Report on NIH Collaborations with Other HHS Agencies for Fiscal Year 2020

Introduction

This annual report captures the extent and nature of activities undertaken by the National Institutes of Health (NIH) in collaboration with the other agencies and divisions of the Department of Health and Human Services (HHS). Tasked with improving the health of the American public, HHS consists of many agencies and divisions, and synergy between these different components is vital to the success of the whole. The strength of working together across the Department was highly evident in the FY2020 response to the challenges presented by the COVID-19 pandemic. In recognition of the important role of collaboration between HHS agencies, Congress added section 403A(a) of the Public Health Service Act, 42 U.S.C. § 283a(a), Annual Reporting to Increase Interagency Collaboration and Coordination, via Section 104 of the National Institutes of Health Reform Act of 2006. This law mandates that the NIH Director provide to the Secretary of HHS an annual report on NIH’s collaborations with other HHS agencies. This, our fourteenth report to the Secretary, covers fiscal year (FY) 2020.

Background

The HHS mission is to enhance the health and well-being of all Americans by providing for effective health and human services and by fostering sound, sustained advances in the sciences underlying medicine, public health, and social services. As outlined in the HHS Strategic Plan FY 2018-2022, the Department sets forth five interrelated, strategic goals to achieve this mission:

• Reform, Strengthen, and Modernize the Nation's Healthcare System
• Protect the Health of Americans Where They Live, Learn, Work, and Play
• Strengthen the Economic and Social Well-Being of Americans Across the Lifespan
• Foster Sound, Sustained Advances in the Sciences
• Promote Effective and Efficient Management and Stewardship

HHS accomplishes its mission and meets its strategic goals and associated objectives, strategies, and performance goals through the work of its eleven operating divisions, including eight agencies in the U.S. Public Health Service and three human service agencies, which administer HHS’s multifaceted programs and initiatives. In addition, staff divisions of the Office of the Secretary provide leadership, direction, and policy guidance to the Department. Together, this ‘HHS Family’ covers a vast spectrum of activities that affect health, public health, and human services outcomes. With more than 115 programs across the Department, the ultimate success of all components of the HHS family is enhanced by interagency collaborations that enable agencies to combine their knowledge and diverse expertise to accomplish their collective mission. Such cross-agency teamwork is necessary to create a collaborative community within HHS that accelerates progress in medicine, health services, and public health programs.

As the largest research arm of HHS, NIH’s mission is “to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to enhance health, lengthen life, and reduce illness and disability,” which it fulfills through its congressionally mandated NIH-Wide Strategic Plan, Fiscal Years 2021-2025. NIH’s collaborative efforts with other HHS agencies are vital to transforming fundamental scientific and technical information into effective, knowledge-based approaches that advance the health and safety of the public, such as disease treatments, preventive interventions, protective health policies and regulations, and public health campaigns. In turn, the information provided by other HHS agencies on public health needs informs the policies and priorities of NIH-funded research.

The interagency collaborations included in this report cover joint activities undertaken by NIH with all other components of HHS, including the staff divisions within the Office of the Secretary (OS)¹ and the ten other operating divisions of HHS:

• Administration for Children and Families (ACF)
• Administration for Community Living (ACL)
• Agency for Healthcare Research and Quality (AHRQ)
• Agency for Toxic Substances & Disease Registry (ATSDR)
• Centers for Disease Control and Prevention (CDC)
• Centers for Medicare & Medicaid Services (CMS)
• Food and Drug Administration (FDA)
• Health Resources and Services Administration (HRSA)
• Indian Health Service (IHS)
• Substance Abuse and Mental Health Services Administration (SAMHSA)

FY2020 Collaborations

NIH and other HHS operating, and staff divisions reported 671 collaborative activities in FY 2020. These cross-agency collaborations demonstrate the complex array of health efforts that NIH contributes to in partnership with the rest of the Department and can be organized into six overarching themes:

• Assessing the Public’s Health – enabling better tracking of disease and disability
• Improving Diagnostics and Treatment – promoting research, and the translation of NIH’s research results into safe and effective diagnostics and treatments
• Preventing Disease and Disability – providing the evidence base for national disease and disability prevention efforts
• Providing Evidence-Based Health Information – equipping public health efforts and the American public with the latest research findings and best available health information
• Keeping Americans Safe – ensuring effective health policy and regulatory protections
• Broad, Multi-Purpose Coordination – coordinating complex strategic planning efforts that cut across the entire Department

Figure 1: Advancing the Public’s Health through the integration of the six thematic Areas of NIH’s Collaborations with Other Agencies of the Department of Health and Human Services demonstrate the broad spectrum of health efforts that NIH contributes to in partnership with the rest of the Department.

FY 2020 Collaborative Activities by the Numbers

In FY 2020, NIH reported 671 collaborations with other HHS entities as depicted in The Complete List of Activities. Seventy-one new collaborations were reported in FY 2020, across a range of issues, including activities devoted to protecting the American people from the novel coronavirus, improving healthcare quality and safety, knowledge, and innovation.

Each collaborative activity has been categorized based on the nature of the activity. Chart 1 illustrates how the activities break down across the following categories:  Committee, Advisory Group, or Work Group (339); Research Initiative (132); Resource Development, (e.g., developing databases, disease registries, and information clearinghouses) (90); Meeting or Workshop (61); Public Education Campaign (15); Health Survey (12); Training Initiative (11); or Other (11).

Chart 2 displays the number of reported collaborative activities that NIH engaged in with each HHS operating or staff division.² As Chart 2 illustrates, the majority of NIH’s collaborations were with CDC (377) and FDA (348). Given the complementary missions of CDC, FDA, and NIH, the three agencies often work together closely to build on each other’s strengths and achieve shared objectives. While NIH conducts and funds basic and applied biomedical and behavioral research, CDC engages in health promotion, prevention of disease, injury and disability, and preparedness for new health threats, and FDA ensures the safety of drugs, medical devices, and many other products that stem from biomedical research. There are also substantial collaborations between NIH and the OS, especially in the coordination of multi-agency initiatives, committees, and working groups.

FY 2020 Collaboration Highlights

FY 2020 was one of the most challenging years in the history of our country and for HHS . The COVID-19 pandemic presented an unprecedented global challenge that caused significant burden on the health and economy of the United States, resulting in more than 600,000 deaths. In keeping with the HHS mission to enhance and protect the health and well-being of all Americans, the Department responded to the pandemic with numerous programs and initiatives that covered a vast spectrum of activities to effect health, public health, and human services outcomes in light of the pandemic. NIH’s collaborative efforts with other HHS agencies were vital to transforming fundamental scientific and technical information into effective, knowledge-based approaches that advanced the health and safety of the public during this challenging time.

In response to the pandemic, the department created a wealth of partnerships with a robust focus on innovative collaborations, including serving on multi-organization committees and workgroups, partnering on research initiatives, and collaborating on resource development.  Highlighted below are five ongoing collaborative initiatives that leverage the expertise and resources of NIH with that of the rest of the Department along with other government and private partners to diagnose, prevent, and treat this rapidly spreading disease.

The Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) is a public-private partnership to develop a coordinated research strategy for prioritizing and speeding development of the most promising treatments and vaccines. Coordinated by the Foundation for the National Institutes of Health (FNIH), ACTIV brings NIH together with its sibling agencies in HHS, including the Biomedical Advanced Research and Development Authority (BARDA) within ASPR, CDC, and FDA; other government agencies including the Department of Defense (DOD) and Department of Veterans Affairs (VA); The Operation (formerly known as Operation Warp Speed); the European Medicines Agency (EMA); and representatives from academia, philanthropic organizations, and numerous biopharmaceutical companies.
Rapid Acceleration of Diagnostics (RADx) initiative was launched to speed innovation in the development, commercialization, and implementation of technologies for SARS-CoV-2 testing. Accurate, fast, easy-to-use, and widely accessible testing is required before the nation can safely return to normal life. Funded by NIH in partnership with BARDA, the program supports innovative approaches for implementation, expansion, accessibility, and acceptance of existing diagnostic testing, and consists of four key components. The RADx Tech and RADx Advanced Technology platforms use a phased approach to support the  development, validation, and commercialization of innovative point-of-care and home-based tests, as well as improvements to existing clinical laboratory methods. RADx Radical advances nontraditional, but potentially transformative, approaches for SARS-CoV-2 testing.  And RADx Underserved Populations leverages existing community partnerships to build community-engaged demonstration projects focused on engagement of populations at high risk of SARS-CoV-2 infection, tailored to the unique needs of different communities. 

SARS-CoV-2 Sequencing for Public Health Emergency Response, Epidemiology and Surveillance (SPHERES) was established to help accelerate the use of near-real-time pathogen genomic data to help guide the pandemic response.  Led by CDC’s Advanced Molecular Detection (AMD) program, SPHERES is intended to help coordinate and support sequencing at state and local public health laboratories across the country, and to better engage clinical, academic and commercial laboratories that are sequencing – or planning to sequence -- SARS-CoV-2 at any scale.  Including three NIH Institutes and Centers, the coalition is designed to improve communication and knowledge-sharing between US laboratories, to develop consensus guidance on data and metadata standards, to reduce barriers to bioinformatic analysis and data sharing, and to better align sequencing requirements and resource needs with different sources of funding, technology, expertise and other means of support.

Community Engagement Alliance Against COVID-19 Disparities (CEAL) initiative was established to seek to understand and address factors that contribute to the disproportionate burden of COVID-19 in underserved communities and apply Community-engaged strategies to enhance awareness, education, access, trust, and inclusion in the science-based response to COVID-19. Currently, CEAL is comprised of 11 research teams working in full partnership with community-based organizations in communities that have a high proportion of racial/ethnic minority groups experiencing a disproportionate burden of COVID-19. They also promote and facilitate the inclusion and participation of these groups in trials undertaken by ACTIV and RADx.

NIH COVID-19 Treatment Guidelines Panel was formed in March 2020, at the beginning of the COVID-19 pandemic in the US, to provide clinicians with rapidly updated guidance on how to care for patients with COVID-19. Coordinated by NIH, the Panel includes members from academia and professional societies and federal agencies, including BARDA, CDC, DoD, FDA, and VA. Working groups that address different areas of the guidelines are charged with identifying relevant information and published scientific literature then conducting a systematic, comprehensive review of that information to determine recommendations. 

Conclusions

HHS accomplishes its mission to enhance the health and well-being of Americans through several hundred programs and initiatives that cover a wide spectrum of activities, serving the American public at every stage of life. America’s investment in NIH provides the nation with a unique resource—a scientific agency devoted to the creation of a knowledge base needed to conquer the most devastating human diseases and disabilities. The synergy between all HHS components, and NIH’s unique role was clearly exemplified in FY 2020 through the advances resulting from the many collaborative partnerships formed to combat the COVID-19 pandemic.  Lessons learned from this rapid and innovative response will be applied for many years to come as NIH and its HHS partners continue to work together to  cultivate ground-breaking research and ensure that scientific knowledge is translated into sound regulations and policies, health services and medical interventions, and information that all Americans can use to lead healthier lives.

NIH appreciates the opportunity to report on its collaborations within the HHS. The policies, programs, and regulatory and service activities developed and carried out by HHS operating and staff divisions are some of the most effective means that the government can use to improve the health and well-being of its citizens, as demonstrated by its response to the COVID-19 pandemic.