Fiscal Year 2022 - HHS.gov

1 DEPARTMENT of HEALTH and HUMAN SERVICES Fiscal year 2022 Public Health and Social Services Emergency Fund Justification of Estimates for Appropriations Committee Public Health and Social Services Emergency Fund 2 TABLE OF CONTENTS Organization Charts .. 9 Assistant Secretary for Preparedness and Response .. 9 Cybersecurity .. 11 Office of National Security .. 12 Introduction and Mission .. 13 Overview of Budget Request .. 15 Overview of Performance .. 18 All Purpose Table .. 23 Appropriations Language .. 24 FY 2022 Proposed Appropriations Language .. 24 FY 2022 Proposed General Provision .. 25 Appropriations Language Analysis .. 26 Amounts Available For Obligation .. 27 Summary of Changes .. 28 Budget Authority by Activity .. 29 Authorizing Legislation .. 30 Appropriations History .. 31 Appropriations Not Authorized by Law .. 32 Assistant Secretary for Preparedness and Response .. 33 Summary of Request .. 33 Preparedness and Emergency Operations .. 38 National Disaster Medical System.

2 48 Medical Reserve Corps .. 65 Hospital Preparedness Program .. 71 Preparedness and Response Innovation .. 109 Biomedical Advanced Research and Development Authority .. 111 Project BioShield .. 126 Strategic National Stockpile .. 132 Policy and Planning .. 146 Operations .. 153 Nonrecurring Expenses Fund .. 156 Assistant Secretary for administration .. 157 Cybersecurity .. 157 Department of Health and Human Services .. 168 Public Health and Social Services Emergency Fund 3 Cyber Incident Response .. 168 Immediate Office of the Secretary .. 172 Office of National Security .. 172 Pandemic Influenza .. 175 Assistant Secretary for Health .. 190 Commissioned Corps Readiness Training .. 190 Public Health Service Ready Reserve .. 193 Public Health and Emergency Response Strike Team .. 196 IDEA Digital Modernization Act .. 198 Budget Authority by Object Class .. 199 Salaries and Expenses .. 200 Detail of Full-Time Equivalent Employment .. 201 Detail of Positions .. 202 Programs Proposed for Elimination.

3 203 Significant Items in Appropriation Committee Reports .. 204 Public Health and Social Services Emergency Fund 4 We are pleased to present the Fiscal year (FY) 2022 Congressional Justification for the Public Health and Social Services Emergency Fund (PHSSEF). The FY 2022 Budget Request directly supports the United States ability to prepare for, respond to, and recover from the consequences of a wide range of natural and man-made medical and public health security threats and includes the FY 2022 budget justification for the Office of the Assistant Secretary for Preparedness and Response (ASPR), Cybersecurity, the Office of National Security (ONS), the Office of Global Affairs pandemic influenza program, and the Public Health Service Commissioned Corps led by the Office of the Assistant Secretary for Health (OASH). Office of the Assistant Secretary for Preparedness and Response ASPR s mission at its core is to save lives and protect the American people. On behalf of HHS, ASPR leads the public health and medical response to disasters and public health emergencies, in accordance with the National Response Framework and Emergency Support Function #8.

4 HHS also supports other federal entities who lead Emergency Support Function #6 with respect to the human and social services, including recovery. ASPR coordinates across HHS, the federal interagency, and supports state, local, territorial, and tribal health partners in preparing for and responding to emergencies and disasters. ASPR also enhances medical surge capacity by organizing, training, equipping, and deploying federal public health and medical personnel and providing logistical support for federal responses to public health emergencies. At the state and local level ASPR supports readiness by coordinating federal grants and cooperative agreements and carrying out drills and operational exercises. Through ASPR s Biomedical Advanced Research and Development Authority (BARDA) and Strategic National Stockpile (SNS), ASPR oversees advanced research, development, procurement, and stockpiling of medical countermeasures ( vaccines, medicines, diagnostics, and other necessary medical supplies).

5 These lifesaving efforts are undertaken in coordination with federal partners across the Public Health Emergency Medical Countermeasures Enterprise. During FY 2020 and 2021, ASPR worked across the interagency on the fight against the most severe pandemic in a century. As part of ASPR, BARDA supported development, manufacturing, and/or purchase of medical countermeasures to combat COVID-19. Less than one month after the SARS-CoV-2 sequence was shared, BARDA immediately began to leverage existing public-private partnerships to develop vaccines, therapeutics, and diagnostics to address COVID-19. BARDA led early coordination among federal agencies to identify and develop medical countermeasures, and BARDA directly supported seven vaccine candidates including development and manufacturing of Moderna and Johnson & Johnson s Janssen vaccine, and purchase of the Pfizer vaccine; 13 therapeutics, including development of the Regeneron monoclonal antibody therapeutic and purchase of the Eli Lilly and Company therapeutics, as well as the convalescent plasma program; 17 rapidly deployable and other technologies, including next generation technologies to administer vaccines; and 42 diagnostic tests ranging from high-throughput tests for laboratories early in the pandemic to rapid point-of-care and at-home tests; 20 of BARDA-supported COVID-19 tests have received emergency use authorization from the Food and Drug administration , and these private sector partners have shipped more than 108 million tests across the country.

6 BARDA also collaborated with the private sector to expand capacity for manufacturing active pharmaceutical ingredients, as well as vaccines and ancillary products such as needles and syringes, purchased the ancillary supplies the SNS needed for vaccine supply kits, and engaged the Centers for Innovation in Advanced Development and Manufacturing for the first time in a pandemic response. In early 2020, BARDA rapidly expanded its broad agency announcements to incorporate COVID-19 medical Public Health and Social Services Emergency Fund 5 countermeasures, refocused its TechWatch program on COVID-19 medical countermeasures to review thousands of submissions, met with hundreds of potential product developers, and pivoted existing agreements with key private sector partners to focus immediately on developing therapeutics and vaccines using flexible platform technologies which BARDA had supported for other potential health security threats. BARDA also provided significant funding and other support to the National Institutes of Health for vaccine and therapeutics clinical trials, as well as for scale-up and manufacturing of new COVID-19 diagnostics.

7 In total, these successful investments continue to yield an enormous benefit to the American people and will be critical to ending the COVID-19 pandemic. The SNS responded to the COVID-19 pandemic by providing needed supplies such as personal protective equipment (PPE) including masks, gloves, and gowns and working in partnership with the ASPR information management team to develop unprecedented visibility into the globally-constrained supply chain. SNS has also supported the country s vaccination efforts. As of April 8, 2021, SNS has delivered more than 1,279,460 ancillary kits to support the administration of three separate COVID-19 vaccines; the kits support vaccinations for approximately 234 million Americans. Based on the lessons learned during the COVID-19 pandemic, SNS has initiated modernization efforts designed to ensure the SNS has the breadth and depth to respond to any future pandemic or public health emergency and bolster the domestic industrial base for critical pharmaceuticals and medical supplies to reduce America s vulnerabilities and reliance on foreign suppliers and manufacturers.

8 In addition to responding to other catastrophic incidents such as hurricanes and other natural disasters, ASPR continues to respond to the COVID-19 pandemic with activated National Disaster Medical System (NDMS) personnel. NDMS is supported by a workforce of up to 6,290 authorized intermittent federal employees organized into 69 teams across the country. NDMS teams contain clinical providers and specialized medical service professionals, including physicians, nurses, advance healthcare providers, fatality management professionals, paramedics, veterinarians, and other support staff, such as logisticians and information technology specialists. In the 2020 COVID-19 response, NDMS managed 5,389 deployments which included deploying many personnel multiple times. In numerous locations throughout the nation, NDMS provided hospital augmentation for critical and emergent care facilities critically depleted of resources and subject matter experts to manage medical and mortuary issues for the honorable care of human remains of American citizens that succumbed to this deadly virus.

9 In 2021, NDMS continues to support the COVID-19 response with teams providing behavioral health support to responders and being deployed on testing and vaccination missions across the country. Years of investment have yielded the ability to provide this surge medical capacity to the unique COVID-19 response; however, more must be done to be able to prepare the nation to be resilient when faced with any public health emergency. To do this, ASPR supports health care coalitions, medical providers, and emergency managers in preparing for incidents that impact medical and public health capabilities. These investments are critical to enabling the requisite federal, state, and local coordination necessary to rise to new challenges. In addition, when an infectious disease outbreak occurs, the public expects immediate access to vaccines, diagnostics, and drugs as was seen during the 2009 H1N1 pandemic and the 2013 Ebola virus epidemic in Africa. However, having these products readily available requires long-range investment for the research and development as well as the procurement of highly specialized products.

10 To meet this public demand, protect health, and save lives in the next pandemic or other public health emergency, the federal government must continue to take action and maintain momentum to develop new medical countermeasures vaccines, drugs, diagnostics, and devices so they are available immediately when Public Health and Social Services Emergency Fund 6 needed. Enhanced partnerships with small and large companies, sustained investments made possible under Project BioShield (PBS), and funding provided for pandemic influenza preparedness over the last decade have successfully led to new capabilities and capacities, including medical countermeasures critical to national health security. These advances continue to boost the nation s readiness to respond to the medical consequences of anthrax, botulism, smallpox, radiological and nuclear agents, chemical agents, and emerging diseases. The medical countermeasure pipeline holds more promise today than ever to combat long-standing threats and newly emerging ones.