Fiscal Year 2010 Budget in Brief

Emergency Preparedness

(dollars in millions)

*American Recovery and Reinvestment Act of 2009 (Recovery Act)
**Total is an estimate based upon the current BioShield Special Reserve Fund (SRF) balance, and the planned procurements using the SRF in FY 2009

To protect our Nation from the threat of pandemic influenza, the FY 2010 Budget request includes $584 million in HHS-wide funding, including $276 million in no-year funding to complete the implementation the HHS Pandemic Influenza Plan. The FY 2010 Budget request also includes approximately $4.6 billion for bioterrorism and emergency preparedness activities across the Department. Funding for these activities is appropriated to the Public Health and Social Services Emergency Fund (PHSSEF) and directly to agencies.

PANDEMIC INFLUENZA

The FY 2010 Budget request for pandemic influenza preparedness includes $276 million in no-year funding for the next phase of the HHS Pandemic Influenza Plan. These funds will be used to continue the advanced development of antiviral drugs and cell-based and recombinant vaccines, and to ensure that the U.S. has sufficient vaccine manufacturing capacity in the event of a pandemic.

Reassortment of avian, swine and human influenza viruses has led to the emergence of a new strain of H1N1 influenza A virus, (2009 H1N1 flu) that is transmissible among humans, and is confirmed to have caused infections in humans in the United States, Canada, Spain, the United Kingdom, and Mexico where human deaths have occurred. On April 28, 2009 the President announced a supplemental request of $1.5 billion for the Federal response to this outbreak. These funds, in addition to the FY 2010 request and the remaining balances, will allow HHS to develop and distribute antivirals and vaccines, and personal protective equipment as well as conduct public health surveillance to track the outbreak.

The FY 2010 request includes no year funds totaling $276 million to enhance the Nation’s preparedness by investing in advanced development activities, which will help build vaccine production capacity, support next generation antivirals, and develop recombinant vaccine technology so HHS can continue to effectively respond to pandemic threats and protect Americans from influenza outbreaks.

In addition to this Budget request, a total of $308 million will fund ongoing annual pandemic influenza activities at FDA, CDC, NIH, and within the HHS Office of the Secretary (OS).

In FY 2006, Congress appropriated $5.6 billion in emergency funding for implementation of the HHS Pandemic Influenza Plan, through two FY 2006 emergency supplemental appropriations. An additional $507 million was appropriated in FY 2009. HHS has used these funds to advance the Nation’s pandemic preparedness by expanding and diversifying domestic vaccine production and surge capacity; enlarging H5N1 pre-pandemic vaccine and antiviral drug stockpiles; supporting advanced development of cell culture and antigen sparing influenza vaccines and new antiviral drugs; supporting advanced development of point-of-care clinical diagnostics; stockpiling medical supplies and ventilators; improving State and local preparedness; expanding risk communication efforts; enhancing FDA's regulatory science base; and expanding surveillance, research, and international collaboration efforts of CDC, NIH, and the HHS Office of Global Health Affairs.

These investments have been crucial in our response to the current 2009 H1N1 flu outbreak. At the time of the President’s announcement, HHS had released 11 million courses of influenza antivirals to the States, deployed staff to regions with outbreaks in the U.S. and Mexico, provided community mitigation guidance, and expanded laboratory testing capacity across the U.S.

FY 2010 Pandemic Preparedness Priorities: HHS will continue efforts to detect and contain an emerging pandemic. The Budget request includes $158 million to continue to build vaccine production capacity, including development next generation recombinant influenza vaccines, expand the domestic pandemic vaccine manufacturing network, and start building of another cell-based influenza vaccine manufacturing facility in the U.S.

The Budget request also includes $53 million to continue support for advanced development of influenza antiviral drugs, which are critical to the response effort in the event of a pandemic. This support is towards new classes of antiviral drugs that are needed as currently circulating avian and human influenza viruses are naturally evolving and developing resistance to the current antiviral drugs in the stockpile. Also these funds will support the development of combination influenza antiviral drug therapies, which may include one or more currently U.S.-licensed antiviral drugs.

Lastly, continued development of next generation ventilators will be supported with $65 million to provide less expensive, more versatile and user-friendly forms of acute respiratory support devices.

In addition to the $276 million for development activities, a total of $308 million is requested in the budgets of the CDC, FDA, NIH, and OS to finance ongoing preparedness activities including:

• Expanding international and domestic surveillance and detection capabilities;
• Accelerating research and development of rapid diagnostic tests, to enable the accurate allocation of scarce countermeasures;
• Improving pandemic preparedness and response capabilities;
• Improving our Nation’s ability to contain a potential pandemic influenza outbreak; and
• Supporting international efforts designed to strengthen the public health and vaccine manufacturing infrastructure, expand surveillance systems, and improve preparedness and response capabilities in countries with the highest numbers of confirmed H5N1 cases.

(dollars in millions)

BIOTERRORISM AND EMERGENCY PREPAREDNESS

The FY 2010 Budget requests $4.6 billion for HHS bioterrorism and emergency response, an increase of $206 million over FY 2009. These funds are to protect Americans from a possible bioterrorist attack or other public health emergency, and are appropriated to the Public Health and Social Services Emergency Fund (PHSSEF) and directly to agency budgets.

PHSSEF ACTIVITIES

The FY 2010 Budget request for the PHSSEF bioterrorism and emergency preparedness activities is $958 million, a net increase of $146 million over FY 2009. The PHSSEF Budget request will support coordination of preparedness and response activities across HHS to improve the Nation’s ability to prepare for, respond to, and recover from the adverse health effects of public health emergencies and disasters.

Assistant Secretary for Preparedness and Response: The Office of the Assistant Secretary for Preparedness and Response (ASPR) is lead for the Federal Government for public health and medical services response efforts under the National Response Framework (NRF), Emergency Support Function (ESF) #8. ASPR coordinates the bioterrorism and emergency preparedness activities of HHS agencies, develops and coordinates national policies and plans, provides program oversight, and serves as the Secretary’s public health emergency representative to other Federal, State and local agencies.

The Budget provides $305 million for advanced research and development of promising medical countermeasures, an increase of $30 million over FY 2009. Within ASPR, the Biomedical Advanced Research Development Authority (BARDA) is responsible for coordinating and administering Federal efforts to develop and procure vaccines and countermeasures to mitigate the medical consequences of potential chemical, biological, radiological and nuclear (CBRN) threat events. Funding in FY 2010 will be towards sustaining support of existing countermeasure development in the high priority areas for anthrax, enhanced biothreats, and acute radiation syndrome. These funds will support product development on previously-initiated development projects for selected countermeasure candidates. The funding for advanced research and development for FY 2010 will be provided through a transfer of funds from the remaining BioShield Special Reserve Fund (SRF). Additionally, all balances from the SRF will be transferred from the Department of Homeland Security to the PHSSEF, which will improve the execution of BioShield. The Budget request also includes $22 million to manage Project BioShield.

ASPR works with Federal, State, local and Tribal partners to ensure coordinated planning and response to bioterrorism and other public health and medical emergencies.

ASPR Budget request includes $36 million for Preparedness and Emergency Operations, an increase of $13 million over FY 2009. This funding will support improved regional coordination; interagency coordination for ESF #8; improve federal response capabilities; and work to address the special needs of at-risk populations. Included within this Budget request is $10 million to prepare for and respond to National Special Security Events and other planned and unplanned events. In FY 2010, ASPR will support the Winter Olympics, special Federal events, and other HHS response requirements as well as unforeseen response activities.

The Budget request also includes $56 million for the National Disaster Medical System (NDMS), an increase of $7 million over FY 2009, to implement emergency readiness response improvements. The Budget request will support training, exercises, medical equipment and other deployable assets for over 100 Disaster Medical Assistance Teams, Disaster Mortuary Operational Response Teams, and other NDMS Teams to improve our Nation’s capacity to respond to a terrorist attack or other public health emergency.

In the FY 2010 Budget, $10 million is included for a medical countermeasure dispensing demonstration project with the United States Postal Service (USPS). The USPS is a unique Federal entity because it reaches the homes of every American, and will be a significant asset in the distribution of MCMs to the public in the event of a public health emergency.

In FY 2010, $426 million is requested for the Hospital Preparedness Program, an increase of $32 million from FY 2009. Funding also provides $6 million for the Emergency System for Advance Registration of Volunteer Health Professionals (ESAR-VHP) program.

The Budget provides $36 million for other ASPR activities, including $10 million for a new Emergency Care System program, which will improve the quality of emergency rooms at regional hospitals, and set national standards. These funds will also support operations, planning and communications, and coordination of international public health activities.

Cybersecurity: The Budget request provides $50 million for cybersecurity, an increase of $41 million, to protect the Department’s information technology infrastructure from cyber attacks by providing continuous security monitoring for all HHS systems, assets, and services. This funding will build off of the $50 million provided in the American Recovery and Reinvestment Act of 2009, and will support a Department-wide collaboration to identify and address security vulnerabilities. Additionally, this will enhance Department-wide computer systems intrusion detection capabilities, security information event management systems, and network forensics capabilities. It also supports all HHS operating divisions’ implementation, operation, and maintenance of security product solutions.

Medical Reserve Corps: Comprised of medical and public health volunteers, the Medical Reserve Corps contributes its expertise to local public health initiatives on an ongoing basis. The Budget request includes $13 million for the Medical Reserve Corps in FY 2010 to enhance the leverage of these efforts during a national catastrophic emergency.

Office of Security and Strategic Information: The Budget includes $5 million for the Office of Security and Strategic Information (OSSI), an increase of $1.6 million over FY 2009. OSSI is responsible for the development, maintenance, and operation of policy and programming in areas of physical security, personnel security, communications security and strategic information. OSSI is also the point of contact for all of HHS in working with the Director of National Intelligence.

HIGHLIGHTED BIOTERRORISM PREPAREDNESS ACTIVITIES

In addition to funding in the PHSSEF, another $3.7 billion in bioterrorism and emergency preparedness funding is requested directly in the appropriations for CDC, FDA, NIH, ACF, and OS.

Morbidity, loss of human life, and economic disruption caused by a terrorist attack or natural disaster could be substantially reduced through effective preparedness. The Budget request focuses on early detection and containment of an infectious outbreak, ensuring proper preparedness and response to an event, and having the countermeasures needed to treat and protect citizens against potential harmful exposures.

Detection and Containment: Quarantine stations improve CDC’s capacity to respond to natural and intentional communicable disease emergencies of public health significance by catching disease at the border and preventing it from spreading to the American public. The FY 2010 Budget provides $27 million to allow CDC to support the 25 quarantine stations located at airports across the country and in key international cities. This effort will also support more robust partnership activities with Federal agencies operating at the ports of entry, including Customs and Border Patrol. The CDC Budget request also provides $34 million for BioSense, the same as FY 2009.

FDA also plays a critical role in early detection through its food defense program. To protect our Nation's food supply, against intentional contamination, $217 million is included in this Budget request, an increase of $4 million over FY 2009, to support key food defense activities, including support for the Food Emergency Response Network. This funding builds on the $950 million in food safety funding which will increase and improve inspections, domestic surveillance, laboratory capacity, and domestic response to prevent and control foodborne illnesses.

Emergency Preparedness and Response: To minimize injury and loss of life resulting from a terrorist attack, our Nation must also have the ability to effectively prepare for and respond to such an event.

The FY 2010 Budget request provides $15 million, the same as FY 2009, to transform the Commissioned Corps into a force that is ready to rapidly respond to public health challenges and health care crises that can result from natural disasters, technological catastrophes, terrorist attacks, and other extraordinary needs.

The Budget request also includes $2 million for the Disaster Human Services Case Management planning and coordination effort in ACF. This program is a collaboration between ACF, ASPR, and the Federal Emergency Management Agency consistent with the command structure and reporting requirements in the National Incident Management Plan and the National Response Framework. A successful demonstration of this concept occurred during HHS’ response to Hurricanes Gustav, when ACF was able to assist 647 families, including 1,924 individuals, by providing healthcare, mental health and human services needs.

HHS continues to demonstrate a strong commitment to prepare States and local public health departments and hospitals for public health emergencies and acts of bioterrorism. In FY 2010, $715 million is requested for such efforts in CDC, which is in addition to the $426 million requested in ASPR. The Upgrading State and Local Capacity Grants Program at CDC and the Hospital Preparedness Cooperative Agreement Grants Program at ASPR prepare States and local public health departments and hospitals for public health emergencies and acts of terrorism. HHS has invested of over $11 billion since September 11, 2001 on these efforts.

Protection and Treatment: Our bioterrorism readiness relies on quickly protecting Americans that have been exposed to a biological, chemical, or radiological threat agent and treating those who have become sick following an exposure. Our Nation's ability to counter bioterrorism ultimately depends on advancing biomedical science to develop next generation countermeasures.

The FY 2009 Budget request for NIH biodefense activities is $1.8 billion, which includes $97 million for radiological/nuclear and chemical countermeasures research. These funds will support basic and applied research on agents with bioterrorism potential which will ultimately lead to the availability of new or improved vaccines and therapies to protect or treat persons exposed to threat agents. This effort addresses a critical threat area to enhance our preparedness for a dirty bomb or other radiological or nuclear disaster.

Within HRSA, $5 million is included for the Preparedness Countermeasures Injury Compensation fund, established by the Public Readiness and Emergency Preparedness (PREP) Act. The program is authorized to provide compensation to individuals suffering from any unintended side effects of a covered countermeasure administered during a disaster. As of March 2009, there have been eight PREP Act declarations for pandemic influenza, anthrax, botulism, smallpox, and acute radiation syndrome. In the event of a large scale terrorist attack, rapid access to large quantities of vaccines and medications is critical for saving lives. The FY 2010 President's Budget includes $596 million, a $25 million increase, for CDC's Strategic National Stockpile, a Federally-owned repository of countermeasures. Increased funds will help support the replacement of expiring products and increasing warehousing costs as the volume of the Stockpile increases, and additional products are added through Project BioShield.

(dollars in millions)

*American Recovery and Reinvestment Act of 2009 (Recovery Act)
**Total is an estimate based upon the current BioShield Special Reserve Fund (SRF) balance, and the planned procurements using the SRF in FY 2009

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