Report on NIH Collaborations with Other HHS Agencies for Fiscal Year 2021

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 unity between these different components is vital to the success of the whole. 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 fifteenth report to the Secretary, covers fiscal year (FY) 2021.

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’ 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)

FY2021 Collaborations

NIH and other HHS operating, and staff divisions reported 741 collaborative activities in FY 2021. 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 2021 Collaborative Activities by the Numbers

In FY 2021, NIH reported 741 collaborations with other HHS entities as depicted below in The Complete List of Activities. Sixty-six new collaborations were reported in FY 2021, 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 (370); Research Initiative (149); Resource Development, (e.g., developing databases, disease registries, and information clearinghouses) (92); Meeting or Workshop (68); Other (21); Public Education Campaign (16); Training Initiative (15); or Health Survey (10).

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 (429) and FDA (390). 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. The 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 Office of the Secretary (OS), especially in the coordination of multi-agency initiatives, committees, and working groups.

FY 2021 Collaboration Highlights

In FY 2021, HHS Secretary Becerra declared the top priorities of the Department to be:

• Ending the pandemic
• Reducing health care costs
• Expanding access to care
• Tackling health disparities
• And strengthening behavioral health.

NIH works closely with its sister agencies to address each of these priorities in myriad ways.  The following example activities describe some of the efforts undertaken in each of these priority areas.

Ending the pandemic

Mitigating the risk posed by COVID-19 to the health and economy of the U.S. remained a top priority for the Department in FY 2021.  Continuing and newly developed innovative partnerships allowed NIH and fellow agencies to work with other government and private partners to accelerate the development and implementation of strategies designed to diagnose, prevent, and treat this continuing pandemic.  One such collaboration, the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-private partnership, continued to develop research strategies for prioritizing and speeding development of the most promising treatments and vaccines. Coordinated by the Foundation for the National Institutes of Health (FNIH), ACTIV brought NIH together with its sister 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); White House officials; the European Medicines Agency (EMA); and representatives from academia, philanthropic organizations, and numerous biopharmaceutical companies.  By the end of FY 2021, this partnership had evaluated preclinical COVID-19 research challenges and published guidance on the use of animal models; assessed the clinical trial capacity for therapeutics testing; designed master protocols for clinical trials to streamline testing potential therapeutic agents; evaluated and prioritized hundreds of therapeutic agents; and launched trials through NIH-supported clinical trial networks. At the time of the writing of this report, results or top-line results of many of the trials have been published. Results from the ACTIV trials have already changed clinical practice, with data from trials contributing to Emergency Use Authorizations from the FDA in several cases and clearly demonstrating which products are unfortunately not effective in other cases. Examples of the ACTIV trials include:

• ACTIV-2 was designed as a Phase 2 trial that can expand seamlessly to Phase 3. The trial enrolled adults with COVID-19 who were not hospitalized and aimed to evaluate safety, to understand if the investigational treatment can reduce the duration of symptoms, and to test if the treatment can increase the proportion of participants with undetectable virus. One of the therapeutics tested in ACTIV-2, Bamlanivimab, was approved under an Emergency Use Authorization by the FDA, although that has since been revoked as it is not effective against current variants.  
• One of the inpatient studies in ACTIV-4 demonstrated that full dose anti-coagulation (blood thinner) treatments given to moderately ill patients hospitalized for COVID-19 reduced the requirement of vital organ support—such as the need for ventilation. ACTIV-4 also showed that full dose anti-coagulation is not effective for critically ill patients. These results changed clinical practice.
• ACTIV-6 is testing the effectiveness of repurposed drugs (drugs that are FDA-approved for non-COVID-19 indications and have known safety profiles) in reducing the duration and severity of symptoms associated with mild-to-moderate COVID-19.

The Tracking Resistance and Coronavirus Evolution (TRACE) Working Group was also initiated within ACTIV, and focused on surveying new viral variants, assessing vaccine and therapeutic resistance, and evaluating the impact of genetic variation on viral biology and on the clinical approaches for preventing and treating illness. 

Another important example of HHS collaboration, the SARS-CoV-2 Assessment of Viral Evolution (SAVE) Program was created to support the generation of data for the SARS-CoV-2 Interagency Group (SIG), established by the Department, to rapidly characterize emerging variants and to actively monitor their ability to evade currently available SARS-CoV-2 vaccines, therapeutics, and diagnostics. SAVE provides a comprehensive real-time risk assessment of emerging mutations in SARS-CoV-2 that could influence transmissibility, virulence, and susceptibility to infection- or vaccine-induced immunity. The SAVE program brings NIH, other HHS and Department of Defense laboratories, and the extramural academic community together to work collaboratively within and across multiple sub-groups to accelerate the pace of variant research and discovery through rapid and open sharing of data.

Reducing health care costs

As part of its plan to reduce health care costs, the Department released a comprehensive strategy to lower costs, including drug prices, through competition, innovation, and transparency. Working with partners across HHS, NIH contributes to this strategy through public-private partnerships with the pharmaceutical industry to drive innovation and transparency.  For example, the Accelerating Medicines Partnership®(AMP), is a public-private partnership between NIH, FDA, multiple biopharmaceutical companies, and  non-profit organizations that seeks to transform the current model for developing new diagnostics and treatments. By jointly identifying and validating promising biological targets for therapeutics, AMP seeks to increase the number of new diagnostics and therapies for patients and reduce the time and cost of developing them. In FY 2021 AMP focused on Alzheimer’s disease; type 2 diabetes; autoimmune disorders of rheumatoid arthritis and systemic lupus erythematosus; Parkinson’s disease; and Schizophrenia.

NIH and FDA also participate in the Foundation for the NIH Biomarkers Consortium, another public-private biomedical research partnership with broad participation from stakeholders across the health field, including government, industry, academia, patient advocacy, and other not-for-profit organizations. Managed by FNIH, the Biomarkers Consortium endeavors to discover, develop, and qualify biological markers (biomarkers) which would allow for better understanding of disease progression and treatment success, resulting in improvements in drug development, clinical care, and regulatory decision-making in areas as diverse as Alzheimer’s disease, cardiovascular disease, diabetes, and breast cancer.

Expanding access to care

NIH collaborates across the Department to pursue HHS’ goal to strengthen equitable access to high quality and affordable healthcare.  For example, NIH works with FDA, HRSA and CMS on the Task Force on Cancer Diagnostic Devices (CD2) for Near-Patient Use. Near-patient diagnostics generally refers to a system whereby a sample is analyzed, and the results are delivered in the same location where the patient is being evaluated. Near-patient diagnostics are often offered at point-of-care settings or as at-home tests when available with a prescription or purchased over the counter. CD2 is a collaborative effort to: detect and diagnose cancer earlier; enhance identification of patients at high risk for developing cancer; improve surveillance of those at risk of cancer recurrence; enhance monitoring of patient response during cancer treatment; reduce the effect of health disparities; and equitably extend the benefits of health care to all populations. The Task Force and Initiative will address cancer types for geographically isolated, medically underserved, and otherwise vulnerable communities.

To expand resources available to individuals wanting to quit smoking no matter where they are located, NIH, CDC, FDA, and OS launched Smokefree.gov. Built with the understanding that different people need different resources as they try to quit, the information and professional assistance available on this website can help to support both immediate and long-term needs as individuals become, and remain, a nonsmoker. Smokefree.gov allows individuals to choose the help that best fits their needs. This collaboration also includes several smoking cessation mobile-optimized websites, text message programs, smartphone applications and social media platforms available in English and Spanish. Tailored content is provided for special populations including women, teens, veterans, and people older than age 60.

Tackling health disparities

In FY 2021, the Department remained committed to reducing health disparities in the American population.  The conditions in the environments where people are born, live, learn, work, and age are significant contributors to ongoing health disparities. In recognition of these environmental factors the HHS Social Determinants of Health (SDoH) Workgroup developed a strategic vision to improve the delivery of, and integration of healthcare and social services for individuals and populations at high risk for adverse outcomes. The SDoH Workgroup, including NIH and all other Operating Divisions, identified how HHS can address SDoH and promoted work with other federal, state, local, tribal, and private sector partners to both ascertain and achieve shared objectives.

The Native American Research for Health (NARCH) program is an NIH collaboration with the Indian Health Service (IHS) that supports partnerships between federally recognized American Indian/Alaska Native (AI/AN) Tribes and research-intensive academic institutions that support health research projects prioritized by the Tribal communities. NARCH supports competitive research linked to the health priorities of AI/AN organizations and health disparities with the goal of fostering trust between AI/AN communities and researchers. NARCH also aims to develop a cadre of AI/AN scientists and health professionals engaged in biomedical, clinical, behavioral, and health services research who will be competitive in securing NIH funding.

Strengthening behavioral health

In FY 2021 the Department continued to make key investments towards bolstering the nation’s mental health infrastructure, expanding access to mental health services and substance use disorder treatment.  For example, launched in April 2018 by NIH with participation from AHRQ, CDC, CMS, FDA, and SAMHSA, the Helping to End Addiction Long Term (HEAL) Initiative continued its aggressive effort to speed scientific solutions to stem the national opioid public health crisis. The overarching goal of HEAL is to provide new hope for individuals, families, and communities affected by addiction to opioids. This Initiative builds on extensive, well-established NIH research, including basic science which describes the complex neurological pathways involved in pain and addiction, implementation science used to develop and test treatment models, and research which integrates behavioral interventions with medications for opioid use disorder.

To address the continuing crisis of behavioral health issues in military families and veterans, the Interagency Task Force on Military and Veterans Mental Health provides an annual review of agency actions, defines specific goals and metrics to aid in measuring progress, and makes additional recommendations to improve mental health and substance use disorder treatment services for Veterans, Service Members, and their families.  Co-chaired by DoD, VA, and HHS, NIH participates along with ACL, OS, and SAMHSA.

Conclusions

HHS accomplishes its mission to enhance the health and well-being of Americans through many complex 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. For this rich knowledge base to improve health, the Department, as well as the entire federal government and the private sector, must continue to work in concert to cultivate ground-breaking research and ensure that scientific knowledge is translated into evidence-based regulations and policies, improved health services and medical intervention delivery, and reliable science-based 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 the government can use to improve the health and well-being of its citizens. The collaborative activities detailed in this report illustrate how NIH works across the Department to cultivate partnerships, leveraging the respective strengths of all HHS agencies to support the HHS mission and strengthen the public health ecosystem.