Part 1. Overview Information

Key Dates

All applications are due by 5:00 PM local time of applicant organization. 

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.

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

Conformance to all requirements (both in the Application Guide and the NOFO) 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.



Table of Contents
Part 1. Overview Information
Key Dates
Part 2. Full Text of Announcement
Section I. Notice of Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Part 2. Full Text of Announcement

Section I. Notice of 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 minoritized 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 including secondhand smoke. 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 better quality health care and improved 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, disability 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 workshop on September 28-29, 2020 that was 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).

Projects must include a focus on one or more of the following NIH-designated populations that experience health disparities in the United States: racial and/or ethnic minority populations, less privileged socioeconomic status (SES), underserved rural populations, persons with disabilities, and sexual and gender minority (SGM) groups. Projects focused on rural populations, SGM groups, and people with disabilities are encouraged to examine intersections with race and/or ethnicity, and/or SES. 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). For conceptualization of SDOH, see the description provided by the NIH-wide Social Determinants of Health Research Coordinating Committee.

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, disability, 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 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.

Areas of Research Interest

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 further explains health and health care disparities, in the context of and after accounting for socioeconomic status (years of education and/or household income) among 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, disability status, 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 of the primary employee, and the mechanisms and pathways by which work influences health disparities for household members, such as 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, 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 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 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.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs.

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

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

• Eligible Agencies of the Federal Government
• 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

Non-domestic (non-U.S.) Entities (Foreign Organizations) 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.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply- 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.

• 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.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; 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 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.

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 their organization to develop an application for support. Individuals from diverse backgrounds, including underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019 and Notice of NIH's Interest in Diversity, NOT-OD-20-031.

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 How to Apply-Application Guide.

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement Section 1.2 Definition of Terms.

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, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. 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 NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

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 NOFO. 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 How to Apply - Application Guide except where instructed in this notice of funding opportunity 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 How to Apply- Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the How to Apply- Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the How to Apply- Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the How to Apply- Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the How to Apply- Application Guide must be followed.

R&R or Modular Budget

All instructions in the How to Apply- Application Guide must be followed.

R&R Subaward Budget

All instructions in the How to Apply-Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the How to Apply- Application Guide must be followed.

PHS 398 Research Plan

All instructions in the How to Apply- 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 How to Apply- Application Guide.

Other Plan(s): 

All instructions in the How to Apply-Application Guide must be followed, with the following additional instructions:

• All applicants planning research (funded or conducted in whole or in part by NIH) that results in the generation of scientific data are required to comply with the instructions for the Data Management and Sharing Plan. All applications, regardless of the amount of direct costs requested for any one year, must address a Data Management and Sharing Plan.

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply- Application Guide.

• No publications or other material, with the exception of blank questionnaires or blank surveys, may be included in the Appendix.

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 How to Apply- 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 How to Apply- 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 How to Apply- Application Guide must be followed.

PHS Assignment Request Form

All instructions in the How to Apply- Application Guide must be followed.

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

See Part 2. 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. 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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 How to Apply-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 Section 7.9.1 Selected Items of Cost.

Applications must be submitted electronically following the instructions described in the How to Apply 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 form. 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 NOFO for information on registration requirements.

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply 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.

Recipients or subrecipients must submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award. See Mandatory Disclosures, 2 CFR 200.113 and NIH Grants Policy Statement Section 4.1.35.

Send written disclosures to the NIH Chief Grants Management Officer listed on the Notice of Award for the IC that funded the award and to the HHS Office of Inspector Grant Self Disclosure Program at [email protected].

Post Submission Materials

Applicants are required to follow the instructions for post-submission materials, as described 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.

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 scored review criteria and additional review criteria (as applicable for the project proposed). An application does not need to be strong in all categories to be judged likely to have a major scientific impact.

Reviewers will consider Factors 1, 2 and 3 in the determination of scientific merit, and in providing an overall impact score. In addition, Factors 1 and 2 will each receive a separate factor score. 

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

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.

2. Review and Selection Process

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 NOFO. 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.

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 Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

Prior to making an award, NIH reviews an applicant’s federal award history in SAM.gov to ensure sound business practices. An applicant can review and comment on any information in the Responsibility/Qualification records available in SAM.gov. NIH will consider any comments by the applicant in the Responsibility/Qualification records in SAM.gov to ascertain the applicant’s integrity, business ethics, and performance record of managing Federal awards per 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

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 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

A Notice of Award (NoA) is the official authorizing document notifying the applicant that an award has been made and that funds may be requested from the designated HHS payment system or office. The NoA is signed by the Grants Management Officer and emailed to the recipient’s business official.

In accepting the award, the recipient agrees that any activities under the award are subject to all provisions currently in effect or implemented during the period of the award, other Department regulations and policies in effect at the time of the award, and applicable statutory provisions.

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Any pre-award costs incurred before receipt of the NoA are at the applicant's own risk.  For more information on the Notice of Award, please refer to the NIH Grants Policy Statement Section 5. The Notice of Award and NIH Grants & Funding website, see Award Process.

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 recipient 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

The following Federal wide and HHS-specific policy requirements apply to awards funded through NIH:

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. 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.
• If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website.
  • HHS recognizes that NIH 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 NOFO.

All federal statutes and regulations relevant to federal financial assistance, including those highlighted in NIH Grants Policy Statement Section 4 Public Policy Requirements, Objectives and Other Appropriation Mandates.

Recipients are responsible for ensuring that their activities comply with all applicable federal regulations.  NIH may terminate awards under certain circumstances.  See 2 CFR Part 200.340 Termination and NIH Grants Policy Statement Section 8.5.2 Remedies for Noncompliance or Enforcement Actions: Suspension, Termination, and Withholding of Support. 

Successful recipients under this NOFO agree that:

Where the award funding involves implementing, acquiring, or upgrading health IT for activities by any funded entity, recipients and subrecipient(s) are required to: Use health IT that meets standards and implementation specifications adopted in 45 CFR part 170, Subpart B, if such standards and implementation specifications can support the activity.  Visit https://www.ecfr.gov/current/title-45/subtitle-A/subchapter-D/part-170/subpart-B to learn more.

Where the award funding involves implementing, acquiring, or upgrading health IT for activities by eligible clinicians in ambulatory settings, or hospitals, eligible under Sections 4101, 4102, and 4201 of the HITECH Act, use health IT certified under the ONC Health IT Certification Program if certified technology can support the activity. Visit https://www.healthit.gov/topic/certification-ehrs/certification-health-it to learn more.

Pursuant to the Cybersecurity Act of 2015, Div. N, § 405, Pub. Law 114-113, 6 USC § 1533(d), the HHS Secretary has established a common set of voluntary, consensus-based, and industry-led guidelines, best practices, methodologies, procedures, and processes.

Successful recipients under this NOFO agree that:

When recipients, subrecipients, or third-party entities have:

1. ongoing and consistent access to HHS owned or operated information or operational technology systems; and 
2. receive, maintain, transmit, store, access, exchange, process, or utilize personal identifiable information (PII) or personal health information (PHI) obtained from the awarding HHS agency for the purposes of executing the award.

Recipients shall develop plans and procedures, modeled after the NIST Cybersecurity framework, to protect HHS systems and data. Please refer to NIH Post-Award Monitoring and Reporting for additional information. 

Not Applicable

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

When multiple years are involved, recipients will be required to submit the Research Performance Progress Report (RPPR) annually and financial statements as required in the NIH Grants Policy Statement Section 8.4.1 Reporting. To learn more about post-award monitoring and reporting, see the NIH Grants & Funding website, see Post-Award Monitoring and Reporting.

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 Section 8.6 Closeout. NIH NOFOs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 2 CFR Part 200.301.

Section VII. Agency Contacts

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

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: https://www.era.nih.gov/need-help (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: [email protected] (preferred method of contact)
Telephone: 301-480-7075

Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
Contact Center Telephone: 800-518-4726
Email: [email protected]

Rada K. Dagher, PhD, MPH
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-451-2187
Email: [email protected]

Nancy L. Jones, PhD, MS
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8945
Email: [email protected]

Anil Wali, PhD
National Cancer Institute (NCI)
Phone: 240-276-6183 
Email: [email protected]

Somdat Mahabir, PhD, MPH
National Cancer Institute (NCI)
Phone: 240-276-6941 
Email: [email protected]

Sheba King Dunston
National Institute on Drug Abuse (NIDA)
Phone: 240-276-6170
E-mail: [email protected]

Jennifer Humensky, PhD
National Institute of Mental Health (NIMH)
Telephone: 301-480-1265
Email: [email protected]

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

Priscilla Grant
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8412
Email: [email protected]

Crystal Wolfrey
National Cancer Institute (NCI)
Phone: 240-276-6277
Email: [email protected]

Pamela G Fleming
National Institute on Drug Abuse (NIDA)
Phone: 301-480-1159
E-mail: [email protected]

Tamara Kees
National Institute of Mental Health (NIMH)
Telephone: 301-443-8811
Email: [email protected]

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.

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 2 CFR Part 200.