ASPR’s BARDA supports the advanced research and development of new MCMs. ASPR develops and makes available MCMs to address serious threats, including chemical, biological, radiological, and nuclear (CBRN) agents and emerging/re-emerging infectious diseases. ASPR will continue to develop and maintain a robust stockpile of MCMs capable of responding to 21st century health security threats. This occurs through multiple programs.
BARDA
The FY 2020 request is $1.6 billion, which is level with the FY 2019 enacted budget. BARDA works with public and private partners to transition candidates for vaccines, antivirals, diagnostics, and medical devices – known as MCMs – from early development into the advanced and late-stages of development and approval. BARDA funding includes support for the ARD, CARB, PBS, and PI programs.
ARD
Within BARDA, the FY 2020 request for ARD is $322 million, which is a $12 million increase compared to the FY 2019 enacted level. ARD supports the development of MCMs to address the primary and secondary effects of exposure to threat agents as well as gaps in preparedness and treatment for the injuries caused by radiation, nuclear, thermal burns, viral hemorrhagic fevers, and chemical agents. ARD addresses biothreat pathogens that may be resistant to stockpiled antibiotics.
SPOTLIGHT on the MCM Pipeline
By fostering partnerships and innovation, ASPR supports MCMs that protect the nation. BARDA is working to transition MCM candidates from basic research into advanced research and development and then towards U.S. Food and Drug Administration (FDA) approval. To do this, BARDA has built a robust research and development pipeline, which has resulted in 43 FDA product approvals since 2006. An example of said MCM is a medication used to treat people exposed to radiation. On March 29, 2018, the FDA approved use of sargramostim to increase survival in adult and pediatric patients acutely exposed to myelosuppressive doses of radiation. Myelosuppression occurs when radiation damages bone marrow. Suppression of bone marrow blocks the production of blood cells. The new medication facilitates recovery of bone marrow cells that develop into white blood cells, which help fight infections.
CARB
The FY 2020 request for CARB is $180 million, which is a $12 million decrease compared to the FY 2019 enacted level. BARDA will continue to support the advanced research and development of promising candidates for biothreat indications and the broad concern of antibiotic resistant bacteria. CARB addresses the threat of engineered biothreat pathogens that may be resistant to stockpiled antibiotics as well as the secondary complications that may come from initial exposure to CBRN threat agents.
SPOTLIGHT on the Division of Research, Innovation, and Ventures (DRIVe)
During FY 2018, BARDA established DRIVe initiative. DRIVe created an innovative ecosystem to expand public-private investment in health security technologies and products, such as wearable diagnostics. DRIVe is driven by industry and entrepreneurial communities that collaborate to protect Americans from some of our most serious, systemic, health security threats. To stimulate innovation, DRIVe forms unique public-private partnerships designed to accelerate transformative technologies. DRIVe promotes innovation by supporting a nationwide network of accelerators, along with venture capital practices, to assist startups and businesses interested in developing transformative MCMs. Through the DRIVe Accelerator Network, research teams forward deploy to where innovation is happening to identify promising solutions. During FY 2020, DRIVe will continue to develop innovative approaches to prevent and treat sepsis; support novel technologies to diagnose and identify individuals exposed to infectious disease; and, incorporate new programs designed to develop products, tools, and technologies that address 21st century threats. Efforts to address sepsis include identifying individuals infected before symptoms appear. Such progress will have dramatic impacts on the health care system and ensure rapid responses to public health threats.
PBS
The FY 2020 request for PBS is $735 million, which is equal to the FY 2019 enacted level. After successful advanced development of MCMs, BARDA supports late-stage development and procurement of promising products through PBS. Once licensed and approved, PBS transitions MCMs to the SNS. The FY 2020 request will support clinical and non-clinical studies, validation of manufacturing processes, late-stage development and procurement of Ebola vaccines and therapeutics, a next-generation anthrax vaccine, new antibacterial drugs, chemical agent MCMs, a new product to temporize burn injuries resulting from exposure to chemical agents, and new MCMs to detect and treat acute exposure to ionizing radiation. New intravenous formulations of stockpiled smallpox antiviral drugs will be made available for special populations and those who are severely ill.
SPOTLIGHT on Thermal Burns
Among the potentially deadly consequences of nuclear agents are burns and blast trauma. BARDA addresses the medical needs and treatment challenges associated with thermal burns by improving the quality of care, for example, and helping burn surgeons to determine the types of new MCMs needed to treat burn injuries effectively. By supporting emergency and routine burn care, BARDA creates more sustainable markets for the products available during mass casualty incidents since they also are used in routine burn care.
PI
The FY 2020 request for PI activities is $256 million, which is level with the FY 2019 enacted level. Funds are critical to domestic pandemic preparedness and the national security infrastructure, including development of a strong workforce for production of MCMs. Funds will be used to sustain previous investments in domestic influenza vaccine manufacturing; ensure that influenza vaccines and therapeutics deploy an effective and timely pandemic response; maintain overall pandemic readiness; and, ensure effective international pandemic preparedness. These activities maintain and improve pre-pandemic and response capabilities, including development of next-generation antivirals. During FY 2018, BARDA supported critical manufacturing efficiency improvements that increased PI vaccine production capacity. BARDA’s strategy accelerates the transition to modern, egg‑independent, cell- or recombinant-based approaches so that the right vaccine is available in the right place and at the right time.
To address the potential catastrophic consequences of 21st century threats, a regional approach is needed to improve national health care readiness and medical surge capacity. Supporting regional disaster health response capabilities requires collaboration among local health care coalitions, trauma centers, public and private health care facilities, and emergency medical services. This is accomplished by integrating preparedness within the health care delivery infrastructure across the public and private sectors and also by increasing coordination with non-government entities, including private sector hospitals and providers. Ultimately, this approach better supports state, local, tribal, and territorial disaster risk reduction, preparedness, mitigation, response, and recovery efforts.
During 2018, Ebola reemerged in the Democratic Republic of the Congo (DRC), with two outbreaks of Ebola virus disease occurring. The first outbreak, in western DRC, was contained quickly. However, the second outbreak, in eastern DRC, is prolonged due to the volatile security situation in that region. The second outbreak has become the second largest Ebola outbreak since the virus was discovered in 1976, surpassed only by the 2014–2016 outbreak in West Africa. This outbreak is unlikely to be the world’s last. Ebola and other highly infectious diseases cross borders. In order to protect the American people, ASPR partners with the Centers for Disease Control and Prevention (CDC) and others to monitor and support domestic preparation. During April 2018, ASPR led a historic exercise, Tranquil Terminus, to review notification processes, coordinate decisions, provide access to the resources needed, and test the movement of patients with highly infectious diseases by both air and ground. The exercise revealed strengths as well as gaps that ASPR is addressing.
NDMS
The budget requests $77 million for NDMS, which is $20 million above the FY 2019 enacted level. The request supports logistics and the regional emergency coordination needed to prepare for and respond to public health emergencies and disasters. Funding will be used for medical response assets, including training for NDMS teams and modernized equipment sets. An increase of $20 million in the request for NDMS will address existing shortfalls in pediatric disaster care. Children represent 25 percent of the U.S. population and face specialized issues. A Pediatric Disaster Care program is being developed jointly by NDMS and HPP to address appropriate planning and response capabilities for those specific needs, such as pediatric triage, decontamination considerations, and mass sheltering. Funds will support regional preparedness cooperative agreements for pediatric disaster care, response assets including training NDMS deployable teams, and medical equipment to assist with the special needs of children.
SPOTLIGHT on HHS emPOWER Program
emPOWER provides public health agencies and their partners with Medicare datasets, mapping tools, training, and technical assistance to protect the health of more than 4.1 million individuals who live independently and rely on life-maintaining electricity-dependent equipment (including ventilators) and healthcare services (such as dialysis and oxygen). Over 53,500 individuals have used the public
HHS emPOWER Map to help communities address electricity-dependency needs. emPOWER’s planning and just-in-time emergency datasets have helped responders to anticipate, plan for, respond to, and conduct life-saving outreach in over
100 local to federal emergencies. emPOWER also provides voluntary training to states and territories to help them develop state Medicaid datasets to protect at-risk children and adults.
HPP
The FY 2020 budget request for HPP is $258 million, which is $7 million below the FY 2019 enacted level. As the only source of federal funding for health care delivery system readiness, HPP focuses on health care provider coordination that enables an effective response to save lives and mitigate negative health outcomes for those impacted by public health and medical emergencies. HPP supports regional health care system readiness through health care coalitions (HCC). HCCs are groups of health care and response organizations that play a critical role in ensuring that each member has what is needed to respond to emergencies and planned events. Preparedness includes addressing medical surge capabilities, access to real-time information and communication systems, and disaster-specific education and training for health care personnel. HPP provides formula‑based cooperative agreements to states, territories, freely associated states, the District of Columbia, and three high-risk subdivisions.
SPOTLIGHT on the Technical Resources, Assistance Center, and Information Exchange (TRACIE)
TRACIE provides technical assistance to support health care emergency preparedness to local, state, regional, tribal, territorial, and federal staff, health care associations, health care entities, and other stakeholders. Through TRACIE’s online tools (https://asprtracie.hhs.gov/), health and emergency management professionals can access the best peer-reviewed resources and experts to call for help. ASPR TRACIE has responded to almost 4,600 requests for technical assistance. TRACIE has over 5,000 (and growing) resources available for download in its resource database and provides access to more than 650 subject matter experts who can advise on a wide-range of topics related to emergency management, public health, disaster clinical medicine, and health care system preparedness, response, and recovery.
PEO
The FY 2020 budget includes $25 million in budget authority for PEO activities, which is equal to the FY 2019 enacted level. The request includes $5 million in three-year funding to prepare for and respond to National Special Security Events, public health emergencies, and other events that are not eligible for assistance under the Stafford Act. Preparedness and response to public health and medical emergencies requires a robust and continuous training and exercise program. HHS has deemed ongoing exercises to be critical to preparing for effective responses during emergencies. Also essential is the operation and maintenance of the Secretary’s Operation Center to ensure that clear and timely information is available to support rapid response to disasters and public health emergencies.
MRC
The FY 2020 budget requests $4 million for MRC, which is $2 million below the FY 2019 enacted level. The funding will support technical assistance to MRC units. The assistance includes identifying and sharing training courses and other resources for developing unit capabilities for responding and deploying during disasters and emergencies as well as other topics specific to MRC, such as volunteer recruitment and retention.
ASPR supports public health agencies’ ability to quickly detect, diagnose, monitor, and respond to infectious diseases and other 21st century threats. This capability is critical to rapidly and effectively dispensing MCMs during an emergency. ASPR has responsibility for the SNS and coordinates with CDC on the “last mile” of MCM distribution and dispensing.
SNS
The FY 2020 request of $620 million for the SNS is $10 million above the FY 2019 enacted level. The increased funding level supports procurements of a newly developed thermal burn bandage and a smallpox antiviral drug. The budget also supports continued training and technical assistance to prepare federal, state, and local partners for effective distribution and dispensing of stockpiled MCMs to individuals exposed to public health threats. As the nation’s largest repository of life-saving MCMs and medical supplies, the SNS is the only federal resource readily available for use in a public health emergency severe enough to cause state and local supplies to be depleted, or when unique medical supplies are required yet not commercially available. The transfer of the SNS to ASPR increases the integration and coordination of response capabilities. ASPR also is looking for opportunities to further streamline the MCM development and procurement enterprise through new synergies between BARDA and the SNS.
ASPR is a leader in preparedness for, response to, and recovery from 21st century health security threats. ASPR provides clear policy direction and improved threat awareness, while continuing to secure adequate resources that help manage the next health threat. ASPR will continue to coordinate with public health agencies as well as the Director of National Intelligence and the Department of Homeland Security to address current and future national security threats.
SPOTLIGHT on NBS
In today’s interconnected world, biological incidents can harm thousands of lives and greatly impact travel and trade. ASPR’s budget includes an increase of $5 million dollars to fund ASPR’s leadership and coordination of the government-wide NBS. Launched in September 2018, NBS manages the risks associated with biological incidents and helps combat serious modern biothreats, whether from natural disease outbreaks, accidents involving high consequence pathogens, or the actions of terrorists. The NBS is led by the HHS Secretary and establishes a vision that prioritizes federal biodefense activities. The NBS is a collaborative effort for HHS and others including the Departments of Defense, Agriculture, and Homeland Security.
The five goals of the NBS are: 1) enable risk awareness to inform decision-making across the biodefense enterprise; 2) ensure biodefense enterprise capabilities to prevent bioincidents; 3) ensure biodefense enterprise preparedness to reduce the impacts of bioincidents; 4) rapidly respond to limit the impacts of bioincidents; and, 5) facilitate recovery to restore the community, economy, and environment after a bioincident.
Policy and Planning
The FY 2020 budget includes $20 million to support ASPR’s Policy and Planning activities, which is $5 million above the FY 2019 enacted level to support the NBS. Funds are critical for development of strategies, plans, and requirements to address 21st century health security threats, advance ASPR’s readiness and response priorities, and support the effective implementation of national preparedness functions and HHS’s responses during events. To set the strategic direction for public health and health care emergency preparedness, response, and recovery, ASPR’s Policy and Planning program will lead the implementation and evaluation of key strategies (including the National Health Security Strategy and the NBS), provide analysis to assess the effectiveness of ASPR programs, and mobilize expert recommendations from national advisory committees.
Operations
The FY 2020 budget includes $31 million for ASPR’s Operations, which is the same as the FY 2019 enacted budget level. The funds will be used to meet ASPR’s goals, including implementation of the mandates in the Pandemic and All-Hazards Preparedness and Advancing Innovation Act of 2018, once enacted. Funds support the continued development and management of program performance, quality improvement, Enterprise Risk Management, and strategic human capital—including organizational workforce leadership and engagement.
