FY 2024 Annual Performance Plan and Report - Strategic Goal 2: Objective 2.1

Fiscal Year 2024
Released March, 2023

Topics on this page: Objective 2.1: Improve capabilities to predict, prevent, prepare for, respond to, and recover from emergencies, disasters, and threats across the nation and globe | Objective 2.1 Table of Related Performance Measures

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.

The Office of the Secretary leads this objective.  The following divisions are responsible for implementing programs under this strategic objective: ACF, ACL, ASPE, ASPR, ATSDR, CDC, CMS, FDA, HRSA, IHS, NIH, OASH, OCR, OGA, and ONC.  In consultation with OMB, 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 2.1 Table of Related Performance Measures

ASPR leads the nation's medical and public health preparedness for, response to, and recovery from disasters and public health emergencies. ASPR constantly scans the horizon to prepare for whatever emergency may come next, whether natural or manmade.  Within ASPR, the Biomedical Advanced Research and Development Authority (BARDA) is the premier advanced research and development office within the United States Government.  BARDA invests in the innovation, advanced research and development, FDA approval, acquisition, and manufacturing of medical countermeasures (MCMs) – including the vaccines, drugs, therapeutics, diagnostic tools needed to combat health security threats.  The data inform the public about BARDA’s capacity to provide an integrated, systematic approach to developing MCMs for public health medical emergencies such as chemical, biological, radiological, and nuclear (CBRN) accidents, incidents and attacks, pandemic influenza, and emerging infectious diseases.  The targets for this measure were met or exceeded each year.  The data sources are stable with no gaps or delays in reporting.  The data reported reflect ASPR’s efforts to prepare for, response to, and recover from disasters and public health emergencies.  Together with industry partners, BARDA’s support spans early development into advanced development and FDA approval.  As of February 2023, BARDA-supported products have achieved 69 FDA approvals, licensures, or clearances.   ASPR also oversees the procurement of MCMs for storage in the Strategic National Stockpile to ensure their availability during a public health emergency.

International Field Epidemiology Training Programs (FETP) are recognized worldwide²¹ as an effective means to strengthen countries’ capacity in surveillance, epidemiology, and outbreak response.  These graduates strengthen public health capacity so individual countries are able to transition from U.S.-led global health investments to more long-term host country ownership.  Frontline is a three-month program that aims to increase the number of capable public health workers in a community setting.  This program is part of three tiers in the FETP program which all help countries meet International Health Regulation guidelines.  In FY 2021, there were 13,537 Frontline program graduates, an increase over FY 2020 and exceeding the FY 2021 target.  By tracking the number of people who graduate from FETP – including the Frontline program every year, CDC can better gauge its impact on developing other countries’ abilities to prevent, detect, and respond to disease outbreaks.

NIH is aiming to accelerate the innovation of new technologies using a design, build, test, and deploy approach to improve future pandemic preparedness and surveillance.  In response to the COVID-19 pandemic, NIH launched the Rapid Acceleration of Diagnostics (RADx®) initiative to speed up innovation in the development and deployment of COVID-19 testing approaches and strategies. To inform approaches and specific capabilities needed for infectious disease surveillance and preparedness, NIH continues to build on the research funding mechanisms used and the lessons learned through RADx®.

In FY 2022, NIH. supported the development of technologies that led to two at-home COVID-19 tests, five point-of-care COVID-19 tests, and two lab-based COVID-19 tests. All nine tests received an FDA emergency use authorization for marketability.  In one representative example, developers created an at-home test that uses a nasal swab to collect viral particles and a lateral flow assay to test for the presence of a COVID-19 protein.  This simple test, which uses lateral flow technologies similar to those found in at-home pregnancy tests, delivers results in 15 minutes.  In another example, developers created a high-throughput, point-of-care test that detects the genetic material found in SARS-CoV-2, the virus that causes COVID-19.  This type of test is beneficial for large-scale testing in settings like nursing homes or schools and is capable of providing results in 15 minutes.  In a final example, developers created a high-throughput, lab-based test that also detects the genetic material found in SARS-CoV-2.  This test is intended for use by qualified laboratory personnel, especially in small hospitals and laboratories.  It has a simpler workflow and can deliver results much faster than conventional lab-based tests.  This type of test can expand the testing capacity of commercial laboratories.

In FY 2023, NIH aims to receive FDA authorization or approvals for two home, point-of-care, or lab-based diagnostics, at least one of which addresses accessibility needs of people with disabilities.  In FY 2024, NIH aims to receive FDA authorization or approval (including updated authorization or approval) for at least two home, point-of-care, or lab-based diagnostics, at least one of which is fully accessible to people with disabilities.

The development of antiviral drugs to combat harmful viruses can take 10-15 years.  When SARS-CoV-2, the coronavirus that causes COVID-19, first emerged, there were no approved treatments or vaccines for treating any coronavirus infection.  However, NIH was able to build on existing research on other coronaviruses that had caused earlier outbreaks or pandemics and actively contribute to the Federal response to COVID-19.  To prepare for future threats posed by known and unknown viruses, NIH is taking a proactive approach by drawing on existing research and investing in antiviral drug discovery and development.  The goal is to generate a pool of new antiviral drugs and increase the availability of antiviral drug candidates that might be used to address future outbreaks or pandemics.  In FY 2022, NIH-funded efforts advanced the preclinical development of multiple antiviral therapeutic candidates.  For example, two separate groups of researchers used lab-based screening tools to identify ways to inhibit the growth of SARS-CoV-2 in host cells.  Other researchers determined that flavanols, a type of flavonoids – natural substances found in fruits, nuts, vegetables, seeds and spices that have been shown to have antiviral effects – more effectively inhibited SARS-CoV-2 than other types of flavonoids that were previously tested.  In addition, another group of researchers created the Small Molecule Antiviral Compound Collection (https://smacc.mml.unc.edu), a public database with curated scientific data to support scientists working on the development of antiviral drugs targeting a broad range of viruses. In FY 2023 and FY 2024, NIH aims to advance the preclinical or clinical development of two antiviral therapeutics each year.

Footnotes

²¹ Traicoff D et al.  2015.  Strong and flexible: Developing a three-tiered curriculum for the Regional Central America Field Epidemiology Training Program.  Pedagogy in Health Promotion 1(2): 74–82.  http://php.sagepub.com/content/1/2/74.full.pdf+html.