FY 2023 Annual Performance Plan and Report - Strategic Goal 4: Objective 4.2

Fiscal Year 2023
Released March, 2022

Topics on this page: Objective 4.2: Invest in the research enterprise and the scientific workforce to maintain leadership in the development of innovations that broaden our understanding of disease, healthcare, public health, and human services resulting in more effective interventions, treatments, and programs | Objective 4.2 Table of Related Performance Measures

Objective 4.2: Invest in the research enterprise and the scientific workforce to maintain leadership in the development of innovations that broaden our understanding of disease, healthcare, public health, and human services resulting in more effective interventions, treatments, and programs

HHS is investing in strategies to support the research enterprise and the scientific workforce. HHS works to build public trust by upholding scientific integrity and quality. HHS is also working to recruit, retain, and develop a diverse and inclusive scientific workforce to conduct basic and applied research in disease, healthcare, public health, and human services. HHS supports innovation in how research is supported, conducted, and translated into interventions that improve health and well-being.

The Office of the Secretary leads this objective. The following divisions are responsible for implementing programs under this strategic objective: AHRQ, ASPE, ASPR, CDC, FDA, HRSA, NIH, OASH, OCR, and OGA. The narrative below provides a brief summary of any past work towards these objectives and strategies planned to improve or maintain performance on these objectives.

Objective 4.2 Table of Related Performance Measures

Preventing the initiation of substance use and minimizing the risks of harmful consequences of substance use are essential parts of addressing SUD. NIH’s prevention research portfolio encompasses a broad range of research on how biological, social, and environmental factors operate to enhance or lessen an individual’s propensity to begin substance use, or to escalate from use to misuse to SUD. This line of research, along with rapidly growing knowledge about substance use and addiction (including tobacco, alcohol, illicit, and nonmedical prescription drug use), is helping to inform the development of evidence-based prevention strategies.

In FY 2021, NIH launched two clinical trials to test two opioid prevention interventions for adolescents and young adults. Both trials are part of the Helping to End Addiction Long-term (HEAL) Initiative® started by NIH to develop scientific solutions to stem the Nation’s opioid public health crisis. In the first trial, researchers tested a videogame intervention, in school-based health centers, for preventing high-risk adolescents, aged 16-19, from starting to use opioids. In the second trial, researchers tested another videogame intervention for preventing opioid use disorder (OUD) in adolescents and young adults, aged 16-25, who are confined in a state juvenile justice system. The researchers chose a videogame intervention because it is more appealing to adolescents and young adults than standard interventions. In addition, it can reach large populations with consistent reliability at potentially lower cost. If proven effective, this may provide a promising approach to prevent adolescents and young adults in a variety of settings from starting to use opioids or escalating from use to misuse to OUD.

In FY 2022, NIH is conducting two studies to test the effectiveness of prevention interventions focused on electronic nicotine delivery systems (including vaping). In FY 2023, NIH will launch 1-2 clinical trials to test multi-level approaches to prevent opioid and other substance misuse by intervening on social determinants of health in addition to individual-level risk factors. (Social determinants of health refer to the conditions in the environments where people are born, live, learn, work, play, worship, and age that affect a wide range of health, functioning, and quality-of-life outcomes and risks.)

A critical part of the NIH mission is the education and training of the next generation of biomedical, behavioral, and clinical scientists. The overall goal of the NIH research training program is to maintain a population of scientists that is well educated, highly trained, and dedicated to meeting the Nation’s future health-related research needs. Success of NIH predoctoral research training programs can be measured, in part, by the number of trainees and fellows that go on to apply for and receive subsequent NIH career development and research awards. Subsequent support is an indicator of retention success in the research arena, and reflects the impact of NIH-funded training on the ability of trainees and fellows to be competitive and sustain a research career with independent funding.

Each year, NIH assesses the degree to which predoctoral trainees and fellows who received NIH-funded training through a National Research Service Award (NRSA) are more likely to remain in research careers and successfully compete for NIH funding after the completion of their degrees as compared to (a) other doctoral students at the same institutions over the same time period who did not receive NRSA support themselves, and (b) doctoral students at institutions not receiving RSA support.  As part of this assessment, NIH determines the award rate to comparison group, which refers to the difference in percentage points between NRSA-funded individuals and other doctoral students at the same institutions who successfully compete for NIH funding after completion of their doctoral degrees.  A 2001 assessment of the early progress of NRSA predoctoral trainees and fellows showed that the percentage of NRSA-funded individuals who applied for funding from NIH or the National Science Foundation was typically 10 percentage points higher than those who graduated from NIH-funded training institutions but who were not direct recipients of NRSA predoctoral funding.  Tracking this measure annually provides NIH with an indication of whether NRSA support continues to play a key role in retaining predoctoral trainees and fellows in biomedical, behavioral, and clinical research careers.

In FY 2021, NIH-funded predoctoral trainees and fellows were 10 percentage points more likely to remain active in biomedical research than non-NIH trainees and fellows. In future years, NIH will continue to assess whether NIH-funded predoctoral trainees and fellows are at least 10 percentage points more likely to remain active in biomedical research than non-NIH trainees and fellows.

NIH is committed to diversifying the Nation’s biomedical research workforce. It funds numerous programs – at the undergraduate, graduate, postdoctoral, and faculty levels – that foster research training and the development of a strong and diverse workforce. The National Institute of General Medical Sciences, a component of NIH, develops and manages many of these programs. A key focus of the Institute is to provide trainees with mentored research training and career development experiences that help them acquire important knowledge and skills to drive scientific discovery and innovation.

This measure highlights a critical component in the development of trainees from underrepresented backgrounds and tracks that data across different career stages. Underrepresented backgrounds include historically underrepresented racial/ethnic minorities (e.g., Blacks or African Americans, Hispanics or Latinos, American Indians or Alaska Natives, Native Hawaiians, and other Pacific Islanders), individuals with disabilities, and individuals from disadvantaged backgrounds (through the undergraduate stage). In FY 2021, the Institute supported 3,779 career development experiences across all career stages for trainees from diverse backgrounds. The Institute aims to support 3,545 and 3,550 career development experiences across all career stages for trainees from diverse background in FY 2022 and FY 2023, respectively.

Established by Congress in 1993, the goal of the Institutional Development Award (IDeA) program is to broaden the geographic distribution of NIH funding. The program supports faculty development and institutional research infrastructure enhancement in states that have historically received low levels of support from NIH. The purpose of the IDeA Networks of Biomedical Research Excellence (INBRE) is to augment and strengthen the biomedical research capacity of IDeA-eligible states. The INBRE represents a collaborative effort to sponsor research between research-intensive institutions and primarily undergraduate institutions (PUIs), community colleges, and tribally controlled colleges and universities (TCCUs).

A primary goal of the INBRE is to provide research opportunities for students from PUIs, community colleges, and TCCUs, and to serve as a "pipeline" for these students to continue in biomedical research careers within IDeA states. Offering these students mentored research experiences is crucial in developing their foundation in biomedical research and their interest in pursuing health research careers. Different types of mentored research experiences are available to these students. Examples include participating in INBRE-supported internship programs; attending research seminars, laboratory meetings, and journal clubs; and preparing oral or poster presentations of individual research projects and presenting them to the scientific community during the state’s annual summer research conference. In FY 2021, an estimated 1,450 undergraduate students participated in mentored research experiences, consistent with the FY 2020 level. In FY 2022 and FY 2023, NIH aims to sustain the number of undergraduate mentored research experiences at the same level as previous years.

The goal of GDUFA II is to enhance the efficiency of the generic drug review process, promote transparency between FDA and generic drug sponsors, and enhance access to high-quality, lower cost generic drugs.  Through the reauthorization of the GDUFA program in 2017 (GDUFA II), FDA acquired additional performance goals and higher expectations for program enhancements and approvals.  The value of this investment in the Generic Drug Review program is reflected by FDA’s performance on its review goals under GDUFA, including the review of standard submissions reflected in this performance measure, as well as FDA’s commitment to meet shorter review goals (8 months) for priority submissions under GDUFA II.  Despite the unforeseen challenges due to the COVID-19 pandemic, having to transition to a remote work environment with an increased workload due to the expedited development and review of generic drug products to help address the public health emergency, FDA rose to the challenge and maintained its high level of performance in meeting GDUFA’s goals and initiatives.  HHS is confident that the new processes introduced through GDUFA II and activities taken under FDA’s Drug Competition Action Plan will continue to help reduce review cycles, to improve approval times, and to boost competition, helping to ensure that safe, effective, high-quality generic drug products are available to the American public.

HRSA’s Federal Office of Rural Health Policy has a statutory charge to advise the HHS Secretary on rural health and telehealth policy issues across the Department, including interactions with the Medicare and Medicaid programs, and support policy-relevant research on rural health issues, consistent with HRSA’s broader focus on access and underserved populations.  HRSA provides funding for the only Federal research programs specifically designed to provide publicly available, policy relevant research on rural health issues.  The Rural Health Research Center (RHRC) Program funds eight core research centers to conduct policy-oriented health services research to assist providers and decision/policy-makers at the federal, state, and local levels to better understand the healthcare-related challenges faced by rural communities and provide information that can be applied in ways that improve health care access and population health.  HRSA supports four research projects per RHRC per year.  The RHRCs produce policy briefs and peer-reviewed journal manuscripts based on their funded research projects.  These publications are made available through the HRSA-funded Rural Health Research Gateway (www.ruralhealthresearch.org).  The Rural Health Research Gateway disseminates and promotes the work of the RHRCs to rural health stakeholders with the goal of informing and raising awareness of key policy issues important to rural communities