[House Hearing, 110 Congress]
[From the U.S. Government Publishing Office]


 
                    BEYOND THE CHECKLIST: ADDRESSING
                    SHORTFALLS IN NATIONAL PANDEMIC
                         INFLUENZA PREPAREDNESS

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

                                HEARING

                               before the

                        SUBCOMMITTEE ON EMERGING
                       THREATS, CYBERSECURITY AND
                         SCIENCE AND TECHNOLOGY

                                 of the

                     COMMITTEE ON HOMELAND SECURITY
                        HOUSE OF REPRESENTATIVES

                       ONE HUNDRED TENTH CONGRESS

                             FIRST SESSION

                               __________

                           SEPTEMBER 26, 2007

                               __________

                           Serial No. 110-72

                               __________

       Printed for the use of the Committee on Homeland Security
                                     
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                     COMMITTEE ON HOMELAND SECURITY

               BENNIE G. THOMPSON, Mississippi, Chairman

LORETTA SANCHEZ, California,         PETER T. KING, New York
EDWARD J. MARKEY, Massachusetts      LAMAR SMITH, Texas
NORMAN D. DICKS, Washington          CHRISTOPHER SHAYS, Connecticut
JANE HARMAN, California              MARK E. SOUDER, Indiana
PETER A. DeFAZIO, Oregon             TOM DAVIS, Virginia
NITA M. LOWEY, New York              DANIEL E. LUNGREN, California
ELEANOR HOLMES NORTON, District of   MIKE ROGERS, Alabama
Columbia                             BOBBY JINDAL, Louisiana
ZOE LOFGREN, California              DAVID G. REICHERT, Washington
SHEILA JACKSON LEE, Texas            MICHAEL T. McCAUL, Texas
DONNA M. CHRISTENSEN, U.S. Virgin    CHARLES W. DENT, Pennsylvania
Islands                              GINNY BROWN-WAITE, Florida
BOB ETHERIDGE, North Carolina         MARSHA BLACKBURN, Tennessee
JAMES R. LANGEVIN, Rhode Island      GUS M. BILIRAKIS, Florida
HENRY CUELLAR, Texas                 DAVID DAVIS, Tennessee
CHRISTOPHER P. CARNEY, Pennsylvania
YVETTE D. CLARKE, New York
AL GREEN, Texas
ED PERLMUTTER, Colorado
VACANCY

            Rosaline Cohen, Staff Director & General Counsel

                     Rosaline Cohen, Chief Counsel

                     Michael Twinchek, Chief Clerk

                Robert O'Connor, Minority Staff Director

                                 ______

   SUBCOMMITTEE ON EMERGING THREATS, CYBERSECURITY, AND SCIENCE AND 
                               TECHNOLOGY

               JAMES R. LANGEVIN, Rhode Island, Chairman

ZOE LOFGREN, California              MICHAEL T. McCAUL, Texas
DONNA M. CHRISTENSEN, U.S. Virgin    DANIEL E. LUNGREN, California
Islands                              GINNY BROWN-WAITE, Florida
BOB ETHERIDGE, North Carolina        MARSHA BLACKBURN, Tennessee
AL GREEN, Texas                      PETER T. KING, New York (Ex 
VACANCY                              Officio)
BENNIE G. THOMPSON, Mississippi (Ex 
Officio)

                    Jacob Olcott, Director & Counsel

        Dr. Chris Beck, Senior Advisor for Science & Technology

                       Carla Zamudio-Dolan, Clerk

       Dr. Diane Berry, Minority Senior Professional Staff Member

                                  (II)


                            C O N T E N T S

                              ----------                              
                                                                   Page

                               STATEMENTS

The Honorable James R. Langevin, a Representative in Congress 
  From the State of Rhode Island, Chairman, Subcommittee on 
  Emerging Threats, Cybersecurity, and Science and Technology:
  Oral Statement.................................................     1
  Prepared Statement.............................................     3
The Honorable Michael T. McCaul, a Representative in Congress 
  From the State of Texas, Ranking Member, Subcommittee on 
  Emerging Threats, Cybersecurity, and Science and Technology....     4
The Honorable Bill Pascrell, Jr., a Representative in Congress 
  From the State of New Jersey...................................    31

                               WITNESSES
                                Panel I

B. Tilman Jolly, MD, Associate Chief Medical Officer for Medical 
  Readiness, Office of Health Affairs, Department of Homeland 
  Security:
  Oral Statement.................................................    13
  Prepared Statement.............................................    15
Ms. Bernice Steinhardt, Director, Strategic Issues, Government 
  Accountability Office:
  Oral Statement.................................................     5
  Prepared Statement.............................................     7
RADM W. Craig Vanderwagen, MD, Assistant Secretary for 
  Preparedness and Response, Department of Health and Human 
  Services:
  Oral Statement.................................................    17
  Prepared Statement.............................................    19

                                Panel II

L. Anthony Cirillo, MD, Center for Emergency Preparedness and 
  Response, Rhode Island Department of Health:
  Oral Statement.................................................    37
  Prepared Statement.............................................    39
Michael C. Caldwell, MD, MPH, Commissioner, Dutchess County 
  Health Department, Poughkeepsie, New York:
  Oral Statement.................................................    49
  Prepared Statement.............................................    51
Peter A. Shult, PhD, Director, Communicable Diseases Division, 
  Wisconsin State Laboratory of Hygiene:
  Oral Statement.................................................    43
  Prepared Statement.............................................    44
David L. Lakey, MD, Commissioner, Texas Department of State 
  Health Services, Center for Consumer and External Affairs:
  Oral Statement.................................................    56
  Preapred Statement.............................................    58

                               Appendexes

Appendix   I.:  Letter
  David L. Lakey, MD.............................................    73
Appendix II.:  Additional Questions and Responses
  Responses from Michael C. Caldwell, MD, MPH....................    75
  Responses from L. Anthony Cirillo, MD..........................    78
  Responses from B. Tilman Jolly, MD.............................    82
  Responses from David L. Lakey, MD..............................    93
  Responses from Peter A. Shult, PhD.............................   101
  Responses from Ms. Bernice Steinhardt..........................   106
  Responses from W. Craig Vanderwagen, MD........................   107


   BEYOND THE CHECKLIST: ADDRESSING SHORTFALLS IN NATIONAL PANDEMIC 
                         INFLUENZA PREPAREDNESS

                              ----------                              


                     wednesday, September 26, 2007

             U.S. House of Representatives,
                    Committee on Homeland Security,
            Subcommittee on Emerging Threats, Cybersecurity
                                and Science and Technology,
                                                    Washington, DC.
    The subcommittee met, pursuant to call, at 10:11 a.m., in 
Room 311, Cannon House Office Building, Hon. James Langevin 
[chairman of the subcommittee] presiding.
    Present: Representatives Langevin, Pascrell, and McCaul.
    Mr. Langevin. [Presiding.] The Committee on Homeland 
Security will come to order. The committee is meeting today to 
receive testimony on Beyond the Checklist: Addressing 
Shortfalls in National Pandemic Influenza Preparedness.
    Good morning. I would like to take this opportunity to 
thank the witnesses on both our panels for apprearing today.
    And I would especially like to thank and welcome Dr. Tony 
Cirillo from my home state of Rhode Island, who will be 
participating in the second panel this morning.
    Let me just say I appreciate your willingness to help 
Congress understand the devastating nature of pandemic 
influenza and to work with us in determining what resources are 
necessary to help prepare the nation before a pandemic occurs.
    Today we will explore what it takes to prepare for and 
respond to an influenza pandemic that would affect every sector 
of society and every person in the world.
    Planning is problematic to begin with because it is so 
difficult to fathom both the potential casualties and the 
impact of such a pandemic.
    Even when we focus just on our own country, the projected 
numbers are still staggering--200,000 dead, 2 million ill, all 
sectors and every aspect of the infrastructure negatively 
impacted.
    Though this is a problem that we will not be able to 
control through standard disease management practices, we can 
and must rise to the challenge. Make no mistake about it--we 
are due for a severe influenza pandemic at some point for a 
variety of reasons.
    The influenza viruses that could result in a pandemic are 
increasing in virulence. Record numbers of humans are now 
living in close proximity to current and potential animal 
carriers.
    Rapid transit moves people and cargo at increasingly faster 
rates, fostering the movement and transfer of diseases. 
Influenza viruses are already mutating faster than we could 
have imagined, and the toll that avian influenza is taking on 
other countries is already devastating.
    The impact this disease could have on the security of our 
homeland is indeed worrisome, which is why awareness and 
preparedness are critical.
    Increased emphasis on pandemic planning and preparedness 
for the United States in recent years has resulted in the 
generation of the National Strategy for Pandemic Influenza, 
released in November 2005, and its Implementation Plan, 
released in May 2006.
    Some departments and agencies within the executive branch 
have also created their own strategies to distribute resources 
and guidance throughout the country at all levels of government 
and to the private sector based on their strategies and the 
National Strategy itself.
    Although these are positive steps, one thing is clear. The 
nation is still not ready for an influenza pandemic to occur 
here or overseas.
    Today we will discuss the insufficiencies of the National 
Strategy and its Implementation Plan and hopefully find ways to 
improve upon our current strategies.
    The Implementation Plan for the National Strategy is 
composed of hundreds of separate actions forming a checklist 
with some 324 items.
    Although checklists are good tools for getting things 
accomplished, we can sometimes make checking things off more 
important than actually achieving the goals and objectives we 
set out for ourselves in the first place.
    Our nation's leaders are not seeing the big picture. 
Instead, they are driving our departments and agencies to focus 
so much effort on checking boxes that there is barely time left 
to actually combat a potential pandemic.
    We need to address the shortfalls in our national pandemic 
influenza preparedness and get beyond the checklist.
    Our effort seems to have gotten stuck at the federal level 
but it is time to shift our resources to the states, 
territories, tribes and localities.
    State, territorial, tribal and local entities have found 
themselves preparing for a pandemic without adequate funding, 
necessary resources, strategy-driven guidance or strong 
leadership.
    When pandemic influenza hits this country, our public 
health professionals and health care practitioners will be 
fighting to save lives and the federal government will be 
assisting in those efforts. We need to cater to them, not the 
checklist.
    Today we will also examine the interactions among the 
members of the executive branch, especially the Department of 
Homeland Security and the Department of Health and Human 
Services as they co-lead activities to manage an influenza 
pandemic when it does strike our nation.
    Unfortunately, there is little evidence that either agency 
knows what their roles and responsibilities would be during an 
actual event.
    And I very much fear another Hurricane Katrina situation, 
where delays in identifying principal federal officials 
resulted in a significant problem and unnecessary losses of 
life. We cannot afford for this to ever happen again.
    We must therefore work the uncertainties out today so that 
we can properly deal with these situations tomorrow. I very 
much appreciate the efforts put forward by our federal and non-
federal colleagues in the private and public sectors, and thank 
you all for being here this morning.
    With that, the chair now recognizes the ranking member of 
the subcommittee, the gentleman from Texas, Mr. McCaul, for the 
purpose of an opening statement.

    Prepared Opening Statement of the Honorable James R. Langevin, 
Chairman, Subcommittee on Emerging Threats, Cybersecurity, and Science 
                             and Technology

    Good morning, I'd like to thank the witnesses on both of our panels 
for appearing today, and I would especially like to thank Dr. Tony 
Cirillo from my home state of Rhode Island who will be participating on 
the second panel. I appreciate your willingness to help Congress 
understand the devastating nature of pandemic influenza--and to work 
with us in determining what resources are necessary to help prepare the 
Nation before a pandemic occurs.
    Today we will explore what it takes to prepare for, and respond to, 
an influenza pandemic that would affect every sector of society, and 
every person in the world. Planning is problematic to begin with, 
because it is so difficult to fathom both the potential casualties and 
the impact of such a pandemic. Even when we focus just on our own 
country, the projected numbers are still staggering--200,000 dead, 2 
million ill, all sectors and every aspect of the infrastructure 
negatively impacted. Though this is a problem that we will not be able 
to control through standard disease management practices, we can and 
must rise to the challenge. Make no mistake about it, we are due for a 
severe influenza pandemic.
    The influenza viruses that could result in a pandemic are 
increasing in virulence. Record numbers of humans are now living in 
proximity to current and potential animal carriers. Rapid transit moves 
people and cargo at increasingly faster rates, fostering the movement 
and transfer of diseases. Influenza viruses are already mutating faster 
than we could have imagined, and the toll that avian influenza is 
taking on other countries is already devastating.
    The impact this disease could have on the security of our homeland 
is indeed worrisome, which is why awareness and preparedness is 
critical. Increased emphasis on pandemic planning and preparedness for 
the United States in recent years has resulted in the generation of the 
National Strategy for Pandemic Influenza (released in November 2005) 
and its Implementation Plan (released in May 2006). Some Departments 
and agencies within the Executive Branch have also created their own 
strategies, and distributed resources and guidance throughout the 
country, at all levels of government, and to the private sector--based 
on their strategies and the National Strategy itself. Although these 
are positive steps, one thing is clear: the Nation is still not ready 
for an influenza pandemic to occur here or overseas.
    Today we will discuss the insufficiencies in the National Strategy 
and its Implementation Plan, and hopefully find ways to improve upon 
our current strategies. The Implementation Plan for the National 
Strategy is composed of hundreds of separate actions--forming a 
checklist with 324 items. Although checklists are good tools for 
getting things accomplished, we can sometimes make checking things off 
more important than actually achieving the goals and objectives we set 
for ourselves in the first place.
    Our Nation's leaders are not seeing the big picture--instead, they 
are driving our Departments and agencies to focus so much effort on 
checking boxes that there is barely time left to actually combat a 
potential pandemic. We need to address the shortfalls in our National 
Pandemic Influenza Preparedness, and get beyond the checklist. Our 
efforts States, Territories, Tribes, and Localities. State, 
territorial, tribal, and local entities have found themselves preparing 
for a pandemic without:
        ` Adequat funding,
        ` Necessary resource,
        ` Strategy-driven guidance, or
        ` Strong leadership.
    When pandemic influenza hits this country, our public health 
professionals and health care practitioners will be fighting to save 
lives, and the Federal government will be assisting in those efforts. 
We need to cater to them, not the checklist. Today we'll also examine 
the interactions among the members of the Executive branch--especially 
the Department of Homeland Security and the Department of Health and 
Human Service as they co-lead activities to manage an influenza 
pandemic when it does strike our nation.
    Unfortunately, there is little evidence that either agency knows 
what their roles and responsibilities would be during an event. I very 
much fear another Hurricane Katrina situation, where delays in 
identifying principal federal officials resulted in the significant 
problems and unnecessary losses of life. We cannot afford for this to 
happen again. We must therefore work the uncertainties out today so we 
can properly deal with these situations tomorrow. I very much 
appreciate the efforts put forward by our Federal and non-federal 
colleagues, in the private and public sectors, and thank you for being 
here this morning.

    Mr. McCaul. I thank the chairman.
    I would like to welcome our distinguished panel of 
witnesses here today, and in particular Dr. David Lakey from my 
home town of Austin, Texas, who will be on the second panel 
here today.
    In the 109th Congress this committee held hearings and a 
series of briefings which examined the National Strategy for 
Pandemic Influenza and its Implementation Plan.
    Today we are more than a year after the Implementation Plan 
was released, and we ask whether we are more prepared today 
than we were then to deal with the potential onset of a 
pandemic.
    I hope the answer is yes, that we are more prepared. I 
think the answer is yes, but there is certainly more to be 
done.
    Never before has the human population anticipated and 
prepared for a pandemic. We cannot be certain that our efforts 
are enough or if they are even realistic. But we do know that 
we are long overdue for an outbreak of influenza.
    The 20th century witnessed three separate pandemics that 
cost hundreds of thousands of lives, and we understand that the 
efforts we make now to prepare for a pandemic, whether it is 
caused by the H5N1 strain or some other unidentified strain, 
will shape the scope of that pandemic and may save countless 
lives.
    The release of the National Strategy and the Implementation 
Plan were certainly, in my view, a step in the right direction.
    I agree that pandemic preparedness efforts should go beyond 
merely checking the box for the action items in the plan and 
that a comprehensive and flexible approach should be adopted.
    I don't want us to overlook the significant 
accomplishments, however, that the federal government has made 
in its efforts to plan for a pandemic. We are working with our 
international partners to limit the spread of H5N1 overseas in 
hopes that it will not reach the United States.
    We are expanding our vaccine development capability and 
stockpiling antiviral drugs which will be critical at the onset 
of the pandemic.
    Plans have been made to increase surge capacity at medical 
facilities and to continue the operations of government and 
private sector business during high rates of absenteeism.
    But we must not be complacent. It is important that the 
relevant players clarify and test their leadership roles and 
responsibilities for a pandemic situation.
    It is also important that others involved in the pandemic 
planning process, including state and local governments, 
understand their roles.
    And while the media coverage of this issue has certainly 
waned, the threat posed by the emergence of pandemic influenza 
to homeland security has not.
    I am happy to see that this committee is continuing its 
examination of pandemic preparedness in this Congress.
    And I want to thank you, Mr. Chairman, for holding this 
hearing, and I yield back.
    Mr. Langevin. I thank the gentleman.
    This is obviously a very busy day on the Hill. We will have 
members coming in and out and several markups going on.
    But other members of the committee are reminded that under 
committee rules, opening statements may be submitted for the 
record.
    And I now welcome the first panel of witnesses. Our first 
witness, Ms. Bernice Steinhardt, is the Director of Strategic 
Studies at the United States Government Accountability Office.
    Our second witness is Dr. Tilman Jolly. Dr. Jolly is the 
associate chief medical officer for medical readiness in the 
Office of Health Affairs at the Department of Homeland 
Security.
    And our third witness is Dr. Craig Vanderwagen, Assistant 
Secretary for Preparedness and Response at the Department of 
Health and Human Services. Dr. Vanderwagen was the senior 
federal health official in the response to Hurricane Katrina 
and Rita.
    We thank all three of our witnesses for their service to 
the nation and for being here today. We look forward to your 
testimony.
    Without objection, the witnesses' full statements will be 
inserted in the record.
    And I now ask each witness to summarize his or her 
statement for 5 minutes, beginning with Ms. Steinhardt.
    Welcome.

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

    Ms. Steinhardt. Thank you very much, Mr. Chairman and Mr. 
McCaul. We really appreciate the opportunity to be here today 
to talk about our recent report on planning for potential 
pandemic influenza in the United States.
    Fortunately, the administration has taken an active 
approach in preparing a national pandemic Strategy and 
Implementation Plan. But we found that much more needs to be 
done to make sure that federal leadership roles are clear and 
that the plan is viable and can be effectively implemented.
    Let me turn to leadership roles first. The plan assigns 
shared leadership roles to the Secretaries of Health and Human 
Services and Homeland Security, the first for medical response 
in a pandemic and the DHS secretary for overall incident 
management and response.
    But given that a severe pandemic would entail not only a 
medical response but would also have to focus on sustaining 
critical infrastructure and the economy, it is not clear when 
in a pandemic the HHS Secretary would have the lead and when 
the DHS Secretary would have the lead.
    And these two are far from the only leadership positions. 
Under the Post-Katrina Reform Act, which was enacted subsequent 
to the pandemic Strategy and Plan, the FEMA administrator has 
now been designated the Principal Domestic Emergency Management 
Advisor to the President.
    And also after the pandemic Plan was prepared, the DHS 
Secretary pre-designated a national Principal Federal Official, 
or a PFO, and created five pandemic regions, each with a 
regional PFO and a Federal Coordinating Officer, or FCO, all of 
them responsible to some extent for coordinating federal 
planning, exercise and support.
    Not only is this leadership structure complex and 
potentially confusing, it has never been tested.
    As this committee well understands, as your remarks 
indicated, Mr. Chairman, one of the major lessons the country 
learned from Katrina was that plans and assumptions have to be 
understood, they have to be tested and the lessons learned 
incorporated into plans before emergencies occur.
    Yet the only national pandemic exercise to date was a 
Cabinet-level tabletop simulation in December 2005, well before 
the national Implementation Plan was released and the 
leadership structure created.
    I want to turn now to our assessment of the national 
pandemic Strategy and Plan. Although the Plan did a good job in 
defining the problem and discussing constraints and challenges, 
it is missing some significant elements. I want to highlight 
just a few here.
    For one thing, the plan does not identify what it will cost 
to carry out. Obviously, our ability to do all that the plan 
outlines is going to be affected by our ability to pay for it.
    Not everything is going to be easily addressed through 
existing mechanisms and could, in fact, place considerable 
stress on existing resources.
    We are also concerned that despite the fact that states, 
local and tribal entities will be on the front lines of the 
pandemic, these stakeholders were not directly involved in 
developing the Strategy and Plan.
    And lastly, we noted that there is no provision in the plan 
for monitoring and reporting on progress and for updating the 
plan to reflect lessons learned from exercises or changes in 
leadership responsibilities or other policy decisions.
    To address these gaps, we outline several steps. First, we 
recommended that the HHS and DHS Secretaries work together to 
develop and conduct rigorous testing, training and exercises 
for pandemic influenza.
    We also recommended that the Homeland Security Council 
establish a specific process and time frame for updating the 
plan, one that involves key non-federal stakeholders and fills 
in other gaps that we identified.
    I would note that HHS and DHS agreed with our 
recommendations, but the Homeland Security Council did not 
respond or offer comments on the report.
    I want to say, in closing, that these gaps are not trivial 
or simply procedural. When a pandemic actually occurs, the 
effectiveness of actions that are taken at the outset are going 
to be of critical importance in helping to limit the spread of 
the disease.
    While we recognize that our understanding of the virus is 
still evolving, it is important to take these steps now before 
a disaster strikes.
    With that, I will conclude my remarks and I look forward to 
your questions. Thank you.
    [The statement of Ms. Steinhardt follows:]

                Prepared Statement of Bernice Steinhardt

    Mr. Chairman and Members of the Subcommittee:
    I am pleased to appear here today to discuss the federal 
government's efforts to prepare for and respond to a possible influenza 
pandemic. An influenza pandemic is a real and significant threat facing 
the United States and the world. Although the timing and severity of 
the next pandemic is unpredictable, there is widespread agreement that 
a pandemic will occur at some point. Unlike incidents that are 
discretely bounded in space or time (such as a storm or a terrorist 
attack), a pandemic is not a singular event, but is likely to come in 
waves, each lasting weeks or months, and could pass through communities 
of all sizes across the nation and the world simultaneously.
    Today, I will discuss (1) federal leadership roles and 
responsibilities for preparing for and responding to a pandemic, (2) 
our assessment of the National Strategy for a Pandemic Influenza 
(Strategy) and the Implementation Plan for the National Strategy for a 
Pandemic Influenza (Plan), and (3) opportunities to increase the 
clarity of federal leadership roles and responsibilities and improve 
pandemic planning.
    This statement is based on our August 14, 2007, report, requested 
by the Ranking Member, Senate Budget Committee; the Chairman and 
Ranking Member, House Committee on Oversight and Government Reform; and 
the Chairman, House Committee on Homeland Security.\1\ Our objectives 
in that report were to address the extent to which (1) federal 
leadership roles and responsibilities for preparing for and responding 
to a pandemic are clearly defined and documented and (2) the Strategy 
and the Plan address the characteristics of an effective national 
strategy; we conducted our work in accordance with generally accepted 
government auditing standards. We analyzed relevant documents, 
interviewed cognizant federal officials, and assessed the Strategy and 
Plan to determine the extent to which they jointly addressed the six 
desirable characteristics of an effective national strategy that we 
developed and used in previous work.\2\ While national strategies 
necessarily vary in content, the six characteristics we identified 
apply to all such planning documents and can help ensure that they are 
effective management tools.
---------------------------------------------------------------------------
    \1\ GAO, Influenza Pandemic: Further Efforts Are Needed to Ensure 
Clearer Leadership Roles and an Effective National Strategy, GAO-07-781 
(Washington, D.C.: Aug. 14, 2007).
    \2\ See GAO, Combating Terrorism: Evaluation of Selected 
Characteristics in National Strategies Related to Terrorism, GAO-04-
408T (Washington, D.C.: Feb. 3, 2004); Rebuilding Iraq: More 
Comprehensive National Strategy Needed to Help Achieve U.S. Goals, GAO-
06-788 (Washington, D.C.: July 11, 2006); and Financial Literacy and 
Education Commission: Further Progress Needed to Ensure an Effective 
National Strategy, GAO-07-100 (Washington, D.C.: Dec. 4, 2006).
---------------------------------------------------------------------------
    In summary, although the administration has taken an active 
approach to this potential disaster by developing a Strategy and Plan, 
and has undertaken a number of other efforts, much more needs to be 
done to ensure that the Plan is more viable and can be effectively 
implemented in the event of an influenza pandemic.
         Key federal leadership roles and responsibilities for 
        preparing for and responding to a pandemic continue to evolve 
        and will require further clarification and testing before the 
        relationships of the many leadership positions are well 
        understood. Most of these leadership roles involve shared 
        responsibilities, and it is not clear how these would work in 
        practice. Because initial actions may help limit the spread of 
        an influenza virus, the effective exercise of shared leadership 
        roles and responsibilities could have substantial consequences. 
        However, only one national, multisector pandemic-related 
        exercise has been held, and that was prior to issuance of the 
        Plan.
         The Strategy and Plan do not fully address the 
        characteristics of an effective national strategy and contain 
        gaps that could hinder the ability of key stakeholders to 
        effectively execute their responsibilities. In addition to the 
        fact that the Strategy and Plan do not clarify how responsible 
        officials will share leadership responsibilities, they do not 
        include a description of the resources required to implement 
        the Plan, and consequently do not provide a picture of 
        priorities or how adjustments might be made in view of resource 
        constraints. Additionally, state and local jurisdictions that 
        will play crucial roles in preparing for and responding to a 
        pandemic were not directly involved in developing the Plan, and 
        the linkage of the Strategy and Plan with other key plans is 
        unclear.
    The gaps in the Strategy and Plan are particularly troubling 
because they can affect the usefulness of these planning documents for 
those with key roles to play and, with no mechanisms for future updates 
or progress assessments, limit opportunities for congressional decision 
makers and the public to assess the extent of progress being made or to 
consider what areas or actions may need additional attention.
    We made two recommendations in our August 2007 report to address 
these concerns.
         We recommended that the Secretaries of Homeland 
        Security and Health and Human Services work together to develop 
        and conduct rigorous testing, training, and exercises for 
        pandemic influenza to ensure that the federal leadership roles 
        are clearly defined and understood and that leaders are able to 
        effectively execute shared responsibilities to address emerging 
        challenges. Once the leadership roles have been clarified 
        through testing, training and exercising, the Secretaries of 
        Homeland Security and Health and Human Services should ensure 
        that these roles and responsibilities are clearly understood by 
        nonfederal partners.
         Our report also recommended that the Homeland Security 
        Council (HSC) establish a specific process and time frame for 
        updating the Plan. This process should involve key nonfederal 
        stakeholders and incorporate lessons learned from exercises and 
        other sources. The next update of the Plan could be improved by 
        addressing the gaps we identified.
    The Department of Health and Human Services (HHS) and the 
Department of Homeland Security (DHS) concurred with the first 
recommendation. The HSC did not comment on the draft report or our 
recommendation.

Background
    To address the potential threat of an influenza pandemic, the 
President and his HSC issued two planning documents. The Strategy was 
issued in November 2005 and is intended to provide a high-level 
overview of the approach that the federal government will take to 
prepare for and respond to an influenza pandemic. It also articulates 
expectations for nonfederal entities--including state, local, and 
tribal governments; the private sector; international partners; and 
individuals--to prepare themselves and their communities.
    The Plan was issued in May 2006 and is intended to lay out broad 
implementation requirements and responsibilities among the appropriate 
federal agencies and clearly define expectations for nonfederal 
entities. The Plan includes 324 action items related to these 
requirements, responsibilities, and expectations and most of them are 
to be completed before or by May 2009. It is intended to support the 
broad framework and goals articulated in the Strategy by outlining 
specific steps that federal departments and agencies should take to 
achieve these goals. It also describes expectations regarding 
preparedness and response efforts of state and local governments, 
tribal entities, the private sector, global partners, and individuals. 
The Plan's chapters cover categories of actions that are intended to 
address major considerations raised by a pandemic, including protecting 
human and animal health; transportation and borders; and international, 
security, and institutional considerations.

Federal Leadership Roles Are Unclear, Evolving, and Untested
    Several federal leadership roles involve shared responsibilities 
for preparing for and responding to an influenza pandemic, including 
the Secretaries of Health and Human Services and Homeland Security, the 
Administrator of the Federal Emergency Management Agency (FEMA), a 
national Principal Federal Official (PFO), and regional PFOs and 
Federal Coordinating Officers (FCO). Many of these leadership roles and 
responsibilities have not been tested under pandemic scenarios, leaving 
unclear how all of these new and developing relationships would work.

Federal Leadership Roles and Responsibilities Are Unclear and Evolving
    The Strategy and Plan do not clarify the specific leadership roles 
and responsibilities for a pandemic. Instead, they restate the existing 
leadership roles and responsibilities, particularly for the Secretaries 
of Homeland Security and Health and Human Services, prescribed in the 
National Response Plan (NRP)--an all-hazards plan for emergencies 
ranging from hurricanes to wildfires to terrorist attacks. However, the 
leadership roles and responsibilities prescribed under the NRP need to 
operate somewhat differently because of the characteristics of a 
pandemic that distinguish it from other emergency incidents. For 
example, because a pandemic influenza is likely to occur in successive 
waves, planning has to consider how to sustain response mechanisms for 
several months to over a year--issues that are not clearly addressed in 
the Plan.
    In addition, the distributed nature of a pandemic, as well as the 
sheer burden of disease across the nation, means that the support 
states, localities, and tribal entities can expect from the federal 
government would be limited in comparison to the aid it mobilizes for 
geographically and temporarily bounded disasters like earthquakes and 
hurricanes. Consequently, legal authorities, roles and 
responsibilities, and lines of authority at all levels of government 
must be clearly defined, effectively communicated, and well understood 
to facilitate rapid and effective decision making. This is also 
important for public and private sector organizations and international 
partners so everyone can better understand what is expected of them 
before and during a pandemic.
    The Strategy and Plan state that the Secretary of Health and Human 
Services is responsible for leading the medical response in a pandemic, 
while the Secretary of Homeland Security is responsible for overall 
domestic incident management and federal coordination. However, since a 
pandemic extends well beyond health and medical boundaries, to include 
sustaining critical infrastructure, private sector activities, the 
movement of goods and services across the nation and the globe, and 
economic and security considerations, it is not clear when, in a 
pandemic, the Secretary of Health and Human Services would be in the 
lead and when the Secretary of Homeland Security would lead.
    A pandemic could threaten our critical infrastructure, such as the 
capability to deliver electricity or food, by removing essential 
personnel from the workplace for weeks or months. The extent to which 
this would be considered a medical response with the Secretary of 
Health and Human Services in the lead, or when it would be under the 
Secretary of Homeland Security's leadership as part of his/her 
responsibility for ensuring that critical infrastructure is protected, 
is unclear. According to HHS officials we interviewed, resolving this 
ambiguity will depend on several factors, including how the outbreak 
occurs and the severity of the pandemic. Although DHS and HHS officials 
emphasize that they are working together on a frequent basis, these 
roles and responsibilities have not been thoroughly tested and 
exercised.
    Moreover, under the Post-Katrina Emergency Management Reform Act of 
2006 (referred to as the Post-Katrina Reform Act in this testimony), 
the FEMA Administrator was designated the principal domestic emergency 
management advisor to the President, the HSC, and the Secretary of 
Homeland Security, adding further complexity to the leadership 
structure in the case of a pandemic.\3\ The act also gives the 
Administrator responsibility for carrying out a national exercise 
program to test and evaluate national preparedness for responding to 
all-hazards, including an influenza pandemic.
---------------------------------------------------------------------------
    \3\ Pub. L. No. 109-295, Title VI.
---------------------------------------------------------------------------
    Other evolving federal leadership roles include those of PFOs and 
FCOs. To assist in planning and coordinating efforts to respond to a 
pandemic, in December 2006 the Secretary of Homeland Security 
predesignated a national PFO and established five pandemic regions each 
with a regional PFO and FCO. PFOs are responsible for facilitating 
federal domestic incident planning and coordination, and FCOs are 
responsible for coordinating federal resources support in a 
presidentially declared major disaster or emergency. However, the 
relationship of these roles to each other as well as with other 
leadership roles in a pandemic is unclear.
    U.S. Coast Guard and FEMA officials we met with recognized that 
planning for and responding to a pandemic would require different 
operational leadership roles and responsibilities than for most other 
emergencies. For example, a FEMA official said that given the number of 
people who would be involved in responding to a pandemic, collaboration 
between HHS, DHS, and FEMA would need to be greater than for any other 
past emergencies. Officials are starting to build on these 
relationships. For example, some of the federal officials with 
leadership roles for an influenza pandemic met during the week of March 
19, 2007, to continue to identify issues and begin developing 
solutions. One of the participants told us that although additional 
coordination meetings are needed, it may be challenging since there is 
no dedicated funding for the staff working on pandemic issues to 
participate in these and other related meetings.
    It is also unclear whether the newly established national and 
regional positions for a pandemic will further clarify leadership roles 
in light of existing and newly emerging plans and issues. For example, 
in 2006, DHS made revisions to the NRP and released a Supplement to the 
Catastrophic Incident Annex--both designed to further clarify federal 
roles and responsibilities and relationships among federal, state, and 
local governments and responders. However, we reported in February 2007 
that these revisions had not been tested and there was little 
information available on the extent to which these and other actions 
DHS was taking to improve readiness were operational.\4\ We also 
reported in May 2007 that FEMA has predesignated five teams of FCOs and 
PFOs in the Gulf Coast and eastern seaboard states at risk of 
hurricanes. However, there is still some question among state and local 
first responders about the need for both positions and how they will 
work together in disaster response.\5\
---------------------------------------------------------------------------
    \4\ GAO, Homeland Security: Management and Programmatic Challenges 
Facing the Department of Homeland Security, GAO-07-398T (Washington, 
D.C.: Feb. 6, 2007).
    \5\ 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-07-835T (Washington, D.C.: 
May 15, 2007).
---------------------------------------------------------------------------
    More recently, DHS reviewed the NRP and its supplemental documents. 
One of the issues this review intended to address was clarifying roles 
and responsibilities of key structures, positions, and levels of 
government, including the role of the PFO and that position's current 
lack of operational authority over the FCO during an emergency. On 
September 10, 2007, DHS released a draft National Response Framework to 
replace the NRP, for public comment. Comments on the framework are due 
October 11, 2007, and comments on the supplemental documents, such as 
revised Emergency Support Function specifications, are due by November 
9, 2007.

Exercising and Testing of Plans Is Crucial in Ensuring Capacity
    Disaster planning, including for a pandemic influenza, needs to be 
tested and refined with a rigorous and robust exercise program to 
expose weaknesses in plans and allow planners to refine them. 
Exercises--particularly for the type and magnitude of emergency 
incidents such as a severe influenza pandemic for which there is little 
actual experience--are essential for developing skills and identifying 
what works well and what needs further improvement. Our prior work 
examining the preparation for and response to Hurricane Katrina 
highlighted the importance of realistic exercises to test and refine 
assumptions, capabilities, and operational procedures, and build upon 
strengths.\6\
---------------------------------------------------------------------------
    \6\ GAO, Hurrican Katrina: GAO's Preliminary Observations Regarding 
Preparedness, Response, and Recovery, GAO-06-442T (Washington, D.C.: 
Mar. 8, 2006).
---------------------------------------------------------------------------
    While pandemic influenza scenarios have been used to exercise 
specific response elements, such as the distribution of stockpiled 
medications at specific locations or jurisdictions, no national 
exercises have tested the new federal leadership structure for pandemic 
influenza.\7\ The only national multisector pandemic exercise to date 
was a tabletop simulation conducted by members of the cabinet in 
December 2005. This tabletop exercise was prior to the release of the 
Plan in May 2006, the establishment of a national PFO and regional PFO 
and FCO positions for a pandemic, and enactment of the Post-Katrina 
Reform Act.
---------------------------------------------------------------------------
    \7\ Congressional Research Service, Pandemic Influenza: Domestic 
Preparedness Efforts, RL 33145 (Washington, D.C.: Feb. 20, 2007).

Gaps in the National Strategy and Plan Limit Their Usefulness
    Our work found that the Strategy and Plan do not address all of the 
characteristics of an effective national strategy as identified in our 
prior work. While national strategies necessarily vary in content, the 
six characteristics we identified apply to all such planning documents 
and can help ensure that they are effective management tools. Gaps and 
deficiencies in these documents are particularly troubling in that a 
pandemic represents a complex challenge that will require the full 
understanding and collaboration of a multitude of entities and 
individuals. The extent to which these documents, that are to provide 
an overall framework to ensure preparedness and response to a pandemic 
influenza, fail to adequately address key areas could have critical 
impact on whether the public and key stakeholders have a clear 
understanding and can effectively execute their roles and 
responsibilities.
    Specifically, we found that the documents fully address only one of 
the six characteristics of an effective national strategy--problem 
definition and risk assessment--because they identified the potential 
problems associated with a pandemic as well as potential threats, 
challenges, and vulnerabilities. The Strategy and Plan did not address 
one characteristic--resources, investments, and risk management--
because they did not discuss the financial resources and investments 
needed to implement the actions called for and therefore, do not 
provide a picture of priorities or how adjustments might be made in 
view of resource constraints. They partially addressed the four 
remaining characteristics, as shown in table 1.

Table 1: Extent to Which the Strategy and Plan Address GAO's Desirable 
Characteristics of an Effective National Strategy


                                                                                   Partially         Does not
                 Desirable characteristic                        Addresses         addresses         address

Clear purpose, scope, and methodology                                                        X
----------------------------------------------------------------------------------------------------------------
Problem definition and risk assessment                                      X
----------------------------------------------------------------------------------------------------------------
Goals, subordinate objectives, activities, and                                               X
performance measures
----------------------------------------------------------------------------------------------------------------
Resources, investments, and risk management                                                                   X
----------------------------------------------------------------------------------------------------------------
Organizational roles, responsibilities, and                                                  X
coordination
----------------------------------------------------------------------------------------------------------------
Integration and implementation                                                               X
----------------------------------------------------------------------------------------------------------------


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

      ------------------------------------------------------

    More specifically, the following are highlights of some of the gaps 
in the Strategy and Plan.

         The Strategy and Plan do not address resources, 
        investments, and risk management. Developing and sustaining the 
        capabilities stipulated in the Plan would require the effective 
        use of federal, state, and local funds. Given that funding 
        needs may not be readily addressed through existing mechanisms 
        and could stress existing government and private resources, it 
        is critical for the Plan to lay out funding requirements. For 
        example, one of the primary objectives of domestic vaccine 
        production capacity is for manufacturers to produce enough 
        vaccine for the entire U.S. population within 6 months. 
        However, the Plan states that production capacity would depend 
        on the availability of future appropriations. Despite the fact 
        that the production of enough vaccine for the population would 
        be critical if a pandemic were to occur, the Plan does not 
        provide even a rough estimate of how much the vaccine could 
        cost for consideration in future appropriations.
         State and local jurisdictions were not directly 
        involved in developing the Strategy and Plan. Neither the 
        Strategy nor Plan described the involvement of key 
        stakeholders, such as state, local, and tribal entities, in 
        their development, even though these stakeholders would be on 
        the front lines in a pandemic and the Plan identifies actions 
        they should complete. Officials told us that state, local, and 
        tribal entities were not directly involved in reviewing and 
        commenting on the Plan, but the drafters of the Plan were 
        generally aware of their concerns.

         Relationships and priorities among action items are 
        not always clear. While some action items depend on other 
        action items, these linkages are not always apparent in the 
        Plan. An HHS official who helped draft the Plan acknowledged 
        that while an effort was made to ensure linkages among action 
        items, there may be gaps in the linkages among interdependent 
        action items within and across the Plan's chapters that focused 
        on such issues as human health, animal health, and 
        transportation and borders considerations.
        In addition, we found that the Plan does not establish 
        priorities among its 324 action items, which becomes especially 
        important as agencies and other parties strive to effectively 
        manage scarce resources and ensure that the most important 
        steps are accomplished.
         Performance measures are focused on activities that 
        are not always linked to results. Most of the Plan's 
        performance measures are focused on activities such as 
        disseminating guidance, but the measures are not always clearly 
        linked with intended results. This lack of linkages to outcomes 
        and results makes it difficult to ascertain whether progress 
        has in fact been made toward achieving the national goals and 
        objectives described in the Strategy and Plan.
         The linkage of the Strategy and Plan with other key 
        plans is unclear. Although the Strategy states that it is 
        consistent with the National Security Strategy and the National 
        Strategy for Homeland Security, it does not state how it is 
        consistent or describe the relationships with these two 
        strategies. In addition, the Plan does not specifically address 
        how the Strategy, Plan, or other related pandemic plans should 
        be integrated with the goals, objectives, and activities of the 
        national initiatives already in place, such as the interim 
        National Preparedness Goal.
        Further, the Strategy and Plan do not provide sufficient detail 
        about how the Strategy, action items in the Plan, and a 
        proposed set of agency plans are to be integrated with other 
        national strategies and frameworks. For example, the Plan 
        contains 39 action items that are response related (i.e., 
        specific actions are to be taken within a prescribed number of 
        hours or days after an outbreak). However, these action items 
        are interspersed among the 324 action items, and the Plan does 
        not describe the linkages of these response-related action 
        items with the NRP or other response related plans.
         The Plan does not contain a process for monitoring and 
        reporting on progress. While most of the action items have 
        deadlines for completion, ranging from 3 months to 3 years, the 
        Plan does not identify a process to monitor and report on the 
        progress of the action items nor does it include a schedule for 
        reporting progress. According to agency officials, the HSC is 
        monitoring executive branch agencies' efforts to complete the 
        action items. However, there is no specific documentation 
        describing this process or institutionalizing it. This is 
        important since some of the action items are not expected to be 
        completed during this administration. Also, a similar 
        monitoring process for those actions items for which nonfederal 
        entities have the lead responsibility does not appear to exist. 
        Additionally, there is no explicit timeline for the HSC to 
        report on the overall progress and thus, when progress is 
        reported is left to the HSC's discretion.
         The Plan does not describe an overall framework for 
        accountability and oversight. hile the plan contains broad 
        information on roles and responsibilities and describes 
        coordination mechanisms for responding to a pandemic, it does 
        not, as noted earlier, clarify how responsible officials would 
        share leadership responsibilities. In addition, it does not 
        describe an overall accountability and oversight framework. 
        Agency officials told us that they had identified individuals 
        to act as overall coordinators to monitor the action items for 
        which their agencies have lead responsibility and provide 
        periodic progress reports to the HSC. However, we could not 
        identify a similar oversight mechanism for the action items 
        that fall to state and local governments or the private sector. 
        This is a concern since some action items, particularly those 
        that are to be completed by state, local, and tribal 
        governments or the private sector, do not identify an entity 
        accountable for carrying out the action.
         Procedures and time frames for updating and revising 
        the Plan were not established. The Plan does not describe a 
        mechanism for updating it to reflect policy decisions, such as 
        clarifications in leadership roles and responsibilities and 
        other lessons learned from exercises, or to incorporate other 
        needed changes. Although the Plan was developed as initial 
        guidance and was intended to be updated and expanded over time, 
        officials in several agencies told us that specific processes 
        or time frames for updating and revising it have not been 
        established.

Opportunities Exist To Clarify Federal Leadership Roles and Improve 
Pandemic Planning
    A pandemic poses some unique challenges and would be unlike other 
emergencies given the likelihood of its duration and geographic 
coverage. Initial actions may help limit the spread of an influenza 
virus, reflecting the importance of a swift and effective response. 
Therefore, the effective exercise of shared leadership roles and 
implementation of pandemic plans could have substantial consequences, 
both in the short and long term.
    Since no national pandemic exercises of federal leadership roles 
and responsibilities have been conducted since the release of the Plan 
in May 2006, and key leadership roles continue to evolve, rigorous 
testing, training, and exercising is needed. Exercises test whether 
leadership roles and responsibilities, as well as procedures and 
processes, are clear and well-understood by key stakeholders. 
Additionally, they help identify weaknesses and allow for corrective 
action to be taken before an actual emergency occurs. Consequently, in 
our August 2007 report, we recommended that the Secretaries of Homeland 
Security and Health and Human Services work together to develop and 
conduct rigorous testing, training, and exercises for pandemic 
influenza to ensure that the federal leadership roles are clearly 
defined and understood and that leaders are able to effectively execute 
shared responsibilities to address emerging challenges. Once the 
leadership roles have been clarified through testing, training, and 
exercising, the Secretaries of Homeland Security and Health and Human 
Services should ensure that these roles and responsibilities are 
clearly understood by state, local, and tribal governments; the private 
and nonprofit sectors; and the international community. DHS and HHS 
concurred with the recommendation, and DHS stated that it is taking 
action on many of the shortfalls identified in the report.
    The Strategy and Plan are important because they broadly describe 
the federal government's approach and planned actions to prepare for 
and respond to a pandemic and also set expectations for states and 
communities, the private sector, and global partners. The extent to 
which the Strategy and Plan fail to adequately address key areas could 
have a critical impact on whether key stakeholders and the public have 
a clear understanding of their roles and responsibilities. However, 
gaps in the Strategy and Plan limit their usefulness as a management 
tool for ensuring accountability and achieving results. The plan is 
silent on when information will be reported or when it will be updated. 
Although the HSC publicly reported on the status of action items in 
December 2006 and July 2007, it is unclear when the next report will be 
issued or how much information will be released. This lack of 
transparency makes it difficult to inform a national dialogue on the 
progress made to date or what further steps are needed. It also 
inhibits congressional oversight of strategies, funding priorities, and 
critical efforts to enhance the nation's level of preparedness.
    Therefore, in our August 2007 report we recommended that the HSC 
establish a specific process and time frame for updating the Plan. We 
stated that this process should involve key nonfederal stakeholders and 
incorporate lessons learned from exercises and other sources. Further, 
we stated that the Plan could be improved by including the following 
information in the next update: (1) resources and investments needed to 
complete the action items and where they should be targeted, (2) a 
process and schedule for monitoring and publicly reporting on progress 
made on completing the action items, (3) clearer linkages with other 
strategies and plans, and (4) clearer descriptions of relationships or 
priorities among actions items and greater use of outcome-focused 
performance measures. The HSC did not comment on the draft report.
    Mr. Chairman and Members of the Subcommittee, this completes my 
statement. I would be pleased to respond to any questions that you 
might have.

    Mr. Langevin. Thank you for your statement.
    I would now recognize Dr. Jolly to summarize his statement 
for 5 minutes.
    Welcome.

   STATEMENT OF DR. B. TILMAN JOLLY, ASSOCIATE CHIEF MEDICAL 
     OFFICER, MEDICAL READINESS, OFFICE OF HEALTH AFFAIRS, 
                DEPARTMENT OF HOMELAND SECURITY

    Dr. Jolly. Thank you, Mr. Chairman, Ranking Member McCaul 
and members of the subcommittee. Thank you for the opportunity 
to testify before the subcommittee to discuss the progress of 
the National Strategy for Pandemic Influenza and its 
Implementation Plan.
    Before I begin, I would like to take this opportunity to 
thank you and members of the full committee on behalf of 
Secretary Chertoff for your continued willingness to work 
alongside the Department to provide leadership in protecting 
and ensuring the security of our homeland.
    I would also like to thank our partners at the Department 
of Health and Human Services and others with whom we work every 
day.
    Pandemic influenza is unique. It is likely to come in 
waves, passing through communities of all sizes across the 
nation and the world simultaneously. The pandemic may last as 
long as 18 months.
    An unmitigated pandemic could result in 200,000 to 2 
million deaths in the United States, depending on its severity.
    Further, an influenza pandemic could have major impacts on 
society and the economy, including our nation's critical 
infrastructure and key resources based on illness and related 
absenteeism.
    DHS has been and remains actively engaged with its federal, 
state, local, territorial, tribal and private sector partners 
to prepare our nation and the international community for an 
influenza pandemic.
    As outlined in the Implementation Plan, DHS is responsible 
for the coordination of the overall domestic federal response 
during an influenza pandemic, including implementing policies 
that facilitate compliance with recommended social distancing 
measures, developing a common operating picture for all federal 
departments and agencies, and ensuring the integrity of the 
nation's infrastructure, domestic security, and entry and exit 
screening for influenza at the borders.
    In working with our partners, such as HHS, the State 
Department and USDA, DHS has developed and implemented a number 
of initiatives and outreach to support continuity of operations 
planning for all levels of government and private-sector 
entities.
    I will highlight a few noteworthy accomplishments and 
responsibilities under the Implementation Plan particular to 
DHS. DHS produced and released the Pandemic Influenza 
Preparedness, Response and Recovery Guide for Critical 
Infrastructure and Key Resources.
    The guide has served to support business and other private 
sector pandemic planning by complementing and enhancing, not 
replacing, their existing continuity planning efforts.
    With that in mind, DHS and its partners developed the guide 
to assist businesses whose existing continuity plans generally 
do not include strategies to protect human health during 
emergencies like a pandemic.
    As a next step, DHS is currently leading the development of 
specific guides for each of the 17 critical infrastructure and 
key resource sectors using the security partnership model.
    In coordination with other federal departments and 
agencies, DHS is developing a coordinated government-wide 
planning forum. An initial analysis of the response 
requirements for federal support has been completed.
    From this analysis, a national plan defining the federal 
concept for coordinating response and recovery operations 
during a pandemic has been developed and will be undergoing 
interagency review.
    Utilizing this planning process, a coordinated federal 
border management plan has been developed and is currently also 
in review. This process included a wide range of partners.
    DHS has also conducted or participated in federal and state 
interagency pandemic influenza exercises and workshops and 
forums with critical infrastructure key resources owners and 
operators.
    Consistent with his role under Homeland Security 
Presidential Directive 5, Secretary Chertoff pre-designated 
Vice Admiral Vivien Crea, the Vice Commandant of the U.S. Coast 
Guard, as the national Principal Federal Official, or PFO, for 
pandemic influenza, and has pre-designated five regional PFOs 
and 10 deputy PFOs.
    Likewise, our partners have pre-designated infrastructure 
liaisons, Federal Coordinating Officers, senior officials for 
health as well as defense coordinating officers.
    Vice Admiral Crea and the regional PFOs have participated 
in multiagency training and coordination sessions regarding 
preparedness duties.
    Additionally, the PFO teams have begun outreach both 
nationally and in their regions in advance of the more 
formalized exercise program which is being developed by DHS.
    On an ongoing basis, DHS participates in interagency 
working groups to develop guidance, including community 
mitigation strategies, medical countermeasures, vaccine 
prioritization and risk communication strategies.
    In closing, significant progress has been made in national 
preparedness for pandemic influenza. In fact, September is 
National Preparedness Month, which encourages all Americans to 
prepare for emergencies and take necessary actions for all 
hazards.
    DHS looks forward to continuing its partnership with the 
federal interagency, state, local, tribal, territorial and 
private sector stakeholders to complete the work of pandemic 
preparedness and to further the nation's ability to prepare 
for, respond to and recover from all hazards.
    Thank you again for the opportunity to testify on behalf of 
the Department of Homeland Security on these issues of critical 
importance to our nation's security and well-being. I would be 
happy to answer any questions you might have.
    [The statement of Dr. Jolly follows:]

               Prepared Statement of B. Tilman Jolly, MD

    Mr. Chairman, Ranking Member McCaul and Members of the 
Subcommittee:
    Thank you for the opportunity to testify before the Subcommittee to 
discuss the progress of the National Strategy for Pandemic Influenza 
and its Implementation Plan. I am Dr. Til Jolly, Associate Chief 
Medical Officer for Medical Readiness, within the Office of Health 
Affairs at the Department of Homeland Security (DHS). Before I begin, I 
would like to take this opportunity to thank you and Members of the 
full Committee on behalf of Secretary Chertoff for your continued 
willingness to work alongside the Department to provide leadership in 
protecting and ensuring the security of our homeland. I would also like 
to thank our partners at the Department of Health and Human Services 
(HHS) and others with whom we work every day.
    To begin, I would like to take a few moments to review some basic 
facts about pandemics and their potential impacts on our nation. 
Pandemic influenza occurs when a novel strain of influenza virus 
emerges that has the ability to infect humans and to cause severe 
disease, and when efficient and sustained transmission between humans 
occurs. This scenario creates unique challenges. Unlike other 
incidents, a pandemic is not a singular event, but is likely to come in 
waves, each lasting weeks or months, passing through communities of all 
sizes across the nation and the world simultaneously. The complete 
pandemic cycle may last as long as 18 months. Based on projections 
modeled by the Department of Health and Human Services from prior 
pandemics, an influenza pandemic could result in 200,000 to 2 million 
deaths in the United States, depending on its severity. Further, an 
influenza pandemic could have major impacts on society and the economy, 
including our nation's critical infrastructure and key resources, as 
many of our nation's workforce could be absent for extended periods of 
time, either sick themselves or caring for loved ones at home.
    The Implementation Plan for the National Strategy for Pandemic 
Influenza was released over a year ago by the President?s Homeland 
Security Council to guide our nation's preparedness and response to an 
influenza pandemic. DHS has been actively engaged with its federal, 
state, local, territorial, tribal, and private sector partners to 
prepare our nation and the international community for an influenza 
pandemic. As outlined in the Implementation Plan DHS is responsible for 
the coordination of the overall domestic Federal response during an 
influenza pandemic, including implementation of policies that 
facilitate compliance with recommended social distancing measures, 
development of a common operating picture for all Federal departments 
and agencies, and ensuring the integrity of the Nation?s 
infrastructure, domestic security and entry and exit screening for 
influenza at the borders.
    To date DHS has accomplished over 80% of the requirements outlined 
in the Implementation Plan. DHS recognizes the key role of HHS in its 
responsibilities to lead clinical disease surveillance and rapid 
detection during a pandemic, and, under Emergency Support Function 
(ESF)-8, to plan, prepare, mitigate and support the coordination of the 
public health and medical emergency response activities during a 
pandemic under ESF-8, including the deployment and distribution of 
vaccines and of antivirals and other life-saving medical 
countermeasures from the Strategic National Stockpile. DHS also 
recognizes the Department of State's role to lead the coordination of 
international efforts including U.S. engagement in a broad range of 
bilateral and multilateral initiatives that build cooperation and 
capacity to fight the spread of avian influenza, to prepare for a 
possible pandemic, and to coordinate with our neighbors Canada and 
Mexico. The Department of Agriculture (USDA) conducts surveillance for 
influenza in domestic animals and animal products, monitoring wildlife 
in partnership with the Department of the Interior, and working to 
ensure an effective veterinary response to a domestic animal outbreak 
of highly pathogenic avian influenza.
    In working with our partners DHS has developed and implemented a 
number of initiatives and outreach to support continuity of operations 
planning for all levels of government and private sector entities. I 
will highlight a few noteworthy accomplishments and responsibilities 
under the Implementation Plan particular to DHS.
    DHS produced and released the Pandemic Influenza Preparedness, 
Response, and Recovery Guide for Critical Infrastructure and Key 
Resources (Guide). Tailored to national goals and capabilities, and to 
the specific needs identified by the private sector, this business 
continuity guidance represents an important first step in working with 
the owners and operators of critical infrastructure to prepare for a 
potentially severe pandemic outbreak. The Guide has served to support 
business and other private sector pandemic planning by complementing 
and enhancing, not replacing, their existing continuity planning 
efforts. With that in mind, the Federal government developed the Guide 
to assist businesses whose existing continuity plans generally do not 
include strategies to protect human health during emergencies such as 
those caused by pandemic influenza or other diverse natural and manmade 
disasters.
    DHS is currently leading the development of specific guides for 
each of the 17 critical infrastructure and key resource sectors. These 
include agriculture, food, and water, public health, emergency 
services, telecommunications, banking, defense systems, transportation, 
energy resources, and others. These guides are being developed 
utilizing the security partnership model and in collaboration with our 
Federal partners.
    In coordination with other Federal departments and agencies, DHS is 
developing a coordinated government-wide planning forum. An initial 
analysis of the response requirements for Federal support has been 
completed. From this analysis, a national plan defining the federal 
concept for coordinating response and recovery operations during a 
pandemic has been developed and will be undergoing interagency review. 
Utilizing this planning process, a coordinated federal border 
management plan has been developed and is currently in review. This 
process included state, local, tribal, territorial, and private sector 
stakeholder input, along with our Federal interagency partners.
    DHS has conducted or participated in federal and state interagency 
pandemic influenza exercises which have focused on varied issues 
related to preparedness. These exercises have included:
         FEMA's Determined Accord series for continuity of 
        operations with federal, state, local, tribal, territorial 
        entities.
         Several Customs and Border Protection exercises--
        addressing transportation and border challenges.
         A U.S. Fire Administration tabletop exercise for 
        development of best practices models and protocols for EMS, 911 
        Call Centers, Fire Services, Emergency Managers, Law 
        Enforcement and Public Works. This will allow for further 
        integration of a unified Federal, state, local and private 
        sector emergency response capabilities.
         HHS sponsored regional National Governors Association 
        Pandemic Influenza exercises, CDC funded and provided guidance 
        for state and local exercises, and DOD pandemic influenza 
        exercises.
         Multiple workshops and forums with the owners and 
        operators of critical infrastructure and key resources.
    Consistent with his role under Homeland Security Presidential 
Directive (HSPD) 5, Secretary Chertoff pre-designated Vice Admiral 
Crea, the Vice Commandant of the US Coast Guard, as the National 
Principal Federal Official (PFO) for pandemic influenza and has pre-
designated five regional PFOs and 10 deputy PFOs. Likewise, our 
partners have pre-designated Infrastructure Liaisons, Federal 
Coordinating Officers, Senior Officials for health as well as Defense 
Coordinating Officers. VADM Crea and the Regional PFOs have 
participated in several training sessions regarding preparedness 
duties, and have held two orientation sessions to date. These sessions 
included updates from the Department of State, the Department of 
Agriculture, the Department of Health and Human Services, the 
Department of Defense, as well as updates from various DHS components 
and staff regarding their work to date. Additionally, the PFO teams 
have begun outreach both nationally and in their regions in advance of 
a more formalized exercise program which is being developed by DHS.
    On an ongoing basis, DHS participates in interagency working groups 
to develop guidance including community mitigation strategies, medical 
countermeasures, vaccine prioritization, and risk communication 
strategies. These groups bring together a wide range of federal 
partners to discuss preparedness issues.
    In closing, significant progress that has been made in national 
preparedness for pandemic influenza. In fact, September is National 
Preparedness Month, which encourages all Americans to prepare for 
emergencies and take the necessary actions for all-hazards. Many of 
these accomplishments can be incorporated into an all-hazards framework 
to promote the national culture of preparedness. DHS looks forward to 
continuing its partnership with the federal interagency, state, local, 
tribal, territorial, and private sector stakeholders to complete the 
work of pandemic preparedness and to further the nation's ability to 
prepare for, respond to, and recover from all-hazards.
    Thank you again for the opportunity to testify on behalf of the 
Department of Homeland Security on these issues of critical importance 
to our nation?s security and well-being. I would be happy to answer any 
questions you might have.

    Mr. Langevin. Thank you, Dr. Jolly, for your testimony.
    I now recognize Dr. Vanderwagen to summarize his statement 
for 5 minutes.
    Welcome.

STATEMENT OF RADM W. CRAIG VANDERWAGEN, MD, ASSISTANT SECRETARY 
 FOR PREPAREDNESS AND RESPONSE, DEPARTMENT OF HEALTH AND HUMAN 
                            SERVICES

    Dr. Vanderwagen. Thank you, Mr. Chairman.
    And it is a great opportunity to come and visit with you 
about the partnership between the legislative and the executive 
branch that I think we have moved forward aggressively on over 
the last couple of years.
    As you may know, the Assistant Secretary for Preparedness 
and Response was established approximately 10 months ago under 
the Pandemic and All-Hazards Preparedness Act.
    We had significant responsibilities transferred to us and 
significant new authorities. We have tried to execute those in 
a very timely manner. We have transferred NDMS. We have 
transferred the Hospital Preparedness Program. We have 
transferred the ESAR-VHP program.
    We have taken on new authorities under BARDA. We are 
standing up the National Biodefense Science Board. And the list 
of accomplishments requested under the law we would be happy to 
share with you in detail if you are interested.
    However, I would note that in August there was a transfer 
of responsibility to the ASPR from the Assistant Secretary for 
Health for pandemic planning and coordination within HHS.
    So I am here today to speak specifically about pandemic 
flu. And you have articulated, I think, most succinctly the 
threat, the risk and what the challenges are.
    I believe that over the last year there has been 
significant progress. I agree with Mr. McCaul. There has been 
significant progress jointly among the states and the federal 
government.
    There is a strong federal lift strategically planned to 
purchase the ability to develop and deliver vaccines as part of 
our overall strategic goal.
    And as was noted by both of you, our strategic goal here, 
our theory of victory, is a delay of this disease spread and a 
reduction in the absolute number of individuals who will be 
affected by the disease.
    And the first line investments to assure that included the 
development of domestic capability in the production and 
delivery of vaccines and antivirals and diagnostics that would 
allow us to be very astute in the way we employed those 
techniques in reducing the rate of infection.
    But as has been noted, it is also now time for us to review 
and update what are the gaps that still persist and what are 
the challenges that are ahead.
    Our belief is it should be built upon some of the success 
that has occurred.
    Accordingly, with our vaccine investments and our 
investments in newer antivirals and in diagnostic capability, 
we are monitoring those production capabilities and we have set 
up milestones for that performance of activity and our funds 
that we have remaining, and we have spent about $3 billion or 
so.
    The balance of funds are established as a reserve to 
continue that progress and development as they achieve certain 
milestones.
    But there are persistent gaps, as I said. Those gaps exist 
in respiratory protection. They exist in how we can make 
community mitigation even more effective potentially using the 
expanded production capability in antivirals to perhaps use 
antivirals in a prophylactic mode as opposed to a pure 
treatment mode, which is where our previous investments have 
been.
    These next steps, however, have to be built upon the 
concept of shared responsibility. Again, as you both stated, 
the role of state and local governments, of business and, 
indeed of individuals and families needs to be explored 
further.
    And their engagement in the gap filling process needs to be 
active and needs to be present. We have started that process 
here in the last couple of months and have met with business 
interests, public health interests, medical interests in 
Seattle, in Raleigh.
    We have other opportunities planned ahead for engagement of 
those stakeholders in this process. And we think that that will 
help us to determine how to divide the shared responsibility 
for development of approaches to meeting those gaps.
    There is a sustainment challenge that also lies out there 
in front of us as well, because what we build today has to be 
sustained over time, and those issues will need to be 
addressed. If not right this minute, they will need to be 
addressed in the way ahead.
    So in summary, ASPR has stood up. We accept the 
responsibility. We work closely with our partners and view 
ourselves as being an integral part of the team led by DHS, but 
our shared responsibility demands that we reach out to our 
stakeholders at the state, local, family and individual level 
if we are going to move ahead with the new steps that remain to 
be addressed.
    And with that, I will stop and be happy to address 
questions.
    [The statement of Dr. Vanderwagen follows:]

         Prepared Statement of RADM William C. Vanderwagen, MD

    Chairman Langevin, Ranking Member McCaul, and distinguished Members 
of the Subcommittee, thank you for the opportunity to present the 
progress HHS has made in national preparedness for pandemic influenza. 
Over the past two years, with the $5.6 billion supplemental funding we 
received from Congress, we have worked closely with our International, 
Federal, state and local partners to advance our preparedness for 
pandemic influenza. While we all understand that preparedness is a 
process that is never completed, the advances I will highlight for you 
today demonstrate what can be accomplished when there is a shared 
vision and support for preparedness. The threat of a pandemic remains a 
real one, and I appreciate that in holding this hearing, you share our 
sense of urgency about our preparedness.
    As you know, the President released the National Strategy for 
Pandemic Influenza in November 2005, followed by a detailed 
Implementation Plan from the Homeland Security Council (HSC) in May 
2006. The HSC Implementation Plan assigned over 300 tasks across the 
Federal Government to improve our Nation's preparedness for pandemic 
influenza. HHS has made substantial progress in the nearly 200 action 
items assigned to our department, completing over 80% in one year. 
These gains are real and measurable, and they cover a broad range of 
preparedness, including enhancing our international laboratory 
networks, developing and releasing guidance on community-based measures 
to mitigate the effects of a pandemic, and expanding the Medical 
Reserve Corps program. We also released the HHS Pandemic Plan and HHS 
Implementation Plan, and those are available alongside additional 
information and planning resources at www.pandemicflu.gov. I will 
highlight for you specific accomplishments in three areas: State and 
Local Preparedness, Countermeasure Procurement and Advanced 
Development, and Federal Preparedness.
    All of these accomplishments are consistent with the mission of my 
office, which Congress created in December 2006 through the Pandemic 
and All-Hazards Preparedness Act. The ASPR mission is to lead the 
nation in preventing, preparing for, and responding to the adverse 
health effects of public health emergencies and disasters, and the 
vision we see is ``A Nation Prepared.'' Within HHS, my office 
coordinates the preparedness and response enterprise, which focuses on 
the continuum of preparedness from research and development of medical 
countermeasures to response delivery platforms that support state and 
local responders in reaching our citizens during an incident.
    Our preparedness for pandemic influenza involves a shared 
responsibility among our entire Department, our partners in the 
International community, the Federal interagency, state, local, tribal 
and territorial governments, the private sector, and, ultimately, 
individuals and families. In addition, we believe our planning for an 
influenza pandemic is part of an all-hazards approach. The gains we 
make in increased preparedness and response capability for pandemic 
influenza will help us across the spectrum of public health emergencies 
and disasters.

Enhanced State and Local Preparedness
    By the end of this year, the Department will have awarded over $600 
million in emergency supplemental funding through the Centers for 
Disease Control and Prevention (CDC) and ASPR to 62 awardees: 50 
states, five U.S. territories, three Freely Associated States of the 
Pacific, New York City, Los Angeles County, Chicago, and the District 
of Columbia to upgrade state and local capacity in regard to pandemic 
influenza preparedness. The funding has occurred in three general 
phases:

    Phase 1--$100 Million
    Senior HHS officials, led by Secretary Leavitt, conducted Pandemic 
Influenza Preparedness Summits in every state to facilitate community-
wide planning and to promote shared responsibility for pandemic 
preparedness. To assess gaps in pandemic preparedness and guide 
preparedness investments, CDC created an assessment tool for awardees 
to use in evaluating their own jurisdiction's current state of 
preparedness.
    The awardees were required to submit: (1) a gap analysis; (2) a 
proposed approach to filling the identified gaps; and (3) an associated 
budget for the critical tasks necessary to address those gaps. High 
priority areas being addressed include:
         Exercising pandemic incident command systems,
         Linking animal and human surveillance systems,
         Augmenting laboratory capacity,
         Plans for vaccine and antiviral distribution, mortuary 
        affairs, and continuity of essential functions

    Phase 2--$250 Million ($225 million for four priority activities 
and $25 million for competitive demonstration projects)
    Of the Phase 2 funds, $225 million were used for four priority 
activities: (1) work with jurisdictional colleagues in emergency 
management, community organizations and other agencies to develop a 
jurisdictional workplan to address gaps identified by the assessment 
process; (2) develop and exercise an antiviral drug distribution plan; 
(3) develop a pandemic exercise schedule to include--at a minimum--
medical surge, mass prophylaxis, non-pharmaceutical public health 
interventions and the antiviral drug distribution exercises; and (4) 
submit the jurisdictional pandemic influenza operational plan.
    Three planning priorities were targeted--state/local exercises of 
key plans (mass vaccination using seasonal flu clinics, community 
containment, medical surge); developing antiviral distribution plans; 
and review of statewide pandemic influenza plans.
         85% of the awardees used seasonal influenza 
        vaccination clinics to exercise mass prophylaxis plans 
        (Highlights--some state medical boards used Emergency Medical 
        Technicians (EMTs) and paramedics to act as vaccinators to 
        reduce the burden on public health staff; some states used 
        drive-through clinics to increase throughput and enforce social 
        distancing.)
         83% of the awardees participated in tabletop exercises 
        of non-pharmaceutical interventions and plans to contain the 
        spread of pandemic influenza. (Emphasis on school closing 
        decisions and discouragement of large public gatherings; the 
        majority of awardees responded that gaps in their existing 
        plans were identified and that further planning refinements are 
        necessary to produce viable and executable plans. Funding in 
        Phase 3 will help address these gaps.)
         Over 50% of the awardees reported conducting exercises 
        of antiviral distribution plans.
         The public health and medical components of this 
        funding supplement have included two of the Target Capabilities 
        identified as part of National Preparedness under Homeland 
        Security Presidential Directive 8: Mass Prophylaxis and Medical 
        Surge.
         97% of the awardees have submitted pandemic influenza 
        operational plans that involve interaction and partnership with 
        law enforcement and emergency management (antiviral 
        distribution), education, and business sectors (community 
        mitigation and continuity of operations).
    The remaining $25 million Phase 2 funds will be used to make 
pandemic influenza emergency supplemental awards based on performance. 
The funds will be awarded competitively to awardees that successfully 
propose a plan to develop, implement and evaluate pandemic influenza 
interventions. Proposals will be solicited for public health 
interventions for which there are few data, unclear consequences, or 
inconclusive effectiveness.

    Phase 3--$250 Million Available.
    CDC has awarded $175 million of Phase 3 funding to support 
awardees' efforts to fill gaps identified in Phases 1 and 2. The 
awardees will be required to utilize the tools developed under the 
auspices of the Homeland Security Exercise Evaluation Program to create 
planning, training, and exercise evaluation programs. A total of $75 
million will be awarded as supplements to the 62 entities that 
currently receive awards through the Hospital Preparedness Program 
(HPP) cooperative agreements. Applications are due in October 2007.
    The HPP transferred from the HHS Health Resources and Services 
Administration (HRSA) to ASPR in March of this year as directed under 
the PAHPA. The Program has continued to focus on enhancing surge 
capacity. Priorities for Medical Surge that were evaluated as part of 
the state plan review are as follows:
         States have the ability to report available beds which 
        is a requirement in the 2006 Hospital Preparedness Program 
        Cooperative Agreement,
         Effective use of civilian volunteers as part of the 
        Emergency System for Advance Registration of Volunteer Health 
        Professionals (ESAR-VHP) and Medical Reserve Corps (MRC) 
        programs,
         Planning for Alternate Care Sites,
         Development of Health Care Coalitions that promote 
        effective sharing of resources in surge situations--Will be 
        funding 10 partnership demonstration projects for $18.1 million 
        in fiscal year 2007, and
         Plans for providing the highest possible standards of 
        care in situations of scarce resources. ASPR partnered with the 
        HHS Agency for Healthcare Research and Quality (AHRQ) in the 
        development of a Community Planning Guide on Mass Medical Care 
        with Scarce Resources. The guide includes a pandemic influenza 
        case study.
    The remainder of the Phase 3 funding has been allocated to the HPP 
program for upgrading state and local pandemic influenza preparedness 
capacities. This funding will establish stockpiles of critical medical 
equipment and supplies, as well as be used to develop plans for 
maintenance, distribution and sharing of those resources. This funding 
may also be used to support the planning and development of alternate 
care sites (ACS) and medical surge exercises for pandemic influenza. 
Examples of allowable activities include:
         Stockpiles of ventilators, ancillary supplies and 
        oxygen,
         Personal protective equipment (PPE) and infection 
        control supplies,
         Alternate care sites--staffing, operational plans and 
        exercises,
         Mass fatality plans and equipment and supplies, and
         Medical surge exercises.
    T3Countermeasure Procurement and Advanced Development
    HHS has also made tremendous progress in addressing the Pandemic 
influenza medical countermeasure goals that emanate from the HSC 
Implementation Plan.

These goals are listed on the table below.
---------------------------------------------------------------------------
    \1\ This figure assumes a severe, 1918-like pandemic.

Vaccine      To establish and maintain a dynamic pre-pandemic influenza
Goal #1       vaccine stockpile available for 20 million persons: H5N1
              stockpiles (40 million doses)
------------------------------------------------------------------------
Vaccine      To provide pandemic vaccine to all U.S. citizens within 6
Goal #2       months of a pandemic declaration: pandemic vaccine (600
              milliondoses)
------------------------------------------------------------------------
Antivirals   To provide influenza antiviral drug stockpiles for
Goal #1       treatment of pandemic illness for 25% of U.S. population
              who we estimate will become clinically ill during a
              pandemic (75 million treatment courses \1\)
------------------------------------------------------------------------
Antivirals   To provide influenza antiviral drug stockpiled for
Goal #2       strategic limited containment at the onset of a pandemic
              (6 million treatment courses)
------------------------------------------------------------------------
Diagnostics  To develop new high throughput laboratory and Point of Care
Goal #1       influenza diagnostics for pandemic virus detection
------------------------------------------------------------------------


 Advanced Development:
         Cell-based vaccines. Current influenza vaccines are 
        based on influenza virus grown in fertilized chicken eggs. In 
        an effort to modernize influenza vaccine manufacturing for 
        greater flexibility and less vulnerability, and to increase 
        domestic manufacturing capacity with the potential for surge 
        production, six contracts were awarded in 2005-06 for $1.1 
        billion to develop seasonal and pandemic cell-based influenza 
        vaccines towards U.S.-licensure. In 2007 three manufacturers 
        will begin late stage pivotal clinical evaluation of their 
        cell-based influenza vaccines with sights set on Biologics 
        License Application (BLA) submissions to FDA in 2008. Further, 
        one manufacturer has already broken ground on new state-of-the 
        art cell-based influenza vaccine manufacturing facilities in 
        North Carolina with completion scheduled in 2010. The ultimate 
        goal here is to strengthen the U.S. domestic manufacturing 
        system and to ensure adequate U.S.-based production capability.

         Antigen-sparing vaccines. To stretch the domestic pre-
        pandemic influenza vaccine manufacturing capacity further and 
        to provide vaccines with broad cross-protective immunity, three 
        contracts were awarded in January 2007 for $133 million to 
        develop antigen-sparing pandemic influenza vaccines towards 
        U.S.-licensure. These H5N1 vaccine candidates formulated with 
        new adjuvants show great promise in mid-stage clinical 
        evaluation with expectations that one or more will be submitted 
        as BLAs in 2008 for licensure. An adjuvant is a vaccine 
        additive that amplifies the immune response. HHS is 
        coordinating studies with a number of manufacturers to 
        determine whether these adjuvants can be used safely and 
        effectively with H5N1 vaccine antigens currently in the 
        stockpile that have been produced by different manufacturers--a 
        key step toward expansion of the pre-pandemic vaccine stockpile 
        supply.

         Next generation vaccines. Our investments in cell 
        culture technology mentioned above will expand production 
        capability. Because of the time vaccine production takes (20--
        23 weeks from identification of the pandemic virus), we are 
        also investing in next generation vaccines with shorter 
        production timelines. To provide pandemic vaccine earlier after 
        the onset of a pandemic, a synopsis for a contract solicitation 
        was issued in August 2007 to seek proposals for advanced 
        development of next generation recombinant influenza vaccines 
        over the next 3--5 years with the goal of accelerating the 
        development of new vaccine technologies that will greatly 
        shorten vaccine production timelines in a pandemic.

         Antivirals. Until recently, there was little incentive 
        for manufacturers to develop new approaches to treat influenza. 
        Currently, we have only two classes of antiviral drugs that are 
        effective against influenza. Only one of those classes of 
        drugs, the neuraminidase inhibitors (oseltamivir 
        [Tamiflu'] and zanamivir [Relenza']), is 
        being actively stockpiled because of the development of 
        resistance to the older class of antiviral drugs. As our 
        options are limited, we need new antiviral candidates in case 
        clinically significant resistance to our current stockpile of 
        antiviral drugs develops. To promote the advanced development 
        of new influenza antiviral drugs towards U.S.-licensure, a 
        contract was awarded in January 2007 for $102 million to 
        develop peramivir, a neuraminidase inhibitor that may be 
        administered in life-threatening influenza illnesses. This drug 
        is in mid-stage clinical evaluation presently. In 2008 more 
        influenza antiviral drug candidates will emerge in the pipeline 
        that may be ready for advanced development and eligible for 
        funding. We need new antiviral candidates should the viruses 
        become resistant to the currently available antivirals.

        Diagnostics. To provide healthcare professionals with a means 
        to distinguish pandemic influenza viruses from other 
        respiratory pathogens including seasonal influenza viruses, 
        four contracts for $12 million were awarded in November 2006 
        for development of rapid point-of-care diagnostic devices. By 
        the end of 2007, two of these devices will be evaluated 
        independently for further clinical development with 
        expectations of licensure submissions in 2009. Solicitations to 
        award contracts for development of high throughput laboratory 
        and single-use home diagnostics for pandemic influenza are also 
        expected to be issued by the end of 2007.

        Ventilators. To close the enormous gap in the availability of 
        ventilators, which will be essential to treat severely-ill 
        patients during an influenza pandemic, a Blue--Ribbon Panel 
        will be assembled this fall to establish the product 
        requirements for a next generation affordable, mobile 
        ventilator. A contract solicitation will be issued early in 
        2008 for the advanced development of next generation 
        ventilators.

 Federal Stockpile Acquisitions.
         Vaccines. To establish pre-pandemic vaccine 
        stockpiles, multiple contracts have been awarded for over $900 
        million between 2004 and 2007 to U.S.-licensed influenza 
        vaccine manufacturers to develop and produce at commercial 
        scale using licensed manufacturing processes and facilities for 
        egg-based inactivated split H5N1 vaccines against multiple 
        virus clades. These stockpiling efforts led to the U.S. 
        licensure of the first H5N1 vaccine in April 2007. To date 15 
        million vaccine single antigen doses have been manufactured as 
        bulk vaccine product, and 11 million more doses will be 
        manufactured this fall for a total of 26 million by the end of 
        2007. I should note, however, that while pre-pandemic vaccine 
        stockpiles are based on our best assumptions of what virus 
        strains are likely to present during a pandemic, they may not 
        closely match the virus that actually arrives. Finally, 
        Secretary Leavitt issued a Pandemic Response Emergency 
        Preparedness Act declaration in January 2007 to provide 
        comprehensive liability immunity for manufacturers and 
        administrators of H5N1 influenza vaccines.

        Antiviral Drugs. The Pandemic Influenza Plan seeks to ensure 
        the availability of antiviral treatment courses for 25 percent 
        of the U.S. population or 81 million treatment courses. To meet 
        the federal stockpile goal of 50 million treatment courses of 
        influenza antiviral drugs for treatment during a pandemic, 37.5 
        million treatment courses of U.S.-licensed neuraminidase 
        inhibitors were purchased in 2006-07 and delivered to the 
        Strategic National Stockpile (SNS). The U.S. now has domestic 
        manufacturing capabilities for these drugs. The remaining 12.5 
        million treatment courses will be purchased in fiscal year 08 
        upon approval of the pending appropriation request. To assist 
        States in meeting their collective pandemic stockpile goal of 
        31 million treatment courses of influenza antiviral drugs, $170 
        million was allocated to subsidize state purchases made using a 
        federal contract with manufacturers of antiviral drugs. To date 
        the States have purchased 15.1 million treatment courses of 
        influenza antivirals for their stockpiles and are expected to 
        reach the overall goal by July 2008.

        Ventilators. The SNS will purchase 2000 new ventilators in 2007 
        for distribution during a pandemic or as required in other all 
        hazards incidents and states can invest in ventilator 
        procurements through the investments being managed through the 
        HPP program.
         Syringes. The SNS will purchase in excess of 20 
        million syringe/needle units in 2007 for usage with pre-
        pandemic influenza vaccines.

 Infrastructure Building.
         Vaccines. To utilize existing facilities for pandemic 
        influenza vaccine manufacturing, two contracts were awarded in 
        May 2007 for $133 million for retrofitting existing domestic 
        biological manufacturing facilities for production of egg-based 
        influenza vaccines and providing warm base operations for up to 
        five years. A contract solicitation for proposals to establish 
        new domestic cell-based influenza vaccine manufacturing 
        facilities is also expected in 2008 with manufacturing capacity 
        requirements of at least 150 milliondoses of pandemic vaccine 
        within six months.
    While we have been making great strides with procurement and 
advanced development we have also drafted guidance on how to maximize 
these investments. We believe it's important to work with stakeholders 
in order to finalize that guidance, and that preparedness is best 
achieved not just by focusing on producing additional products, but by 
assuring that they are deployed and used optimally. This requires 
leadership in developing guidance and promoting preparedness, 
consultation with those who have a critical role in implementation 
(including states and professional societies), and understanding and 
overcoming any barriers to achieving success.

Federal Preparedness Planning
    For the past six months, ASPR has been a lead partner in the 
development of a U.S. Government-wide Pandemic Influenza Strategic 
Plan, which describes what steps Federal Departments will take to 
respond to the emergence of a novel influenza virus abroad and here in 
the homeland. This strategic planning process further codifies the HHS 
public health and medical responsibility to mitigate illness and reduce 
deaths during a pandemic through the provision of medical 
countermeasures and materiel, community mitigation guidance, necessary 
laboratory and surveillance tools, and some of the nation's finest 
public health and medical emergency response personnel.
    The Department's operational plan for pandemic influenza response 
details how HHS will fulfill its important responsibilities and how 
ASPR will coordinate the deployment and utilization of HHS assets and 
expertise. This plan, or playbook as we call it, will be further 
refined in the coming months to ensure a seamless integration with the 
U.S. Government-wide Plan. Further, HHS Operating Divisions including 
the CDC are developing their own detailed operational plans that are 
aligned with the Department's plan to enable a cohesive Departmental 
preparedness approach. A goal for next year is to work with states to 
develop regional playbooks that will continue to promote integrated 
planning across all tiers of government.
    HHS held a number of exercises to test the operational plans I have 
described. ASPR hosted Department-wide exercises with senior leadership 
to test how we will leverage the full scope of HHS resources and 
capabilities in response to pandemic influenza. ASPR has pre-identified 
six Senior Federal Officials to work in coordination with the pre-
designated Pandemic Influenza Principal Federal Officials, and our 
Senior Federal Officials are engaged in State-sponsored exercises 
taking place in their regions. In addition, CDC launched an extensive 
exercise program to identify planning gaps and stretch the limits of 
their assumptions and response strategies.
    The last two exercises have included state participation to promote 
seamless preparedness integration across the different tiers of 
response. The state participants were actively involved in the planning 
meetings leading up to the conduct of both of these CDC-sponsored 
exercises.
         April 25--27, 2007: coordinated activities with State 
        Emergency Operations Centers (EOCs) and State Health Department 
        EOCs from three states (Arkansas, Florida and Ohio).
         August 14--16: CDC Pan Flu Surge exercise, where 
        representatives from five states (Arkansas, Florida, Georgia, 
        Michigan and Ohio) served in our Exercise Control Group to 
        replicate the activities of their states and those of other 
        states that were not actively represented.

    The CDC's Division of Strategic National Stockpile (DSNS) also 
conducted a number of exercises. For example:
        --Operation Wild Canary, a full scale exercise executed in 
        partnership with the State of Iowa. The purpose of the exercise 
        was to test antiviral distribution from the federal stockpile 
        down to the local treatment facility. During the exercise the 
        DSNS deployed training material exactly replicating Iowa's pro-
        rata allocation of antiviral drugs to the state receipt, stage, 
        and store site in Des Moines. From there the state sent 
        antiviral drugs on a pre-established allocation to distribution 
        hubs throughout the state. Local treatment facilities then 
        received their antiviral allocation from the distribution hubs.

    Some examples of state and local promising practices in pandemic 
influenza activities include:
        --Maine
                 Formed pandemic influenza workgroups on all 
                levels including:
                         Statewide Steering Committee including 
                        public constituents
                         County Pandemic Influenza Planning 
                        Groups including public constituents and 
                        association and governmental members at the 
                        county and local level.
                         Intergovernmental Pandemic Influenza 
                        Planning Committee including the Departments of 
                        Agriculture and Inland Fisheries, the Maine 
                        Emergency Management Agency, and Maine 
                        Emergency Medical Services.

        --Wisconsin
    The state has significantly improved planning for treatment centers 
resources and personnel. As a result of pandemic influenza planning the 
state has a better understanding of their treatment facilities' 
capabilities, as well as an accurate location and point of contacts for 
each treatment facility, which has helped to improve their overall 
level of preparedness.

        --Atlanta, Georgia and Los Angeles County, California
                 Both cities are working with the Business 
                Executives for National Security (BENS) to engage local 
                corporations in preparedness planning.
                 In an upcoming exercise drill, the L.A. 
                Business Force/Homeland Security Advisory Council will 
                be the first private-sector representative ever 
                included in a security exercise at the vital Port of 
                Los Angeles/Long Beach, the gateway for 40 percent of 
                all U.S. trade.
    Thank you for the opportunity to present the progress HHS has made 
in national preparedness for pandemic influenza. With your leadership 
and support, we have made substantial progress. The threat remains 
real, and we have much left to do to ensure that we meet our mission of 
a Nation prepared for a potential influenza pandemic.
    This concludes my testimony. I will be happy to answer any 
questions.

    Mr. Langevin. Thank you, Dr. Vanderwagen.
    I thank all the witnesses for their testimony. Each of the 
members will have 5 minutes to question the panel. And I now 
recognize myself for questions.
    Again, I want to thank you all for your testimony. Let me 
address a question to the panel.
    To me, it would seem that an effective system of planning 
and response to pandemic influenza is one in which it would 
have broad-ranging benefits in other areas of public health 
threat, whether naturally occurring or manmade.
    So my question would be how does pandemic flu planning help 
in other ways? And what are we doing to ensure that it is 
helping in other ways?
    Again, it would seem to me that we should be thinking about 
this as we develop plans so that we might spend dollars more 
efficiently.
    Dr. Jolly. I will begin, sir. I think that you are correct. 
There are a number of ways in which a pandemic planning process 
can assist other planning processes.
    In the health focus, which I think Admiral Vanderwagen will 
focus on, there are certainly some areas of synergy. And 
outside of the purely health realm, when we think of operations 
of critical infrastructures, continuity planning and complex 
organizational structures that may be required for complex 
crises, the pandemic planning we have done related to those 
issues certainly can help those.
    There are some unique aspects, as we have discussed, with 
pandemic--the length of time that it lasts, the wave nature and 
some of the specific issues. But some of those continuity 
planning processes and the operational planning at the federal 
level certainly apply to those.
    And we have really taken the tack now of trying to apply 
those to a broader set of hazards.
    Dr. Vanderwagen. Yes, I agree with Til wholeheartedly, and 
I will just give you one example. And, sir, I have been to your 
state, Rhode Island, and visited the Rhode Island Medical 
Center, visited with the staff up there.
    There are great examples of how all-hazards preparedness as 
applied to pandemic or any other disaster are demonstrated, and 
I expect that we will hear some of that today.
    This first part of the week I was down in North Carolina 
for a couple of days visiting with them around their planning. 
And last year alone in North Carolina, they conducted 87 
exercises for pandemic flu.
    But what was clear was that they were using assets that 
they would deploy and involve in just about any sort of hazard. 
Hurricane is one that they live with frequently there in North 
Carolina.
    But the exercises, while focused on pandemic flu and some 
of the unique qualities, as Til suggested, they were exercising 
the whole system--the communication between public safety and 
health, the delivery of assets to communities, and that could 
be for any infectious disease or other demand.
    So I think there are some great examples where the states 
and localities really are using pandemic to build an all-
hazards response base while having the unique capabilities for 
pandemic.
    Ms. Steinhardt. If I can just add to Dr. Vanderwagen's 
comments, the important thing in any emergency that requires 
the enormous amount of coordination across multiple sectors and 
multiple actors is building those relationships before 
emergencies occur.
    You can't start getting to know people in the middle of an 
emergency. So having those relationships in place, 
understanding who one is supposed to turn to--all of that is 
very vital to being able to respond effectively in an 
emergency.
    And so any kind of planning and exercising that forges 
those relationships is going to benefit us in any emergency.
    Mr. Langevin. Let me follow up with this. Some would argue 
that the grant strategy--the grants that are offered to states, 
for example, are not well coordinated and that, you know, you 
can spend money if it is for preparedness for pandemic flu, but 
you are not able to spend that money in other areas that could 
be part of the response system to a public health threat.
    And someone argued that there is not good coordination in 
how you are writing and offering grants to states and other 
areas.
    So can you comment on that, you know, the coordination 
between DHS and HHS grants, for example?
    Dr. Vanderwagen. Yes. And there is a real risk there of a 
disconnect and bureaucratic silos at play.
    But I think that the most recent amount of money that we 
provided to the states, $75 million for pandemic flu, included 
guidance that would allow them to purchase assets that have 
utility in other than pandemic flu--ventilators, for instance, 
may be useful in a variety of settings not limited to pandemic 
flu.
    In terms of engagement with our DHS colleagues--and again, 
I will give you a North Carolina example. They were looking to 
develop a paratransit capability for evacuation of patients 
with special needs.
    And what they were able to do was merge USERA grants, CDC 
grants and the ASPR Hospital Preparedness grants using the 
authorities of each one of those to put together a package that 
would allow them to purchase and have constructed the 
appropriate paratransit equipment.
    It takes extreme work and communication on our part at the 
federal level, but I think the states that have been most 
successful also take a collaborative internal approach to this 
where they look at all the grants and they look at how they can 
use it for the ends that they are really trying to achieve.
    So I think it takes work at both the federal level and the 
state level to try and make those work effectively together.
    Dr. Jolly. And I would concur with Admiral Vanderwagen and 
Ms. Steinhardt that the opportunities in pandemic preparedness 
based on the grant funding for pandemic really play out in 
overall all-hazards preparedness, giving public health, 
emergency management, security, law enforcement--all the 
elements that come to play in complex crises--an opportunity to 
sit down together and go through scenarios, while mostly 
focused on pandemic in this case, allow them to get to know 
each other, get to know their various needs and the unique 
aspects of their roles, and help to coordinate those, and can 
only have benefits for other crises.
    Ms. Steinhardt. I hope to be able to answer your question 
better in a few months, because we are actually looking at 
these issues of state and local planning and exercising 
currently in an ongoing engagement for this committee.
    But I want to say now that one of the things we have 
observed is that this is a longstanding, I think, challenge to 
better integrate not only the funding but the communities 
themselves of public health and emergency management.
    They still speak different languages. They have different 
vocabularies. They are getting to know one another. And I think 
around pandemic planning is the immediate task at hand, but it 
will work in other areas as well.
    Mr. Langevin. Thank you.
    Let me turn to the GAO, to Ms. Steinhardt, for a minute. I 
was troubled when I read in the GAO's report on the National 
Strategy that both the Secretary of Homeland Security and the 
Secretary of Health and Human Services would be co-leaders 
during an influenza pandemic but that how they would actually 
lead at the same time has not yet been made clear.
    You made reference to this in your opening statement. Could 
you expand on this finding?
    Ms. Steinhardt. This is a kind of new model for us in the 
federal government to have these shared responsibilities.
    I think it is appropriate to recognize that for the major 
challenges like pandemic influenza that face the nation that it 
does take the efforts of multiple departments and competencies.
    But how exactly that works still has to be figured out. 
That is why we argued so strongly for having tests and 
exercises. Only when you go through a simulation of an actual 
situation can those kinds of details be worked out.
    We understand it conceptually, but how it would work in 
practice we need to see.
    Mr. Langevin. As a follow up, Dr. Jolly and Dr. 
Vanderwagen, during a pandemic when would the Secretary of 
Homeland Security lead and when would the Secretary of Health 
and Human Services lead?
    Dr. Jolly. Well, under the construct, the Secretary of 
Homeland Security is responsible for overall domestic 
preparedness and incident coordination at the federal level and 
would lead the overall federal activities, while the Secretary 
of Health and Human Services led the health and medical 
response, which is a very large job just by itself.
    And our PFO group, our Principal Federal Official group, 
working with HHS, FEMA, our operations--and others are working 
through the exact specifics of how that works down at the lower 
levels.
    Dr. Vanderwagen. Yes. I agree with that. We, I think, 
understand ourselves as having a finite and discrete 
responsibility under the overall leadership of DHS.
    Where this becomes an incident that has national 
significance, there is no question, the leadership resides with 
the Secretary of Homeland Security.
    With regards to public messaging, with regards to strategic 
thinking about application of assets to the medical and public 
health piece, we have that responsibility, but that still 
resides under the overall leadership of the secretary of 
homeland security.
    And the constructs--that is, the actual operational 
planning--is as Til has described, and I think Ms. Steinhardt 
did as well. That operational construct is now being 
established.
    And in fact, we have tested it some in that Vice Admiral 
Crea and some of her folks have participated in CDC exercises 
around pandemic flu to begin to see how the health nests under 
her leadership.
    Mr. Langevin. Well, this is obviously an area we want to 
continue to watch and to be involved in. Obviously, we can't 
wait until an actual event occurs and hope that, you know, the 
left hand knows what the right hand is doing.
    And as Ms. Steinhardt pointed out, you know, conducting 
exercises and actually simulating this is really the best way 
to make sure it is going to function properly in the event that 
a national emergency like this would occur.
    With that, I now recognize--well, actually, before I do 
that, let me just welcome the gentleman from New Jersey, Mr. 
Pascrell, who has joined us, and was an original member of the 
Homeland Security Committee when it was a select committee and 
left for a brief time when he went on the Ways and Means 
Committee. And now he is back joining us, as well as being on 
Ways and Means, also on the Homeland Security Committee.
    Welcome back, Bill.
    The chair now recognizes the gentleman from Texas for 5 
minutes for the purpose of questions.
    Mr. McCaul. I thank the chairman.
    I do want to welcome back Mr. Pascrell to the committee. It 
is good to have you here.
    As we approach the flu season, it is a joyful time of the 
year. I get to drag my five little children, kicking and 
screaming, to the doctor's office, holding them down as they 
get their flu vaccines.
    We try to anticipate the next sort of mutation, if you 
will, in preparation for this vaccine, and overall I think we 
have been very fortunate in terms of our ability to predict and 
foresee.
    The issue with a pandemic would be a mutation that would be 
unforeseen, some sort of variation like the avian flu that 
suddenly becomes, you know, transmittable human to human.
    And that is a scenario that we obviously are most concerned 
with. And how do we stop it? As we all know, it has been about 
40 years since we have had one in this country, and we are long 
overdue for that.
    My first question is more science related. So for the two 
doctors that we have, in terms of vaccines, you know, it seems 
to me that in the event we have a pandemic that is an 
unforeseen mutation of a virus, the ability to quickly develop 
a vaccine would be key in terms of minimizing the loss of life.
    I know that there has been some research now going from 
egg-based to cell-based vaccines, and I would like to hear from 
you in terms of the progress that we have made in that regard 
in terms of developing, you know, vaccines that we can get to, 
you know, the market more quickly.
    Dr. Vanderwagen. Yes. Well, it is an extremely good 
question, and one that we have really tried to focus on pretty 
steadily.
    Our investments have been with multiple manufacturers to 
develop cell-based technologies for production in this country.
    That doesn't provide a tremendous amount of shortening of 
the time period from the time the virus is identified until you 
have a manufacturing capability to put it out there, but it is 
a cleaner, more modern and sophisticated technology that 
doesn't depend on chickens for eggs.
    And in an avian flu, that is--you know, we have 
biosecurity and so on, but still, it is shifting to 
that new technology.
    Where we think there will be the breakthrough in terms of 
reducing the production time from the identification of virus 
to the actual production capability of vaccine at production 
levels is with the development of a recombinant vaccine.
    And we are about ready to award a contract for a producer 
of that, and we hope to have a couple producers in that game, 
not limited to one, that would allow us to see if, in fact, the 
promise of an 8-week turnaround instead of a 20-week turnaround 
is as we think it might be.
    That combined with the developments now in adjuvant 
therapies added to the antigen--remember, the vaccine has an 
antigen that stimulates your immune system--now the 
technologies of developing adjuvants that augment that immune 
response at a much lower dose of antigen.
    And the research in this area is also very promising. If it 
plays out, and there are clinical studies under way now to 
assure that they are safe and effective, as advertised--if that 
works out, it may give us a twentyfold increase in our existing 
pre-pandemic vaccine stockpiles.
    And in the future, if we have to produce a new vaccine, it 
will change the character of how much we need to develop an 
antigen in order to get a good vaccine with a good immune 
response.
    So progress is moving along very smartly in the technology 
and science arena here with vaccine development for influenza, 
particularly pandemic flu.
    Mr. McCaul. Can you forecast maybe the time frame that that 
technology would be available?
    Dr. Vanderwagen. I think the RPA that is the recombinant 
technology for this--proof of concept is out there. We are 
talking a year or so. 2010 we think we will have that 
available--is the way we are thinking about it.
    The adjuvants that I mentioned to you may occur sooner than 
that. In 2009, perhaps we will have final clinical efficacies, 
and everybody will be convinced that we have got the safe 
product for pre-use.
    Mr. McCaul. Dr. Jolly?
    Dr. Jolly. We certainly support that. I think the planning 
and the community mitigation guidance and other strategies take 
into account the current situation, but we certainly support 
further research.
    And I think this argues for a couple of things. One, the 
vaccine research for pandemic can only benefit vaccine research 
for other diseases.
    And I think there is a wide range of things both in the 
emergency management realm and just in public health that this 
can really help. If this technology works for one, it can 
certainly work for others.
    I also applaud and sympathize with your efforts to get your 
family vaccinated.
    And that really argues for our increased vigilance and 
message to the public about seasonal flu and to really utilize 
the seasonal flu vaccine because seasonal flu is not a trivial 
matter just by itself.
    Mr. McCaul. Well, I find it to be a very exciting and 
promising area, and the other--this is also sort of more 
science-based, but antivirals--where are we with those?
    And also, where are we with the stockpiles in the event of 
an outbreak?
    Obviously, as you mentioned, Dr. Vanderwagen, about the 
idea of them being used as both prophylactic and after 
exposure--do we have enough, say Tamiflu and other antivirals? 
Do we have enough stockpiled right now in the event there is a 
pandemic outbreak?
    Dr. Vanderwagen. Well, let me answer the first part of that 
first, and that is where are we. We are on plan. You may recall 
that we strategically made the decision to purchase enough to 
treat everyone that we thought would be at risk and got ill.
    And so the planned investment was to purchase adequate 
amounts with our state partners to treat 25 percent of the 
population who we projected would be ill. We are on plan for 
that.
    The last purchases to fill out the 81 million treatment 
courses for that will occur in fiscal year 2008.
    With regards to the use of antivirals in prophylaxis, we 
made that strategic decision about purchasing for treatment 
because at the time, production capability was fairly limited, 
15 million or so a year treatment courses.
    Now that production capability is much more robust than 
that, which gives us the opportunity to visit with our 
stakeholder partners--the states, businesses, even down to 
individuals and families--the question of where is the 
responsibility for shared acquisition if, in fact, the science 
supports the use.
    And that is sort of a question that we are analyzing right 
now. What is the science base for using antivirals in a 
prophylaxis environment and what are the risks of doing that in 
terms of developing resistance, for instance, and therefore 
losing the utility of the tool?
    We are also developing additional antivirals, at least one 
that attacks at the same spot that Relenza and Tamiflu--I am 
drawing a blank there--aging, what can I tell you--that is 
similar in action but can be delivered through the bloodstream 
parenterally, as we say in medicine, which for extremely sick 
people would be another alternative that would be very useful.
    So there are developments on the horizon. There are some 
gap questions to be answered both from a science perspective 
and from a shared responsibility perspective.
    But if, in fact, the science supported it and we worked out 
the shared responsibility, there is a potential use there in 
post-exposure prophylaxis and for those who are at high risk 
like medical workers of acquiring the disease.
    We know, for instance, in seasonal influenza 15 percent to 
30 percent of health workers in hospitals taking care of very 
ill people with flu get sick. So there is another target 
population at risk that we need to consider.
    Mr. McCaul. Ms. Steinhardt and Dr. Jolly, if you could 
comment on that as well, is our stockpile, national stockpile, 
of antivirals adequate to meet the need if a pandemic occurs 
this year?
    Ms. Steinhardt. Well, I can't say that we have assessed 
that specifically, but I think a lot of it has to do with 
whether we change the use of antivirals.
    If we are using them just as treatment--and obviously, we 
don't have enough to treat the entire population--or if we are 
going to use them prophylactically.
    But I must say that this is now the opportunity to think 
about if we do have limited supplies, whether of antivirals or 
vaccines, if we were to have pandemic influenza in the nearer 
term, what sort of priorities are we going to set for 
distributing those supplies. That is, I think, a key question 
for us.
    Mr. McCaul. Dr. Jolly?
    Dr. Jolly. I would agree with Craig. We are building up the 
stockpile, and we are shifting from an analysis that involves 
purely treatment to potentially a larger amount of that for 
prophylaxis and trying to develop the science base, because 
there is no medicine that doesn't have a risk associated with 
it, and there certainly are risks associated with wide use.
    And the other point I would make is that antivirals are not 
the entire answer. We really want to be careful to make 
everyone understand that having an antiviral isn't necessarily 
100 percent curative or preventative.
    But in fact, it is incorporated into a wide range of 
strategies that don't include pharmaceuticals such as the 
community mitigation strategies that were led by the CDC with 
multiple agencies involved that are really part of the overall 
strategy.
    Mr. McCaul. I see my time has expired, but I want to close 
with the same point that the chairman made, and that is the 
exercises. I think there has been one exercise to date. Was 
that a tabletop or was that a field exercise?
    Ms. Steinhardt. It was a tabletop exercise, and it was 
before actually the issuance of the Plan.
    Mr. McCaul. The Plan. Yes.
    I would strongly encourage, Dr. Jolly, that you consider 
conducting a field exercise in the event a pandemic broke out.
    I think having worked with the Joint Terrorism Task Forces 
in my prior lifetime, I think when you do these things in the 
field, you kind of get a better sense for who is supposed to be 
doing what in a real sense.
    So with that, I will yield whatever time in have left, 
which I see is zero.
    [Laughter.]
    Mr. Langevin. And then some.
    [Laughter.]
    Mr. Langevin. I thank the gentleman.
    And the chair now recognizes the gentleman from New Jersey 
for 5 minutes.
    Mr. Pascrell. Thank you, Mr. Chairman. It is good to be 
back.
    I follow this issue very carefully, and I have some 
questions for the Rear Admiral Vanderwagen.
    I want to thank you for convening the hearing. I appreciate 
the administration appearing today. This is very important, 
because I believe that the sense of urgency shown by Congress 
and the administration has diminished, and not increased, in 
recent months.
    Despite the fact that the World Health Organization has now 
confirmed a total of 327 cases of avian flu and 199 deaths, 
including recent disturbing reports out of Vietnam Egypt and 
Indonesia.
    To date, I understand the administration has requested and 
Congress has appropriated $6.1 billion for implementation of 
the $7.1 billion National Strategy on Pandemic Influenza, 
including $2.3 billion most recently on the fiscal year 2006 
emergency supplemental appropriations bill.
    This administration has been evasive in answering questions 
about why the funds allocated for the purchase of the antiviral 
drugs have not been spent to complete the stockpile.
    I have here in my hand three letters. These three letters 
went to Secretary Leavitt from the House Republican leadership 
in June, one letter came from the House Democratic leadership 
in August, and the last letter is from Senator Thad Cochran, 
who wrote that letter to the Secretary in September.
    All of them ask the question why we have only purchased 
enough drugs for 15 percent of the population when the NSPI 
calls for 25 percent of the population to be covered by the 
stockpile.
    And my first question to you, Rear Admiral, is why have 
these letters gone unanswered?
    Dr. Vanderwagen. I can't speak to that, sir. I will have to 
ask that question of the executive secretary and the folks who 
manage the correspondence.
    Mr. Pascrell. You don't know why the letters have been 
unanswered. I mean, they came from all sectors of the campus 
here, and we still don't have an answer for them.
    This committee doesn't have an answer for them. The 
Congress doesn't have an answer for them. Who in God's name do 
you think you are kidding? Who do you believe we'll believe on 
this side of the aisle--excuse me, if I may continue--the 
urgency of this situation?
    Who do you think is going to believe you?
    Dr. Vanderwagen. Let me go back to your first question.
    Mr. Pascrell. Sure.
    Dr. Vanderwagen. I have just been informed that two of 
those answers have been provided to the Hill for the first two 
of those, and we will provide documentation of that for you, 
sir.
    Mr. Pascrell. We don't have those answers yet, and we would 
like to have those answers.
    Dr. Vanderwagen. Right.
    Mr. Pascrell. Do you know what is contained in them?
    Dr. Vanderwagen. I haven't seen them myself, no, but I----
    Mr. Pascrell. In addition, Rear Admiral, how much of the 
funding allocated to you has been set aside for antiviral 
purchases, and how much has been set aside for vaccine purchase 
and development?
    Dr. Vanderwagen. Right.
    Mr. Pascrell. Have all of these funds been spent?
    Dr. Vanderwagen. We currently have obligated $3.2 billion, 
$2.4 billion of that for vaccines including cell-based 
vaccines, antigen sparing activities, facilities retrofitting, 
international vaccine development, the H5N1 pre-pandemic 
stockpile.
    We have a total commitment of $796 million for antivirals. 
That includes $103 million for advanced development, $523 
million for federal stockpiles and $170 million for state 
stockpiles. We have an additional $27 million invested in 
advanced diagnostics.
    Mr. Pascrell. So how much haven't you spent?
    Dr. Vanderwagen. We have a balance remaining that is set 
aside in reserve for those advances that we have agreed to work 
with the vaccine companies to do. We are monitoring their 
progress. We have agreed to milestones. And when they achieve 
those milestones, we would continue to make investments.
    That was our business arrangement with those producers, 
that if they hit certain milestones in production, we would 
then advance further investment.
    Mr. Pascrell. Why is it that we apparently had--and there 
is no seamless solution. We understand that. But why haven't we 
used our capacity to purchase and stockpile the very drugs we 
know that work?
    And we have sent mixed signals to the pharmaceuticals. They 
are not going to continue to make these unless, you know, we 
purchase them.
    And if they have been tried, if they have been tested, it 
seems to me that we are circumventing the solution, not 
exercising urgency and talking about developing another set of 
solutions, which you know is going to be 3 years to 5 years. 
Let's go back to the history of these things.
    I don't understand that. Maybe you can help me understand.
    Dr. Vanderwagen. The investments that we were to make for 
antivirals for treatment are on plan. We have stated 
forthrightly that we would purchase X amount in 2007 and we 
would purchase the balance of that in 2008. There has been no 
real change in that plan. That is out there in the marketplace. 
That has been a consistent message from us.
    The advanced development investments we think by 2010 will 
have payoffs that have huge benefits for the population, as you 
may have heard me respond to Mr. McCaul.
    Mr. Pascrell. I think that, Mr. Chairman, if I may 
conclude--my time is up--I really still don't sense the urgency 
that is necessary that on both sides of the aisle has been 
expressed and is not being implemented.
    And I would hope that through the chair and through the 
ranking member that this could be brought to bear, in that we 
can get the answers that they talk about in these letters, 
which started 4 months ago, 5 months ago.
    And now we are hearing at this committee hearing that there 
are answers but they just haven't gotten to us yet. Would you 
please follow up on that, sir?
    Mr. Langevin. Absolutely.
    Mr. Pascrell. Thank you.
    Mr. Langevin. I can guarantee that to the gentleman. And I 
thank the gentleman from New Jersey for his questions. You 
clearly have not lost your passion for homeland security 
issues. I thank the gentleman.
    In consultation with the ranking member, what we would like 
to do--there are two votes on right now. Hopefully that will go 
quickly.
    We would like to go for a second round of questions with 
this panel, since many members are at markups and other 
meetings right now. We will go for a very brief second round 
with this panel and then go to the second panel when we return.
    I would say that we should be back here in about 20 
minutes.
    With that, the committee stands in recess.
    [Recess.]
    Mr. Langevin. The committee will come to order. I thank the 
witnesses for waiting.
    And I understand that at least two of our guests have a 
meeting at the White House actually for an exercise that is 
going on right now, so we are going to be very brief and adhere 
to the 5-minute rule, and hopefully we will get you out of here 
in just a couple of minutes.
    If I can talk to Dr. Jolly and Dr. Vanderwagen--let me 
address my questions there We were talking about earlier how we 
can better coordinate homeland security and HHS grants with 
respect to pandemic flu that could be also beneficial in other 
areas.
    Let me ask this. How can we better coordinate all public 
health grant monies, especially those that come from HHS? 
Again, my understanding is that not all grants have common 
goals and performance measures.
    My question is: is there a system in place at HHS to 
coordinate things like goals and performance measures, 
especially when there are multiple grants, perhaps some from 
CDC, some from the ASPR, dealing with the same topics, such as 
pandemic flu?
    Dr. Vanderwagen. Yes, sir, Mr. Chairman, and indeed, there 
is a fairly well defined process of planning that goes into the 
grant guidance that we provide, remembering that the Centers 
for Disease Control's investments are more targeted at public 
health types of interventions and public health programs at the 
community level, where the hospital preparedness dollars are 
really targeting the medical side of that.
    Our interest here is to see the public health and the 
medical community act in concert on these activities. And 
unfortunately, in this country, we had seen a large gap develop 
between the public health and medical communities.
    And one of our goals is to bring them into greater 
proximity. Accordingly, we are not only trying to align the 
expectations from the grants, recognizing that public health is 
slightly different than clinical medicine, we are also now 
trying to bring our grants into the same time sequence as the 
DHS grants so that the states and communities are looking at 
the whole grant package in the same time frame rather than 
looking at one in March and then one in August and then maybe 
one in October.
    And so those are the active steps that we are taking. First 
meeting before we issue guidance to assure that they 
synchronize. And secondly, to try and fix the timing on our 
public health and hospital grants to align more closely with 
DHS and their timing.
    Dr. Jolly. And to add on Admiral Vanderwagen's statement, 
Mr. Chairman, the timing and sequence are quite important, and 
also the content of the grants.
    We have an active effort now growing within DHS and HHS to 
communicate among those that are responsible for the grant 
guidance at one agency so that the other agency knows what that 
grant guidance is and can help to harmonize that.
    And one of the roles--as you know, our office is a 
relatively new office in Health Affairs. One of the roles of 
our division of medical readiness is to take a look at the DHS 
grants and also coordinate across the HHS grants and try to 
harmonize those.
    And it is going to be a stepwise process over time, but I 
think we can make some real improvements in that.
    Mr. Langevin. Well, I plan to pay particularly close 
attention to that, and that will be part of our oversight as we 
go forward. I think it is beneficial for both departments and 
the country, and ultimately the states and our citizens are 
going to benefit.
    Very quickly, for DHS and HHS once again, when we conduct 
exercises--we spoke about exercises earlier here, and practice, 
and making sure that we are ironing out the issues before they 
actually occur.
    When we conduct exercises, it is important to conduct them 
in the most realistic way possible and, to the extent we can, 
use current requirements to show us how well we might do in 
future situations.
    During a pandemic, DHS and HHS will be the lead federal 
agencies in terms of managing the response, as we discussed 
earlier. I believe that we should test our systems now using, 
for example, seasonal influenza as a proxy for pandemic 
influenza.
    So my question for you, Dr. Vanderwagen, is why don't you 
take this year's influenza season and make a concerted effort 
to see how many people we can vaccinate in the shortest period 
of time, basically pretending that seasonal influenza is 
actually pandemic influenza?
    Can you get HHS programs such as the National Immunization 
Program to step up and work with other HHS entities and systems 
to exercise in this way?
    Dr. Vanderwagen. Yes, sir. And in fact, in 2006 I--you 
know, I live in Howard County up the road here, and the state 
of Maryland was test driving its ability to deliver vaccines in 
an event of a pandemic by using the seasonal flu as the test 
bed.
    And essentially, they had a drive-through approach so that 
we could maintain social distancing and yet provide access to 
vaccines for the population.
    It took me 3 hours to get my vaccine, but it worked. And we 
are promoting more of that kind of use of vaccination 
opportunities as a test drive of how they would do mass 
prophylaxis in the environment of a pandemic flu.
    I think that is a capital idea. Some states have done it. 
We are trying to promote it more holistically to all states.
    I think Dr. Gerberding on Wednesday this past week, a week 
ago, when she made the announcements regarding this year's 
seasonal flu--that was one of the points that she tried to 
make.
    So I think we are on the same page with you, sir. It 
remains for us to demonstrate to you how that went off.
    Dr. Jolly. And I would agree that some of the operational 
elements of vaccinating individuals and some of the other 
things--countermeasure issues can benefit from those types of 
exercises.
    That is a very good idea, and something that other states 
have tried and will continue to refine.
    And on some of the larger exercise issues, we have plans 
within our Principal Federal Official group to exercise within 
that group and then lead that into a series of leadership level 
interagency exercises and to culminate in another cabinet-level 
exercise over a period of time as the schedule develops.
    Mr. Langevin. Very good. Well, I see benefits across a 
range of areas in conducting such an exercise, so--well, I 
thank you for the answers.
    And I now recognize the gentleman from Texas for 5 minutes 
for questions.
    Mr. McCaul. Thank you, Mr. Chairman.
    I will be brief. We have a vote in, I think, 15 minutes.
    Ms. Steinhardt, you mentioned in your testimony certain 
gaps that are currently, in terms of our readiness, our 
preparedness.
    I would like, if you could, to focus on sort of the 
highlights of those gaps and how we can do a better job.
    Ms. Steinhardt. Yes, I would be happy to. Ones I think that 
I wanted to highlight in particular--first, the fact that there 
are--in the National Strategy and Plan there is no mention of 
the resources that are going to be required to carry out the 
Plan. There are well over 300 action items in the plan.
    Dr. Vanderwagen and Dr. Jolly mentioned earlier the vaccine 
program and supplemental appropriations. But there are many 
others that are called for in the Plan beyond those that are 
covered in the supplemental appropriations, and there is not 
even an estimate of what would be entailed.
    So that is one important gap. And certainly, from an 
oversight perspective, it is really critical.
    Another gap that we were particularly mindful of was the 
fact that state and local and tribal entities weren't involved 
in actually producing the plan and preparing the plan.
    They are responsible for close to 100 of the action items, 
either as the lead or in some sort of support capacity, and yet 
they weren't consulted when the plan was being developed, and 
that I think is something that needs to be addressed.
    And then the plan itself--within the plan there is no 
institutional process for updating it as new events unfold, as 
we learn from exercises and so on. There is no process to 
update the plan or to monitor progress on a regular basis.
    There are several others that we point out in our report 
and statement, but those are the ones I would highlight.
    Mr. McCaul. Thank you.
    And I do want to thank the witnesses again. I think we have 
made some progress. And as Dr. Vanderwagen mentioned, I think 
we are partners in this, and so I look forward to working with 
you to make sure we are prepared. Thank you.
    Mr. Langevin. I thank the gentleman.
    And with that, no further questions. I thank the panel for 
their testimony, your presence here today and for the work that 
you are doing on behalf of the country.
    And we look forward to continuing oversight in this area 
and partnership with you in this effort. Thank you very much.
    With that, the first panel is dismissed. And if we can have 
the second panel come to the front. Very good.
    Well, gentlemen, thank you for being here. I want to 
welcome the second panel of witnesses.
    Our first witness is Dr. Anthony Cirillo, the chief of the 
Center for Emergency Preparedness and Response in the state of 
Rhode Island Department of Health. He is also a practicing 
emergency room physician.
    In addition to that, prior to his present post, he was 
chief of emergency medicine at Pawtucket Memorial Hospital in 
Rhode Island.
    Welcome, Dr. Cirillo.
    Our second witness is Dr. Peter Shult. Dr. Shult is the 
director of the Communicable Disease Division and Emergency 
Laboratory Response and Chief Virologist of the Wisconsin State 
Laboratory of Hygiene.
    He is also clinical associate professor of the Department 
of Medical Microbiology and Immunology at the University of 
Wisconsin-Madison.
    Welcome.
    And our third witness is Dr. Michael Caldwell, commissioner 
of the Dutchess County Health Department of Poughkeepsie, New 
York. Dr. Caldwell is the immediate past president of the 
National Association of City and County Health Officials.
    He is also an internal medicine physician and a public 
health officer with 12 years of experience in local public 
health practice.
    Our fourth witness is Dr. David Lakey, commissioner of the 
Texas Department of State Health Services.
    We want to welcome all of our panel here today. I thank all 
four of our witnesses for their service to their states and to 
the nation and again for being here today.
    Without objection, the witnesses' full statements will be 
inserted into the record. I now ask each witness to summarize 
his statement for 5 minutes, beginning with Dr. Cirillo.

    STATEMENT OF DR. L. ANTHOHY CIRILLO, CHIEF, CENTER FOR 
EMERGENCY PREPAREDNESS AND RESPONSE, RHODE ISLAND DEPARTMENT OF 
                             HEALTH

    Dr. Cirillo. Mr. Chairman and members of the committee, I 
would like to thank you for allowing me to testify today to 
discuss the current successes and ongoing challenges in 
planning and preparing for a pandemic influenza event.
    I would like to share with you my dual perspective as both 
the coordinator of public health emergency preparedness for our 
nation's smallest state and as a practicing emergency physician 
in an urban community hospital.
    Today I can share with you that although significant 
progress has been made in preparing the public health and 
health care sectors for response to a pandemic, there is still 
considerable work that needs to be done, and there are 
challenges both in scope and depth of preparation that will 
need to be addressed in order for our country to meet the 
challenge of a pandemic event.
    In Rhode Island, the Department of Health serves as the 
sole public health agency within the state, as there is no 
other city-or county-based public health infrastructure.
    As such, the department is responsible for the 
administration of all traditional public health programs both 
promotional and protectional.
    The Center for Emergency Preparedness and Response oversees 
all public health emergency preparedness grants, including the 
CDC Public Health Emergency Preparedness Grant and the Hospital 
Preparedness Program Grant administered through the office of 
the ASPR.
    Under the leadership of U.S. Secretary of Health and Human 
Services Michael Leavitt, who issued a challenge to prepare for 
a pandemic during his state visits in 2006, Rhode Island 
undertook a spectrum of activities.
    The successes that have been achieved in pandemic 
preparedness in Rhode Island have come, to a great extent, due 
to the strength of our partnerships and working relationships 
within the state and the New England region.
    In Rhode Island, we have strived to develop an integrated 
and coordinated system for the public health and health care 
sectors to respond to any public health emergency, including a 
pandemic.
    Ongoing coordination with our hospitals through the 
Hospital Preparedness Program facilitated the establishment of 
10 health care coordinating service regions in the state in 
order to respond to the needs for health care during a 
pandemic.
    Stockpiling of critical supplies at the state level, 
including patient care equipment, personal protective 
equipment, ventilators and other support materials has begun in 
order to provide an initial cache of medical equipment needed 
to supply alternate care sites during a pandemic.
    Outreach and risk communication messaging in the senior 
community, other special populations and the general public 
through brochures, newspaper inserts, classroom materials and 
public service announcements has already occurred.
    Regional interstate coordination in pandemic preparedness 
has also occurred among the six New England states and the 
state of New York. Each of these states has participated 
together in work groups focused on a number of pandemic topics.
    This collaborative effort resulted in a 2-day summit and a 
multistate tabletop exercise held to coordinate the interstate 
response to a pandemic.
    Despite the progress that I have described, there is still 
considerable work to be done. Ongoing challenges include, 
number one, inadequate funding and resources to purchase enough 
material to ensure care of anticipated numbers of patients 
during a pandemic.
    Two, shifting and evolving federal grant priorities related 
to pandemic flu and overall public health preparedness which 
create inefficiencies in program management.
    Three, the disincentives to the purchase of antiviral 
medications Tamiflu and Relenza due to exclusion from the 
shelf-life extension program of state health supplies of these 
medications.
    Now, as an emergency physician, I have personally witnessed 
the increasing demand for medical care being placed on hospital 
emergency departments. With the number of uninsured Americans 
now in excess of 47 million, more and more individuals do not 
have appropriate access to medical care.
    In the absence of a medical home, people who experience 
injury or illness will seek care in the one environment where 
they know they will never be turned away, and that is the 
emergency department.
    However, emergency departments today are overcrowded. Surge 
capacity is diminished or being eliminated altogether. 
Ambulances are diverted to other hospitals. And the shortage of 
medical specialists is worsening.
    According to data recently released by the CDC, emergency 
department visits are at an all-time high of 115 million in 
2005. That was an increase of five million visits in just 1 
year alone.
    And from 1995 through 2005, emergency department visits 
increased by 20 percent, while the number of functioning and 
operating emergency departments decreased by 9 percent.
    Because of the extraordinary demands that a pandemic will 
place on the health care delivery system, it is imperative that 
we are able to engage the general public and encourage them to 
assume responsibility for their own preparedness.
    Just as the saying goes that all disasters are local, so is 
the response to a disaster. In the truest sense for a pandemic, 
this means that preparedness must begin with individuals, 
families, neighborhoods and communities.
    It is critical to the successful response that we develop a 
culture of preparedness in this country in order to ensure that 
those who have the means to prepare for themselves do so.
    If we can accomplish this, then the burden of response on 
government will be reduced so that scarce resources available 
can be shifted and allocated to those who are most at risk.
    In conclusion, I would like to share with you the following 
closing thoughts. States and local health entities are willing 
partners in the development of systems to respond to a pandemic 
event or other public health emergency.
    However, the resources and support of the federal 
government are essential to creating and sustaining the 
capability and capacity required to prepare for and respond to 
all public health emergencies.
    Incorporating new grant requirements and updates to 
national planning documents related to a pandemic or other 
public health emergency requires considerable time at the state 
and local level and utilization of resources in order to 
effectively reach the entire health care responder community 
and the general public.
    Therefore, it is critical that all federal preparedness 
programs related to pandemic or other public health emergencies 
be more closely aligned and coordinated so that we at the state 
level can more effectively develop an appropriate response to 
all public health emergencies.
    Mr. Chairman and members of the committee, I thank you for 
the opportunity to discuss these important issues with you 
today and would be happy to answer any questions you may have.
    [The statement of Dr. Cirillo follows:]

        Prepared Statement of L. Anthony Cirillo, MD, F.A.C.E.P

    Mr. Chairman and members of the committee, my name is L. Anthony 
Cirillo, M.D., F.A.C.E.P. I serve as the Chief of the Center for 
Emergency Preparedness and Response (CEPR) for the State of Rhode 
Island Department of Health and as a practicing emergency department 
physician employed by Emergency Medicine Physicians (EMP), a single 
specialty medical group practice.
    I would like to thank you for allowing me to testify today to 
discuss the current successes and ongoing challenges in planning and 
preparing for a pandemic influenza event. I would like to share with 
you my dual perspective as both the coordinator of public health 
emergency preparedness for our nation's smallest state and as a 
practicing emergency physician in an urban community hospital. As of 
today, I can share with you that although progress has been made in 
preparing the public health and healthcare sectors for response to a 
pandemic influenza event, there is still considerable work that needs 
to be done, and there are challenges both of scope and depth of 
preparation that will need to be addressed in order for our country to 
meet the challenge of a pandemic influenza event.

The Rhode Island Experience
    The Rhode Island Department of Health serves as the sole public 
health agency within the state as there is no other city / county based 
public health infrastructure. As such, the department is responsible 
for the administration of all traditional public health promotional and 
protection programs, including Healthy People 2010, food and water 
protection, laboratory, epidemiology and disease control. Beginning in 
early 2006, the Center for Emergency Preparedness and Response (CEPR) 
was established by Dr. David Gifford, the Director of Health. CEPR was 
established to coordinate all public health emergency preparedness 
activities on behalf of the department. CEPR serves as the liaison 
entity, on behalf of HEALTH, for all other emergency preparedness 
efforts within the state and is the designated lead agency for 
Emergency Support Function 8 (ESF-8), Health & Medical, within the 
state's Emergency Operations Plan.
    In my role as the Chief of CEPR, I serve as the Principal 
Investigator, on behalf of the department, for both the CDC Public 
Health Emergency Preparedness (PHEP) and the Hospital Preparedness 
Program grant administered through the office of the Assistant 
Secretary for Preparedness and Response (ASPR) within the Department of 
Health & Human Services. In addition, CEPR serves as the representative 
entity in participation in the development of investment justifications 
under the Department of Homeland Security grant funded programs.
    The successes in pandemic preparedness in Rhode Island have come, 
to a great extent, due to the strength of our partnerships and working 
relationships within the state and the New England region. I would like 
to acknowledge here today, two other Rhode Islanders who represent key 
partners within the state with whom the Department of Health has worked 
closely with in these efforts. Mr. Thomas Kilday, who currently serves 
as the Homeland Security Grant Manager at the Rhode Island Emergency 
Management Agency, is a paramedic and previously served as the Program 
Manager for the Hospital Preparedness Program at the Department of 
Health. Mr. Peter Ginaitt, who currently serves as the Director of 
Emergency Preparedness for Lifespan, the state's largest healthcare 
system, is a former state representative and retired Captain of 
Emergency Medical Services for the City of Warwick.
    In Rhode Island, we have strived to develop an integrated and 
coordinated system for the public health and healthcare systems to 
respond to a pandemic influenza event or other public health emergency. 
Ongoing coordination with our hospitals through the Hospital 
Preparedness Program facilitated the establishment of ten healthcare 
coordinating service regions in the state for pandemic influenza. In 
this model, each of the ten acute care hospitals within the state would 
serve as the coordinating entity for a geographic area. Utilizing the 
Hospital Incident Command System for management of healthcare in that 
area, each hospital will report to the Department of Health as the 
coordinating entity for all ESF-8 activities within the state.
    Volunteers during a pandemic event will be coordinated through 
Volunteer Reception Centers (VCRs) which will be managed by the 
Volunteer Center of Rhode Island (VCRI), a non-profit organization with 
expertise in volunteer coordination. VCRI has been provided funding 
through the Pandemic Flu grants and has established a single, unified 
statewide volunteer management system. VCRI will be able to open ten 
volunteer reception centers simultaneously to manage volunteers 
throughout the state. Volunteers will be pre-credentialed utilizing the 
Emergency System for Advanced Registration of Volunteer Health 
Professionals (ESAR-VHP), another program funded under the Hospital 
Preparedness Program grant.
    Stockpiling of critical supplies including patient care equipment, 
personal protective equipment, ventilators, and other support materials 
at the state level has begun in order to provide an initial cache of 
materials to equip Alternate Care Sites (ACS) in each of the hospital 
coordinated healthcare regions.
    Outreach and risk communication messaging to the senior community, 
other special populations, and the general public through brochures, 
newspaper inserts, classroom materials, and public service 
announcements has already occurred.
    Regional interstate cooperation in pandemic preparedness planning 
has also occurred among the six New England states and the State of New 
York. Early in 2006, after US Secretary of Health and Human Services 
Michael Leavitt's visits to the states to discuss pandemic 
preparedness, coordinated planning and response to a pandemic event, 
representatives from each of the Departments of Health in seven states 
participated in workgroups on the following topics:
        1. Community Containment
        2. Personal Protective Equipment
        3. Antiviral Medication / Vaccine Utilization
        4. Laboratory Testing / Disease Surveillance
        5. Fatality Management
        6. Surge Capacity
    These workgroups met in person or by teleconference for\ 3 months 
culminating in a two-day summit held in Boston in late June 2006. These 
workgroups identified common best practices among all the states, as 
well as the areas of differing response strategies. A key lesson from 
the summit meeting was that in order for there to be effective public 
health response to a pandemic, this response needed to be coordinated 
with state governmental leadership and emergency management agencies as 
well. Therefore a tabletop exercise was held at the Naval War College 
in Newport, RI in August 2006. Participating in this exercise was the 
seven states noted above as well as representatives from the FEMA 
Region I and HHS Region I offices.
    Despite the progress referenced above, there is still considerable 
work to be done. Ongoing challenges include:
        1. Inadequate funding to purchase enough materiel to ensure 
        care of anticipated numbers of patients during a pandemic 
        influenza event, as federal funding for preparedness continues 
        to decrease.
        2. Shifting and inconsistent federal grant priorities related 
        to pandemic flu and overall public health emergency 
        preparedness efforts which create inefficiencies in program 
        management.
        3. Disincentives to the purchase of antivirals due to exclusion 
        of state held cache from Shelf Life Extension Program (SLEP).
        4. Continued need to coordinate planning across state borders, 
        especially in those states with multiple and close state 
        borders.

The Emergency Department Experience
    As a practicing emergency physician, I have personally witnessed 
and shared with my colleagues across the country, the increasing demand 
for clinical services being placed on emergency departments. With an 
increase in the number of uninsured Americans now in excess of 47 
million, more and more individuals do not have appropriate access to 
medical care. In the absence of a medical home, people who experience 
injury or illness of themselves or loved ones will seek care in the one 
environment where they know they will never be turned away, the 
Emergency Department. Emergency departments are the health care safety 
net for everyone in this country--the uninsured and the insured.
    Emergency departments are overcrowded, surge capacity is diminished 
or being eliminated altogether, ambulances are diverted to other 
hospitals, patients admitted to the hospital are waiting longer for 
transfer to inpatient beds, and the shortage of medical specialists is 
worsening. These are the findings of the Institute of Medicine (IOM) 
report ``Hospital-Based Emergency Care: At the Breaking Point,'' 
released in June 2006.
    On June 29, the Centers for Disease Control and Prevention (CDC) 
released its results from its 2005 National Hospital Ambulatory Medical 
Care Survey (NHAMCS), the longest continuously running, nationally 
representative survey of hospital emergency department and hospital 
outpatient department use.
    According to the CDC data:
         Emergency visits are at an all-time high of 115 
        million in 2005--an increase of 5 million visits in one year.
         From 1995 through 2005, the number of emergency 
        department visits increased by 20%, from 96.5 million to 115.3 
        million visits annually. This represents an average increase of 
        more than 1.7 million visits per year.
         During this same period, the number of hospital 
        emergency departments decreased by 9%, from 4,176 to 3,795.
    Hospitals and Emergency Departments in this country are being 
challenged to meet the everyday demand for healthcare services. As the 
population grows and ages there will be more people requiring 
healthcare services. As the number of uninsured Americans increases, 
more and more of this care is provided without reimbursement. The 
overall effect of this increase in demand for healthcare services at 
the emergency department and hospital level is to significantly reduce, 
and in many facilities eliminate, any surge capacity for response to a 
public health emergency, whether it is a pandemic event or a mass 
casualty incident.
    Every day emergency physicians save lives across America. Emergency 
departments provide an essential community service and are the safety 
net of medical care in this country. However, emergency departments are 
at the breaking point and additional resources and long-term solutions 
must be provided before systemic failure eliminates the ability of 
emergency physicians to provide care when and where it is needed.
    There is a secondary concerning effect of the increase in the 
demand being placed on hospitals and emergency departments that is a 
reluctance to invest in preparedness activities. As the healthcare 
delivery system has become more stressed, both in terms of volume of 
services and uncertainty in levels of reimbursement, there is an 
increased reluctance to expend financial resources on preparedness 
activities, both in support of training and exercises. Although 
regulatory demands on hospitals and other healthcare facilities to 
prepare for public health emergencies continue to increase, there is no 
reimbursement for such activities from private insurers. This puts a 
greater demand on funding for preparedness activities to come from 
federal or state sources.
    Hospitals today operate utilizing just-in-time inventory management 
systems, making the delivery of healthcare more cost-effective, but 
significantly reducing the on-hand availability of additional materiel 
needed to respond to large scale public health emergencies. Again, this 
places a greater demand on funding from federal or state sources to 
meet this critical need.

Engaging and educating the largest part of the response pyramid.
    Given that it is unlikely that there will be adequate stockpiles of 
supplies and equipment for an entire pandemic event, it is imperative 
that we are able to engage the general public and encourage them to 
assume responsibility for their own preparedness. Just as the saying 
goes that ``all disasters are local'', so is the response to a 
disaster. In the truest sense for a pandemic, this means that 
preparedness must begin with individuals, families, neighborhoods, and 
communities.
    It is this last challenge that is the most difficult, and likely 
the most important in ensuring that society at large will remain intact 
during a prolonged pandemic event. As the perception of risk of a 
pandemic event wanes in the media and general public, the receptiveness 
of the public to risk communication related to preparedness also wanes.
    It is critical to the successful response to a pandemic event that 
we develop a ``culture of preparedness'' in this country, in order to 
ensure that those who have the means to prepare for themselves do so. 
If we can accomplish this through risk communication and broad-reaching 
educational programs, then the burden of response on government will be 
reduced so that scarce resources can be shifted to those who are most 
at risk.
    However, reaching and educating the base of the pyramid takes time. 
While those of us directly involved in preparedness activities can 
devote the necessary time to incorporate new information and plans 
regarding a pandemic or other public health emergency into our working 
knowledge, it is not the primary focus of the general public or other 
healthcare professionals.

Conclusion
    States and our local healthcare partners are willing participants 
in the development of systems to respond to a pandemic event or other 
public health emergency. While the resources and support of the federal 
government is essential to the creating and sustaining the capability 
and capacity required to sustain a response to a large scale ongoing 
incident like a pandemic event, the coordination of all large scale 
public health emergencies will be at the state and local level.
    It is important to understand that increased requirements to 
deliver training and undertake exercises and drills related to pandemic 
event or other public health emergencies require considerable planning 
time and utilization of resources in order to be effective. In many 
cases, these resources are being stretched very thinly, both at the 
state and healthcare facility level. As the requirements for delivery 
of more training, drills and exercises increase under federal grant 
programs it is critical that all federal preparedness grant programs 
related to pandemic influenza or other public health emergency be more 
closely aligned and coordinated so that we at the state level can more 
effectively develop an appropriate response to whatever public health 
emergency may occur.
    Mr. Chairman and members of the committee, I thank you for the 
opportunity to discuss these important issues with you this morning and 
would be happy to answer any questions at this time.

    Mr. Langevin. Thank you, Dr. Cirillo.
    With that, I want to recognize Dr. Shult to summarize his 
statement for 5 minutes.
    Welcome.

 STATEMENT OF PETER A. SHULT, DIRECTOR, COMMUNICABLE DISEASES 
        DIVISION, WISCONSIN STATE LABORATORY OF HYGIENE

    Mr. Shult. Thank you, Mr. Chairman and members of the 
subcommittee. I am here today representing the Association of 
Public Health Laboratories, of which the Wisconsin State 
Laboratory of Hygiene is a member.
    As the name implies, the APHL is the association for state 
and local governmental laboratories that perform testing of 
public health significance.
    In the event of an influenza pandemic, it is currently 
highly unlikely that a well-matched vaccine, the best 
countermeasure, will be available when a pandemic begins.
    Instead, current national plans call for the initiation of 
drastic community mitigation measures augmented with 
distribution of limited antiviral supplies to impede the 
pandemic's progress.
    This will require documentation of the emergence of a novel 
influenza virus and confirmation of sustained community 
transmission of the virus using highly specialized laboratory 
testing performed solely by a public health laboratory.
    Maintaining this capability and response readiness will be 
a challenge for the public health laboratory, given limited and 
now declining federal support and a greatly expanded role, well 
beyond diagnostic testing, in emergency preparedness and 
response.
    Public health laboratories are the leaders in laboratory 
preparedness and response efforts, key national security assets 
that serve as reference laboratories in the National Laboratory 
Response Network.
    These laboratories are capable of performing highly 
advanced, accurate tests that allow rapid detection and 
identification of biological agents of public health 
significance, including seasonal influenza strains and newly 
emergent subtypes of influenza with pandemic potential such as 
the H5N1.
    This testing capability is critical to state and national 
influenza surveillance.
    Furthermore, because of the potential introduction of a 
novel virus into the United States from international 
travelers, CDC now requires that states conduct this 
surveillance year-round.
    The public health laboratory must also work closely with 
private-sector laboratories that provide diagnostic testing to 
support patient care, with agriculture and veterinary 
laboratories responsible for monitoring influenza within animal 
populations, and with a host of other public health and 
emergency first responder partners.
    Maintaining these networks is resource-intensive and 
difficult to accomplish without adequate funding.
    The public health laboratories are heavily reliant on the 
expertise at CDC--in this case, the CDC's influenza division--
to assist in outbreak response and to develop new methods for 
detection of influenza.
    The CDC is also critical in helping facilitate 
collaboration among laboratory partners to ensure adequate 
testing surge capacity is available for pandemic response.
    DHS has created the Integrated Consortium of Laboratory 
Networks to address coordination and integration of the 
different federal level agency networks.
    However, the work of the ICLN has not yet been apparent to 
the front line public health laboratory serving an all-hazards 
mission with diminishing resources.
    Traditionally, public health laboratories have relied on 
state resources and minimal allotments from the CDC's 
epidemiology and laboratory capacity funding to support 
laboratory influenza surveillance.
    Although further supplemental funding has been appropriated 
for pandemic influenza preparedness, to date few public health 
laboratories have benefitted from these funds, despite 
increased expectations for rapid testing and year-round 
surveillance.
    Only because of funding from the CDC's public health 
emergency preparedness program has substantial laboratory 
emergency response infrastructure to respond to bioterrorism, 
pandemic influenza and other public health emergencies been 
developed. However, this funding has also begun to decline.
    In conclusion, given the critical role of the public health 
laboratory in detecting and monitoring both seasonal and novel 
potentially pandemic strains of influenza, as well as other 
potential public health threats, the substantial testing 
capabilities and capacities that have been developed and that I 
have described in my written testimony need to be sustained.
    And future improvements in diagnostic technology and 
networking activities, such as communications and information-
and data-sharing among laboratories and with response partners 
need to be made.
    Without sustained federal funding from CDC and other 
agencies, our ability to fulfill this pandemic and all-hazards 
public health and national security mission will be 
compromised.
    I ask your help in not letting this happen. Thank you very 
much, and I would be glad to answer any questions.
    [The statement of Mr. Shult follows:]

                 Prepared Statement of Dr. Peter Shult

    My name is Dr. Peter Shult and I am here today representing the 
Association of Public Health Laboratories, APHL. I am currently the 
Director of the Communicable Diseases Division of the Wisconsin State 
Laboratory of Hygiene. As its name implies, APHL is the association for 
state and local governmental laboratories that perform testing of 
public health significance.
    Public health agencies worldwide have been tasked with leading 
preparedness and response planning efforts necessary to minimize the 
impacts of seasonal influenza epidemics as well as the next pandemic. 
In the case of pandemic influenza, it is currently highly unlikely that 
a well-matched vaccine, the best countermeasure, will be available when 
a pandemic begins. In addition, sufficient supplies of influenza 
antiviral medications might not be available. Consequently, current 
national plans for pandemic response call for attempting to mitigate 
the effects of a pandemic early on by relying on strategies for case 
containment (isolation and quarantine), social distancing (school 
closures and social distancing of adults in the community and at work) 
and infection control (hand hygiene, cough etiquette). Initiation of 
these rather drastic measures will require documentation of emergence 
in the U.S. of a novel influenza A subtype and confirmation of 
sustained community transmission of the virus. This will require 
laboratory testing; the responsibility for this testing role will rest 
with the public health laboratory--state and local governmental 
laboratories tasked with supporting their public health jurisdictions 
in preparedness and response activities.

Role of the public health laboratory
    The public health laboratory is the leader in laboratory 
preparedness and response efforts. Public health laboratories, serve as 
reference labs in the Laboratory Response Network (LRN). They are a key 
national security asset, providing some of the most advanced and rapid 
testing available in the LRN. These laboratories are capable of 
performing tests to rapidly detect and identify highly dangerous 
biological agents. Public health laboratories also have established 
linkages with law enforcement, including the FBI, and utilize chain-of-
custody and testing protocols consistent with legal evidentiary 
requirements. The state public health laboratory has developed a 
culture of emergency response. There is an expectation that we follow 
incident command structure, and that we have continuity-of-operations 
plans. We coordinate with other first responders, hazardous-materials 
teams and law enforcement on a regular basis responding to unknown 
threats and suspicious packages. We're emergency responders from the 
lab perspective.
    The LRN was established to address only those agents that could be 
used for biological terrorism (BT). However, since that time, the LRN 
has been utilized to address non-terrorism agents as well, an ``all 
hazards'' philosophy. At the state level, infrastructure developed as a 
result of funding from the Centers for Disease Control and Prevention's 
(CDC) Public Health Emergency Preparedness (PHEP) Cooperative 
Agreements, like upgrading laboratory facility biosafety levels, 
purchasing state-of-the-art molecular detection equipment, and hiring 
staff with advanced diagnostics expertise, has significantly improved 
the public health laboratory's ability to respond to emerging diseases. 
In Wisconsin, we could not have weathered the SARS, monkeypox and mumps 
outbreaks of recent years without the resources provided through the 
PHEP and LRN. These resources are also helping us improve annual 
influenza surveillance using state-of-the-art methods, and prepare for 
a potential pandemic. The public health laboratory will be an integral 
part of any public health response to pandemic influenza and must be 
included in comprehensive local, state or federal plans for 
preparedness and response.
    Laboratory results are critical for influenza surveillance and for 
public health decisions during both routine ``seasonal'' influenza and 
during pandemic alerts and pandemic periods. Public health laboratories 
contribute significantly to surveillance efforts within each state and 
to national surveillance efforts as members of a network of World 
Health Organization collaborating laboratories, coordinated in the U.S. 
by the CDC. Specifically, public health laboratories provide highly 
accurate and rapid testing for confirmation and identification of 
``seasonal'' influenza strains as well as newly emergent subtypes of 
influenza such as H5N1. This testing incorporates the use of newer 
state-of-the-art methods as well as traditional methods that require 
growing the virus. Laboratory testing is the only way to attribute 
``flu-like'' illness to a specific pathogen, either influenza or one of 
the hundreds of other viral respiratory pathogens that circulate each 
year.
    In addition, during ``seasonal'' influenza, laboratory testing is 
critical to:
         determine when, where and which strains and subtypes 
        of influenza viruses are circulating;
         monitor the extent and duration of the epidemic;
         detect novel influenza subtypes such as H5N1;
         optimize the use of vaccines and antivirals including 
        monitoring for antiviral resistance
    Public health laboratories also provide virus samples to CDC for 
further characterization throughout ``seasonal'' and pandemic periods, 
and this information contributes to the selection of future vaccine 
strains. In fact, one of the viruses used to make last year's vaccine 
came from the Wisconsin State Laboratory of Hygiene.
    Because of the potential introduction of a novel virus into the 
U.S. from international travelers, CDC now requires that states conduct 
year-round surveillance. Although it has become commonplace these days 
to think of planning for a pandemic only in terms of avian flu or more 
specifically H5N1, the reality is other avian influenza viruses have 
been implicated in human disease (including avian influenza H7N7, H9N2, 
H7N2, H7N3). It is essential that current influenza surveillance 
programs provide for rapid detection of any novel strain.
    While the public health laboratory focus is on surveillance to 
support response and control measures, they must also work closely with 
private sector laboratories that provide diagnostic testing to support 
clinician diagnosis and treatment of their patients. Public health 
laboratories provide confirmatory testing for clinical laboratories, 
education to clinicians and clinical labs regarding the use and 
interpretation of rapid influenza tests, and guidance for handling and 
submission of suspect pandemic strains from clinical and physician 
office laboratories. These are resource intense activities that are 
difficult to maintain without funding.
    During the early stages and throughout a pandemic, additional goals 
for diagnostic testing at public health laboratories will include:
         detecting and confirming initial cases of pandemic 
        influenza in communities and confirming that sustained person-
        to-person transmission has occurred to initiate targeted 
        community-level interventions including containment (isolation 
        and quarantine), social distancing strategies and infection 
        control;
         differentiate patients with pandemic influenza from 
        those infected with the ``seasonal'' strain or other 
        respiratory viruses;
         monitor the pandemic's geographic and regional spread 
        through laboratory testing;
         measure the impact of interventions such as 
        vaccination, antiviral therapy, and non-pharmacologic 
        interventions; and
         monitor the pandemic strain to determine the 
        effectiveness of any vaccine (when available and the mergence 
        of antiviral resistance
    In addition to these direct response roles, we provide the 
diagnostic expertise in the development of pandemic preparedness and 
response plans and their exercise within states, and provide faculty 
and expertise to support CDC laboratory training efforts domestically 
and internationally. Public health laboratories also maintain a close 
working relationship with agricultural and veterinary diagnostic 
laboratories to monitor influenza activity within animal populations 
that may impact human populations.
    While state public health laboratories have significant expertise 
in infectious disease testing, we heavily rely on the expertise at CDC 
to assist in outbreaks, and develop new methods for detection of 
emerging pathogens that can rapidly be deployed to our laboratories. 
CDC's influenza division has developed the advanced detection tools 
currently available in public health laboratories to detect and subtype 
the influenza A virus, to monitor seasonal circulating strains and 
detect novel viruses strains. Beginning in 2003, CDC has provided 
protocols and training for state public health laboratories to perform 
real-time RT-PCR for molecular detection of Influenza A & B viruses, 
and for subtyping Influenza A H1, H3, H5 and H7 subtypes. The currently 
circulating H5N1 strains have been undergoing rapid evolution, so it is 
essential that CDC continue to carefully monitor the performance of the 
real-time RT-PCR assays currently in use in public health laboratories 
by testing H5 samples received from other countries.
    The CDC is also working with APHL and other partners on other 
critical issues related to pandemic influenza response. I have no doubt 
with the first emergence of a pandemic influenza strain--particularly 
if it happens to be H5N1--there will be a panic with consequent 
pressure on public health, including the laboratory, to respond 
immediately. How much laboratory capacity will be needed for 
surveillance and diagnostic support during the early stages of a 
perceived or real influenza pandemic affecting the U.S.? What is the 
best way for public health and private sector laboratories to 
collaborate and support any surge in testing needs? There will, no 
doubt, be a need for other surge capacities to ensure adequate 
materials and supplies for diagnostic testing and enhanced 
transportation mechanisms to move these goods and supplies as well as 
patient specimens to the laboratories.
    It is important to point out that currently there exist no 
stockpiles of critical laboratory supplies and materials analogous to 
those developed for pharmaceuticals and other critical emergency 
response supplies. This could prove to be a critical shortfall! These 
questions and issues are currently being addressed through an APHL/CDC 
clinical laboratory partner's workgroup. From a public health 
perspective, it is assumed that as the pandemic peaks, every ill 
patient will not need laboratory testing. However, the demand for 
testing from patients and doctors will rapidly outstrip testing 
capacities. These are critical issues that must be addressed pre-
pandemic. APHL is also working with CDC to develop guidance on the use 
of various diagnostic tests from the introduction of the novel strain, 
through the peak of the pandemic, and into the recovery period.

Resources to support the public health laboratory
    Traditionally public health laboratories have relied on state 
resources and the CDC's Epidemiology and Laboratory Capacity (ELC) 
funding to support laboratory influenza surveillance. In 2006, ELC 
provided $2.2 million to support epidemiology and laboratory activities 
for seasonal influenza surveillance across 50 states. Although 
supplemental funding has been appropriated for pandemic influenza 
preparedness, to date many public health laboratories have not 
benefited from these funds, despite increased expectations for rapid 
testing and year-round surveillance.
    Substantial state public health laboratory capability and capacity 
to respond to bioterrorism, pandemic influenza and other public health 
emergencies has been developed in States over the last several years 
with the help of other federal funding sources. The degree to which 
this has been accomplished is related to the distribution of this 
funding to public health laboratories which has been highly variable on 
a state-by-state basis both in terms of the type and amount of funding 
received and the period of time over which it was received.
    In general, Public Health Emergency Preparedness (PHEP) funding 
from the CDC has supported laboratories' efforts to:
         build state-of-the-art diagnostic capability and 
        capacity for rapid and accurate laboratory diagnosis of primary 
        agents of bioterrorism (BT) and other major public health 
        threats such as SARS and pandemic influenza as a Laboratory 
        Response Network Reference laboratory.
         develop state-based networks of clinical laboratories, 
        and provide them with emergency response and specimen shipping 
        guidelines and protocols, 24/7/365 state courier systems to 
        ensure rapid transport of specimens, emergency messaging and 
        electronic data sharing capabilities, training in diagnostic 
        testing to recognize and rule-out the presence of priority 
        bioterrorism agents or other agents of public health 
        importance.
         develop and support training programs for Hazardous 
        Material teams to improve coordinated response to hazardous 
        materials incidents involving ``white powders'' and other 
        unknown substances,
         to support preparedness and response planning and 
        develop emergency response protocols with other response 
        partners including state food testing and veterinary diagnostic 
        laboratories,) and Federal (CDC, FBI, USPS) response agencies.
    The outcome of these efforts in Wisconsin and other states can be 
measured in part by the significant role the public health laboratory, 
with these enhanced capabilities and capacities, and the clinical 
laboratory networks, with whom they collaborate closely, played in a 
number of recent, high profile outbreaks including SARS (2003), 
Monkeypox (2003), pertussis (2003-06), mumps (2006), norovirus (2006-
07) and the E.coli O157:H7 spinach outbreak (2006) to name but a few.
    In addition to responding to bioterrorism, pandemic influenza and 
other public health threats, public health laboratories are serving an 
all-hazards mission, providing environmental testing for bioterrorism 
and chemical terrorism agents, participating in the Food Emergency 
Response Network sponsored by FDA and USDA, and responding, sometimes 
daily, to a host of unknown threat emergencies. DHS has created the 
Integrated Consortium of Laboratory Networks to address coordination 
and integration of the networks at the Federal level. The ICLN is 
charged with assuring coordination across the networks. The work of the 
ICLN has not yet been apparent to the front-line public health 
laboratory serving an all-hazards mission with diminishing resources.
    In Wisconsin and in many other states, substantial laboratory 
emergency response capability, capacity and infrastructure has been 
developed. But this is only the beginning of addressing laboratory 
needs; what has been built needs to be sustained and this is where the 
greatest problem may lie.
    Maintenance of what has been built in terms of emergency laboratory 
response capability much less continuous future improvements in 
diagnostic technology, information and data sharing, etc. now may be in 
jeopardy.
         Despite the ongoing threat of pandemic influenza and 
        in the face of numerous infectious disease outbreaks many state 
        and local public health laboratories have suffered recent 
        substantial cuts in funding. In Wisconsin, fiscal year 2007 
        PHEP funding to the public health laboratory was cut by nearly 
        60% and this cut will be carried over to fiscal year 2008. ELC 
        funding to the Wisconsin public health laboratory also has 
        dropped substantially over the past 5 years.
         A number of state public health laboratories did not 
        receive any ELC or Pandemic Influenza Supplemental funding and 
        received substantially less PHEP funding than Wisconsin because 
        these funds were not allocated to them by their states. Further 
        cuts to these public health laboratories would be devastating.
         Costs (salaries, diagnostic equipment maintenance, 
        materials, etc.) to maintain this laboratory response 
        infrastructure are significant and, in fact, are increasing and 
        will continue to do so.
         Direct state support of these emergency laboratory 
        response efforts is variable and in many cases non-existent 
        (this is the case in Wisconsin). This forces the laboratory to 
        have to re-allocate their state funding allotment or perhaps 
        collected fees to emergency preparedness and response at the 
        expense of other laboratory activities that may still have 
        public health importance.
         The clinical laboratories, who will be on the front 
        line in response to public health emergencies such as pandemic 
        influenza and bioterrorism and with whom the state public 
        health laboratories have formed critical partnerships are now 
        highly dependent on the public health laboratory for reference 
        and confirmatory testing, training, communications and data 
        sharing, emergency response guidance, etc. And the fact is, in 
        many circumstances, the public health laboratory may not be 
        able to mount an effective laboratory response to a public 
        health emergency without their clinical lab partners.
    Federal funding must continue to sustain the laboratory capability 
and capacity necessary to effectively support the public health 
response to pandemic influenza, bioterrorism and other public health 
threats, and the expanding all-hazards mission. What will be the 
outcome if funding of these laboratory efforts continues to diminish or 
is eliminated altogether?
         Diagnostic capability and laboratory technical 
        expertise needed to respond to current and future threats 
        within the state public health laboratory, the nation's LRN 
        reference laboratories, will not be maintained.
         Adequate staffing levels of diagnostic and support 
        personnel will not be maintained. This is a particularly bad 
        outcome in terms of surge capacity needed during an influenza 
        pandemic when perhaps 30% or more of the workforce may be 
        incapacitated at various points of time during the pandemic.
         The ability to bring online the newest diagnostic 
        technologies needed for response to current and future 
        infectious disease threats will be severely diminished.
         The ability to sustain the highly effective network of 
        LRN Sentinel clinical, LRN reference public health and other 
        laboratories (food testing, veterinary), the very backbone of 
        the LRN, will be lost.
         Training of clinical laboratorians in diagnostic 
        procedure to support public health emergency response will 
        cease to be available through the public health laboratory, the 
        current major provider of such training.

Conclusion
    In conclusion, the public health laboratory likely will be a 
critical component of the trigger that initiates the pandemic response 
plan and community mitigation strategies. The ability to confirm that a 
patient is infected with a novel strain of influenza resides solely in 
public health laboratories. Public health laboratories must be prepared 
to provide crucial influenza diagnostic and surveillance services to 
quickly detect and monitor the progression of a novel virus and provide 
testing to support ongoing response decisions. Pandemic influenza 
preparedness plans depend upon the public health laboratory delivering 
effective and coordinated diagnostic services, results, and 
communication. Epidemiologic surveillance programs that monitor for 
pandemic influenza rely heavily on accurate laboratory testing and, 
therefore, must have timely information. Furthermore, in the event of 
pandemic influenza, the appropriate use of antivirals and vaccination 
can only be accomplished with public health laboratory support. Public 
health laboratories are now called upon to fulfill a pandemic and all-
hazards public health and national security mission. Without sustained 
federal funding from CDC and other agencies, our ability to respond to 
the increasing number of potential threats will be compromised.

Appendix-Influenza Primer
    Influenza is a major public health concern in the U.S. as well as 
globally. Two types of influenza, A and B, are responsible each year 
for seasonal epidemics that affect 5--20% of the population causing 
significant illness with resultant lost time from work and school 
across all ages. The highest rates of illness occur in the very young 
often resulting in severe illness and hospitalization. Young pre-school 
and school-aged children are also responsible for initial transmission 
of influenza in the community. The elderly, particularly those over the 
age of 65 also suffer high rates of hospitalization and a 
disproportionate percent (90%) of the mortality which totals over 35, 
000 each year in the U.S. This morbidity and mortality occurs despite 
the availability of effective prophylaxis (vaccine) and treatment 
(antivirals) measures
    In recent years, avian influenza, so-called ``bird flu'' also has 
become a major concern. Aquatic bird species world-wide serve as the 
natural host for all of the subtypes of type A influenza known. Usually 
these viruses cause little or no illness in their natural host. 
Occasionally, however, certain subtypes mutate and become capable of 
causing severe illness with very high mortality, particularly within 
domestic poultry populations. These novel subtypes can also become 
capable of infecting humans resulting in very severe disease with high 
mortality. This is the situation that has been unfolding in the Far and 
Middle East, countries of Africa and Europe with the emergence of the 
H5N1 subtype of influenza since 2003. Since then, this virus has been 
responsible for the direct death or slaughter of hundreds of millions 
of poultry in affected countries. In addition, 328 human cases with 200 
deaths have been documented in 12 countries. Almost all of these human 
cases, mostly children and young adults, have resulted from direct 
contact with infected poultry; there is no evidence thus far of 
sustained human-to-human transmission. Should sustained human-to human 
transmission of this or another novel subtype of influenza A occur, the 
result would likely be a worldwide epidemic, or pandemic of influenza.
    During the past century, 3 influenza pandemics occurred with the 
biggest occurring in 1918-1919. This Great Influenza Pandemic or 
Spanish Influenza Pandemic as it was called was responsible for over 
20million deaths worldwide and over 500,000 deaths in the U.S. while 
infecting an estimated 45% of the entire global population. The two 
subsequent pandemics in 1957 (``Asian influenza'') and 1968 (``Hong 
Kong influenza''), although milder in terms of morbidity and mortality, 
nevertheless had profound impacts on the global population.
    Most experts feel that another pandemic is inevitable and many feel 
that we are now overdue. With today's much greater population and 
global interconnectivity even a mild to moderate pandemic, similar to 
the last two, occurring as multiple waves over a period of two years or 
longer, would rapidly affect the world with rates of infection of up to 
50%, mortality measured in the millions (100,000s in the U.S.) and 
severe social, infrastructure and economic disruptions.

    Mr. Langevin. Thank you, Dr. Shult. I appreciate your 
testimony.
    And the chair now recognizes Dr. Caldwell to summarize his 
statement for 5 minutes.
    Welcome.

STATEMENT OF MICHAEL CALDWELL, MD, MPH, COMMISSIONER, DUTCHESS 
        COUNTY HEALTH DEPARTMENT, POUGHKEEPSIE, NEW YORK

    Dr. Caldwell. Good afternoon, Chairman Langevin, 
Representative McCaul. It is a pleasure to be here to speak to 
you on behalf of all the local departments of health in our 
country.
    I come from Dutchess County, New York, the place and the 
home of Franklin and Eleanor Roosevelt, so greetings from 
there, and please, if you do come to visit, please let me know.
    You know, Franklin Roosevelt won the presidency four times. 
Did you know that his home town of Hyde Park in the county of 
Dutchess never voted for him? Never. It was sad for Franklin.
    And I tell you, it is kind of a microcosm of what it is 
like doing public health in Dutchess County. It is a challenge. 
We have a challenge in our county and we have a challenge in 
our country.
    The combined efforts of my colleagues in local public 
health departments in first response will determine the initial 
as well as the ultimate impact of an influenza pandemic on the 
people of the United States.
    Health departments are planning, but the success of those 
plans relies on the crucial linkages that have been built 
between our local public health departments and a range of 
governmental and community partners at the local level, 
including also the state and the federal level.
    The relationships among these responders in many 
disciplines across our commissions, regardless of who their 
federal counterparts may be--they are growing more robust. They 
are better coordinated.
    And I really want to answer your question that you asked, 
very simply, are we more prepared, and the answer is, yes. 
Today I bring you a story of progress, a story of success at 
the local level, but clearly an opportunity to improve, and an 
opportunity that I think needs to be led and demonstrate the 
leadership at our federal level.
    There is no question that local emergency preparedness has 
evolved into an all-hazards approach right now. It requires 
communities to assure that all capabilities are necessary to 
respond to a wide range of emergencies.
    Our health departments do not and cannot stand alone. All 
of our planning must be integrated with all of our partners and 
first responders. And one of the great advances we have had is 
the strength and mandate of the National Incident Management 
System, the Incident Command System.
    Just this past week, I spent 3 full days in Poughkeepsie, 
New York completing the ICS-300 training with colleagues from 
emergency response--police, fire, EMS, water plant operators, 
state emergency management officials, state troopers, public 
health nurses. We really have made progress in that area.
    In Dutchess County, we have learned this new language and 
we have put it into effect.
    But more really needs to be done. We need to strengthen 
these opportunities. We need to strengthen this planning. And 
we also need to exercise and evaluate.
    It is very important to know that the greatest strength 
that we provide at the local level is the strength of our 
American workforce.
    Our astute clinicians and the partnerships that we have 
with our colleagues, our trained health care professionals, our 
alert hospitals--these effective partners are forged between 
these entities and our capable colleagues in local public 
health.
    Ultimately, the local public health departments are the 
boots on the ground element of our nation's disease system. My 
health department receives and responds to thousands of 
infectious disease reports each year.
    After September 11th, our county's hospitals and emergency 
departments began reporting on our hospital emergency response 
data system.
    We also have partnerships not only with our health care 
providers but veterinarians and pharmacists. Soon we will be 
also reaching out not only to schools and school nurses but 
colleges and businesses.
    We are actively engaged in cross training our entire 
community to be aware and be prepared.
    We are also providing and improving our community alert 
network, our reverse 911 system of communication. We think that 
is one of our major roles and something that we are working 
hard to improve.
    Ultimately, we believe that we need a strategy of 
implementation, not just planning. And the implementation 
happens at our level. We need the resources. We need the 
people. We need to exercise and evaluate. And we need to 
improve. We need sustainable and a growing commitment from the 
federal government.
    Unfortunately, we have seen mixed messages from our federal 
leadership. There does not appear to be adequate coordination 
or cooperation between the planners of Health and Human 
Services and the Department of Homeland Security.
    We have seen clear examples of us being left out of the 
development of the national response plan.
    It makes no sense to develop a plan among federal officials 
and then just tell the local officials how it is going to work 
without integrating them and involving them in the first place, 
and also including in the development of those plans the 
understanding of how it is going to be implemented and carried 
out.
    We are hopeful that the federal colleagues of ours will 
hear this message, and as we improve the future planning and 
the future versions of these plans, we will be able to get 
feedback from our testing.
    And we are going to learn nothing unless we exercise and 
test our plans and constantly revise them.
    So we are hopeful today by you having this hearing. We want 
to thank you for the recognition that we have made progress, 
that we need to do better. We need to continue our 
conversation.
    And we look to the federal government to be able to serve 
as an example to us at the local level. If we see that there is 
miscommunication and miscoordination at the federal level, that 
impacts us at the local level and makes our jobs more 
difficult.
    If my emergency response department and my health 
department have different planning tools, it makes it more 
difficult for us to integrate those tools.
    Overall, our community and families depend on us for 
leadership. They depend on us for competency, for guidance, but 
most importantly, for action. We should not and we cannot let 
them down.
    Public health preparedness is a long-term challenge, 
whether it is for pandemic influenza or any other emergency. We 
obviously cannot do everything at once, but we are making great 
strides. I am pleased with it.
    And I want you to know that local public health departments 
are integral in both the planning as well as the execution of 
any pandemic influenza efforts. Thank you very much.
    [The statement of Dr. Caldwell follows:]

           Prepared Statement of Michael D. Caldwell, MD, MPH

    Good Morning Chairman Langevin, Representative McCaul, and 
distinguished Members of the Committee. It is my pleasure to address 
you today on behalf of the nation's 2800 local public health 
departments, who work on the front lines to protect their communities 
from pandemic influenza, as well as a multitude of other public health 
threats. I am a Past President of the National Association of County 
and City Health Officials and I have had an opportunity to learn from 
my colleagues across the country. I have had the privilege of 
representing our local public health departments by participation in 
focus groups for the development of standards for Fusion Centers to 
capture, coordinate, and rapidly communicate intelligence among all 
levels of government. In my home County of Dutchess in New York, I have 
been deeply engaged in pandemic influenza preparations under the 
leadership of our County Executive William R. Steinhaus. Today, I am 
happy to report to you on the progress made by local health departments 
and their community partners. I will also point out areas of concern 
that we have identified as shortfalls in current national pandemic 
influenza preparedness.
    The combined efforts of local health departments and our colleagues 
in first response will determine the initial, as well as the ultimate 
impact of an influenza pandemic on the people of the United States. I 
will describe how local health departments are planning our response to 
a worldwide influenza outbreak, with an emphasis on how the success of 
those plans relies on the crucial linkages that have been built between 
local public health departments and a range of governmental and 
community partners. Relationships among responders in many disciplines 
and sectors across our local communities, regardless of who their 
federal counterparts may be, are growing more robust and better 
coordinated. If we are to protect our communities adequately, we have 
no choice but to reach out, engage, communicate and cooperate with our 
local partners.

    Pandemic Influenza Preparedness Must be Integrated into All-Hazards 
Preparedness
    Local emergency preparedness is based on an `all-hazards' approach. 
This approach requires communities to assure the essential capabilities 
necessary to respond to a wide range of emergencies: intentional or 
naturally occurring infectious disease outbreaks; chemical, explosive 
or radiologic accident or attack; weather-related disaster; or other 
emergency.
    Since 2001, with the elevated awareness of the country's 
vulnerability to intentional attacks with biological agents, there has 
developed a better understanding of public health's unique role in 
protecting our homeland. Whether the communicable disease threat is a 
novel influenza virus, smallpox, anthrax, West Nile Virus, SARS, or 
other emerging pathogen capable of causing widespread illness and 
death, there is a core of universal public health response capabilities 
for which all local health departments across the country are planning, 
training, exercising and engaging in a process of continuous evaluation 
and improvement.
    However, our local health departments do not and cannot stand 
alone. All planning and response is and must be integrated with other 
local entities, most notably public safety first responders, but also 
state, federal and non-governmental partners. Fundamental to such 
integration is a shared command and management framework. With its 
strong foundation in the Incident Command System (ICS), the broader 
National Incident Management System (NIMS) developed under Homeland 
Security Presidential Directive 5 provides this common underpinning for 
all public health and public safety preparedness. Adoption of NIMS is 
facilitating the integration of language, mental models and even 
certain cultural aspects of public safety by public health 
professionals.
    Just this past week, I spent three full days in Poughkeepsie, NY 
completing the ICS-300 training with colleague emergency response 
partners which included local police, fire, EMS, water-plant operators, 
state emergency management officials, state troopers, public health 
nurses and many other disciplines mandated to be trained. These 
mandates, while burdensome, provide many important benefits, including 
opportunities to meet and work with the very individuals who we will 
likely meet in the Emergency Operations Center (EOC) during a real 
emergency. I have always said that the EOC should be the last place for 
exchanging business cards of introduction with your critical partners.
    In Dutchess County, the staff of our health department have learned 
this new language and approach. They have grown accustomed to planning 
and exercising within an incident command system. We practice this in 
many ways. For instance, we use incident command for our seasonal 
influenza vaccination clinics, so that we will know exactly how to 
address a need for mass vaccination. We have worked closely with the 
local police to address traffic and safety issues in planning our 
system of PODS, or points of mass distribution sites, which we would 
need to distribute medication during a pandemic or other public health 
emergency.
    Through these opportunities to strengthen relationships, our county 
emergency management agency now understands and uses the expertise that 
our health department offers in epidemiologic surveillance, 
environmental health, and medicine. We work side-by-side on planning, 
education and evaluation. The health department is now included in 
emergency drills undertaken by other county agencies and organizations. 
This enables us to uncover and address discrepancies between the 
emergency plans of individual organizations, so that the expectations 
of every responding agency are universally understood.

Key Elements of Front Line Pandemic Influenza Preparedness

1. DISEASE SURVEILLANCE
    The purpose of a strong surveillance system is to create time in 
which to intervene and to eliminate or mitigate threats. In local 
public health, practical disease surveillance means a system by which 
clinicians in private practice or in hospital settings can detect and 
report a novel flu virus or a patient who is suspected to have a 
reportable disease or an unusual case presentation to a public health 
authority capable of receiving, interpreting and responding to such a 
report. Ultimately, the country may reach a point where electronic 
medical records and associated systems will enable automatic reporting 
of diseases or suspicious symptoms, but such capability will be 
immensely challenging in this intensely diverse and complex national 
environment. We cannot wait, nor can we depend solely on technology 
when so much is at stake.
    Our greatest strength is in our American workforce--our astute 
clinicians, our trained healthcare professionals, our alert hospitals--
and the effective partnerships that are forged between these entities 
and capable local public health departments. It is important not to 
underestimate the immediate and important utility of this model of 
disease surveillance. As we recently witnessed with the case of the 
mismanagement of the internationally traveling groom with multi-drug 
resistant tuberculosis, all electronic monitoring efforts can be 
thwarted by just one human error. All of our new multi-billion dollar 
monitoring systems must be complemented with continued vigilance, 
training, testing and evaluation of our front line agencies and their 
workers.
    Local health departments are the `boots on the ground' elements of 
our nation's disease surveillance system. My health department receives 
and responds to thousands of infectious disease reports each year. In 
preparation for pandemic influenza, we have determined that syndromic 
surveillance must accompany traditional methods of case reporting. 
Syndromic surveillance will allow prompt identification of potential 
communicable disease clusters and trigger response long before 
laboratory confirmation is received.
    After 9/11, our county hospitals' emergency departments began 
reporting individual patient's symptomatology to the state and local 
health departments via the HERDS (Hospital Emergency Response Data 
System) data base. In addition to this statewide effort, our local 
health department makes direct phone contact daily with each emergency 
room to identify clusters of illness or unusual presentations. This 
ongoing networking effort with local emergency departments and 
infection control staff has proved to be crucial in the early 
identification and response to infectious disease. We have also 
partnered with select community health care providers and veterinarians 
to function as sentinel sites for syndrome and emergent infectious 
disease identification.
    Our most recent effort for improving our surveillance capacity is 
to work with schools, particularly school nurses. We are training them 
in the basic principles of epidemiology and disease surveillance and 
asking them to report absences due to sickness to us more frequently. 
It is our intention to expand these syndromic surveillance efforts to 
local colleges and major businesses soon. We are actively engaged in 
cross-training the majority of environmental sanitarians and public 
health nurses in the basics of outbreak response so they can assist in 
case investigation, contact tracing and outbreak control efforts should 
a large scale event occur.

2. COMMUNITY AWARENESS & SELF-SUFFICIENCY
    One thing that we understand about a pandemic is that there will 
never be enough hospital beds to take care of the sick. We can predict 
that we will be asking both the sick and the well to stay home to help 
stem the spread of pandemic influenza. But we also know that our 
community needs early education, rapid communication and preparation so 
they will understand this if a serious epidemic occurs. Therefore, in 
Dutchess County we are placing a great emphasis on community education 
and have reached out to the schools, the business community, law 
enforcement, emergency services and home care agencies. Reaching every 
Dutchess resident in a meaningful fashion is a huge task. We can't do 
it all at once, but we work at it consistently because we believe that 
community understanding and cooperation will be absolutely essential in 
reducing the toll of a pandemic.
    Our county's home care agencies are developing a unified emergency 
preparedness home care plan. This will enable our residents to know 
that there will be people available to deliver some medical and nursing 
care in their homes if they get sick.
    There is a tremendous desire for information regarding pandemic 
influenza across all sectors and a there is a great deal of work ahead 
for local health departments in spreading the word. This effort will be 
worth the return if we can reduce panic and increase creative response 
options when the need arises, which it will.

3. COMMUNITY INFECTION CONTROL
    Over the past several years, the legal foundation required for 
public health to adequately protect the public in a catastrophic health 
emergency has been significantly strengthened in many states. Both 
state and local health departments have closely examined our respective 
responsibilities to isolate and/or quarantine persons, to control 
private property, or otherwise to intervene in private activities. All 
these would be unprecedented actions, requiring enormous pre-planning.
    Our health department has worked with the County Attorney's office 
to educate legal, law enforcement, and emergency medical professionals 
about isolation and quarantine. We also conducted a ``tabletop'' 
exercise to test our knowledge and we will be continuing to follow-up 
on these efforts.

4. MASS DISTRIBUTION OF VACCINES AND MEDICATIONS
    Timely development of an effective vaccine, in sufficient quantity 
to immunize the population against a novel virus, is a huge challenge 
that the Federal government has taken important steps to confront. 
Local health departments are responsible on the ground for accepting 
delivery of the Strategic National Stockpile in which such a vaccine or 
anti-viral medications would be stored. Mindful that we do not now have 
the ability to manufacture sufficient quantities of such 
countermeasures, we must still have in place all of the planning, 
staffing and public information systems necessary to promptly 
distribute them to all priority populations in the county.
    While we've not experienced a pandemic flu, local health 
departments have had parallel experiences and exercises that have 
tested our ability to provide mass vaccine and medication distribution. 
During the 2004 seasonal flu vaccine shortage, with delayed shipments 
causing the public to become extremely anxious to get their flu shots, 
our department gave 5800 doses in two days to our most vulnerable 
populations. (Dutchess County has a population of 300,000.)
    Yet again, we could not have managed this mobilization without the 
full support of our public safety partners, who provided security, 
traffic control and emergency medical care. These are no minor feats in 
a mass setting, especially in a real life situation where emotions are 
running high and the chance of panic is never far away. The public 
already has benefited greatly from the collaboration between public 
health and public safety agencies. Only through a highly coordinated 
and very broad approach will we achieve maximum homeland security in 
the face of an influenza pandemic.
    Another example of the ongoing efforts to enhance inclusiveness and 
communications between agencies is that I was invited and am now a 
member of our Dutchess County Chiefs of Police Association. When I 
entered public health school and when I began my position as 
Commissioner of Health back in 1994, I could not have imagined being a 
member of the Chiefs of Police Association. Times have changed and so 
have our thinking and response to new and emerging threats.

People are Key to Preparedness
    Prior to 9/11, many local health departments were open only during 
conventional business hours. Unlike fire or police departments, there 
was no tradition, structure, or funding for operating 24/7. That has 
changed. Now we all have 24/7 coverage and an ability to call out our 
staff regardless of the hour. But we do it mostly by increasing 
expectations for existing staff. In Dutchess County, we have 
established two new positions for public health preparedness. We have 
no large cadre of new staff. However, our entire health department 
staff, from the clerical staff to the Commissioner, have received and 
will continue to receive training in the ICS system.
    One characteristic of all the operational capacities needed for 
effective pandemic influenza planning I have described above is that 
they are labor-intensive. While we do need to make certain capital 
purchases in public health, such as communication equipment and 
personal protective gear, the bulk of our costs are for people. It is 
people who do the collaborative planning in the county and work closely 
with their state counterparts. It is people who learn new skills for 
their new roles in preparedness. It is people who educate the 
community. It is people who reach out to hospitals, businesses, 
schools, and all the non-governmental organizations whose help we need 
to prepare our communities for a pandemic.
    The structure and funding of the nation's pandemic influenza 
preparedness efforts simply do not recognize this reality. A NACCHO 
survey showed that the average grant received by local health 
departments nationally for all-hazards preparedness declined by 20% 
from fiscal year 2005 to fiscal year 2006. Supplemental federal funds 
for state and local health department work specifically in pandemic 
influenza preparedness will terminate in August 2008. We are deeply 
worried that, as federal priorities change, our ability to sustain the 
workforce that must continue the complex job of preparedness will 
diminish. Our local funding for all-hazards public health preparedness 
has been eroding steadily.

Federal Leadership
    It is a positive step that so many in this country are paying 
attention to pandemic influenza before we find that threat a reality. 
We often tend to focus on the last event, but in this case the focus 
has been on being proactive--a fact which is evidenced by the very 
existence of this hearing. Your leadership on this issue is 
appreciated.
    However, there doesn't always appear to be cooperation and 
coordination between preparedness planners at the Federal level and 
those working at the local and state levels. In addition, the 
Department of Homeland Security (DHS) has made progress in 
understanding and integrating public health in fits and starts. Initial 
efforts toward fulfilling HSPD-8 showed limited understanding of what 
public health even was and how it would mount a response in an 
incident. As I described above, pandemic influenza response will 
require much more than medical care and hospital beds.
    NACCHO has long been concerned that DHS planners, unlike their 
state and local counterparts, have little appreciation for the local 
public health role in pandemic influenza response and for the kinds of 
local operational realities I have described above. The vast assortment 
of DHS committees and task forces have only a smattering of public 
health representation and the opportunities for meaningful input have 
been scant. We respectfully suggest that, while including 
representation from the Department of Health and Human Services in DHS 
work is important, it is not an effective substitute for gaining the 
input of public health departments who are doing the operational 
planning every day.
    For example, we share the frustration of many local and state 
officials about their lack of representation in the revision process 
for the National Response Plan (NRP), which will govern response to 
pandemic influenza, as well as all other national emergencies. DHS 
tasked 12 workgroups to focus on specific issue areas of the NRP. One 
of these workgroups focused on 'State and Local Roles and 
Responsibilities,'' but had only six state government representatives 
and no local government representatives, compared to a group of 
approximately 40 federal representatives. None of the state 
representatives were public health officials. If DHS intends the new 
National Response Framework to address pandemic influenza effectively, 
local and state governmental public health experts should be engaged at 
the beginning, not during a comment period at the very end.
    The input of local responders in public health and every other 
discipline of public safety must be brought to bear on DHS plans and 
guidance in a manner that enables serious listening and timely input. 
That is the only way to bridge the federal gulf between traditional 
emergency response and public health emergency response. At the local 
level, we believe that public health and its public safety partners 
understand the true meaning of ``all-hazards'' preparedness, as well as 
the special place that pandemic influenza planning has within that 
context. We strongly urge improvements in this regard at the federal 
level.
    Federal agencies need to collaborate in sending coordinated and 
reinforcing messages to all grantees at state and local levels that 
multidisciplinary cooperation is a high priority. Through the structure 
of grant programs and the guidance provided, DHS and HHS can either 
facilitate local efforts in that regard or hinder them with 
inconsistent guidance. HHS guidance for public health emergency 
preparedness has been incorporating many dimensions of the NRP, such as 
required training in the National Incident Management System. In 
general, however, federal agencies are developing and disseminating 
uncoordinated, fragmented, and dissimilar plans for addressing pandemic 
influenza.
    Finally, while much time is spent asking local and state emergency 
personnel to understand how the national response plan is structured, 
we need to remember that no matter how serious the emergency, the 
response always begins locally. And in the case of pandemic influenza, 
the effectiveness of that early response will determine how the 
emergency unfolds. Standardization is important to the extent that it 
can be realized, but national plans also must support a response in 
every corner of this diverse country. A top-down, one-size-fits-all 
approach simply will not be successful.
    Whether pandemic influenza or some other disaster afflicts our 
nation, there is no shortage of dedicated Americans at every level of 
government working hard on homeland security. Continuing to promote, 
support, and build local partnerships among public health, health care, 
public safety, emergency management, and a host of private sector 
partners will only improve our ability to protect the health and safety 
of our communities.
    Thank you, on behalf of all the nation's local health departments, 
for your concern and leadership.

    Mr. Langevin. Thank you, Dr. Caldwell.
    Before I go to Dr. Lakey, there is a vote on right now. My 
intention is to go to Dr. Lakey for your statement and then we 
will recess for about 20 minutes, come back for a very brief 
round of questions and then conclude.
    With that, I recognize Dr. Lakey for the purpose of 
summarizing his statement for 5 minutes.

STATEMENT OF DAVID LAKEY, MD, COMMISSIONER, TEXAS DEPARTMENT OF 
STATE HEALTH SERVICES, CENTER FOR CONSUMER AND EXTERNAL AFFAIRS

    Dr. Lakey. Good morning, Chairman and members. My name is 
David Lakey, and I am the commissioner of the Texas Department 
of State Health Services.
    And I want to thank you for this opportunity to testify on 
the progress and the challenges we face in Texas preparing for 
pandemic influenza.
    In order to understand these, you have to understand 
something about the Texas structure. The governor's department 
or division of emergency directs overall disaster response in 
the state of Texas.
    Department of State Health Services, however, is the 
primary agency for coordinating health and medical preparedness 
and for coordination of pandemic flu prevention, detection, 
response and recovery.
    We have significant experience in Texas in disaster 
response. However, pandemic influenza response is unique, as 
has been outlined here earlier today.
    There are issues related to the geographical spread. There 
are issues related to the length and duration of the pandemic. 
And thus, pandemic influenza is not just a medical issue. It is 
a societal issue as we respond.
    One of the strategies in public health to respond--one of 
the cornerstones is called social distancing, basically keeping 
individuals apart so they do not spread the disease one to 
another.
    And this includes closing schools, canceling public events, 
working from home--and these are hard decisions. These 
decisions are made locally, and we have to work as a state with 
our local partners to make sure that there is continuity in how 
these decisions are made.
    We also have to address worker safety issues to make sure 
that the first responders are safe when they respond to 
individuals with influenza, so they do not become the next 
victims.
    We also are struggling with how do we continue our 
operations to make sure we have continuity of operation plans. 
In a situation where you have 30 percent or 40 percent of 
workers absent, how do we continue to keep government 
functional, businesses functional, utilities that are being 
provided?
    We also have to look at hospital surge capacity, especially 
intensive care surge capacity. This will be a major stress on 
the hospital system and the medical system during a pandemic.
    Thus, with that background, we have been working for 
several years now on how do we respond as a state to this 
threat. And we have done this in collaboration with many 
stakeholders, our local partners, our federal partners, so that 
we can develop comprehensive plans in the state of Texas for 
disaster response.
    This is a part of the overall state disaster preparedness 
plan, and we have also developed a more comprehensive 122-page 
guideline for pandemic influenza that outlines what we 
specifically need to do in each stage of the pandemic.
    We have worked to make sure that we can allocate and 
distribute the antivirals if they are available. We have worked 
to make sure that we can vaccinate individuals very rapidly, as 
was discussed earlier today.
    And we have made sure that we have set up a statewide 
laboratory diagnostic system, part of the Laboratory Response 
Network that was discussed just a minute ago, so that we can 
rapidly diagnose individuals with influenza in a matter of 
about 3 hours after the samples are sent to the system of 10 
labs across the state of Texas.
    We have also provided guidelines to the local health 
departments so that it is an integrated response in Texas and 
have developed information tool kits for health care providers 
and community leaders.
    A couple other projects we have been working on this summer 
have been the development, working with the CDC, to look at our 
laws in the state of Texas to make sure we do have the right 
legal infrastructure during a pandemic.
    And we have been working with state agencies across Texas 
to make sure that there are continuity of operation plans in 
all agencies in state government and that there is some 
consistency in H.R. policies throughout state government when a 
pandemic occurs.
    We believe that there are really three critical components 
of a strong response to pandemic influenza. First, we need to 
build and maintain a strong public health system. This is 
locally, at the state and at the federal level.
    We need to create partnerships between the federal, state 
and local level and international partners and private partners 
in this response.
    And we need to recognize that there are differences between 
local areas and maintain the flexibility that allows states and 
localities to act effectively and efficiently during this 
threat.
    It can't be overemphasized, the importance of a strong 
public health system. Texas' success has been due to building 
on the public health system and using an all-hazards approach 
for all types of threats, so we can identify them, monitor 
them, ensure that we can respond effectively, and that we 
communicate with our public and our private partners during 
this time period.
    A couple of examples of the strengths that have occurred in 
Texas include the development of our Strategic National 
Stockpile Operations Plan. That has been reviewed by the CDC 
and it received a very high score this last month.
    Our plans have had favorable recognition by the CDC. We 
learned during Katrina and Rita the need for a multiagency 
coordinating center during any type of disaster where we bring 
the individuals that need to take care of the logistic 
components of ICS, Incident Command System, together, all 
incident command systems, so we can have a coordinated 
response.
    We have established a surveillance system for all viruses, 
respiratory viruses, so we can identify them early. And we have 
been coordinating with our CDC partners and other partners at 
the border ports of entry and at major airports.
    And finally, we have developed a public health information 
network so we can disseminate information quickly to our 
partners throughout the state of Texas.
    And again, it is important to have a very strong public 
health response. It is also important to have federal, state 
and local partnerships. This is not something that the state 
can do on its own. And this has to be coordinated through all 
these different partners.
    This needs to be sustained. There has to be sustained 
commitment and consistent direction from the federal level in 
order to ensure that these programs that have been developed 
continue.
    This is an ongoing threat, and in order for us to be 
successful, we have to have integration across all levels of 
government and coordination across jurisdictional lines.
    We understand the need for partnerships in Texas. We have 
very large cities. Four of the 20 largest cities in the nation 
are in Texas, and we need to coordinate from the state level 
with these cities.
    We have sea and airports that are among the busiest in the 
country. We need to partner with them as part of this disaster 
preparedness.
    And over half the U.S.-Mexico border is in our state, and 
over a million individuals cross the border legally every day, 
and thus we need to work in partnership with our Mexican 
colleagues.
    We also believe that there is an importance for flexibility 
in the overall response, that there is flexibility in preparing 
and responding to a pandemic and that different localities have 
different challenges that need to be addressed.
    We need to have flexibility in the use of human, financial 
and medical resources.
    Texas is a local-controlled state, and so many of the 
decisions for pandemic influenza will be made at the local 
level, and they need to have the flexibility to be able to 
respond appropriately.
    Ninety-five percent of all the funds that come to Texas go 
to the local health departments to ensure their ability to 
respond.
    In summary, as I said, there are three priorities that I 
think are critical. One is to have a strong public health 
system.
    The second is to have consistent partnerships between the 
local, state, federal and international partners.
    And third, we need to have flexibility, and it is 
essential, in order for the state to respond appropriately.
    Federal funds allow Texas to build an emergency response 
infrastructure to enhance our overall preparedness, and it 
needs to be sustained in order for these programs to continue.
    And we appreciate the investment from the federal level and 
look forward to a sustained partnership. And I appreciate your 
time today.
    [The statement of Dr. Lakey follows:]

                 Prepared Statement of Dr. David Lakey

    Opening
    Good morning Mr. Chairman and members of the Subcommittee. Thank 
you for the opportunity to testify on the Texas perspective on planning 
for Pandemic Influenza.
    My name is Dr. David Lakey and I am the Commissioner for the Texas 
Department of State Health Services, known as DSHS, which is the 
primary state agency responsible for coordination of pandemic influenza 
prevention, detection, response and recovery. I became Commissioner on 
January 2, 2007. Prior to that, I served as an associate professor of 
medicine, chief of the Division of Clinical Infectious Disease and 
medical director of the Center for Pulmonary and Infectious Disease 
Control at the University of Texas Health Center in Tyler. At the UT 
Center for Biosecurity and Public Health Preparedness, I was the 
associate director for infectious disease and biosecurity. In addition, 
I chaired a bioterrorism preparedness committee for 34 hospitals in 
East Texas and led development of the Public Health Laboratory of East 
Texas in 2002.
    As the state's public health authority, it is our mission to 
promote optimal health for individuals and communities while providing 
effective health, mental health and substance abuse services to Texans. 
Some of these activities range from ensuring essential public health 
services, such as immunizations to children, tuberculosis prevention 
and treatment, and food safety regulation to health care safety net 
services for our neediest Texans, like low income women with breast and 
cervical cancer or treatment for individuals with mental health 
illness. Our department also regulates health care facilities and many 
health care professions.

Integrating Pandemic Influenza Response into All-Hazards Approach
    Today, I am here to discuss the major successes and unique 
challenges that Texas has experienced in preparing for Pandemic 
Influenza. Texas faces many different emergency situations, ranging 
from hurricanes, floods, and tornados to infectious disease outbreaks, 
such as measles. That is why Texas has taken an all-hazards approach by 
integrating pandemic influenza preparedness and planning into our 
health and medical response plans. By taking an all-hazards approach, 
DSHS is building an emergency preparedness infrastructure that can 
quickly respond to natural, infectious disease and manmade disasters. 
In a large state like Texas, with very large and small communities, 
this approach requires working closely with local jurisdictions, health 
departments and responders. Although influenza pandemics have unique 
characteristics, response preparations still need to be part of an all-
hazards plan. After a pandemic outbreak begins, it is too late to 
prepare.
    First let me outline for you the emergency response structure in 
Texas and DSHS' primary responsibilities for health and medical 
preparedness and response.

    Public Health and Medical Emergency Support
    The Governor's Division of Emergency Management directs the state's 
role in disaster response: to maintain overall situational awareness 
and support community response, to provide guidance to local 
jurisdictions, and to coordinate securing and deploying federal and 
other resources when state and local assets are insufficient to meet 
the need. DSHS serves as the primary agency for public health and 
medical services. Our agency is responsible for coordinating health and 
medical preparedness and response activities according to the National 
Response Plan that addresses not only public health and medical 
services, but also nuclear and/or radiological incidents.

Texas Pandemic Influenza Plan Operating Guidelines
    Influenza is always on the watch list, and Texas preparations have 
been ongoing to get ready for pandemic influenza. In Texas, influenza 
surveillance activities continue to expand--from identifying Texas 
illnesses to monitoring global events. Texas began developing its 
current Pandemic Influenza Plan in 2002. The Texas plan, which 
complements the revised World Health Organization plan and the U.S. 
plan, includes:
         Guidance to local health departments for working with 
        their community leaders;
         Considerations surrounding allocation and distribution 
        of vaccines and antivirals;
         Updated designs for mass vaccination clinics based on 
        real-time, full-scale exercises;
         Development of information toolkits for health care 
        providers and community leaders.
    The plan was developed working in concert with our partners at the 
local, state and federal levels, including the private sector.

DSHS Responsibilities During an Influenza Pandemic
    In Texas, DSHS is the primary state agency responsible for 
coordination of pandemic flu prevention, detection, response, and 
recovery, working under the overall framework of the state's emergency 
management system led by our Governor's Division of Emergency 
Management. These roles include:
         Developing and maintaining a statewide pandemic flu 
        response plan to provide guidance in preventing, preparing for, 
        identifying and responding to pandemic flu that affects the 
        state;
         Developing and maintaining a statewide pandemic flu 
        surveillance system to detect circulating flu strains;
         Sustaining Texas' ability to rapidly isolate and 
        subtype flu virus;
         Coordinating and supporting training and awareness 
        campaigns for the public related to identifying, preventing and 
        controlling spread of pandemic flu;
         Ensuring timely dissemination of pandemic flu vaccine 
        when it becomes available;
         Organizing attempts to stop, slow, or otherwise limit 
        the spread of pandemic flu by providing guidance to local 
        health departments on activating official response teams, 
        enhancing disease surveillance, collecting specimens and 
        starting interventions;
         Managing and supporting efforts to ensure timely 
        dissemination of Strategic National Stockpile (SNS) resources, 
        including other pharmaceuticals and medical supplies;
         Directing provision of disaster mental health to first 
        responders and those affected.

Recent Successes in Pandemic Preparation
    Texas and the Department of State Health Services have achieved 
some notable successes in our efforts to conduct preparedness and 
response planning for pandemic influenza.

    Strategic National Stockpile (SNS) Technical Assistance Review
    Just last week, CDC conducted a technical assistance review of our 
state plans for the implementation of the Strategic National Stockpile 
(SNS) plan. While Texas' score is not official, DSHS has been told that 
it will receive a state level score in the high 90's out of a possible 
100. This comprehensive review looked at Texas' readiness and ability 
to put into action its SNS operations.

CDC Review of Texas Pandemic Influenza Operational Plan
    Another recent success was the recognition from the Centers for 
Disease Control and Prevention (CDC) which provided a review of the six 
priority areas of the Texas pandemic influenza operational plan. These 
six priority areas include:
         Antiviral Allocation, Distribution and Storage;
         Communications;
         Surveillance/Laboratory;
         Continuity of Operations;
         Mass Vaccination, and
         Community Containment/Mitigation.
    Of these six priority areas, two in particular, Communications and 
the Antiviral Allocation, Distribution, and Storage Plans were 
identified as best practices in these areas of preparedness. The DSHS 
Pandemic Influenza Communication Plan was lauded as being in--depth, 
detailed and reflected exemplary effort in its development. While the 
DSHS Anti--Viral Distribution Plan was cited for being well--thought 
out plans with elements that were exercised and proven to be effective.

Multi-Agency Coordinating Center (MACC)
    Another success grew out of the integration of an all-hazards 
approach to health and medical emergency preparedness. The back-to-back 
impacts of Hurricanes Katrina and Rita tested the capabilities of DSHS, 
with federal, state and local partners, to respond to physical and 
mental health needs resulting from these natural catastrophes. These 
events led Texas to create the Multi-Agency Coordinating Center (MACC), 
which provides a state health and medical response across Texas' health 
and human services agencies during emergencies including pandemic 
influenza. The MACC has allowed DSHS to better coordinate with state 
and local partners, in both the public and private sectors, to 
strengthen the state's public health infrastructure in responding to 
health and medical emergencies. A state-level pandemic exercise was 
conducted in mid-August 2007. Lessons learned from that activity and 
real-life activations were incorporated into MACC emergency operation 
procedures. After action reports relating to the past hurricanes and 
recent flooding responses have also led to continued improvement of 
systems which enhance pandemic preparedness in Texas.

Increased Surveillance Activities
    To enhance disease surveillance activities for pandemic influenza, 
DSHS has instituted procedures and policies for the surveillance and 
evaluation of cases of Influenza-like Illness (ILI), including a 
registered sentinel network of primary care providers. This includes 
working closely with the DSHS Public Health Laboratory to identify both 
influenza and other respiratory viruses. In addition, DSHS has an 
ongoing collaborative relationship with the CDC Division of Global 
Migration and Quarantine, both with training exercises as well as true 
public health events of concern regarding the potential introduction of 
communicable infectious agents, including H5N1 avian influenza and 
tuberculosis. These activities are closely coordinated with CDC and 
other partners involved with ports of entry and departure, both along 
the Texas--Mexico border and other International Ports of Entry at 
major airports. These measures include strengthening surveillance, 
laboratory, and hospital response capacity and improving statewide 
communication about public health and medical threats through the 
Public Health Information Network (PHIN). The PHIN is an electronic 
system for quick distribution of specific health and medical 
information to local health departments, community leaders and medical 
providers throughout the state. In addition, the PHIN provides video 
conferencing and distance learning capabilities, along with a mechanism 
for ensuring the security of health data that is transferred from those 
members of the network to DSHS.

Laboratory Response Network
    Over the past 5 years, Texas has worked to develop a Laboratory 
Response Network (LRN) across the state. Currently, our state has 
established 10 high level containment LRN laboratories that can rapidly 
diagnose infections of significant public health concern. Of these 
labs, eight can now also diagnose H5N1 avian influenza in about three 
hours after a sample is submitted to them. This type of infrastructure 
facilitates a rapid public health response throughout the state and is 
a critical component in the early identification of a pandemic 
influenza outbreak.

Some Remaining Challenges in Pandemic Preparation
Size of Texas and its International Border with Mexico
    One of the biggest challenges in preparing for pandemic influenza 
in Texas is reaching all our residents quickly. The size and diversity 
of Texas results in a wide variety of needs and requires a large number 
of resources to meet those needs. It is further from El Paso to Houston 
than it is from El Paso to San Diego, California. Texas has four of the 
nation's largest cities by population and also some of the most rural 
and sparsely populated areas in the country. In addition, over half of 
the U.S.--Mexico International Border is in a part of Texas that covers 
32 different counties and four separate Mexican states. Communications 
between all these different public health agencies is essential. When 
you consider that over a million legal crossings take place each day 
along this border, it is a test of theTexas public health system to 
work in a binational effort with Mexico to identify and prevent the 
potential for pandemic influenza. Other factors that complicate the 
disease surveillance activities along the Texas--Mexico border is that 
cross-border trade more than tripled since 1993, along with rapid 
population growth on both sides of the border. Added to the challenges 
represented by the Texas--Mexico border are other points of entry such 
as sea ports and international airports. Strong public health systems 
along the Texas--Mexico border and at other designated U.S. points of 
entry serve not only our state but the entire nation to minimize any 
potential for spreading pandemic influenza in the United States.

Texas: A Local Control State
    Texas is a local control state, and many final decisions about 
pandemic influenza will be made at the local government level. The DSHS 
plan was developed with local input to provide a simple, flexible 
process adaptable for state, regional, and local jurisdictional use. In 
those areas of the state where there is no local health department, the 
DSHS regional offices serve as the local health authorities. The goal 
has been to ensure that Texas continues to build and enhance processes 
to provide public health planning and response capacity at all levels 
in all communities. To build local preparedness capacity, DSHS began 
contracting with local health departments (LHDs) in 2002. DSHS has 
directed 95% of federal funds to preparedness activities at the local 
level including direct contracts with local health departments. 
Separate funding is provided to local governments through two CDC 
sponsored special initiatives, Cities Readiness Initiative (CRI) and 
Early Warning Infectious Disease Surveillance (EWIDS).
    To be successful locally, it is essential to allow more flexibility 
for differences in responding to local needs. Maintaining essential 
public services is a big concern. Hospitals could be inundated; medical 
staff could be in short supply; police forces may face citizen 
discontent and other security issues; and keeping citizens supplied 
with food, clean water, and other basic essentials could become a 
serious challenge, especially if workers themselves are sick or home 
caring for loved ones.

Restrictions on Use of Federally-subsidized Antiviral Medications
    Antiviral medications can be effective in preventing and treating 
influenza viruses in a pandemic, especially in reducing the duration of 
symptoms and some influenza complications. Their use forms one part of 
a comprehensive approach taken by DSHS to containing pandemic 
influenza. This approach begins with a strong seasonal flu program to 
increase vaccination rates, improve surveillance, provide education, 
and develop best practices for treatment. Planning for antiviral use 
includes identifying target groups to receive these drugs, allocating 
and delivering antiviral drugs, communicating critical information, and 
monitoring the effects of antiviral drugs. The priority groups to get 
any available influenza vaccine or limited antivirals during an 
influenza pandemic may be different from the groups identified for 
influenza shots during a typical influenza season.
    Texas had the opportunity to purchase the antiviral medications 
Tamiflu' and Relenza' at a deep discount, based 
on a low federal contract price. The Texas Legislature appropriated $10 
million in general revenue funds in 2007 to purchase additional 
antivirals for the state supply under the federal contract. This will 
purchase about 675,000 courses. About 1.5 million courses remain 
available to Texas for purchase at the federally subsidized price. This 
remaining amount has been offered to eligible local entities to 
purchase at the federally subsidized price.
    However, there are important drawbacks to purchasing antivirals for 
stockpiling under this special federal contracting price. There are 
national policies that prohibit using medications bought on the federal 
contract for anything but a pandemic declared by the CDC and thus we 
are not allowed to rotate through the stockpile. Furthermore, since 
these antiviral medications have a limited shelf life of about five 
years, our inability to use antivirals purchased under the federal 
contract for seasonal flu or other illnesses when the fifth year draws 
close impacts our state's investment in these medications. Other 
factors include the uncertainty as to whether currently available 
antivirals will be effective against an emerging, unknown pandemic flu 
virus. Better and/or less expensive antiviral medications may become 
available between now and the start of a pandemic. These unknowns and 
limitations create a challenge in making the case that the purchase of 
antiviral medications is a good investment.

A Pandemic is Unique
    There are differences in health and medical responses required for 
a hurricane versus a pandemic influenza outbreak. A pandemic is unique 
in that this is a societal issue, and not just a medical issue. The 
state and local communities will have to adjust by modifying their 
normal medical and non-medical responses, such as employing social 
distancing measures like school and public closures and sheltering in 
place to counter spread of pandemic influenza. A number of other 
factors exist making a pandemic influenza response unique. That is why 
we believe that a multi-faceted, comprehensive approach will better 
prepare Texas for containing pandemic influenza.
    One challenge is preparing for many different response scenarios, 
including the inavailability of vaccines and antivirals. People will 
likely need to change their behaviors to reduce illness and death. In 
the absence of an effective vaccine, ``social distancing'' will be a 
key tool in slowing the transmission of a pandemic influenza. ``Social 
distancing'' is a term which encompasses such things as school 
closures, cancellation of public events, working from home, minimizing 
travel on public transportation, and a range of other steps to 
essentially keep people away from each other to mitigate spread of the 
disease. The detailed decisions on such restrictive measures must be 
made locally. The need for social distancing will take on a greater 
importance as schools may need to close and activities such as shopping 
or large-group activities may have to be limited. Local communities 
might have to figure out how to maintain these restrictive measures for 
an extended period.
    Texas is one of 18 states taking part in Social Distancing Public 
Health Law Project sponsored by the Association of State and 
Territorial Health Officials (ASTHO) in collaboration with the Centers 
for Disease Control and Prevention Public Health Policy Center (CDC). 
The project's goal is to assist states in assessing their legal 
preparedness to implement social distancing measures for both declared 
and undeclared public health emergencies. A careful review social 
distancing laws as they currently exist in Texas has already been done. 
We are working with state elected officials, other state agencies, 
along with private and other public partners to identify gaps, 
omissions, and potential conflicts between laws and if statutory 
changes are needed.
    Worker safety is another issue that must be addressed. In 
responding to a pandemic influenza outbreak, the very workers that are 
responsible for helping to control the outbreak and care for the ill 
become at risk of being infected. More than that, workers who keep 
essential services such as food and water in supply are susceptible. 
For that reason, the federal government and states have purchased 
antivirals as one tool to help protect first responders, health care 
personnel and those essential infrastructure workers. Education of 
infection control practitioners is also critical to assessing potential 
exposure situations and preventing the spread of the disease in the 
healthcare setting to other employees and patients. Other worker safety 
supplies, such as masks, are important for response efforts, but are 
not something that we would normally stockpile for a typical disaster 
response.
    In pandemic preparations, we must plan for a scenario where 30 to 
40 % of the workforce is absent. A key effort will be continuity of 
operations planning. Planning for scenarios where such a large number 
of the workforce is not present represents a challenge for government 
and also for the private sector. DSHS has been involved in this effort 
on many fronts, including putting together a business summit and by 
working with other state agencies to coordinate the human resources 
policies of Texas state agencies in the event of a pandemic. More work 
is needed in this area to help educate our businesses and communities 
of the potential impact of a pandemic and strategies that will help 
mitigate its impact.
    A final factor relating to the uniqueness of pandemic influenza 
response is the difficulty hospitals will have due to their limited 
surge capacity, especially in the area of intensive care. Because the 
pandemic occurs in waves and affects such a broad cross-section of our 
population, we can anticipate that even a mild pandemic would be a 
major stress on the medical/hospital system. Hospitals are a critical 
component of the response system in a pandemic flu outbreak and direct 
discussions with hospital organizations and their members is necessary 
to determine how this type of surge will impact the operations of 
hospitals.

Closing
    Despite the complexity and challenges that come with pandemic 
influenza preparedness planning, DSHS is always working to enhance the 
public health infrastructure across the state. That includes continued 
efforts to coordinate assessment and planning with not only our local 
partners, both public and private, but other neighboring states and 
Mexican Border States for prevention and containment of illnesses. The 
goal has been to ensure that Texas continues to build and enhance 
processes to provide public health response capacity at all levels in 
all communities. CDC Public Health Preparedness (PHP) funding over the 
last five years has allowed Texas to build an emergency response 
infrastructure in those areas where it did not previously exist and to 
enhance PHP programs in the larger metropolitan areas. As Texas' Public 
Health Preparedness and Response efforts have evolved, particularly 
with the threat of pandemic influenza, focus has shifted from building 
infrastructure to building response capacity in support of a program 
that has grown in sophistication and complexity. It is my hope that the 
federal government will give states the flexibility to be able to make 
the necessary adjustments to meet the diverse needs of its population 
and the continued support to build and maintain the capacity to protect 
our state and nation from an influenza pandemic.
    Thank you for this opportunity to address you on a subject of great 
public health importance.

    Mr. Langevin. Very good. Thank you, Dr. Lakey.
    With that, as I said, it is my intention to recess for 
about 15 minutes or 20 minutes. We have two votes. We will come 
back for a very brief round of questions.
    Dr. Lakey. Thank you.
    Mr. Langevin. Thank you very much.
    The committee stands in recess.
    [Recess.]
    Mr. Langevin. We appreciate the panel sticking around for a 
few more minutes, and we will get right to the questions. I 
will begin with Dr. Cirillo.
    In your opinion, are hospitals and major medical centers 
getting enough federal funding and guidance to prepare for an 
influenza pandemic?
    And how do you propose getting all of the funding resources 
and guidance that you feel are necessary down to primary care 
providers?
    Dr. Cirillo. I will be honest with you, Congressman, that 
there has not been enough money, and the amount of money that 
it would take to say that we are fully prepared, if we could 
ever say that, is very significant.
    We did calculations in Rhode Island for a year-long 
pandemic in order to try and have enough medical equipment, 
supplies and to be able to provide some reimbursement to health 
care providers who would come and assist the state, and the 
price tag for that, for 1 year, was $550 million.
    And those were, you know, rough calculations, but that 
gives you some sense of the amount of money that it would take 
to really continue to deliver health care to, you know, an 
increasingly sick and large number of patients.
    I think what we have done is tried to build on those 
partnerships that we have had through the Hospital Preparedness 
Program. That has allowed us to try and create common 
infrastructure, to create common efficiencies with the 
hospitals.
    The challenges that we face, though, are that even if we 
can stand up alternate care sites and find extra space, the 
issue of where will the ongoing supplies come from once we get 
through our initial cash, and where will we continue to find 
and recruit health care providers--we have discussed the issues 
of doing, if you will, battlefield promotions.
    You know, how can we take medical students even early on in 
their career and quickly give them some just-in-time training 
to increase their ability to provide care?
    How do we take family members and teach them the basic 
skills of family health care, to try and allow people to be 
taken care of at home or at an alternate care site or at a 
hospital?
    So those challenges of resources are still the critical 
ones that although we can create that infrastructure, when the 
rubber really hits the road, I think my greatest concern is 
that the resources that we have will be utilized fairly 
quickly.
    And then it will become increasingly difficult to keep the 
same standard of care and the challenge of decreasing standards 
of care or altering them really is something that is very 
difficult.
    Mr. Langevin. Let me ask this question, because it is 
funding related, and the panel can comment on either the 
previous question or the current one that I have.
    I understand that many of the preparedness grants from HHS, 
for example, are 1-year grants. Why is this?
    And wouldn't it be more efficient to put more multiyear 
grants out there, which would encourage states and agencies to 
develop longer-term, more broad-reaching goals?
    We will start with Dr. Cirillo, and then if anyone else 
would like to comment.
    Dr. Cirillo. I think we have tried to encourage our federal 
colleagues to look at that as an option. I would like to share 
a very Rhode Island sailing analogy, which is if I decide I 
want to sail from Newport to the cape, I know where I want to 
end up.
    Along the way, I may have to change and tack with the wind 
a little bit, but I have a goal of where I want to be in a 
certain period of time.
    And on our level, if we continue to change priorities and 
change terminology and change strategies every year, it really 
takes more away from actually being prepared and devotes more 
time, money and resources to just managing the program, and 
that is really not what we want to do.
    So I think a longer strategy--much as the bills and the 
programs are authorized for a multiyear basis, we would like to 
see at the state level that the grants are administered on a 
multiyear basis so that we can establish long-term goals, long-
term strategies and keep moving toward those in a coordinated 
fashion.
    Mr. Langevin. Any comment from the panel?
    Mr. Shult. If I could maybe bridge the two questions, I 
agree with all of the previous comments. We have gotten 
substantial, although now declining, levels of funding to build 
laboratory capacity in terms of our diagnostic testing, our 
laboratory networks and developing an emergency response 
culture.
    That needs to be sustained. A lot of that money now is 
going to sustaining some very highly trained staff where if the 
money goes away, we are going to be in jeopardy hanging onto 
them.
    So I think Wisconsin has benefitted probably better than 
some other states in that regard.
    I would echo the comment that--well, and then to make up 
the shortfall, funding essentially comes out of my operating 
budget in my division and ultimately my public health lab.
    It makes it difficult, if we are making decisions on a 
year-to-year basis, never quite sure how much funding is going 
to be there, and how much shortfall I am going to have to make 
up.
    So we have enough, we have had an adequate amount to build 
substantial capacity capability. That needs to be sustained, 
but it would help us a lot to be able to do this on a multiyear 
basis so we can set up the long-term goals and maybe shift 
priorities.
    Mr. Langevin. Anyone else?
    Dr. Caldwell. I can tell you that the national county and 
city health officials are very concerned that we have seen 
declines of 20 percent or more in the all-hazards preparedness 
dollars that have gone out to local departments of health--and 
to know that the pandemic influenza preparedness funding is 
expected to terminate in August 2008.
    You know from your own experience that when federal 
resources are made available that states and communities will 
take those resources and match them.
    They will do that more readily if they know there is a 
sustainable commitment over time. And a lot of this has to do 
with hiring personnel, as you are well aware.
    And that is the core part of what we have been trying to do 
initially, is to build our capacity of professionals to help us 
with the planning as well as the development of partnership-
building and ultimately of exercising and evaluating this.
    This is a long-term commitment. The long-term vision is 
there. And the federal government needs to provide the strength 
and the foundation to say we are making this a priority in many 
ways through the passage of certain acts that this is the goal 
that we have, the public health preparedness and emergencies 
act, what it is we need to do, and also the resources behind 
it.
    When my county executive sees that there is going to be 
possibly a termination of funding, he is very uncertain of 
whether he is also going to be able to match money as well, or 
start a program and then know that maybe he will have to be 
fully responsible for it completely, and then not even know 
whether that may be something that could be implemented.
    So therefore, not only in my jurisdiction, but across the 
country people are wondering, ``Well, should we go and make the 
extra effort or are we going to be stuck?''
    Mr. Langevin. Dr. Lakey, any comment?
    Dr. Lakey. I think my comments echo the comments that have 
already been made. Every year significant effort comes from our 
agency in the whole grants management process of reallocating 
the funds.
    And having sustainable funding to the local health 
departments would go a long way in getting them to step up and 
be a full partner in this. Actually, on the local side, there 
is a lot of effort that they have to put into every year in 
this whole grants management project.
    I think also, on your first question, I don't think the 
hospital component is a huge issue. For example, in Austin, a 
city of 1.3 million, we would expect that we would have 13,000 
individuals that would be hospitalized during a pandemic.
    And so there are significant preparedness activities that 
have to take place in the hospitals, and they need the 
consistent funding.
    And they also need to make sure that when that occurs there 
is some flexibility on how they are going to be able to bill 
patients and be able to get the ongoing revenue.
    If they are taking care of patients in a non-traditional 
manner on different floors, et cetera, are they still going to 
be able to keep the billing--be able to keep the financial 
security of the hospital--during that time period? And that is 
an issue that I hear from hospitals when I discuss it with 
them.
    Mr. Langevin. Thank you.
    The chair now recognizes the ranking member, the gentleman 
from Texas, for 5 minutes.
    Mr. McCaul. Thank you, Mr. Chairman.
    Well, first I want to thank the witnesses for their 
patience. I know it has been a long hearing, and we don't 
control the votes--at least, I have no control over that. And 
thank you for being here.
    You know, the long-term commitment is important on the part 
of the federal government on an issue that is so important as 
this one.
    I think long term we will have the technology, hopefully, 
as we heard on the prior panel, to develop the technology for 
vaccines that could be readily made within a matter of weeks.
    But until that time, we have to look at antiviral 
medications and a whole host of other things to deal with this 
situation if it happens before that time. We are long overdue 
for a pandemic outbreak in this country. It has been about 40 
years.
    First, I wanted to get a comment from the panel on--and I 
asked this question of the DHS officials, but I would like to 
get your perspective from a state and local level.
    How prepared are we and ready are we in terms of the 
antiviral stockpile in this nation in the event a pandemic 
broke out today? And why don't we just go down the panel, 
starting with you, Dr. Cirillo?
    Dr. Cirillo. I was encouraged to hear, Sir, that at the 
federal level clearly the production capacity has exceeded what 
was expected. And that is encouraging to hear.
    The federal government had established some federal 
stockpiles and it sounds like they are meeting those goals, 
according to Admiral Vanderwagen.
    I think the challenge for us is that there is still an 
expectation that the states were going to participate through a 
negotiated contract in purchasing antivirals to keep at the 
state level.
    And while from a policy and strategic point of view we 
agree with that, the challenge is that that is an investment 
that really is at risk.
    And again, I would reference that those medications that we 
choose to stockpile at the state level are not currently 
available to be included in the shelf-life extension program.
    So if I purchase N95 masks or hand gels, those are items 
that are really able to used for lots of different events, and 
they don't go away. They don't expire.
    The decision to invest, you know, scarce resources 
financially into antivirals--and if we don't have the next 
pandemic for another 4 years and those expire, I really have 
lost that investment.
    And so that really is a challenge for us. So the decision 
at the state level of how much financially to invest in 
antivirals really is the basis of--that is an at-risk 
investment.
    Am I better buying more masks or, you know, investing in 
something that I know will expire and I may not get any value 
out of it?
    Mr. McCaul. Dr. Shult?
    Mr. Shult. Just to reiterate some of the comments, I can't 
speak directly to the antiviral stockpiles, but to point out 
again or reemphasize the critical need for accurate, very 
rapid, highly reliable diagnostic testing to make best use of 
the stockpiles, however they are.
    And another element of that is another key role right now 
for public health laboratories working with the CDC is monitor 
the emergence of antiviral resistance that we have already seen 
with one whole class of antivirals.
    And this is something that would have to be monitored 
throughout the pandemic period, which could last 18 months to 2 
years.
    So however the stockpile sorts out, the laboratories are 
going to need to have that very rapid diagnostic testing and 
surveillance that goes along with it.
    Mr. McCaul. That is a good point.
    Dr. Caldwell?
    Dr. Caldwell. Yes, it is concerning to me at some level 
that there is so much emphasis being put on antivirals, which 
we don't even know are going to work, investing millions upon 
millions of dollars on that, while at the same time not making 
a one-to-one commitment for the resources we need to actually 
get the vaccine or antivirals into people's hands.
    And that is where local health departments come in. You 
know, we are the ones responsible on the ground for accepting 
the strategic national stockpile. And we have had experience in 
having moments where we have practiced trying to get medicine 
to people very quickly.
    Let's go back to the 2004 seasonal flu vaccine shortage, 
where there were delayed shipments and people were anxious and 
concerned, and the public became extremely vulnerable and 
worried.
    We somehow in Dutchess County were able to give out nearly 
6,000 doses in a couple days to our most vulnerable 
populations. But that is only actually because of the efforts 
that we had made in emergency preparedness and practicing. We 
did better with that.
    And we need there to be a recognition that the unknown 
strain, the unknown--hopefully we will be able to develop a 
vaccine quickly. But the amount of money that you have in 
antivirals that if they work, maybe--you know, are they going 
to take 1 day off of the illness, or are they actually going to 
save lives? We just don't know.
    And I think that if you are going to make the commitment 
into putting dollars into medicines, you need to at least make 
a one-to-one commitment into putting it into the strategies, 
the implementation strategies, the practice and the planning at 
the local level.
    Mr. McCaul. That is a very good point.
    Dr. Lakey?
    Dr. Lakey. Thank you. I agree that antivirals are only one 
component of a comprehensive plan for the state. I think it is 
an important part of the comprehensive plan and for the state.
    I worked this issue quite a bit this last legislative 
session in Texas. We were offered the ability to buy $34 
million worth of antiviral medicines. It came out of the 
legislative session with $10 million, and that was a hard sell.
    One of the reasons that it was a hard sell was with ongoing 
health concerns in the state, spending $10 million for a 
medicine that has a 5-year shelf life and the unpredictability 
of pandemic influenza made a lot of other issues seem more 
important at the state level than purchasing the antiviral 
medicines.
    I think that the 5-year shelf life played a key role in the 
difficulty we had in making the case for the state to invest in 
the antiviral medicines. And so I think that is a key issue 
that needs to be looked into.
    Mr. McCaul. And, Dr. Lakey, following up on that, can you 
describe the national policies that prohibit using these 
medications bought under a federal contract?
    Dr. Lakey. Under the federal contract, it is negotiated at 
a low rate and with a national subsidy, and with that, we are 
not allowed to utilize the medicines except for a pandemic, in 
a pandemic influenza.
    We are not allowed to rotate through the stockpile so that 
we could use so much this influenza season and replace it with 
additional antivirals that are purchased. Basically it is just 
put on a shelf and we are not allowed to utilize it except for 
the pandemic.
    And that is where this 5-year shelf life really comes into 
play.
    Mr. McCaul. That may make some sense to take another look 
at the contracts so we can fully utilize our resources.
    One thing we discussed, Dr. Lakey, yesterday--I wanted you 
to expand on--is in terms of hospital bed space, the 
availability, you mentioned a concern of yours in terms of your 
ability to inspect the hospitals as it relates to CMS's ability 
to fund.
    Can you elaborate on this? And what, if anything, would you 
recommend we do at the federal level to fix this?
    Dr. Lakey. Sure. The situation is that our agency does 
initial hospital licensing, initial inspections to hospitals, 
to allow them to bill Medicaid and Medicare.
    We have been told that initial inspections for new 
hospitals are the last priority, that we are not allowed to do 
them unless all other types of inspections are done, and 
basically that is a situation that never occurs.
    And so we have multiple hospitals in Texas that are 
awaiting inspections in order to come up and be able to bill 
Medicaid and Medicare as part of their business plan that are 
not allowed to do that at this time.
    And so we have 17 hospitals currently sitting in Texas 
awaiting--and they are ambulatory care centers and smaller 
hospitals that we can't inspect.
    There are other options for the hospitals. They can go 
through JCAHO accreditation. They can be deemed under a parent 
hospital so they are part of a feeder system into that 
hospital.
    Or if there is an access-to-care issue--the problem for 
Texas is we are not an access-to-care state, and so we have 
offered to use general revenue and other sources in the state 
to either take care of that backlog or to do the initial 
inspections.
    We have offered to be able to couple them with other type 
of inspections and then told that we can't do that. And so 
there are multiple facilities in Texas that we can't bring up 
because of those issues.
    Mr. McCaul. I am curious with the other three panelists 
whether you are experiencing that same problem in your 
respective states.
    Dr. Cirillo. I don't think we share the same challenge that 
Dr. Lakey is facing in Texas. I think our greatest challenge in 
terms of hospitals is the issue of capacity.
    And again, within Rhode Island, the hospitals operate on an 
inpatient basis at greater than 95 percent capacity on every 
day.
    And so when we talk about where would we accommodate surge, 
again, not just for pandemic--we had the experience in Rhode 
Island of the Station Nightclub Fire, and that was a challenge 
to try and despite heroic efforts by first responders and 
people at hospitals, to create that capacity in a real-time 
event.
    And that really is the challenge, to deal with the 
unexpected. So my concern on the hospital level is how do we 
continue to support them in difficult financial times, to 
invest in preparedness when they are really trying to invest in 
their day-to-day operation, to remain open.
    Mr. McCaul. Any comments from the other two?
    Mr. Shult. And again, from a laboratory perspective, we 
have spent a lot of time working with the clinical labs 
throughout the state and bringing them up to speed in terms of 
emergency response, their role in a pandemic and what the 
pandemic is going to do to them.
    We are all going to be affected by this. And they have real 
concerns as well, similar to what have been echoed here as far 
as their capacity to respond, keeping in mind they are critical 
to maintaining day-to-day patient care that has to go on 
anyhow, much less the complications that are going to arise 
from a pandemic.
    So right now we have been working with them, but they are 
feeling very much at a loss as to whether they are going to be 
able to respond adequately to serve the clinical or their 
clinicians' needs.
    Mr. McCaul. Dr. Caldwell?
    Dr. Caldwell. Yes, in the state of New York, we are 
actually cutting back on hospitals and beds, believe it or not, 
because they feel there is an oversupply, so it is in some ways 
a reverse problem.
    But when you look at, you know, how are we trying to 
prepare for the large part of our population being sick and 
very ill, we are thinking that we are going to have to have a 
lot of people taken care of at home.
    And right now, part of our strategy and planning in 
Dutchess County and many of my colleague counties is to work 
with our home care agencies and to work with them and build 
their capacities to develop some unified emergency preparedness 
home care plans, enabling our residents to know that there will 
be people available to deliver some medical and nursing care in 
their homes if they get sick.
    Now, are we going to be able to activate hundreds of 
ventilators, and where are you going to get the staff to 
activate these ventilators? And I just don't see it being a 
realistic possibility. I think there is going to be some type 
of very rationing situation. It is going to be hard.
    I mean, we are not going to be taking over hotels. People 
used to say, ``Oh, we are going to take over hotels and put 
people there.'' That is not going to happen. The hotels aren't 
going to want it. Nobody is going to want to go to the hotel, 
and nobody is going to staff the hotels.
    And so we need to look at what already exists in our 
community, try to think of how people are going to approach the 
situation, given that it is not just going to be people getting 
sick. All kinds of things are going to be going on.
    There is going to be distribution of food problems. People 
are going to have trouble getting their food and their water 
supplies and their other regular medicine.
    So I do have one other comment about the previous topic of 
pharmaceutical stockpile and pharmacies.
    Instead of us in Dutchess County sort of going out and 
buying our own mini-stockpile, what we have done through our 
relationship-building efforts is work with our local 
pharmacies, so we have a memorandum of understanding with all 
the pharmacies in our county to know what is on their shelves.
    And should there be an outbreak, they will then immediately 
inform us of what is on their shelves, so that will be our sort 
of--rotating many stockpiles, which won't cost us any money.
    And of course, they may not have all that we want, but it 
is at least something that we can have some control over at any 
time, and it doesn't cost us any money.
    As a matter of fact, it is an investment in our continued 
relationship. While it is not antivirals, it may be something 
else, like, for example, some other antibacterial that we may 
need for some other agent that may come along.
    Mr. McCaul. That is very creative.
    And I appreciate the chair's indulgence. And just in 
conclusion, I do want to stress again the importance of 
exercises. I think those are very important. I hope that your 
partner at the federal level will work with you on those.
    And lastly, Dr. Lakey, you mentioned the border, and I 
think that is an obvious concern on a lot of levels, but 
certainly from a health standpoint, in terms of who is coming 
into the country. I think we need to have a better level of 
control over who is coming into the country.
    And certainly, when we had the avian flu outbreak, knowing 
who is coming over from those parts of the world that could be 
impacted--and I know that on the science and technology 
standpoint, there has been some pretty good technology that is 
out there that could potentially spot if someone who has a high 
fever, for instance, coming through an airport.
    And so I hope that we will be able to make some progress on 
that level as well.
    And with that, I yield back.
    Mr. Langevin. I thank the gentleman.
    I want to thank the panel for being here today as well as 
the previous panel. I thank the witnesses for their valuable 
testimony and the members for their questions.
    We obviously have a lot of work to do in this area. We look 
forward to a continued partnership at the local, state and the 
federal level to make sure that we get this right and we can 
protect the American people from both pandemic flu or another 
public health threat.
    Thank you very much again.
    The members of the subcommittee may have additional 
questions for the witnesses, and we ask that you respond 
expeditiously in writing to those questions.
    Hearing no further business, the subcommittee now stands 
adjourned.
    [Whereupon, at 1:17 p.m., the subcommittee was adjourned.]


                          Appendix I:  Letter

                              ----------                              

                          House of Representatives,
      Subcommittee on Emerging Threats, Cybersecurity, and 
                                    Science and Technology,
                                  Washington, DC, October 25, 2007.
Hon. Jim Langevin
Chairman, Subcommittee on Emerging Threats, Cybersecurity, and 
        Science and Technology, 109 Cannon House Office 
        Buildig, Washington, D.C. 20515

    Dear Chairman Langevin: Thank you for allowing me to tesify 
about pandemic influenza preparedness before the Subcommittee 
at its hearing on September 26. It was an important opportunity 
to enhance communication between the federal government and 
states as we work together to strengthen health and security 
across the nation.
    Please allow me to make two brief clarifications regarding 
my testimony. I mentioned the percentage of preparedness 
funding that Texas has directed to the local level including 
direct contracts with local health departments. That statement 
should have referred specifically to pandemic influenza 
preparedness funding. In addition, the percentage of funding 
awarded for local and regional pandemic preparedness activities 
was overstated. The correct figure is ninety percent.
    Again, I appreciate the opportunity to present to the 
Subcommittee regarding these issues. Please contact me if I can 
ever be of assistance.

            Sincerely,

                                      David L. Lakey, M.D.,
                                                       Commissioner


            Appendix II:  Additional Questions and Responses

                              ----------                              


Questions from the Honorable James Langevin, Chairman, Subcommittee on 
              Emerging Threats, Cybersecurity, and Science

              Responses from Michael C. Caldwell, MD, MPH

    Question 1.: What additional resources are needed at the local 
level to prepare for and respond to pandemic influenza? What is needed 
at that level--that is not needed at other levels of government or in 
the private sector?
    Effective pandemic influenza preparedness at the local level 
requires a continued, iterative process of planning, testing the plans 
either through response to a real event of lesser magnitude or via 
``tabletop'' exercise, identifying gaps and areas needing improvement, 
achieving those improvements, and re-testing. While this methodology is 
not unique to the local level, locally it requires reaching out to 
every community organization, institution, or agency that will be 
affected by a pandemic to engage them in practical response planning. 
The breadth and depth of activity required to build and sustain such 
community engagement, unique to the local level, is a long and labor-
intensive effort. It can be accomplished only with a sustained 
commitment of sufficient funds to pay for the people that do this work. 
Local pandemic influenza preparedness is not simply a matter of one-
time capital purchases of medications, vaccines, or equipment--rather, 
it requires constructing and sustaining the community response systems 
that will make a difference in survival rates. NACCHO believes that a 
return to previously-appropriated levels of funding for state and local 
public health preparedness ($940 million in FY05), accompanied by 
performance and accountability measures that genuinely reflect the 
local planning, exercising and continuous improvement that is needed, 
would enable consistent progress. Moreover, it is important to address 
the funding levels for anti-viral purchases and the shelf-life 
extension problem that now discourages state or local investment.

    Question 2.: The best preparation for public health emergencies 
involves skilled public health workers who plan and exercise their 
plans for emergency response jointly with local elected officials, 
police and fire departments, emergency managers, hospitals, physicians, 
schools, businesses, and other community partners. Please describe how 
this has occurred in Dutchess County regarding pandemic influenza 
preparedness.
    In Dutchess County, we have prepared and distributed informational 
materials and have offered trainings to area businesses, schools, faith 
based organizations and other entities as part of our Pandemic Flu 
Emergency Preparedness activities. We have organized table top 
exercises with our area partners, including the local hospitals. 
Additionally, our regular flu immunization clinics have been used as 
opportunities to drill the techniques that will be needed in an 
emergency situation, when medications would have to be distributed to 
the public in a short period of time. Nine clinics were held in 
November and December 2006 throughout the county. Each site selected 
could accommodate large numbers of attendees without traffic problems 
or long waiting times. Clinic hours were increased over the years and 
each site had inside waiting areas. Other agencies such as the 
Sheriff's Department, the Department of Mental Hygiene, Public Works, 
and the Office for the Aging assisted in mounting these efforts. This 
type of exercise is being replicated again this year as we run our 2007 
flu clinics.
    Furthermore, Dutchess County has recruited a local Medical Reserve 
Corps of over 300 volunteers whoa re been trained to provide assistance 
with medical care, special needs care, as well as non technical needs. 
This cadre of citizen volunteers is meant to be fully integrated into 
the County's emergency planning and response program.
    Preparing for a pandemic is part of more comprehensive Emergency 
Preparedness efforts, looking at multiple scenarios. In Dutchess 
County, we have also been working on a continuity of operations plan. 
During a pandemic event, more than 40% of the workforce could 
potentially be unable to come to work. This plan addresses issues of 
providing a safe environment, prophylaxis, training and tools needed to 
perform essential public health functions in our community. Such a plan 
is critical in a pandemic when the public health and other public 
resources will be stretched thin providing vaccines and antivirals to 
the public in a mass clinic or Point of Distribution site.

    Question 3.: What can the federal government do to assist city and 
county public health personnel strengthen and coordinate surveillance 
at those levels? How do you see information from localities throughout 
the country, rolling up into a cohesive real-time disease surveillance 
picture?
    Response: Local health department (LHD) involvement in 
biosurveillance systems development and implementation is critical. 
LHDs are the traditional entry point for routine disease surveillance 
and investigation, and function as first responders in a public health 
emergency. As such, LHDs are keenly aware of the information needed to 
monitor for public health emergencies and mount response and mitigation 
activities. LHDs must be actively involved in the definition of data 
and functional requirements for biosurveillance systems and in the 
local implementation of such systems. State and federal public health 
agencies must ensure that LHDs have timely access to any data collected 
about their local community.
    Existing relationships between LHDs and local hospitals and 
providers should be leveraged for biosurveillance implementation 
efforts. LHDs have established relationships with hospitals, physicians 
and other healthcare providers in their communities for disease 
reporting and preparedness planning and response. As most responses to 
emergencies are locally managed, it is critical that these existing 
relationships are maintained and strengthened to ensure rapid response 
to public health threats. These relationships remain essential even 
when a state health agency or the CDC initiates the data collection 
effort, such as with the CDC's implementation of BioSense.i 
Additionally, over-reliance on biosurveillance data as the only 
indicator of a public health emergency must be avoided. Electronic 
biosurveillance systems will not replace astute clinicians and LHD 
relationships with their clinical communities to detect, monitor and 
control public health emergencies. Uniform national adoption of an 
electronic medical record is absolutely essential to eventual 
development of any fully effective real-time disease surveillance 
system.
---------------------------------------------------------------------------
    iBioSense is the national program designed to improve 
the nation's capabilities for real-time biosurveillance and situational 
awareness at a time when the vast number of health-related information 
systems that exist nationally vary in their ability to share data to 
support immediate biosurveillance needs.

    Question 4.: In your testimony, you state ``. . .we have seen mixed 
messages from our federal leadership. There does not seem to be 
adequate coordination or cooperation between the planners of Health and 
Human Services and the Department of Homeland Security.'' Please 
provide examples of mixed messages from federal leadership, as well as 
examples of inadequate coordination and cooperation between HHS and 
DHS.
    HHS and DHS have separate and uncoordinated grant programs for 
state and local preparedness. Pandemic influenza planning is a major 
expectation of the CDC grants, but not of the DHS grants for police/
fire/emergency management. DHS has undertaken the BioWatch surveillance 
initiative, but it has not been coordinated with any HHS 
biosurveillance initiatives, although the responders at the local level 
are the same.

    Question 5.: In your testimony, you state ``. . .we have seen clear 
examples of us being left out of the development of the National 
Response Plan.'' Please provide us with some of these clear examples.
    Response: There was no representation of local health departments 
on any of the 12 workgroups that were formed to fashion the detailed 
revisions of the National Response Plan.

    Question 6.: In your testimony, you state ``. . .in the state of 
New York, we are actually cutting back on hospitals and beds, believe 
it or not, because they feel there is an oversupply. . .'' Who believes 
there is an oversupply, and on what data are they basing this belief? 
Please provide data regarding the numbers of hospitals and beds, as 
well as to what numbers of each the stat is cutting back. What specific 
impact do you believe this will have if we are to have an influenza 
pandemic?
    Response: In New York State, the hospital environment has been 
dominated by mergers and restructuring, which inevitably have an impact 
not only on the number of beds, but also the types of beds available. 
This will in turn affect the ability of hospitals to accommodate a 
surge that would be associated with a pandemic.
    Response: New York State has recently undergone an extensive review 
of its hospital system structure and capacity. The formal review was 
known as the ``Berger Commission'' and its detailed report can be 
accessed at http://www.nyhealthcarecommission.org/ While some parts of 
New York State operate at a high hospital bed occupancy rate, many 
areas of the state do not. The Berger Commission was created to address 
the concern that overall, New York State is over-bedded by 
approximately 25 %. The Commission noted that ``a fundamental driver of 
the crisis in our health care delivery system is excess capacity. New 
York is over-bedded an many hospital beds lie empty on any given day. 
The statewide hospital occupancy rate has fallen from 82.8% of 
certified beds in 1983 to 65.3% in 2004, a decrease of 17.5%. Occupancy 
rates vary by region and are especially low in Wetern, Northern, and 
Central regions.''

    Question 7.: According to the Implementation Plan for the National 
Strategy for Pandemic Influenza, ``The Federal Government shall, and 
State, local, and tribal governments should, define and test actions 
and priorities required to prepare for and respond to a pandemic, 
within 6 months'' of when the Plan was released--so the deadline would 
have been October 2006. What are the challenges here? Are you waiting 
for the Federal government to provide you with guidance and resources?
    Response: The initial CDC grant guidance for the first phase ($100 
million) of pandemic influenza funding was released in May 2006. 
Planning and exercising the full panoply of local resources required 
for response is a continuous iterative process, as described above, and 
it certainly takes more than four months. As funding dedicated for 
state and local pandemic influenza preparedness ends, it will be 
essential that federal expectations for pan flu preparedness and for 
all-hazards preparedness be harmonized and realistic within the 
resources made available.

    Question 8.: According to the Implementation Plan for the National 
Strategy for Pandemic Influenza, ``State, local, and tribal law 
enforcement agencies should coordinate with appropriate medical 
facilities and countermeasure distribution centers in their 
jurisdictions to coordinate security matters, within 6 months'' of when 
the Plan was released--so the deadline would have been October 2006. To 
your knowledge, has any of this coordination taken place? If so, how, 
and if not, how would you recommend this happen?
    Planning and exercising of Points of Distribution for the Strategic 
National Stockpile has taken place in many jurisdictions with law 
enforcement involvement for several years now, and most intensively in 
those that receive Cities Readiness Initiative funding. DHS 
expectations for law enforcement engagement with medical facilities and 
countermeasure distribution centers should be directly and explicitly 
connected to and consistent with HHS expectations for hospitals and 
health departments.

    Question 9.: What roles do associations play in assisting their 
constituents with emergency and pandemic preparedness?
    Response: NACCHO has developed a robust collection of on-line tools 
and a peer assistance network for local health departments engaged in 
emergency preparedness. NACCHO also coordinates and disseminates the 
work of eight local Advanced Practice Centers for Public Health 
Preparedness, which develop and evaluate cutting-edge preparedness 
tools and methodologies. We share information on federal actions and 
provide input to a vast array of HHS and CDC workgroups and advisory 
groups.

    Question 10.: The Government Accountability Office (GAO) says in 
its report that State, Territorial, Tribal, Local, and other 
stakeholders need to be involved in providing input to the National 
Strategy for Pandemic Influenza and its Implementation Plan, especially 
as the National Strategy evolves. If you were at the White House, how 
would you ensure this happens?
    Response: Local stakeholder representatives should be identified 
and engaged at the beginning of the federal planning process They 
should be engaged in review of early drafts and given enough time to 
consult meaningfully with their constituents and to provide written 
responses. While this is not a rulemaking process, the federal authors 
of the strategy and plan should be required to identify what the 
stakeholder advice was and explain why it was disregarded or adopted.

    Question 11.: As you all know, public health has been identified as 
one of the critical infrastructures of our Nation. Have you been 
included in the planning undertaken by the Department of Homeland 
Security to protect the public health infrastructure? From what you 
know about this work, how does it affect you in your state and local 
positions? What more do you think needs to be done in this regard, 
especially in advance of an influenza pandemic?
    Response: NACCHO is a member of the Government Coordinating Council 
of the Public Health and Healthcare sector (one of 17 identified 
sectors). This work has no current impact at the local level because 
the Public Health and Health Care Critical Infrastructure plan is not 
functional and has no funding behind it.

    Questions from the Honorable Michael T. McCaul, Ranking Member, 
      Subcommittee on Emerging Threats, Cybersecurity, and Science

    Question 12.: At the hearing, Dr. Caldwell testified that most 
hospitals operate at ``95% capacity everyday,'' and that New York is 
actually reducing the number of hospital beds because of 
``oversupply.''
    Please see response to Question # 6 above which references the New 
York State ``Berger Commission.'' The detailed report can be located at 
http://www.nyhealthcarecommission.org/

    Question 13.: What ability do local hospitals in your states have 
to accommodate a surge that would be associated with a pandemic?
    Response: Local hospitals are expected to have a surge of up to ten 
percent (10%) over their normal capacity. Most local hospitals in NY 
are close to that surge capacity.

    Question 14.: What type of procedures are in place to increase 
capacity should a pandemic occur?
    The biggest concern for us is what happens when the surge is over 
the proposed ten percent? What do we do when hospitals are over 
capacity? Our local hospitals are in the process of developing a plan 
to address that very question. We need to come up with a model to set 
up alternate sites of care and that is a huge challenge for our local 
healthcare systems.

Questions from the Honorable James Langevin, chairman, Subcommittee on 
              Emerging Threats, Cybersecurity, and Science

                 Responses from L. Anthony Cirillo, MD

    Question 1.: The Implementation Plan for the National Strategy for 
Pandemic Influenza provided this task, ``All Federal, local, tribal, 
and private sector medical facilities should ensure that protocols for 
transporting influenza specimens to appropriate reference laboratories 
are in place within 3 months''--which would have been July 2006. What 
challenges do you see with executing this task?
    Response: The greatest challenges to the development and 
maintenance of a system to ensure the transport of influenza specimens 
to reference laboratories is actually support of the labs themselves 
and the development of a more efficient process for dissemination of 
the information obtained from testing of influenza specimens. During a 
pandemic, or even during seasonal flu, the capacity of laboratories to 
process influenza specimens in a timely manner is limited by the number 
of staff trained and assigned to this process. Like many other aspects 
of the healthcare system, the surge capacity of the laboratories is 
limited. While cross-training of lab personnel occurs, and can help to 
provide short term support for increased testing demand, it provides 
only limited increased capacity. Additionally, systems must be 
developed for the rapid analysis and dissemination of information 
obtained from testing such as geographic patterns of illness, 
susceptibility to antiviral medications, appropriateness of match to 
current influenza vaccine. It is critical that this information be 
quickly shared with the healthcare and public health sectors for 
ongoing adjustment of medical and public health interventions during a 
pandemic.

    Question 2.: The Implementation Plan for the National Strategy for 
Pandemic Influenza states that, ``All health care facilities should 
develop, test, and be prepared to implement infection control campaigns 
for pandemic influenza, within 6 months'' of when the Plan was released 
(deadline: October 2006). Our hospitals and other health care 
facilities are more than familiar with infection control measures. Can 
you describe the specific challenges in identifying and implementing 
infection control measures for pandemic influenza?
    Response: The challenges to instituting infection control measures 
at hospitals and other healthcare facilities during a pandemic will be 
due to a lack of adequate capacity of the healthcare system and the 
infectious nature of influenza. In order to operate cost-effectively, 
hospitals today are operating at or near their licensed inpatient bed 
capacity. While this operational efficiency is financially prudent, it 
may significantly limit the ability of the hospitals to efficiently 
segregate patients during a pandemic. Given the increased demand for 
healthcare services anticipated during a pandemic, it is likely that 
all existing inpatient bed capacity will be utilized at all times. 
Attempts at segregating patients with influenza from patients receiving 
medical services for all other medical conditions may initially be 
possible, but as the numbers of inpatients continues to surge, the need 
to provide care quickly, in the next available bed, may very well 
overwhelm any system designed to segregate infectious from non-
infectious patients. An additional challenge during an influenza 
pandemic will be that people (including patients, staff, and visitors) 
may be already infected, and contagious, prior to the development of 
symptoms of influenza. So, even in the best of circumstances, 
segregation of patients with demonstrated influenza illness will not 
likely prevent the spread of illness to other clinical areas within a 
healthcare facility. Given these realities, it is unclear if the 
expenditure of resources needed to segregate patients will yield much 
in the way of significant reductions in illness spread.

    Question 3.: According to the Implementation Plan for the National 
Strategy for Pandemic Influenza, ``The Federal Government shall, and 
State, local, and tribal governments should, define and test actions 
and priorities required to prepare for and respond to a pandemic, 
within 6 months'' of when the Plan was released--so the deadline would 
have been October 2006. What are the challenges here? Are you waiting 
for the Federal government to provide you with guidance and resources?
    Response: Given the worldwide nature of a pandemic by definition, 
it is appropriate that the overall strategy related to the management 
of pandemic be developed on a global level. However, while a global 
strategy for pandemic influenza may be developed through agencies such 
as the World Health Organization (WHO), the implementation of that 
strategy will be different based upon the local effect of the pandemic 
and the availability of supplies, medications, and personnel. Within 
the United States, there will be an expectation for consistency of 
care. As such, it is again appropriate that a national approach be 
taken in responding to a pandemic influenza event. Thus the federal 
government, especially the Centers for Disease Control and Prevention 
(CDC), should take the lead in the development of standardized and 
universal strategies for key aspects of pandemic influenza management. 
These key aspects include issues such as prioritization of antiviral 
medication and influenza vaccine distribution and guidance on 
effectiveness and appropriateness of personal protective equipment 
(masks, gloves, etc.). After Secretary Leavitt's visit to states during 
late 2005 / early 2006, the challenge to states at that time was the 
lack of guidance at the federal level on many of these key issues. Over 
the past nearly two years, there have now been numerous reports, from 
various agencies, on many key issues related to pandemic influenza 
management. As such, the challenge for state and local public health 
departments is now to continually update and revise pandemic influenza 
local strategies as guidance continues to be updated at the federal 
level. While updates in guidance and recommendations are necessary, and 
should reflect the latest in our understanding of how to mitigate the 
effects of a pandemic on society, it does require significant resources 
to continue to update planning documents, and more importantly, 
communicate these changes to all of the partners involved in pandemic 
preparedness. Lastly, as plans continue to evolve and change, there is 
a need for ongoing trainings and exercises to ensure that plans can be 
effectively implemented which again, requires significant investments 
of time and money at the state, local, and private sector levels.

    Question 4.: According to the Implementation Plan for the National 
Strategy for Pandemic Influenza, ``State, local, and tribal law 
enforcement agencies should coordinate with appropriate medical 
facilities and countermeasure distribution centers in their 
jurisdictions to coordinate security matters, within 6 months'' of when 
the Plan was released--so the deadline would have been October 2006. To 
your knowledge, has any of this coordination taken place? If so, how, 
and if not, how would you recommend this happen?
    Response: Within Rhode Island (and many other states) coordination 
of specific functions such as law enforcement /security is accomplished 
in concert with the state Emergency Operations Plan (EOP) utilizing the 
Emergency Support Function (ESF) delegation of functional 
responsibility. In Rhode Island, the Rhode Island State Police (RISP) 
serve as the lead agency for coordination of law enforcement planning 
related to emergency scenarios. The Department of Health serves as the 
lead agency for pandemic planning within the state by direction of the 
Governor. The Director of Health, Dr. David Gifford has established the 
Pandemic Flu Director's Advisory Group, comprised of key state agency 
directors. The commanding officer for the Rhode Island State Police (or 
his designee) attends these meetings to coordinate state agency 
planning for a pandemic. The RISP are also members of the Rhode Island 
Police Chiefs Association through which additional planning activities 
have occurred related to pandemic flu. Lastly, the RISP also serve as 
the law enforcement agency responsible for security evaluations of all 
medication distribution sites under the federal Strategic National 
Stockpile (SNS) program. In this capacity, they work together with law 
enforcement officials in all municipalities in the identification of 
appropriate facilities for distribution of medications or vaccines 
during a public health emergency.

    Question 5.: In your testimony, you described regional interstate 
coordination in pandemic preparedness, and that the ``. . 
.collaborative effort resulted in a two-day summit and multistate 
tabletop exercise held to coordinate the interstate response to a 
pandemic.'' Please provide additional information regarding the 
regional interstate coordination and collaborative efforts you 
mentioned in testimony, the two-day summit, and the multistate tabletop 
exercise. What lessons have been observed and learned?
    Response: As noted above in Answer #3, after Secretary Leavitt's 
state visits, the states were charged with developing a comprehensive 
strategy for responding to a pandemic influenza event. Within the New 
England region, it was recognized that the geographic proximity of 
states within the region would necessitate a collaborative approach to 
pandemic influenza planning. Also as noted above, early on after 
Secretary Leavitt's visits, there was limited guidance on how to 
prepare for a pandemic influenza event. Given this lack of national 
guidance, the six New England states and New York State began a 
collaborative process to identify best and common practices among the 
states. At least one representative from each state was assigned to 
participate in workgroups on the following issues: Antiviral 
medications, Community Containment, Mass Fatality Management, 
Laboratory/Illness Surveillance, Personal Protective Equipment (PPE), 
and Surge Capacity. These groups met by conference call from March 
through June 2006. The work of these groups culminated in a two-day 
meeting in Boston, MA on June 29th & 30th. During this meeting, 
consensus assumptions, positions and planning strategies were 
identified for many, although not all aspects, of pan flu planning. The 
key lessons learned from these activities were delineation of common 
planning assumptions including attack rates of illness, and approaches 
to school closures and risk communication, especially in mass media 
markets that traverse state boundaries. Another key lesson learned was 
the need to integrate planning in the public health / healthcare sector 
with planning efforts in the emergency management sectors. In order to 
accomplish this, an exercise was hosted by the Naval War College in 
Newport, RI in August 2006. The exercise brought together leaders from 
each state including health care/public health, emergency management, 
and the Governor's office from each state. In addition, two meetings of 
the State Directors of Health were also coordinated by the Region I 
Office of the US Department of Health & Human Services.

    Question 6.: In your testimony, you mentioned ``. . .the 
disincentives to the purchase of antiviral medications Tamiflu and 
Relenza due to exclusion from the shelf-life extension program of state 
health supplies of these medications.'' Please provide the Committee 
with additional information regarding these disincentives, the shelf-
life extension program, etc. How do you propose this situation be 
changed, understanding that the federal government is seeking to ensure 
that states are preparing for pandemic influenza specifically?
    Response: Antiviral medications may have a significant impact on 
mitigating the effects of pandemic related illness on society. There is 
however, also the possibility that current antivirals will have little 
to no effect on the duration or severity of illness. It is this primary 
uncertainty that makes the purchase of antiviral medications a 
calculated risk for states in preparing for a pandemic influenza event. 
Even more important than the development of strategies for stockpiling 
and distribution in the community, is the fundamental question as to 
the value of antiviral medications. Historically during seasonal 
influenza outbreaks, patients who are treated very early on in their 
illness course have shown a small decrease in the length and severity 
of illness. However, there is no guarantee that these effects would be 
seen during a pandemic influenza event, as the specific virus is 
currently not known. In testing and treatment of patients infected with 
H5N1 (Avian Flu), there has been only limited clinical treatment 
success in reducing illness and mortality. In addition to the 
uncertainty of the efficacy of antivirals during a pandemic, there is 
concern about the current policy of the US Food & Drug Administration 
(FDA) that does not allow for utilization of antiviral medications for 
clinical treatment if the antiviral medications have reached their 
expiration date. Even for states who have stored these medications in 
accordance with acceptable temperature and humidity ranges, there have 
been no exceptions to the strict expiration date policy. The Shelf Life 
Extension Program (SLEP) was created to allow for periodic re-
verification of the potency of medications or vaccines currently held 
in federal stockpiles. It is possible to expand the scope of the SLEP 
program to include the caches of antivirals that states are purchasing 
for a pandemic influenza event. There would need to be some 
modifications to the program to allow for the manufacturers to provide 
samples of each lot of medication produced to the SLEP program for 
batch verification. As long as states can ensure that locally held 
caches are kept at appropriate environmental conditions, then the 
entire manufacturer batch would be eligible for SLEP extension.

    Question 7.: In your testimony, you mentioned ``. . .it is critical 
that all federal preparedness programs related to pandemic or other 
public health emergencies be more closely aligned and coordinated so 
that we at the state level can more effectively develop an appropriate 
response to all public health emergencies.'' How do you suggest this be 
accomplished by the federal government?
    Response: One of the challenges facing states in their preparedness 
efforts is the lack of coordination and alignment of federal grant 
funding goals and objectives. Currently the US Departments of Health 
and Human Services and Homeland Security are providing funding for 
emergency preparedness, with a specific focus on pandemic influenza 
preparedness activities. However, both between, and even within 
agencies there are gaps in collaboration of grant funding and planning 
priorities at the federal level. This lack of coordination, especially 
within HHS, results in grant funding for the same issue, such as 
pandemic influenza, with conflicting grant deliverables, performance 
measures, reporting systems, and grant timelines. This lack in 
coordination at the federal level results in inefficiencies in grant 
management at the state level attempting to design a single pandemic 
influenza planning strategy with multiple different ``asks'' from each 
grant. Improved coordination must occur at the most senior level of HHS 
and DHS in order for these gaps in grant planning to occur. Within HHS, 
the Secretary should establish a single set of priorities and guidance 
for pandemic influenza preparedness. This single set of priorities and 
guidance should also be reflected in uniform definitions, performance 
measures, and timelines for all pandemic influenza grant funding.

    Question 8.: What roles do associations play in assisting their 
constituents with emergency and pandemic preparedness?
    Response: The private sector, including professional associations 
and businesses will play a critical role in the successful response of 
society to a pandemic event. The ability to incorporate associations 
such as representatives of hospitals, nursing homes, and healthcare 
professionals in pandemic influenza event will be crucial in order to 
muster and coordinated existing healthcare and non-healthcare 
infrastructure during a pandemic. Just as there is an added 
inefficiency to coordinated planning between federal agencies, there is 
a significant benefit to be gained by early involvement of other key 
stakeholders.

    Question 9.: The Government Accountability Office (GAO) says in its 
report that State, Territorial, Tribal, Local, and other stakeholders 
need to be involved in providing input to the National Strategy for 
Pandemic Influenza and its Implementation Plan, especially as the 
National Strategy evolves. If you were at the White House, how would 
you ensure this happens?
    Response: As has been mentioned above, I believe it is appropriate 
for a significant portion of the guidance on best practices for 
pandemic influenza preparedness to be developed at the federal level. 
However, the process for the development of guidance at the federal 
level must incorporate the realities of the implementation at the local 
level. Therefore, it is important that federal policy makers and 
subject matter experts include representatives of state, local, and 
tribal entities in the development of guidance and policies regarding 
pandemic influenza. The input of state, local, and tribal entities is 
probably most efficiently ensured through the incorporation of 
representative associations for these groups. Examples of these 
associations would be groups like the Association of State and 
Territorial Health Officials (ASHTO), the National Association of City 
and County Health Officials (NACCHO), the National Governor's 
Association (NGA) and representatives of healthcare professional 
organizations like the American Medical Association (AMA) and American 
Nurses Association (ANA). Since these associations and organizations 
are well recognized as leaders within their respective memberships, 
they can serve as a conduit of information throughout the development 
and refinement of guidance and policies related to pandemic influenza.

    Question 10.: As you all know, public health has been identified as 
one of the critical infrastructures of our Nation. Have you been 
included in the planning undertaken by the Department of Homeland 
Security to protect the public health infrastructure? From what you 
know about this work, how does it affect you in your state and local 
positions? What more do you think needs to be done in this regard, 
especially in advance of an influenza pandemic?
    Response: Initially after state visit of Secretary Leavitt, the 
public health sector was much more involved in the management of a 
pandemic influenza event than the emergency management / Department of 
Homeland Security arenas. However, there has been much recent work by 
the Federal Emergency Management Agency to improve the coordination of 
pandemic flu preparedness and response activities. Ongoing efforts 
related to pandemic flu planning must focus on identifying 
methodologies to improve the coordination of planning in a ``top down'' 
manner, but with inclusion of others as noted in Answer #9. Here in 
Rhode Island, there has been considerable discussion between the 
Department of Health and the State of Rhode Island Emergency Management 
Agency regarding the protection of critical infrastructure and 
maintenance of society during a prolonged pandemic event.

      Questions from Honorable Michael T. McCaul, Ranking Member, 
      Subcommittee on Emerging Threats, Cybersecurity, and Science

    Question 1.: At the hearing, you described national policies that 
prohibit using medications bought on the federal contract for anything 
but a pandemic. This makes the procurement of antivirals an ``at risk'' 
investment.

    Question 2.: How do current federal regulations influence your 
efforts to stockpile antiviral medications?

    Question 3.: What do you see as a practical solution that would 
reduce the investment risk of procuring antiviral medications while 
ensuring adequate supplies of these medications are available in the 
event of a pandemic?
    Response: Please refer to Answer #6 above regarding antiviral 
medications in response to Questions #1--3.

Questions from the Honorable Bennie G. Thompson, Chairman, Committee on 
                           Homeland Security

                   Responses from B. Tilman Jolly, MD

    Question 1.: What is the status of the pandemic influenza exercises 
that were to be incorporated into the National Exercise Program? How 
many will there be, when are they occurring, and who all will be 
involved?
    Response: Pandemic Influenza (PI) exercises and the Pandemic 
Influenza Exercise series (PIX) remain a priority for the National 
Exercise Division (NED). The first Principal-Level Exercise (PLE) of FY 
2008, PLE 1-08, will focus specifically on Pandemic Influenza, and the 
myriad issues associated with a PI outbreak arriving in the United 
States. In support of that PLE, two Assistant Secretary-level exercises 
are being conducted. The first exercise--which has already occurred--
was hosted by the State Department in October, and focused on the U.S. 
response to an influenza outbreak prior to arrival in the U.S. This 
exercise included 21 senior officials from 12 agencies and White House 
offices. The results will inform and support the Cabinet level exercise 
in 2008. A similar exercise, also at the Assistant Secretary level, is 
being developed to cover issues related to an outbreak in the U.S.--and 
it will also inform and support the PLE. The Homeland Security Council 
is currently refining the scope of the PLE 1-08 exercise. The exercise 
is scheduled to be conducted in February 2008.
    In order to maximize lessons learned and address issues identified 
in the conduct of PLE 1-08, the Regional Pandemic Influenza Exercises 
will occur after that exercise. These exercises will take place in each 
of the five PI regions identified by the Department of Homeland 
Security (DHS), and will involve Regional representation (from state 
and federal partners) as well as activity at the Headquarters level. 
The current scope of the Regional PIX focuses on interaction between 
the Regions and Headquarters, although that may shift depending upon 
the lessons learned and issues identified during PLE 1-08.
    FEMA Regions I and II are co-hosting both a PI workshop and a PI 
functional exercise in November and December 2007 to examine the 
regions' response to a PI outbreak at the local level. Further, the 
Office of Health Affairs will conduct a PI Principal Federal Officials 
(PFO) workshop in late November 2008 to provide the first test of 
communications capabilities between Regional and National-level PFOs. 
Lessons learned from each of these exercises will also be incorporated 
into the PIX.

    Question 2.: Two things result from exercises: (1) the 
identification of actions necessary to correct problems, and (2) 
lessons learned. Knowing this, the Department of Homeland Security has 
created two activities--the Corrective Action Program, and the Lessons 
Learned Information Sharing system (with information pushed to 
LLIS.gov). After the pandemic influenza exercises have occurred as part 
of the National Exercise Program, what plans are there for using the 
Corrective Action Program and the Lessons Learned Information Sharing 
system? How does (or will) the Office of Health Affairs work to get the 
necessary information vetted and included in these programs? What part 
of the Office of Health Affairs will be staying on top of the 
situation, ensuring that corrective actions are taken, and that lessons 
are truly learned--before a pandemic occurs?
    Response: The National Exercise Program (NEP) requires the use of 
the Homeland Security Exercise and Evaluation Program (HSEEP) and the 
Corrective Action Program (CAP) to identify and resolve major issues 
from exercises and promotes the use of Lessons Learned Information 
Sharing System (LLIS) for distribution of lessons learned applicable 
and appropriate to the broader emergency management community. Any 
Pandemic Influenza (PI) exercises conducted within the NEP will utilize 
HSEEP, CAP and LLIS as part of the After Action Report process. 
(Additionally, exercises conducted outside of the NEP are encouraged to 
utilize tools provided through HSEEP, CAP and LLIS.) The Department's 
Office of Health Affairs (OHA) has representatives on the DHS Exercise 
and Evaluation Steering Committee and has participated in the 
development of the HSEEP and DHS-specific CAP procedures.
    CAP is a formal process and methodology that defines the roles and 
responsibilities for identification, development, prioritization, 
tracking, and analysis of corrective actions following exercises or 
real-world incidents that should receive consideration within the 
Department or the Interagency dependent upon the issue. It is an 
overarching program that refers issues to appropriate organizations--
such as the Office of Health Affairs--for priority action. The CAP 
System is a web-based tool that enables Federal, State, and local 
emergency response and homeland security officials to implement the CAP 
process.
    Since the launch of Lessons Learned Information Sharing (LLIS.gov) 
in April 2004, the Department of Homeland Security has sought to raise 
awareness of the program, increase membership, and encourage usage 
among its desired audience of emergency response and homeland security 
professionals through a coordinated outreach and awareness strategy. 
These efforts have increased LLIS.gov membership to more than 40,000 
professionals from all relevant disciplines, levels of government, and 
all 50 states and territories.

    Question 3.: What is the status of the Department of Homeland 
Security's pandemic influenza implementation plan? Previously, Dr. 
Runge (the Chief Medical Officer), has referred to this plan in 
testimony before Congress. We understand that it has been drafted 
completely, but that it is has not yet been posted to PandemicFlu.gov 
or the Department's own website. Has the draft plan been circulated 
throughout the Department? When do you expect that it will be 
finalized? What is it that personnel throughout the Department are 
working from to help the Department and the Nation prepare for an 
influenza pandemic?
    Response: The Department's pandemic influenza plan is in final 
draft form and has been circulated throughout DHS for use in developing 
component plans. We anticipate being able to revise it based upon a 
final version of a Federal Strategic Plan, which has been developed by 
a group led by DHS, and which is now in interagency review.

    Question 4.: According to the White House, DHS was to have worked 
with others to complete this action item from the Implementation Plan 
for the National Strategy for Pandemic Influenza--by October 2006. The 
task is, ``DOJ, DHS, and DOD shall engage in contingency planning and 
related exercises to ensure they are prepared to maintain essential 
operations and conduct missions, as permitted by law, in support of 
quarantine enforcement and/or assist State, local, and tribal entities 
in law enforcement emergencies that may arise in the course of an 
outbreak, within 6 months.'' Why has this task not been completed yet?
    Response: This item was extended because of the requirement for 
further development of a national quarantine policy and the ongoing 
interagency work being done on the Federal Pandemic Influenza Strategic 
Plan and the Federal Pandemic Influenza Border Management Plan. Policy 
issues surrounding quarantine are within the purview of other parts of 
the Executive Branch. As these policy issues become more clear, the 
operational elements can be accomplished.

    Question 5.: According to the White House, DHS was to have 
completed this action item from the Implementation Plan for the 
National Strategy for Pandemic Influenza--by December 2006. The task 
is, ``DHS, in coordination with DOT, HHS, and USDA, shall conduct 
tabletop discussions and other outreach with private sector 
transportation and border entities to provide background on the scope 
of a pandemic, to assess current preparedness, and jointly develop a 
planning guide, within 8 months.'' Why has this task not been completed 
yet?
    Response:
    The planning guide is under development as part of the broader 
efforts to complete sector-specific guides for all CI/KR sectors. 
Meetings with the various transportation modes are in progress. Modes 
that have completed their Guidelines (evidenced by endorsement by the 
Sector and Government Coordinating Councils) are: Mass Transit, Highway 
and Motor Carriers, and Rail. Work with Aviation and Maritime are in 
the final stages. Completion of the planning document is dependent on 
Border Policy development and Border CONOPS which have not been 
finalized by a collection of interagency partners.

    Question 6.: According to the White House, DHS was to have 
completed this action item from the Implementation Plan for the 
National Strategy for Pandemic Influenza--by April 2007. The task is, 
``DHS and DOT, in coordination with DOD, HHS, USDA, USTR, DOL, and DOS, 
shall develop detailed operational plans and protocols to respond to 
potential pandemic-related scenarios, including inbound aircraft/
vessel/land border traffic with suspected case of pandemic influenza, 
international outbreak, multiple domestic outbreaks, and potential mass 
migration, within 12 months.'' Why has this task not been completed 
yet?
    Response: This item was extended and will be addressed in the 
Border CONOPS that will be included as part of the interagency border 
management plan currently under development pending completion of a 
Federal Strategic Plan now in interagency review.
    Led by OHA, DHS continues to be heavily involved in an interagency 
effort that is currently finalizing a Federal strategic level pandemic 
influenza plan. When completed, this plan will effectively outline the 
roles, responsibilities and possible courses of action of all federal 
departments and agencies in preparing for and responding to a pandemic. 
An integral component of the strategic plan dealing with the complex 
issues involved in attempting to delay the entry of a pandemic through 
a variety of border management measures, has been completed by a 
separate interagency working group led by the IMPT and is currently 
undergoing internal review. There are several complex federal policy 
decisions involving issues such as screening and possible quarantine of 
passengers and potential diversion of flights pending, that impact the 
private sector. Engagement with the private sector has begun, a full 
review of operational and economic impacts need to be determined in 
order to finalize both plans. The goal is to have both plans completed 
prior to a principals level pandemic exercise that has been tentatively 
scheduled for mid February 2008. Once finalized, the federal strategic 
plan, incorporating the border management annex, will meet all the 
performance measures of the referenced action item(s).

    Question 7.: According to the White House, DHS was to have 
completed this action item from the Implementation Plan for the 
National Strategy for Pandemic Influenza--by April 2007. The task is, 
``DOT and DHS, in coordination with HHS, USDA, and transportation 
stakeholders, shall develop planning guidance and materials for State, 
local, and tribal governments, including scenarios that highlight 
transportation and border challenges and responses to overcome those 
challenges, and an overview of transportation roles and 
responsibilities under the NRP, within 12 months.'' Why has this task 
not been completed yet?
    Response: This item was extended and will be included as part of 
the interagency border management plan currently under development. 
Additionally, DOT and DHS POCs convened a working group to include 
transportation stakeholders, HHS and USDA. The group identified 
multiple documents that provide tailored guidance and planning 
materials that are available to state, local, and tribal governments as 
well as transportation stakeholders. Transportation roles and 
responsibilities are outlined in the NRP Emergency Support Function 
#1--Transportation Annex. The NRP has been widely distributed to 
stakeholders. Examples of documents are:
        1. The Role of Law Enforcement in Public Health Emergencies 
        (September, 2006); DOJ: Bureau of Justice Assistance; 38 pp. 
        Challenges addressed include: responding to and managing 
        incidents; risks to Law Enforcement to disease; immunization 
        and PPE; protecting the community; Law Enforcement's role 
        during involuntary restrictions, including quarantine; and 
        other subject areas.
        2. HHS Pandemic Influenza Plan supplement 9: managing travel-
        related risk of disease transmission; 16 pp. Challenges 
        addressed include: Engaging community partners; protocols for 
        managing ill passengers at ports of entry; quarantine 
        preparedness at ports of entry; legal preparedness; and others.
        3. DHS: Pandemic Influenza: Preparedness, Response, and 
        Recovery; Guide for Critical Infrastructure and Key Resources 
        (June 21, 2006) 84 pp. Challenges addressed include: 
        recommendations for planning, preparedness, response and 
        recovery for businesses (transportation sector is one of the 
        primary CI/KR elements); assessment recommendations on the 
        risks, impacts, and implications of pandemic-related 
        disruptions to international production, supply chain, and 
        goods and personnel movement; border challenges; and others.
        4. DOL: Guidance on Preparing Workplaces for an Influenza 
        Pandemic (OSHA 3327-02N 2007); 44 pp. This document provides 
        guidance to all stakeholders to meet the following Pandemic 
        Influenza challenges that directly relate to the transportation 
        sector and border issues: how Influenza Can Spread Between 
        People; classifying Employee Exposure to Pandemic Influenza at 
        Work; How to Maintain Operations During a Pandemic; How 
        Organizations Can Protect Their Employees; The Difference 
        Between a Surgical Mask and a Respirator; Steps Every Employer 
        Can Take to Reduce the Risk of Exposure to Pandemic Influenza 
        in Their Workplace.

    Question 8.: According to the White House, DHS was to have 
completed this action item from the Implementation Plan for the 
National Strategy for Pandemic Influenza--by April 2007. The task is, 
``DOT and DHS, in coordination with HHS, DOD, DOS, airlines/air space 
users, the cruise line industry, and appropriate State and local health 
authorities, shall develop protocols to manage and/or divert inbound 
international flights and vessels with suspected cases of pandemic 
influenza that identify roles, actions, relevant authorities, and 
events that trigger response, within 12 months.'' Why has this task not 
been completed yet?
    Response: This item was extended and will be included as part of 
the interagency border management plan currently under development 
pending completion of the Federal Strategic Plan now in interagency 
review.
    Led by the IMPT and coordinated by DHS/OHA, an interagency working 
group has completed a draft pandemic influenza border management plan 
that will be an integral component to the overall federal strategic 
pandemic influenza plan. While a draft plan has been completed, there 
are several complex federal policy decisions that have yet to be 
resolved. These areas include the screening and possible quarantine and 
isolation of ill passengers or passengers suspected of being exposed to 
pandemic influenza; and the possible denial of entry into the US of 
non-resident aliens during a pandemic. These complex federal policy 
decisions impact the private sector. Engagement with the private has 
begun, a full review of operational and economic impacts need to be 
determined. Interagency groups, in conjunction with and coordinated by 
sub-PCC and PCCs, continue to work towards finalizing these issues. 
Once finalized, the federal strategic plan , incorporating the border 
management annex, will meet all the performance measures of the 
referenced action item(s).

    Question 9.: According to the White House, DHS was to have 
completed this action item from the Implementation Plan for the 
National Strategy for Pandemic Influenza--by December 2006. The task 
is, ``HHS, DHS, and DOT, in coordination with DOS, DOC, Treasury, and 
USDA, shall develop policy guidelines for international and domestic 
travel restrictions during a pandemic based on the ability to delay the 
spread of disease and the resulting health benefits, associated 
economic impacts, international implications, and operational 
feasibility, within 8 months.'' Why has this task not been completed 
yet?
    Response: This item was extended and will be included as part of 
the interagency border management plan currently under development 
pending completion of the Federal Strategic Plan now in interagency 
review.
    Led by the IMPT and coordinated by DHS/OHA, an interagency working 
group has completed a draft pandemic influenza border management plan 
that will be an integral component to the overall federal strategic 
pandemic influenza plan. While a draft plan has been completed, there 
are several complex federal policy decisions that have yet to be 
resolved. These areas include the screening and possible quarantine and 
isolation of ill passengers or passengers suspected of being exposed to 
pandemic influenza; and the possible denial of entry into the US of 
non-resident aliens during a pandemic. These complex federal policy 
decisions impact the private sector. Engagement with the private has 
begun, a full review of operational and economic impacts need to be 
determined. Interagency groups, in conjunction with and coordinated by 
sub-PCC and PCCs, continue to work towards finalizing these issues. 
Once finalized, the federal strategic plan , incorporating the border 
management annex, will meet all the performance measures of the 
referenced action item(s).

    Question 10.: According to the White House, DHS was to have 
completed this action item from the Implementation Plan for the 
National Strategy for Pandemic Influenza--by February 2007. The task 
is, ``DHS, DOT, and HHS, in coordination with transportation and border 
stakeholders, and appropriate State and local health authorities, shall 
develop aviation, land border, and maritime entry and exit protocols 
and/or screening protocols, and education materials for non-medical, 
front-line screeners and officers to identify potentially infected 
persons or cargo, within 10 months.'' Why has this task not been 
completed yet?
    Response: This item was extended and will be included as part of 
the interagency border management plan currently under development 
pending completion of the Federal Strategic Plan now in interagency 
review.
    Led by the IMPT and coordinated by DHS/OHA, an interagency working 
group has completed a draft pandemic influenza border management plan 
that will be an integral component to the overall federal strategic 
pandemic influenza plan. While a draft plan has been completed, there 
are several complex federal policy decisions that have yet to be 
resolved. These areas include the screening and possible quarantine and 
isolation of ill passengers or passengers suspected of being exposed to 
pandemic influenza; and the possible denial of entry into the US of 
non-resident aliens during a pandemic. These complex federal policy 
decisions impact the private sector. Engagement with the private has 
begun, a full review of operational and economic impacts need to be 
determined. Interagency groups, in conjunction with and coordinated by 
sub-PCC and PCCs, continue to work towards finalizing these issues. 
Once finalized, the federal strategic plan , incorporating the border 
management annex, will meet all the performance measures of the 
referenced action item(s).

    Question 11.: According to the White House, DHS was to have 
completed this action item from the Implementation Plan for the 
National Strategy for Pandemic Influenza--by February 2007. The task 
is, ``DHS and HHS, in coordination with DOT, DOJ, and appropriate State 
and local health authorities, shall develop detection, diagnosis, 
quarantine, isolation, EMS transport, reporting, and enforcement 
protocols and education materials for travelers, and undocumented 
aliens apprehended at and between Ports of Entry, who have signs or 
symptoms of pandemic influenza or who may have been exposed to 
influenza, within 10 months.'' Why has this task not been completed 
yet?
    Response: This item was extended and will be included as part of 
the interagency border management plan currently under development 
pending completion of the Federal Strategic Plan now in interagency 
review.
    Led by the IMPT and coordinated by DHS/OHA, an interagency working 
group has completed a draft pandemic influenza border management plan 
that will be an integral component to the overall federal strategic 
pandemic influenza plan. While a draft plan has been completed, there 
are several complex federal policy decisions that have yet to be 
resolved. These areas include the screening and possible quarantine and 
isolation of ill passengers or passengers suspected of being exposed to 
pandemic influenza; and the possible denial of entry into the US of 
non-resident aliens during a pandemic. These complex federal policy 
decisions impact the private sector. Engagement with the private has 
begun, a full review of operational and economic impacts need to be 
determined. Interagency groups, in conjunction with and coordinated by 
sub-PCC and PCCs, continue to work towards finalizing these issues. 
Once finalized, the federal strategic plan , incorporating the border 
management annex, will meet all the performance measures of the 
referenced action item(s).

    Question 11.: Please provide us with information regarding the 
changes in ESF-8 from the National Response Plan to the National 
Response Framework. What impact will these changes--and any others in 
other parts of the National Response Framework--have on the pandemic 
influenza plans you already have in place?
    Response: The goals and objectives of ESF-8, and pandemic influenza 
plans, remain essentially unchanged under the National Response 
Framework. The need to work within an organized national structure, led 
by the Secretary of Homeland Security, working in close partnership 
with ESF-8 and others is still critical.

    Question 13.: How does the National Strategy for Pandemic Influenza 
relate to and work with the National Strategy for Homeland Security?
    Response: A detailed analysis of these documents is beyond the 
scope of the answer to a single question. However, pandemic influenza, 
particularly severe instances, represents a threat to the homeland in 
much the same way that other threat scenarios do. These strategic 
documents work in concert and in concert with other key planning 
documents.

    Question 14.: In his testimony, Dr. Jolly stated that, ``. . .DHS 
is currently leading the development of specific guides for each of the 
17 critical infrastructure and key resource sectors using the security 
partnership model.'' Please describe the security partnership model and 
how it is being applied to develop these guides. What is the status of 
these guides--when will they be completed? If they are available now, 
please forward them to the Committee staff.

                               FACT SHEET

         SECTOR-SPECIFIC PANDEMIC INFLUENZA PLANNING GUIDELINES

    The Guidelines are the product of collaboration between the 
Department of Homeland Security's Partnership and Outreach Division 
(POD) and the 17 Critical Infrastructure and Key Resource (CI/KR) 
Sectors. The Guidelines are part of an effort to develop Sector-
Specific Pandemic Planning Guidelines for all 17 of the Nation's CI/KR 
Sectors. These Guidelines are an annex to the Pandemic Influenza 
Preparedness, Response, and Recovery Guide for Critical Infrastructure 
and Key Resources (CI/KR Pandemic Influenza Guide), and have been 
designed to assist owners and operators within each Sector to plan for 
a catastrophic pandemic.
    The Guidelines are the next practical step in the ongoing 
requirement of the Department of Homeland Security (DHS) to support and 
facilitate effective pandemic preparedness and partnerships with the 
public and private sectors. The Implementation Plan for the National 
Strategy for Pandemic Influenza articulates the requirement for these 
Guidelines in task 9.1.2.1, which specifies:
        ``DHS, in coordination with Sector-Specific Agencies, critical 
        infrastructure owners and operators, and States, localities and 
        tribal entities, shall develop sector-specific planning 
        guidelines focused on sector-specific requirements and cross-
        sector dependencies.''

Purpose of Guidelines
         The Guidelines serve as a non-prescriptive reference 
        and a practical tool that business continuity planners can use 
        to augment and tailor their existing emergency response plans 
        to the exceptional challenges specific to a pandemic outbreak.
         It is important to integrate these Guidelines with 
        existing business continuity and emergency response plans and/
        or the CI/KR Pandemic Influenza Guide's comprehensive framework 
        for pandemic catastrophic planning.

    Guideline Development Process within the Sector Partnership 
Framework
    Given the potentially extreme consequences a severe pandemic could 
have on our Nation's economic and social stability, the importance of 
strong public-private sector partnerships in our preparedness efforts 
has never been more important. The POD pandemic support team is eager 
to work with you to develop practical and useful tools to assist you 
with pandemic influenza planning.
         The POD pandemic support team worked closely with the 
        Sector-Specific Agency (SSA), Sector Coordinating Council 
        (SCC), and Government Coordinating Council (GCC) of the Sector 
        to develop a concise document that captures the sector-specific 
        planning challenges a sector may face during a pandemic 
        influenza outbreak.
         The team's first step was to work with subject matter 
        experts identified by each sector to learn more about the 
        unique operational and structural characteristics of the 
        sector.
         With that input in hand, the team then developed a 
        draft Guideline and distributed it to the membership of the SCC 
        and GCC for formal review and comment.
    Each of the guidelines is being developed within the Sector 
Partnership Framework (also known as the Sector Partnership Model), 
which is outlined in the National Infrastructure Protection Plan 
(NIPP). The goal of the Sector Partnership Framework, including all of 
its associated structures, partnerships, and information-sharing 
networks, is to establish the context, framework, and support for 
activities required to implement and sustain the national CI/KR 
protection effort.
    The framework is the primary organizational structure for 
coordinating CI/KR efforts and activities. The Sector Partnership 
Framework encourages formation of SCCs and GCCs as described above. DHS 
also provides guidance, tools, and support to enable these groups to 
work together to carry out their respective roles and responsibilities. 
SCCs and corresponding GCCs work in tandem to create a coordinated 
national framework for CI/KR protection within and across sectors. The 
POD Pandemic team has worked closely with representatives of each SCC 
and GCC in the development, review, and endorsement of each Sector-
Specific Guideline. Additionally, as noted above, each SCC and GCC 
formally jointly reviews and endorses their Sector guideline.

Guideline Development Status Report
    The guidelines are being developed with a four-phase guideline 
development process:
         Phase One--Research and Create a Draft Review 
        Guideline: In collaboration with the appropriate SSA/SCC/GCC 
        representatives, the DHS teams will develop for each CI/KR 
        sector a draft Sector-specific Review Guideline.
         Phase Two--Formal SSA/SCC/GCC Review and Development: 
        the DHS teams will engage with each sector's SSA and SCC/GCC to 
        formally evaluate, enhance and endorse their sector's draft 
        review guideline.
         Phase Three--Workshop: with a sector endorsed 
        Guideline complete a CI/KR Guide and COP-E Update and Sector-
        specific Guideline Workshop(s).
         Phase Four--Distribute Final Approved Guidelines and 
        Post at Websites: after completing reviews and receiving formal 
        approval, DHS will distribute through the SSA and SCC/GCC to 
        the sectors and post on federal websites.
    There are 22 guidelines covering all 17 CI/KR Sectors, and there 
are currently drafts for each of these documents in various stages of 
development, as noted below. DHS anticipates posting all 22 guidelines 
on www.pandemicflu.gov and www.ready.gov in March 2008.
        1. Banking and Finance, Phase 1
        2. Chemical, Phase 2
        3. Commercial Facilities, Phase 3
        4. Communications, Phase 3
        5. Dams, Phase 3
        6. Defense Industrial Base, Phase 1
        7. Emergency Services, Phase 1
        8. Energy
                a. Oil and Natural Gas, Phase 3
                b. Electricity, Phase 3
        9. Food and Agriculture, Phase 2
        10. Government Facilities, Phase 1
        11. Information Technology, Phase 3
        12. National Monuments and Icons, Phase 1
        13. Nuclear, Phase 3
        14. Postal and Shipping, Phase 1
        15. Public Health and Healthcare, Phase 2
        16. Transportation
                a. Aviation, Phase 1
                b. Highway Motor Carrier, Phase 3
                c. Maritime, Phase 2
                d. Mass Transit, Phase 3
                e. Railroad, Phase 3
        17. Water, Phase 3

    Question 15.: In his testimony, Dr. Jolly stated that, ``. . .DHS 
is developing a coordinated government-wide planning forum.'' Please 
provide specifics regarding this planning forum. How is coordinated? 
Which governmental agencies participate? What does the forum produce? 
How often does it meet?
    Response: DHS is working within a construct that is coordinated by 
the Incident Management Planning Team, within the Operations 
Directorate. This interagency body is working to develop strategic 
plans for all threat scenarios. Subject matter expertise from within 
DHS guides the process, and participants include all departments and 
agencies involved in preparedness and response for each issue. This 
group works in various forms every day to developing these plans.

    Question 16.: In his testimony, Dr. Jolly stated that, ``an initial 
analysis of the response requirements for federal support has been 
completed.'' Please describe this analysis, and highlight its findings 
(providing the actual analysis is also sufficient to answer this 
question).
    Response:
        a. The Office of Health Affairs (OHA) in close coordination 
        with the Department of Homeland Security's (DHS) Incident 
        Management Planning Team (IMPT) has developed a Federal 
        Pandemic Influenza Strategic Plan.
        b. The Federal Pandemic Influenza Strategic Plan is the 
        distillation of over six months of planning development which 
        included an interagency review of the plan by over 53 different 
        Federal Departments and Agencies. Over 2,500 comments were 
        received and integrated into the final draft of this plan. The 
        final draft of this plan is projected to be submitted to the 
        Homeland Security Council (HSC) for review/approval NLT 
        December of 2007.
        c. This plan was developed following the five phase process 
        established in the National Planning and Execution System 
        (NPES). The figure below highlights the NPES Incident Decision 
        Making Process that was utilized to develop the plan.

                                                      National Planning and Execution System (NPES)
                                                            Incident Decision Making Process



  ..................................................            Phase 1             Phase 2             Phase 3             Phase 4             Phase 5
                                                      Understanding                                 
                                                              

  ..................................................       \01\ Mission        \02\ Mission               \04\ COA  \07\ Plan/Order           \09\ Plan
                                                         Identification            Analysis            Analysis         Preparation          Refinement

  ..................................................                                  \03\ COA            \05\ COA   \08\ Rehearsal
                                                                                Development                    Comparison

  ..................................................                                                      \06\ COA
                                                                                                       Approval


               Contingency (Deliberate) Planning Process

                      Figure 1. NPES IDMP Process

        d. This process requires extensive analysis during each phase 
        of the plan development. For example, over 30 different guest 
        speakers and 22 separate interagency meetings were conducted 
        during the mission analysis phase of the process.
        e. The current final draft of the plan identifies Federal 
        support requirements at the strategic level. This plan is over 
        50 pages long with hundreds of supporting pages (to include 
        multiple briefings) of supporting analysis. The Federal 
        Pandemic Influenza Strategic Plan is the result of the analysis 
        and provides the Federal response during each of the seven 
        Federal Pandemic Influenza Stages identified in the Pandemic 
        Influenza Implementation Plan.
    Question: In his testimony, Dr. Jolly stated that, ``. . .a 
national plan defining the federal concept for coordinating response 
and recovery operations during a pandemic has been developed and will 
be undergoing interagency review.'' Please describe this national plan. 
What is the federal concept for coordinating response and recovery 
operations during a pandemic? What is the status of the interagency 
review--when do you expect that it will be completed? (Providing the 
plan is sufficient to both describe the plan and answer the question 
regarding the federal concept.)
    Response: This national plan provides strategic level guidance that 
identifies key responsibilities and requirements across the Federal 
government. The federal concept relies on the construct outlined in the 
National Response Plan, the National Response Framework, HSPD-5, and 
other documents. As Secretary Leavitt and others have pointed out, 
overall response and recovery will also depend heavily on actions at 
the state and local level, due to the expected nature of a pandemic. 
The plan has been submitted for interagency review, which is a complex 
process. We continue to encourage a complete and efficient review 
process, but cannot predict precisely when this review process will 
conclude.

    Question: In his testimony, Dr. Jolly stated that, ``. . .a 
coordinated federal border management plan has been developed and is 
currently under review. This process included a wide range of 
partners.'' Please describe this border management plan. Who were the 
partners that helped to develop this plan? What is the status of the 
review--when do you expect that it will be completed? Who is conducting 
this review? (Providing the plan is sufficient to both describe the 
plan and answer the question regarding the federal concept.)
    Response: This border management plan provides strategic guidance 
for managing issues at our border during a pandemic, and identifies 
capabilities required to carry out that guidance. Partners included all 
departments and agencies involved in preparedness for this issue, along 
with representatives of state, county, and local public health, and 
public health laboratories. The plan is under review by the DHS 
Incident Management Planning Team, an interagency body. Wider review is 
pending review of the broader Federal Strategic Plan, now undergoing 
interagency review.

    Question 19.: What are the five regions to which the pre-designated 
regional PFOs and deputy PFOs are assigned? Do these personnel 
physically reside in these regions? If not, why not?
    Response:
    The five regions to which Principal Federal Officials (PFOs) and 
Deputy PFOs are assigned:
        Region A consists of Standard Federal Regions I and II:
        CT, MA, ME, NH, RI, VT, NJ, NY, PR and VI.

        Region B consists of Standard Federal Regions III and IV:
        DE, DC, MD, PA, VA, WV, AL, FL, GA, KY, MS, NC, SC and TN.

        Region C consists of Standard Federal Regions V and VIII:
        IL, IN, MI, MN, OH, WI, CO, MT, ND, SD, UT and WY.

        Region D consists of Standard Federal Regions VI and VII:
        IA, KS, MO, NE, AR, LA, NM, OK and TX.

        Region E consists of Standard Federal Regions IX and X:
        AZ, CA, HI, NV, AK, ID, OR, WA, AS, GU, MP, FM, MH, and PW.

        The PFOs and Deputy PFOs reside in the region to which they are 
        assigned.

    Question 20.: In his testimony, Dr. Jolly stated that, ``. . .the 
PFO teams have begun outreach both nationally and in their regions in 
advance of the more formalized exercise program being developed by 
DHS.'' Please describe these outreach efforts, as well as the more 
formalized exercise program being developed by DHS. Who is responsible 
for developing this program? When do you expect that this more 
formalized exercise program will be implemented?
    Response: The PFO teams have been participating in various state, 
local and regional Pandemic Influenza workshops sponsored by the 
Association of State and Territorial Health Officials (ASTHO), the 
National Governors Association, and HHS. The most recent outreach 
involved observing the CDC Internal Pan Flu Exercise in August 2007 in 
Atlanta, GA. The Regional PFOs have also taken opportunities to meet 
with some of the state governors to discuss issues related to PI 
preparedness and response efforts.
    The FEMA National Exercise Program is responsible for planning, 
coordinating, and developing exercises related to Pandemic Influenza in 
coordination with DHS Operations Coordination (the Program Manager), 
the Office of Health Affairs, and the National PFO Team headed by VADM 
Crea. The Pandemic Influenza PFO Teams are scheduled to conduct an 
internal exercise on 27 Nov 2007 involving the Regional PFO Teams 
operating from their pre-designated Joint Field Office locations and 
communicating the appropriate situational reports to the National PFO 
Team at the National Operations Center. The teams will also be given 
specific exercise scenarios and injects that are specific to their 
regional Area of Responsibility.

    Question 21.: In his testimony, Dr. Jolly stated that, ``on an 
ongoing basis, DHS participates in interagency working groups to 
develop guidance, including community mitigation strategies, medical 
countermeasures, vaccine prioritization and risk communication 
strategies.'' Which interagency working groups does DHS participate in? 
Please provide a comprehensive list.
    Response: DHS participates on an ongoing basis on workgroups 
addressing a list of pandemic issues, including community mitigation, 
medical countermeasures, vaccine prioritization, and border management, 
along with other less formal groups that address specific issues as 
they arise.
    Interagency committees that DHS (specifically OHA) participates in 
include:
         Pandemic Influenza Strategic Guidance Planning Process
         Border Management IMPT Process
         Pandemic Influenza Vaccine Prioritization Interagency 
        Work Group (as co-lead)
         Pandemic Influenza Antiviral Household Prophylaxis 
        Work Group
         Antiviral Drug Stockpiling by Employers in Preparation 
        for an Influenza Pandemic Work Group
         State Panflu Operational Plans Workgroup
         DHS Human Capital Pandemic Planning Work Group
         HHS/ASPR PanFlu Risk Management Steering Committee

    Question: In answering to a question from Rep. Langevin (During a 
pandemic, when would the Secretary of Homeland Security lead and when 
would the Secretary of Health and Human Services lead?), Dr. Jolly 
stated that, ``. . .under the construct, the Secretary of Homeland 
Security is responsible for overall domestic preparedness and incident 
coordination at the federal level and would lead the overall federal 
activities, while the Secretary of Health and Human Services led the 
health and medical response. . . '' Please describe--using scenarios as 
you see fit--when the Secretary of Homeland Security and the Secretary 
of Health and Human Services would execute the responsibilities 
articulated by Dr. Jolly in his testimony, and lead various efforts 
during the response to an influenza pandemic.
    Response: As stated in my testimony, and consistent with the 
National Response Plan, the National Response Framework, HSPD-5, and 
other guiding documents, The Secretary of Homeland Security and the 
Secretary of Health and Human Services will fulfill these specific 
duties. During a pandemic, which would likely have wide-ranging and 
severe effects, the Secretary of Homeland Security would serve as the 
leader of the federal response, coordinating activities of all 
departments and agencies working through the ESF structure. The 
Secretary of the Health and Human Services will fulfill the major 
responsibility of overseeing the public health and medical response as 
outlined by RADM Vanderwagen.

    Question: How is DHS trying to bring its grants into the same time 
sequence as the HHS grants? How is it trying to harmonize the DHS and 
HHS grants? Is DHS trying to do this with the grants put out by any 
other member of the Executive Branch? If so, which departments and 
agencies?
    Response: In June 2005, DHS and the U.S. Department of Health and 
Human Services (HHS) established a Joint Grant Program Steering 
Committee to facilitate the integration of preparedness activities 
across State and local preparedness programs managed by both 
Departments. This committee is staffed by key program offices from both 
Departments, including the DHS Grant Programs and National Preparedness 
Directorates within FEMA and the Office of Health Affairs in the 
National Protection and Programs Directorate, and the HHS Office of the 
Assistant Secretary for Preparedness and Response, the Centers for 
Disease Control and Prevention, and the Office of the Surgeon General.
    The mission of this grants coordination committee supports 
requirements outlined in the White House Federal Response to Hurricane 
Katrina: Lessons Learned report as well as the newly issued Homeland 
Security Presidential Directive 21: Public Health and Medical 
Preparedness, which directs the Secretary of Health and Human Services, 
in coordination with the Secretary of Homeland Security, to develop and 
maintain processes for coordinating Federal grant programs for public 
health and medical preparedness using grant application guidance, 
investment justifications, reporting, program performance measures, and 
accountability for future funding in order to promote cross-sector, 
regional, and capability-based coordination.
    Through this committee and ongoing coordination among program 
offices, DHS and HHS will continue to work with State and local 
applicants to support and, where possible, integrate preparedness 
activities regarding programs managed by both Departments. This 
includes supporting a range of activities that are achieved through 
collaboration at the State and local level among public safety, 
emergency management, health and medical communities, and non-
governmental entities, such as:
         Developing clear public health emergency plans that 
        delineate who will do what during each stage of the response
         Identifying the specific competencies needed to 
        complete the tasks associated with the operational plan
         Implementing effective training programs that 
        specifically support the competencies related to the public 
        health emergency plan
         Conducting joint exercises to meet multiple 
        requirements from various grant programs
         Engaging special needs populations and/or those who 
        represent them in preparedness planning and exercise activities
         Conducting joint training for local decision-makers 
        (including government administrators, health and medical 
        professionals, and emergency managers) on issues of joint 
        concern, such as pandemic flu preparedness or risk 
        communication
    Given that the application periods and allowable activities are 
frequently driven by statutory provisions, the alignment of application 
deadlines and award cycles is a longer-term issue that must be 
carefully considered by both Departments. However, emphasizing a 
coordinated approach to programmatic activities under the grants, 
particularly those that may overlap across Departments, is a primary 
focus of the grant steering committee's work and the guidance 
development process for all relevant components.

    Question 24.: In his testimony, Dr. Jolly stated that ``. . .we 
have plans within our Principal Federal Officials group to exercise 
within that group and then lead that into a series of leadership level 
interagency exercises and to culminate in another cabinet-level 
exercise over a period of time as the schedule develops.'' What are 
these plans? When will the PFO group be exercised? When is the series 
of leadership level interagency exercise scheduled to occur? When will 
the next cabinet-level exercise occur?
    Response: The plans refer to the PFO Team exercise workshop being 
conducted November 27, 2007. The PFO Team for Pandemic Influenza 
Response conducted an exercise workshop on November 27, 2007. It served 
as an internal communication and information exchange exercise 
involving the regional teams operating from their pre-designated Joint 
Field Office locations, and the National PFO operating from the 
National Operations Center. The findings from this first exercise will 
be the basis for additional training and exercise venues for the PFO 
teams.
    The FEMA National Exercise Program is working actively with the 
White House Homeland Security Council's Planning, Training, Exercise 
and Evaluation Council (PTEEC) Policy Coordination Committee (PCC) on 
both an Assistant-Secretary Level and Principals-Level Exercise for 
Pandemic Influenza. The Cabinet level exercise is scheduled for 
February, 2008.. A series of exercises are expected for development 
over the next few years. The FEMA National Exercise Program, lead by 
Mr. Jim Kish, and the PTEEC PCC is developing the schedule and details 
for the next exercise. Mr. Kish can be contacted at 202 786-9580.

    Question 25.: Can the National Biosurveillance Integration System 
(NBIS) be used to track seasonal influenza now, treating the disease as 
if it were pandemic influenza? Is this occurring now? If not, what 
other proxy diseases is NBIS using to continuously stress the System 
and ensure it will be ready (or as ready as possible) when an influenza 
pandemic does occur?
    Response: NBIS currently tracks seasonal influenza with specific 
attention to any warning signs of a potential or actual pandemic event. 
The monitoring, within the Center (National Biosurveillance Integration 
Center), utilizes subject matter experts and epidemiologic strategies 
in conjunction with our National Biosurveillance System Group (NBSG) 
partners in accordance with its biosurveillance mission. Principle 
responsibility in tracking seasonal influenza and monitoring for 
pandemic influenza lies with our NBIS interagency partner, Department 
of Health and Human Services, who is also a member of the NBSG.
    NBIS uses the System on a 24/7 basis to track major diseases events 
on a worldwide basis to proactively maintain a readiness posture. 
Notification procedures, for routine and urgent issues, are regularly 
utilized to maintain situational awareness with senior leadership and 
key stakeholders within DHS and the interagency partners.

    Question: What is the current status of NBIS? How long will it take 
before you feel that NBIS will be able to function well enough to track 
the beginnings of an influenza pandemic? What else is necessary to get 
NBIS to the fully functional state that you envision?
    Response: NBIS, as a total, integrative, collaborative system of 
interagency inputs and surveillance systems with supportive IT 
structure is expected to reach its Initial Operating Capability (IOC) 
this January. It is scheduled to reach its Full Operating Capability 
(FOC) in September, 2008, pursuant to Public Law 110-53. The National 
Biosurveillance Integration Center (NBIC) is fully operational now with 
two specific analytic elements: a 24-hour a day 7-day a week Watch Desk 
manned by U.S. Public Health Service officers located within the 
Department's National Operations Center and a select group of full-time 
subject matter experts/analysts including NBIC's first interagency 
detailee (a senior epidemiologist from the Center for Disease Control). 
This combined effort provides round-the-clock receipt and assessment of 
over 350 varied sources of information to track and examine ongoing 
bio-events occurring globally in multiple domains, and the ability to 
determine relative significance to homeland security. Via our partner 
agencies with whom we have Memorandums of Understanding (HHS, DoD, , 
USDA, DOI, and State Dept) as well as our internal DHS components, the 
NBIC is capable of receiving and responding to events and tracking 
information that is currently provided by the primary responsible 
agencies, as part of this developing interagency system. To reach full 
functional capability we still require the final integration and 
testing of the NBIS 2.0 SBU IT System (scheduled for initial 
operational capability in January 2008), increased integration of 
existing information streams from MOU agencies, and detailing of 
Subject Matter Experts from the primary domains of interest--all of 
which is addressed in the Implementing Recommendations of the 9/11 
Commission Act of 2007 (PL-110-53).

Questions from the Bennie G. Thompson, Chairman, Committee on Homeland 
                                Security

                   Responses from David L. Lakey, MD

    Question 1.: Please describe how the academic centers interact with 
the State Department of Health in Texas. How can this interaction be 
improved in advance of a pandemic?
    Response:  The Texas Department of State Health Services 
(DSHS) interacts with academia on public health emergency preparedness 
issues on several levels.
         DSHS has several forums for communication with the 
        academic health science centers located in Texas. Three members 
        of the DSHS Preparedness Coordinating Council (PCC), which is 
        the Commissioner's statewide advisory committee on 
        preparedness, are from academic health science centers. In 
        addition, several years ago DSHS formed the Academic Senior 
        Advisory Forum on Public Health Preparedness that includes 
        representatives from academic institutions across the state as 
        members. This group, which meets every six months, serves in an 
        advisory capacity to the Commissioner of State Health Services 
        regarding health and medical preparedness.
         DSHS also works collaboratively with the two Centers 
        for Public Health Preparedness in Texas, located at Texas A&M 
        University and at the University of Texas at Houston. 
        Representatives of these institutions work with DSHS to ensure 
        coordination of strategic planning and implementation of 
        activities in order to maximize use of federal funds provided 
        to Texas.
         Following Hurricanes Katrina and Rita, DSHS made a 
        concerted effort to ensure that all 10 of the state's academic 
        health science centers and approximately 100 schools of nursing 
        were connected with and included in their respective local 
        emergency management infrastructures. DSHS has also engaged 
        colleges and universities that have allied ancilliary and 
        health practice majors and/or programs, including social work, 
        veterinarian and pharmacist programs.
         During the 2005 response to Hurricanes Katrina and 
        Rita, a remarkable collaboration developed DSHS and the 
        academic institutions When Houston was designated as the 
        receiving site for Louisiana residents evacuating New Orleans, 
        medical, civic and academic leaders worked diligently to open 
        medical shelters in Houston's two civic arenas; in a short time 
        they established a comprehensive medical triage, treatment and 
        in-patient presence to support medical needs of those Louisiana 
        residents. Similarly, in College Station, Texas A&M's School of 
        Veterinarian Medicine cleared out, cleaned, disinfected, and 
        opened for human use their large animal hospital. This facility 
        housed several hundred medical evacuees from the Houston--
        Beaumont area of Texas who left in the face of Rita. In the 
        Panhandle of Texas, Texas Tech University Health Science Center 
        staff and residents established an in-patient treatment 
        facility at the former Reese AFB, while in Tyler, the 
        University of Texas Health Science Center cared for medical 
        special needs persons in the local community college gym. 
        Schools of nursing, pharmacy, mental health and other academic 
        programs contributed significant support to state-wide efforts 
        to assist with medical needs of evacuees.
         The DSHS Regulatory Division has been working with the 
        Executive Chancellor for Health Affairs of the University of 
        Texas System on new ways to enhance DSHS' capacity to respond 
        effectively to emergent public health and medical situations. 
        Current plans include increasing the number UT of School of 
        Nursing Graduate Students working with preceptors in DSHS on 
        specific projects.
         DSHS interaction with Academic Health Centers could be 
        improved in advance of a pandemic by documenting potential 
        response roles and activation plans in the following 
        categories:
         Diagnostic capabilities and ``surge capacity;''
         Mass dispensing, triage, and care;
         Emergency-event enhanced surveillance;
         Emergency hotline support;
         Just-in-time training;
         Expert consultation; and
         Forum for consideration of unique therapies Media 
        resources.

    Question 2.: You advocate an all-hazards approach, which includes 
pandemic influenza, for public health emergency preparedness. Please 
describe how the unique characteristics of different hazards are 
addressed by planning efforts. Specifically, how does planning for an 
influenza pandemic differ from all of the other hazards?
        Response:
         DSHS advocates an all hazards approach for public 
        health preparedness because core public health can and should 
        be applied to any type of emergency incident, whether it 
        qualifies as a public health emergency or not.
         Core public health include:
                 Monitoring health status to identify community 
                health problems;
                 Diagnosing and investigating health problems 
                and hazards in the community;
                 Informing, educating, and empowering people to 
                take action about health issues;
                 Enforcing laws and regulations that protect 
                health and ensure safety; and
                 Linking people to needed personal health 
                services and assuring provision of health care when 
                otherwise unavailable.
         In Texas, the responsibility to develop or support 
        emergency response plans is assigned to the Governor's Division 
        of Emergency Management (GDEM). Public health professionals 
        participate in planning initiatives at all jurisdictional 
        levels. Hazard and vulnerability assessment is a key step in 
        the plan development process, and when a health impact is 
        anticipated, DSHS explores a potential response role for public 
        health.
         Since it is anticipated that pandemic influenza will 
        occur in multiple waves of illness, a lengthy, sustained 
        response and recovery operation will be required. It is likely 
        that over the course of the pandemic up to 50 percent of the 
        workforce may be absent due to illness, caretaking 
        responsibilities, fear of contagion, and loss of public 
        transportation or imposition of public health disease control 
        measures. Consequently, DSHS is working in Texas to engage non-
        traditional public health partners who know most about critical 
        public infrastructure in planning for continuity of business 
        operations.
         Because absenteeism over the course of the pandemic 
        will be high, state employees might be cross trained to provide 
        essential services and functions at state agencies besides 
        their own place of employment. Therefore, continuity of 
        operations planning during a pandemic must address the HR 
        issues that need to be handled uniformly across state agencies.
         Response to most hazards is quick decontamination and 
        recovery. The response to a pandemic influenza outbreak will be 
        to mitigate the overall impact with strategies to reduce 
        mortality and morbidity, to flatten the outbreak curve thereby 
        reducing the peak of illnesses and buy time in order to produce 
        vaccine and to maintain continuity operations over a longer 
        period of time.
         Due to the extended nature of pandemics when compared 
        to disasters of limited duration, like an explosion or 3-day 
        flood, the response to the former is more complex. These may 
        include a huge volume of resources to be managed, potential 
        school closures, along with early warning and public messaging 
        challenges.

    Question 3.: From the public health perspective, there are certain 
similarities and differences between disasters and pandemics. Please 
describe a few of both, and talk about the implications you see for 
federal support from both the Department of Homeland Security and the 
Department of Health and Human Services
    Response:  Disasters tend to be limited in scope to a 
certain area while pandemics tend to have widespread geographic impact.
         Disasters themselves tend to have a short duration 
        followed by a variable recovery period. Pandemics tend to last 
        for several months with multiple waves lasting several weeks 
        each. Timing of an interim recovery period for a pandemic is 
        critically short and unpredictable and the overall recovery 
        period may take years.
         In disasters, material loss predominates while in 
        pandemics human loss does.
         Those responding to disasters can count on local 
        material aid and state/federal response. During a pandemic, 
        response is local; state/federal response may be very limited.
         To receive adequate support, the following are needed:
                 Conducting studies to guide preparedness and 
                response scientifically;
                 Funding local laboratories to identify 
                pandemic influenza;
                 Funding sustained efforts at the state and 
                local level;
                 Increasing manpower to control sporadic 
                outbreaks;
                 Suspending federal laws that limit state's 
                ability to get antivirals and vaccines to people, close 
                borders, or otherwise limit state response efforts.
         From a public health perspective, the pressure on the 
        U.S. Department of Homeland Security (DHS) and the Department 
        of Health and Human would intensify during a pandemic. 
        Traditional support such as staffing, equipment, and supplies 
        that DHS provides through FEMA and other federal agencies would 
        not be available since the entire nation would be affected at 
        the same time. Public health at the state and local level would 
        have to respond with existing resources and would not be able 
        to expect additional resource support from the federal 
        government.
         HHS would have to consider significant waiver of 
        regulations for health care institutions such as hospitals and 
        nursing facilities. An altered standard of care must be 
        considered since facility and medical staff would be extremely 
        overtaxed. Medical surge temporary facilities would not be able 
        to meet Medicare standards.
         DHS and HHS should consider mechanisms to support the 
        continued re-supply of pharmaceuticals, medical supplies, 
        antivirals, and other infrastructure resources for healthcare 
        facilities. Traditional supply chains will be disrupted. 
        Increased security will be required for manufacturing, 
        warehousing, and transportation of these public health and 
        medical supplies and equipment.

    Question 4.: How has pandemic influenza been incorporated into the 
Texas Homeland Security Strategic Plan? How do you think your efforts 
could be modeled for other states?
        Response:  The Texas Homeland Security Strategic Plan 
        states that ``health related emergencies are a homeland 
        security focus. . .'' This plan addresses the importance of 
        optimal detection and rapid response as well as human and 
        animal health surveillance. Texas's Pandemic Influenza Response 
        Plan is found in Appendix 7 to the Health and Medical Annex H 
        of the Texas State Emergency Management Plan, which is a 
        companion document to the Texas Homeland Security Strategic 
        Plan.
         Strengths of Appendix 7 to Annex H which could serve 
        as models for other states include:
                 Assignment of supporting roles for 26 distinct 
                agencies, including two agencies engaged in the state's 
                preparedness planning efforts for the first time, the 
                Office of the Secretary of State and the Division of 
                Economic Development and Tourism within the Office of 
                the Governor.
                 Addition of a clear, strong and significant 
                manpower commitment from the Texas Military Forces to 
                fully support pandemic influenza response and recovery 
                operations.
                 Clear between this plan, which is response to 
                human influenza, and the Foreign and Emerging Animal 
                Diseases (FEAD) Plan, which includes response to avian 
                flu. The Texas Animal Health Commission holds primary 
                responsibility for the FEAD plan which includes a 
                supporting role for DSHS.
                 Addition of educational efforts to agency 
                stakeholders as a general responsibility for all 
                agencies.

    Question 5.: Please discuss how improving our efficacy against 
seasonal flu may reduce risk in the event of a pandemic.
    Response:
         Seasonal flu is a significant public health problem 
        that is a major cause of morbidity and mortality annually in 
        Texas: Approximately 36,000 US deaths are attributed to 
        seasonal influenza each year; an estimated 3,000-4,000 Texas 
        deaths annually.
                 Seasonal flu and pandemic flu have several 
                characteristics in common:
                 Given that pandemic flu is likely to emerge as 
                a combination of seasonal flu and avian flu strains, 
                vaccination against seasonal flu may be expected to 
                offer some degree of cross protection against a 
                pandemic flu strain.
                 At the very least, vaccination may avoid a co-
                infection of seasonal flu on top of a pandemic flu 
                infection.
         Antiviral medications currently being considered for 
        use against pandemic flu have been developed for use against 
        seasonal flu. Rather than simply stockpiling these for use 
        against pandemic flu, their use should integrated into broader 
        treatment/prophylaxis standards of practice within the health 
        provider community; thereby:-
                 Reducing impact of seasonal influenza on 
                citizens;
                 Recruiting private providers into the overall 
                response effort;
                 Incorporating retail pharmacies into antiviral 
                distribution pipelines, perhaps setting up a ``vendor 
                managed inventory'' type of stockpile distribution 
                within the network of retail pharmacies;
         Widespread seasonal influenza vaccination of citizens 
        should be a part of any seasonal influenza / pandemic flu 
        response plan. Widespread seasonal flu vaccination needs to be 
        incorporated into standards of practice so that private 
        providers and pharmacies are reimbursed for costs of covering 
        their patients. Seasonal flu vaccination is still consistently 
        underutilized and current vaccine production is not sufficient 
        for national and state needs. Increased doses of seasonal 
        vaccine will not be produced by manufacturers until demand for 
        current production levels is exceeded. Not only will this 
        provide greater seasonal flu protection for the population each 
        year, but also increase vaccine production capacity in case 
        pandemic flu hits this state and nation.
                 Seasonal flu vaccine is expected to provide at 
                least some partial protection against pandemic flu, in 
                addition to reducing the impact of pandemic infection 
                by minimizing risk for seasonal/pandemic flu CO-
                infections. The last two pandemic flu pandemics have 
                been a result of a resortment process between a novel 
                avian strain (such H5/N1) as combined with a 
                circulating seasonal strain. At least part of the 
                emerging, resorted pandemic strain will have seasonal 
                components for which seasonal vaccination will provide 
                at least partial protection.
         Public health should not be expected to carry the full 
        responsibility for addressing pandemic flu response efforts. A 
        large number of Texans have health care providers and 
        insurance. This existing framework of care should be better 
        utilized in statewide management of seasonal influenza, as well 
        as continuing to serve as primary care and prevention platforms 
        for dealing with pandemic flu. Treatment and prevention of 
        seasonal flu should be incorporated into standards of practice. 
        This will position healthcare providers and the public to deal 
        more effectively with a pandemic.
         Concerns about development of antiviral resistance 
        through routine use of antivirals may be offset by the 
        following:
                 The pandemic strain that emerges will likely 
                have a different sensitivity/resistance pattern than 
                the circulating seasonal strain.
                 Manufacturers will be encouraged to have new 
                antivirals in the development pipeline.
                 Closer surveillance of resistance patterns may 
                document that use of less costly antivirals, such as 
                the M2 agent amantadine, alone or in combination with 
                other medications.
         Strategic surveillance with rapid testing for 
        seasonal/pandemic flu should be in place so that identification 
        of introduction of seasonal/pandemic flu into Texas occurs at 
        the earliest possible moment. Models of disease spread and 
        epidemiologic experience with spread of infection document that 
        early intervention (control and prevention through targeted use 
        of antivirals and vaccines) will be the major determinant on 
        reducing the effect of seasonal and pandemic flu on morbidity 
        and mortality within the population. The ability to rapidly 
        distinguish between seasonal and pandemic flu strains is of 
        vital importance in this early detection effort.
         The same personal and community precautions that help 
        prevent spread of seasonal flu , such as cough etiquette (for 
        example covering the mouth with a sleeve, rather than a hand); 
        good hand washing / hand sanitation; staying home when ill, and 
        human resources policies that promote influenza prevention in 
        the workplace will help prevent spread of a pandemic strain of 
        influenza. Additional community strategies to mitigate a 
        pandemic are likely to be more accepted and better followed if 
        citizens already take personal, school, and workplace 
        prevention of influenza seriously.

    Question 6.: What do you think we can do now to address health 
disparities, and prevent pandemic influenza from disproportionately 
affecting parts of our population?
         Disparities in public health can be seen in both of 
        the following areas:
                 Persons 65 and older not receiving seasonal 
                flu vaccine: 28.6% of non-Hispanic whites, 49.4% of 
                Hispanics and 54.1% of African-Americans. Minority 
                seniors are almost twice as likely to not receive 
                seasonal flu vaccine. (Source: 2006 BRFSS).
                 Lack of healthcare coverage in adults under 
                the age of 65: 13.9% of non-Hispanic whites, 30.0% of 
                African-Americans, and 50.1% of Hispanics. Hispanics 
                are more than 3 times and African-Americans 2 times as 
                likely to not have health care coverage. (Source: 2006 
                BRFSS).
                 Addressing these disparities related to 
                influenza prevention could include additional programs 
                for seasonal immunization with a focus on closing the 
                disparity gap, As systems are developed to provide 
                seasonal immunizations, the capacity to deliver 
                pandemic immunizations would increase.
                 Department of Homeland Security has provided 
                Texas with some funding to exercise hurricane 
                evacuation and sheltering for the last 3 years. Texas 
                has studied special needs evacuees, including those 
                along the border area, in a situation without 
                utilities. Through the Governor's Division of Emergency 
                Management and the National Emergency Response and 
                Rescue Training Center, Texas has worked to identify 
                and quantify those individuals who will need special 
                evacuation assistance, special medical assistance. More 
                effort will need to be made through planning and 
                exercising to continue to discover additional 
                requirements needed for extended sheltering and 
                staffing.
                 It is unlikely that enough measures can be put 
                into place to prevent pandemic influenza from 
                disproportionately affecting parts of the population. 
                Health care workers will be disproportionately exposed 
                early on with relatively little warning. Residents in 
                some areas along the international border will be less 
                likely to have access to health departments for 
                information and aid. They may be disproportionately 
                exposed by immigration. Reaching rural and remote areas 
                with screening and surveillance will continue to be a 
                challenge.

    Question 7. According to the Implementation Plan for the National 
Strategy for Pandemic Influenza, ``The Federal Government shall, and 
State, local, and tribal governments should, define and test actions 
and priorities required prepare for and respond to a pandemic, within 6 
months'' of when the Plan was released--so the deadline would have been 
October 2006. What are challenges here? Are you waiting for the Federal 
government to provide you with guidance and resources?
    Response:  Traditionally, Texas has not waited for federal 
guidance to define and test actions and priorities. Texas has had a 
Pandemic Influenza Plan at the Department of State Health Services 
since 2004. It was updated and posted in October 2005. It has since 
been renamed the Pandemic Influenza Plan Operating Guidelines (PIPOG). 
Revisions to the plan have been made to reflect changes in science, 
federal guidance and available resources and as additional pieces of 
the plans are developed and tested. DSHS will post revised planning 
guidelines by the end of 2007. Local health departments have developed 
plans specific to their jurisdictions. State and local plans are 
routinely exercised and modified based on after action reports.
         Some of the challenges include:
                 Aligning Texas plans developed prior to 
                receiving federal guidelines takes time.
                 With several federal plans and guidelines 
                coming from different agencies, including Homeland 
                Security, Health and Human Services, and Centers for 
                Disease Control and Prevention, determining which 
                federal guidelines take priority can be a challenge.
         Consequently, it is preferable that:
                 A clear line of leadership to the states is 
                established.
                 One set of guidelines which represents the 
                collective guidance of all involved federal agencies be 
                developed.

    Question 8.: According to the Implementation Plan for the National 
Strategy for Pandemic Influenza, ``State, local, and tribal law 
enforcement agencies should coordinate with appropriate medical 
facilities and countermeasure distribution centers in their 
jurisdictions to coordinate security matters, within 6 months'' of when 
the Plan was released--so the deadline would have been October 2006. To 
your knowledge, has any of this coordination taken place? If so, how, 
and if not, how would you recommend this happen?
    Response:  Coordination between law enforcement agencies 
and local health departments is a key element in countermeasure 
distribution planning of medication from the National Stockpile. This 
coordination has happened with varying of success in local 
jurisdictions in Texas and nationwide. This coordination did not appear 
to increase substantially as a result of release of this plan. The 
importance of this coordination and expected results should be 
communicated and emphasized through law enforcement channels to be 
effective. This might be done through professional associations as well 
as licensing bodies.

    Question 9.: What roles do associations play in assisting their 
constituents with emergency and pandemic preparedness?
        Response:  Some associations have an advisory role in 
        developing plans and operational guidelines for pandemic 
        preparedness and response. For example, the Texas Medical 
        Association currently has a representative on the Preparedness 
        Coordinating Council, which provides oversight for all 
        preparedness activities. There are also organizations that have 
        been identified in Annex H: Health and Medical to the State 
        Emergency Plan as having a responsibility in any statewide 
        public health disaster response. Other public health and 
        medical associations play a key role in helping Texas be better 
        prepared. These organizations are partners with DSHS in 
        increasing the ability for a timely preparedness response to a 
        or natural disaster and include the Texas Hospital Association, 
        the Texas Nurses Association, and the Texas Association of 
        Local Health Officials.
    Question 10. The Government Accountability Office (GAO) says in its 
report that State, Territorial, Tribal, Local, and other stakeholders 
need to be involved in providing input to the National Strategy for 
Pandemic Influenza and its implementation Plan, especially as the 
National Strategy evolves. If you were at the White House, how would 
you ensure this happens?
         Response: States vary in their response planning to 
        pandemic influenza. There are differences in interpretation of 
        federal guidelines. State and federal planning are not 
        synchronized, with the states often planning in advance of the 
        release of federal guidelines. In addition, states do not 
        always coordinate with each other, in part due to substantial 
        differences in governmental structure, law, and demographics.
        It would be helpful to include state stakeholders at the 
        beginning of planning processes rather than at the middle or 
        end. The best way to achieve that is to provide multiple 
        vehicles for stakeholders to participate in the process.

    Question 11.: As you all know, public health has been identified as 
one of the critical infrastructures of our Nation.
        a. Have you been included in the planning undertaken by the 
        Department of Homeland Security to protect the public health 
        infrastructure?
        Response:  Although DSHS has not been directly involved 
        in the planning undertaken by the of Homeland Security (DHS), 
        DSHS works collaboratively with the Texas Office of Homeland 
        Security and with the Texas Governor's Division of Emergency 
        Management. DSHS provided input on the Texas Homeland Security 
        Strategic Plan 2005--2010.

        b. From what you know about this work, how does it affect you 
        in your and local positions?
    Response:
         Two documents, the National Strategy for Pandemic 
        Influenza (November 2005) and the National Strategy for 
        Pandemic Influenza implementation Strategy (May 2006), provided 
        Texas with a general framework for the state response as well 
        as roles and responsibilities for federal agencies. These 
        documents were used to validate the Texas plan that had already 
        been developed and to additional elements to be included.
         DHS will be responsible for coordination of the 
        overall federal response during an influenza pandemic, while 
        the DHS Office of Health Affairs will be leading coordination 
        of efforts that affect state and local policies. This will 
        include implementation of policies that facilitate compliance 
        with recommended social distancing measures, and entry and exit 
        screening for influenza at the borders as they ensure domestic 
        security. Texas has 1,240 miles of international border with 
        many bridges for vehicle and foot traffic to and from Mexico. 
        Many border counties in Texas do not have local health 
        departments. Therefore, surveillance at the points of entry 
        will be critical to Texas during an influenza pandemic. Other 
        initiatives by DHS that affect Texas include the publication of 
        the Pandemic Influenza Preparedness Response and Recovery Guide 
        for Critical Infrastructure and Key Resources (The Guide). 
        Texas has used the Guide for a State-level Pandemic Influenza 
        Exercise. Texas has also participated in the Determined Accord 
        Pan Flu exercise developed by DHS and FEMA.

    c. What more do you think needs to be done in this regard, 
especially in advance of an influenza pandemic?
     DSHS would like to have greater interaction with 
representatives of federal agencies or the DHS Regional (PFOs) planners 
during preparedness exercises. All plans have elements that may be 
subject to ``interpretation,'' and by having federal representatives 
present at state-level exercises, some of the ambiguities can be 
resolved more quickly.

    Question 12.: How do current federal regulations influence your 
efforts to stockpile antiviral medications?

    Response:
         Lack of ability to rotate antiviral stock, to 
        implement shelf-life extension program, and limitations on 
        approved uses affected decision-making by the Texas Legislature 
        when deciding on how many state resources could be allocated 
        for purchasing antiviral medications for a state stockpile.
         Supplies provided from federal contracts are 
        restricted to use during pandemic influenza. However, current 
        federal guidelines and packaged labeling do not allow for 
        rotation of antiviral purchased using the federal contract. 
        This creates the potential for waste.
         Federal policy discontinues the Shelf-life Extension 
        Program for antiviral drugs once they are delivered to the 
        states. There is no clear guidance on how long antivirals from 
        the Strategic National Stockpile (SNS) that have expired dates 
        will be viable in state stockpiles that cannot qualify for a 
        Shelf-life Extension Program.

        Question 13.: What do you see as a practical solution that 
        would reduce the investment risk of procuring antiviral 
        medications while ensuring adequate supplies of these 
        medications are available in the event of a pandemic?
    Response:
         Remove the ``For Government Use Only'' labeling on 
        antiviral packaging to facilitate and allow rotation of stock.
         Similar to smallpox vaccine and medications in the 
        SNS, hold samples from each lot distributed to states for 
        analysis in a Shelf-life Extension Program, thereby allowing 
        antiviral in state possession to remain usable after expiration 
        date.
         Negotiate extension of current federally subsidized 
        contract or a new reduced price to allow more community 
        critical entities to purchase antiviral at a reduced cost.
         Assist with long-term storage rental or adding 
        environmental controls to state owned warehousing and security 
        of storage facilities.

    Question 14.: What ability do local hospitals in your states have 
to accommodate a surge that would be associated with a pandemic?
    Response:
         Texas hospitals have developed plans to augment 
        staffing during a pandemic. These include developing databases 
        of available personnel, developing callback lists, and working 
        with state medical and nursing organizations to identify and 
        recruit individuals who are available during a pandemic.
         In Texas, 65.9 percent of hospitals reported having a 
        database of credentialed clinicians while 52.8 percent reported 
        having a database of other health professionals to contact 
        during a pandemic.
        However, there is concern about being able to meet staffing 
        demands over the long term. The ability to provide staffing 
        will be a limiting factor in being able to meet surge demands 
        during a pandemic.
         Currently, availability of resources and equipment to 
        support a surge capacity event varies throughout Texas. 
        Hospitals typically keep 72 hours of inventory in stock. To 
        support resource availability, work group participants report 
        that some hospitals and Regional Advisory Councils are creating 
        or contracting with distributors to create equipment and supply 
        caches. Similarly, a number of hospitals have pre-purchase 
        contracts in place to deliver specified supplies within 72 
        hours of a disaster in the event communication systems are 
        disrupted.

    Question 15.: What type of procedures are in place to increase 
capacity should a pandemic occur?
        Response:
         Most Texas hospitals have the ability to increase bed 
        capacity and supporting physical infrastructure during a 
        pandemic. The majority (59.7 percent) have a bed expansion plan 
        in place and local health departments, city and county 
        governments, and other entities have created plans and 
        processes to open medical shelters if needed. Alternative plans 
        and procedures for increasing physical infrastructure capacity 
        have been developed discharging patients to make room for 
        disaster victims).
         During Hurricanes Katrina and Rita, human resources 
        were available to provide health and medical care in a mass 
        care environment. Physicians, nurses, allied health 
        professionals, mental health professionals, and others 
        volunteered to provide care.
         DSHS is implementing the Texas Disaster Volunteer 
        Registry, the state's version of the federally-mandated 
        Emergency Systems for Advance Registration of Volunteer Health 
        Professionals (ESAR-VHP), which should be operational this 
        winter. The Registry is being built in collaboration with the 
        state's key medical licensing and regulatory boards and 
        supporting professional organizations, such as the Texas Board 
        of Medical Examiners, the Texas Medical Association and the 
        Texas Osteopathic Medical Association. The Registry will 
        provide: (1) pre-registration of medical/healthcare 
        professional volunteers, as well as supportive lay volunteers; 
        (2) verification of professional and (3) credentialing of 
        professionals--all in any effort to enhance rapid medical 
        response to disasters or public health emergencies.
         During Hurricanes Katrina and Rita, evidence indicates 
        that Texas was able to obtain medical supplies, medications, 
        and durable medical equipment to support patient care.
         The following DoD and VA hospitals are included in and 
        participate regionally in the Texas medical surge efforts:
         Amarillo VA Health Care System
         Veterans Affairs Medical Center
         Veterans Affairs Medical Center-Bonham
         U S Veterans Hospital
         Central Texas VA Health Care System
         Central Texas Veterans Healthcare System--Waco Campus
         Audie L. Murphy Memorial Veterans Hospital
         Kerrville VA Medical Center
         Michael E. DeBakey VA Medical Center
         William Beaumont Army Medical Center
         Carl R. Army Medical Center
         Brooke Army Medical Center

     Questions from the Honorable James Langevin, Chairman of the 
   Subcommittee on Emerging Threats, Cybersecurity, and Science and 
                               Technology

                   Response from Peter A. Shult, Phd

    Question 1.: Do the activities and responsibilities of public 
health laboratories differ when dealing with seasonal influenza versus 
the more virulent strain expected for pandemic influenza?
    Response 1.: The basic diagnostic, networking and reporting 
activities and responsibilities of the public health laboratory (PHL), 
as outlined in my testimony document (pages 1--4, Role of the pubic 
health laboratory) , are fundamentally the same in response to either 
seasonal or pandemic influenza. In the earliest stages of a pandemic we 
would be trying to detect and identify the novel influenza subtype and 
differentiate it from seasonal influenza strains and other respiratory 
pathogens that might be circulating using diagnostic methodologies we 
currently employ. Results would be immediately shared with our state 
and local health departments and with the Centers for Disease Control 
and Prevention (CDC). Furthermore, unusual viral isolates and patient 
specimens from which they came would be immediately forwarded to the 
CDC for further characterization as is our current protocol. Finally, 
we would be interacting with other virus laboratories and rapid 
influenza testing sites within our states to monitor their results and 
acquire unusual isolates or specimens that they might encounter for 
further characterization and expedited delivery to CDC as necessary, 
similar in the way that we do now. The biggest difference and challenge 
for the PHL in response to a pandemic would be carrying out these 
activities during likely periods of reduced staffing (due to personal 
or family illness, etc)and significant supply interruptions. This 
points out the critical need for PHLs and all response agencies to 
develop and exercise Continuity of Operation Plans.

    Question 2.: What additional resources do public health 
laboratories throughout the Nation--including the territories--need to 
be able to better address naturally-occurring and intentionally-
distributed disease agents that threaten our country?
    Response 2.: Largely as a result of Public Health Emergency 
Preparedness funding from the CDC over the last five or so years, PHLs 
have been able to build significant, state-of-the-art molecular-based 
diagnostic testing capability and capacity for the rapid and accurate 
identification of priority agents of bioterrorism and other significant 
public health threats. In addition, PHLs have been able to develop 
strong relationships and working networks with clinical laboratories 
within their states in order to prepare these laboratories to safely, 
effectively and cooperatively respond in the event of a public health 
emergency. The cost of these activities in terms of needed staffing, 
training, diagnostic equipment and reagents, laboratory security 
systems, specimen courier systems, emergency communications and 
electronic data sharing systems, etc. has been great. However, the 
value to public health of this enhanced laboratory response capability 
and capacity is undeniable as evidenced by the effective responses, in 
recent years, to threats such as SARS, monkeypox, pertussis and several 
nationwide foodborne outbreaks, to name but a few. Consistent and 
sustained funding of PHLs will now be critical to maintain the PHL 
needs already addressed (listed above and in the testimony document) 
not to mention provide for newer and likely more expensive diagnostic 
and information and data sharing technologies that will be needed for 
even more effective response to public health threats in the future.

    Question 3.: What sorts of cautions should laboratorians take into 
consideration regarding the use of rapid diagnostic tests for detecting 
Influenza A viruses?
    Question 3.: There are about 15 different hand-held rapid tests for 
influenza on the market today. A number of these are simple enough that 
they are permitted to be performed in the point-of-care setting without 
laboratory expertise or credentialing. Despite their simplicity, rapid 
results and relatively low price, these tests have significant 
limitations:
         In general, the diagnostic sensitivity (ability to 
        detect true positives) of these tests is limited (on average, 
        70--75% according to the CDC) which means patients with 
        influenza may be misdiagnosed as not having influenza. In some 
        cases this is due to inherent limitations of the test itself or 
        to the type of specimen the test calls for (e.g. throat swab, 
        which is usually not the optimum specimen for influenza, but is 
        recommended for its ease of collection). Furthermore, it is not 
        certain which, if any of these tests will work for detection of 
        a novel, potentially pandemic influenza strain. The result is a 
        patient that might otherwise be treated for influenza may not 
        be.
     A limitation of any diagnostic test including these rapid 
flu tests is when they are performed during periods of low influenza 
prevalence (early during a typical flu season or during the earliest 
stages after the emergence of a novel influenza strain), false positive 
results often occur. This would be particularly worrisome early on 
during a pandemic period when false positive results may result in 
premature triggering of mitigation strategies, unnecessary usage of 
antivirals and unnecessary concern or panic.
    Both of these limitations can be overcome by performing and 
interpreting these tests in the context of available clinical 
information indicative of influenza and surveillance information that 
confirms that influenza is circulating in the community. Also, rapid 
test sites should be strongly encouraged to confirm suspect (i.e. early 
or off-season).rapid results with more accurate laboratory testing, 
which is available at a PHL or larger clinical lab. The PHL should take 
the lead in identifying and training rapid test sites in proper rapid 
test usage and interpretation and provide up-to-date influenza 
surveillance information for appropriate epidemiological context for 
the test results.
         Another concern is widespread use of rapid tests will 
        interrupt influenza surveillance since these specimens will not 
        come to the PHL for testing. This limitation can be overcome 
        (as demonstrated in Wisconsin and other states) by working with 
        and encouraging rapid tests sites to share both specimens for 
        confirmatory testing and their test results data, with minimal 
        inconvenience or financial impact to them.
         Perhaps the biggest concern with widespread usage of 
        these rapid tests is maintaining appropriate biosafety. This is 
        of particular concern for non-laboratorian users of these tests 
        in non-traditional, non-laboratory, point-of-care settings 
        (physician offices, nursing homes, pharmacies, etc) where 
        appropriate facilities, safety devices and personal protective 
        equipment (PPE) may not be available or used. While simple to 
        perform, these tests have steps that can generate infectious 
        aerosols that could infect the user and those in the testing 
        vicinity. These users need basic biosafety training, which can 
        (should ) be provided by knowledgeable PHL or other clinical 
        laboratorians.

    Question 4.: How have the public health laboratories worked with 
the Department of Homeland Security to address issues such as 
bioterrorism, and naturally occurring infectious disease agents such as 
pandemic influenza? What role has the Integrated Consortium of 
Laboratory Networks played so far in this regard?
    Response 4.: It is my experience in Wisconsin and the opinion of 
other PHLs that we have had only very limited or indirect interaction 
with the Department of Homeland Security (DHS). At the level of our PHL 
association, the Association of Public Health Laboratories (APHL), 
significant interactions have occurred including:
         Through our national association, APHL, we have 
        established working relationships with Dr. Randy Long and the 
        Integrated Consortium of Laboratory Networks (ICLN). We now 
        have public health laboratorians participating on various 
        subgroups of the ICLN. These subgroups are working on issues 
        such as proficiency testing, accreditation, quality control, 
        methods collection, training, radiological testing capacity.
         APHL has also worked with DHS and DoD on the 
        development of the All-Hazards Receipt Facilities and screening 
        protocols for PHLs for processing unknown environmental 
        samples.
         APHL is also participating in the DHS lead and AOAC 
        facilitated process to evaluate PCR assays for use in 
        autonomous detection systems. APHL strongly opposes the use of 
        biological and chemical agent detection kits and devices for 
        field testing in the absence of performance standardization, 
        field validation and certified individuals trained in the 
        application of these kits and devices.
    Public health laboratory preparedness and response efforts have 
been largely (solely?) directed by the CDC at the federal level and by 
our state health departments and emergency management agencies. The 
latter, in Wisconsin, has had more direct interaction with DHS. 
However, PHLs play an integral role in state emergency response 
planning and exercising of these plans consistent with federal response 
plans (Pandemic influenza, NRP/NIMS, etc.). As for the Integrated 
Consortium of Laboratory Networks (ICLN), I think I speak for many PHLs 
in saying we recognize what the ICLN is and what its basic goals are 
(this has been presented at a number of professional meetings attended 
by PHL directors and laboratorians), but we have not been directly 
affected by this initiative or consulted during its development. 
However, PHLs have developed (or are in the process of doing so) close 
working relationships with state and federal agency laboratories within 
their states responsible for food, animal and water testing during a 
public health or environmental emergency. Each of these labs (at least 
in Wisconsin) is part of their own national network in much the same 
way that the PHL is part of the LRN. For example, our state veterinary 
diagnostic lab belongs to the National Animal Health Laboratory Network 
(NAHLN) and our state agriculture/food lab belongs to the Food 
Emergency response Network (FERN). Our efforts in planning, 
communication and collaborative response to an emergency with these 
other laboratories, at this point, has been at the state level with 
little direct coordination at the federal level apparent to us.

    Question 5.: In your testimony, you stated that there is a ``. . 
.critical need for accurate, very rapid, highly reliable diagnostic 
testing to make best use of the stockpiles. . . Please provide more 
information regarding this critical need. How much more rapid and 
reliable do you believe diagnostic testing should be, and how would 
this testing make best use of the stockpiles?
    Response 5.: Antiviral stockpiles are a major focus of state and 
national pandemic preparedness and response efforts. The use of 
antivirals for prophylaxis and treatment will be a critical adjunct to 
other community mitigation measures particularly during the early 
stages and perhaps throughout the first wave of a pandemic in the 
absence of a vaccine. It is possible if not likely that supplies of 
antivirals may be limited in a given location. Even if there are 
sufficient supplies, their mobilization and use will need to be 
carefully considered and coordinated. The trigger for any pandemic 
response, including use of the antivirals will require laboratory 
confirmation that a novel influenza subtype has emerged and is being 
transmitted among the population. Most state PHLs now have this 
capability since they have been provided funding from the CDC for 
resources (staff, diagnostic equipment and reagents, etc)to provide 
state-of the art, rapid (2-4 hours from specimen receipt), highly 
sensitive and specific molecular-based diagnostic testing for seasonal 
and potentially pandemic strains of influenza. These labs also have 
excellent diagnostic methods for a large number of other respiratory 
pathogens that might need to be ruled out. Thus, if these capabilities 
can be maintained and even better tests brought online in the future 
with adequate funding, a sensitive trigger for pandemic response is 
available. However, as the outbreak or pandemic progresses and once 
antiviral stockpiles are distributed to the point-of-care, diagnostic 
testing and subsequent treatment decisions will be at the level of the 
clinician. At this point, it would be advantageous to have highly 
accurate point-of-care testing available to help ensure appropriate use 
and prevent over- and misuse of the antivirals. As I have pointed out 
in question 3., this currently isn't the case. Clearly more development 
in this area is needed. Even with improved point-of-care diagnostics, 
up to date regional laboratory-based surveillance data, necessary 
confirmatory testing and antiviral susceptibility testing needs to be 
made available. This should be among the critical roles for the PHL.

    Question 6.: A number of testing protocols have been provided to 
members of the Laboratory Response Network for Bioterrorism, to test 
for various biological agents. However, there is concern about those 
situations in which particular agents are not identified or suspected 
ahead of testing. Further, in the case of pandemic influenza--
especially if the virus causing the pandemic does not happen to be 
H5N1--there will certainly not be any accompanying notes describing the 
makeup of the virus. How are specimens analyzed before any disease 
identification has been made (in other words, how do the labs deal with 
specimens of unknown composition)?
    Response 6.: Biosafety is a paramount concern in any clinical 
laboratory and especially in the PHL where we frequently are involved 
in unknown and unusual outbreak situations. In fact, it is the norm 
that we do not know what pathogen(s) we might encounter. In addition, 
we often receive and immediately test specimens from patients from whom 
we have no clinical or relevant epidemiologic information. We always 
operate from the premise that the specimen contains the worse possible 
agent. . .always! This is the same philosophy that is the underpinning 
for ``Universal Precautions'', familiar to all care givers and 
laboratorians in safely handling blood and body fluids that might 
contain bloodborne pathogens. Consequently, all patient specimens or 
unknown isolates received for further characterization should be 
initially handled and processed in a biological safety cabinet (BSC) in 
(at a minimum) a Biosafety Level 2 (BSL-2) laboratory using practices 
and PPE appropriate to that biosafety level. . While impeccable sterile 
technique is the mainstay of safe handling of the specimen/isolate, the 
BSC, when used properly, provides a high level of protection (from 
routine pathogens as well as agents of greater public health concern 
such as primary agents of bioterrorism, influenza, SARS virus,etc.) for 
the laboratorian doing the testing and those around him. In the event 
that we might suspect a patient or environmental specimen, test 
material referred to us or generated during the testing within our lab 
contains a pathogen requiring a higher level of biosafety, work would 
be carried out in our BSL-3, or ``containment'' laboratory, which 
provides a much higher level of containment and requires more 
specialized equipment and a higher level of PPE to protect the facility 
and better protect the testing staff. Our biosafety protocols are 
carefully written and rigorously followed and are consistent with 
guidelines set forth by the CDC.
    While I am very confident of the effectiveness of these protocols 
and of the biosafety expertise within the PHL, I am much less confident 
when it come to clinical diagnostic labs, particularly those in smaller 
hospital and clinics, and point-of-care testing sites (mentioned 
above). These hospital-based labs will likely be the frontline 
responders in an infectious disease emergency, whether naturally 
occurring or intentional. Here is where our concern should really lie 
and where intensive training efforts should be directed. Indeed, we in 
Wisconsin and other states have begun these efforts.

    Question 7.: How are the public health laboratories working with 
the CDC to ``. . .monitor the emergency of antiviral resistance that we 
have already seen with one whole class of antivirals''? To which class 
are you referring?
    Response 7.: During the 2005-06 influenza season, the CDC announced 
and published evidence that showed greater the 90% of the circulating 
seasonal influenza type A viruses tested were resistant to one of the 
two classes of antivirals available for treatment or prophylaxis of 
influenza, the adamantanes (amantadine and rimantadine). Results last 
season were similar. Consequently, use of the adamantanes is no longer 
recommended. Immediately after these results were reported (in winter 
2006), the Wisconsin State laboratory of Hygiene (WSLH) was contacted 
by the CDC and asked to bring online antiviral susceptibility testing 
for the adamantanes to provide surge capacity for the CDC to continue 
to monitor the level of resistance to the antiviral of seasonal 
influenza and in case a novel subtype emerged. At least 2 other state 
PHLs have followed suit. Last year these PHLs contributed to the 
surveillance efforts and stand ready to continue these efforts this 
year and respond should a novel subtype emerge. While some funding was 
initially secured (at least in Wisconsin) from CDC to purchase 
expensive equipment and reagents for this testing, actual PHL antiviral 
resistance surveillance testing largely has been self-funded. The CDC 
has also begun surveillance for resistance to the only remaining class 
of influenza antiviral, the neuraminidase inhibitors 
(Relenza' and Tamiflu'). Discussions with CDC are 
currently underway for some state PHLs to help with this surveillance 
as well; however, currently only CDC has this capability. The long term 
goal would be to have the CDC, supported by select PHLs to maintain 
ongoing surveillance for antiviral resistance among circulating 
seasonal influenza strains and have this testing available should a 
novel, possibly pandemic strain of influenza virus emerge. Given the 
previously mentioned reliance on antiviral for pandemic response, this 
surveillance will be critical. However, these efforts need to be 
supported with stable funding.

    Question 8.: The Implementation Plan for the National Strategy for 
Pandemic Influenza provided this task, ``All Federal, State, local, 
tribal, and private sector medical facilities should ensure that 
protocols for transporting influenza specimens to appropriate reference 
laboratories are in place within 3 months''--which would have been July 
2006. What challenges do you see with executing this task? Why has this 
task has been so difficult to address throughout the country?
    Response 8.: In my firsthand experience in Wisconsin and knowledge 
of some other states, Public Health Emergency Preparedness and other 
funding from CDC has been used to fund critical specimen transportation 
to PHLs . Funded activities include development of emergency response 
and specimen shipping guidelines and protocols, maintaining statewide 
repositories of critical specimen collection supplies and shipping kits 
for use by clinical labs and local health departments, training on 
specimen shipping procedures and regulation, contracting with private 
couriers (in fact more than one for redundancy)or maintaining the 
laboratory's own courier, among others. While these activities were 
originally carried out for response to bioterrorism, they have ``all 
hazards'', including pandemic influenza, applicability. At least in 
Wisconsin (and I know other states as well), our specimen transport 
systems and protocols have been frequently and successfully utilized 
and practiced during a number of recent outbreaks (some quite large) we 
have been involved in and exercises we carry out with our clinical 
laboratory partners. This capacity now exists. The challenge, as I see 
it, will be maintaining this capacity during a pandemic when courier 
services will be disrupted due to illness or fear of carrying certain 
specimens (a concern we have had expressed to us by the larger 
commercial couriers vs. the small private company and HMO or large 
clinical lab couriers we utilize), specimen collection supplies and 
shippers may be in short supply, etc. We are currently considering 
these issues with partners in response and examining ways to provide 
redundancies for transport, augment stockpiles of critical supplies, 
prioritize critical testing needs that absolutely require specimens be 
shipped to my lab and at the same time cover costs. An issue on the 
national level that has not yet been addressed to my knowledge is how 
will the state PHL get critical specimens to the CDC, our reference 
laboratory, given the consequences of a pandemic described above.

    Questions 9.: According to the Implementation Plan for the National 
Strategy for Pandemic Influenza, ``The Federal Government shall, and 
State, local, and tribal governments should, define and test actions 
and priorities required to prepare for and respond to a pandemic, 
within 6 months'' of when the Plan was released--so the deadline would 
have been October 2006. What are the challenges here? Are you waiting 
for the Federal government to provide you with guidance and resources?
    Response 9.: Given the critical role of the PHL in preparedness 
planning and response to pandemic influenza, working in close 
collaboration with other national, state and local public health and 
emergency response partners, their priorities need to be addressed (and 
funded) and actions defined and exercised. To date, my laboratory has 
only engaged in relatively limited tabletop exercises with clinical 
laboratory partners and with local and state public health agencies 
with minimal involvement with other traditional emergency response 
partners. Despite their limited scope, these exercises have been 
extremely valuable in defining the likely obstacles to an effective 
laboratory and public health response and how these might be overcome 
and providing valuable and actionable lessons learned. In my opinion 
(and that of other state PHL colleagues with broader experience with 
more complex exercises) conducting broader community-based exercises is 
extraordinarily complex to plan and carryout, expensive and disruptive 
to day-to-day work activities. This is not surprising given the 
immensity and diversity of a pandemic's likely impact and the response 
needed. I am in favor of our laboratory's approach in testing parts of 
the plan (both national and state plans) with limited response 
partners; however, I acknowledge that larger exercises with more 
diverse participants to test a specific aspect of the plan (e.g. 
conducting vaccine clinics, antiviral stockpile mobilization, etc) 
likely will be needed.

    Questions 10.: According to the Implementation Plan for the 
National Strategy for Pandemic Influenza, ``State, local, and tribal 
law enforcement agencies should coordinate with appropriate medical 
facilities and countermeasure distribution centers in their 
jurisdictions to coordinate security matters, within 6 months'' of when 
the Plan was released--so the deadline would have been October 2006. To 
your knowledge, has any of this coordination taken place? If so, how, 
and if not, how would you recommend this happen?
    Response 10.: This question is really beyond the scope of the 
laboratory and definitely beyond my experience.

    Questions 11.: What roles do associations play in assisting their 
constituents with emergency and pandemic preparedness?
    Response 11.: Speaking only about laboratory-related professional 
associations [including the APHL, American Society for Microbiology 
(ASM), College of American Pathologists (CAP), American Clinical 
Laboratory Association (ACLA), to name a few] it has been my experience 
that these associations have been very active and effective in 
assisting their constituents with emergency and pandemic preparedness. 
Each of these associations' website is loaded with planning documents, 
testing recommendations and protocols and links to resources, many of 
which have been collaboratively developed. Moreover, these associations 
provide their input to national planning efforts. I have participated 
in and facilitated a number of very effective working groups among 
these associations, largely coordinated by the CDC, that have tackled 
issues related to emergency (including pandemic influenza) preparedness 
and response including:
        Roles for the large national clinical labs in pandemic 
        response
        Development of testing guidelines
        Impact of new generation point-of-care tests on 
        laboratory diagnosis
        Biosafety issues
    The same can be said about numerous public health and clinical 
specialty associations Engaging the leadership of these associations in 
planning efforts and using these associations to reach their thousands 
of constituents to share information is a highly efficient and 
effective element of preparedness and response planning.

    Question 12.: The Government Accountability Office (GAO) says in 
its report that State, Territorial, Tribal, Local, and other 
stakeholders need to be involved in providing input to the National 
Strategy for Pandemic Influenza and its Implementation Plan, especially 
as the National Strategy evolves. If you were at the White House, how 
would you ensure this happens?
    Response 12.: As an extension of my answer to question 11, relevant 
federal agencies should be responsible and held accountable for 
implementation of the National Strategy and for engaging relevant 
partners (much as CDC has done with laboratories and state and local 
public health agencies). Key partners should include professional 
associations that can ensure content experts are identified (with 
significant experience in laboratory science and public health, for 
instance) and state and local input is solicited in the development and 
implementation of policies and plans. It also needs to be recognized 
that emergency response in the final analysis will be carried out 
primarily at the local and state level with support needed from federal 
resources.

    Questions 13.: As you all know, public health has been identified 
as one of the critical infrastructures of our Nation. Have you been 
included in the planning undertaken by the Department of Homeland 
Security to protect the public health infrastructure? From what you 
know about this work, how does it affect you in your state and local 
positions? What more do you think needs to be done in this regard, 
especially in advance of an influenza pandemic?
    Response 13.: Neither the WSLH nor any other PHL that I am aware of 
has been included in planning undertaken by DHS to protect PH 
infrastructure. It is important, however, that DHS and other federal 
agencies recognize the importance of the PHL and the clinical 
laboratory networks we oversee within our states for response to 
pandemic influenza or other public health emergencies. Conversely, we 
(PHLs and public health in general) need to fully understand the role, 
authority and expectations of DHS in protecting public health 
infrastructure, starting with defining public health infrastructure and 
what the term ``protect the PH infrastructure'' refers to. I interpret 
it to mean strengthen and sustain public health (including the PHL) 
capabilities and capacity now so we are prepared to mount an effective 
public health response to any emergency such as pandemic influenza. . 
.and protect public health capabilities and capacity during the 
response. It is obvious to me that the first steps need to be 
communication, so that we all can ultimately recognize and understand 
each other's roles and expectations, and a commitment to funding this 
critical response element.
    Responses respectfully submitted on behalf of the Association of 
Public Health Laboratories by:
Peter A Shult, PH.d.
Director, Communicable disease Division
and Emergency Laboratory Response
Wisconsin State Laboratory of Hygiene

Questions from the Honorable James Langevin, chairman, Subcommittee on 
              Emerging Threats, Cybersecurity, and Science

                   Responses from Bernice Steinhardt

    Question 1.: Regarding the Implementation Plan for the National 
Strategy for Pandemic Influenza, you state in your report that, ``. . 
.because many of the performance measures do not provide information 
about the impacts of proposed actions, it will be difficult to assess 
the extent to which we are better prepared--OR--to identify areas 
needing additional attention.'' What sort of process do you propose 
should be used to rectify this situation now?
    Response: In our August 14, 2007, report (Influenza Pandemic: 
Further Efforts Are Needed to Ensure Clearer Federal Leadership Roles 
and an Effective National Strategy, GAO-07-781), we reported that many 
of the performance measures contained in the Implementation Plan 
consisted of actions to be completed such as guidance developed and 
disseminated. Without a clear linkage to anticipated results these 
measures make it difficult to ascertain whether progress is being made 
toward achieving the goals and objectives described in the Plan and the 
National Strategy for Pandemic Influenza.
    In our report, we recommended that the Homeland Security Council 
establish a specific process and time frame for updating the Plan. We 
further recommended that during this update, the Plan could be improved 
by including information in the Plan such as a greater use of outcome-
focused performance measures.

    Question 2.: You state in your report that one of the difficulties 
with the National Strategy for Pandemic Influenza is that it has not 
been made clear how it relates to and interacts with others of our 
National Strategies. How have other National Strategies have made this 
clear? How would you recommend this occur now with the National 
Strategy for Pandemic Influenza?
    Response: Over the past several years, GAO has reviewed several 
national strategies and we have found that these strategies could have 
better described how they were linked to the goals, objectives, and 
activities of other related strategies.
    As part of our recommendation to the Homeland Security Council to 
establish a specific process and time frame for updating the Plan, we 
stated that the Council's next update of the Plan should more clearly 
describe the linkages between the Plan with other related strategies 
and plans.

    Question 3.: You state in your report that State, Territorial, 
Tribal, Local and other stakeholders need to be involved in providing 
input to the National Strategy for Pandemic Influenza and its 
Implementation Plan, especially as the National Strategy evolves. How 
do you propose this should occur? Who should be responsible for 
ensuring stakeholders are not only invited to provide input, but that 
their input is indeed incorporated?
    Again, in our recommendation to the Homeland Security Council 
regarding the need to update the Plan, we stated that the update 
process should involve key stakeholders and incorporate lessons learned 
from exercises and other sources. Since the Implementation Plan is the 
responsibility of the Homeland Security Council, it should be up to the 
Council to not only invite stakeholders to provide input to the next 
update of the Plan, but to also make sure that the Plan reflects their 
input. In addition, the agencies that worked with the Council in 
drafting the Plan, such as the Departments of Homeland Security and 
Health and Human Services, could hold forums and discussions with their 
stakeholders and seek their input during the update process.

           Questions from the Committee on Homeland Security

              Responses from RADM W. Craig Vanderwagen, MD

    Question 1.: The Assistant Secretary for Preparedness and Response 
has a unit that deals with exercises. The Office of the Assistant 
Secretary for Preparedness and Response has also reached out to the 
Department of Homeland Security regarding the use of the Lessons 
Learned Information Sharing system. How is HHS using the system? How 
are personnel in the Office of the Assistant Secretary of Preparedness 
and Response working with those in the Office of Health Affairs, the 
National Exercise Program, and other programs at the Department of 
Homeland Security, to combine efforts and data?
    Response: The Training, Exercise and Lessons Learned Team (TE&LL) 
in the Office of the Assistant Secretary for Preparedness and Response 
(ASPR), as appropriate, maximally employs the Department of Homeland 
Security's (DHS) tools and systems as prescribed in HSPD-8 to manage 
HHS training activities, exercises, and lessons learned.
    The TE&LL Team represents HHS at the Exercise and Evaluation Sub 
Policy Coordinating Committee (PCC) (formerly the Plans, Training and 
Exercise PCC of the Homeland Security Council). Within this forum HHS 
liaises with DHS and the National Exercise Program, and all other 
Departments and agencies. This body meets bi-weekly and offers an 
excellent forum for interdepartmental communications.
    The TE&LL Team represents HHS on the Executive Steering Committee 
of the National Exercise Program (NEP), and collaborates frequently 
with DHS on submitting joint exercise proposals (Pandemic Influenza 
Exercise Series). HHS also sits on the TOPOFF 4 Executive Steering 
Committee, and participates in all Principal Level Exercise and Senior 
Official Exercise activities. DHS acts as the executive agent for 
managing all of the preceding committees.
    HHS participates in all principal National Exercise Schedule (NEXS) 
conferences and meetings.
    HHS maintains five blanket purchasing agreements (BPAs) with many 
of the same vendors that DHS utilizes for managing their HSPD-8 
activities. This leads to better synergy and alignment between HHS and 
the HSPD-8 tools and activities. With help from contract support, HHS 
is actively moving all of its major training, exercise, and lessons 
learned paper-based systems to the HSPD-8 electronic based system.
    A standing weekly call is held between the Assistant Secretary for 
Preparedness and Response and the DHS Office of Health Affairs Acting 
Assistant Secretary/Chief Medical Officer to coordinate efforts and 
activities.
    At HHS' Strategic Readiness Plan (SRP) Roll Out in August 2007, 
multiple DHS programs were invited to participate along with their 
leadership (Corrective Action Program, National Exercise System 
directors). At the SRP Roll Out the Department formally adopted the 
HSPD-8 tools into its training, exercise, and lessons learned 
management processes.
    Some components of HHS have achieved initial integration with DHS's 
Lessons Learned Information Sharing (LLIS.gov) system. For example, the 
Centers for Disease Control and Prevention (CDC) Coordinating Office 
for Terrorism Preparedness and Emergency Response (COTPER), Division of 
State and Local Readiness (DSLR) has partnered with LLIS.gov to develop 
the CDC DSLR ``Channel'' on LLIS.gov. Channels are secure areas of 
LLIS.gov dedicated and customized to the preferences of a specific 
community of interest, organization, or jurisdiction. The CDC DSLR has 
written into its grant guidance that LLIS.gov is the official 
repository of State and local jurisdictions' exercise schedules. To 
date, CDC DSLR grantees have uploaded more than 80 exercise schedules 
to the LLIS.gov Channel. Additionally, the Channel is used as a shared 
workspace and information sharing forum for federal, State, and local 
health stakeholders.

    Question 2.: Please provide us with information regarding the 
changes in ESF-8 from the National Response Plan to the National 
Response Framework. What impact will these changes--and any others in 
other parts of the National Response Framework--have on the pandemic 
influenza plans you already have in place?
    Response: The text for the ESF#8 Annex currently contained in the 
National Response Framework is the same language HHS submitted to DHS 
for the National Response Plan and supports the HHS/ESF#8 effort to 
prevent, protect, respond, and recover from all domestic response 
activities. There is no impact on pandemic influenza planning. The text 
was updated to reflect recent legislative changes impacting ESF#8. This 
included the following:
         In the event of a public health emergency the 
        Secretary of HHS shall assume command and control, when 
        appropriate, of Federal emergency public health and medical 
        response assets that have appropriate MOUs in place, except for 
        members of the Armed Forces, who remain under the authority and 
        control of the Secretary of Defense.
         The Secretary of HHS, through the Office of the 
        Assistant Secretary for Preparedness and Response (ASPR), 
        coordinates national ESF#8 preparedness, response, and recovery 
        actions.
         Updated to reflect the transfer of the National 
        Disaster Medical System (NDMS) from DHS to HHS.

    Question 3.: According to the White House, HHS was to have 
completed this action item from the Implementation Plan for the 
National Strategy for Pandemic Influenza--by July 2006. The task is, 
``HHS shall improve the speed at which it performs mortality 
surveillance through the 122 Cities Mortality Reporting System within 3 
months.'' Why has this task not been completed yet?
    Response: Since the release of the National Strategy for Pandemic 
Influenza Implementation Plan, much has been accomplished to realize 
the U.S. Government's pandemic preparedness and response goals of: (1) 
stopping, slowing, or otherwise limiting the spread of a pandemic to 
the United States; (2) limiting the domestic spread of a pandemic and 
mitigating disease, suffering, and death; and (3) sustaining 
infrastructure and mitigating impact to the economy and the functioning 
of society.
    Although we have realized progress in expanding disease 
surveillance abroad, critical gaps remain with respect to ``real-time'' 
disease detection and clinical surveillance in the United States. As 
part of its national influenza surveillance effort, the CDC currently 
receives weekly mortality reports from 122 cities and metropolitan 
areas in the United States. This information helps the CDC track trends 
in disease spread, identify severely affected populations, and monitor 
the impact of influenza on health. One of the limitations of this 
system, however, is an approximately 2-week lag in obtaining data. 
BioSense is a national program intended to improve the Nation's 
capabilities by conducting nearly real-time clinical disease 
surveillance. Of the nearly 6,000 hospitals in the United States, only 
700 hospitals are currently engaged in some stage of implementation for 
sharing data with the BioSense program.

    Question 4.: According to the White House, HHS was to have 
completed this action item from the Implementation Plan for the 
National Strategy for Pandemic Influenza--by October 2006. The task is, 
``HHS, in coordination with DHS, DOT, DOS, DOC, and DOJ, shall develop 
policy recommendations for aviation, land border, and maritime entry 
and exit protocols and/or screening and review the need for domestic 
response protocols or screening within 6 months.'' Why has this task 
not been completed yet?
    Since the release of the National Strategy for Pandemic Influenza 
Implementation Plan, much has been accomplished to realize the U.S. 
Government's pandemic preparedness and response goals of: (1) stopping, 
slowing, or otherwise limiting the spread of a pandemic to the United 
States; (2) limiting the domestic spread of a pandemic and mitigating 
disease, suffering, and death; and (3) sustaining infrastructure and 
mitigating impact to the economy and the functioning of society.
    Once an influenza pandemic reaches the United States, the primary 
focus is safeguarding the health of Americans. The U.S. Government is 
working to enhance the Nation's ability to detect and respond early and 
effectively to a pandemic. To better identify the first cases of 
pandemic influenza in a community, the U.S. Government has provided 
resources to State and local health departments to increase the number 
of sentinel providers and improve laboratory detection at public health 
laboratories. The U.S. Laboratory Response Network (LRN), which 
includes State public health laboratories, is prepared to conduct 
initial testing of suspected human infection with H5N1 within 24 hours 
of receipt. To ensure that suspected cases can be promptly confirmed 
and treated, the Federal Government is working with industry partners 
to develop rapid diagnostic tests to quickly discriminate pandemic 
influenza from seasonal influenza or other illnesses.

    Question 5.: According to the White House, HHS was to have 
completed this action item from the Implementation Plan for the 
National Strategy for Pandemic Influenza--by January 2007. The task is, 
``HHS, in coordination with DHS, DOS, DOD, DOL, VA, and in 
collaboration with State, local, and tribal governments and private 
sector partners, shall develop plans for the allocation, distribution, 
and administration of pre-pandemic vaccine, within 9 months.'' Why has 
this task not been completed yet?

Allocation
    Medical countermeasures have little utility if they cannot be 
delivered quickly to those in need, yet the logistical challenges of 
rapidly allocating, distributing, and administering countermeasures to 
300 million Americans are substantial. Although we have made 
significant investments in distribution capacity since 2002 through the 
Strategic National Stockpile, State and local grant programs, and the 
Cities Readiness Initiative, much work remains. Guidance and resources 
have been provided to State, local, tribal, and territorial governments 
to facilitate completion of distribution plans for medical 
countermeasure stockpiles. Recipients of pandemic influenza 
supplemental funding are required to complete and exercise these plans.
    Countermeasure allocation and distribution is important for 
preparing our Nation for pandemic influenza and other naturally 
occurring infectious diseases, as well as for chemical and nuclear 
attacks. In the future we may be faced with the need to prioritize 
scarce medical resources during a major disaster. The pandemic efforts 
could well serve as a template for allocating and distributing life-
saving countermeasures against other threats. The ongoing guidance 
development process for prioritizing and deploying countermeasures 
during a pandemic represents our first steps in addressing this complex 
ethical and logistical challenge.
    One major goal of the U.S. pandemic influenza vaccination program 
is to vaccinate all persons in the United States who choose to be 
vaccinated. An interdepartmental working group led by HHS developed and 
prepared a draft report leading to guidance that analyzed and 
established prioritization tables of different functional population 
groups and accompanying rationale for the allocation of pre-pandemic 
and pandemic influenza vaccines at the onset and during an influenza 
pandemic with a CDC severity index of 5. This report is distributed 
currently for public comment through Dec. 31, 2007 (See http://
www.aspe.hhs.gov/panflu/vaccinepriorities.shtml). Final guidance is 
expected in early 2008.
    The draft guidance is firmly rooted in the most up-to-date 
scientific information available, and directly considers the values of 
our society and the ethical issues involved in planning a phased 
approach to pandemic vaccination. Information considered by the working 
group included rigorous scientific assessments of pandemics and 
pandemic vaccines, national and homeland security issues, essential 
community services and the infrastructures and workforces critical to 
maintaining them, and the perspectives of state and local public health 
and homeland security experts. Historical analysis of the influenza 
pandemics of 1918, 1957, and 1968 and their effects provided valuable 
insights to this draft guidance. Ethical considerations presented by an 
ethicist who served on the working group and by academic ethicists also 
were important to the working group process and deliberations.
    A formal decision-analysis process also was undertaken that 
considered the objectives of a pandemic vaccination program and the 
degree to which protecting population groups (defined by their 
occupation, age, and health status) contributed to meeting those 
objectives. Based on this process, groups that ranked highest were 
frontline public health responders, essential health care workers, 
emergency medical service providers, and law enforcement personnel. 
Among the general population groups, infants and toddlers ranked 
highest.
    It is recognized that vaccine supply to meet this goal will likely 
not be available all at once, but rather, develop at varying rates 
depending on both vaccine characteristics (antigen required) and 
production capacity. Given that influenza vaccine supply will increase 
incrementally as vaccine is produced during a pandemic, allocation 
decisions will have to be made. Such decisions should be based on 
publicly articulated and discussed program objectives and principles. 
The overarching objectives guiding vaccine allocation and use during a 
pandemic are to reduce the impact of the pandemic on health and 
minimize disruption to society and the economy.
    One of the most important findings of the working group analysis, 
and the strongest message from the public and stakeholder meetings, was 
that there is no single, overriding objective for pandemic vaccination 
and no single target group to protect at the exclusion of others. 
Rather, there are several important objectives and, thus, vaccine 
should be allocated simultaneously to several groups. Each of the 
meetings came to the same conclusions about which program objectives 
are most important:
         Protecting those who are essential to the pandemic 
        response and provide care for persons who are ill,
         Protecting those who maintain essential community 
        services,
         Protecting children, and
         Protecting workers who are at greater risk of 
        infection due to their job.
    In addition to these, the important Federal objective of 
maintaining homeland and national security was factored into the 
guidance.
    General guidance includes the following:
         The need to target vaccine to maintain security, 
        health care, and essential services will depend on how severe 
        the pandemic is, as rates of absenteeism and the ability to 
        supply essential products and services will differ between more 
        and less severe pandemics. As a result, groups targeted for 
        earlier vaccination will differ by pandemic severity.
         Allocation of pandemic vaccines to States will be in 
        proportion to the State's population.
         Whereas States should follow the national guidance, 
        they will have some flexibility in defining the target groups 
        and implementing the guidance to best fit their local 
        situations.
         Within the parameters of the guidance, a small 
        proportion of each State's vaccine allocation may be maintained 
        at the State level for distribution based on the specific needs 
        of that jurisdiction.
         In past pandemics, groups at increased risk for 
        serious illness and death have differed by age and health 
        status. Because the high-risk groups in the next pandemic are 
        not known, this guidance will be reassessed and may be modified 
        at the time of the pandemic.
         Guidance on pandemic vaccine allocation and targeting 
        will be re-assessed periodically to consider the potential 
        impacts of new scientific advances, changes in vaccine 
        production capacity, and advances in other medical and public 
        health measures.
    Guidance for targeting vaccination was developed in a structure 
that defines target groups in four broad categories--people who: (1) 
protect homeland and national security, (2) provide health care and 
community support services, (3) maintain critical infrastructure, and 
(4) are in the general population. Within categories, vaccination 
target groups are clustered into levels. In general, all groups within 
a category and level will have the same priority for vaccination. 
Within a category, levels are listed in descending order of priority 
for vaccine. Levels across categories are not necessarily comparable in 
terms of vaccine prioritization.
    Allocation and targeting of vaccine integrating categories occurs 
in tiers. By design, groups in a tier (cutting across categories) are 
vaccinated simultaneously unless vaccine supply is so limited that sub-
prioritization is needed. Finally, groups in vaccination tiers differ 
depending on pandemic severity, defined as severe, moderate, and less 
severe as described in the Pandemic Severity Index.

Distribution/Administration
    During 2007, HHS/CDC with HHS/BARDA developed plans in consultation 
with other federal government departments including DHS, State and 
local governments and domestic influenza vaccine manufacturers for 
distribution of pre-pandemic and pandemic influenza vaccines from the 
domestic manufacturer distribution centers to points of distribution 
(PODs) within States for the near (<18 mos.) and long term. On August 
15--17, 2007 CDC in coordination with HHS/BARDA, DHS, the States of 
Ohio and Arkansas, and one of the domestic influenza vaccine 
manufacturers conducted a pandemic influenza vaccine training exercise 
to test the communication and actual shipment of vaccine from the 
manufacturer to State points of distribution according the HHS plan for 
pandemic vaccine distribution. During the exercise, an influenza 
pandemic event from HHS to the vaccine manufacturer and the States and 
the need for shipment of pandemic influenza vaccine to the States was 
communicated effectively, and mock containers of vaccine were 
successfully transported overnight from the vaccine manufacturer to the 
PODs of the two States.

    Question 6.: According to the White House, HHS was to have 
completed this action item from the Implementation Plan for the 
National Strategy for Pandemic Influenza--by April 2007. The task is, 
``HHS, in coordination with DHS, DOT, DOS, DOD, air carriers/air space 
users, the cruise line industry, and appropriate State and local health 
authorities, shall develop en route protocols for crewmembers onboard 
aircraft and vessels to identify and respond to travelers who become 
ill en route and to make timely notification to Federal agencies, 
health care providers, and other relevant authorities, within 12 
months.'' Why has this task not been completed yet?
    Response: If a pandemic begins outside the United States, and 
international containment efforts fail, the U.S. Government has planned 
a series of layered border measures that may be implemented 
incrementally during a severe pandemic to slow the entry of a pandemic 
virus into the United States while allowing the flow of goods and 
people. These border measures during the early stages of a severe 
pandemic may include flight restrictions from affected regions, 
issuance of health guidance to travelers intending to enter the United 
States, health screening of travelers before departure, en route, and 
on arrival to the United States, as well as public health measures to 
limit onward transmission of the disease.
    We are working closely with our neighbors Canada and Mexico to 
establish a common North American approach to delay the arrival and 
impact of a pandemic. One of the objectives of the pandemic planning 
efforts in the Security and Prosperity Partnership is the development 
of the North American Plan for Avian and Pandemic Influenza. This 
trilateral plan, now being finalized, establishes a framework for 
coordinated, trilateral actions regarding communication, responses to 
avian and pandemic influenza, border monitoring, and critical 
infrastructure protection. Developed as part of the Plan is a concept 
of operations for responding to aircraft inbound to North America that 
are carrying passengers potentially infected with the pandemic virus. 
This approach is currently being shared with other aviation partners 
around the world. U.S. Quarantine Stations, located at ports of entry 
and land-border crossings where international travelers arrive, will 
play an important role in delaying the introduction of pandemic 
influenza into the United States and helping to limit its spread. The 
number of quarantine stations in the United States has more than 
doubled since 2004, expanding from 8 to 20 locations, with quarantine 
stations in Dallas and Philadelphia added this past year.

    Response 7.: According to the White House, HHS was to have 
completed this action item from the Implementation Plan for the 
National Strategy for Pandemic Influenza--by April 2007. The task is, 
HHS, in coordination with DHS, shall review and approve State Pandemic 
Influenz a plans to supplement and support DHS State Homeland Security 
Strategies to ensure that Federal homeland security grants, training, 
exercises, technical, and other forms of assistance are applied to a 
common set of priorities, capabilities, and performance benchmarks, in 
conformance with the National Preparedness Goal, within 12 months.'' 
Why has this task not been completed yet?
    HHS provided interim assessments to the respective State Health 
Officials and their Governor's Chief of Staff. Each draft interim 
assessment contained jurisdiction-specific feedback as well as general 
feedback from the participating federal departments.

    Question 8.: According to the White House, HHS was to have 
completed this action item from the Implementation Plan for the 
National Strategy for Pandemic Influenza--by April 2007. The task is, 
``HHS, in collaboration with State, territorial, tribal, and local 
health care delivery partners, shall develop and execute strategies to 
effectively implement target group recommendations, within 12 months.'' 
Why has this task not been completed yet?
    Response: At the beginning of a pandemic, the scarcity of vaccine 
will require the limited supply to be prioritized for distribution and 
administration. The Federal Government has begun a process to revise 
previous interim guidance for Federal, State, local, tribal, and 
territorial planners on groups to target for earlier access to pandemic 
vaccines. The U.S. Government has sought input from influenza experts, 
State and local public health officials, homeland security experts, 
ethicists, private sector stakeholders, and the public in developing 
this guidance.

    Question 9.: In his testimony, Dr. Vanderwagen stated that, ``. . 
.there was a transfer of responsibility to the ASPR from the Assistant 
Secretary for Health for pandemic planning and coordination within 
HHS.'' What does this transfer entail? Why did the transfer occur? What 
are the implications for this transfer?
    Response: The Pandemic and All-Hazards Preparedness Act (PAHPA), 
Public Law No. 109-417, established the position of the Assistant 
Secretary for Preparedness and Response (ASPR) and designated the ASPR 
as the principal advisor to the Secretary on all matters related to 
public health and medical emergency preparedness and response. Under 
PAHPA, the ASPR office assumed responsibility for leadership and 
coordination of public health and medical preparedness and response 
activities within HHS, including planning and coordination of 
activities related to pandemic influenza.
    Prior to the transfer, the Assistant Secretary for Health (ASH) was 
responsible for leading pandemic influenza planning and served as the 
lead HHS contact to the Homeland Security Council (HSC), while the 
Assistant Secretary for Public Health Emergency Preparedness (ASPHEP) 
executed all initiatives. The transfer brings all pandemic influenza 
activities, from planning to execution, under one umbrella; ASPR is now 
also the HHS pandemic influenza lead contact to the HSC.
    ASPR's pandemic influenza activities include overseeing the 
advanced research, development, and procurement of qualified medical 
countermeasures and qualified pandemic or epidemic products through the 
Biomedical Advanced Research and Development Authority (BARDA). ASPR 
also administers pandemic preparedness and response efforts through the 
National Disaster Medical System (NDMS) and the Emergency System for 
Advance Registration of Volunteer Health Professionals (ESAR-VHP), and 
coordinates closely with the Medical Reserve Corps (MRC).
    The consolidation of the Department's public health and medical 
preparedness and response efforts under ASPR will ensure a unified, 
integrated approach in preparing for and responding to the public 
health and medical effects of natural and man-made disasters, including 
pandemic influenza Through ASPR, the Department will be better able to 
coordinate interagency activities between HHS, other Federal 
departments, agencies, and offices, and State and local officials, as 
well as private sector entities, responsible for emergency preparedness 
and the protection of the civilian population.

    Question 10.: During the hearing, Dr. Vanderwagen discussed with 
the Members of the Committee on Homeland Security various aspects of 
the Strategic National Stockpile, including the purchase and 
stockpiling of antiviral medications. In answering a question put 
forward by Rep. Pascrell about letters of inquire from Congress (that 
went to Secretary of Health and Human Services Leavitt--one letter from 
the House Republican leadership in June, one letter from the House 
Democratic leadership in August, and one from Senator Thad Cochran in 
September), Assistant Secretary Vanderwagen stated that two of these 
letters had been responded to by the Department of Health and Human 
Services. When were these letters sent, and to whom? Has the third 
response to Senator Cochran been made as well? Please attach copies of 
all of these letters when answering this question for the record.
        Copies of the following letters are enclosed: \1\
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    \1\ See attachments below.
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        Representative Boehner Letter dated June 21 / Reply dated 
        November 6
        Representative Hoyer Letter dated August 1 / Reply dated 
        November 26
        Senator Cochran Letter dated September 11 / Reply dated 
        November 26
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        
        

    Question 11.: In his testimony, Dr. Vanderwagen stated that, ``. . 
.gaps exist in respiratory protection.'' Please expand upon this 
statement. What are these gaps? How would HHS like to see these gaps 
filled?
    Response: HHS has done an assessment of the need for respiratory 
protection devices based on Pandemic Severity 5 (PS-5) pandemic. 
Current and near-term guidance documents and recommended practices were 
used as guides to assess the need. This assessment covers the needs for 
all segments of the US population (health care, public safety, 
business, and general public). Based on this assessment the need for 
N95 respirators is 5.3 billion and surgical masks is 26.9 billion. An 
evaluation was also done of the US market for these items and the surge 
capacity of the US manufacturing base. The need exceeds the market 
numbers by about 10-fold. HHS is currently working on strategies to 
address these gaps and the responsibilities of government, health care, 
business, and the general public for specific portions of the gap. 
While it is clear stockpiling and increasing domestic production will 
be part of any proposed solution, it is premature to give specifics to 
the solution to be proposed.

    Question 12.: In his testimony, Dr. Vanderwagen stated that, ``. . 
.gaps. . .exist in how we can make community mitigation even more 
effective potentially using the expanded production capability in 
antivirals to perhaps use antivirals in a prophylactic mode as opposed 
to a pure treatment mode. . .'' Please provide more information 
regarding the use of antivirals in a prophylactic (as opposed to pure 
treatment) mode. Is HHS putting this forward as policy at this time? 
Aside from using antivirals prophylactically, how else does HHS 
envision making community mitigation even more effective?
    Antiviral drug use will be an important component of a pandemic 
influenza response. While current antiviral drug use strategies and 
stockpiled assets are targeted primarily for treatment of persons with 
pandemic illness, expanded antiviral drug production has allowed 
additional new strategies to be considered. In February 2007, the U.S. 
Government released community mitigation guidance for mitigating the 
impact of a pandemic. This community mitigation strategy includes 
antiviral medications for treatment of ill persons and if sufficient 
supply exists, for prophylaxis for household contacts of an ill person. 
Mathematical models of the potential effects of community mitigation 
illustrate the additive effects that antiviral prophylaxis offers in 
reducing disease transmission.
    An interagency working group, with representatives from State, 
local and tribal public health agencies, considered scientific issues, 
ethics and values, and perspectives of stakeholders in developing draft 
guidance on antiviral use strategies and stockpiling. A draft guidance, 
which was developed by this working group led by HHS and is under 
public review, provides guidance for the use of influenza antiviral 
medications assuming that effective community mitigation measures will 
reduce pandemic illness by one-half.
    Draft guidance on antiviral use was based on goals of the U.S. 
national pandemic response which are to slow the spread of pandemic 
disease, reduce impacts on health, and minimize societal and economic 
disruption. The working group recommended the following strategies and 
settings for antiviral use to meet these goals:
         Containing or suppressing initial pandemic outbreaks 
        overseas and in the U.S. with treatment and post-exposure 
        prophylaxis (PEP) among individuals identified as exposed to 
        pandemic influenza and/or geographically targeted prophylaxis 
        for geographic areas where exposure is thought likely to occur;
         Reducing introduction of infection into the United 
        States early in an influenza pandemic by post-exposure 
        prophylaxis of exposed travelers as part of a risk-based policy 
        at U.S. borders;
         Treatment of persons with pandemic illness who present 
        for care early during their illness and would benefit from such 
        treatment;
         Prophylaxis of critical health care workers, emergency 
        service personnel, and workers with unique roles maintaining 
        critical infrastructures for the duration of community 
        outbreaks;
         Post-exposure prophylaxis of household contacts of 
        persons with influenza illness as a component of community 
        mitigation; and
         Post-exposure prophylaxis of workers in the health 
        care sector with limited patient contact, of persons with 
        compromised immune systems who are unable to be protected by 
        vaccination, and of persons living in closed settings such as 
        nursing homes and prisons if a pandemic outbreak occurs at that 
        facility.
    Antiviral drugs stockpiled by the Department of Defense and by some 
private sector businesses will protect military and critical support 
capabilities and employees, respectively, and contribute to maintaining 
essential societal and economic infrastructures. We recognize that 
shipment or use of antiviral medications for purposes beyond those in 
the labeled indication, which may include use for prophylaxis rather 
than treatment, would require consultation with the Food and Drug 
Administration, and either an Investigative New Drug exemption or an 
Emergency Use Authorization.
    This draft guidance is based on consideration of scientific, 
behavioral, and logistical issues, as well as societal values. Further 
discussions with stakeholders and the public are underway as part of a 
transparent process and to move forward in addressing implementation 
issues. Rapid implementation of these strategies during a pandemic will 
pose substantial challenges. Planning should include defining 
occupational target groups and developing approaches to ensure 
appropriate targeted prescribing and dispensing of antiviral drugs for 
both treatment and post-exposure prophylaxis. Periodic reassessment of 
antiviral drug guidance will be important based on scientific and 
technological advances and surveillance for antiviral resistance. 
Strategies also need to be continuously reviewed as a pandemic occurs 
and progresses to take into account the characteristics of the virus 
and epidemiology of disease in regard to control measures.
    Consistent implementation of the social distancing measures 
included in the Community Mitigation Guidance is important to produce 
reductions in disease transmissions within and among communities. HHS 
is working with public health agencies in every State to incorporate 
community mitigation in their pandemic planning activities. It is also 
important that State planners are aware of any potential adverse 
consequences due to these interventions and take actions to minimize 
the negative impact of these strategies. To enhance individual and 
community adherence to these community mitigation measures, HHS is 
providing guidance to State planners to encourage continued work with 
the private sector, public health, education, and community-based and 
faith-based organizations to address feasibility concerns, develop 
clear and appropriate public messaging, and minimize any adverse 
consequences associated with implementation.
    In addition and complimentary to social distancing, another key 
countermeasure among those used to mitigate an influenza pandemic in a 
community setting is the usage of masks and respirators. In some 
workplaces, employers will not be able to eliminate the risk of 
exposure to pandemic influenza for all employees and respirators will 
be an important component of protecting these employees and allowing 
them to perform essential work. Respirators are used to reduce an 
employee's exposure to airborne contaminants. Respirators are designed 
to fit the face and to provide a tight seal between the respirator's 
edge and the face. A proper seal between the user's face and the 
respirator forces inhaled air to be pulled through the respirator's 
filter material and not through gaps between the face and respirator. 
Respirators must be used in the context of a comprehensive respiratory 
protection program, (see OSHA standard 29 CFR 1910.134, or 
www.osha.gov/SLTC/respiratoryprotection/index.html).

    Question 13.: In his testimony, Dr. Vanderwagen stated that the 
engagement of state and local governments, businesses, individuals and 
families ``. . .in the gap filling process needs to be active and needs 
to be present. We have started that process here in the last couple of 
months, and have met with business interests, public health interests, 
medical interests in Seattle, in Raleigh.'' How have all of these 
entities been engaged? What has been done to start this process? Please 
include, but do not limit, information regarding the activities in 
Seattle and Raleigh.
    The purpose of the meetings in Seattle and Raleigh was to present 
modeling efforts we had undertaken to determine the requirements for 
certain types of material during a pandemic. We discussed antivirals, 
face masks and N95 respirators, and ventilators.  The participants 
included a broad range of stakeholders to include emergency response, 
public health, health care and private sector.  We discussed the 
magnitude of the need and how the various stakeholders could work 
together to fill the gaps. A consistent message from the stakeholders 
was that they are willing to be active partners with the Federal 
government but more specific guidance is needed. Since these initial 
meetings in Seattle and Raleigh, there have been subsequent meetings 
with a broad range of stakeholders to continue the discussions about 
shared responsibility for meeting the needs for antiviral medications 
as well as masks and respirators. Specific guidance is being developed.
    More broadly, HHS and other Federal agencies recognize that the 
private sector has an important role to play in preparing for, 
responding to, and recovering from a pandemic. The private sector owns 
and operates over 85 percent of the critical infrastructure in the 
United States, and therefore represents an integral part of our society 
because of the critical goods and services that it provides. Moreover, 
it touches the majority of our population on a daily basis, through 
employer-employee or vendor-customer relationships. For these reasons, 
it is essential that the U.S. private sector be engaged in preparedness 
and response activities for a pandemic. In the event of an influenza 
pandemic, businesses and other employers will play a key role in 
protecting employees' health and safety as well as limiting the 
negative impact to the community, economy, and society.
    Since November 2005, HHS has produced numerous tools for businesses 
of all types and sizes to assist them in planning for a pandemic. 
Several checklists have been produced that include information for 
businesses in general (Business Pandemic Influenza Planning Checklist), 
as well as Planning for U.S. Businesses with Overseas Operations, 
Health Insurer Pandemic Influenza Planning Checklist, and Travel 
Industry Pandemic Influenza Planning Checklist. State governments, 
local governments, and thousands of businesses and employers in this 
country and worldwide have used the checklists to improve their 
pandemic planning efforts. In coordination with other Federal agencies, 
other tools for businesses have been developed and distributed for use, 
including:
        1. Guidance on Preparing Workplaces for an Influenza Pandemic: 
        guidance and recommendations on infection control in the 
        workplace, including information on engineering controls, work 
        practices, and personal protective equipment, such as 
        respirators and surgical masks.
        2. Guidance for Protecting Workers against Avian Flu: 
        information for protecting employees who may have been exposed 
        to avian influenza.
        3. Cover Your Cough: flyers and posters showing ways to reduce 
        transmission of respiratory illnesses.
        4. Stopping the Spread of Germs at Work: basic precautions for 
        protecting employee health.
        5. Quick Cards for Employees to Protect Yourself from Avian 
        Flu: general precautions and specific information for poultry 
        employees, laboratory employees, animal handlers, food 
        handlers, and healthcare workers .
        6. Pandemic Influenza Preparedness and Response Guidance for 
        Healthcare Workers and Healthcare Employers: information and 
        tools helpful to healthcare planners.
    Over the last year, HHS and other agencies have conducted an 
extensive outreach effort to the private sector, particularly critical 
infrastructure businesses. In the last year, more than 150 
presentations, workshops, and fora have been conducted and attended by 
thousands of key stakeholders from critical infrastructure entities (e. 
g., healthcare operations, banking and finance entities, operations 
centers, retail operations, transportation and trucking operations, 
supply warehousing operations, grocery and food suppliers, and supply 
distributors) as well as businesses of all types. These information 
sharing sessions have provided practical action-oriented information to 
identify essential functions and critical planning elements and to 
assist businesses in protecting the health of employees and in 
maintaining continuity of business operations during a pandemic.
    In addition, the CDC Community Mitigation Guidance includes 
specific planning recommendations for aligning business practices with 
public health protection interventions. The document provides clear 
steps an employer can take to potentially slow the spread of pandemic 
influenza, help keep workplaces safe, and reduce the number of people 
who become sick. All of these tools listed above are posted on 
www.pandemicflu.gov.

    Question 14.: In his testimony, Dr. Vanderwagen stated that ``the 
last purchase to fill out the 81 million treatment courses for 
[antiviral medications] will occur in fiscal year 2008.'' When exactly 
in fiscal year 2008 will this purchase be made?
    Due to business reasons including possibilities of price increases, 
VA and HHS/BARDA renegotiated contracts with Roche for the purchase of 
Tamiflu antiviral drug for Federal and State pandemic antiviral drug 
stockpiles. Purchases of 12.6 million treatment courses of Tamiflu 
(Roche) and Relenza (GSK) for adults and children are expected by HHS 
in November 2007 with delivery to the SNS by the end of calendar year 
2007 to reach the 50 million treatment course goal of influenza 
antivirals for the federal pandemic stockpile.

    Question 15.: How is HHS trying to bring its own grants (to the 
public health, health care delivery, and other health-related 
communities) into better alignment and the same time sequence? How is 
HHS trying to bring its grants into the same time sequence as the DHS 
grants?
    The Department of Homeland Security grants cycle is dependent upon 
when their annual appropriations bill is signed into law, which causes 
variability in the date that awards are released each year. However, 
DHS grant awards have historically been released earlier in Federal 
Fiscal Year (FY) than the Department of Health and Human Services (HHS) 
cooperative agreement awards, which have been released in late August 
or early September. HHS is currently exploring several options that 
will better align the HHS awards with the DHS grants, and enable States 
to engage in better strategic planning across preparedness programs and 
among emergency responders.

    Question 16.: What is the reasoning for HHS disallowing the states 
to rotate antivirals through their stockpiles? What plans does HHS have 
for when the antivirals in the Federal and state stockpiles expire?
    HHS has no role or policy in the rotation of influenza antiviral 
drug stocks in State stockpiles. These matters are between the States 
and the manufacturers that must be conducted in accordance with FDA 
guidelines. Since 1985 DoD with FDA have practiced a Shelf Life 
Extension Program (SLEP) for large federal stockpiles of some 
pharmaceutical products including licensed influenza antiviral drug 
products, which are kept under strict environmentally controlled 
conditions and tested continuously with validated testing procedures. 
FDA and DoD do not have the resources or the legal authority to conduct 
a SLEP for State stockpiles. Alternatively, HHS encourages the 
manufacturers of influenza antivirals to submit product stability data 
that support longer expiration dating. To that end, Roche submitted in 
November 2007 data to FDA for consideration of 7 year expiration dating 
for Tamiflu, which is licensed currently for 5 years expiration.

    Question 17.: How is HHS using real-world situations (such as this 
year's influenza season) to optimize its surveillance, health care 
delivery, and other mechanisms to better prepare for pandemic 
influenza? What role do programs--such as the National Immunization 
Program--play in greater-than-normal activities designed to not just 
address seasonal influenza but prepare for a pandemic?
    CDC has approached planning for the 2007-2008 influenza season by 
utilizing some of the paradigms originally developed for pandemic 
response. This season, in anticipation of new ``drift'' strains 
circulating in the U.S., CDC leadership convened a task force to 
enhance surveillance systems and explore contingency plans in the event 
of a severe influenza season. This approach is using lessons learned 
and methods from pandemic planning and exercises to address the 
following areas:
    Enhanced surveillance
                 Communications to State health departments to 
                expedite reporting.
                 Active solicitation of viral specimens from 
                partner laboratories for monitoring of genetic drift in 
                circulating strains.
                 Pilot ``super sentinel'' sites established for 
                daily reporting of outpatient illness and testing.
     Vaccine effectiveness evaluation
         Literature review/analysis of scientific data from 
        previous seasons with suboptimal vaccine match.
         Active dialogue with public health officials in 
        partner countries and Department of Defense on recent vaccine 
        effectiveness analyses
         Collaboration with research partners to expedite 
        vaccine effectiveness for upcoming season on existing 
        platforms.
     Strategies for use of countermeasures
         Performed assessment of supply and surge production 
        capability of manufacturers of antiviral medications and rapid 
        influenza test kits.
     Mitigation
         Working groups formed to develop strategies for 
        community guidance and health care system recommendations in 
        the event of a severe influenza season.
     Immunization:
         Pilot test in progress with preparedness grantees to 
        measure data collection for vaccine administration in public 
        clinics (the pilot test will be completed December 31, 2007).
         Promotion of novel State approaches to rapid and 
        nontraditional vaccination methods, e.g., drive-through 
        vaccination.
     Health Communications
         Broadened annual flu communications to emphasize use 
        of antiviral medications, respiratory hygiene, and infection 
        control.
         Aggressive promotion of vaccination during National 
        Influenza Vaccination Week by CDC Director and subject matter 
        experts through more than 50 media interviews, popular and 
        scientific publications, campaigns with industry partners, 
        ``new media'' avenues such as webinars and MySpace, and revised 
        CDC flu web site.
     Exercises
    The Pandemic Influenza Cooperative Agreement for the 62 state, 
local, territorial, and tribal nations requires grantees to develop and 
implement a program to assess capabilities for non-pharmaceutical 
interventions, medical surge, and use of seasonal influenza clinics to 
exercise mass prophylaxis capabilities. As administrator of the 
cooperative agreement, CDC
         developed and distributed to grantees a tabletop 
        exercise kit on school closures
         provided supplemental guidance on use of seasonal 
        influenza clinics under circumstances that approximate those 
        expected during an influenza pandemic
         gathered and analyzed data from exercises
         is working with grantees to identify and address gaps 
        in state and local preparedness and response.

    Question 18.: Please describe the BioSense program. What is its 
role in picking up on outbreaks, epidemics, and pandemics? How does/
will BioSense interact with the National Biosurveillance Integration 
System (NBIS)?

Description of BioSense
    BioSense is a national program intended to improve the nation's 
capabilities for conducting near real-time biosurveillance, further 
enabling health situational awareness efforts through access to 
existing data from healthcare organizations across the country. The 
primary objective is to expedite response coordination among Federal, 
State, local public health and healthcare organizations by providing 
each level of public health access to the same data, at the same time. 
Consequently, if a bioterrorism event or a disease outbreak occurs, 
every level of public health will be able to see healthcare data from 
their community in near real-time.

BioSense functionalities include:
         Line lists of data anomalies found by automated 
        statistical testing to facilitate rapid screening for new 
        outbreaks;
         Time series graphs to determine the likely importance 
        of data anomalies and monitor disease trends;
         Line lists and patient detail views to examine data at 
        a granular level; and interactive maps to display count data 
        both over geographic area and time.

The Role of BioSense
    BioSense provides the ability to assess the impact of an outbreak 
or other public health event and the healthcare system's ability to 
react to it. The role of BioSense in providing health situational 
awareness supports public health efforts not only during outbreaks, 
epidemics, and pandemics but in catastrophic events as well.

Examples of how BioSense is being utilized include:
         The recent California Wildfires--The BioIntelligence 
        Center (BIC) provided the California Commissioner of Health 
        regular reports of BioSense data reflecting the prevalence and 
        trends of respiratory illnesses and burns in the areas affected 
        by the fires. California's Commissioner of Health wrote a 
        letter to Dr. Gerberding highlighting the utility of BioSense 
        and the reports provided.
         The Influenza Module--a new component of the BioSense 
        application, displays relevant flu data from BioSense alongside 
        traditional influenza surveillance data sets from the Influenza 
        Division at CDC. The success of the initial prototype resulted 
        in the program receiving a SAS Award and prompted a plan to 
        make the Influenza module scalable and accessible to local and 
        State public health departments. The Influenza Module data are 
        presented in a variety of formats, allowing simultaneous views 
        of multiple data sources and facilitating simpler comparisons. 
        The Influenza Module will improve the ability of public health 
        officials at local, State, and national levels to monitor 
        influenza activity across the nation and in their State and to 
        provide health situational awareness of influenza. State public 
        health officials, State influenza surveillance coordinators, 
        and CDC epidemiologists will be the first groups with access to 
        the new tool.
         Regular Flu Exercises--BioSense is used in these 
        preparedness exercises throughout the year. The after-action 
        evaluations and summaries further inform the optimal role for 
        BioSense in outbreaks, epidemics, and pandemics.
         Ongoing collaboration enhances communication between 
        the BIC and local, State, and Federal public health. Utilizing 
        BioSense data, the BIC has communicated with public health 
        regarding events such as:
                 A norovirus outbreak at a DoD base in South 
                Carolina
                 An influenza outbreak at several hospitals in 
                one region of Texas
                 An influenza outbreak at several hospitals in 
                one region of Missouri
                 A rash outbreak at a single hospital in Ohio
                 A possible outbreak of meningitis at a single 
                hospital in Indiana
                 Identifying a potential cholera outbreak and 
                discovering there was a cholera drill at a single 
                hospital in Illinois
                 A respiratory outbreak at a DoD base in South 
                Carolina.
    In each of these collaborations, the local/State public health 
departments were appreciative of the information and support. Potential 
future collaborations were discussed in each of these events.

Collaboration with DHS and NBIS
    In collaboration with the Department of Homeland Security (DHS) and 
the National Biosurveillance Integration System (NBIS), a BioSense 
Analyst from CDC has begun a detail with DHS. This work will help build 
a bridge between the surveillance efforts of BioSense and NBIS and will 
define how the programs will work together in the future.
         Create summary reports of human health status by 
        geographic region and disease category. The format and 
        frequency for these is considered under development. The 
        reports are both for information purposes and to provide 
        substance upon which to base the refinement of specification 
        requirements for the NBIS concept of operations as well as for 
        other health indicator information sources.
         Serve as a human health domain expert for dialogue and 
        interactions regarding population health threat events of 
        interest. This includes providing a social network bridge for 
        reaching back to other human resources and information systems 
        at CDC.
         Maintain a log of identified issues and requirements 
        that are relevant to enhancing the surveillance collaboration 
        between CDC and DHS/NBIS.
         Update and summarize a comprehensive needs assessment 
        report at least every two weeks to inform next steps in the 
        refinement of the CDC/DHS biosurveillance interaction. 
        Considerations will include emergency as well as non-emergency 
        situational awareness information needs, communications, 
        organizational implications, and other relevant identified 
        factors.
    BioSense contributes to biosurveillance by providing jurisdiction-
specific access to data for users outside CDC; a consolidated and 
cross-jurisdictional national view of data for Federal users; and daily 
monitoring and analysis.
         Users at various levels (local, State, and Federal 
        public health, as well as individual facilities) have 
        simultaneous access to several streams of surveillance data, 
        presented in a common user-friendly interface. The ability to 
        simultaneously access several data types, including non-Federal 
        hospitals and Federal (VA and DoD) outpatient clinics, 
        contributes to system utility.
         Federal users include staff from the CDC Division of 
        Emergency Preparedness and Response (DEPR), other CDC programs, 
        and the Directors Emergency Operations Center (DEOC).
    BioSense data are analyzed at three levels of aggregation. Counts, 
aggregated by week, are used to track longer-term trends in community 
levels of diseases, especially seasonal influenza and gastrointestinal 
disease, and to provide context for other analyses.
    The CDC BioIntelligence Center (BIC) provides a team of analysts 
who assist users outside CDC, monitor data from a national and cross-
jurisdictional viewpoint, and support the DEOC in preparedness 
exercises. BIC staff answers questions and provides assistance to users 
outside CDC to assist them in making best use of the BioSense System. 
The staff examines the BioSense application each day, and performs 
additional analyses for trends and statistical increases in disease 
indicators of concern, paying special attention to diseases and 
geographic areas with known outbreaks. Finally, BIC staff participate 
in BioSense application quality control and enhancement efforts.

    Question 19.: Aside from the potential of H5N1 to cause an 
influenza pandemic, other strains may also be cause for concern. What 
other strains is HHS tracking that it believes may also cause an 
influenza pandemic? Does HHS believe H3N2 to be of particular concern 
over other strains? Is the CDC involved in tracking the increasing 
prevalence and spread of H3N2? When did the CDC begin tracking H3N2? If 
the CDC did not pick up on the spread of H3N2 (particularly in Central 
and South America) on its own, who alerted the CDC as to this threat?
    The WHO collaborating laboratory at CDC tracks human and animal 
influenza in humans, and USDA/SEPRL tracks in animals, especially 
birds. Among non-human influenza strains, particular attention is being 
paid to the H7 and H9 avian subtypes, because these both have been 
shown to cause infections in humans.
    H3N2 is a human influenza virus that first appeared in 1968 with 
the pandemic Hong Kong flu. This influenza virus subtype virus has been 
tracked annually globally by WHO and within the U.S by CDC since its 
emergence in 1968 and, along with type A/H1N1 virus and type B 
influenza virus, is capable of causing seasonal epidemics. For this 
reason, these three strains are monitored closely by the WHO Global 
Influenza Surveillance Network in which the WHO Collaborating Center at 
CDC plays a major role. The CDC regularly receives reports and viruses 
from Central and South America as part of its ongoing surveillance 
efforts the results of which are combined with other data collected 
globally to select the appropriate strains to be included in the annual 
influenza vaccine.

    Questions from the Honorable Michael T. McCaul, Ranking Member 
      Subcommittee on Emerging Threats, Cybersecurity, and Science

    Question 20.: At the hearing you briefly discussed the current 
State of vaccine production technology. Could please elaborate by 
answering the following questions?
    Key medical countermeasure goals of the HHS Pandemic Influenza Plan 
are to establish national pre-pandemic influenza vaccine stockpiles for 
20 million persons in the critical workforce for administration at the 
onset of an influenza pandemic and to provide pandemic influenza 
vaccine to every American within six months of the isolation of a 
pandemic influenza virus strain. The first stage of the pandemic 
medical countermeasure program involves investment during 2006-07 into 
the expansion of vaccine manufacturing capacity (egg- and cell-based), 
the advanced development of new cell-based vaccines, antigen-sparing 
technologies, the establishment and maintenance of pre-pandemic vaccine 
stockpiles, and vaccine manufacturing infrastructure building of 
existing domestic facilities to produce pandemic vaccines. Building 
upon the foundation laid down during the initial stage activities is 
the second stage of the pandemic medical countermeasure program to be 
implemented in 2008-09.
         In June 2007, HHS awarded $132.5 million to sanofi 
        pasteur and MedImmune for the retrofitting of existing domestic 
        manufacturing facilities of U.S.-licensed biologicals for 
        pandemic influenza vaccine production to increase domestic egg-
        based influenza vaccine production capacity and for warm base 
        manufacturing operations. Concept facility design plans were 
        submitted in September 2007, and detailed facility design plans 
        are expected in December 2007 by these two manufacturers. Later 
        in FY08 a solicitation for proposals to build and validate new 
        domestic facilities for the manufacturing of cell-based 
        influenza vaccines is anticipated.
         In January 2007, HHS awarded three contracts totaling 
        $132.5 million to GlaxoSmithKline, Novartis, and IOMAI for the 
        advanced development of H5N1 influenza vaccines using antigen-
        sparing techniques towards U.S. licensure and expanded domestic 
        vaccine manufacturing surge capacity. U.S. clinical trials were 
        initiated in Sept. 2007 for evaluation of the safety, 
        immunogenicity, and cross-reactivity of egg-based inactivated 
        H5N1 vaccines using the companies' proprietary adjuvants with 
        the likelihood that U.S. licensure of one influenza vaccine 
        with adjuvant will be sought in 2008. Additional funding ($95 
        million) may be needed for one company depending on the 
        successful completion of Phase 1 trials by the end of 2007.
         In May 2006, HHS added five contracts for over $1 
        billion to GlaxoSmithKline, MedImmune, Novartis (formerly 
        Chiron), Solvay, and Dynport (with Baxter) to the cell-based 
        influenza vaccine program that had awarded sanofi pasteur a 
        contract previously in April 2005 ($97.1 million) for support 
        of advanced development of cell-based influenza vaccines 
        towards U.S. licensure and expanded domestic vaccine 
        manufacturing surge capacity. HHS provided additional funding 
        ($201.3 million) on Oct. 12, 2007 to the contract with Dynport 
        Vaccine Company, due to the Contractor's high performance and 
        decision to utilize non-wild type pandemic influenza virus 
        strains to manufacture pandemic influenza vaccines. U.S. 
        clinical studies (Phase 1 to 3) of cell-based seasonal 
        influenza vaccines began in the fall of 2007 for these 
        manufacturers with the likelihood that U.S. licensure of two 
        cell-based influenza vaccines will be sought in 2008. In July 
        2007 groundbreaking of a new cell-based influenza vaccine 
        manufacturing facility in North Carolina occurred by one of 
        these contracted manufacturers. An estimated $133 million 
        funding may be needed in FY08 for another manufacturer to 
        conduct Phase 3 clinical studies. These contracts are expected 
        to enable domestic production of 240+million courses of cell-
        based pandemic vaccine within six months of influenza pandemic 
        onset by 2011.
         HHS issued a Request for Proposals (RFP) on Oct. 19, 
        2007 for the advanced development of next generation 
        recombinant influenza vaccines towards U.S. licensure that may 
        shorten the timeline for production and release of pandemic 
        influenza vaccine.
         Using HHS Strategic National Stockpile (SNS) funds, 
        HHS awarded two contracts totaling $164 million in Fall 2005 to 
        purchase approximately 2.7 million courses of H5N1 clade 1 bulk 
        vaccine from sanofi pasteur and Novartis (formerly Chiron). 
        With funding from the December 2005 supplemental, HHS awarded 
        three contracts for $207 million in November 2006 to procure 
        3.7 million vaccine courses of H5N1 clade 1 and 2 bulk vaccine 
        from sanofi pasteur, Novartis, and GlaxoSmithKline. Recognizing 
        that the H5N1 virus continues to evolve, this purchase included 
        both clade 1 and clade 2 vaccine. The term ``clade'' refers to 
        the genetic variants (antigenic drift) of an influenza virus 
        strain. The first licensed H5N1 vaccine, which was developed 
        and manufactured by sanofi pasteur, was supported by HHS and 
        was licensed by the FDA in April 2007. Additional task orders 
        from these contracts were issued in August 2007 for the 
        manufacturing of at least 5.6 million vaccine courses of H5N1 
        bulk vaccine at a cost of $415.8 million. These H5N1 vaccines, 
        manufactured during the fall of 2007, were matched against 
        three circulating strains (subclade 2.1, 2.2 and 2.3) of H5N1 
        influenza viruses. As of October 30, 2007, HHS has obligated 
        $2.3 billion out of the $3.2 billion allocated for pandemic 
        vaccine-related activities. The total number of H5N1 vaccine 
        courses in the national pre-pandemic influenza vaccine 
        stockpile will be 13 million by Dec. 2007

    Question 21.: How quickly (once a flu strain is identified) can a 
vaccine be manufactured based on current egg-based production methods?
    The manufacturing production cycle for domestic egg- and cell-based 
inactivated pandemic influenza vaccines is estimated at 20--23 weeks 
from the availability of a pandemic influenza virus isolate to lot 
release and shipment of pandemic influenza vaccine from manufacturers 
to points of distribution within States. Alternatively, the 
manufacturing production cycle of next generation recombinant pandemic 
influenza vaccines may be 5--12 weeks post pandemic onset; however, 
development of these vaccines is further behind cell-based influenza 
vaccines and with considerably less infrastructure, integration, and 
manufacturing capacity. HHS expects to award contracts in FY08 for 
advanced development of next generation recombinant influenza vaccines.

    Question 22.: What is the status of faster, cell-based technology?
    First we note that, although cell-based technology is likely to be 
preferable for a variety of reasons, it has not yet been demonstrated 
that cell-based technology will be able to generate equal or larger 
numbers of vaccine doses faster than egg-based technologies.
    In May 2006, HHS funded five contracts for over $1 billion to 
GlaxoSmithKline, MedImmune, Novartis (formerly Chiron), Solvay, and 
Dynport (with Baxter) for the cell-based influenza vaccine program that 
had awarded sanofi pasteur a contract previously in Apr. 2005 ($97.1 
million) for support of advanced development of cell-based influenza 
vaccines towards U.S. licensure and expanded domestic vaccine 
manufacturing surge capacity. HHS provided additional funding ($201.3 
million) on Oct. 12, 2007 to the contract with Dynport Vaccine Company, 
due to the Contractor's high performance and decision to utilize non-
wild type pandemic influenza virus strains to manufacture pandemic 
influenza vaccines. Two Phase 3, one Phase 2, and one Phase 1 clinical 
studies in the U.S. using cell-based seasonal influenza vaccines from 
four manufacturers began in the fall of 2007 for these manufacturers 
with the likelihood that U.S. licensure of two cell-based influenza 
vaccines will be in sought in 2008. In July 2007 groundbreaking of a 
new cell-based influenza vaccine manufacturing facility in North 
Carolina occurred by one of these contracted manufacturers. These 
contracts are expected to enable domestic production of 240+ million 
courses of cell-based pandemic vaccine within six months of influenza 
pandemic onset by 2011. The total funding for advanced development of 
cell-based influenza vaccine development reached $1.3 million during 
this reporting period.
    We note that the manufacturing production cycle of next generation 
recombinant pandemic influenza vaccines may eventually be accomplished 
in 5--12 weeks post pandemic onset. However, development of these next 
generation vaccines is further behind cell-based influenza vaccines and 
with considerably less infrastructure, integration, and manufacturing 
capacity. HHS expects to award contracts in FY08 for advance 
development of next generation recombinant influenza vaccines.

                                 
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