FY 2022 Annual Performance Plan and Report - Goal 2 Objective 4

Fiscal Year 2022
Released June, 2021

Topics on this page: Goal 2. Objective 4 | Objective 2.4 Table of Related Performance Measures

Goal 2. Objective 4: Prepare for and respond to public health emergencies

As demonstrated during the COVID-19 pandemic, the health of Americans during public health emergencies and other incidents depends on the effectiveness of preparedness, mitigation, response and recovery efforts.  Threats in an increasingly interconnected, complex, and dangerous world include naturally emerging infectious diseases such as COVID-19; frequent and severe weather events; state and non-state actors that have access to chemical, biological, radiological, or nuclear agents; non-state actors who commit acts of mass violence; and cyber-attacks.

HHS is engaged in the research, development, and procurement of medical countermeasures, which include vaccines, drugs, therapies, and diagnostic tools to address COVID-19 as well as other emerging infectious diseases.  HHS collaborates with others to ensure that the appropriate number of safe and effective medical countermeasures are developed and stockpiled and can be easily distributed to save lives during an incident.  HHS also invests in building the capacity of other countries to detect, prevent, and respond to incidents.

In the previous administration, the Office of the Secretary led this objective.  The following divisions are responsible for implementing programs under this strategic objective: ACF, ACL, ASA, ASPA, ASPR, CDC, CMS, FDA, HRSA, IHS, IOS, NIH, OASH, OCR, OGA, and SAMHSA.  HHS has determined that performance toward this objective is progressing.  The narrative below provides a brief summary of progress made and achievements or challenges, as well as plans to improve or maintain performance.

Objective 2.4 Table of Related Performance Measures

Maintain the percentage of CDC-funded Public Health Emergency Preparedness (PHEP) state and local public health agencies that can convene, within 60 minutes of notification, a team of trained staff that can make decisions about appropriate response and interaction with partners (Lead Agency - CDC; Measure ID - 13.5.3) ²⁰

Public health agencies must be able to rapidly convene key management staff (within 60 minutes of notification) to appropriately respond to an emergency.  This effort includes the integration of information and the prioritization of resources to ensure timely and effective coordination within the public health agency and key response partners.  CDC uses the data from this measure to evaluate the ability to assemble a minimum of six key decision-makers who can cover all of the activated incident management lead roles needed to effectively manage a public health agency's response.  This measure does not report the ability to assemble large groups of public health staff or to deploy a group of responders.

In response to the pandemic, CDC allowed PHEP recipients to use FY 2019 PHEP funds to support critical COVID-19 response activities.  Specific examples of how recipients planned to use funds include laboratory equipment, reagents and other specialized materials and supplies needed for lab processing and testing of COVID-19 samples; electronic staffing systems; communications and call center equipment; and contact tracing.  CDC also modified FY 2019 and FY 2020 PHEP program requirements as a result of the current COVID-19 pandemic response underway in the 62 PHEP jurisdictions.  To support this critical work and reduce recipient burden, CDC integrated PHEP planning requirements with COVID-19 pandemic response activities, allowing recipients to use their response to the current public health incident to demonstrate their preparedness capabilities.  Among the changes, CDC has waived all drill requirements, including the staff assembly drill (Measure 13.5.3).  As a result, data will not be reported for FY 2019 and FY 2020.  In FY 2021 and FY 2022 CDC will continue to work with recipients to help identify preparedness gaps based on COVID-19 lessons learned and develop targeted strategies to improve performance.

Increase the number of new licensed medical countermeasures within Biomedical Advanced Research and Development Authority (BARDA) (Lead Agency - ASPR; Measure ID - 2.4.13a)

Medical countermeasures are federally regulated products used during a public health emergency.  Examples of emergencies include chemical, biological, radiological and nuclear (CBRN) agents, pandemic influenza, and emerging (or re-emerging) infectious diseases.  Through the BARDA program, ASPR develops and makes available medical countermeasures to prepare for and respond to national emergencies.  Each of APSR's products is designed to address a particular gap in our ability to address these emergencies.  In addition, ASPR oversees purchases of medical countermeasures for storage in the Strategic National Stockpile.

Within ASPR, BARDA invests in the innovation, advanced research and development, acquisition, and manufacturing of medical countermeasures – the vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products needed to combat health security threats.  To date, BARDA has received 59 FDA approvals, licensures, and clearances for medical countermeasures.  For more information about BARDA's medical countermeasures, please see  https://www.medicalcountermeasures.gov/barda.

ASPR's approach to advanced research and development has a proven track record of success due to continuous collaboration with NIH, CDC, FDA, and the Departments of Defense, Homeland Security, Veteran Affairs, and Agriculture.  HHS sets research and development priorities under a five-year strategy and implementation plan.

An example of the medical countermeasures developed to save lives is progress on multi-drug resistant (MDR) organisms, which are a threat to national security and public health.  As rates of antimicrobial resistance (AMR) in pathogens continue to increase new therapeutics and vaccines are essential to combat the growing crisis.  Every year, 2.8 million Americans develop a drug resistant infection and 35,000 people die.  Globally, MDR infections kill 700,000 each year - current estimates are that MDR organisms will kill more than 10 million a year by 2050 if left unchecked.  BARDA supports development and procurement of medical countermeasures to protect Americans against CBRN threats.  MDR does not discriminate, and victims of CBRN events are at risk of suffering fatal complications from drug resistant infections.  One of BARDA's top priorities is to develop a vaccine to protect people from these threats.

During FY 2021 and FY 2022, ASPR continues to support the development of critical medical countermeasures to increase national preparedness including:

• New antiviral therapeutic and vaccine candidates against Ebola Sudan and Marburg viruses
• A second antiviral candidate against smallpox
• A next generation botulinum antitoxin
• New antidotes for treatment of chemical agents (for example, mustard gas exposure and chlorine gas)
• Diagnostic devices to confirm infection with biological agents and identify an effective antibiotic sooner
• Innovations for advanced, portable ECMO (extracorporeal membrane oxygenation) devices
• Innovations in early-stage medical countermeasure research and development focusing on sepsis, wearable diagnostics and distributed manufacturing technologies,
• New candidate products for addressing the pathologies resulting from radiological or nuclear events, including thermal burns
• Multi-tissue human microphysiological models ("body-on-a-chip") incorporating immune system models for screening of vaccines and therapeutics
• Novel antibacterial drugs, diagnostics, and vaccines

The U.S. government has undertaken a government-wide response to combat the SARS-CoV-2 virus and limit negative health outcomes.  ASPR has received resources from several COVID-19 supplemental appropriations to enhance ongoing efforts and continue a comprehensive and coordinated response.

ASPR continues to work with partners across the Federal government, the states, and the private sector to focus on priorities related to addressing SARS-CoV-2 and other threats.  ASPR has expanded agreements with companies to develop medical countermeasures that enhance national health security, and continues to seek insight from partners in the private and public sectors to identify promising technologies.  Strengthening health security in the face of the novel coronavirus outbreak involves launching multiple products that address different aspects of COVID-19.  For example, to protect the American people from this new coronavirus, health care professionals need medical countermeasures that enable quick and accurate diagnosis, vaccination to prevent the spread of the virus, and treatment for those infected with effective therapeutics or antivirals.

²⁰ CDC results are based on jurisdictions (N) that allocated PHEP funding for pulsed-field gel electrophoresis E.coli activities.

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