Strategic Objective 2.1: Improve capabilities to predict, prevent, prepare for, respond to, and recover from disasters, public health and medical emergencies, and threats across the nation and globe

HHS invests in strategies to predict, prevent, prepare for, respond to, and recover from emergencies, disasters, and threats.  HHS leverages opportunities to improve collaboration and coordination, to build capacity and foster readiness for effective emergency and disaster response.  HHS advances comprehensive planning for mitigation and response.  HHS also applies knowledge gained from the effective and efficient use and application of technology, data, and research to improve preparedness and health and human services outcomes during emergencies and disasters.

Objectives represent the changes, outcomes and impact the HHS Strategic Plan is trying to achieve.  This objective is informed by data and evidence, including the information below.

• Six events were declared Public Health Emergencies of International Concern between 2007 and 2020: the 2009 H1N1 influenza pandemic, Ebola (West African outbreak 2013–2015, outbreak in Democratic Republic of Congo 2018–2020), poliomyelitis (2014 to present), Zika (2016) and COVID-19 (2020 to present).  (Source: Public health emergencies of international concern: a historic overview)
• The United States has sustained 308 weather and climate disasters since 1980 where overall costs exceeded $1 billion.  As of October 8, 2021, 18 such events resulted in the deaths of 538 people, with many more affected.  Human-caused disasters, including chemical releases, industrial and mining accidents, transportation and maritime disasters, mass shootings and terrorist incidents, among others, harm thousands of people in the United States and around the world each year.  (Source: Billion-Dollar Weather and Climate Disasters)
• The 2020 global pandemic caused by SARS-CoV-2 and previous coronavirus outbreaks underscores the critical need to develop vaccines capable of broad protection against multiple coronavirus strains, including newly emerging viruses and variants.  NIH established a multidisciplinary research program specifically to design and advance pan-coronavirus vaccine candidates.  (Source: NIAID Issues New Awards to Fund “Pan-Coronavirus” Vaccines)
• Many rural communities are experiencing increases in COVID-19 cases and similar challenges as are urban areas, but rural healthcare systems also face unique considerations compared to their urban counterparts.  Workforce and other resource shortages, socioeconomic factors that compound resident health risks, and other public health issues often complicate the ability to plan for and respond to natural and human-caused emergencies in rural areas.  (Source: Rural Health and COVID-19)
• Over the course of the COVID-19 pandemic, non-Hispanic American Indian or Alaska Native, non-Hispanic Black, and Hispanic populations experienced significantly higher rates of hospitalization due to COVID-19 compared to non-Hispanic Whites.  (Source: Disparities in Hospitalizations)  Hispanic or Latino, non-Hispanic Black, and non-Hispanic American Indian or Alaska Native people also have a disproportionate burden of COVID-19 deaths among specific age groups across the lifespan—children, youth, adults, and older adults.  (Source: Disparities in Deaths)
• CDC's Global Rapid Response Team members deployed to support surveillance activities internationally, repatriation flights from Japan, as well as preparedness and response activities in Asia and Africa.  Since CDC activated its emergency operations center (EOC) to respond to COVID-19 on January 6, 2020, GRRT has deployed over 250 responders on 498 deployments for more than 19,000 person-days to 40 states, Washington D.C., tribal nations, and four territories, as well as CDC's EOC in Atlanta, Georgia.  (Source: Global Rapid Response Team Expands Scope to U.S. Response)
• The COVID-19 pandemic revealed vulnerabilities in the global medical supply chain that required HHS to expand and enhance the Strategic National Stockpile's capability to respond to a nationwide emerging infectious disease, now and in the future.  (Source: Response to the COVID-19 Pandemic)
• Medical emergency responders (e.g., doctors and nurses) enrolled in a Department of Health and Human Services program can be called up and sent to help states and localities in a public health emergency.  (Source: Public Health Preparedness: HHS Should Take Actions to Ensure It Has an Adequate Number of Effectively Trained Emergency Responders)
• HHS is currently implementing recommendations to ensure it has an adequate number of effectively trained emergency responders.  HHS responded to COVID-19, in part, by deploying responders enrolled in the National Disaster Medical System (NDMS).  NDMS is the main program through which HHS enrolls responders to assist with the federal medical and public health response to public health emergencies.  HHS deploys NDMS responders to provide, among other things, patient care and movement.  (Source: Public Health Preparedness: HHS Should Take Actions to Ensure It Has an Adequate Number of Effectively Trained Emergency Responders)  In 2020 alone, the NIEHS Worker Training Program provided health and safety training to more than 25,000 people engaged in hazmat disaster preparedness and infectious disease response.  (Source: Where We Train: Worker Training Program)

Contributing OpDivs and StaffDivs

ACF, ACL, ASPE, ASPR, ATSDR, CDC, CMS, FDA, HRSA, IHS, NIH, OASH, OCR, OGA, and ONC work to achieve this objective.

HHS OpDivs and StaffDivs engage and work with a broad range of partners and stakeholders to implement the strategies and achieve this Objective.  They include: the Centers of Excellence in Regulatory Science and Innovation (CERSI) Cooperative Agreement Grant Program, Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X) Joint Oversight Committee, Domestic Mutual Reliance, European Medicines Agency (EMA) COVID-19, Expert Committee on Biological Standardization, FDA and the Department of Defense (DoD) [MOU 225-19-001], FDA and the HHS Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) [MOU 225-13-0028], FDA and the National Institute of Standards and Technology [MOU 225-21-006], Food Emergency Response Network (FERN), Forum on Medical and Public Health Preparedness for Disasters and Emergencies, Global Polio Eradication Initiative, Global Regulatory Harmonization and Convergence, Interagency Board for Emergency Preparedness and Response, International Coalition of Medicines Regulatory Authorities (ICMRA), Measles & Rubella Initiative (M&RI), National Integrated Food Safety System (IFSS), One Health, Pediatric Cluster, Rapid Response Teams, US-Canada Regulatory Cooperation Council (RCC), and WHO Collaborating Centres for Biological Standardization.

Strategies

Leverage opportunities for improved collaboration and coordination to strengthen capacity for effective emergency and disaster readiness, response, and recovery

• Expand and build HHS support and assistance to state, tribal, local, and territorial partners, and communities to strengthen the capacity and resilience of public health departments and laboratory operations and facilities to meet needs and demand during response and recovery efforts.
• Strengthen the coordination between domestic and international stakeholders and modernization of programs, policies, guidance, and funding mechanisms to support robust emergency and disaster response planning, infrastructure, and capabilities, including disaster human services capabilities.
• Foster collaboration between key partners and stakeholders at the federal, state, tribal, local, and territorial levels, including partner organizations like the Federal Emergency Management Agency, private sector organizations, and global partners like the World Health Organization to increase awareness of opportunities to develop integrated guidance and plans as well as fill gaps in service and critical functions necessary to better anticipate, identify, and promptly respond to threats, emergencies, and disasters.
• Address health disparities and promote trust, and community resilience, especially for underserved communities disproportionately affected by emergencies, by improving engagement and collaboration across federal, state, tribal, local, and territorial stakeholders and community organizations, and with relevant international partners, ensuring response efforts are informed by health and human services equity principles.
• Focus resources on developing the capacity of the HHS emergency response workforce through effective training and technical assistance to improve the Department's readiness to meet the needs and demands of all communities they support during emergency response and recovery efforts.

Plan for mitigation and response, including the communication and dissemination of information, the development and availability of medical countermeasures, and the use of regulatory flexibilities

• Advance the development and availability of safe effective medical countermeasures to support preparedness and response efforts, and maximize their effective use by providing comprehensive and accessible guidance and public health communications to critical partners, including distribution and response networks, academic partners, hospital systems, clinical organizations, and the public.
• Build a diverse, agile U.S. public health supply chain while sustaining long-term domestic manufacturing capability for medical countermeasures and medical products to reduce and prevent shortages and ensure continuous supply during times of need.
• Ensure that HHS is prepared to make effective use of available waiver options and systems in place to expand and maximize flexibilities when a public health emergency is declared, ensuring response efforts can scale to readily support communities.
• Facilitate communication and coordination with public and private partners to leverage existing flexibilities and make new flexibilities available for the benefit of response efforts during a public health emergencies and disasters.
• Leverage and expand partnerships with state, tribal, local, and territorial partners and community-based, faith-based, and non-profit organizations as well as international partners to generate and disseminate risk communication and outreach materials that are evidence-based and culturally appropriate to improve awareness, knowledge, and uptake of mitigation measures during emergencies and disasters.
• Disseminate consistent and plain language communications to ensure affected individuals and communities, including those living or working in high-risk areas, are notified in a timely, culturally-tailored manner to minimize risk and ensure their safety.
• Ensure the resilience of the public health industrial base (PHIB) supply chain with improvements in the robustness, visibility and agility of the supply chain in coordination with interagency and private sector partners; wherein robustness includes broadening domestic manufacturing capacity and diversification of sources, visibility includes increased transparency and mapping of PHIB supply chains, and agility is an improved flexibility and responsiveness of actors in the system.

Apply lessons learned from the use and application of technology, data, and research to improve preparedness and health and human services outcomes during emergencies and disasters

• Enhance research, analytic, and learning capabilities through more efficient, accurate, and trusted collection, application, and integration of data from new and existing data streams across a series of disciplines, including demographic, environmental, genetic or genomic, biomedical, economic, geospatial, and ecological data, to better understand health impacts of emergencies and disasters.
• Improve coordination and collaboration efforts with federal, state, tribal, local, territorial, and international partners to enhance integrated surveillance and monitoring capacity to ensure equity in emergency response planning, coordination, and delivery and sustaining global health security.
• Invest in modernizing information technology infrastructure to foster data sharing and interoperability across systems in coordination with partners to ensure data insights are representative, actionable, and readily available to decisionmakers and researchers before, during, and after an emergency or disaster to inform preparedness, response, and forecasting.
• Leverage data collection, monitoring, and reporting systems, including critical demographic data, to improve the production, availability, and equitable supply of necessary countermeasures and medical equipment, including Personal Protective Equipment (PPE), when they are needed during emergencies and disasters.
• Provide training, education, and technical assistance to foster a multidisciplinary cadre of culturally-appropriate public health and research professionals to conduct studies to better understand the human health impacts, including mental health, of public health emergencies and disasters, especially among especially among groups that are disproportionately affected.
• Support innovative research and development for medical countermeasures, including clinical trials, and data integration capabilities to better prepare for and support safe and healthy outcomes during emergencies and disasters.

Performance Goals

The HHS Annual Performance Plan provides information on the Department's measures of progress towards achieving the goals and objectives described in the HHS Strategic Plan for FY 2022–2026.  Below are the related performance measures for this Objective.

• Increase the number of new licensed medical countermeasures across BARDA programs
• Number of cumulative Field Epidemiology Training Program (FETP) - Frontline graduates
• By 2026, establish a formalized funding pathway for the development, validation, and regulatory review of diagnostic technologies to enhance surveillance and pandemic preparedness
• By 2026, advance the preclinical or clinical development of 10 antivirals for current or future infectious disease threats

Learn More About HHS Work in this Objective

• 2021: Advancing Regulatory Science at FDA: Focus Areas of Regulatory Science (FARS): The report highlights the areas FDA has identified as needing continued targeted investment in regulatory science research to fulfill FDA's regulatory and public health mission.
• Advancing Health Literacy to Enhance Equitable Community Responses to COVID-19: This HHS Office of Minority Health initiative seeks to demonstrate the effectiveness of local government implementation of evidence-based health literacy strategies that are culturally appropriate to enhance COVID-19 testing, contact tracing and/or other mitigation measures (e.g., public health prevention practices and vaccination) in racial and ethnic minority populations and other socially vulnerable populations, including racial and ethnic minority rural communities.
• BARDA Industry Day: The annual BARDA Industry Day is a way to connect and communicate with public and private sector partners working in the health security space.
• CDC Disaster Science Responder Research Program: Develops timely, scalable approaches for occupational health research so that research may be started quicky in the event of a disaster or public health emergency.
• CDC Division of Global Health Protection Strategic Plan Overview 2019–2022 : The plan supports the vision of a healthier, safer world that is able to prevent, detect, and respond to public health threats.
• CDC Emergency Preparedness and Response Program: Prepares for, responds to, and researches chemical, biological, radiological, and natural disasters.  The program integrates and evaluates occupational safety and health topics to protect response and recovery workers.
• CDC Protective Technology Program: Advances the state of knowledge and application of technical methods (e.g., fit testing methods), processes, techniques, tools, and materials that support the development and use of personal protective equipment.
• Center for Biologics Evaluation and Research 2021–2025 Strategic Plan: The plan outlines the Center's strategic direction for supporting CBER's mission and striving toward CBER's vision over the next five years.
• Centers for Research in Emerging Infectious Diseases (CREID): NIAID engages a global network of research centers to study how and when viruses and other pathogens emerge from wildlife and spillover into humans.  The Centers for Research in Emerging Infectious Diseases (CREID) facilitates early warnings of emerging diseases, facilitating a rapid response and possibly curbing potential disease threats before they develop into widespread pandemics.
• Civil Rights Toolkit for Medical Emergencies/Pandemic Responses: This project will establish best principles for states and healthcare providers on Crisis Standards of Care (CSC) plans and develop a Civil Rights Toolkit for Medical Emergencies/Pandemic Responses for their use. 
• CMS Pandemic Plan: CMS improved its Pandemic Plan to ensure the Agency is able to meet the needs of its stakeholders and as a result, now stands better prepared for any future pandemic events.  CMS' Pandemic plan has not simply been updated, it has been completely redesigned and provides CMS with the guidance and decision-making framework needed to best meet the needs of its internal and external stakeholders.  The plan also details the steps taken to protect those on the CMS workforce who worked tirelessly to fulfill the agency's mission in service to all Medicare and Medicaid beneficiaries and all Americans enrolled in individual or group market coverage.
• Coalition for Epidemic Preparedness Innovations (CEPI): CBER collaborated with CEPI and NIH to convene a public workshop to discuss the scientific, clinical, and regulatory challenges encountered in the identification, characterization, and qualification of biomarkers for preventative vaccines.
• Compounding Animal Drugs: FDA is continuing to address animal drug compounding and is developing a compliance program that balances FDA's current understanding about the safety, effectiveness, and quality of animal drugs compounded from bulk drug substances and the need for those drugs when no FDA-approved (including conditionally approved) or indexed drug can be used to treat the animal.
• Developing the National Public Health Strategy for the Prevention and Control of Vector-Borne Diseases in Humans: To address the growing threat to public health, CDC, five federal departments, and the Environmental Protection Agency developed a joint National Public Health Framework for the Prevention and Control of Vector-Borne Diseases in Humans.
• Disaster Research Response (DR2) Program: When disasters and emergencies happen, timely and ethical collection of exposure data helps provide answers to the public's concerns about immediate and long-term health impacts.  The NIH Disaster Research Response (DR2) Program provides training, funding, and data collection tools for this purpose.
• Emergency Playbook for Federal Human Services Programs: This playbook aims to synthesize lessons learned and recommendations from existing resources, emergency management protocols, and interviews with federal program staff about responding to emergencies and disasters.  As federal human services program staff serve populations that often experience marginalization, economic disadvantages, and disproportionate negative impacts in a disaster or emergency context, this playbook emphasizes opportunities for federal programs to deliver human services equitably to all populations during and after major emergencies, especially those with multi-state impacts.
• HHS and industry partners expand U.S.-based pharmaceutical manufacturing for COVID-19 response: HHS will work with a team of private industry partners to expand pharmaceutical manufacturing in the United States for use in producing medicines needed during the COVID-19 response and future public health emergencies.
• Medical Countermeasures Initiative (MCMi): The MCMi facilitates the development and availability of medical countermeasures—including drugs, vaccines, and diagnostic tests—to protecting the United States from chemical, biological, radiological, nuclear (CBRN), and emerging infectious disease threats such as pandemic influenza, Ebola virus disease (EVD), and Zika virus infections.
• National Clearinghouse for Worker Safety and Health Training: Provides training, resources, reports, and news to ensure their safety of workers responding to disasters, public health emergencies, and other hazardous events.
• National Disaster Medical System (NDMS): The devastation of natural and man-made disasters brings an urgent need for health and medical care.  Hurricanes, earthquakes, pandemic disease, major transportation accidents, and terrorist attacks can overwhelm state, local, tribal, or territorial resources.  At a state’s request, NDMS provides personnel, equipment, supplies, and a system of partner hospitals work to together with state and local personnel to provide care when Americans need it most.
• National Strategy and Action Plans for Combating Antibiotic Resistant Bacteria: The National Action Plan for Combating Antibiotic-Resistant Bacteria (CARB), 2020–2025, presents coordinated, strategic actions that the United States Government will take in the next five years to improve the health and well-being of all Americans by changing the course of antibiotic resistance.
• New Era of Smarter Food Safety: FDA is taking a new approach to food safety, leveraging technology and other tools and approaches to create a safer and more digital, traceable food system.
• Partnering to Protect: Public and Private Sectors Unite Against Antimicrobial Resistance: ASPR/BARDA is partnering with the private sector to combat antimicrobial resistant bacteria.
• President's Task Force on Environmental Health Risks and Safety Risks to Children: HHS co-chairs the President's Task Force on Environmental Health Risks and Safety Risks to Children whose Subcommittee on Climate, Emergencies and Disasters works to address gaps in health protection, promotion, and research related to climate change, public health emergencies and disasters by convening and coordinating relevant activities of federal agencies and stakeholders.
• Public Health Emergency: For more information about how ASPR coordinates preparedness and response efforts in a public health emergency, go to https://www.phe.gov.
• Public Health Emergency Preparedness (PHEP) Cooperative Agreement: The Public Health Emergency Preparedness (PHEP) cooperative agreement is a critical source of funding for state, local, and territorial public health departments.  Since 2002, the PHEP cooperative agreement has provided assistance to public health departments across the nation.  This helps health departments build and strengthen their abilities to effectively respond to a range of public health threats, including infectious diseases, natural disasters, and biological, chemical, nuclear, and radiological events.
• Rural Healthcare Surge Readiness: Provides up-to-date and critical resources for rural healthcare systems preparing for and responding to a COVID-19 surge, spanning a wide range of healthcare settings and a broad array of topics ranging from behavioral health to healthcare operations to telehealth.
• Supporting Antimicrobial Stewardship in Veterinary Settings: Goals for Fiscal Years 2019–2023: The focus of this plan is on actions being taken by the FDA Center for Veterinary Medicine (CVM) and other stakeholders to support antimicrobial stewardship in veterinary settings.
• Technical Resources, Assistance Center, and Information Exchange (TRACIE): Created to meet the information and technical assistance needs of regional ASPR staff, healthcare coalitions, healthcare entities, healthcare providers, emergency managers, public health practitioners, and others working in disaster medicine, healthcare system preparedness, and public health emergency preparedness.