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 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.



Table of Contents
Part 1. Overview Information
Key Dates
Part 2. Full Text of Announcement
Section I. 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. Funding Opportunity Description

Key Definitions for the FOA:

Discrimination: A socially structured action that is unfair or unjustified and harms individuals and groups. Discrimination can be attributed to social interactions that occur to protect more powerful and privileged groups or institutions at the detriment of other groups. Racism refers to discrimination based on race or ethnicity.

Structural discrimination refers to macro-level conditions (e.g., residential segregation) that limit opportunities, resources, and well-being of less privileged groups (Healthy People 2020, https://www.healthypeople.gov/2020/topics-objectives/topic/social-determinants-health/interventions-resources/discrimination).

Structural racism and discrimination (SRD): For the purposes of this FOA, SRD refers to structural racism and discrimination on the basis of race/ethnicity and/or other statuses, including but not limited to gender, sexual orientation, gender identity, disability status, social class or socioeconomic status, religion, national origin, immigration status, limited English proficiency, or physical characteristics or health conditions.

NIH-designated Populations with Health Disparities: Racial and ethnic minorities, socioeconomically disadvantaged populations, underserved rural populations, and sexual and gender minorities in the U.S. (see https://www.nimhd.nih.gov/about/overview/).

Background

There is increasing recognition that racism and discrimination contribute to poorer health outcomes for racial/ethnic minorities and other populations that experience health disparities. In fact, all populations with health disparities experience increased exposure to racism and/or other forms of discrimination over the life course. There is also a growing societal recognition that racism and discrimination extend beyond the behavior of individuals to include SRD, which is embedded in historical societal, institutional, organizational and governmental structures through formal and informal processes, procedures, and practices that limit both opportunities and resources to segments of the population. SRD is supported by the power structures that exist in society and in the institutions that are most likely to influence health outcomes.

Despite this enhanced awareness, racism and discrimination are not routinely included as determinants of health in biomedical research. Health research on racism and discrimination to date has largely focused on interpersonal interactions, and to a lesser extent, one specific form of SRD, residential segregation. Typically, such research focuses on the adverse health consequences of SRD exposures. Less research has explored the resilience among populations exposed to SRD or community strategies to resist or mitigate historic or contemporary SRD exposures. Additionally, intervention research has rarely emphasized reduction of SRD as a strategy to improve health and reduce disparities. Research on mitigation of SRD is needed to inform health care and social policies at all levels.

Health research and interventions need to routinely incorporate constructs and measurement of SRD across multiple socioecological domains and levels of influence in order to improve minority health, promote health equity, and eliminate health disparities (see the NIMHD Research Framework for more information: https://www.nimhd.nih.gov/about/overview/research-framework.html). Examples of domains in which SRD may occur include, but are not limited to, the following:

• Organizational/Institutional: Organizational-level climate; workplace hiring, promotion, or disciplinary practices; academic tracking, stigmatization, school disciplinary and admission practices; tolerance of abuse/harassment; health care system practices.
• Neighborhood/Community: Housing or lending practices and property value assessments; zoning laws; neighborhood distribution of public transportation, green spaces, grocery stores, hospitals and emergency departments, and ambulatory health clinics; resource allocation for schools through local tax base; location of cellular towers for mobile access, highways and major thoroughfares, and industrial or waste sites; criminal justice profiling; police-involved violence;targeted social marketing of harmful or ineffective products; hate crimes.
• Societal: Criminal justice policies and sentencing practices, land/water use rights, self-governance or political representation for tribal communities and US territories, immigration and asylum policies and procedures, gerrymandering, voter suppression laws or practices, religious and cultural discrimination, depiction or representation in national media and social media.

Research Objectives

This initiative will support intervention research to address the impact of SRD on minority health and health disparities.

Research projects must address SRD in one or more NIH-designated populations with health disparities in the US and should address documented disparities in health outcomes. Applications are expected to provide a justification for why the specific types of SRD included constitute SRD, such as how the racism or discrimination is structural rather than reflecting individual-level behavior and how the SRD results in differential treatment or outcomes for less advantaged individuals, groups or populations. For example, with a project examining discriminatory school disciplinary practices, documentation of different overall rates of student suspensions or expulsions by race/ethnicity would not be sufficient to label this pattern as SRD. However, different rates of student suspensions or expulsions by race/ethnicity for the same type of student behavior or violation could be evidence of SRD. Applications are also expected to provide a conceptual model identifying hypothesized pathways between the SRD and health outcomes. Potential health outcomes may reflect health status; health condition-specific or all-cause disability, quality of life, mortality and morbidity; biological measures that reflect cumulative exposures to and effects of SRD; health behaviors; or access to, utilization of, or quality of health care.

It is also expected that projects will collect data on SRD beyond individual self-reported perceptions and experiences to include data at organizational, community or societal levels. Potential data sources for SRD may include but are not limited to U.S. Census data, birth and mortality records; health surveillance data; crime statistics; traditional and social media data, school-based or educational data; labor statistics; voting records; local, state, and Federal law and policies; home ownership covenants; and organizational/institutional mission statements, policy guidance, operating procedures, or other relevant documents.

Projects are expected to involve collaborations with relevant organizations or groups or stakeholders, such as academic institutions, health service providers and systems, state and local public health agencies or other governmental agencies such as housing and transportation, criminal justice systems, school systems, patient or consumer advocacy groups, community-based organizations, and faith-based organizations. Multidisciplinary research teams, including researchers from areas outside of the health sciences, such as economics, education, history, criminology, law, and political science, are encouraged.

Research projects may focus on health promotion, prevention services, and/or treatment of chronic condition. Interventions may focus primarily on addressing SRD to improve health outcomes, or SRD may be included as one of several determinants of health addressed to improve health outcomes. For both types of intervention approaches, interventions must directly address the cause or source of SRD, not just help individuals or populations to cope with SRD. To this end, it is expected that investigators will collaborate with leadership from organizations, agencies, or programs where the SRD is originating from or being sustained (e.g., a project addressing SRD in the workplace should involve organizational leaders, human resource managers, or other relevant personnel involved in establishing, maintaining, or enforcing workplace policies and practices rather than only involving employees within a workplace). It is also expected that interventions will involve other relevant personnel or individuals within the setting (e.g., teachers, clinicians, co-workers, bystanders) as appropriate to enact changes to SRD, not just those who are directly experiencing SRD.

Research designs should allow for the assessment of mechanisms through which the intervention modifies SRD and how these changes result in improvement in the targeted health outcomes. Mechanisms of interest related to SRD include changes to behaviors, environments, or policies at the interpersonal, organizational, neighborhood/community, or societal level.

Investigators who wish to evaluate the effect of an intervention on a health-related biomedical or behavioral outcome are strongly encouraged to use appropriate intervention study designs, such as a parallel group- or cluster-randomized trial, a stepped-wedge group- or cluster randomized trial, a rigorous quasi-experimental design such as a group- or cluster-level regression discontinuity design or an interrupted time-series design, or a rigorous alternative. Intervention designs that lack comparison conditions or sites (e.g., an intervention implemented in a single clinic or neighborhood) are strongly discouraged. Whenever participants are assigned to study arms in groups or clusters (e.g., families, clinics, schools, worksites, communities, counties, states) and observations taken on individual participants are analyzed for intervention effects, special methods are required for analysis and sample size. Methods consistent with plans for assignment of participants and delivery of interventions should be documented in the application. Additional information is available at ?https://researchmethodsresources.nih.gov/. Research designs comparing interventions with and without SRD components are encouraged. It is expected that the interventions will have potential for sustainability in the intervention setting after the project is over as well as scalability to be implemented in other settings.

Applicants are strongly encouraged to assess social determinants of health using measures available in the Social Determinants of Health Collection of the PhenX Toolkit (www.phenxtoolkit.org), as appropriate.

Applications Not Responsive to the FOA

• Projects without a focus on addressing SRD toward one or more NIH-designated populations with health disparities.
• Projects that are individual-level randomized clinical trials.
• Projects that are exclusively qualitative or that only use individual-level data.
• Projects that do not examine the impact of SRD on health-related outcomes.
• Projects that propose data collection or testing of interventions outside of the U.S.
• Projects that include prohibited policy lobbying or advocacy activities (see https://grants.nih.gov/grants/lobbying_guidance.htm for more information).

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.

Specific Areas of Research Interest

NCI is committed to eliminating cancer related disparities and promoting equity in cancer prevention, diagnosis, treatment, and survivorship. For this FOA, NCI seeks intervention projects focused on addressing structural/institutional racism/discrimination (SRD) that influence cancer-related outcomes -- from early detection through end of life. Projects submitted to NCI may focus on cancer prevention, diagnosis, treatment, and/or survivorship based and provide a conceptual model identifying hypothesized pathways or mechanisms between the SRD and cancer-related outcomes. Areas of specific interest to NCI include multilevel interventions focused on addressing SRD to improve cancer outcomes, or interventions that address several determinants of health in addition to SRD.

NCI areas of interest in intervention research include, but are not limited to:

• Multi-level, multi-component interventions that address SRD as well as other determinants of health to prevent cancer, improve cancer care for patients, and/or improve cancer outcomes.
• Intervention research examining family, organization, neighborhood, cultural and community factors that may moderate SRD exposure and cancer prevention and care.
• Intervention research focusing on the prevention of cancer that incorporates risk and resilience factors in response to structural racism such as historical trauma, immigration policies, school and language-based discrimination, housing and criminal justice practices, etc.
• Research on development of cancer treatment interventions and service delivery approaches that address systemic racism and structural barriers health services such as staff training, service delivery settings and schedules, use of digital platforms, language and health literacy barriers, costs, etc.
• Mechanistic studies of the effects of discrimination-based trauma and/or chronic experiences on biological processes (e.g., epigenome, inflammation, microbiome, or other molecular/cellular processes) that contribute to poorer cancer and overall health outcomes.

NIMHD encourages projects that use approaches that encompass multiple domains (e.g., biological, behavioral, socio-cultural, environmental, physical environment, and health system) and multiple levels (e.g., individual, interpersonal, community, and societal) to address the impact of SRD on minority health and health disparities (see the NIMHD Research Framework, https://www.nimhd.nih.gov/about/overview/research-framework.html, for examples of health determinants of interest).

Areas of specific interest to NIMHD include but are not limited to the following:

• Interventions to address the impact of structural racial/ethnic, sexual and gender, and/or socioeconomic status-based discrimination in the criminal justice system (e.g., police stops, arrests, bail and pre-trial detainment and diversion, sentencing, and probation and parole practices) on the health and well-being of individuals, families, and communities.
• Interventions that address the cumulative and chronic experiences of SRD impact on biological processes (e.g., epigenome, allostatic load, inflammation, microbiome, and neurological signatures) that contribute to poor health outcomes.
• Interventions that address the impact of SRD related to social and mass media practices and policies, such as stereotyping, targeted marketing, cyberbullying and hate speech, on community/population-level health.
• Interventions to improve mental and physical health by fostering positive interactions and more inclusive social climates in schools, workplaces, and other organizations/institutions.
• Interventions that address SRD in healthcare settings across multiple domains (clinicians and staff interacting with patients, physical space, service delivery structure, financing, access, and others) in order to improve health care outcomes.
• Place-based interventions to address SRD in multiple sectors (criminal justice, education, labor, transportation, parks and recreation, housing, and others) based on community priorities and strategies.
• Multi-level, multi-component interventions that address SRD as well as other determinants of health to prevent chronic disease, unintentional injury, or violence victimization and perpetration.

NCCIH promotes research on the use of complementary and integrative health approaches for improving minority health and eliminating disparities in health conditions such as mental health, emotional well-being, behavioral health, or pain. Complementary approaches include those with physical and/or psychological therapeutic inputs, often called mind and body approaches (e.g., acupuncture, yoga, tai chi, qi gong, meditation, hypnosis, music therapy, art therapy, spinal or chiropractic manipulation, and massage) as well as approaches with dietary or nutritional therapeutic inputs, or considered natural products (e.g., botanicals, probiotics/microbials, naturally derived peptides, dietary supplements, and special diets). Integrative approaches include therapies that combine complementary approaches with conventional medical interventions such as pharmacologic, surgery, or device-based treatments. Treatment-based Intervention studies to establish efficacy of complementary and integrative approaches would NOT be accepted by NCCIH for this FOA. For these types of studies, please consider submitting to NCCIH’s clinical research funding opportunities, https://www.nccih.nih.gov/grants/funding/clinicaltrials.

Areas of interest to NCCIH include but are not limited to:

• Studies to examine the impact of SRD on access to, implementation, adherence, dissemination, and adoption of evidence-based complementary and integrative health approaches for prevention and treatment of mental health, emotional well-being, behavioral health, or pain among health disparity populations.
• Dissemination and Implementation of systemic interventions that address SRD in order to improve access to evidence-based complementary and integrative health approaches to target mental health, emotional well-being, behavioral health, or pain in diverse settings (e.g., schools, criminal justice, health care).

NEI supports research that addresses topics relevant to preventing and treating vision loss and improving quality of life through expanding opportunities for people who are blind or have low vision. Areas of specific interest include but are not limited to the following:

• Research investigating the impact of institutional or provider bias, particularly structural racism and discrimination, in the delivery of vision healthcare services
• Interventional research that incorporates resilience, community support, and other potential protective factors that may reduce or buffer the impact of structural racism and discrimination on eye and vison health outcomes
• Implementation and dissemination research on approaches to increase the uptake of evidence-based strategies addressing structural racism and discrimination encountered by people with visual impairment
• Investigations of structural factors and institutional discrimination/racism that affect immigrant populations who experience vision health disparities living in different regions of the country

The National Eye Institute will not support clinical trials that are greater than minimal risk on this funding opportunity. Minimal risk is defined as the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

NHGRI is interested in supporting interventional research that will: 1) identify effective strategies for addressing SRD at various levels of influence within and across organizations, institutions, or groups that directly and indirectly contribute to health disparities in genomic medicine; 2) assess SRD interventions that affect practice of genomic medicine and use of genomic information beyond healthcare settings with an impact health outcomes; or 3) address relationships among exposure to SRD, epigenetics, and health or wellness outcomes. NHGRI defines genomic medicine as use of genomic information in clinical care and the health outcomes associated with that clinical use at an individual, group, and population levels. NHGRI defines epigenetics as a field of study focused on changes in DNA that do not involve alterations to the underlying sequence and how certain epigenetic modifications may be passed on from one generation to the next.

Areas of specific interest include but are not limited to the following:

1. Interventions that propose regulations, policies, guidelines or protocols that prevent or discourage SRD in the use of genomic data, knowledge, and technologies within research, healthcare or societal settings.
2. Multi-component or multi-level interventions designed to eliminate SRD in the advancement and practice of genetic or genomic medicine and achieve equity in genetic or genomic health service delivery or health outcomes.
3. SRD interventions within healthcare organizations, laboratories, and public health systems to ensure equity in the availability, accessibility, comprehensiveness, and quality of genetic or genomic medicine in one or more NIH-designated populations with health disparities in the US.
4. Interventions that address structural factors contributing to racist or discriminatory bias in the design, implementation, dissemination, and translation of genomic research, especially for populations whose genetic ancestry is underrepresented in genomic research.
5. SRD interventions targeting sources of cumulative and chronic trauma, stress, or other experiences that effect epigenetic changes as well as downstream biological processes (e.g., gene expression) or biological pathways.

Applicants are encouraged to incorporate the measures from PhenX Toolkit (https://www.phenxtoolkit.org/), whenever possible.

In general, NHGRI supports studies that provide generalizable methods and knowledge that can be applied across genomics. Approaches that use a particular disease or organ system as a proof of principle, but can show that methods, outcomes and/or knowledge gained are generalizable, may be in scope for NHGRI. Approaches that are comprehensive across the genome or are generalizable across variants, tissues, diseases, or function also may be in scope for NHGRI.

Applications whose primary scientific objective is to understand a single biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention, will not be in scope for NHGRI. Applications relevant only to a particular disease or organ system should be directed to the appropriate Institute or Center.

Applicants are strongly encouraged to contact the NHGRI program directors listed below to discuss the relevance of their proposed topic(s) to the research mission of NHGRI.

NIA promotes research related to aging and life course health and well-being, including research on Alzheimer’s Disease and related dementias (AD/ADRD). A strategic priority of NIA is understanding the environmental, sociocultural, behavioral and biological drivers of health inequities and disparities related to aging and AD/ADRD. NIA also supports research to develop strategies for the improvement of health among midlife and older adults in racial minority and other populations that experience health inequities/disparities. These priorities are outlined in NIA’s strategic directions for health disparities research and the NAPA Health Disparities milestones and reflected within NIA’s Health Disparities framework.

NIA encourages investigations of the impacts of the multiple pathways of Structural Racism and Discrimination (SRD) and subsequent health consequences on individuals across the adult lifespan. NIA also encourages research that will investigate how SRD works synergistically with other mechanisms (or forms) of racism (e.g., individual or cultural racism) to influence health outcomes.

Applicants proposing to develop interventions are expected to proactively identify a theory or model that applies to the intervention proposed and the critical variables expected to result in change. Applications are required to use an appropriate experimental design to test the proposed theory, to identify the essential components of complex interventions, or to elucidate the mechanism(s) by which an intervention exerts its effects. For the development of behavioral interventions, applicants are encouraged to articulate their research aims and the stage of intervention development proposed using the NIH Stage Model framework.

NIA interests include, but are not limited to, the following:

• Research that examines the mechanisms explaining how interventions can modify health disparities and well-being outcomes at older ages due to structural racism.
• Approaches investigating how interventions could modify cumulative and chronic experiences of SRD’s impact on mechanisms related to premature aging or increased risk for AD/ADRD.
• Studies to elucidate whether and how interventions connecting structural racism to aging- relevant health outcomes, including well-being, independent function, cognition and AD/ADRD, operate on multiple levels (e.g., individual, interpersonal, societal).
• Multi-level, multi-component interventions that address SRD in healthcare settings to improve aging outcomes, prevent premature aging or AD/ADRD, and/or improve care for older adults, including those with AD/ADRD.

NIBIB supports the development and integration of advanced bioengineering, sensing, imaging, and computational technologies for the improvement of human health and medical care.

Areas of specific interest to NIBIB under this FOA include, but are not limited to, intervention research that addresses

1. the eradication of implicit bias and racism in approaches and assumptions in needs finding, specification, design and testing of biomedical technologies,
2. improving minority health, promoting health equity, and eliminating health disparities through the innovation of novel technologies or enhancement of existing technologies in biomedical imaging, bioinformatics and bioengineering.

NIBIB funding of clinical trials will be in accordance with NOT-EB-21-005 "NIBIB Guidance for Support of Clinical Trial Applications." Briefly, NIBIB will only support mission-focused (see NIBIB's program areas) early-stage clinical trial applications, i.e., feasibility, Phase I, first-in-human, safety, or other small clinical trials, that inform early-stage technology development. NIBIB will not support applications proposing pivotal, Phase II, III, IV, or trials in which the primary outcome is efficacy, effectiveness, or a post-market concern. Also, mechanistic trials are not supported unless the primary focus of the project is on technology development.

NICHD seeks applications that will address questions relevant to the NICHD mission and should align with the NICHD Strategic Plan.

NICHD is interested in interventions that involve the following populations: Infants, children, adolescents, and individuals in the transition from adolescence to adulthood; pregnant and lactating persons; individuals of reproductive age with regards to reproductive health; girls and women from pre-puberty through perimenopause with regards to research on gynecological and/or reproductive health; individuals of any age with intellectual and developmental delays and/or disabilities. NICHD is interested in intervention research regarding the impact of parents and other caretakers and/or family members exposure to SRD on health outcomes of the NICHD populations of interest. NICHD is also interested in interventional studies that use natural experiments and policy change intervention designs.

NICHD is interested in interventions that address the following health and health-related outcomes: Maternal and infant mortality and morbidity, adolescent and young adult mortality and morbidity; contraceptive use and non-use; reproductive health, gynecological health, and fertility; and, for NICHD populations of interest, access to health care and diagnosis and treatment of health problems. NICHD is interested in research on all the domains in which SRD may occur that are listed in this RFA, with particular interest in interventions implemented in educational settings; the criminal justice system, including the juvenile justice system; facilities serving individuals with intellectual disabilities; and gynecological/reproductive health settings. NICHD is also interested in interventions on SRD that affect exposure to violence among NICHD populations of interest.

The National Center for Medical Rehabilitation Research within NICHD seeks applications for intervention research on individuals with physical disabilities. Areas of interest include but are not limited to referrals for and access to health care and inpatient and outpatient rehabilitation services for both primary and secondary conditions, and outcomes related to improving functional outcomes.

NIDA is interested in supporting prevention, treatment, and health services research to address the impact of structural racism and discrimination on substance use initiation, escalation of use, substance use disorders, substance use consequences, and comorbid conditions including HIV. NIDA prioritizes research that leads to the uptake and sustainability of effective practices and programs. To ensure interventions fit well into service settings, investigators are strongly encouraged to partner with stakeholders (e.g., those who the intervention is meant to benefit and those who will implement the intervention outside of a research study) at all phases of the intervention development and research process. NIDA is interested in interventions addressing SRD within a broad range of service settings, including justice, child welfare, social services, healthcare, education, and community settings.

Some specific topics of interest are listed below, but proposals need not be limited to these topics:

• Interventions to address systemic biases affecting arrest, incarceration, probation, and post-sentencing practices with impact on substance use trajectories, HIV/HCV risk, addiction-related health outcomes, and health disparities experienced by minoritized communities.
• Interventions to address social determinants of health by promoting resiliency and confronting structural racism, with a focus on stigma, discrimination, and prejudice in the context of SUD and HIV prevention and treatment services.
• Research on the impact of strategies to mitigate or reverse structural racism affecting social and economic contexts (e.g., resource inequalities, employment and educational opportunities, personal safety, etc.) on community-level risk factors for or risk indicators of substance use onset and escalation.
• Examining the impact of impending local, state, and national policy changes designed to improve health equity to understand potential effects on substance use patterns, substance misuse, and comorbid outcomes.
• Research partnerships with state/local officials to assess the impact on substance use and related health outcomes of public policy measures that address equity within housing, education, employment, and other areas.
• Research partnerships with state/local agencies and private or public health systems to develop and test models to eliminate systemic barriers to substance use prevention services, addiction care or addiction and HIV care, particularly those rooted in racism or structural discrimination.

NIDCD encourages interventional projects that aim to better understand and address the impact of structural racism and discrimination (SRD) on minority health and health disparities as they relate to the mission areas of hearing, balance, taste, smell, voice, speech, and language across the lifespan. Areas of interest include but are not limited to applications that address the influence and mitigation of SRD on:

• the diagnosis, treatment, and re/habilitation of childhood hearing, voice, speech, and language disorders.
• the diagnosis, treatment, and rehabilitation of adults with communication disorders including but not limited to hearing loss and acquired neurologic communication disorders.
• the development and validation of culturally responsive diagnostic and treatment approaches for hearing, voice, speech, and language disorders that are tailored to the needs of culturally and linguistically diverse people.

In addition, NIDCD encourages research partnerships with community representatives and organizations, health service providers, public health agencies, and policy makers to ensure that findings can be translated into sustainable community- and system-level changes that promote health equity. NIDCD encourages innovative clinical and translational research that provides the foundation for improving accessible and affordable health care for individuals who are deaf, hard of hearing, or present with communication disorders.

NIDCR is interested in interventional research that addresses SRD, with the goal of improving minority oral health and reduce oral health disparities, is of interest through this FOA.

Areas of specific interest to NIDCR include, but are not limited to, the following:

• Examination of racial/ethnic differences in management and treatment approaches for dental, oral, and craniofacial diseases/conditions, and the role of multi-level SRD factors (e.g. policies, organization characteristics, provider unconscious/implicit bias, etc.) in contributing to these differences.
• Examination of the impact of SRD on access to and quality of care and oral health outcomes, including the role residential segregation may play.
• Examination of the role of language barriers, cultural differences between patients and dental providers, or other impacts of multi-level SRD that may prevent minority groups from seeking oral health care.
• Identification of family, organizational, neighborhood, cultural, and community protective factors that moderate the relationship between SRD exposures and oral health.
• Interventions that address SRD in settings where oral health care is delivered across multiple domains (e.g. provider-patient interactions, service delivery, access to care, etc.) to improve oral health outcomes in minority groups that experience a higher prevalence of oral disease than their counterparts.

NIDDK is committed to promoting health equity and reducing and eliminating health disparities relevant to diabetes and other endocrine and metabolic diseases; digestive diseases, nutritional disorders, and obesity; and kidney, urologic, and hematologic diseases. For this FOA, NIDDK is interested in intervention projects focused on understanding and addressing the impact of structural racism and discrimination (SRD) on patients and populations disproportionately affected by conditions that fall within the mission of NIDDK. Meaningful stakeholder engaged approaches are encouraged to improve feasibility and maximum potential for sustainability of successful interventions beyond the funded project period. NIDDK is also interested in observational studies, such as deep characterization of SRD that will inform interventional studies and evaluation of natural experiments that employ appropriate designs and methodologies necessary to strengthen causal inferences.

NIDDK will not support studies that focus solely on training health care providers or testing communication and dissemination strategies to facilitate the use of health information.

The mission of the National Institute of Environmental Health Sciences (NIEHS) is to discover how the environment affects people in order to promote healthier lives. NIEHS is interested in applications that are within scope of our 2018-2023 Strategic Plan, that meet the criteria established in this FOA, and focus on intervention research that mitigates or prevents the impacts of environmental exposures on communities due to structural racism and discrimination (SRD). Examples of environmental exposures which are considered of primary interest for NIEHS include but are not limited to: industrial chemicals or manufacturing byproducts, metals, pesticides, herbicides, air pollutants and other inhaled toxicants, particulates, or fibers, fungal, and bacterial or biologically derived toxins. Applicants are strongly encouraged to utilize community engaged research approaches that ensure equity, such as including community partners as part of the research team along with letters of support from community partners. Applications that demonstrate collaborative (i.e., community-academic partnerships) intervention approaches to address the negative health effects of SRD across multiple populations with environmental health disparities will be prioritized. NIEHS is particularly interested in intervention research on a subtype of SRD - environmental racism. For the purposes of this FOA, environmental racism includes the use of racist and discriminatory practices in determining which communities receive health-protective (i.e., green space) or health-harming infrastructure (i.e., industrial complexes). Areas of specific interest to NIEHS include, but are not limited to:

• Interventions that prevent or mitigate single or combined environmental exposures disproportionately affecting the health of one or more communities impacted by environmental racism
• Interventions that address the disproportionate health impacts of exposures due to climate change, extreme weather and natural or human caused disasters on communities affected by environmental racism
• Interventions that prevent or mitigate disproportionate exposures in the built environment (e.g., mold or lead in housing, lack of greenspace) attributed to systemic neighborhood disinvestment
• Interventions that address the role of environmental racism in occupational exposures
• Interventions that promote the resiliency of communities experiencing environmental racism

NIGMS supports basic research that increases our understanding of biological processes and lays the foundation for advances in disease diagnosis, treatment, and prevention. NIGMS' research mission is aimed at understanding the principles, mechanisms, and processes that underlie living organisms, often using research models. NIGMS does not support research that is relevant to the diseases, organ systems, stages of life, or populations within the mission areas
of other NIH Institutes and Centers. Areas of interest to NIGMS include but are not limited to studies that address:

• The impact of structural racism and discrimination (SRD) on health disparities that affect conditions related to clinical areas that NIGMS supports: sepsis (see NOT-GM-19-054), injury and critical illness, anesthesiology, clinical pharmacology, wound healing, and innate immunity and inflammation.
• The sources of bias in computational research using electronic health records and other health-related data (e.g., artificial intelligence, machine learning, and development of improved algorithms and other methodologies), and/or the development of effective strategies to reduce these disparities.
• Computational modeling to understand the sources of SRD on health disparities in infectious disease spread, and/or to develop effective strategies to reduce these disparities.
• Mechanistic studies of the effects of discrimination-based social trauma on epigenetic and other molecular or cellular processes.

NIMH is interested in applications that focus on mental health as the primary outcome. Intervention research may include mental health promotion, prevention and/or treatment Interventions. Interventions may focus primarily on addressing structural racism and discrimination to improve mental health outcomes. Consistent with NIMH’s experimental therapeutics approach, research designs should allow for the assessment of mechanisms through which the intervention modifies structural racism and discrimination and how these changes result in improvement in the targeted mental health outcomes. See the Support for Clinical Trials at NIMH web page for additional information regarding dedicated FOAs for NIMH clinical trials research support.

Areas of interest include, but are not limited to:

• Interventions to address structural racism and discrimination by cultivating positive interactions and inclusive climates in schools, workplaces and other institutions, with the goal of improving mental health.
• Interventions to improve mental health and associated comorbidities by addressing structural racism and discrimination that takes place in different institutional settings (e.g., child welfare, juvenile and criminal justice, education, housing, etc.).
• Interventions to address structural racism and discrimination at the community level, with the goal of reducing risk for mental health and associated difficulties.
• Studies to develop interventions targeting mutable factors indicative of structural racism and discrimination to reduce adverse mental health outcomes.

HIV/AIDS Research:

• Studies to identify and address the mechanisms, pathways and negative impact of structural racism, discrimination, and intersectional stigma on HIV outcomes across the prevention, care and treatment continuum.
• Studies that examine the impact of bias and discrimination on patient-provider communication, informed decision-making, and HIV care outcomes in service delivery settings.
• Research to understand the role of structural racism and discrimination on uptake of HIV testing, PrEP and other biomedical prevention strategies on individuals from high-incidence populations.
• Research to explore strengths-based approaches, mechanisms for change and opportunities for trust-building and engagement in communities that have been historically impacted by racism and discrimination and are also disproportionately impacted by HIV.
• Studies to identify societal factors that contribute to persistent discrimination, polices or laws associated with HIV vulnerabilities or resiliencies (positive outcomes) over time.
• Studies to identify ways to combat HIV misinformation and poorly delivered communication that contributes to racism, xenophobia and other discriminatory practices that negatively impact HIV outcomes.

NINR supports research that uses nursing’s holistic perspective to improve individual and population health outcomes and eliminate health inequities by bridging biomedical science and provision of healthcare services with the realities of people’s lives and living conditions (i.e., social determinants) across the clinical and community settings where nurses practice. These settings include hospitals, clinics, people’s homes, long-term care facilities, schools, workplaces, criminal justice facilities, and the community at large. NINR recognizes the importance of engaging with and responding to the experiences of individuals, households, and populations.

Areas of specific interest to NINR include but are not limited to the following topics:

• Developmental, evaluation, and implementation research concerning interventions, programs, and policies aimed at addressing structural discrimination across clinical and community settings for their health effects. Studies adopting natural experiment, and clinical trial designs are all of interest, especially those adopting a holistic perspective on individual and population health.
• Studies aimed at better understanding factors moderating negative health effects of SRD. Studies of innovative models of care including social care and trauma-informed care are encouraged.
• Research on system level interventions to reduce negative effects of implicit bias in healthcare providers on health outcomes for NIH-designated populations with health disparities.

NINR will not support studies that focus solely on training nurses or other healthcare providers to reduce SRD.

OBSSR is part of the Office of the Director of NIH and works in partnership with the 27 NIH Institutes and Centers to ensure that behavioral and social sciences research is well integrated into the NIH research enterprise. In alignment with its strategic priorities, OBSSR is interested in providing co-funding support for project(s) funded under this RFA that do one or more of the following: incorporate novel ways of assessing SRD; focus on the mechanisms through which SRD influence health outcomes; incorporate implementation science approaches; utilize innovative methods to evaluate natural experiments of existing efforts; identify protective factors and resiliency-based approaches. Note that OBSSR does not accept assignment of applications or manage awards that are funded. Please contact one of the ICs for inquiries regarding the suitability of the proposed project for the RFA and the IC’s research portfolio.

ODP is the lead office at the NIH responsible for assessing, facilitating, and stimulating research in disease prevention, and disseminating the results of this research to improve public health. In partnership with the 27 NIH Institutes and Centers, ODP strives to increase the scope, quality, dissemination, and impact of NIH-supported prevention research. The ODP is interested in providing co-funding support for intervention projects that have strong implications for disease prevention, promise for wide uptake, and that include innovative and appropriate design, measurement, and analysis methods. For this FOA, ODP is interested in multi-site or multi-community interventions that address common risk factors for death and disability among populations that experience health disparities, including tobacco use, overweight/obesity, poor diet, physical inactivity, alcohol misuse, drug misuse, risky sexual behavior, injury and violence, infectious disease, and environmental health. For additional information about ODP’s research priorities and interests, please refer to the ODP Strategic Plan for Fiscal Years 2019 2023.

Applications must be relevant to the objectives of at least one of the participating NIH Institutes and Centers (IC) listed above. ODP does not award grants. Please contact the relevant IC Scientific/Research Contact(s) listed below for questions regarding IC research priorities and funding.

The Office of Nutrition Research (ONR) develops, leads, and manages trans-NIH nutrition research initiatives in cooperation with the ICs and other NIH Offices. The ONR also coordinates implementation of the Strategic Plan for NIH Nutrition Research through Implementation Working Groups (IWGs). The ONR IWGs develop research initiatives or programs, including this NOSI, that fulfill the objectives and cross-cutting research areas outlined within the Strategic Plan. ONR is particularly interested in proposals that align with its mission of advancing nutrition science to promote health, and to reduce the burden of diet-related diseases and nutrition health disparities.

The ONR does not award grants but co-funds applications and/or research projects, therefore, applications must be relevant to the objectives of at least one of the participating NIH Institutes and Centers (IC) listed in this announcement. Please contact the relevant IC Scientific/Research Contact(s) listed for questions regarding IC research priorities and funding.

ORWH is part of the Office of the Director of NIH and works in partnership with the 27 NIH Institutes and Centers to ensure that women's health research is part of the scientific framework at the NIH and is supported in the larger scientific community. Research in recent decades has adopted an intersectionality framework to study and explain the complex nature of inequality. Integrating the purposeful accounting of sex as a biological variable (SABV) and gender as a social variable, alongside race and social class considerations in biomedical research, will enhance understanding of the effects of discrimination and its magnitude on mental and physical health (i.e., impacts on maternal morbidity and mortality or multimorbidities among groups of women). ORWH is interested in providing support for interdisciplinary, behavioral, clinical, and/or translational studies incorporating intersectional analyses into studies of racism and discrimination exposure among populations experiencing health disparities, including groups of women who are understudied, underrepresented, and underreported in research. For additional guidance, please refer to the 2019-2023 Trans-NIH Strategic Plan for the Health of Women on the ORWH website (https://www.nih.gov/women/strategicplan).

SGMRO resides in the NIH Office of the Director and coordinates research and activities related to the health of sexual and gender minorities (SGM; see NOT-OD-19-139 for more information) by working directly with the agency’s Institutes, Centers, and Offices. A robust and growing body of evidence demonstrates that SGM individuals often face institutional discrimination and poorer health outcomes than their non-SGM peers. SGM persons with intersecting identities, including those based on race, ethnicity, and/or other statuses highlighted in this FOA, may face distinct and exacerbated health issues and inequities, and structural racism and discrimination may act as key drivers, modifiers, and intensifiers of the health-related concerns and challenges of these individuals. SGMRO is interested in social, behavioral, clinical, translational, and health services research to investigate how structural racism and discrimination adversely affect the lives and well-being of the most vulnerable SGM communities and to develop sustainable long-term interventions and strategies to attend to these pressing issues. Please note that SGMRO is only able to co-fund applications that are administered by one of the participating Institutes or Centers listed on this funding opportunity.

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

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

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 FOA.

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

• 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 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.

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.

• 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 his/her 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.

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, per 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 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 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

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity
  

The letter of intent should be sent to:

Crystal L. Barksdale, PhD, MPH
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-827-4228
Email: [email protected]

Page Limitations

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

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.

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

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:

Research Strategy: Identify the health disparity populations that will be the focus of the project and describe the documented health disparity that will be studied. Provide a justification for how the specific types of SRD to be studied constitute SRD. Provide a conceptual model that describes hypothesized causal pathways between SRD and health outcomes. Describe data sources that will be used to document SRD. Provide a data analytic plan that specifies how multi-level factors, intervention effects and interactions, or outcomes will be handled, as appropriate. Describe and specify the roles of collaborators. Describe how the intervention will directly address the cause or source of SRD. Specify how organizations, agencies, or programs where the SRD is originating from or being sustained will be involved in the project, including involvement of leadership from these organizations as well as other individuals or groups. Describe the potential of the intervention to be sustainable in the intervention settings after the project is over and scalable to other settings.

Other Plan(s):

Note: Effective for due dates on or after January 25, 2023, the Data Management and Sharing Plan will be attached in the Other Plan(s) attachment in FORMS-H application forms packages.

All instructions in the SF424 (R&R) 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 SF424 (R&R) 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 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 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 FOA 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 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.

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.

Note: Effective for due dates on or after January 25, 2023, the Data Sharing Plan and Genomic Data Sharing Plan (GDS) will not be evaluated at time of review.

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.

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).

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.

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.

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

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the 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. 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.
• Representation of health disparity populations and/or types of SRD addressed.

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.

Recipients must comply with any funding restrictions described in Section IV.6. 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 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

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, including of note, but not limited to:

• Federal wide Research Terms and Conditions
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

If a recipient is successful and receives a Notice of Award, 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.

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS will be required to complete an HHS Assurance of Compliance form (HHS 690) in which the recipient agrees, as a term and condition of receiving the grant, to administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, age, sex and disability, and agreeing to comply with federal conscience laws, where applicable. This includes ensuring that entities take meaningful steps to provide meaningful access to persons with limited English proficiency; and ensuring effective communication with persons with disabilities. Where applicable, Title XI and Section 1557 prohibit discrimination on the basis of sexual orientation, and gender identity. 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 https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/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.

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.htmlandhttps://www.lep.gov.

• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html.

• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.

• For guidance on administering programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

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 and 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.

Not Applicable

3. Data Management and Sharing

Note: The NIH Policy for Data Management and Sharing is effective for due dates on or after January 25, 2023.

Consistent with the 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.

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. NIH FOAs 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 45 CFR Part 75.301 and 2 CFR Part 200.301.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later. All recipients 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 the threshold. 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 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, 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 and 2 CFR Part 200 Award Term and Condition 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.

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]

Crystal L. Barksdale, PhD, MPH
National Institute on Minority Health and Health Disparities (NIMHD)
Phone: 301-827-4228
Email: [email protected]

Roberto Flores, PhD, MPH
Office of Nutrition Research (ONR)
Phone: 240-276-7119
Email: [email protected]

Shannon E. Nicks, PhD, MPH
National Institute on Drug Abuse (NIDA)
Phone: 301-451-8754
Email: [email protected]

Hiroko Iida, DDS, MPH
National Institute of Dental and Craniofacial Research (NIDCR)
Phone: 301-594-7404
Email: [email protected]

Jennifer Alvidrez, PhD
Office of Disease Prevention (ODP)
Phone: 301-827-0071
Email: [email protected]

Zeynep Erim
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Phone: (301) 451-4792
Email: [email protected]

Damiya Eve Whitaker, PsyD, MA
Office of Research on Women's Health (ORWH)
Phone:301-451-8206
Email: [email protected]

Cheri Wiggs
National Eye Institute (NEI)
Phone: (301) 402-0276
Email: [email protected]

Juanita J. Chinn, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Phone: 301-827-4901
Email: [email protected]

Della White
National Institute of General Medical Sciences (NIGMS)
Email: [email protected]

Kelly Anne King, Au.D., PhD
National Institute on Deafness and Other Communication Disorders (NIDCD)
Phone: 301-402-3458
Email: [email protected]

Christopher Barnhart, PhD
Sexual & Gender Minority Research Office (SGMRO)
Phone: 301-594-8983
Email: [email protected]

Beda Jean-Francois, PhD
National Center for Complementary & Integrative Health (NCCIH)
Phone: 202-313-2144
Email: [email protected]

Alexander M. Talkovsky, PhD
National Institute of Mental Health (NIMH) Division of Translational Research
Phone: 301-827-7614
Email: [email protected]

Mary Rooney, PhD
National Institute of Mental Health (NIMH) Division of Services and Intervention Research
Email: [email protected]

Frank Bandiera, PhD
National Institute on Aging (NIA)
Division of Behavioral and Social Research (DBSR)
Phone: 301-496-3131
Email: [email protected]

Damali Martin, PhD
National Institute on Aging (NIA)
Division of Neuroscience (DN)
Phone: 301402-8310
Email: [email protected]

Rene Sterling
National Human Genome Research Institute (NHGRI)
Phone: 301.435.1275
Email: [email protected]

Ebony B Madden
National Human Genome Research Institute (NHGRI)
Phone: 301-503-5620
Email: [email protected]

Lindsey Ann Martin, PhD
National Institute of Environmental Health Sciences (NIEHS)
Phone: 984-287-4036
Email: [email protected]

Shalanda A. Bynum, PhD, MPH
National Institute of Nursing Research (NINR)
Phone: 301-755-4355
Email: [email protected]

Robert C Rivers
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Phone: 301-443-8415
Email: [email protected]

April Oh, PhD, MPH
National Cancer Institute (NCI)
Phone: 240-753-3154
Email: [email protected]

Center for Scientific Review (CSR)

Email: [email protected]

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

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

Diana Rutberg, MBA
National Institute of Dental and Craniofacial Research (NIDCR)
Telephone: 301-594-4798
Email: [email protected]

Katie Ellis
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Phone: 301-451-4791
Email: [email protected]

Karen Robinsonsmith
National Eye Institute (NEI)
Phone: (301) 451-2020
Email: [email protected]

Margaret Young
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-642-4552
Email: [email protected]

Kelly Aubrecht
National Institute of General Medical Sciences (NIGMS)
Email: [email protected]

Samantha Tempchin
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-435-1404
Email: [email protected]

Debbie Chen
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-594-3788
Email: [email protected]

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

Ryan Blakeney
National Institute on Aging (NIA)
Phone: 301-451-9802
Email: [email protected]

Jenny L Greer
National Institute of Environmental Health Sciences (NIEHS)
Phone: 984.287.3332
Email: [email protected]

Kelli Oster
National Institute of Nursing Research (NINR)
Telephone: 301-594-2177
Email: [email protected]

Tommy Gunter
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Phone: 301-451-3447
Email: [email protected]

Crystal Wolfrey
National Cancer Institute (NCI)
Phone: 240-276-6277
E-mail: [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 45 CFR Part 75 and 2 CFR Part 200.