Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Minority Health and Health Disparities (NIMHD)

National Institute on Aging (NIA)

National Institute on Drug Abuse (NIDA)

National Institute of Environmental Health Sciences (NIEHS)

National Institute of Mental Health (NIMH)

National Cancer Institute (NCI)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Sexual and Gender Minority Research Office (SGMRO)

Office of Research on Women's Health (ORWH)

Funding Opportunity Title
The Role of Work in Health Disparities in the U.S. (R01 Clinical Trials Optional)
Activity Code

R01 Research Project Grant

Announcement Type
New
Related Notices
  • October 13, 2021 - Notice of NICHD Participation in PAR-21-275, "The Role of Work in Health Disparities in the U.S. (R01 Clinical Trials Optional)". See Notice NOT-HD-21-044
Funding Opportunity Announcement (FOA) Number
PAR-21-275
Companion Funding Opportunity
None
Assistance Listing Number(s)
93.307, 93.393, 93.396, 93.399, 93.113, 93.866, 93.279, 93.242, 93.313, 93.865
Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to support innovative population-based research that can contribute to identifying and characterizing pathways and mechanisms through which work or occupation influences health outcomes and health status among populations with health and/or health care disparities, and how work functions as a social determinant of health.

Key Dates

Posted Date
June 25, 2021
Open Date (Earliest Submission Date)
September 05, 2021
Letter of Intent Due Date(s)

Not Applicable

The following table includes NIH standard due dates marked with an asterisk.
Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
October 05, 2021 * November 05, 2021 * January 07, 2022 * March 2022 May 2022 July 2022
February 05, 2022 * March 05, 2022 * May 07, 2022 * July 2022 October 2022 December 2022
June 05, 2022 * July 05, 2022 * September 07, 2022 * November 2022 January 2023 April 2023
October 05, 2022 * November 05, 2022 * January 07, 2023 * March 2023 May 2023 July 2023
February 05, 2023 * March 05, 2023 * May 07, 2023 * July 2023 October 2023 December 2023
June 05, 2023 * July 05, 2023 * September 07, 2023 * November 2023 January 2024 April 2024
October 05, 2023 * November 05, 2023 * January 07, 2024 * March 2024 May 2024 July 2024
February 05, 2024 * March 05, 2024 * May 07, 2024 * July 2024 October 2024 December 2024
June 05, 2024 * July 05, 2024 * September 07, 2024 * November 2024 January 2025 April 2025

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

Applicants are encouraged to apply early to allow adequate time to make any corrections to errors found in the application during the submission process by the due date.

Expiration Date
September 08, 2024
Due Dates for E.O. 12372

Not Applicable

Required Application Instructions

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide, except where instructed to do otherwise (in this FOA or in a Notice from NIH Guide for Grants and Contracts).

Conformance to all requirements (both in the Application Guide and the FOA) is required and strictly enforced. Applicants must read and follow all application instructions in the Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the Application Guide, follow the program-specific instructions.

Applications that do not comply with these instructions may be delayed or not accepted for review.

There are several options available to submit your application through Grants.gov to NIH and Department of Health and Human Services partners. You must use one of these submission options to access the application forms for this opportunity.

  1. Use the NIH ASSIST system to prepare, submit and track your application online.
  2. Use an institutional system-to-system (S2S) solution to prepare and submit your application to Grants.gov and eRA Commons to track your application. Check with your institutional officials regarding availability.

  3. Use Grants.gov Workspace to prepare and submit your application and eRA Commons to track your application.


  4. Table of Contents

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background

Although scientific and technological discoveries have improved the health of the U.S. population overall, some populations continue to experience a disproportionate burden of disease and risk factors, unmet health care needs and other adverse health conditions. Work activity is known to be important to health as a source of “exposures and risk factors,” a source of beneficial social and economic resources, and attainment of social position and status. In addition to formal work, under-employment and unpaid and informal work arrangements are also important work activities to understand. While the contribution of work to health outcomes and substantial occupational segregation for populations that experience health disparities are known, few studies have explored to what extent and by what mechanisms work explains health disparities, especially in the contexts of racial and ethnic populations and socioeconomic status. Because work can be modified and is amenable to intervention, the examination of the role of work as a social determinant of health (SDOH) presents an opportunity for research that may illuminate causal pathways and potential solutions for health disparities.

Vast literature demonstrates the importance of work for health outcomes, mostly through direct effects due to exposures and risk factors arising from someone’s occupation or workplace experiences. For example, 8.4% of all cancer deaths are attributable to workplace exposures. Workplace physical conditions such as excessive heat or cold, noise, physical exertion, and chemical hazards have been linked to multiple diseases. Workplace psychosocial hazards such as job strain (low control, high psychological demands) are consistently associated with cardiovascular disease. Job strain is also associated with depression, postpartum depression, and obesity. Precarious employment is linked to poor mental health. Underemployment is linked to lower levels of health and wellbeing than adequate employment. Workplace discrimination is linked to poor mental health and substance use.

Work, as a source of beneficial social and economic resources, is also linked to health care outcomes and health outcomes. In the U.S., employment linked benefits constitute the primary source of health insurance coverage for about half of the population, which influences access to and use of care, and the type of insurance contributes to quality of care. Work policies, such as paid sick leave, are linked to use of preventive health services, such as cancer screenings and immunizations. Also, increases in paid parental leave are linked with decreases in perinatal, neonatal, post-neonatal, infant, and child mortality.

Profound occupational segregation in the U.S. labor force is strongly patterned by social identities that characterize populations who experience health disparities. For example, African American/Black and Latino/Hispanic persons are the least likely to be in managerial and professional jobs and the most likely to be in service and blue-collar jobs. A national study found consistent associations between working in race-segregated occupations and poor worker health. However, the degree to which occupational segregation can be explained by education versus structural racism needs to be evaluated. Another study found that occupational segregation accounted for disproportionate mortality rates for Latino/Hispanic and African American/Black workers during the COVID-19 pandemic. There is also segregation within a workplace by social identities (e.g., gender, age, social class, sexual orientation, immigrant status, formerly incarcerated, marital status, head of household) that can result in large differences in exposure to workplace hazards and receipt of benefits from workplace policies, but the extent to which this explains disparities in health and health care outcomes is unknown. Structural racism and discrimination within macro-level conditions that limit opportunities, resources, and power, shown by census tract areas with high social vulnerability, are linked to substantial health disparities. However, what is not known is the extent that these place-based health disparities are due to regional or location specific income inequality, unfavorable labor market conditions, unequal occupational opportunities, and/or high unemployment rates. Moreover, there are large differences in life trajectories based on someone’s work, including differences in achieving social status and position, and in access to work-related resources and social networks, but how these influence health and health care disparities is yet to be examined. Given the unequal distribution of “work” among populations affected by health disparities, work is implicated in both health and health care disparities and research is needed to examine the mechanisms and pathways through which this unequal distribution influences health and health care disparities.

A few studies have demonstrated proof-of-concept that occupational segregation by race and ethnicity and the resulting unequal exposure to occupational risk factors explain a proportion of the population-level disparities seen in health outcomes. For example, disproportional employment of African American/Black persons in jobs with lower substantive complexity may explain up to 30% of the disparity seen in all-cause mortality rates. Occupational health disparities research has mainly focused on work as a source of hazardous exposures linked with a specific health outcome. This initiative is a call for research to examine work beyond only being a source of “exposures and risk factors,” examining it also as a source of beneficial social and economic resources and attainment of social position and status.

Research Objectives

The main objective of this initiative is to determine the extent and mechanisms by which work as a SDOH both contributes to, and helps ameliorate, health and health care disparities. A recent workshop on September 28-29, 2020 organized by NIMHD (https://www.nimhd.nih.gov/news-events/conferences-events/hd-workshop.html) highlighted key ideas for furthering research on work as a SDOH that include conceptualizing work as a social class marker, as a source of “exposures and risk factors,” and as a source of beneficial social and economic resources such as income and wealth, neighborhood conditions, health care access, education, and social networks. Some key questions include: What are the specific and modifiable mechanisms by which work explains health disparities? To what extent does work as a social class marker, source of “exposures and risk factors” and/or source of beneficial social and economic resources explain health disparities? Which health disparities does work as a SDOH explain?

Of particular interest are projects designed to examine pathways and mechanisms using conceptual model(s) grounded in minority health and health disparities theories that recognize that health disparities arise by multiple and overlapping contributing factors acting at multiple levels of influence (See the NIMHD Research Framework, https://www.nimhd.nih.gov/about/overview/research-framework.html).

Studies must examine NIH-designated U.S. health disparity populations, e.g. racial and ethnic minority populations, sexual and gender minority groups, underserved rural populations, and socioeconomically disadvantaged populations of any race or ethnicity (https://www.nimhd.nih.gov/about/overview/).

Studies involving primary data collection with human participants are strongly encouraged to incorporate SDOH measures from the Core and Specialty collections that are available in the Social Determinants of Health Collection of the PhenX Toolkit (www.phenxtoolkit.org).

Of interest are intersectional approaches that consider different social identities and the embeddedness of individuals within families, households, and communities. Life course approaches that consider the role of work in shaping cumulative processes and critical transitions including periods of unemployment, under-employment, and unpaid and informal work arrangements, are also encouraged. Also, of interest is considering the role of work at the household level with influences on the health of partners and extended families, and the intergenerational transmission to children and their health. In addition, exploring the role of inequity-generating mechanisms that constrain choices around work and health such as racism and discrimination by sex, age, marital status, immigration status, social class, and other power structures is also encouraged.

Additionally, of interest are projects that explore whether work can explain the health or health care disparities seen within diseases or conditions (e.g., COVID-19, opioid use disorder, mental/behavioral health, diabetes, cancer, heart disease, asthma, and maternal and infant health ) as well as disparities in co-morbidities and general indicators of health such as greater global burden of disease, quality of life, and daily functioning. Projects that utilize a syndemics lens (i.e., multiple disease states that are interlinked because of social, environmental, and structural conditions), to examine the role of work in disparities in co-occurring health conditions, are encouraged.

Also, of interest are projects that explore how work contributes to health care disparities including but not limited to disparities in access to preventive, specialty, and emergency care, in health insurance coverage, and in quality of health care. Moreover, given the reciprocal relationship between work and health, of interest are projects that examine how health impacts access to different work opportunities, working conditions, and work benefits, and how that varies by different social identities.

Projects may involve primary data collection and/or secondary analysis of existing datasets. Projects may utilize observational studies, natural experiments, quasi-experiments, simulation modeling, as well as use of large-scale longitudinal data sets, data mining techniques, registries, surveillance data, and linking to administrative data sets such as the Occupational Information Network (O*NET). Quantitative and mixed methods approaches are encouraged.

Investigators are encouraged as appropriate for the research questions posed, to forge research collaborations with community partners and stakeholders in the conceptualization, planning and implementation of the research to generate better-informed hypotheses and enhance the translation of the research results into practice.

Applications Not Responsive to the FOA

  • Projects that only explore pathways and mechanisms for how hazardous exposures are linked to a specific health outcome, without exploring how they contribute to population-level minority health, health disparities or health care disparities.
  • Projects that do not include a focus on one or more NIH-designated populations that experience health disparities in the United States.
  • Projects conducting research outside of the U.S. or its territories and possessions, the Commonwealth of Puerto Rico, or the Trust Territory of the Pacific Islands, or requesting foreign components.
  • Projects that do not utilize a clear conceptual framework and theoretical model to guide the analyses.
  • Projects that only describe the existence of health disparities related to work without examining the mechanisms through which work contributes to these disparities.

Non-responsive applications will not be reviewed. Applicants are strongly encouraged to reach out to the relevant scientific contacts to discuss whether their applications are responsive.

Areas of Research Interest

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

NICHD's mission is to lead research and training to understand human development, improve reproductive health, enhance the lives of children and adolescents, and optimize abilities for all. The NICHD's broad and diverse research portfolio includes research related to conception and pregnancy; typical and atypical development in childhood; childhood trauma and critical illness; the transition from adolescence to adulthood; reproductive health; rehabilitation; intellectual, developmental, and physical disabilities; and population dynamics across the lifespan. For this PAR, NICHD encourages research that integrates cross-cutting topics: health disparities, disease prevention, infectious disease, and nutrition.

In response to PAR-21-275, topics of interest to NICHD include, but are not limited to research on:

  • Work and educational, occupational, and/or life course pathways contributing to health disparities,
  • The impact of employment on health outcomes for persons with intellectual, developmental, learning, physical and psychological disabilities,
  • Variation in state employment policies on health outcomes,
  • The physical location of work and ease of getting to service providers, whether of direct health care or facilitators of healthy behaviors (e.g., grocery stores and gyms),
  • Labor market change (e.g., growth/dissolution of occupations/industries, changes in certification/education requirements) and associated occupational exposures with health, fertility, and pregnancy outcomes,
  • Consequences of bias and discrimination in workplace policies (e.g., differential hiring, salary and promotion practices) on health, fertility, and pregnancy outcomes,
  • Job-related exposures (e.g., essential and frontline workers during the COVID19 pandemic, high risk/stress occupations, shift work, etc.) and their impact on child health, reproductive health, and pregnancy outcomes.

National Institute on Minority Health and Health Disparities (NIMHD):

NIMHD is interested in studies that evaluate:

  • The role of work as a SDOH, teasing apart work as a social class marker, as a source of “exposures and risk factors”, and/or source of beneficial social and economic resources.
  • The extent to which work as a SDOH explains health and health care disparities, in the context of socioeconomic status (years of education and/or household income) and racial or ethnic minority populations.
  • The mechanisms and causal pathways by which work contributes to health and health care disparities. This includes mechanisms influenced by structural racism, such as occupational segregation and workplace segregation as well as other inequity-generating mechanisms such as climates of racism, perceived societal discrimination by other factors such as sex, age, marital status, immigration status, social class, and other power structures that constrain choices around work and health.
  • The mechanisms and causal pathways by which work as a SDOH contributes to health disparities for specific diseases or clusters of diseases (e.g., syndemics), health conditions, and general indicators of health such as greater global burden of disease, quality of life, and daily functioning.
  • The mechanisms and causal pathways by which work as a SDOH contributes to health care disparities in access to and quality of primary care, preventive services, and specialty consultations, after accounting for type of health insurance coverage.
  • The role of work as a SDOH for household units, and the mechanisms and pathways by which work influences health disparities for household members, such as primary employee, partners, children, grandparents, dependents, and extended families.
  • The extent to which work as a SDOH influenced by structural racism within macro-level conditions (e.g., decline in unions, globalization and workplace restructuring, entrepreneurism, rise of self-employment occupations, rise of the gig economy, increases in precarious jobs, percent of immigrants in labor force, natural disasters such as COVID-19, recessions) can explain, exacerbate, or mitigate national, regional or location specific health disparities.
  • The extent to which work as a SDOH is influenced by system-level trends, shifts in labor, and sector disruptions (e.g., issues of social justice versus individualism, distributive justice versus free market, economics and the tradeoff between efficiency and equity) and their role in exacerbating or mitigating the contribution of work to health and health care disparities.
  • The implementation of laws and regulations at the municipal, state or national levels (e.g., paid family and medical leave, paid sick leave, workers’ compensation, medical benefits, minimum wage, and diversity, equity and inclusion policies) and their differential effects for populations with health disparities.
  • The reciprocal relationship between work and health, and how health for populations, such as increased burden of disease and co-morbidities impacts work as a SDOH, including access to different work opportunities, working conditions, and work benefits, and how that varies by different social identities.

National Institute on Aging (NIA):

The NIA mission is to support and conduct genetic, biological, clinical, behavioral, social, and economic research on aging; foster the development of research and scientists in aging; provide research resources to facilitate innovative aging research; and disseminate information about aging and advances in research to the public, health care professionals, and the scientific community, among a variety of audiences. NIA’s interest in this FOA includes research to understand the influences employment, occupational factors, and voluntary/involuntary job loss on life course health and aging, including Alzheimer’s Disease and Alzheimer’s Disease Related Dementias (AD/ADRD).

Specific areas of interest include, but are not limited to, research elucidating life course pathways via occupational circumstances leading to disparities in mid and later-life cognitive and health outcomes; the relationships between labor market change (e.g., growth/dissolution of occupations/industries, changes in certification/education requirements, etc.) and associated occupational exposures with health and disability at older age; the consequences of occupational and workplace policies (e.g. shift work, high-risk jobs, etc.) on health outcomes at older ages; experimental or quasi-experimental approaches using changes in workplace/labor policies from the national to the firm level (e.g., Fair Labor Standards Act, Minimum Wages, shift work regulations, unions, paid childcare/eldercare, etc.) to conduct causal analyses of work-related factors on health and cognition in mid- and later life; how hazardous job-related exposures across the work life (e.g., front-line or essential workers during the COVID19 pandemic, high risk/stress occupations, etc.) are related to later life health and cognition; how timing and duration of job loss and retirement (e.g., disruption or completion of work history) influence health and cognition in later life; how occupation and occupation change over the life course influence health, well-being, and cognition (e.g., job qualities and benefits); how differences in social isolation or integration caused by occupational experiences serve as risk or protective for cognitive and health outcomes; how workplace accommodation influences disability and/or decline among persons with cognitive, sensory, or motor disabilities as they continue to age.

Applicants are encouraged to consult summaries of two recent NIA-sponsored activities, including a series of teleconferences on Work, the Workplace, and Aging and a recent National Academies Planning Meeting on how workplace policies and qualities promote health and support work into older ages, for recent discussions of scientific challenges and opportunities related to these topics.

Note where appropriate in FOA: NIA requires all applicants planning to collect data provide plans to document and share all research data (see https://www.nia.nih.gov/research/data-sharing-resources-researchers). All projects should strive to employ common data elements/constructs and those developing new/innovative measures should employ approaches supporting crosswalks to common data elements/constructs.

National Institute on Drug Abuse (NIDA):

NIDA is interested in research that explicates the mechanisms by which employment and drug use are related, in order to inform the future development and testing of interventions to directly address those mechanisms. NIDA encourages stakeholders and end users to be active partners in all stages of research so that findings have greater potential to directly influence practice. Examples of NIDA interest areas include, but are not limited to:

  • Studies to understand the structural (e.g., loss of venues or sectors) and individual level (e.g., occupational injuries) aspects of employment and their influence on drug use (including opioids and stimulants) and related health problems including infectious disease (e.g., HIV, HCV) and mental illness.
  • Studies of the effects of drug involvement on employment opportunities, job seeking behaviors, job training/job readiness, and job retention to identify the mechanisms by which use impacts employment and vice versa.
  • Studies that examine structural or social aspects work environments that might facilitate or hinder recovery, e.g., peer recovery groups in restaurant or entertainment industry.
  • Studies that examine how structural aspects of engaging in treatment (e.g., residential treatment, daily visits to an Opioid Treatment Program, timing of appointments, transportation) influence occupational opportunities and outcomes.
  • Studies that examine the influence of structural aspects of work environments and/or employment outcomes for family members or supportive others (e.g., parents, spouses) and how those factors influence substance use, treatment and recovery outcomes for individuals who have a substance use disorder.
  • Studies that examine how working in a peer recovery support role influences the worker’s own substance use, mental health, and recovery.

National Institute of Environmental Health Sciences (NIEHS):

The mission of the NIEHS is to discover how the environment affects people to promote healthier lives. NIEHS has long recognized the harmful impacts of the physical work environment and other occupational exposures on human health. These workplace exposures disproportionately affect health disparity populations and are often an issue of environmental justice.

NIEHS is interested in applications that focus on the intersection of work as a social determinant of health, the physical environment (that includes exposures to toxicants) and other social determinants of health in creating or intensifying environmental health disparities at the population level. Community engaged research approaches are strongly encouraged as well as applications that move the science of environmental health disparities towards achieving environmental justice for affected populations. NIEHS encourages prospective applicants to review our 2018-2023 Strategic Plan; the NIEHS Research to Action program also provides examples of community engaged research grants focused on occupational exposures.

National Institute on Mental Health (NIMH):

NIMH is interested in studies that examine:

  • The mechanisms and potential causal pathways by which work as a SDOH affects mental health symptoms/disorders, either by contributing to, or ameliorating mental health care disparities in individuals and among household members. Establishing causal pathways could be examined through randomized controlled trials where appropriate, or through analytic methods such as instrumental variables, propensity score matching, or other appropriate analytic methods.
  • The extent to which work as a SDOH differentially impacts the presence and severity of mental health symptoms in individuals who have histories of job loss and/or periods of underemployment, and/or the mechanisms and potential causal pathways that contribute to the impact of such job loss/underemployment on the mental health symptoms among members of their family, neighborhood, and community.
  • The extent to which work as a SDOH impacts interpersonal relationships that may affect mental health status, for example, by creating differences in quality of interpersonal relationships within the work environment (e.g., perceptions of interpersonal disconnectedness, bullying, verbal abuse) that contribute to worsening mental health status, including feelings of hopelessness, isolation, burdensomeness, emotion dysregulation, and presence of suicide ideation and behaviors.
  • The extent to which work as a SDOH promotes positive experiences at the individual (e.g., improved self-efficacy, improved belongingness), familial (e.g., positive familial relationship, reduced family conflict, improved family functioning), neighborhood (e.g., neighborhood cohesion, support), and community-level (e.g., improved community investment, reduced community violence) to reduce presence and severity of mental health symptoms.

For research on the effectiveness of interventions or services, NIMH requires a study design using an experimental therapeutics approach, in which clinical trials test intervention effects on mental health outcomes as well as elucidate the intervention’s mechanism(s) of action. Clinical trials applications that do not adhere to the experimental therapeutics framework will be considered non-responsive to this FOA. Therefore, applications must specify intervention target/mechanism and assess whether intervention-induced changes in the target account for the hypothesized outcome. In the case of services interventions, targets/mechanisms might involve change in service-user, family and/or provider behavior, or in organizational/system-level factors to improve access, engagement, continuity, quality, equity, and/or value of services. Studies adapting interventions for racial and ethnic minority populations (e.g., American Indians/Alaska Natives, Asian Americans, Blacks/African Americans, Hispanics/Latinos, and Native Hawaiians and other Pacific Islanders), sexual and gender minorities, socioeconomically disadvantaged populations, and underserved rural populations should provide an empirical rationale for the adaptation/augmentation target and a clear hypothesis and plan to address the target mechanism by which the adapted intervention will enhance outcomes. See the Support for Clinical Trials at NIMH web page for additional information. NIMH also encourages researchers to provide a data analytic plan that specifies how multi-level factors, effects and interactions, or outcomes will be conducted.

See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information

Funding Instrument

Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

Application Types Allowed
New
Renewal
Resubmission
Revision

The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

Clinical Trial?

Optional: Accepting applications that either propose or do not propose clinical trial(s).

Need help determining whether you are doing a clinical trial?

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

Award Budget
Application budgets are not limited but need to reflect the actual needs of the proposed project.
Award Project Period

The scope of the proposed project should determine the project period. The maximum project period is 5 years.

NIH grants policies as described in the NIH Grants Policy Statement will apply to the applications submitted and awards made from this FOA.

Section III. Eligibility Information

1. Eligible Applicants

Eligible Organizations

Higher Education Institutions

  • Public/State Controlled Institutions of Higher Education
  • Private Institutions of Higher Education

The following types of Higher Education Institutions are always encouraged to apply for NIH support as Public or Private Institutions of Higher Education:

  • Hispanic-serving Institutions
  • Historically Black Colleges and Universities (HBCUs)
  • Tribally Controlled Colleges and Universities (TCCUs)
  • Alaska Native and Native Hawaiian Serving Institutions
  • Asian American Native American Pacific Islander Serving Institutions (AANAPISIs)

Nonprofits Other Than Institutions of Higher Education

  • Nonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)
  • Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)

For-Profit Organizations

  • Small Businesses
  • For-Profit Organizations (Other than Small Businesses)

Local Governments

  • State Governments
  • County Governments
  • City or Township Governments
  • Special District Governments
  • Indian/Native American Tribal Governments (Federally Recognized)
  • Indian/Native American Tribal Governments (Other than Federally Recognized)

Federal Governments

  • U.S. Territory or Possession

Other

  • Independent School Districts
  • Public Housing Authorities/Indian Housing Authorities
  • Native American Tribal Organizations (other than Federally recognized tribal governments)
  • Faith-based or Community-based Organizations
  • Regional Organizations
Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.

Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Foreign components, as defined in the NIH Grants Policy Statement, are not allowed. 

Required Registrations

Applicant organizations

Applicant organizations must complete and maintain the following registrations as described in the SF 424 (R&R) Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. The NIH Policy on Late Submission of Grant Applications states that failure to complete registrations in advance of a due date is not a valid reason for a late submission.

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. After obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active DUNS number and SAM registration in order to complete the Grants.gov registration.

Program Directors/Principal Investigators (PD(s)/PI(s))

All PD(s)/PI(s) must have an eRA Commons account.  PD(s)/PI(s) should work with their organizational officials to either create a new account or to affiliate their existing account with the applicant organization in eRA Commons. If the PD/PI is also the organizational Signing Official, they must have two distinct eRA Commons accounts, one for each role. Obtaining an eRA Commons account can take up to 2 weeks.

Eligible Individuals (Program Director/Principal Investigator)

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

For institutions/organizations proposing multiple PDs/PIs, visit the Multiple Program Director/Principal Investigator Policy and submission details in the Senior/Key Person Profile (Expanded) Component of the SF424 (R&R) Application Guide.

2. Cost Sharing

This FOA does not require cost sharing as defined in the NIH Grants Policy Statement.

3. Additional Information on Eligibility

Number of Applications

Applicant organizations may submit more than one application, provided that each application is scientifically distinct.

The NIH will not accept duplicate or highly overlapping applications under review at the same time.  This means that the NIH will not accept:

  • A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
  • A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
  • An application that has substantial overlap with another application pending appeal of initial peer review (see NOT-OD-11-101).

Section IV. Application and Submission Information

1. Requesting an Application Package

The application forms package specific to this opportunity must be accessed through ASSIST, Grants.gov Workspace or an institutional system-to-system solution. Links to apply using ASSIST or Grants.gov Workspace are available in Part 1 of this FOA. See your administrative office for instructions if you plan to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in the Research (R) Instructions in the SF424 (R&R) Application Guide except where instructed in this funding opportunity announcement to do otherwise. Conformance to the requirements in the Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Letter of Intent

Not Applicable

Page Limitations

All page limitations described in the SF424 Application Guide and the Table of Page Limits must be followed.

Instructions for Application Submission

The following section supplements the instructions found in the SF424 (R&R) Application Guide and should be used for preparing an application to this FOA.

SF424(R&R) Cover

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the SF424 (R&R) Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the SF424 (R&R) Application Guide must be followed.

R&R or Modular Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

R&R Subaward Budget

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the SF424 (R&R) Application Guide must be followed.

PHS 398 Research Plan

All instructions in the SF424 (R&R) Application Guide must be followed, with the following additional instructions:

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide.

The following modifications also apply:

  • All applications, regardless of the amount of direct costs requested for any one year, should address a Data Sharing Plan.
Appendix:
Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.
PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the SF424 (R&R) Application Guide, with the following additional instructions:

If you answered “Yes” to the question “Are Human Subjects Involved?” on the R&R Other Project Information form, you must include at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or Delayed Onset Study record.

Study Record: PHS Human Subjects and Clinical Trials Information

All instructions in the SF424 (R&R) Application Guide must be followed.

Delayed Onset Study

Note: Delayed onset does NOT apply to a study that can be described but will not start immediately (i.e., delayed start).All instructions in the SF424 (R&R) Application Guide must be followed.

PHS Assignment Request Form

All instructions in the SF424 (R&R) Application Guide must be followed.

3. Unique Entity Identifier and System for Award Management (SAM)

See Part 1. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov.

4. Submission Dates and Times

Part I. Overview Information contains information about Key Dates and times. Applicants are encouraged to submit applications before the due date to ensure they have time to make any application corrections that might be necessary for successful submission. When a submission date falls on a weekend or Federal holiday, the application deadline is automatically extended to the next business day.

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Policy on Late Application Submission.

Applicants are responsible for viewing their application before the due date in the eRA Commons to ensure accurate and successful submission.

Information on the submission process and a definition of on-time submission are provided in the SF424 (R&R) Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

All NIH awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Pre-award costs are allowable only as described in the NIH Grants Policy Statement.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the SF424 (R&R) Application Guide.  Paper applications will not be accepted.

Applicants must complete all required registrations before the application due date. Section III. Eligibility Information contains information about registration.

For assistance with your electronic application or for more information on the electronic submission process, visit How to Apply – Application Guide. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Dealing with System Issues guidance. For assistance with application submission, contact the Application Submission Contacts in Section VII.

Important reminders:

All PD(s)/PI(s) must include their eRA Commons ID in the Credential field of the Senior/Key Person Profile Component of the SF424(R&R) Application Package. Failure to register in the Commons and to include a valid PD/PI Commons ID in the credential field will prevent the successful submission of an electronic application to NIH. See Section III of this FOA for information on registration requirements.

The applicant organization must ensure that the DUNS number it provides on the application is the same number used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the SF424 (R&R) Application Guide.

See more tips for avoiding common errors.

Upon receipt, applications will be evaluated for completeness and compliance with application instructions by the Center for Scientific Review and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

Requests of $500,000 or more for direct costs in any year

Applicants requesting $500,000 or more in direct costs in any year (excluding consortium F&A) must contact a Scientific/ Research Contact at least 6 weeks before submitting the application and follow the Policy on the Acceptance for Review of Unsolicited Applications that Request $500,000 or More in Direct Costs as described in the SF424 (R&R) Application Guide.

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described in the policy. Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

Only the review criteria described below will be considered in the review process.  Applications submitted to the NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

In addition, for applicatoins involving clinical trials: A proposed Clinical Trial application may include study design, methods, and intervention that are not by themselves innovative but address important questions or unmet needs. Additionally, the results of the clinical trial may indicate that further clinical development of the intervention is unwarranted or lead to new avenues of scientific investigation.

Overall Impact

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria and additional review criteria (as applicable for the project proposed).

Scored Review Criteria

Reviewers will consider each of the review criteria below in the determination of scientific merit, and give a separate score for each. An application does not need to be strong in all categories to be judged likely to have major scientific impact. For example, a project that by its nature is not innovative may be essential to advance a field.

Significance

Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?

Upon successful completion of the aims, will the project significantly advance the understanding of Work as a Social Determinant of Health?

In addition, for applications involving clinical trials

Are the scientific rationale and need for a clinical trial to test the proposed hypothesis or intervention well supported by preliminary data, clinical and/or preclinical studies, or information in the literature or knowledge of biological mechanisms? For trials focusing on clinical or public health endpoints, is this clinical trial necessary for testing the safety, efficacy or effectiveness of an intervention that could lead to a change in clinical practice, community behaviors or health care policy? For trials focusing on mechanistic, behavioral, physiological, biochemical, or other biomedical endpoints, is this trial needed to advance scientific understanding?

Investigator(s)

Are the PD(s)/PI(s), collaborators, and other researchers well suited to the project? If Early Stage Investigators or those in the early stages of independent careers, do they have appropriate experience and training? If established, have they demonstrated an ongoing record of accomplishments that have advanced their field(s)? If the project is collaborative or multi-PD/PI, do the investigators have complementary and integrated expertise; are their leadership approach, governance and organizational structure appropriate for the project?

In addition, for applications involving clinical trials

With regard to the proposed leadership for the project, do the PD/PI(s) and key personnel have the expertise, experience, and ability to organize, manage and implement the proposed clinical trial and meet milestones and timelines? Do they have appropriate expertise in study coordination, data management and statistics? For a multicenter trial, is the organizational structure appropriate and does the application identify a core of potential center investigators and staffing for a coordinating center?

Innovation

Does the application challenge and seek to shift current research or clinical practice paradigms by utilizing novel theoretical concepts, approaches or methodologies, instrumentation, or interventions? Are the concepts, approaches or methodologies, instrumentation, or interventions novel to one field of research or novel in a broad sense? Is a refinement, improvement, or new application of theoretical concepts, approaches or methodologies, instrumentation, or interventions proposed?

In addition, for applications involving clinical trials

Does the design/research plan include innovative elements, as appropriate, that enhance its sensitivity, potential for information or potential to advance scientific knowledge or clinical practice?

Approach

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? Have the investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? Are potential problems, alternative strategies, and benchmarks for success presented? If the project is in the early stages of development, will the strategy establish feasibility and will particularly risky aspects be managed? Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? Given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results? Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified?

Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?

Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

Are planned analyses and statistical approach appropriate for the proposed study design and methods used to assign participants and deliver interventions? Are the procedures for data management and quality control of data adequate at clinical site(s) or at center laboratories, as applicable? Have the methods for standardization of procedures for data management to assess the effect of the intervention and quality control been addressed? Is there a plan to complete data analysis within the proposed period of the award?

Environment

Will the scientific environment in which the work will be done contribute to the probability of success? Are the institutional support, equipment and other physical resources available to the investigators adequate for the project proposed? Will the project benefit from unique features of the scientific environment, subject populations, or collaborative arrangements?

In addition, for applications involving clinical trials

If proposed, are the administrative, data coordinating, enrollment and laboratory/testing centers, appropriate for the trial proposed?

Does the application adequately address the capability and ability to conduct the trial at the proposed site(s) or centers? Are the plans to add or drop enrollment centers, as needed, appropriate?

If international site(s) is/are proposed, does the application adequately address the complexity of executing the clinical trial?

If multi-sites/centers, is there evidence of the ability of the individual site or center to: (1) enroll the proposed numbers; (2) adhere to the protocol; (3) collect and transmit data in an accurate and timely fashion; and, (4) operate within the proposed organizational structure?

Additional Review Criteria

As applicable for the project proposed, reviewers will evaluate the following additional items while determining scientific and technical merit, and in providing an overall impact score, but will not give separate scores for these items.

Study Timeline

Specific to applications involving clinical trials
Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate?

Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls)?

Protections for Human Subjects

For research that involves human subjects but does not involve one of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate the justification for involvement of human subjects and the proposed protections from research risk relating to their participation according to the following five review criteria: 1) risk to subjects, 2) adequacy of protection against risks, 3) potential benefits to the subjects and others, 4) importance of the knowledge to be gained, and 5) data and safety monitoring for clinical trials.

For research that involves human subjects and meets the criteria for one or more of the categories of research that are exempt under 45 CFR Part 46, the committee will evaluate: 1) the justification for the exemption, 2) human subjects involvement and characteristics, and 3) sources of materials. For additional information on review of the Human Subjects section, please refer to the Guidelines for the Review of Human Subjects.

Inclusion of Women, Minorities, and Individuals Across the Lifespan

When the proposed project involves human subjects and/or NIH-defined clinical research, the committee will evaluate the proposed plans for the inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion (or exclusion) of individuals of all ages (including children and older adults) to determine if it is justified in terms of the scientific goals and research strategy proposed. For additional information on review of the Inclusion section, please refer to the Guidelines for the Review of Inclusion in Clinical Research.

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following criteria: (1) description of proposed procedures involving animals, including species, strains, ages, sex, and total number to be used; (2) justifications for the use of animals versus alternative models and for the appropriateness of the species proposed; (3) interventions to minimize discomfort, distress, pain and injury; and (4) justification for euthanasia method if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals. Reviewers will assess the use of chimpanzees as they would any other application proposing the use of vertebrate animals. For additional information on review of the Vertebrate Animals section, please refer to the Worksheet for Review of the Vertebrate Animal Section.

Biohazards

Reviewers will assess whether materials or procedures proposed are potentially hazardous to research personnel and/or the environment, and if needed, determine whether adequate protection is proposed.

Resubmissions

For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

Renewals

For Renewals, the committee will consider the progress made in the last funding period.

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

Additional Review Considerations

As applicable for the project proposed, reviewers will consider each of the following items, but will not give scores for these items, and should not consider them in providing an overall impact score.

Applications from Foreign Organizations

Not Applicable.

Select Agent Research

Reviewers will assess the information provided in this section of the application, including 1) the Select Agent(s) to be used in the proposed research, 2) the registration status of all entities where Select Agent(s) will be used, 3) the procedures that will be used to monitor possession use and transfer of Select Agent(s), and 4) plans for appropriate biosafety, biocontainment, and security of the Select Agent(s).

Resource Sharing Plans

Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3)  Genomic Data Sharing Plan (GDS).

Authentication of Key Biological and/or Chemical Resources:

For projects involving key biological and/or chemical resources, reviewers will comment on the brief plans proposed for identifying and ensuring the validity of those resources.

Budget and Period of Support

Reviewers will consider whether the budget and the requested period of support are fully justified and reasonable in relation to the proposed research.

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by Center for Scientific Review, in accordance with NIH peer review policy and procedures, using the stated review criteria. Assignment to a Scientific Review Group will be shown in the eRA Commons.

As part of the scientific peer review, all applications will receive a written critique.

Applications may undergo a selection process in which only those applications deemed to have the highest scientific and technical merit (generally the top half of applications under review) will be discussed and assigned an overall impact score.

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

After the peer review of the application is completed, the PD/PI will be able to access his or her Summary Statement (written critique) via the eRA Commons. Refer to Part 1 for dates for peer review, advisory council review, and earliest start date.

Information regarding the disposition of applications is available in the NIH Grants Policy Statement.

Section VI. Award Administration Information

1. Award Notices

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided to the applicant organization for successful applications. The NoA signed by the grants management officer is the authorizing document and will be sent via email to the recipient's business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

Any application awarded in response to this FOA will be subject to terms and conditions found on the Award Conditions and Information for NIH Grants website.  This includes any recent legislation and policy applicable to awards that is highlighted on this website.

Individual awards are based on the application submitted to, and as approved by, the NIH and are subject to the IC-specific terms and conditions identified in the NoA.

ClinicalTrials.gov: If an award provides for one or more clinical trials. By law (Title VIII, Section 801 of Public Law 110-85), the "responsible party" must register and submit results information for certain “applicable clinical trials” on the ClinicalTrials.gov Protocol Registration and Results System Information Website (https://register.clinicaltrials.gov). NIH expects registration and results reporting of all trials whether required under the law or not. For more information, see https://grants.nih.gov/policy/clinical-trials/reporting/index.htm

Institutional Review Board or Independent Ethics Committee Approval: Recipient institutions must ensure that all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee must provide NIH copies of documents related to all major changes in the status of ongoing protocols.

Data and Safety Monitoring Requirements: The NIH policy for data and safety monitoring requires oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) to ensure the safety of participants and the validity and integrity of the data. Further information concerning these requirements is found at http://grants.nih.gov/grants/policy/hs/data_safety.htm and in the application instructions (SF424 (R&R) and PHS 398).

Investigational New Drug or Investigational Device Exemption Requirements: Consistent with federal regulations, clinical research projects involving the use of investigational therapeutics, vaccines, or other medical interventions (including licensed products and devices for a purpose other than that for which they were licensed) in humans under a research protocol must be performed under a Food and Drug Administration (FDA) investigational new drug (IND) or investigational device exemption (IDE).

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

Recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex. This includes ensuring programs are accessible to persons with limited English proficiency. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html.

HHS recognizes that research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this FOA.

Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697.

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a Federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgement about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

When multiple years are involved, awardees will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement.

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $25,000.  See the NIH Grants Policy Statement for additional information on this reporting requirement.

In accordance with the regulatory requirements provided at 45 CFR 75.113 and Appendix XII to 45 CFR Part 75, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS).  This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313).  As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available.  Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 – Award Term and Conditions for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity and welcome the opportunity to answer questions from potential applicants.

Application Submission Contacts

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: http://grants.nih.gov/support/ (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

Scientific/Research Contact(s)

Rada K. Dagher, PhD, MPH
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-451-2187
Email: rada.dagher@nih.gov

Nancy L. Jones, PhD, MS
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8945
Email: nancy.jones@nih.gov

Anil Wali, PhD
National Cancer Institute (NCI)
Phone: 240-276-6183 
Email: walia@mail.nih.gov

Somdat Mahabir, PhD, MPH
National Cancer Institute (NCI)
Phone: 240-276-6941 
Email: mahabir@mail.nih.gov

John Phillips, Ph. D.
National Institute on Aging (NIA)
Phone: 301-827-4137
Email: john.phillips@nih.gov

Sheba King Dunston
National Institute On Drug Abuse (NIDA)
Phone: 240-276-6170
E-mail: sheba.dunston@nih.gov

Lindsey Ann Martin, PhD
National Institute of Environmental Health Sciences (NIEHS)
Phone: 984-287-4036
E-mail: lindsey.martin@nih.gov

Jennifer Humensky, PhD
National Institute of Mental Health (NIMH)
Telephone: 301-480-1265
Email: jennifer.humensky@nih.gov

Damiya Eve Whitaker
Office Of Research On Women's Health (ORWH)
Phone: 240-276-6170
E-mail: damiya.whitaker@nih.gov

Christopher Barnhart, PhD
Sexual & Gender Minority Research Office (SGMRO)
Telephone: 301-594-8983
Email: christopher.barnhart@nih.gov

Peer Review Contact(s)

Examine your eRA Commons account for review assignment and contact information (information appears two weeks after the submission due date).

Financial/Grants Management Contact(s)

Priscilla Grant
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8412
Email: pg38h@nih.gov

Crystal Wolfrey
National Cancer Institute (NCI)
Phone: 240-276-6277
Email: wolfreyc@mail.nih.gov

Rhashonda Cochran
National Institute on Aging (NIA)
Phone: 301-451-6645
Email: rhashonda.cochran@nih.gov

Pamela G Fleming
National Institute On Drug Abuse (NIDA)
Phone: 301-480-1159
E-mail: pfleming@mail.nih.gov

Jenny L Greer
National Institute of Environmental Health Sciences (NIEHS)
Phone: 984.287.3332
E-mail: jenny.greer@nih.gov

Tamara Kees
National Institute of Mental Health (NIMH)
Telephone: 301-443-8811
Email: tamara.kees@nih.gov

Section VIII. Other Information

Recently issued trans-NIH policy notices may affect your application submission. A full list of policy notices published by NIH is provided in the NIH Guide for Grants and Contracts. All awards are subject to the terms and conditions, cost principles, and other considerations described in the NIH Grants Policy Statement.

Authority and Regulations

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.


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