandemic planning and response--is the need to respond and make policy 
decisions in the face of medical and scientific uncertainty. Influenza 
can evolve in unpredictable ways; because we knew little about this 
virus when it first emerged, our surveillance system was intensive and 
relied heavily upon identifying and counting individual cases of 
persons hospitalized for influenza. With the knowledge we have gained, 
we expect to modify our surveillance approach in the fall to one that 
is more sustainable and less resource-intensive. Since case-based 
hospital surveillance will likely be impractical during the expected 
upsurge in influenza-like illness, the approach entails an overall 
assessment of the amount of influenza-like illness activity (for both 
mild and severe disease), combined with laboratory testing from a 
limited number of representative outpatient and hospital sites. Our 
primary approach to track the overall trajectory of the potential 
outbreak will be to monitor visits to hospital emergency departments 
for influenza-like illness, through what is called ``syndromic 
surveillance,'' and conduct periodic telephone surveys for symptoms of 
influenza-like illnesses.
              mass vaccination and antiviral distribution
    The best tool we have to prevent influenza infection and severe 
disease is vaccination. We are hopeful that a vaccine against H1N1 will 
be available before the virus returns. If ample supplies of this 
vaccine are available, we will provide it to people most likely to 
develop severe illness from influenza, people who are likely to spread 
the virus to those persons, and essential personnel who are likely to 
come in contact with the virus such as health care workers. However, 
because we do not yet know how much vaccine will be available, we must 
prepare for a range of options, both regarding who will be vaccinated 
and how vaccines will be administered. These include vaccination by 
private medical providers, vaccination in public clinics, mass 
vaccination clinics in schools, and vaccination using Point-of-
Distribution (POD) sites. We have conducted numerous POD trainings and 
exercises for staff and volunteers over the last several years and have 
identified 200 POD sites within walking distance of most city 
residents.
    If an H1N1 vaccine is not available in ample supplies before the 
virus returns, we will have to rely more on antiviral medications to 
protect persons at risk for severe disease. We are developing 
contingency plans for use of antivirals that will rely on distribution 
to hospitals as well as community health centers. We are aware that for 
some populations, such as homebound and incarcerated persons, accessing 
these sites will be difficult, so we are working on plans to address 
the needs of vulnerable populations as well.
    As part of on-going planning activities, we intend to define the 
threshold for releasing stockpiled pandemic influenza response items 
such as antivirals, personal protective equipment, and ventilators, and 
develop guidance for organizations that would receive supplies from the 
Strategic National Stockpile (SNS) and to refine plans for the delivery 
of supplies to hospitals, long-term facilities, home-based care 
agencies, and other outpatient providers.
    A significant challenge for public health departments will be 
responding to an H1N1 outbreak while we are also promoting vaccination 
against seasonal influenza. The overlap of these activities will 
further strain private providers, health care facilities, long-term 
care facilities, and the Health Department.
                  health care surge capacity planning
    DOHMH works closely with New York City's hospitals, outpatient 
centers, congregate care facilities, and emergency medical service 
agencies to handle a surge in persons seeking care for influenza. We 
have developed medical surge protocols and built a local medical cache 
of ventilators and personal protective equipment. DOHMH has also 
conducted city-wide pandemic influenza exercises and drills with local, 
State, and Federal partners, and hospitals and community health 
centers. DOHMH has also engaged congregate care facilities and major 
health agencies to provide guidance regarding care for patients at home 
or other residential settings during a pandemic.
    During the peak of the pandemic this past spring, some hospital 
emergency departments were overwhelmed. Many emergency departments saw 
a 200 percent increase in the number of patient visits. To deal with 
overcrowding, some hospitals created additional space by setting up a 
tent outside of their emergency departments or used outpatient clinic 
space to allow those patients with influenza to be quickly separated 
from others. In response to the demands placed on hospitals, DOHMH 
provided clinical algorithms, screening, and isolation guidelines. We 
also delivered personal protective equipment and pediatric Tamiflu 
suspension to hospitals.
    DOHMH recognizes the need to take action to avoid this overcrowding 
in the future. We are working to develop better ways to guide people's 
decision-making about when it is necessary to seek medical assistance. 
To reduce visits to emergency departments by the ``worried well'', we 
plan to publicize the availability of up-to-date guidance on our 
website. The website will provide suggestions for people with mild 
cases of influenza-like symptoms so that they can confidently care for 
themselves at home. We plan to develop non-hospital sources of medical 
advice for patients who need it. We are working on ways to disseminate 
this information through community and faith-based organizations as 
well as schools. To provide an alternative to hospital emergency 
departments, DOHMH is also working with community health centers to 
assure that they have the resources needed to expand operations during 
resurgence of H1N1. DOHMH will also encourage hospitals to develop 
specialized influenza clinics or alternate emergency departments to 
treat patients with influenza-like illness so that they can handle the 
patient load and reduce exposure to influenza in patients seen in 
emergency departments for other reasons.
                         school closure policy
    Under what conditions health officials should close schools to 
limit the spread of H1N1 is a question that will come up again in the 
fall. Our current thinking is that if the virus does not increase in 
its severity from the spring, the New York City health department is 
not likely to recommend widespread or prolonged school closures because 
the disease has been mild in the nearly all children, because such 
closures would not stop the spread of the virus, and because the 
economic and social disruption caused by school closures is 
substantial. We will recommend that children and staff with symptoms 
stay home and that children or staff at risk for severe disease who 
come in contact with ill persons consult with their medical provider 
about taking antiviral medications. Individual schools may need to be 
closed by school authorities if too many staff members are ill for the 
school to administratively function. On the other hand, if there is 
evidence to suggest that the virus is more severe or the disease 
incidence is far greater than they were in the spring, school closures 
and other measures to reduce contact among large numbers of persons may 
be considered.
                           infection control
    DOHMH continues to refine its guidance concerning infection control 
in hospital, community, congregate, and high-risk settings, including 
day care, universities, home visiting programs, and others. We are also 
refining worker protection guidance for all public and occupational 
groups, which will vary depending on the severity of the outbreak. On 
July 23, 2009, CDC's Healthcare Infection Control Practices Advisory 
Committee unanimously voted to recommend that surgical masks be worn by 
health care workers caring for H1N1 patients, except when specific 
medical procedures are performed, in which case N-95 masks are 
recommended. DOHMH strongly endorses this infection control 
recommendation.
                           incident response
    The single most important way to build a strong preparedness 
foundation is to build a strong workforce. DOHMH, with help from CDC's 
Public Health Emergency Preparedness grant, supports staff positions 
with preparedness and response expertise. In addition, DOHMH trains all 
employees on the agency's Incident Command System. We have also 
developed automated notification systems so that all agency staff can 
be quickly mobilized to respond to any public health emergency. DOHMH 
has also created the largest Medical Reserve Corps in the country, with 
over 8,300 volunteers to call upon during an emergency response.
    DOHMH also provides funding and expertise to key city partners to 
purchase stockpiles of pandemic countermeasures and facilitate 
development of pandemic influenza plans for city agencies and the 
populations they serve, including the Department of Homeless Services, 
the Human Services Administration, and the Department of Corrections, 
as well as coordinating plans with the Office of the Chief Medical 
Examiner.
                   communications and public outreach
    To communicate accurately and rapidly to the public about 
influenza, DOHMH is continuing to develop numerous templates for fact 
sheets and press releases in many languages. These materials help us 
provide well-considered information at very short notice to many 
audiences. DOHMH also continues to focus on the importance of health 
care provider awareness and education through regular communication and 
through our Health Alert Network, as providers may be the first to 
recognize unusual disease patterns that precede an outbreak.
    To ensure timely communication with the public and the health care 
community, DOHMH plans to enhance its existing protocols for rapid 
development and clearance of public messages. CDC Public Health 
Emergency Response funds will be used to further develop our ability to 
communicate to New Yorkers in a variety of ways about H1N1. We will 
also develop pandemic-specific public information and education 
initiatives, including a range of community and workplace outreach 
activities, especially to high-risk populations, and an advertisement 
campaign. In addition, funds will be used for health care provider 
education and training.
                             funding needs
    To date, the cost of the H1N1 response for the city health 
department activities alone has been approximately $4 million. City-
wide, costs are estimated to exceed $12.6 million. Core capacity 
building at DOHMH to prepare for a fall recurrence of H1N1 are expected 
to cost the Department more than $70 million, including laboratory 
equipment, information technology support tools, occupational health 
supplies and training, vaccine distribution, and procurement, storage, 
and management of mechanical ventilators, and personal protective 
equipment for health department and other key city personnel. City-
wide, the costs to fully prepare for a pandemic could exceed $160 
million, including costs to the city's school system, the Medical 
Examiner's Office, the Fire and Police Departments, and the city's 
public hospital system. The cost of response if the H1N1 recurrence is 
severe could be almost a half a billion dollars for all city agencies.
    We are grateful for the additional funds recently provided by 
Congress and those being allocated through the Public Health Emergency 
Response Grants. The additional $7 million New York City expects to 
receive for public health preparedness as well as $2.4 million for 
hospital preparedness, will provide critical support as we continue to 
build our core capacity and prepare for the influenza season and the 
possibility that a more severe H1N1 virus will return. It is, however, 
only a fraction of the real need.
    While there are many factors involved in planning for an influenza 
outbreak, the single most important resource is personnel. A well-
trained workforce is critical to the successful response to any 
emergency. CDC's Public Health Emergency Preparedness grant, the 
Hospital Emergency Preparedness Program funding and the Urban Area 
Security Initiative funding have been extremely important to New York 
City's preparedness. However, the steady erosion of funding in the last 
few years hinders our ability to maintain progress and retain the 
critical workforce needed to respond to the unique risks and public 
health emergencies in New York City.
    The primary source of support for the preparedness infrastructure 
in New York City, the Public Health Emergency Preparedness Cooperative 
Agreement through CDC, has steadily decreased since 2002 dropping 
approximately 26 percent. In 2004, the Cities Readiness Initiative 
program, initially provided to 21 high-risk cities, was created to 
prepare major U.S. cities and metropolitan areas to dispense 
antibiotics to their entire population within 24 hours. Recent formula 
changes have resulted in a 25 percent reduction in New York City's 
allocation, and we have been advised that we will receive another 25 
percent reduction in the next grant year.
    Although we appreciate the gap funding that is being provided 
through recent supplemental appropriations, this is one-time funding 
that cannot be used to close our personnel gaps--nor to replenish more 
than $12.6 million in tax levy dollars we used for the recent H1N1 
outbreak. In authorizing future funding mechanisms, we urge you to 
consider the need for stable, predictable, and risk-based funding that 
helps localities maintain their emergency preparedness infrastructure. 
That is the key to real preparedness.
    Thank you for the opportunity to testify. I will be happy to answer 
any questions you may have.

    Ms. Clarke. I thank all the witnesses for their testimony. 
I remind Members that he or she will have 5 minutes to question 
the panel. I will now recognize myself for questions.
    I want to thank all of the witnesses for taking the time to 
come and share your experiences in managing this outbreak. As 
the only Member of this committee from New York City, I 
especially want to welcome Commissioner Farley and thank him 
for his diligence for managing this crisis in the city.
    New York was hit hard with H1N1, with the highest death 
count--63 total--of any State, and 43 deaths in New York City. 
Confirmed cases in New York total 2,738 to date, and the 
fourth-highest case count.
    Commissioner Farley also testified that as of July 1, 909 
people diagnosed with H1N1 have been hospitalized in New York 
City alone.
    Dr. Farley, tell us about the lessons learned by New York 
City during the H1N1 outbreaks. Have you been able to rectify 
the lack of guidance coming out regarding school closures, 
managing H1N1 in other institutional settings and getting 
information out to the public?
    Dr. Farley. H1N1 ended up--while we had a pandemic 
influenza preparedness plan, H1N1 was a little bit different 
from what we had expected. It was a very widespread infection, 
caused many, many cases, but it was milder than what we had 
prepared for. So we had to adapt our pandemic preparedness 
plan. That caused changes in policy about issues such as school 
closures.
    One of the lessons, I think, learned from this is that it 
is important to have the ability to closely track the arrival 
and the severity of a virus such as this and to be able to 
change your plan according to the information you get. We were 
fortunate to have funding for capacity, for surveillance, and 
for laboratory testing, so we felt we had a very good handle on 
where the virus was in the city, how severe the cases were.
    We had to again adapt our response in light of that. That 
adaptation at times involved us in giving guidance that was 
somewhat in conflict with the guidance from the Centers for 
Disease Control, so one of the lessons learned is that, at the 
National level, plans need to be flexible for differences in 
different areas and for differences in how severe the 
infectious virus may be.
    Ms. Clarke. Let me ask then, your concerns or your 
challenges around institutional settings, the outbreak, for 
instance--the Krome DRO facility in Miami, it is a temporary 
immigration detention center, is just one example, for 
instance, at the Federal level. We know there has been an 
outbreak at Rikers Island jail.
    Can you tell us about how the city handled the outbreak, as 
well as the concerns of union and employees there?
    Dr. Farley. We did have infections occurring in people who 
were at Rikers Island jail. This is a jail in which many people 
are arrested frequently, so there is a lot of communication 
between the general city population and the jail.
    We took very aggressive action to try to limit the spread 
of the infection within the jail and, when necessary, provide 
prophylactic medication to people who were at risk, who came in 
contact with those with the infection. We were able to contain 
the transmission in the jail, but it did point out to us the 
fact that there are populations who can't follow general 
guidance. They don't have an opportunity to not come in when 
they are sick; they are forced to stay in that institution. So 
we do have to have guidance for congregant settings like that.
    But I think we did show that by taking proper precautions, 
we were able to control the spread of that infection in that 
institution.
    Ms. Clarke. Aside from the recently issued CDC guidance, 
what guidance have you given these facilities regarding their 
operations, protecting both employees and detainees, and their 
continued operation during a pandemic?
    Dr. Farley. We provided specialized guidance to a variety 
of different congregant settings, as well as jails, schools, 
day care centers, each to a certain extent tailored to their 
particular operations. That guidance did, to a certain extent, 
differ from guidance from the Centers for Disease Control.
    There was a period there when the infection was already 
clearly very widespread in New York City, but the guidance from 
the Centers for Disease Control was trying to essentially 
contain it, and it was clearly past the containment stage. So 
there were settings where, for example, we were not 
recommending N95 masks because we felt that the virus was 
similar to seasonal influenza and the droplet precautions were 
adequate, and the virus was around and that CDC was still 
recommending N95 masks. So our ability to adapt to the 
situation, we thought was important, and we still believe it 
was successful.
    Ms. Clarke. Thank you very much.
    I now recognize the Ranking Member of the full committee, 
the gentleman from New York, Mr. King, for his questions at 
this time.
    Mr. King. Thank you, Ms. Clarke, and let me thank the 
witnesses for their patience and forbearance today for putting 
up with us and our schedule. I can speak for the Chairman; we 
had no control over it, but I want to thank you for sticking 
around.
    I also want to join with Congresswoman Clarke in welcoming 
Dr. Farley and thanking you for your service to the city. Let 
me begin with a question to Dr. Farley, but also open up to 
Director Muth and Dr. Horton.
    I know that Congresswoman Clarke mentioned the fatalities 
in New York. We had a high number compared to the rest of the 
country, and I live right outside the city and many of my 
constituents take the commuter lines into the city. But still, 
for the most part, this was treated in the papers, after the 
first few days in the media, as not being a big deal, as being 
somewhat under control; and yet there was a 200 percent 
increase in the emergency rooms.
    Now, if this were a more severe strain of the virus, and 
people were more ill than they were this past spring, do you 
think that you can adapt to that surge both from those who are 
genuinely sick and those, the ``worried well,'' who are seeing 
reports in the papers of more fatalities or more serious 
illnesses who will rush in.
    I know when we--I have dealt with a number of New York 
hospitals as far as if, God forbid, there is ever a dirty bomb 
attack. Doctors tell me they are more concerned about the 
people who are not sick, who would rush to the emergency room 
even, than those who are actually affected by the act itself or 
the attack itself.
    Anyway, I would ask you and also Director Muth and Dr. 
Horton whether or not you believe the hospitals are prepared 
for that type of surge capacity.
    Dr. Farley. As I said, the hospital emergency departments 
were strained by large numbers of people coming there. Some of 
those were the ``worried well.'' Some of those were people who 
had symptoms of disease.
    Mr. King. Those were symptoms that were not that bad? The 
fact is, you said this was a very mild strain.
    Dr. Farley. Yes. The vast majority of people got over this 
fine, so it was not a very severe strain. Nevertheless there 
were large numbers of people coming to the emergency 
departments.
    Our way of trying to handle that going forward is to, 
first, communicate to people about the fact that if they are 
well they do not need to come to the emergency department. Even 
if they have mild symptoms, they don't necessarily need to come 
to any medical provider; they might be able to do it over the 
telephone. Also to provide alternate sites to get medical care, 
such as community health centers; and also to work with 
hospitals to handle people who will nonetheless have to come 
there, again having potentially separate specialized flu 
clinics or flu emergency departments.
    I think, with that, the hospitals can handle this. I think 
they will be strained, but I do think they can handle that. But 
all of these pieces need to be put in place.
    As a separate issue, if we have a more severe strain of--a 
surge of people with very severe disease, the New York City 
Health Department has done a lot to try to increase the number 
of ventilators, so that patients who have severe enough disease 
that they need to be on a ventilator can be handled.
    Dr. Horton. The first point I would like to make is just, I 
am very reluctant to continue to characterize this as a 
``mild'' virus. We are saying that it is similar to seasonal 
and----
    Mr. King. As far as results, if there are a high number of 
deaths there would have been more people rushing to the 
emergency room. That was the point I was making.
    Dr. Horton. I am making the point, with seasonal flu, even 
with the fact that a good portion of the population is already 
partially immune to the new virus and the fact that we have a 
vaccine in place well before it hits, we still see 35- to 
45,000 deaths and hundreds of thousands of hospitalizations.
    Now, in this case, where there is a novel virus where 
virtually nobody is immune to the virus and there was not a 
vaccine in place early, I think we can anticipate problems.
    A couple of other comments; I would just comment on what 
Dr. Farley said, a couple of other steps.
    I think there is some evidence, I could say as a doctor 
myself, that physicians and nurses working in hospitals are not 
consistently complying with recommendations about infection 
control and personal protection. I think we need to get 
everybody up to snuff and operating to ensure that the 
hospitals and health facilities themselves not become a nidus 
of infection in communities and that we are doing everything 
that we can to protect health care workers so they can stay on 
board. So I think that is extremely important.
    Also individual hospitals, each one of them, should have a 
surge plan, which means, when they activate it, they can 
discharge patients that are ready to be sent home early and 
they can restrict the admission of--new elective admission to 
the hospital to ensure they maximize hospital capacity. So 
there are a couple of additional steps I think they can take to 
help the health system absorb some of this additional activity.
    Mr. King. Director Muth.
    Mr. Muth. Congressman, I spent 30 years at the local level 
riding medic units and everything, and I would say our system 
is strained every day, especially the ERs.
    So our concern certainly would be that the extra pressure 
that a pandemic would put onto that system I think would be 
very tough to handle, although I do think one of the ways of 
handling that certainly is through the public education effort.
    I think we need to do a push to educate the public at all 
levels across the country with the same message, which I think 
is critical. To follow what Dr. Horton said, that if they are 
not--letting them know if they are not ill, then they don't 
necessarily need to go to a hospital or to a private physician.
    Many in our population depend on a hospital for their 
primary care. So you are going to have that compounding the 
situation.
    Mr. King. Just to ask one question on the record; I don't 
expect a answer, just for the record.
    Vice President Biden took a lot of heat when he made the 
remark about travel on the Metro, but in densely populated 
areas such as New York, Chicago, Boston, San Francisco, where 
so many people do go on subways and commuter lines, if this did 
become a more severe strain, would the city of New York look 
into whether or not we would cut back or encourage people not 
to take the subway lines?
    Dr. Farley. We did look into the issue of mass transit in 
New York City. The vast majority of people in New York City 
rely on mass transit, and the feeling was, we could not shut 
down the mass transit system because then people couldn't go to 
work including health care workers and other essential 
personnel.
    There are things we can do to reduce the number of people 
on mass transit and encourage people other ways to get around. 
But the fact is in a densely populated city like New York, more 
people are going to come in contact with each other in many 
locations; and so you will likely have more spread of a virus 
like this.
    Mr. King. Thank you very much.
    Thank you, Madam Chairwoman.
    Ms. Clarke. Ms. Richardson, I understand it is your turn to 
ask your questions.
    Ms. Richardson. Thank you, Madam Chairwoman, and Ranking 
Member for having this very much-needed hearing.
    I would like to speak to the employees, the Federal 
employees aspect, and I had an opportunity to read your 
testimony and congratulations to all of you who hung in here 
through all of these votes we have.
    Is anyone still here from DHS? Okay.
    HHS? Okay, great.
    In your testimony, you said that folks were not receiving 
consistent and timely information and not adequate resources 
and differences from a Texas airport and various airports of 
what the procedure was.
    Do you feel better empowered today with the folks to be 
able to respond? Have you seen any difference since when that 
occurred to where we are right now?
    Ms. Kelley. I think in TSA, in particular, there is a 
recognition that they had serious communication issues with not 
getting the message out to employees.
    We had a meeting as recently as yesterday with TSA about 
communication, and so I think there is a much clearer 
recognition, hopefully; and we have offered to work with them 
to help figure it out so it does not happen again.
    In CBP, in Customs and Border Protection, this MOU that was 
just signed this morning was really the issue. In my view, that 
was much less a communication issue than their not being 
willing to put out a very clear message that employees had the 
choice to wear a mask, if they felt that it was important to 
them and they thought it was important to their families.
    Ms. Richardson. So as far as the Customs folks, they are 
now aware of--as of today, it is their choice to wear a mask?
    Ms. Kelley. As of today, because of the MOU that NTEU 
negotiated, it will be clear to them and NTEU will communicate 
that message to every employee we represent there to make sure 
they have the information, yes.
    Ms. Richardson. Has TSA, to this point--the employees--
received a blanket communication that that is their option as 
well?
    Ms. Kelley. My understanding is, the communication we have 
was issued May 29, but it only got as far as the heads of each 
of the airports, that it did not seem to get into the hands of 
the TSOs. I believe--following yesterday's meeting, I know 
actually, as of about 10 days ago, it started making its way to 
the front lines; and I believe, following our meeting 
yesterday, that that will be clarified for all employees.
    Ms. Richardson. Could you please advise this committee 
within the next 2 weeks if for some reason that communication 
does not get out to all of you?
    Ms. Kelley. I would be glad to do that.
    Ms. Richardson. Thank you very much.
    I yield back the balance of my time.
    Ms. Clarke. I now recognize the gentlelady from Texas, Ms. 
Jackson Lee, for 5 minutes.
    Ms. Jackson Lee. Thank you. I appreciate Ms. Richardson and 
her line of questioning, and I thank you for allowing me to 
question as well. I am glad that she acknowledged that 
individuals are here from DHS and from Health and Human 
Services.
    Madam Chairwoman, I was delayed because of the earlier 
panel because I was in back-to-back meetings on negotiating 
health care reform in one meeting dealing specifically with the 
global issue of what we were addressing and a second one that 
was Texas-based. So I am going to make some comments and ask 
some questions that sort of generate back to the first panel.
    But I do want to place on the record that Texas also had a 
very high impact; and the number of counties include, for H1N1, 
Baylor County, Brazoria County, Cameron, Collin, Comal, Dallas, 
Denton, El Paso, Guadalupe, Hidalgo, Harris, Johnson, 
Montgomery, Fort Bend, Grimes, Matagorda, Tarrant, Travis, 
Nueces, Starr, and Upshur Counties. Texas is a huge State with 
a lot of counties.
    I think, Ms. Kelley, you were focusing on the concern that 
I had, along with the State commissioners, and I am very glad 
Secretaries Lute and Corr have indicated they will now have 
regional strategies. I hope they call them regional teams. 
Obviously, that doesn't go directly to Federal employees.
    But, let me ask you, Ms. Kelley, do you think an ounce of 
prevention is worth a pound of cure?
    Ms. Kelley. I do, and I think especially when it comes to 
front-line employees who are facing these very real threats of 
running into travelers who may be carrying any kind of a virus, 
that they have the right to make that choice on their own.
    Ms. Jackson Lee. I remember the debate of TSA, in 
particular, and TSOs asking for masks, and I remember the 
confusion of not being able to get an answer; is that correct?
    Ms. Kelley. In TSA, that was correct. In Customs and Border 
Protection, they were told no, they were not allowed to wear 
the mask.
    Ms. Jackson Lee. So in addition to confusion, it was also 
an answer that was a rejection. With the MOU, do you feel that 
there is a greater stakeholder position right now, we don't 
know how it is going to turn out, but we do know you have a 
stakeholder position; is that important?
    Ms. Kelley. It is very important, and I believe that the 
language is very clear that employees now have that right. As 
you say, implementation will be the real test.
    Do you also think, and I really respect scientists because 
they are dispassionate. They look at things as 1, 2, 3. But 
isn't it important or do you feel it is important because most 
of us are laymen and not scientists, that we have the right 
amount of passion and concern and also quick acting so that 
there brings a sense of calmness, whether it is a Federal 
employee or the broader community?
    Ms. Kelley. Absolutely. The more information the better, 
and in English that employees can understand; not in scientific 
or medical language which often causes even more confusion. So 
the clearer, the more direct, the better.
    Ms. Jackson Lee. Thank you very much. Let me ask the two 
commissioners from California and New York and certainly 
Maryland, Texas, unique, not represented here on the panel, but 
a lot of different counties, enormously diverse, as some of 
your States are as well. My concern is that the CDC and others 
who were engaged did act dispassionately as scientists. I 
believe that is very important. But do you believe it is 
important for there to be quick-acting communication with State 
agencies, and do you believe that these regional sites which 
may be over a certain number of States would also be important 
to come to large cities like New York, large cities like Los 
Angeles, large cities like Baltimore, and large cities like 
Houston, that there is an on-site team in these larger cities?
    The commissioner from New York.
    Dr. Farley. Our communication in this outbreak was mainly 
through Centers for Disease Control on health issues. There are 
larger issues there, and if this outbreak was more severe and 
if it impacted on critical infrastructure, we would need to 
have discussions with agencies outside of health agencies in 
having a regional coordination, a regional presence, would be 
valuable.
    Ms. Jackson Lee. You wouldn't object, however, if you had 
localized coordination, meaning some of these officials on-site 
in New York City?
    Dr. Farley. That would be valuable in New York City, yes.
    Ms. Jackson Lee. The gentleman from California.
    Mr. Horton. I certainly agree. I think that representation 
would be helpful. I think in the case of what we have seen so 
far, there was very good vertical integration of messaging. But 
recognizing the fact that both across the United States and 
within States there is a lot of regional differences, to the 
extent that the whole process of communication can be 
regionalized, that may bring additional helpful information to 
myself, for example, as a State health officer, to know what is 
happening and the differences between different regions within 
the State and perhaps within the country.
    Ms. Jackson Lee. A particular team that might be dispatched 
to an L.A. or a San Francisco, would also be helpful? A team 
dispatched to a large city would also be helpful?
    Mr. Horton. An epidemiology team, yes. For example, at the 
very beginning of the outbreak in southern California, as I 
mentioned in my comments, the Centers for Disease Control 
provided epidemiologists on-site that were matched with 
epidemiologists from the State and that worked locally in 
southern California to assess. That was a very effective way of 
getting early information about the outbreak itself, how severe 
it was, and how transmissible it was. I think that is a very 
valid approach.
    Ms. Jackson Lee. Thank you. Madam Chairwoman, if I can 
conclude, I do just want to say this: The most vulnerable were 
our large school districts, and I would like to place on the 
record for DHS and HHS that there needs to be some focusing on 
school districts, and I would ask for a team such as the ones 
the commissioner has mentioned to not only be on the cities, 
but that they should be teamed up with school districts because 
that is where our impact was, that is where parents were 
panicking, and that is where we had no answers. I know it well, 
having a number of those schools in my congressional district. 
I thank this second panel, and I look forward to meeting with 
HHS and DHS on this issue going forward.
    Thank you.
    Ms. Clarke [presiding]. I have a second round of questions. 
I don't know if the gentlelady from Texas does.
    I am very mindful of everyone's time at this stage, but 
there are a couple of outstanding issues that I want to have on 
the record, and that has to do with the drug resistance issue. 
I want to raise this with both Dr. Horton and Dr. Farley.
    By January 2009, our committee found that the 
pharmaceutical interventions for pandemic influenza would be 
limited. This turned out to be the case with novel H1N1. There 
was and is no readily available vaccine, and this particular 
strain of H1N1 was already resistant to two of the four 
antivirals ordinarily useful in combating influenza. How are 
you overcoming this problem to deal with the H1N1 now? How do 
you think this problem needs to be addressed in the future, and 
what do you need from Congress to make this happen?
    Mr. Horton. I will be the first to speak from California.
    First of all, the information I have is that currently the 
information we have about the H1N1 virus is that it is almost 
universally sensitive to the two most commonly used and 
stockpiled antiviral medications that are available to us.
    The stockpile that was set up under the direction of the 
Federal Government, and most States bought their purchases, 
oseltamivir or Tamiflu, and Relenza. To my knowledge, to date, 
there have been only a handful of cases of H1N1 that have been 
resistant to those drugs.
    So I think we are very encouraged at least at this point. 
To my knowledge, the information we have so far from the 
southern hemisphere is that the genetic composition and the 
phenotypic expression of the virus has not changed. So I am 
feeling that despite the fact that there is some resistance to 
other organisms, to date anyway, we are feeling good that we 
have the antivirals on hand to combat the problem.
    Dr. Farley. I agree that the antivirals we have now are 
effective against the virus. However, the virus can develop the 
ability to become resistant to the antivirals we are using now. 
In which case then, if we didn't have a vaccine, we would have 
no tools.
    So I do think there is value to developing additional 
antivirals to keep one step ahead of the influenza virus.
    Mr. Horton. I would agree with that.
    Ms. Clarke. I yield 5 minutes to Congresswoman Jackson Lee.
    Ms. Jackson Lee. Thank you very much. I ended on the note 
dealing with school districts, and I would appreciate it if the 
three health directors would comment on the uniqueness of 
schools and school districts as it relates to health 
intelligence, getting to you as State leaders and then it 
transmitting to the consumer. I hate to call a student a 
consumer of H1N1, that is not the interpretation I want given, 
but the impacted individual. It seems in our State, certainly 
children were the most vulnerable. Schools were an immediate 
source, and I would also want to put on the record that we have 
noted that a few summer camps have also been, in essence, 
victimized by H1N1. May I start here, please.
    Dr. Farley. This particular strain of influenza, H1N1, 
particularly favored younger people. There was transmission 
among younger people. There may very well have been 
transmission among schools. That makes them important sites for 
us to consider how to prevent infection with the next epidemic 
wave.
    I understand today there are recommendations that children 
are a high priority group for vaccination when the vaccine 
becomes available. It is important for us to vaccinate children 
to try to prevent infection in the fall.
    Ms. Jackson Lee. Mr. Horton.
    Mr. Horton. How I would like to address your question and 
concern is just to point out what really is needed is cross 
sectorial collaboration on a much stronger level. I think what 
we experienced early this spring when the CDC came out with 
recommendations with regard to school closures was a few 
hiccups, to say the least.
    I would like to think vertical integration allowed us to 
respond to that, and CDC modified it in a very timely fashion. 
But nonetheless, I think public health needs to be more aware 
of the implications of public health recommendations, like 
school closures.
    I mean, how is education going to continue? How are 
nutrition programs going to continue? What is going to be the 
impact on the parents and their workplaces if we send kids home 
from schools? All of those factors, we need public health to 
put the science forward in terms of the effectiveness of 
closing a school, but we also have to factor in the social 
impacts of that and make sure that we have everybody on the 
same page, that we have communicated effectively with the 
school authorities to ensure that we all agree that this is the 
right step, we are aware of the implications, and we have a 
consistent communication to the parents and the children.
    Ms. Jackson Lee. I think that is what was missing.
    Mr. Muth.
    Mr. Muth. Madame, I am from an emergency management field, 
not the medical field.
    I would like to say, getting back to the whole topic of 
communications, within Maryland, we certainly have the problem 
with the National Capital Region in that it is very likely that 
we would have a person living in Maryland, possibly dropping a 
child off in the District of Columbia for school, and either 
living or working in VA. Because of that tri-State or the two 
States and the District of Columbia, it is really critical that 
we are all issuing the same guidance and direction. That 
certainly was a stumbling block for us in the spring event.
    Also, because the CDC, and I am not blaming or putting 
fault on them, but constantly changing the guidance for closing 
schools also created confusion in those areas. So I think we 
have a ways to go to ensure that the communication is across 
the board and going back to your idea of regional teams, I 
think that is a great idea. Part of it should be the whole 
communication package should go along with that.
    Ms. Jackson Lee. We don't want communication to be missing, 
and we don't want to dumb down the communication, in essence, 
to suggest that people should not be concerned.
    Mr. Muth. No. Absolutely not. I think the facts should come 
out as the facts are.
    Ms. Jackson Lee. Ms. Kelley, Federal employees are 
everywhere, and many times dealing with the public. Do you 
think it is crucial that, beyond the MOU you have, there be an 
immediate contact communication with our Federal employees and 
their leadership when there is a sign of a pandemic of the kind 
that H1N1 could have been?
    Ms. Kelley. I do.
    Ms. Jackson Lee. I thank you very much. I yield back.
    Ms. Clarke. I thank the witnesses for their valuable 
testimony and the Members for their questions.
    Before concluding, I would like to remind our second panel 
of witnesses that the Members of the committee may have 
additional questions for you, and we will ask you to respond 
expeditiously in writing to those questions.
    Hearing no further business, the committee stands 
adjourned.
    [Whereupon, at 5:51 p.m., the committee was adjourned.]


                            A P P E N D I X

                              ----------                              

Questions From Chairman Bennie G. Thompson of Mississippi for Ms. Jane 
      Holl Lute, Deputy Secretary, Department of Homeland Security
    Question 1. During the hearing, various Members asked you about 
lessons learned from responding to the H1N1 outbreaks/pandemic. How is 
the Department of Homeland Security identifying lessons learned from 
its preparedness for, detection of, and response to the H1N1 outbreaks 
and pandemic influenza? Is this information being added to the DHS 
Lessons Learned Information Sharing (LLIS) system? If not, why not?
    Answer. The Department of Homeland Security (DHS) has identified 
lessons learned from the response to the spring outbreak of H1N1, and 
has in fact implemented changes to improve our response for the fall 
wave. Specifically, while DHS found that the United States Government 
(USG) pandemic planning began in 2005 was of great value in responding 
to the H1N1 outbreak, DHS learned that much of what actually occurred 
in the spring was not contemplated by prior planning. First, contrary 
to planning scenarios, based upon the H1N1 spring outbreak, DHS learned 
that an initial outbreak with high mortality rate in one country does 
not necessarily mean that the same pattern will follow in the United 
States. In fact, the H1N1 spring outbreak in the United States proved 
to have a relatively mild or low mortality rate and relatively few 
hospitalizations. DHS also learned that contrary to our planning 
scenarios where outbreaks usually start overseas in Africa or Southeast 
Asia, a pandemic can start with little or no warning closer if not at 
home, here in the Americas. Fortunately, the USG was able to use the 
information developed over the years to adjust plans for community 
mitigation, for determining science-based border strategies, for 
vaccine prioritization, for pre-deploying antiviral medications quickly 
to States and for rapidly creating messages that helped the public 
understand what the Nation was facing. Also, very importantly, over the 
years, DHS developed close working relationships with interagency 
partners, which facilitated coordinated response and communications.
    DHS was always planning for the ``worst-case scenario'' which is 
appropriate, but not enough attention was paid to adapting our policies 
and plans for a mild to moderate pandemic. Since the spring, the USG 
has been working on focusing our preparations on the current pandemic 
scenario. DHS found that, while the Department did an excellent job 
stockpiling personal protective equipment and antivirals for the DHS 
workforce, the Department must continue to review and update the 
policies that address workforce protection, communications, and 
training of employees.
    These lessons learned became a major component of the Federal 
Action Matrix that is currently used to track and monitor aspects of 
the USG preparation and response to H1N1. Action items were developed 
for improvement in the following areas: DHS incident response 
coordination, DHS external communications, workforce protection and 
guidance, support of the Secretary as the Principal Federal Official, 
and in incident preparedness and continuity of operations. Coupled with 
the development of a four-pillared approach to preparedness, response, 
and recovery, the USG is in a much better position to deal with a 
future pandemic as a result of this after-action work.
    LLIS currently contains pandemic influenza lessons learned. DHS 
intends to include updated information on lessons learned from the 
current H1N1 response on LLIS.
    Question 2. FEMA Disaster Assistance Policy 9523.17 mentions the 
Federal Coordinating Official (FCO) for an influenza pandemic. Who is 
the FCO for the H1N1 pandemic?
    Answer. There are pre-designated H1N1 team leaders and teams for 
each State and U.S. Territory. If a declaration is warranted and 
declared, the President would appoint an FCO for the declared State or 
territory to execute any appropriate Stafford Act programs. At this 
time, the plan is not for a single FCO for H1N1.
    Question 3. In your testimony, you made reference to finalizing 
operational plans to ensure that DHS essential functions are maintained 
and personnel are protected during a sustained outbreak. Please forward 
these operational plans, the DHS strategic plan for pandemic influenza, 
and H1N1 and pandemic plans created by the DHS components and major 
offices to the committee.
    Answer. The Department of Homeland Security, in coordination with 
Federal, State, local, Tribal, private sector, and non-governmental 
organizational (NGO) partners, continues to develop and execute 
pandemic influenza-related planning activities. Ensuring that all 
essential functions are maintained and protected during a sustained 
outbreak has been an integral component in all pandemic planning and 
operations. The second implementation plan is the DHS 2009-H1N1 
Influenza Implementation Plan, which has been signed by Secretary 
Napolitano and is provided to the committee as requested as an 
attachment to this document.
    The DHS 2009-H1N1 Influenza Implementation Plan identifies specific 
component roles and responsibilities, and it also directs all DHS 
components to develop plans that address key preparation and response 
actions, performance of mission essential functions, workforce 
protection, continuity of operations, and communications with key 
stakeholders during the H1N1 influenza pandemic. For example, FEMA 
developed a Pandemic Influenza Plan (April 19, 2009) that focuses on 
FEMA's responsibilities to maintain essential functions and services, 
ensure the safety of its employees, coordinate Federal response and 
support interagency activities, and communicate with internal and 
external stakeholders. FEMA is also developing a FEMA H1N1 Plan to 
include guidance for workforce protection, mission sustainment, special 
considerations for response in an H1N1 environment, and support to 
other Federal agencies.
    Question 4. When will the DHS strategic plan for pandemic influenza 
be posted on Flu.gov?
    Answer. The DHS strategic plan for pandemic influenza is the DHS 
2009-H1N1 Influenza Implementation Plan, which has been signed by 
Secretary Napolitano. This document establishes an integrated strategy 
for H1N1 preparedness and response based on the Framework's four 
pillars as described in our response to question No. 6. The DHS plan is 
also ``For Official Use Only'', and it will not be posted to the 
website.
    Question 5. Please describe the ``active engagement'' of DHS with 
its tribal partners.
    Answer. The Department of Homeland Security (DHS) via the Office of 
Intergovernmental Programs engaged in outreach during the Spring H1N1 
outbreak and has on-going engagement with the tribal community in 
preparation for the upcoming H1N1 flu season. Working with the 
Department of Health and Human Services (HHS) and in particular, Indian 
Health Services (IHS) who has the lead, DHS coordinates directly with 
tribes, through national and regional tribal associations, and with the 
Bureau of Indian Affairs to provide guidance on H1N1 readiness efforts 
for individuals, communities, businesses, and schools. DHS is working 
with several HHS components--the Indian Health Service (IHS), Centers 
for Disease Control and Prevention (CDC), and the Office of the 
Assistant Secretary for Preparedness and Response (ASPR)--to ensure 
that we are communicating and coordinating our outreach to Tribes. DHS 
Intergovernmental Programs (IGP) send regular e-mail communications to 
Tribal leaders and Tribal organizations as new materials related to 
H1N1 issues are developed. DHS has engaged and is looking to engage 
with its other Federal partners at four of the largest Tribal 
stakeholder organizations at their annual conferences over the next 2 
months concerning the latest information on H1N1, the Conferences are:
    a. September 9-11, 2009: National Native American Law Enforcement 
        Association Annual Conference, Tulsa, OK;
    b. September 14-16, 2009: National Indian Health Board Annual 
        Consumer Conference, Washington, DC;
    c. October 11-16, 2009: National Congress of American Indians 
        Convention, Palm Springs, CA;
    d. October 22-25, 2009: National Indian Education Association 
        Conference, Milwaukee, WI.
    Question 6. In your testimony, you stated that, ``we will be 
prepared and we will be ready'' for the pandemic this fall. Please 
provide a timeline detailing activities that will be undertaken to 
reach a full state of readiness.
    Answer. To achieve a full state of readiness, the Federal 
Government, through its various Departments and agencies, and the White 
House National Security Staff (NSS) are leading the effort to meet the 
preparedness and response challenges that the H1N1 virus presents to 
the Nation. Together, we are achieving substantive progress toward 
meeting the goals set by the White House. Our ``whole of government'' 
approach to addressing these challenges compels Federal Departments and 
agencies to work collaboratively and under exceptionally tight 
timelines.
    On August 5, 2009, the NSS published the National Framework for 
2009-H1N1 Preparedness and Response. This document provides specified 
tasks and suspense dates assigned to Departments for action. The 
Framework also categorizes the tasks into four pillars.\1\ DHS utilized 
the Framework's pillars and leveraged previous pandemic influenza 
planning products to develop the DHS 2009-H1N1 Implementation Plan.
---------------------------------------------------------------------------
    \1\ The following are the four pillars established in the National 
Framework for 2009-H1N1 Preparedness and Response: Surveillance.--
Enhanced efforts to achieve timely and accurate situational awareness 
of evolving disease and the impact on critical sectors to inform policy 
and operational decisions; Mitigation Measures.--Interventions to slow 
the spread of illness and reduce the impact of infection and illness on 
individuals and communities; Vaccination.--Actions to secure safe and 
effective vaccines and to ready a national vaccination program to 
enable the United States to begin voluntary immunization upon a 
recommendation that this approach is warranted; Communications and 
Education.--A coordinated campaign to foster a convergence of action 
across all levels of government, the private sector, the entire health 
care sector, faith-based and community-based organizations, and 
individuals.
---------------------------------------------------------------------------
    Additionally, after examining the effects of the first wave of 
H1N1, DHS collected lessons learned from the initial outbreak, and the 
Department provided guidance to components relating to their 
preparation for future waves of H1N1. This guidance outlined activities 
and timelines associated with the activation and deployment of 
component resources and the H1N1 Regional Coordination Teams.
    Information from the Framework, DHS lessons learned from the 
initial H1N1 outbreak, and guidance to DHS components has been 
distilled into a Federal Action Item Matrix containing action items 
designed to track and manage the Federal Government's approach to H1N1 
response. These action items will address and ameliorate our collective 
preparedness and response requirements. We plan to have all action 
items resolved and in place by October 15, 2009.
    Question 7. How has DHS worked with the coordinating councils to 
develop and provide pandemic influenza guidance, clarification of roles 
and responsibilities, possible actions (such as border closures), etc.?
    Answer. The Department of Homeland Security's (DHS) Partnership and 
Outreach Division (POD) has worked closely with representatives from 
the Sector-Specific Agencies, Sector Coordinating Councils (SCCs), and 
Government Coordinating Councils (GCCs) to develop planning guidance, 
and has conducted workshops to assist the private-sector business 
community within the critical infrastructure and key resources (CIKR) 
sectors in planning for a pandemic influenza outbreak.
    In 2006, DHS released the Pandemic Influenza Preparedness, 
Response, and Recovery Guide for Critical Infrastructure and Key 
Resources (CIKR Pandemic Influenza Guide) and, subsequently, the 
individual sector-specific annexes. The CIKR Pandemic Influenza Guide 
may be found at www.flu.gov. Since the publication of that Guide in 
2006, DHS and subject-matter experts provided by and coordinated 
through the respective CIKR SCCs have been drafting individual sector-
specific guides aimed at preparing the sectors for a high-severity 
influenza pandemic.
    In addition to the Guide, POD worked with the SCCs and GCCs to 
develop workshops targeting CIKR business owners and operators and 
their contingency planners across the United States. Nine web-based 
workshops were conducted during the fall of 2008 for the Commercial 
Facilities, Defense Industrial Base, Emergency Services, Energy, Food 
and Agriculture, Water, and Information Technology/Communication 
sectors. During these workshops, participants had opportunities to ask 
questions about the latest USG pandemic planning guidance.
    At this time, POD, HHS, and other sector-specific agencies are 
reviewing and updating the draft sector-specific guides to ensure 
consistency with USG guidance for the 2009-2010 influenza season. When 
final, these guides will be disseminated to the sector partners, and 
POD will work with those partners on any upcoming activities and 
actions. Additionally, implementing a border closure is not part of the 
national strategy for responding to a pandemic.
    Question 8. Please describe DHS efforts to plan for H1N1 occurring 
at the same time as other major incidents, including hurricanes and 
acts of biological terrorism.
    Answer. The Department of Homeland Security has taken several steps 
to prepare for the possibility of a second wave of the H1N1 influenza 
occurring simultaneously with other major incidents.
    The DHS Office of Operations Coordination and Planning (OPS) and 
the Office of Health Affairs (OHA) established an Operational Planning 
Team (OPT) to provide surge support to the planning and operational 
support efforts needed to augment our capabilities to prepare and 
respond to the challenges that 2009 H1N1 presents to the Nation. The 
OPT's initial charter laid the foundation for a Federal Strategic 
Multi-Incident Plan, to be incorporated within the family of National 
Planning Scenarios in the Integrated Planning System, National Planning 
Annex I, to Homeland Security Presidential Directive-8.
    In developing a draft of this multi-incident plan, the OPT took an 
all-hazards approach to address threats that may occur simultaneously 
with a 2009 H1N1 influenza outbreak. Special consideration was given to 
managing requirements for a major hurricane during an H1N1 outbreak.
    Interagency cooperation led to the completion of the draft Federal 
Strategic Multi-Incident Plan on July 9, 2009. Participating agencies 
included DHS, the Department of Health and Human Services, the 
Department of Education, the Department of Transportation, the 
Department of Justice, the Department of Defense, the Department of 
Commerce, the U.S. Department of Agriculture, the Department of State, 
the Department of Labor, the Department of Treasury, and the Department 
of Veterans Affairs. Through the information analysis planning process, 
threat scenarios, objectives, and tasks were produced. The OPT 
developed and analyzed courses of action to address both common all-
hazards threat characteristics and unique scenarios that may occur 
simultaneously.
    In addition to the work undertaken by the OPT, DHS OPS and FEMA 
senior leaders conducted a multi-threat tabletop exercise on August 11, 
2009, in which the leadership examined and analyzed the challenges and 
response requirements relating to simultaneous response to a second 
H1N1 wave and a hurricane in the southeastern United States.
    In accordance with the FEMA Pandemic Influenza Plan, FEMA has 
activated its Headquarters and Regional Pandemic Response Teams (PRT). 
In anticipation of the potential impacts of a pandemic on FEMA, the 
PRTs will develop strategies to plan, manage, and coordinate the 
effects of a pandemic on our ability to carry out FEMA's mission.
    Question 9. What responsibilities does the DHS Science and 
Technology Directorate have with respect to addressing pandemic 
influenza? Please provide information including specifics regarding all 
on-going research, including diagnostic tests.
    Answer. The Science and Technology (S&T) Directorate addresses 
pandemic influenza by providing technical support for event planning 
and response efforts as well as conducting studies to better understand 
how disease spreads.
    These studies include analyzing potential mitigation strategies to 
minimize the spread of influenza outside of the United States, assuming 
the outbreak starts in the United States; analyzing the benefits of 
various screening strategies for passengers leaving the United States 
and entering foreign countries; and analyzing social mitigation 
strategies such as social distancing and school closures when 
implemented in the United States. These studies seek to determine if 
the implementation of a layered approach can delay the peak outbreak in 
a foreign country.
    S&T is also working on an all-hazards basis to promote resilient 
communities. This includes enhancing coordination and cooperation among 
first responders and between the public and private sectors; working to 
make the States' 211 help systems more effective; developing metrics to 
measure the psycho-social impacts of extreme events; and seeking to 
better understand and improve official communications regarding degrees 
of risk and best steps to mitigate risk.
    During an event, the S&T Directorate provides on-call technical 
support as needed. In addition, the Biodefense Knowledge Center, funded 
by the S&T Directorate and operated out of the Lawrence Livermore 
National Laboratory, also supports planning and preparatory efforts by 
providing information and rapid response to queries regarding 
biological agents such as influenza.
    The S&T Directorate is not currently involved in the development of 
pandemic influenza diagnostics assays; the Department of Health and 
Human Services is the lead for diagnostic-related activities as they 
pertain to pandemic influenza.
    Question 10. How has the National Biosurveillance Integration 
Center maintained constant, real-time, dynamic biosurveillance of the 
H1N1 outbreaks/pandemic? Please provide specifics and examples of 
reports and products.
    Answer. Specific examples include:
   NBIC continued/continues to issue reports including specific 
        H1N1 data on a daily basis. From April 24--September 14, 2009 a 
        total of 163 reports were prepared providing real-time, dynamic 
        updates to NBIS Member Agencies (examples attached 20090915 
        NBIC report and 20090914 NBIC report).
   Through an aggressive daily production cycle that ensured 
        24-hour coverage, NBIC assembled and centralized individual 
        domain data-feeds utilizing the Biosurveillance Common 
        Operating Network (BCON).
     BCON provided automated data-feed scanning of 2009-H1N1 
            and related biosurveillance events (at a dynamically 
            constant rate of approximately 790 sources every 2 
            hours).\2\
---------------------------------------------------------------------------
    \2\ Declared on 11 June 2009.
---------------------------------------------------------------------------
    The NBIC aggressively pursued the development of additional 
biosurveillance related tools to enable it to provide more timely 
information to Federal, State, local, and Tribal leaders; with the 
express purpose of enhancing their decision-making in preparation for 
the return of H1N1 in the fall of 2009.
   Recognizing the potentially devastating consequences on 
        multiple critical infrastructure areas of the United States, 
        the NBIC engaged with the National Infrastructure Simulation 
        and Analysis Center (NISAC) to model potential outbreak 
        characteristics and infrastructure impacts of a resurgent 
        novel-H1N1 virus. The results of the NISAC Modeling effort were 
        analyzed and reviewed by an aggressive and thorough interagency 
        process that engaged all NBIS Member Agencies and additional 
        Federal participants (including the Departments of Energy, 
        Education, and Labor). The impact-analysis was shared with all 
        of the foregoing departments and agencies to provide additional 
        insight into ``most-likely scenario'' effects regarding the 
        anticipated resurgence of H1N1. This NBIC interagency 
        assessment includes insights regarding the measurable dynamics 
        associated with the impact of absenteeism, reduction of 
        productivity and (for example) the perception of the safety of 
        food commodities that could potentially limit the functionality 
        of many critical infrastructures and key resources if there is 
        a resurgence of the 2009-H1N1 novel influenza virus.
     With the goal of achieving accurate real-time 
            interpretation of the output, NBIC hosted specific 
            interagency collaboration and coordination meetings 
            regarding the development of the Modeling effort and 
            Assessment report with the Department of Health and Human 
            Services (HHS) (including the Centers for Disease Control 
            and Prevention (CDC)) on 22 July 2009 and the United States 
            Department of Agriculture (USDA) on August 13, 2009.
     To garner specific subject matter and domain-specific 
            insight, NBIC hosted an interagency collaboration and 
            coordination conference regarding the development of the 
            Modeling effort and Assessment report on July 22, 2009. 
            Participants in the conference or post-conference 
            discussions included representatives from: NBIS Member 
            Agencies (State, Defense, Justice (FBI), Interior, USDA, 
            Commerce, HHS (including CDC and FDA), Transportation, 
            Veterans Affairs, U.S. Postal Service, EPA); the 
            Departments of Education, Energy, Labor; and internal DHS 
            offices including Infrastructure Protection, Intelligence 
            and Analysis, and the Office of Health Affairs.
     Finalization of the assessment is pending the results of a 
            second modeling run. The parameters for the second run are 
            being finalized with HHS this week. The modeling run and 
            subsequent assessment update should be completed by 
            November 30, 2009.
        This Modeling effort can be used to provide further 
            focus to interagency biosurveillance efforts and associated 
            analytic efforts regarding key indicators that may result 
            in earlier cueing and more effective mitigation strategies 
            as the 2009-H1N1 influenza season unfolds.
        A briefing on the NBIC-led, interagency Assessment will 
            be provided to the Department of Homeland Security 
            Secretary and Deputy Secretary.
          The Executive Summary of the DHS Secretary's briefing 
            will be shared with other Federal Departments and State and 
            Local Government Representatives once cleared by DHS 
            leadership.
   Throughout the emergence of the 2009-H1N1 pandemic, the 
        compilation of biosurveillance information from the NBIS 
        community continued on a daily basis, including daily 
        interagency teleconference calls used to create an interagency 
        cross-domain report.
     After receiving updates from interagency SMEs, NBIC 
            analysts update 2009-H1N1 reports on its main visual and 
            reporting tool, the Biosurveillance Common Operating 
            Picture (BCOP).
        The BCOP is a geospatial tool that allows users to 
            review specific in-depth information/reports that are 
            updated on a daily basis, including the various key 
            dynamics associated with the likely return of H1N1 to 
            include a timeline of events, State-by-State case counts, 
            specific reports about local communities (at such time as 
            they are developed) and links to the relevant SMEs in the 
            NBIS community.
          NBIC continued/continues to issue reports and update 
            the BCOP to include specific H1N1 data on a daily basis. 
            From April 24-September 14, 2009 a total of 163 updates 
            were prepared providing real-time, dynamic information to 
            NBIS Member Agencies (attached document 20090914 FED 
            Worldwide H1N1 Influenza).
        To increase the situational awareness of State and 
            local governmental agencies, the Secretary of DHS approved 
            the development and deployment of an H1N1-specific BCOP 
            (one that is accessible by State and local governmental 
            representatives).
          The H1N1-BCOP will be accessible to all validated 
            State and Local officials through the Homeland Security 
            Information Network (HSIN) by the end of September 2009.\3\
---------------------------------------------------------------------------
    \3\ This differs from the Federal version of the BCOP which allows 
users to investigate multiple biological events outside of 2009-H1N1.
---------------------------------------------------------------------------
   In coordination with the DHS/Office of Health Affairs (OHA) 
        H1N1 Overarching Integrated Process Team (DHS/OHA H1N1-OIPT), 
        the NBIC provides tailored inputs to a special 2009-H1N1 weekly 
        Situation Report (SITREP). These H1N1-SITREPs inform the 
        Secretary of DHS and, like the information posted to the BCOP, 
        are interagency products. The H1N1-SITREP includes information 
        regarding any potential mutation of 2009-H1N1 or any 
        coinfection (normal seasonal flu plus H1N1 flu) that could 
        suggest a change in the lethality or rate of infection among 
        the population (attached document 20090911 NBIS Input to H1N1 
        Influenza SITREP).
    Question 11. How has the National planning scenario for pandemic 
influenza informed DHS plans and response efforts for the H1N1 
outbreaks/pandemic? Please provide specifics.
    Answer. National Planning Scenario No. 03, Biological Disease 
Outbreak--Pandemic Influenza played a significant role in the 
development of Federal H1N1 plans and response efforts. The initial 
Federal Pandemic Influenza Operations Plan \4\ developed by DHS in 
coordination with interagency partners established a solid foundation 
that facilitated the rapid development of the 2009 H1N1-specific plans 
described in our responses to questions No. 3 and No. 6.
---------------------------------------------------------------------------
    \4\ DHS developed a draft of a Federal Pandemic Influenza 
Operations Plan (OPLAN) in 2007. This plan was not finalized due to the 
October 2007 compression of the 15 National Planning Scenarios into 
eight scenario sets by the Homeland Security Council Deputies Committee 
and direction by the Deputies that the pandemic influenza scenario 
would be last in order of development priority.
---------------------------------------------------------------------------
    Question 12. What H1N1 guidance and training have been provided to 
DHS personnel in general and in the DHS components specifically (i.e., 
guidance for components, tailored for their specific operations and 
challenges)? Please provide copies of these documents to the committee 
with the specific dates they were released.
    Answer.
Training
    On August 20, 2009 Secretary Napolitano presented awareness 
information in video format that is available to all DHS employees via 
Component intranets as well as the DHS internet webpage. The video can 
be viewed at http://www.dhs.gov/files/programs/gc_1241202408781.shtm.
    In 2007, the Office of Health Affairs developed a general awareness 
video for Pandemic Influenza. This was made available to all Components 
to use or include in their learning management system. While not H1N1-
specific it does provide basic influenza prevention.
    Multiple Components have developed and conducted specific training 
programs. A partial list of training follows:
    Customs and Border Protection (CBP).--This Component had been 
conducting Pandemic Influenza training for over a year. A partial list 
of training classes and the number of employees trained is shown below.

------------------------------------------------------------------------
                                        TRAEN
             Module Name                 Code        Number Complete
------------------------------------------------------------------------
Avian Influenza Fundamentals........     139700  50,267 employees.
Bird Handling Procedures............     139704  32,479 employees.
PI for International Employees......     139705  6,461 employees.
PI Safety--Protecting Yourself......     139701  36,787 employees.
PI Safety--Protecting Your Family...     139702  35,134 employees.
PI Safety--Protecting the Public....     139703  35,972 employees.
------------------------------------------------------------------------

    This list does not include additional respiratory protection, 
train-the-trainer for fit-testing, and personal protective equipment 
training that were also conducted since this training is also 
applicable to other hazards.
    FEMA.--FEMA developed a basic training class that is being used at 
Presidentially-declared disasters as part of the basic safety 
orientation program. This training was completed in May 2009 and has 
been in use as needed since that time.
    TSA.--Has conducted the class described in the table below: The 
Influenza Awareness and Precautions Briefing is estimated to be 40 
minutes in length and covers general information on the common cold, 
flu and Avian flu, what precautionary steps you can take as well as 
outlines the TSA strategic plan and strategy for Pandemic Influenza.

Length: 0.75
Audience: TSA Employees
Contact: ***.*****@tsa.dhs.gov
CPEs: 0.00
Source: Vendor Developed
Contact Hours: 0.75
Goals: Differentiate among the common cold, the common flu, and the 
avian flu; Describe the treatment options for each type of ailment; 
Identify the preparedness and response measures you can take to protect 
yourself and your family; Describe the National Strategy for protecting 
the United States from a pandemic flu; Describe TSAs plan for 
communicating information about our on-going efforts; Describe the TSA 
response plan to a possible avian flu outbreak in the United States.
Credit Hours: 0.75

    In addition, TSA posted N95 Respiratory Protection Training to the 
Online Learning Center it will be activated in the near future as other 
influenza training products are completed, including online H1N1 
Awareness Training.
    USCIS.--Collateral Duty Safety Officers have participated in formal 
training on the USCIS Pandemic Plan and their role in its 
implementation. Two special courses are in the final stages of 
development. The first course addresses illness in USCIS employees and 
a second course deals with ill applicants and visitors to USCIS 
offices.
    USCG.--The USCG began conducting general awareness training on 
Pandemic Influenza approximately 2 years ago, using two different 
programs. One is the DHS developed program and the other is a USCG 
program that addresses specific USCG situations. In addition to these 
programs the USCG also has developed and conducted specialized training 
for their three most at-risk groups, Aids to Navigation (due to Avian 
Influenza), Boarding and Deployable Operations, and medical personnel 
and medical corpsmen.
    FLETC.--FLETC has a half day of training planned for all FLETC 
management on Safety and Emergency Management. It will include the 
Pandemic flu and H1N1, as well as hurricane planning, etc. At present 
it is scheduled for Sept 22, though the date may move slightly.
    USSS.--Train the trainer for respirator training and for 
accomplishing fit-testing at field locations. Approximately 100 
personnel initially trained as the trainers. Program will be increased 
significantly to accomplish training and fit testing of N95 for our 
established mission essential personnel. The target for completion is 
training approximately 3,400 employees. Posters are being developed for 
deployment throughout the Service. The distribution will occur via e-
mail allowing the field offices to print as many as they need and save 
on mail costs. A brochure was developed specifically for the United 
Nations General Assembly details. The information will be presented 
specifically to the shift leaders for distribution to their teams at 
the United Nations. USSS is working on the Avian Pandemic DVD done a 
few years ago and re-working it to a smaller content so it can play on 
the internal website. The goal is to deploy the program to all 
employees but the method and content are still being completed. A 
``Pandemic Info'' link has been established on the USSS internal 
webpage.
    ICE.--ICE began conducting non-mandatory, general awareness 
training, via ICE University on pandemic influenza approximately 2\1/2\ 
years ago. These courses remain available to ICE employees.
    Avian/Pandemic Influenza.--This educational module teaches common 
ways to avoid catching and spreading the flu, whether pandemic flu or 
seasonal flu. This courseware is for FYI purposes only.
    Pandemic Influenza Educational Series.--While this course was 
originally developed as an awareness training for avian influenza 
(H5N1), these training modules present an opportunity to increase 
awareness and gain greater understanding of the implications of and 
personal protective measures for all types of pandemic influenza. All 
ICE employees are encouraged to complete each module in the series and 
supervisors are invited to use the modules for roll call training or 
similar group training opportunities.
    At the outset of the H1N1 influenza outbreak, ICE addressed the use 
of facemasks and respirators as a mitigation strategy to decrease the 
exposure to the virus for at risk personnel. Specifically, ICE launched 
a fit-testing program throughout the United States, training fit 
testers. To date, ICE has trained over 10,000 law enforcement and 
mission-essential personnel in the use of N95 respirators. The cadre of 
over 300 fit testers, located throughout the United States, is well-
positioned to ensure continued protection of the ICE workforce.
    In addition, ICE will be conducting a hybrid H1N1 Table Top 
Exercise (TTX) over a 3-day session to include senior leadership from 
all ICE Program and Field Offices throughout the United States. The ICE 
H1N1 TTX is designed to provide an opportunity for every ICE program to 
reinforce leadership roles, responsibilities, and authorities while 
responding to the current H1N1 event and to engage in discussions about 
how ICE will manage its missions and its people in preparation for the 
next wave of H1N1.
Guidance
    A variety of guidance documents for use Department-wide were 
developed by the Office of the Chief Human Capital Office, Office of 
Health Affairs, and the Office of the Chief Administrative Officer. 
These documents were fully coordinated within DHS and then used to 
develop a DHS Employee H1N1 information page. These documents address 
risk exposure, personal protective equipment, disinfection, time and 
attendance, personnel guidance for managers and supervisors and a host 
of H1N1-related topics. The documents and webpage were developed and 
constructed during August 2009 with the official announcement of the 
page occurring on August 17, 2009. Availability of this information was 
highly promoted via Pandemic Planning, occupational safety and health, 
and human resources groups. Announcement of the page was the lead story 
on the DHS intranet for approximately a week in mid-August. This 
guidance provides the basis of workforce protection for all DHS 
employees and is being used by Components to develop or refine their 
own Pandemic Influenza plans. It should be noted that this page is 
undergoing constant review and update as additional information and 
guidance becomes available. These documents have been attached to the 
main workflow.
    Question 13. What exercises have been conducted by DHS regarding 
pandemic influenza (including intradepartmental pandemic influenza 
tabletops and workshops)? Please provide specific dates, information 
regarding attendees, scenarios upon which these exercises were based, 
how/whether the Homeland Security Exercise and Evaluation Program 
(HSEEP) was used, how the National Exercise Program provided support, 
after-action reports, and how information from these exercises 
(including after-action reports) were put into LLIS.
    Answer.

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                            HSEEP
       DHS PI Exercises              Type              Dates           Attendees         Scenario         Compliance      NEP Support?   LLIS Reporting?
--------------------------------------------------------------------------------------------------------------------------------------------------------
Intra-DHS....................  Table Top (TTX).  Oct 28, 2008....  DHS Component     Overseas          Yes; standard    NEP staff/       Used as central
                                                                    representatives.  outbreak          planning         liaison          information
                                                                                      spreads to US     conferences      provided for     repository
                                                                                      Focus on DHS      and              technical        during
                                                                                      incident          documentation.   contributions    planning and
                                                                                      management.                        to exercise      hosts the
                                                                                                                         development.     after-action
                                                                                                                                          report.
Intra-DHS....................  TTX.............  Apr 3, 2009.....  DHS Component     Overseas          Yes; standard    NEP staff/       Used as central
                                                                    representatives.  outbreak          planning         liaison          information
                                                                                      spreads to US;    conferences      provided for     repository
                                                                                      Workforce         and              technical        during
                                                                                      protection        documentation.   contributions    planning and
                                                                                      focused.                           to exercise      hosts the
                                                                                                                         development.     after-action
                                                                                                                                          report.
Intra-DHS....................  TTX.............  Sept 10, 2009...  DHS Assistant     Real-world H1N1   Yes; standard    NEP staff/       Used as central
                                                                    Secretaries/      threat; Focus     planning         liaison          information
                                                                    Component         is Continuity     conferences      provided for     repository
                                                                    leadership.       of operations     and              technical        during
                                                                                      and Workforce     documentation.   contributions    planning and
                                                                                      protection.                        to exercise      hosts the
                                                                                                                         development.     after-action
                                                                                                                                          report.
Principal Level Exercise 1-08  TTX.............  Feb 2008........  Interagency       International     Yes; standard    NEP sponsored..  No; the White
                                                                    Deputy            outbreak.         planning                          House
                                                                    Secretaries.                        conferences                       maintains
                                                                                                        and                               control of the
                                                                                                        documentation.                    Summary of
                                                                                                                                          Conclusions.
Through the Regional Exercise  Workshops,        ................  All levels/       Various.........  Yes; especially  Sponsor of       Various means
 Support Program, DHS/FEMA      Seminars, TTX's                     jurisdictions;                      those            exercise         of information
 has sponsored exercises        Functional,                         including                           utilizing DHS    support--prima   management.
 across the US at various       Full scale.                         senior                              funding.         rily through
 levels of government.                                              officials.                                           the Regional
                                                                                                                         Exercise
                                                                                                                         Support
                                                                                                                         Program.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Question 14. How do the recently created Regional Coordination 
Teams for pandemic influenza differ from the previously established 
teams? Please provide specifics.
    Answer. The previous National Pandemic Influenza Principal Federal 
Official (NPI-PFO) team included a national Principal Federal Official 
for a pandemic event, as well as NPI-PFO field teams. For the H1N1 
influenza outbreak, Secretary Napolitano elected to serve as the sole 
Principal Federal Official and replace the NPI-PFO field teams with 
reconfigured H1N1 Regional Coordination Teams (RCTs), To reflect these 
modifications, the pandemic ``regions,'' their associated staffing, and 
responsibilities as outlined in the NPI-PFO structure have been renamed 
and reconfigured to reflect Secretary Napolitano's intent. The H1N1 RCT 
structure and mission reflect those necessary changes.
    Secretary Napolitano has outlined the following seven missions for 
the RCTs:
    1. Serve as a conduit between the many Federal agencies engaged in 
        H1N1 response efforts and DHS's various partners in the States;
    2. Identify, and respond, through previously established incident 
        management architecture, to critical information requirements, 
        enabling the Secretary to make decisions related to the 
        Secretary's role as the Principal Federal Official for the H1N1 
        Pandemic;
    3. Serve as the Secretary's primary source in the field for 
        awareness of strategic issues related to the H1N1 pandemic and 
        help broker resolution of significant disputed issues;
    4. Identify and help reconcile regional conflicts involving varying 
        social distancing policies and national resources, especially 
        those affecting commercial activities outside of a single 
        Robert T. Stafford Disaster Relief and Emergency Assistance 
        Act, Public Law 100-707, declaration ``affected area'' and 
        during a compressed time cycle;
    5. Report through the FEMA Regional Administrator and the Federal 
        Coordinating Officer (FCO). This will ensure that the FEMA 
        Regional Administrators can focus on emergency management and 
        regional administration functions and the FCOs can focus on and 
        lead the administration and coordination of relief at the 
        operational and tactical levels as required by law;
    6. Assist DHS component and other Federal interagency leaders in 
        the field to coordinate and collaborate to achieve nationally 
        directed strategic objectives, including those related to entry 
        and exit screening, quarantine, isolation, vaccination, 
        continuity of operations, and continuity of government;
    7. Coordinate with the Designated Agency Safety and Health Official 
        within DHS, Components, and other Department and Agency safety 
        officers in the field through the chair and appropriate members 
        of the DHS Safety and Occupational Health Committee, on all 
        action affecting personnel regarding personal protective 
        equipment and distribution of anti-viral medications.
    Question 15. In your testimony, you stated that personal protective 
equipment has been prepositioned at 120 DHS locations and field offices 
Nation-wide. Where are these locations and to which offices are they 
assigned?
    Answer.
U.S. Immigration and Customs Enforcement (ICE)
ICE National Capitol Region
ICE Alternate Operating Facility

ICE SAC Atlanta, GA; ICE SAC Baltimore, MD; ICE SAC Boston, MA; ICE SAC 
Buffalo, NY; ICE SAC Chicago, IL; ICE SAC Irving, TX; ICE SAC Denver, 
CO; ICE SAC Detroit, MI; ICE SAC El Paso, TX; ICE SAC Honolulu, HI; ICE 
SAC Houston, TX; ICE SAC Los Angeles, CA; ICE SAC Miami, FL; ICE SAC 
New Orleans, LA; ICE SAC New York, NY; ICE SAC Newark, NJ; ICE SAC 
Philadelphia, PA; ICE SAC Phoenix, AZ; ICE SAC San Antonio, TX; ICE SAC 
San Diego, CA; ICE SAC San Francisco, CA; ICE SAC San Juan, Puerto 
Rico; ICE SAC Seattle, WA; ICE SAC St. Paul, MN; ICE SAC Tampa, FL; ICE 
SAC Washington, DC; ICE FOD Atlanta, GA; ICE FOD Boston, MA; ICE FOD 
Buffalo, NY; ICE FOD Chicago, IL; ICE FOD Dallas, TX; ICE FOD Denver, 
CO; ICE FOD Detroit, MI; ICE FOD El Paso, TX; ICE FOD Houston, TX; ICE 
FOD Los Angeles, CA; ICE FOD Miami, FL; ICE FOD Newark, NJ; ICE FOD New 
Orleans, LA; ICE FOD New York, NY; ICE FOD Philadelphia, PA; ICE FOD 
Phoenix, AZ; ICE FOD Salt Lake City, UT; ICE FOD San Antonio, TX; ICE 
FOD San Diego, CA; ICE FOD San Francisco, CA; ICE FOD Seattle, WA; ICE 
FOD Saint Paul, MN; ICE FOD Washington, DC. Total--51 ICE Locations.

CBP Air Cargo, Humble, TX; CBP Laredo, TX; CBP Price Main (ATCET) 
Carson, CA; CBP--Miami International Airport; CBP New Orleans, 
Louisiana 70112; CBP Newark, NJ 07102; CBP Jamaica, NY; CBP Portland, 
OR; CBP San Diego, Otay Mesa Commercial Facility; Area Port of San 
Francisco; CBP San Juan Puerto Rico; CBP Seattle, WA; Area Port of 
Tampa; Area Port: Orlando; Area Port: Jacksonville; Mariposa Port of 
Entry. Total--23 CBP locations.

DHS TSA Warehouse
GSA Distribution Center
Springfield, VA 22150
    Total--TSA

DHS STOCKPILE
Cumberland Logistics Center (FEMA)
USCG central warehousing operations:
Harrisonburg, VA
USCG Locations the PPE Push Packs were pre-positioned:
Charlevoix, MI 49720-9999
Duluth, MN 55802-2492
USCGC ASPEN (WLB-208)
San Francisco, CA 94130-5013
USCGC CYPRESS (WLB-210)
Mobile, AL 36615-1390
USCGC ELM (WLB-204)
Atlantic Beach, NC 28512-5633
USCGC FIR (WLB-213)
Astoria, OR 97103
USCGC HICKORY (WLB-212)
Homer, AK 99603-0101
USCGC HOLLYHOCK (WLB-214)
Port Huron, MI 48060
USCGC JUNIPER (WLB-201)
Newport, RI 02841-1716
USCGC KUKUI (WLB-203)
USCGC MAPLE (WLB-207)
Sitka, AK 99835-9454
USCGC OAK (WLB-211)
Charleston, SC 29405-2421
USCGC SEQUOIA (WLB-215)
USCGC SPAR (WLB-206)
Kodiak, AK 99619-0651
USCGC SYCAMORE (WLB-209)
Cordova, AK 99574
USCGC WALNUT (WLB-205)
Honolulu, HI 96819
USCGC WILLOW (WLB-202)
Newport, RI 02841-1716
USCGC ABBIE BURGESS (WLM-553)
Rockland, ME 04841-3417
USCGC ANTHONY PETIT (WLM-558)
Ketchikan, AK 99901
USCGC BARBARA MABRITY (WLM-559)
Mobile, AL 36615-1390
USCGC FRANK DREW (WLM-557)
Portsmouth, VA 23703-2703
USCGC GEORGE COBB (WLM-564)
San Pedro, CA 90731-0208
USCGC HARRY CLAIBORNE (WLM-561)
Galveston, TX 77553
USCGC HENRY BLAKE (WLM-563)
Everett, WA 98207-5001
USCGC IDA LEWIS (WLM-551)
Newport, RI 02841-1716
USCGC JAMES RANKIN (WLM-555)
Baltimore, MD 21226-2703
USCGC JOSHUA APPLEBY (WLM-556)
St Petersburg, FL 33701-5099
USCGC KATHERINE WALKER (WLM-552)
Bayonne, NJ 07002-5041
USCGC MARCUS HANNA (WLM-554)
South Portland, ME 04106-0007
USCGC MARIA BRAY (WLM-562)
Atlantic Beach, FL 32233
USCGC WILLIAM TATE (WLM-560)
Philadelphia, PA 19147
USCGC BLUEBELL (WLI-313)
Portland, OR 97217-3992
USCGC BUCKTHORN (WLI-642)
Sault Ste. Marie, MI 49783-9501
USCGC BAYBERRY (WLI-65400)
Seattle, WA 98134-1192
USCGC BLACKBERRY (WLI-65303)
Long Beach, NC 28465-8443
USCGC ELDERBERRY (WLI-65401)
Petersburg, AK 99833-0550
USCGC ANVIL (WLIC-75301)
Charleston, SC 29401-1817
USCGC AXE (WLIC-75310)
Morgan City, LA 70380-6030
USCGC CLAMP (WLIC-75306)
Galveston, TX 77553-3001
USCGC HAMMER (WLIC-75302)
Mayport, FL 32233
USCGC HATCHET (WLIC-75309)
Galveston, TX 77553-3001
USCGC HUDSON (WLIC-801)
Miami Beach, FL 33139-5101
USCGC KENNEBEC (WLIC-802)
Portsmouth, VA 23703-2199
USCGC PAMLICO (WLIC-800)
New Orleans, LA 70117-4698
USCGC SAGINAW (WLIC-803)
Mobile, AL 36615-1390
USCGC SLEDGE (WLIC-75303)
Baltimore, MD 21226-2704
USCGC SMILAX (WLIC-315)
Atlantic Beach, NC 28512-5633
USCGC VISE (WLIC-75305)
St. Petersburg, FL 33701-5030
USCGC CHENA (WLR-75409)
Hickman, KY 42050-1132
USCGC CHEYENNE (WLR-75405)
St. Louis, MO 63118-3284
USCGC CHIPPEWA (WLR-75404)
Buchanan, TN 38222-7181
USCGC CIMARRON (WLR-65502)
Buchanan, TN 38222-4201
USCGC GASCONADE (WLR-75401)
Omaha, NE 68112-0337
USCGC GREENBRIER (WLR-75501)
Natchez, MS 39122-8909
USCGC KANAWHA (WLR-75407)
Pine Bluff, AR 71611-7627
USCGC KANKAKEE (WLR-75500)
Memphis, TN 38105-1502
USCGC KICKAPOO (WLR-75406)
Vicksburg, MS 39180-0031
USCGC MUSKINGUM (WLR-75402)
Sallisaw, OK 74955-0626
USCGC OBION (WLR-65503)
Owensboro, KY 42303-0277
USCGC OSAGE (WLR-65505)
Sewickley, PA 15143-2093
USCGC OUACHITA (WLR-65501)
E. Chattanooga, TN 37416-2825
USCGC PATOKA (WLR-75408)
Greenville, MS 38701-9584
USCGC SANGAMON (WLR-65506)
East Peoria, IL 61601-2039
USCGC SCIOTO (WLR-65504)
Keokuk, IA 52632-5851
USCGC WEDGE (WLR-75307)
Demopolis, AL 36732-9999
USCGC WYACONDA (WLR-75403)
Dubuque, IA 52001-7652
    USCG total buoy tenders: 66.

Delivery locations for prepositioning of surgical masks:
CBP Warehouse
Indianapolis, IN 46278
USCG 1: Attn: USCG Pandemic Stockpile
DHS 1: Attn: DHS PPE Stockpile Program
Cumberland Logistics Center (FEMA)
USCIS 1: Attn: USCIS Pandemic Stockpile
FEMA 1: Distribution Center--Atlanta
FEMA 2: Distribution Center--Ft. Worth
FEMA 3: Distribution Center--Moffett Field
FEMA 4: Distribution Center--Frederick
FEMA 5: Cumberland Distribution Center
MTW 1: Mount Weather Emergency Operations Center
USSS 1: U.S. Secret Service
Beltsville, MD 20708
NCR 1: DHS National Capital Region
    Question 16. Please provide copies of all of the employee messages 
that were distributed by DHS and its components regarding H1N1 
guidance.
    Answer. Attached to the main workflow are copies (15) of the 
employee messages that were distributed to DHS.*
---------------------------------------------------------------------------
    * The information has been retained in committee files.
---------------------------------------------------------------------------
    Please note that some of the early guidance has been revised and 
superseded based on advice from OSHA and CDC as more was learned about 
H1N1.
    Question 17. Has the Department established vaccine priorities for 
which employees will receive H1N1 immunization first? If so, please 
describe these priorities and the criteria used to develop these 
priorities.
    Answer. Based on HHS/CDC H1N1 vaccine target group recommendations, 
the Department of Homeland Security (DHS) has prescribed vaccine 
prioritization for its Federal employees who fall into the five 
priority groups of health care and emergency medical services workers, 
pregnant women, those employees 24 years of age or younger, persons 
aged 25-64 years of age with underlying health conditions associated 
with higher risks of medical complications from influenza, and 
household contacts and caregivers for children under 6 months of age.
    DHS will follow HHS, CDC, and the Office of Personnel Management's 
(OPM) publication, ``Preparing for the Flu: A Communications Toolkit 
for the Federal Workforce'' at http://www.flu.gov/professional/federal/
workplace/federal_toolkit.pdf and will determine the prioritization of 
its employees for H1N1 vaccine in accordance with the groups 
recommended at http://www.cdc.gov/h1n1flu/vaccination/acip.htm. OHA has 
taken measures to ensure DHS operational components identify both 
mission critical and emergency personnel.
 Questions From Chairman Bennie G. Thompson of Mississippi for William 
    Corr, Deputy Secretary, Department of Health and Human Services
    Question 1. When will clinical trials for the H1N1 vaccine be 
completed?
    Answer. With its sister agencies in the Department of Health and 
Human Services, the National Institute of Allergy and Infectious 
Diseases (NIAID), a component of the National Institutes of Health 
(NIH), has designed and is in the process of implementing clinical 
trials for the novel H1N1 2009 influenza vaccine through the Nation-
wide network of NIAID Vaccine and Treatment Evaluation Units (VTEUs). 
Data from these trials will provide knowledge to help inform public 
health policy decisions and provide guidance for the 2009-H1N1 
immunization plan. The initial NIAID-supported H1N1 trials are designed 
to answer three primary questions:
   Are these vaccines well-tolerated in healthy people of 
        various ages?
   How large of a vaccine dose, and how many doses of vaccine, 
        are needed to induce an immune response that is predictive of 
        protection?
   Can 2009-H1N1 influenza vaccine be safely administered at 
        the same time or sequentially with the seasonal influenza 
        vaccine, and will both vaccines induce protective immune 
        responses?
    These studies are assessing the vaccines in multiple age groups, 
including children aged 6 months and older, healthy adults, and healthy 
elderly adults over 65 years of age. Complete immune response data from 
the first trials--those studying two doses in healthy adults--are 
expected in late October. Preliminary data indicate that the vaccines 
are safe and that a single 15-microgram dose induces what is likely to 
be a protective immune response in healthy adults between the ages of 
18 and 64. For adults aged 65 and over, the preliminary data indicate 
that the immune response to the 2009-H1N1 influenza vaccine is less 
robust, as is the case with seasonal influenza vaccine. Data on how the 
pediatric populations respond immunologically following a first and 
second dose of H1N1 vaccine are expected in mid-November. Early data 
from the pediatric trials suggest that one dose of vaccine in older 
children, aged 10 to 17 years, may be adequate to induce a robust 
immune response. Younger children may require a second dose, as is the 
case with seasonal influenza vaccine. Complete immune response data 
from studies of administration of the 2009-H1N1 influenza vaccine with 
the seasonal influenza vaccine in both adults and children are expected 
to be available by mid-December. Preliminary data are expected to be 
available in October.
    In addition to these initial trials, NIAID is supporting additional 
studies in populations who may be at higher risk of complications from 
influenza. For example, the first clinical trial of 2009-H1N1 influenza 
vaccine in pregnant women began on September 9; preliminary data are 
expected in late October. Additional trials in pregnant women are 
expected to begin in late October. Clinical trials of the vaccine in 
other populations are in development.
    Finally, NIAID is supporting trials of 2009-H1N1 influenza vaccines 
with adjuvants, which are additives that help create a more vigorous 
immune response to a vaccine. These trials are expected to begin in 
mid-September, with the first preliminary immune response data expected 
in mid- to late October.
    In addition, five manufacturers licensed by FDA to produce seasonal 
influenza vaccine for the United States are also conducting clinical 
studies with the H1N1. These studies were designed with guidance from 
FDA to evaluate the immune response to the vaccine, and determine the 
optimal dose. The populations studied by the various manufacturers 
include children 6 months of age and older, adults, and the elderly. 
The preliminary results from the manufacturers' clinical studies 
regarding the number of doses and the immune response induced are 
consistent with the results of the NIH studies discussed above. The 
trials are on-going.
    Question 2. Please describe HHS efforts to plan for H1N1 occurring 
at the same time as other major incidents, including hurricanes and 
acts of biological terrorism.
    Answer. Multiple simultaneous events are always a possibility, and 
over the years the Department has responded to co-occurring events. 
There are playbooks to guide the response for each type of event, and 
the Secretary's Operations Center coordinates the response to each 
event. To plan specifically for an H1N1 outbreak occurring at the same 
time as a hurricane, the Office of the Assistant Secretary of 
Preparedness and Response (ASPR), the Office of Preparedness and 
Emergency Operations (OPEO) conducted four 3-hour tabletop exercises, 
titled ``HHS Preparation to Respond to Multiple Events Tabletop 
Exercise--Steps to Responsiveness'' between May and July 2009.
    Our purpose in conducting this series of tabletop exercises was to 
share knowledge and gain an understanding of how each ASPR organization 
would respond and integrate into the overall ESF No. 8 response. Our 
method was to build each exercise on the previous exercise discussions, 
focusing on OPEO considerations in response to an impending hurricane 
and on-going influenza outbreak, relationships between Emergency 
Management Group entities, and team preparedness, and readiness 
considerations. The exercises assisted in achieving the following 
objectives:
   Identify command and control procedures and structures when 
        dealing with multiple ESF No. 8 events.
   Understand capabilities and expectations for resource and 
        volunteer management.
   Identify and establish expectations for evacuation, mass 
        care, and patient movement.
    Question 3. Will the antivirals in the National stockpile be 
replenished on an on-going basis? If so, how often and what are the 
challenges in doing so?
    Answer. All of the antiviral drugs that were released in the spring 
from the Strategic National Stockpile (SNS) have been replenished. 
Future decisions to replenish antiviral drugs will be made based on 
need for product, available manufacturer supply and available funding.
    Question 4. Which traditional surveillance systems were and are 
used by the Centers for Disease Control and Prevention to track the 
progress of the novel H1N1 outbreaks/pandemic?
    Answer. The Epidemiology and Prevention Branch in the Influenza 
Division at CDC collects, compiles, and analyzes information on 
influenza activity year-round in the United States and produces a 
weekly report from October through mid-May. The U.S. influenza 
surveillance system is a collaborative effort between CDC and its many 
partners in State and local health departments, public health and 
clinical laboratories, vital statistics offices, health care providers, 
clinics, and emergency departments. Information in five categories is 
collected from nine different data sources.
   Viral Surveillance.--About 80 U.S. World Health Organization 
        (WHO) Collaborating Laboratories and 70 National Respiratory 
        and Enteric Virus Surveillance System (NREVSS) laboratories, 
        located throughout the United States, participate in virologic 
        surveillance for influenza. All State public health 
        laboratories participate as WHO collaborating laboratories 
        along with some county public health laboratories and some 
        large tertiary care or academic medical centers. Most NREVSS 
        laboratories participating in influenza surveillance are 
        hospital laboratories. In 2007, human infection with a novel 
        influenza A virus became a nationally notifiable condition. The 
        2009 influenza A (H1N1) virus is a novel virus. Novel influenza 
        A virus infections include all human infections with influenza 
        A viruses that are different from currently circulating human 
        influenza H1 and H3 viruses.
   Outpatient Illness Surveillance.--Information on patient 
        visits to health care providers for influenza-like illness is 
        collected through the U.S. Outpatient Influenza-like Illness 
        Surveillance Network (ILINet).
   Mortality Surveillance.--Rapid tracking of influenza-
        associated deaths is done through two systems:
     122 Cities Mortality Reporting System. Each week, the 
            vital statistics offices of 122 cities report the total 
            number of death certificates received and the number of 
            those for which pneumonia or influenza was listed as the 
            underlying or contributing cause of death by age group. The 
            percentage of all deaths due to pneumonia and influenza 
            (P&I) are compared with a seasonal baseline and epidemic 
            threshold value calculated for each week.
     Surveillance for Influenza-associated Pediatric Mortality. 
            Influenza-associated deaths in children (persons less than 
            18 years) was added as a nationally notifiable condition in 
            2004. Laboratory-confirmed influenza-associated deaths in 
            children are reported through the Nationally Notifiable 
            Disease Surveillance System.
   Hospitalization Surveillance.--Two systems monitor 
        hospitalizations with laboratory confirmed influenza 
        infections.
     Emerging Infections Program (EIP). The EIP Influenza 
            Project conducts surveillance for laboratory-confirmed 
            influenza related hospitalizations in children (persons 
            less than 18 years) and adults in 60 counties covering 12 
            metropolitan areas of 10 States (San Francisco, CA; Denver, 
            CO; New Haven, CT; Atlanta, GA; Baltimore, MD; Minneapolis/
            St. Paul, MN; Albuquerque, NM; Las Cruces, NM; Albany, NY; 
            Rochester, NY; Portland, OR; and Nashville, TN).
     New Vaccine Surveillance Network (NVSN). The New Vaccine 
            Surveillance Network (NVSN) provides population-based 
            estimates of laboratory-confirmed influenza hospitalization 
            rates for children less than 5 years old residing in three 
            counties: Hamilton County, OH; Davidson County, TN; and 
            Monroe County, NY.
   Summary of the Geographic Spread of Influenza.--State health 
        departments report the estimated level of spread of influenza 
        activity in their States each week through the State and 
        Territorial Epidemiologists Reports. States report influenza 
        activity as no activity, sporadic, local, regional, or 
        widespread.
    For a more detailed explanation of these influenza surveillance 
systems visit: Flu Activity and Surveillance.
    Question 5. Which vaccine manufacturers are providing bulk 
components for the H1N1 vaccine? Are these the same manufacturers who 
already produce U.S.-licensed seasonal vaccine? If not, please provide 
the list of these manufacturers as well.
    Answer. Six manufacturers are licensed to manufacture seasonal 
influenza vaccine in the United States: CSL Limited, GlaxoSmithKline 
Biologicals, ID Biomedical Corp of Quebec, MedImmune, LLS, Novartis 
Vaccines and Diagnostics Limited, and sanofi pasteur Inc.
    On September 15, 2009, FDA-approved supplements to the existing 
Biologics License Applications from four of these licensed influenza 
manufacturers to include Influenza A (H1N1) 2009 Monovalent Vaccine. 
These vaccines are made by CSL Limited, MedImmune LLC., Novartis 
Vaccines and Diagnostics, Limited, and sanofi pasteur, Inc. These 
manufacturers make their own bulk components; however, they will 
provide the monovalent Influenza A (H1N1) 2009 in final finished 
containers, not in bulk form.
  Questions From Ranking Member Peter T. King of New York for William 
    Corr, Deputy Secretary, Department of Health and Human Services
    Question 1a. While a vaccine is a critical component of the 
National strategy to mitigate pandemic influenza, other non-
pharmaceutical tools also have the potential to limit disease and play 
an important role in a dynamic influenza strategy. In terms of a point-
of-care diagnostic that can determine a pandemic strain for the coming 
influenza season, does HHS: See value in, and
    Answer. Yes, HHS/ASPR sees value in point-of-care diagnostics.
    Question 1b. Plan to procure such a piece of technology?
    Answer. HHS/ASPR and HHS/CDC together invested in development of 
point-of-care influenza diagnostic detection systems. It was an 
investigational test of such a system that was used as part of a 
clinical evaluation in the first case of 2009-H1N1 in California.
    Question 2a. In terms of personal protective equipment (PPE): What 
is HHS' response to the claim that the National stockpile contains only 
enough face masks to provide for the American population for 3 days?
    Answer. The Strategic National Stockpile (SNS) includes respirators 
and facemasks, but they are not intended to be used to help protect the 
general American population. The respirators and facemasks in the SNS 
are intended to be provided to States to help protect health care 
workers in accordance with published guidance for use. CDC's guidance 
recommends the use of respirators primarily for health care workers in 
close contact with patients with influenza-like illness (ILI) and the 
use of facemasks by patients with ILI while they are in a health care 
setting to limit the spread of influenza. CDC's guidance generally does 
not recommend the use of respirators or facemasks for workers in non-
health care occupational settings for general work activities or in 
community and home settings except in certain circumstances for persons 
at increased risk of severe illness from influenza.
    Question 2b. Has HHS considered procuring advanced but commercially 
available PPE technologies, such as masks and gowns that neutralize 
virus particles?
    Answer. Issuing contracts for the purchase of PPE is a competitive 
process. HHS contract requirements for the purchase of PPE are set 
according to Federal acquisition regulations and do not exclude the 
purchase of PPE with antimicrobial properties. To date, HHS has 
purchased respirators for critical workforce from three vendors on the 
GSA supply schedule competitive process.
    Question 3. Lastly, can BioShield funds be used for pandemic 
influenza procurements, whether pharmaceutical or non-pharmaceutical in 
nature?
    Answer. No. BioShield funds support the procurement and advanced 
development of medical countermeasures for chemical, biological, 
radiological, and nuclear agents.
  Questions From the Honorable Michael T. McCaul of Texas for William 
    Corr, Deputy Secretary, Department of Health and Human Services
    Question 1a. In your testimony, you stated that the number of 
antiviral courses States have on hand is 35 million and the size of the 
Strategic National Stockpile (SNS) is between 75-100 million. According 
to information obtained from the Department of Health and Human 
Services, however, the SNS currently holds over 48 million regimens of 
antiviral drugs, with States holding an additional 23 million regimens 
(prior to the H1N1 response).
    Can you please clarify the discrepancy in these figures?
    Question 1b. Will the supplies on hand be sufficient for a second 
wave of pandemic flu occurring concurrently with seasonal flu? Or do 
you plan to purchase more antivirals?
    Answer. Prior to H1N1, States bought 23.5 million treatment courses 
of antivirals for their stockpiles and HHS had 50 million treatment 
courses of antivirals in the SNS. In May 2009, with the H1N1 outbreaks 
in the United States, 11.5 million treatment courses of antivirals were 
deployed pro-rata to the States. Additionally, nearly 1 million 
treatment courses were provided to Mexico and other countries. 
Subsequently, HHS replenished the antiviral stockpile by purchasing 13 
million treatment courses of antivirals. Additionally, States purchased 
another 2.1 million treatment courses of antivirals for their 
stockpiles, bringing the total amount of antivirals in States to about 
37.1 million treatment courses.
    HHS is awaiting delivery of an additional 1 million treatment 
courses of antiviral drugs and has plans to procure more antiviral 
drugs upon availability of contingency funds.
   Questions From Chairman Bennie G. Thompson of Mississippi for Ms. 
      Bernice Steinhardt, Director, Strategic Issues, Government 
                         Accountability Office
    Question 1. Which recommendations from GAO's work on pandemic 
influenza remain open? What is the current status, given recent changes 
(e.g. the combining of the Homeland and National Security Councils, the 
new DHS regional coordination teams)?
    Answer. As of July 2009, GAO has made 24 pandemic preparedness 
recommendations that Federal agencies have generally agreed to. There 
have been 11 recommendations, however, that have not yet been fully 
implemented. Several of these open recommendations are particularly 
relevant to planning and preparedness for the 2009 H1N1 pandemic in the 
coming months.
   First, given the change in administration and the associated 
        transition of senior Federal officials, the shared leadership 
        roles that have been established between HHS and DHS for a 
        pandemic, along with other responsible Federal officials, 
        should be rigorously tested and exercised.
   Second, the 3-year period covered by the National Pandemic 
        Implementation Plan is now over and it will be important for 
        the White House National Security Staff (NSS), which supports 
        the Homeland Security Council (HSC) in this administration, to 
        establish a process for updating the National Pandemic 
        Implementation Plan so that the updated plan can address the 
        gaps we have identified, as well as lessons learned from the 
        2009 H1N1 pandemic.
   Third, DHS should continue to work with other Federal 
        agencies and private sector members of the critical 
        infrastructure coordinating councils to help address the 
        challenges of coordination and clarify roles and 
        responsibilities of Federal and State governments.
   Fourth, although HHS, DHS, Education, and the White House 
        hosted an H1N1 summit in July 2009 to aid State and local 
        governments in pandemic planning, DHS and HHS could also hold 
        additional meetings with States to help them address previously 
        identified gaps in their pandemic planning.
   Finally, greater monitoring and reporting of agencies' 
        progress in plans to protect their workers during a pandemic 
        are needed to insure the readiness of agencies to continue 
        operations while protecting their employees in the event of a 
        pandemic.
Questions From Ranking Member Peter T. King of New York for Ms. Bernice 
   Steinhardt, Director, Strategic Issues, Government Accountability 
                                 Office
    Question 1a. GAO has found that there is no mechanism in place to 
monitor agencies' progress in developing workforce protection plans. 
DHS was charged with this responsibility, but the Homeland Security 
Council has not mandated this.
    Why do you feel DHS is the right agency to handle this 
responsibility?
    Answer. The National Security Presidential Directive/NSPD 51 
designates the Secretary of Homeland Security to serve as the 
President's lead agent for coordinating overall continuity operations 
and activities of executive departments and agencies. Among other 
responsibilities, the Secretary is directed to ``Coordinate the 
implementation, execution, and assessment of continuity operations and 
activities''. As we reported in June 2009, the primary threat to 
continuity of operations during a pandemic is the threat to employee 
health.
    Agencies' protection of its workforce from infection is a key 
element of pandemic influenza operational plans. As originally 
envisioned under the Homeland Security Council's (HSC) Implementation 
Plan for the National Strategy for Pandemic Influenza, DHS was charged 
with, among other things, monitoring and reporting to the Executive 
Office of the President on the readiness of departments and agencies to 
continue their operations while protecting their workers during an 
influenza pandemic. Although DHS officials said they were subsequently 
informed that they did not have to prepare a report, having DHS monitor 
and report on the status of agencies' pandemic plans to protect the 
safety and health of their employees while maintaining essential 
operations could enhance agencies' accountability for this 
responsibility and serve as an effective way of tracking agencies' 
progress in making their pandemic plans operational by planning for the 
protection of their workforce.
    Question 1b. What office within DHS should handle this?
    Answer. The scope of our report did not include an assessment of 
which DHS office or offices should be selected to lead or manage the 
assessments.
   Question From Chairman Bennie G. Thompson of Mississippi for Ms. 
  Colleen M. Kelley, National President, National Treasury Employees 
                                 Union
    Question. Does NTEU have a position on which Federal workers should 
get vaccinated against H1N1 first?
    Answer. NTEU's position is that Federal employees whose jobs 
necessitate their close interaction with and proximity to the public, 
such as Customs and Border Protection (CBP) Officers, CBP Agriculture 
Specialists, and Transportation Security Officers in inspection 
positions at domestic airports and U.S. air, sea, and land ports of 
entry, should be among the first to be provided with the vaccine, if 
agencies distribute it to workers. The choice to get vaccinated, 
however, should be the choice of the Federal employee and not mandated.
   Questions From Chairman Bennie G. Thompson of Mississippi for Mr. 
  Richard G. Muth, Executive Director, Maryland Emergency Management 
                                 Agency
    Question 1. In your testimony, you refer to the need for greater 
consistency between public health and emergency management planning 
guidance so that the various agencies can work together seamlessly. 
What guidance were you referring to? Please provide specific examples.
    Answer.
   Guidance for emergency management planning generally is 
        directed by the Comprehensive Planning Guidance and other 
        paradigms, such as NUREG for nuclear planning.
   Planning guidance differs as MEMA uses standard emergency 
        management planning guidance while other agencies including the 
        Maryland Department of Health and Mental Hygiene are required 
        to use CDC guidance.
   NIMS/ICS is Federally required but this is not adhered to by 
        all entities.
   Scalability and flexibility is essential. Unfortunately, 
        these were not found in all State flu planning; the Strategic 
        National Stockpile Plan (SNS) especially needs to have these 
        characteristics.
    Unintended consequences:
   Plans must be integrated in similar formats with all State 
        hazard events in mind. When these commonalities do not occur, 
        operational staff using the plans, those committing resources 
        and decision makers at the highest levels are unable to fulfill 
        their responsibilities. Thus, resources can be wasted, 
        decisions poorly drawn and, most critically, citizens can be 
        put at risk.
    Question 2. What criteria will the State use to determine 
activation of the Emergency Operations Center in response to the H1N1 
influenza pandemic?
   The State Emergency Operations Center (SEOC) at MEMA is 
        always at Level 1 through its 24/7 Maryland Joint Operations 
        Center (MJOC). This capability is available for all-hazard 
        efforts.
   Pursuant to criteria in State law, when more than two State 
        departments are involved in an incident, the Level of the SEOC 
        may be raised to accommodate the incident.
   State staff is called in via an automated call-down system.
   While H1N1 may have some unique features, it will be treated 
        as a ``Notice Event'' meaning that MEMA is aware of its 
        occurrence, similar to a hurricane and Levels will be increased 
        as required.
   As with other health incidents, DHMH is the lead State 
        agency, the subject matter experts as it were and MEMA 
        coordinator of operations and State resources.
    Consequence/benefits:
   Maintaining standardized levels and adherence to State law 
        and procedures in an all-hazards posture allows for the most 
        efficient and reliable means of operation before and during an 
        incident.
   Standardization further creates an atmosphere of ``no 
        surprises'' or as few as possible when dealing with 
        emergencies.
   Staff from MEMA and any other involved State agency has been 
        trained on and is knowledgeable of procedures and anticipated 
        actions.
Questions From Chairman Bennie G. Thompson of Mississippi for Dr. Mark 
      B. Horton, Director, California Department of Public Health
    Question 1. Do you believe there is a need for greater consistency 
between public health and emergency management planning guidance so 
that the various agencies can work together seamlessly? If so, please 
provide examples specific to the State of California. If not, why not?
    Answer. In California, the California Emergency Management Agency 
(CalEMA) recognized that the H1N1 outbreak was a public health disaster 
and that an effective response required public health to lead 
California's efforts. CalEMA provided (and continues to provide) 
support to the State's public health infrastructure which includes our 
sister department, the Emergency Medical Services Authority (EMSA).
    We do believe there is a need for greater coordination between 
public health and emergency management functions at the Federal level. 
From the State perspective it often appeared that was not a clear 
articulation of roles and responsibilities between the Health and Human 
Services Agency and the Department of Homeland Security. For example 
there appeared to be overlap between the two organizations with respect 
to public communications, requests to States for information and 
reporting requirements. From a public information standpoint, the first 
issue has been recently resolved with the institution of jointly-hosted 
conference calls. To sustain an adequate response to the continued 
outbreak, it will be necessary to ensure that there is a common 
understanding of roles and responsibilities, coordination of timelines, 
consistency of public information and guidance, and integration across 
funding streams. Absent that understanding by all concerned it will be 
difficult to mount an integrated medical response if public health 
first responders are faced with reporting within multiple command 
structures.
    It is important to note that this outbreak has clearly demonstrated 
the need to identify specific funding to ensure that emergency 
preparedness policy and funding decisions continue to include all-
hazard preparedness for public health in addition to first responders 
such as police and fire.
    Question 2. What criteria will the State use to determine 
activation of the Emergency Operations Center in response to the H1N1 
influenza pandemic?
    Answer. In California, the Joint Emergency Operating Center (JEOC) 
is currently operating at a moderate level of activation to coordinate 
response efforts across Federal, State, and local agencies for the on-
going H1N1 emergency State-wide. CDPH and EMSA are coordinating with 
CalEMA to identify trigger points for more intense activation status.
    The State response in April, 2009 was guided by The Pandemic 
Influenza Preparedness and Response Plan, as adopted by CDPH (then the 
Department of Health Services) in September 2006. The Plan indicates 
that the first case of laboratory-confirmed novel influenza virus human 
infection in California or elsewhere in the United States, or evidence 
of sustained human-to-human transmission anywhere in the world, will 
result in activation of the relevant components of the emergency 
management organization and may trigger a Governor's proclamation of a 
state of emergency. On Friday, April 17, 2009, the Centers for Disease 
Control, through laboratory data supplied by the Federal Border 
Infectious Disease Surveillance (BIDs) program office located in San 
Diego, determined that two California influenza cases had a unique 
combination of gene segments not previously reported among swine or 
human influenza viruses in the United States or elsewhere. CDPH staff 
worked through the weekend with CDC staff to collect additional 
information. Although human-to-human transmission had not yet been 
verified, on Monday, April 21, 2009 the CDPH Joint Emergency Operation 
Center (JEOC) went to full activation. On April 28, 2009, the Governor 
declared a state of emergency.
    Operational levels are commensurate with the level of H1N1 activity 
in the State and appear adequate at this time. Activation status is 
regularly reviewed by emergency support personnel and staffing and 
resources are constantly reassessed. Given that we are at a higher 
stage of alert and in a proclaimed State of Emergency for public 
health, activation status will remain elevated throughout the pandemic, 
even as State Operations Center (SOC) and JEOC staffing levels 
fluctuate based on demand from differing disciplines.
   Questions From Chairman Bennie G. Thompson of Mississippi for Dr. 
Thomas A. Farley, New York City Department of Health and Mental Hygiene
    Question 1. How is New York City modifying its pandemic influenza 
plan to address the H1N1 pandemic?
    Answer. Response was not received at the time of publication.
    Question 2. What specific lessons were learned by New York City in 
addressing the H1N1 cases at Rikers Island and to protect those that 
may have come into contact with these patients?
    Answer. Response was not received at the time of publication.
    Question 3. What guidance was developed and distributed by New York 
City for how to deal with H1N1 in institutional settings?
    Answer. Response was not received at the time of publication.
    Question 4. How is the New York City Department of Health and 
Mental Hygiene working with the New York State Department of Health to 
respond to the H1N1 outbreaks/pandemic?
    Answer. Response was not received at the time of publication.

                                 
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