+---------------+------------------------------------------------------+
| Number range  | ###### Testimony                                     |
| CHAPTER       |                                                      |
|               | **Committee on Homeland Security**                   |
| ![](media/    |                                                      |
| image1.wmf){w | **Subcommittee on Emerging Threats,**                |
| idth="1.44861 |                                                      |
| 1111111111in" | **Cybersecurity, and Science and Technology**        |
| heig          |                                                      |
| ht="1.4895833 | **and Governmental Affairs**                         |
| 333333333in"} |                                                      |
|               | ### United States House of Representatives           |
+---------------+------------------------------------------------------+

+-----------------------------------------------------------------------+
| **Safeguarding our Nation: HHS Emergency Preparedness Efforts**       |
|                                                                       |
| ***Statement of***                                                    |
|                                                                       |
| **RADM W. Craig Vanderwagen, M.D.**                                   |
|                                                                       |
| ***Assistant Secretary for Preparedness and Response***               |
|                                                                       |
| ***U.S. Department of Health and Human Services***                    |
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![](media/image2.png){width="2.0in" height="2.0in"}

> **For Release on Delivery**

**Expected at 10:30am**

#### Thursday July 22, 2008

**The Rhode Island State House**

**Smith Street, Room 313,**

**Providence, RI**

Good Morning Chairman Langevin, Mr. McCaul, and Members of the
Committee. I am RADM W. Craig Vanderwagen, M.D., the Assistant Secretary
for Preparedness and Response (ASPR) at the U.S. Department of Health
and Human Services (HHS). I appreciate this opportunity to discuss the
HHS plans and initiatives in public health and emergency preparedness to
respond to emerging biological threats, including pandemic influenza.
HHS's Office of the ASPR has adopted an "all-hazards" approach to our
preparedness and response activities, moving us from stand alone plans
to a process that addresses all of the hazards that potentially threaten
the public's health. We have collaborated and coordinated closely with
our Federal interagency partners and have provided States and
municipalities with funding to enhance their public health and medical
preparedness.

**Emergency Preparedness**

Our "all-hazards" preparedness involves a [shared
responsibility]{.underline} among our entire Department, our partners in
the international community, the Federal, State, local, Tribal and
Territorial governments, the private sector, and, ultimately,
individuals and families. Additionally, before an event, government
agencies at all levels work with the private sector to plan and exercise
so they can be ready when a disaster occurs. During an emergency, local
and State response agencies, including public health departments, are
the first to respond. For regional or severe emergencies, the Federal
government may be asked to provide additional resources and coordinate
response efforts across multiple jurisdictions.

In that context, some of the emergency preparedness efforts currently
being led by HHS involve working with our Federal, State, and local
partners. For instance, we support State and local authorities through
the Hospital Preparedness Program and the Public Health Emergency
Preparedness Program for a broad range of medical and public health
preparedness activities, including the development of medical and public
health plans for response, increasing the number of exercises to
evaluate these plans, increasing the training opportunities in key
preparedness areas, increasing epidemiological and laboratory detection
capabilities, establishment of local stockpiles of critical medical
equipment and supplies, improving surveillance and investigation
capabilities, maintenance and distribution of countermeasures, and
sharing of resources. 

**Emergency Support Function #8 -- Public Health and Medical Services**

The National Response Framework (NRF) Emergency Support Function (ESF)
#8 -- Public Health and Medical Services -- provides the mechanism for
coordinated Federal assistance to supplement State, local, Tribal, and
Territorial resources in response to a public health and medical
disaster, potential or actual incidents requiring a coordinated Federal
response, and/or during a developing health and medical emergency. The
Secretary of HHS; here forth the Secretary, leads all Federal public
health and medical response to public health emergencies and incidents
covered by the NRF*.* The response addresses medical needs and other
functional needs of those requiring medical care and other assistance
during an emergency.

Except for the personnel and assets under the command of the Department
of Defense, the Secretary assumes operational control of Federal
emergency public health and medical response assets, as necessary, in
the event of a public health emergency. The Secretary, through ASPR,
coordinates National ESF #8 preparedness, response, and recovery
actions.

HHS has implemented an incident command system that is National Incident
Management System compliant. Additionally, all states have established
emergency operation centers and have also implemented an incident
command system. We have trained and equipped response personnel who
include not only the National Disaster Medical System (NDMS) teams, but
also Public Health Service Commissioned Corps Officers.

The operational command of personnel deployed under our auspices is
fully consistent with and supportive of the Department of Homeland
Security's (DHS's) role as overall incident manager, including liaisons
in the National Operations Center, National Response Coordination
Center, and the Joint Field Office. The HHS recognizes and supports the
overall lead of DHS in coordinating the Federal response and we take
seriously our role as the lead Federal agency for Public Health and
Medical Services through ESF #8, of the NRF.

**Pandemic and All-Hazards Preparedness Act (PAHPA)**

Consistent with requirements contained in the Public Health Service Act,
as amended by the Pandemic and All-Hazards Preparedness Act (PAHPA), HHS
has updated the performance measures for both the Hospital Preparedness
Program and the Public Health Emergency Preparedness Program. Specific
improvements include greater clarity in language, the use of
definitions, and the addition of targets. For example, in FY 2006, HHS
asked grantees to report participating hospitals\' ability to track bed
status electronically, and report it to the grantee\'s Emergency
Operations Center within 60 minutes of a request. In 2007, the numerator
and denominator were defined to improve clarity. For FY 2008, the target
percentage of hospitals able to report was increased to 100 percent by
the end of the end of the year.

HHS strongly supported the new accountability provisions included in
PAHPA and is implementing these provisions. First, FY 2009 award funds
will be based on the successful achievement of targets during the
previous budget cycle. In addition, the matching provision will be
applied to the Public Health Emergency Preparedness Program (PHEP) in FY
2009. We also intend, through notice and comment, to apply the matching
provision to the Hospital Preparedness Program (HPP) in FY 2009. The
audit and carryover provisions apply to both the PHEP and HPP programs
currently; the withholding provision will be applied to these programs
in FY 2009. The HPP and PHEP programs implemented the maintenance of
funding provision in FY 2007.

**Public Health Emergency Preparedness (PHEP) Program**

From FY 2002- FY 2008, the Public Health Emergency Preparedness (PHEP)
program has provided \$6.3 billion to State, local, Tribal, and
Territorial public health departments. This amount includes targeted
supplements to prepare for smallpox (in FY 2003) and for an influenza
pandemic (FY 2005 -- FY 2007). This program has greatly increased the
preparedness capabilities of public health departments:

-   All States can receive and evaluate urgent disease reports 24/7,
    while in 1999 only 12 could do so.

-   All States now conduct year-round influenza surveillance.

-   The number of State and local public health laboratories that can
    detect biological agents as members of CDC's Laboratory Response
    Network (LRN) has increased to 110 in 2007, from 83 in 2002. For
    chemical agents, the number increased to 47, from 0 in 2001. Rather
    than having to rely on confirmation from laboratories at CDC, LRN
    laboratories can produce conclusive results. This allows local
    authorities to respond quickly to emergencies.

-   All States have trained public health staff roles and
    responsibilities during an emergency as outlined in the Incident
    Command System, while in 1999 only 14 did so.

-   All States routinely conduct exercises to test public health
    departments' ability to respond to emergencies. Such exercises were
    uncommon before PHEP funding.

**Hospital Preparedness Program (HPP)**

We have made considerable investments in building the healthcare
preparedness and response capabilities required during an incident
resulting in mass casualties, and are committed to performance
measurement. Over the past five years, the Hospital Preparedness Program
(HPP) has provided more than \$2.6 billion to fund the development of
medical surge capacity and capability at the State and local level. As a
result of HPP funds awarded to States and Territories, hospitals and
other healthcare entities:

-   Increased their ability to provide needed beds during an emergency;

-   Can now track bed and resource availability using electronic
    systems;

-   Engaged with other responders through interoperable communication
    systems;

-   Appropriately train their healthcare workers for all-hazards
    approach to emergencies,

-   Protect their healthcare workers with proper equipment;

-   Have installed equipment necessary to decontaminate patients;

-   Have developed fatality management and hospital evacuation plans,
    and

-   Coordinate [regional]{.underline} exercises.

**Regional Emergency Coordination**

HHS has worked diligently to partner with State, Tribal, Territorial,
and local officials to enhance their level of preparedness and to ensure
they can see how HHS will respond to disasters. Our Regional Emergency
Coordination/Coordinator (REC) program has been enhanced. In the past
year, we have increased the number of RECs from 10 to over 30. The REC's
role is to work with the States and local jurisdictions to coordinate
and enhance preparedness within the region. I have personally been to
each of the 10 HHS regions to participate in local exercises and meet
with State and local health leadership to discuss the level of
preparedness and how HHS can support them.

**US Public Health Service, Volunteer Personnel**

HHS has a number of resources that are rapidly available to deploy in
response to a biological event. The full-time U.S. Public Health Service
(USPHS) responders include the Rapid Deployment Force (RDF) Teams,
Applied Public Health Teams (APHT), Mental Health Teams (MHT) and
additional USPHS Officers. Volunteer healthcare professionals are
available through the Medical Reserve Corps, which has over 160,000
members in approximately 700 teams. The Emergency System for Advance
Registration of Volunteer Health Professionals (ESAR-VHP) ensures the
availability of volunteers for quick exchange between jurisdictions.

**National Disaster Medical System**

We are also continuously improving HHS's operational capabilities to
respond to emergencies. The NDMS, transferred from the Department of
Homeland Security to HHS, remains the "tip of the spear" as the Federal
disaster healthcare response capability, maintaining 6,200 medical and
public health professionals and over 1,800 participating hospitals that
offer definitive care services, with approximately 34,000 available beds
(at most recent count). NDMS field teams include the Disaster Medical
Assistance Teams (DMAT), Disaster Mortuary Operational Response Teams
(DMORT), National Medical Response Teams (NMRT), and International
Medical and Surgical Response Teams (IMSRT).

Since the transfer of NDMS last year, we have achieved a number of
accomplishments aimed at improving the System including the integration
of NDMS into the larger ESF# 8 response framework and regionalization of
NDMS response operations and caches to provide increased accountability
and standardization for supplies as well as fiscal savings. Future goals
for NDMS include enhancing readiness and accountability through
regionalization of NDMS response operations and enhancing equipment
caches.

**Federal Medical Stations**

The HHS Federal Medical Station (FMS) is a deployable healthcare
platform that can provide non-acute hospital bed surge capacity and
special medical needs sheltering. A standard FMS can house approximately
250 patients and is staffed by the Rapid Deployment Force teams. The FMS
are useful in care of patients with suspected or confirmed exposure to
biological threats, and who may require for example, observation,
limited definitive care, or primary care.

**Playbooks**

HHS prepares playbooks for the different scenarios of man-made and
natural disasters. For biological emergencies response there are
separate playbooks including *anthrax*, *Clostridium* botulinum, small
pox, and pandemic *influenza*. These playbooks are used by HHS during an
event and include sections for the:

-   Scenario;

-   Concept of operations, or CONOPs, for the response ;

-   Action steps;

-   Briefing and decision papers; and

-   Essential elements of information.

The action steps are time-oriented, and include pre-event steps should
there be credible intelligence that the risk of an event is high. The
action steps are arranged into natural stages for a response and include
a trigger for each stage, a recommended strategy to follow, and specific
actions to take.

ASPR has written and exercised playbooks based on 11 of the 15 National
exercise scenarios. The process of developing these playbooks provides
opportunities for input from our ESF #8 Federal partners. Additionally,
HHS playbooks, starting with the hurricane playbook, will be placed on
the HHS web site to facilitate their examination and use by State,
local, Tribal, and Territorial, officials. We will make additional
playbooks available as they become ready for release.

**The Medical Response System for TRiage, TRansport, TReatment**

HHS has developed a response system called the TR system for Treatment,
Triage and Transport in an event, that takes into account the factors
and character of the agent or threat, in determining medical response.
The triage of individuals will be based on medical evaluation including
where they were during and shortly after the event with particular
attention to special needs that they may have. The initial triage will
attempt to separate people into three broad categories:

-   those needing immediate medical attention, which would include those
    with clinical effects of known exposure to a biological agent or
    highly suspect exposure risk;

-   those without clinical effects to the biological agent but at risk
    from potential exposure (due to location, etc.);

-   those with minimal or no likelihood of exposure and no clinical
    effects from the biological agent, who do not require immediate
    medical care.

**MedMap**

HHS is developing an interactive geographic information system
(GIS)-based mapping system, called MedMap, which will include data for
resources in a response to any type of hazard such as potential medical
care sites and assembly centers in the U.S., evacuation routes, hazards,
etc. so that up-to-date information will be immediately available by
which to organize the response. Determining which local medical care and
assembly center facilities are functional or not in the exposure area is
essential, as is having information on what regional and nationwide
resources are available.

**Response Operations**

HHS maintains an operations center 24/7/365. The Secretary's Operations
Center (SOC) is directly connected to the DHS National Operations Center
and the FEMA National Response Operations Center. It serves as the focal
point for situational awareness, information management and response
coordination for HHS. We have established relationships with subject
matter experts from within HHS Operating and Staff Divisions such as
NIH, CDC, FDA, and ASPR.

**Homeland Security Presidential Directive #18**

In January, 2007 the President issued Homeland Security Presidential
Directive (HSPD) #18, which directed the Secretary and the Federal
Government in development and acquisition of medical countermeasures for
weapons of mass destruction. The HSPD-18 builds on the *[National
Strategy to Combat Weapons of Mass Destruction and Biodefense for the
21^st^ Century]{.underline}* by focusing on medical countermeasure
research, development, and acquisition efforts. The HSPD-18 objectives
for countermeasure include (1) identification of target threats with
potential for catastrophic impact on public health and able to be
mitigated; (2) yielding rapidly deployable and flexible capabilities to
address threats; (3) integration with WMD consequence management through
risk assessments of threats, vulnerabilities, and capabilities; and (4)
development of realistic, effective concepts of response for an attack.
With this in mind, the research, development, acquisition of medical
countermeasures is driven by principles that focus on (1) current and
anticipated threat agents with greatest potential for use, and
catastrophic consequences; (2) greatest potential to prevent, treat, and
mitigate WMD threats; and (3) integration with effective deployment
strategies supportable by realistic current or future operational and
logistical capabilities.

The biological threats focus of HSPD-18 addresses four distinct
categories which present unique challenges and significant opportunities
for development of medical countermeasures.

(1) **Traditional agents** are naturally occurring microorganisms or
    toxins with the potential to be disseminated to cause mass
    casualties. Such agents include *Yersinia pestis*, plague; and
    *Bacillus anthracis*, anthrax.

(2) **Enhanced Agents** are modified or selected traditional agents that
    enhance their ability to cause mass casualties. Such agents would
    include antibiotic resistant organisms that as such, circumvent
    medical countermeasures.

(3) **Emerging Agents** are pathogens that previously did not pose a
    recognizable risk to human populations, but are now identified to
    pose this risk, such as Severe Acute Respiratory Syndrome (SARS).

(4) **Advanced Agents** are novel pathogens or biomolecules that have
    been artificially engineered, and can circumvent current medical
    countermeasures to produce a more severe or enhanced spectrum of
    disease. In a way, genetically engineered smallpox strains could fit
    under this guise, as would engineered Ebola strains.

The HSPD-18 authorizes the Secretary to lead Federal Government efforts
to research, develop, and acquire medical countermeasures via
establishment of an interagency committee to provide advice in setting
medical countermeasure requirements, research, development, and
procurement activities; and establishment of a strategic planning
initiative to integrate requirements, development and acquisition of
countermeasures across the full range of research and life cycle
development. The Public Health Emergency Medical Countermeasures
Enterprise (PHEMCE) and the *[PHEMCE Strategy and Implementation Plan
for CBRN Threats]{.underline}* address these directives respectively.

**Medical Countermeasures**

**Biomedical Advanced Research and Development Authority -- Development
and Acquisition**

Our progress in securing medical countermeasures begins with and depends
on effective planning. The central framework for medical countermeasures
planning and implementation in the Federal government is the HHS PHEMCE,
established in July 2006.  This coordinated interagency group is led by
the ASPR, and includes the Centers for Disease Control and Prevention
(CDC), the Food and Drug Administration (FDA), and the National
Institutes of Health (NIH) as well as our partners from the Department
of Defense (DOD), DHS, and Department of Veterans Affairs (VA).  Through
this Enterprise-wide effort, we are able to ensure that Federal
activities with respect to needed medical countermeasures are
effectively coordinated from research and development to acquisition and
ultimately deployment.  This supports a range of programs that I will
briefly summarize for developing and acquiring medical countermeasures
for man-made and naturally-occurring public health threats while
building domestic manufacturing infrastructure. 

HHS established the Biomedical Advanced Research and Development
Authority (BARDA) to direct and coordinate the Department's
countermeasure and product advanced research and development
activities.  In support of the mission and priorities of PHEMCE, BARDA
establishes systems that encourage and facilitate the development and
acquisition of medical countermeasures such as vaccines, therapeutics,
and diagnostics, as well as innovative approaches to meet the threat of
chemical, biological, radiological and nuclear (CBRN) agents and
emerging infectious diseases, including pandemic influenza.  The BARDA
provides an integrated, systematic approach to the development and
purchase of the necessary vaccines, drugs, therapies and diagnostic
tools for public health emergencies.  It directs and coordinates the
Department's countermeasure and product advanced development activities
and medical countermeasure domestic manufacturing infrastructure
building, including strategic planning for medical countermeasure
research, development, and procurement. This coordinated approach is
critical to achieving success in the area of bioterrorism preparedness.

> **Anthrax:** Anthrax remains a top priority for ongoing public health
> emergency preparedness efforts at HHS. The Department is committed to
> developing and acquiring a robust, comprehensive portfolio of medical
> countermeasures against this threat.  Antibiotics represent the first
> line of defense to protect the nation following an anthrax attack. 
> Today, we have over 60 million courses of antibiotics on hand and on
> order for the Strategic National Stockpile (SNS).  Anthrax vaccines
> are also an essential element of our national preparedness.  It is
> possible that vaccines given as post-exposure prophylaxis in
> combination with antibiotics could provide longer-term protection, or
> allow for a reduction in the duration of the antibiotic regimen. HHS
> has awarded contracts for the acquisition of nearly 30 million doses
> of anthrax vaccine since 2005, including the recent contract award of
> 18.75 million doses of Anthrax Vaccine Adsorbed (AVA, BioThrax™) in
> partnership with the DoD.  In addition, antitoxins are necessary to
> treat individuals with advanced stages of infection, and may
> contribute to a more successful therapeutic outcome.  Beginning in
> 2007, HHS has awarded contracts to two manufacturers to deliver
> antitoxins sufficient for treating 30,000 people.  These vaccine and
> antitoxin contracts were awarded under the authorities of the Project
> BioShield Act of 2004.  In addition, three BARDA contracts for the
> advanced development of other anthrax therapeutic candidates were
> recently awarded through a partnership with the NIH/ National
> Institute of Allergy and Infectious Diseases (NIAID).
>
> HHS remains committed to the development and acquisition of a second
> generation anthrax vaccine.  While procuring and continuing to improve
> the currently available anthrax vaccine, HHS is investing over \$40
> million in the continued development of a recombinant anthrax
> vaccine.  This investment builds on the recombinant vaccine program
> that has been ongoing at the NIAID since 2002.  BARDA also released a
> Request for Proposals (RFP) in March 2008 for a recombinant anthrax
> vaccine contract award.  In addition, BARDA and NIAID released a Broad
> Agency Announcement in September 2007 for vaccine enhancement that
> will support important improvements in storage conditions and
> administration for vaccines against a wide array of biological
> threats; these proposals are currently under USG review.
>
> **Smallpox virus:** In June 2007, BARDA awarded a contract for a next
> generation modified vaccinia Ankara (MVA) smallpox vaccine for use in
> immune-compromised Americans. This was the first BARDA contract to
> utilize performance-based milestone payments allowable under the
> Pandemic and All Hazards Preparedness Act (PAHPA).   HHS/CDC has also
> procured ACAM-2000, a live, single-dose smallpox vaccine developed by
> Acambis, which is the first new bio-defense vaccine to be approved by
> the FDA.
>
> **Botulinum toxin**: In June 2006, HHS awarded a contract under
> Project BioShield to the Cangene Corporation for 200,000 doses of a
> botulinum antitoxin that targets all 7 serotypes of Clostridium
> botulinum.  The \$363 million contract will expand greatly our
> existing stockpiles in the SNS. Deliveries of this product to the SNS
> initiated in 2007.
>
> **Pandemic Influenza:** The pandemic influenza program is focused on
> vaccines, antivirals, diagnostics, and non-pharmaceutical
> countermeasures.  In December 2005, and June 2006, Congress
> appropriated \$5.6 billion for HHS pandemic influenza preparedness
> efforts. With these funds, scientists and public health experts at HHS
> have built an aggressive and broad-based medical countermeasures
> program for pandemic influenza.  These funds support the acquisition
> of existing products, advanced development projects to produce
> modernized and next-generation countermeasures, and the retrofitting
> and construction of the facilities necessary to produce pandemic
> influenza vaccines. 
>
> With respect to vaccines, HHS has a number of efforts underway.  These
> efforts supported the first U.S. licensure of an H5N1 vaccine in April
> 2007, which was highlighted as the number one medical breakthrough of
> 2007.  By the end of 2007, HHS in coordination with DoD had stockpiled
> 12 million courses of pre-pandemic H5N1. However, maintaining a
> domestic production capability for these priority countermeasures is
> also an essential component of the pandemic influenza preparedness
> strategy.  In May 2006, HHS awarded five contracts for over \$1
> billion to GlaxoSmithKline, MedImmune, Novartis (formerly Chiron),
> Solvay, and Dynport (with Baxter) for support of advanced development
> of cell-based influenza vaccines toward U.S. licensure and expanded
> domestic vaccine manufacturing surge capacity. In June 2007, we
> awarded two contracts for the retrofitting of existing domestic
> biological manufacturing facilities to produce egg-based influenza
> vaccines and included warm base operations for up to five years. 
> Additionally, contract awards are expected in 2008 for the
> construction of new domestic facilities for manufacturing cell-based
> influenza vaccines that is expected to quadruple the domestic pandemic
> vaccine manufacturing surge capacity by 2012.
>
> A robust and groundbreaking advanced development program has led to
> the rapid maturation of modernized cell-based influenza vaccine
> production and antigen-sparing technologies. New combinations of
> adjuvants and products provided by multiple manufacturers are
> currently supported by performance-driven milestone contracts. More
> rapid vaccine production may be afforded by the development of next
> generation recombinant influenza vaccines, which HHS will support.
>
> Antiviral drugs have become an increasingly important medical
> countermeasure for influenza.  Today, in coordination with DoD and VA,
> the SNS contains 50 million treatment courses of antiviral drugs,
> completing the Federal stockpile one year ahead of schedule.  HHS has
> also supported antiviral stockpiling at the State level.  Through a
> Federally subsidized program, States have purchased 22 million
> treatment courses of influenza antiviral drugs to date and are
> expected to reach our goal of 31 million courses by the end of 2008.
>
> The nature of severe influenza infections has also required us to
> focus on preparedness through non-pharmaceutical countermeasures, such
> as ventilators which play an essential role in the health care of
> critically ill patients.  The FY 2009 President's Budget includes \$25
> million to develop ventilators that are more amenable to public health
> emergency use.  This presents a prime example of the integrative,
> all-hazards approach that the PHEMC Enterprise seeks.  A more portable
> and easier to use ventilator could be an essential tool for responding
> to many different public health threats, when having a sufficient
> supply of ventilators could have an impact on the morbidity and
> mortality of exposure.

**Medical Countermeasures**

**Strategic National Stockpile -- Distribution and Dispensing**

The Division of Strategic National Stockpile (DSNS) at CDC can deploy
medical countermeasures rapidly after notification to do so. In addition
to medical countermeasures that can be tailored to meet the event's
specific needs, the DSNS inventory contains supplies and materiel
required in the medical management of burns, trauma, injuries that may
be seen in conjunction with explosive threats.

The collaborative arrangements DSNS has with a variety of agencies,
corporations, companies, and organizations are essential to not only
increase the ability of state and local public health agencies to
dispense medical countermeasures in a timely manner but also are
critical to identifying and overcoming many of the inherent challenges.
The broadness of the partnership is vital in that each of the
participants brings not only a different perspective to the challenges
but also expands the possibilities for finding answers to breach
obstacles and barriers. Developing partnerships with private and public
sector agencies to sponsor closed points of dispensing (PODs) is
necessary to alleviate the burden on PODs for the general public.
Lightening the load on these general public PODs reduces many of the
challenges faced by local health agencies, i.e., staffing, security.
These partnerships also reflect the directives within HSPD-21 and PAHPA
to cultivate, enhance, and maintain interagency collaboration.

An example of this collaborative partnership is demonstrated as
CDC/COTPER work with the Business Executives for National Security
(BENS) to promote the involvement of private corporations in
preparedness planning and response. BENS is working with the State of
Georgia and Los Angeles County to establish a model system, to hopefully
be duplicated nationally, of corporate points of dispensing. This pilot
initiative is funded through the CDC PHEP Cooperative Agreement. BENS
officials presented and networked with state and local planners at all
four regional Cities Readiness Initiative workshops.

**Homeland Security Presidential Directive #21**

On October 18, 2007 President Bush signed HSPD #21, "Public Health and
Medical Preparedness," establishing a new National Strategy for Public
Health and Medical Preparedness (the Strategy). 

As directed by HSPD-21, HHS has been successful in establishing two
advisory committees. The National Biosurveillance Advisory Committee has
been established as a subcommittee to the CDC Advisory Committee to the
Director (ACD) and a Disaster Mental Health Advisory Committee is being
established as a subcommittee under the National Biodefense Science
Board (NBSB) which advises the Secretary. Additionally, HHS leads the
development of a national strategy on biosurveillance through CDC's
efforts and creation of the Biosurveillance Coordination Unit charged
with coordinating the necessary activities to address the mandates of
HSPD-21 in the development of a strategy and implementation plan for the
nation's next-generation biosurveillance capability.

Under the leadership of CDC, the HSPD-21 requirement to ensure the
adequate flow of information before, during, and after an event,
including critical biosurveillance data and risk analysis has quickly
drafted a strategic plan of national scope. Planning is being undertaken
using a broad collaborative approach that will increase stakeholder
buy-in, assure effective implementation, and guide the strategic
allocation of resources.

Also delegated to CDC leadership, HSPD-21 requirements pertaining to
48-hour post attack countermeasure distribution are being addressed
through the strategic development of new models of distribution and
dispensing of medical countermeasures that would enhance and improve the
existing capabilities of the DSNS and its state and city partners. New
models can incorporate other partners into a national network, including
the CDC Laboratory Network, Department of Veterans Affairs, businesses,
and hospital and pharmaceutical distribution systems.

Tasked to DHS leadership, HSPD-21 requirements for health risk and
threat briefings to non-health political leaders at the state and city
level are being met with active involvement of HHS health experts.

Finally, HHS is implementing HSPD-21 through the establishment of the
[Emergency Care Coordination Center (ECCC)]{.underline}. This new
center, an intradepartmental and interdepartmental collaborative effort
involving the DOD, DHS, Department of Transportation and VA, will serve
as the coordinating focal point for an Emergency Care Enterprise,
coordinating with the Federal Interagency Committee on Emergency Medical
Services. Its vision is exceptional daily emergency care for all persons
of the United States and its mission is to promote Federal, State,
local, tribal and private sector collaboration to support and enhance
the nation's emergency medical care.

The ECCC will assist the US Government with policy implementation and
guidance on daily emergency care issues and promote both clinical and
systems-based research. Through these efforts, ASPR and its Federal
partners will improve the effectiveness of pre-hospital and hospital
based emergency care by leveraging research outcomes, private sector
findings and best practices. The ECCC will promote improved daily
emergency care capabilities to improve resiliency of our local community
healthcare systems. This will provide a stronger foundation on which to
advance disaster preparedness efforts and strengthen our Nation's
ability to respond to mass casualty events. Currently, the ECCC Charter
is being finalized and we anticipate having the Center up and running by
the end of the year.

**Global Health Coordination**

In addition to these domestic efforts, other approaches to improving our
national capabilities include partnering with allied nations. At the
recent Global Health Security Action Group ministerial meeting, there
was some consideration paid to the possibility of establishing
international laboratory networks among the member nations. Links with
Canada would be particularly useful given the geographic proximity.
Informal discussions among the scientists and subject matter experts
have been ongoing for a few years but no formal arrangements have been
made. We continue to explore possibilities that serve the national
interest.

**Conclusion**

HHS staff work diligently to progress and expand the initiatives in
public health and emergency preparedness for emerging biological
threats. We continue to assess potential biological threats in the
context of an all hazards approach, and compare the plans and programs
available to us for mitigating these threats to ensure we are focused on
the right initiatives. Through cooperation with our Federal partners,
and State, local, Tribal, and Territorial governments, we have
implemented a number of preparedness programs and assets that have
strengthened our ability to respond to a biological event.

Thank you for your time and interest. I am happy to answer any
questions.