The HHS PHEMCE Implementation Plan will coordinate the investment of resources from programs across HHS including NIH biodefense research and development, advanced development, and the Special Reserve Fund authorized under Project BioShield.  The HHS PHEMCE Implementation Plan will be released in the first half of 2007 and will support the Secretary’s promise to increase transparency with our stakeholders and to make HHS a better business partner. The HHS Implementation Plan will be reviewed at least biennially and revised to reflect changes in the threat scope and the availability of new or improved countermeasures.

While ASPR has moved forward with the Enterprise and through other efforts, more remains to be done.  The FY 2008 request supports our continued efforts to improve the early detection and containment of an infectious disease outbreak; to ensure proper preparedness and response to naturally occurring and manmade events; provide support for the development and procurement of countermeasures needed to treat and mitigate the health effects of exposure to CBRN threats and emerging diseases; and prepare the Nation for a potential influenza pandemic.

Today I will detail for you the FY 2008 budget request for Department of Health and Human Services’ emergency preparedness activities and discuss how these activities are coordinated across the Department.  I am joined by Dr. Julie Gerberding, the Director of the Centers for Disease Control and Prevention, and Dr. Anthony Fauci, the Director of the National Institutes of Health, National Institute of Allergy and Infectious Diseases.  My colleagues will speak more specifically about activities within their organizations.

The FY 2008 President’s Budget includes $5.5 billion for emergency preparedness.  Within this total, $4.3 billion is requested for efforts to respond to a terrorist attack and other emergency preparedness activities across the Department including $1.5 billion for CDC bioterrorism preparedness activities; $1.7 billion for NIH Biodefense and radiological, nuclear, and chemical countermeasure research; and $751 million for the Office of the Assistant Secretary for Preparedness and Response.

The total also includes $1.2 billion for the third year of the President’s Pandemic Influenza Preparedness Plan.  Within this amount, $870 million will be directed to expand cell- and egg-based vaccine production, purchase antiviral drugs, and to accelerate research and development of rapid point of care diagnostic tests.   Since December 2005, HHS has funded the first stage of pandemic preparedness activities including expanding domestic vaccine production and surge capacity; increasing H5N1 vaccine and antiviral drug stockpiles; and supporting advanced development of cell culture and antigen sparing influenza vaccines.  As of February 1, 2007, HHS has 4 million courses of H5N1 vaccine on hand and 2.7 million to 3.5 million courses on order as well as 23.8 million courses of antivirals on hand and 13.3 million courses on order.  

For the Office of the Assistant Secretary for Preparedness and Response, the FY 2008 budget request includes $751 million.  The request will support investments to leverage state and local public health emergency response capacity developed since 2002 as well as the expansion and integration of federal assets available to support communities to prevent, respond to and recover from disasters and other public health emergencies.  This includes investments to support the development of medical countermeasures as well as continued progress toward improving human response assets, such as those found in the National Disaster Medical System (NDMS), and broad based partnerships to ensure systems of support that extend beyond the federal capacity.   Effective preparedness and response requires a comprehensive approach.  Using an enterprise model, we have and will continue to engage those at all levels of government, the private sector and the international community.  Through these investments and management of these programs, we will strengthen our National preparedness system.

The request for ASPR emphasizes and promotes regional response coordination to improve state and local preparedness.  The request includes $42 million to respond to the recommendations of the White House report, The Federal Response to Hurricane Katrina: Lessons Learned including an increase of $6 million, for a total of $53 million, to improve operational capabilities of NDMS.   

The budget also includes $414 million for the Hospital Preparedness Program which focuses on the development of partnerships at the local, state, and regional level, thereby improving overall facility surge capacity.  Consistent with the goals of this program, in FY 2007, HHS will direct $75 million in pandemic influenza supplemental funding to increase medical surge capability for states and localities.  This funding will complement existing efforts to improve emergency preparedness supported through the Hospital Preparedness program.

The budget request also includes investments that will enable us to maximize federal resources for the development and acquisition of medical countermeasures including $22 million to manage the Project BioShield Program and $189 million for the Advanced Development Program to carry out the important new opportunities created in the Biomedical Advanced Research and Development Authority.

In exercising the procurement authorities under Project BioShield, HHS has launched acquisition programs to address each of the four threat agents originally deemed by the Department of Homeland Security (DHS) to be threats to the U.S. population sufficient to affect national security, including Bacillus anthracis (anthrax), smallpox virus, botulinum toxins, and radiological/nuclear agents. These activities were highlighted in the 2004-2006 Project BioShield Report to Congress that described the past two years’ activities since passage of the Project BioShield Act of 2004.  Under these BioShield acquisition contracts, medical countermeasures to address radiological or nuclear threats and anthrax have already been delivered to the SNS, and contracts for additional medical countermeasures to address anthrax and botulism have been awarded.  Medical countermeasure priority requirements to address the additional nine biological threat agents identified in September 2006 by DHS as material threats to national security will be addressed in the HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Implementation Plan, discussed previously, that will be released in the first half of this year.  Despite these successes, more can and must be done.

There are new challenges to our Nation’s public health.  Bringing new medical countermeasures – to protect the population from the health effects of a CBRN event – from development to procurement involves many challenges.   The discovery and development of new medical countermeasures is costly, time consuming, and a risky business.  While we have achieved successes, we have also been forced to make difficult decisions.  As you know, HHS recently announced the termination of a contract with VaxGen for the delivery of 75 million doses of anthrax vaccine.   In this case, the candidate product was placed on clinical hold by the FDA, and the company failed to meet critical milestone dates.  HHS remains committed to the established requirements to respond to the health impacts for an rPA vaccine.   HHS will continue efforts to procure anthrax vaccines that will protect 25 million people in the event of an anthrax attack. 

HHS has successfully procured other products to respond to an anthrax attack.  Today, there are antibiotic tablets sufficient to treat 40 million people and approximately ten million doses of the AVA anthrax vaccine in the SNS.  Delivery of the therapeutic anthrax antitoxins acquired under BioShield is anticipated to begin this year.

To increase the maturity of the candidate pool of promising medical countermeasures available to protect the population from CBRN attacks, the FY 2008 request includes $189 million for advanced development of medical countermeasures.  The Project BioShield Special Reserve Fund supports the procurement of medical countermeasures for the SNS, but is not designed to support the advanced development of medical countermeasures.  Additional funding, in the form of advanced development, is to move promising MCM candidate products from discovery research and development through the rigorous advanced development pipeline to become eligible for procurement using the Project BioShield Special Reserve Fund.  However, limited funding has been provided to date directly for advanced development of such products.  The FY 2008 request for advanced development will bridge the gap between NIH research and development programs and Project BioShield, and it is critical to BARDA implementation.

As you know, the Pandemic and All-Hazards Preparedness Act was enacted into law in December 2006.  This law has broad implications for the Department, as well as our federal partners, states, communities, and tribes.  In addition to establishing the new Assistant Secretary for Preparedness and Response, the law returned NDMS to the Department of Health and Human Services, and it provides new authorities regarding the acquisition of medical countermeasures and new standards and authorities for preparedness grants and contracts.  The Act also establishes the Biomedical Advanced Research and Development Authority (BARDA) to promote the advanced development of countermeasures to protect Americans against the public health consequences of CBRN attacks and against the threat of emerging infectious diseases, including an influenza pandemic.

Shortly after the enactment of this legislation, the Secretary established a Department-wide process coordinated by our office to manage the implementation of this statute.  This includes the participation of over 200 representatives of the Department including both CDC and NIH in ten working groups from Agency heads to senior staff levels.  We expect this process to complete a robust implementation plan that will lay out our approach to meeting the requirements of this law.

Within six months of enactment, the Secretary will develop a strategic plan (to be incorporated into the National Health Security Strategy) to integrate biodefense and emerging infectious disease requirements with advanced research and development, strategic initiatives for innovation, and the procurement of qualified countermeasures. 

In addition to the advanced development activities called for in the Act, the Department is also directed to perform several tasks intended to improve the federal, state and local readiness for natural and man-made disasters. Specifically, the Act directs the Secretary, in coordination with the Departments of Homeland Security, Defense and Veterans Affairs to conduct a joint review of the NDMS, including an evaluation of medical surge capacity.  The review will specifically evaluate the benefits and feasibility of improving the ability of HHS to provide additional medical surge capacity to local communities in the event of a public health emergency.  Additionally, the review will assess the feasibility of improving surge capacity through the acquisition and operation of mobile medical assets and the adoption of telemedicine practices.  The Act also provides ASPR with the responsibility for managing the Hospital Preparedness Cooperative Agreement Program.

New investments in FY 2008 as well as existing assets and capabilities must be coordinated across the Department and with other federal, state, local and tribal partners to ensure effective preparedness and response to a possible CBRN terrorist attack or other public health emergency.

ASPR works closely with CDC and the Division of the Strategic National Stockpile (DSNS).  Presently, ASPR coordinates with the CDC in determining how vaccines, drugs and therapeutics in the SNS are deployed and utilized if there were a CBRN attack.  A goal of the PHEMCE is to facilitate a close relationship between ASPR and the CDC Strategic National Stockpile to: ensure alignment with the medical countermeasure priorities; assess storage requirements for medical countermeasures; and plan for Federal Points of Dispensing for countermeasures.

ASPR, in collaboration with CDC, also provides guidance and leadership for the Cities Readiness Initiative (CRI).  The primary goal of the CRI is to minimize the loss of lives during a catastrophic public health emergency by providing needed drugs to 100% of an at risk population within 48 hours of the decision to do so.  Through CRI, HHS works directly with state and local officials to develop receipt, distribution and dispensing plans and capabilities for providing stockpile items to their citizens.  In FY 2007, an additional 36 metropolitan statistical areas are being added to the current 36 CRI cities and are being provided with funding and technical assistance. 

ASPR and CDC also provide guidance and leadership on encouraging states and localities to develop plans to provide prophylaxis through alternate methods that may decrease the burden on traditional Points of Dispensing.  One such method involves the United States Postal Service (USPS) and employs local postal workers, escorted by local security personnel, to deliver antibiotics directly to residences in the event of a bioterrorism event for which such countermeasures are appropriate.  An in-field operational drill in Seattle, Washington in November, 2006 demonstrated the feasibility of this “quick strike” concept.  USPS delivered simulated drug packages and information sheets to the residents of two entire zip codes (approximately 36,000 households – home to approximately 130,000 people) in less than eight hours.

ASPR is the lead for the Department for planning activities required to fulfill HHS mass casualty care responsibilities under Emergency Support Function #8 of the National Response Plan and Homeland Security Presidential Directive 10.  These responsibilities include developing a federal asset to provide over 30,000 patient beds.  To assist in fulfilling this responsibility, ASPR has partnered with CDC to develop and field the deployable Federal Medical Station project to increase bed capacity and aid health care response and recovery efforts at the state and local levels.  Federal Medical Stations were deployed to Louisiana, Mississippi and Texas in response to Hurricanes Katrina and Rita to support the medical needs of evacuee populations.  HHS deployed 5,500 beds – 22 units – and associated med/surge supplies and pharmaceuticals in support of these events. 

ASPR works closely with federal partners, including CDC and NIH, to develop operational playbooks for high priority scenarios – such as hurricanes, pandemic influenza, earthquakes, anthrax, and a ten kiloton nuclear detonation; to provide guidance to health care providers about the diagnosis and treatment of radiation casualties through Radiation Event Medical Management website; and to develop standard operating procedures for ESF #8 and Incident Response Coordination Team logistics.

ASPR provides technical leadership, coordinates and builds partnerships, and supports program efforts to better prepare our country and the world for global threats like pandemic influenza.  An influenza pandemic could have catastrophic effects throughout the world.  While we do not currently have the means to prevent a pandemic, there are many steps that the Department is taking that will help detect, contain and respond to a global influenza pandemic. 

ASPR coordinates its pandemic influenza efforts with CDC, NIH, HRSA, FDA, the HHS’ Office of Global Health Affairs, and the National Vaccine Program Office, as well as other Federal partners including the USAID, USDA, DoD, DOS, DHS, and regional and multilateral international organizations.  In FY 2006, ASPR awarded $32 million for international pandemic influenza preparedness efforts, which included the expansion of global surveillance networks by increasing laboratory, diagnostic and epidemiological activities; development of national pandemic plans and communications efforts in a number of vulnerable countries; training health care workers in acute respiratory disease case recognition and disease management; and building influenza vaccine production capacity in key developing countries through a global initiative with the World Health Organization.

ASPR looks forward to promoting continued progress in integrating preparedness and response efforts across the Department.  In 2006, ASPR created a dedicated Office of Policy and Strategic Planning that initiated a strategic planning process which will support the HHS Strategic Plan and chart the course ahead for the Office as it directs and coordinates HHS-wide capabilities to ensure the Nation is prepared to respond to a potential terrorist attack and other public health and medical emergencies.

Last revised: August 29,2008