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.

No late applications will be accepted for this Notice of Funding Opportunity (NOFO).

It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed to do otherwise (in this NOFO or in a Notice from the NIH Guide for Grants and Contracts). Conformance to all requirements (both in the How to Apply - Application Guide and the NOFO) is required and strictly enforced. Applicants must read and follow all application instructions in the How to Apply - Application Guide as well as any program-specific instructions noted in Section IV. When the program-specific instructions deviate from those in the How to Apply - 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.
   
   



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:

Definitions:

• Environmental justice research: Seeks to document and address the disproportionate environmental burdens and benefits associated with social inequalities.

The purpose of this Notice of Funding Opportunity Announcement (NOFO) is to support the Environmental Health Disparities Centers program (referred to as the EHD Centers) initiated at NIMHD in 2011. The EHD Centers will conduct multidisciplinary environmental health disparities and environmental justice research, engage in research capacity building, lead community-engaged research activities, and support early career development with a disease agnostic focus. A recent environmental justice executive order (https://www.federalregister.gov/documents/2023/04/26/2023-08955/revitalizing-our-nations-commitment-to-environmental-justice-for-all#p-121) calls for the just treatment and meaningful involvement of all people in agency decision-making and activities affecting human health and the environment to provide equitable access to a healthy environment. This initiative will stimulate basic and applied research within the EHD Centers program to generate innovative approaches to alleviating environmental health disparities through environmental justice research. Examining environmental factors within the context of social determinants of health (SDOH) is important as these are the most amenable to prevention and intervention strategies for reducing health disparities. NIH has defined SDOH as the conditions in which people are born, grow, learn, work, play, live, and age, and the wider set of structural factors shaping the conditions of daily life (see: https://www.ninr.nih.gov/research/nih-sdohrcc#tabs2). Structural SDOH, as well as individual demographic and social factors, play a key role in creating and sustaining health disparities within the U.S. and occur across multiple levels of influence (e.g., individual, community) across the life course. SDOH may interact with other determinants of health, such as biological, psychological, behavioral, chemical, and other environmental factors to further promote or compromise health.

Health equity research accounts for and addresses SDOH among populations who are disproportionately experiencing health disparities. NIMHD research priorities focus on populations experiencing health disparities (defined here: https://www.nimhd.nih.gov/resources/understanding-health-disparities/minority-health-and-health-disparities-definitions.html) with a specific focus on racial and ethnic minority and socioeconomically disadvantaged populations in general, and especially for persons with disabilities, sexual and gender minorities, and persons from rural and/or under resourced areas within the US and its territories. Populations experiencing health disparities endure higher levels of stress and cumulative exposures to adverse social factors, (e.g., poverty, low quality education, food insecurity, discrimination, redlining, in addition to physical, biological, and chemical environmental exposures (e.g., microplastics in food and water supplies, extreme heat, air and water pollution). These factors, many of which may be experienced in early life, may have consequences for health across the life course. Yet, access to positive effects of the natural and built environment (e.g., green space, clean water, fresh food, and opportunities for physical activity) and policies buffering against hazardous environmental exposures are often disproportionately lower in these communities where persons with health disparities live. Climate change has exacerbated these issues in populations experiencing health disparities thus increasing their risk of poor health outcomes. Indigenous Knowledges – the evolving knowledge acquired by Indigenous and local peoples over time through their identity with the land and direct contact with the environment and shared through oral tradition and cultural expressions – is often overlooked and excluded within research on environmental health. More environmental justice research is needed to achieve health equity among these disproportionately affected populations.

Research Objectives

This funding opportunity is intended to focus on environmental health disparities and environmental justice research for populations and communities experiencing health disparities. Funding will support centers to conduct multidisciplinary research that builds research capacity, generates innovative approaches to mitigate detrimental environmental exposures and improves access to healthy and sustainable environments. The initiative invites new and renewal applications that will prioritize local intervention research which engages communities and resource limited institutions through equitable partnerships to identify strategies and determine appropriate methods to address environmental health disparities. Consideration of different frameworks such as the NIMHD research framework (see: https://www.nimhd.nih.gov/about/overview/research-framework/nimhd-framework.html) and the NIEHS translational research framework (see: https://www.niehs.nih.gov/research/programs/translational/framework-details) will facilitate the identification of multilevel and multidomain studies to mitigate environmental health disparities and inform translation of research into practice. Applicants should address the disproportionate environmental burdens and upstream SDOH associated with environmental health inequities through multidisciplinary and multilevel research within the US and its territories.

NIH has long supported a broad research portfolio addressing inequities related to environmental exposures and their impacts on health. Despite these efforts, more transformative intervention research is needed across the NIH to address disproportionate impacts and improve the health and well-being of all affected communities. Although climate change can affect environmental health disparities, this initiative will not explicitly focus on climate change and health. Applications focused on climate change and health without a strong focus on environmental justice and environmental health disparities in populations experiencing health disparities will not be considered responsive and should consider funding opportunities through the NIH Climate Change and Health Initiative: https://www.nih.gov/climateandhealth.

Required Components:

Each EHD center application must include the following components:

• Administrative Core
• Investigator Development Core
• Community Engagement and Dissemination Core
• Research Project(s)

Administrative Core

The Administrative Core (AC) will provide oversight and monitor progress for the center's research and pilot projects. The core must be directed by the center’s PD(s)/PI(s), who are expected to engage with leadership at their institution to facilitate the success of the center and collaborators. The core is expected to foster synergy between the other cores’ research and pilot projects and other activities through the development of shared resources, tools, common data elements, and/or analytic strategies. The core’s responsibilities are as follows: ensure that component plans are implemented per proposed timelines, submit annual progress reports to the NIH, monitor progress on research and pilot projects, and ensure that all center activities comply with Federal policies and regulations. Additionally, the AC will establish and maintain a publicly accessible website. Website content will be updated at least annually to include publications, and reader-friendly summaries of research projects' progress, results, and impact on participant communities. Through the efforts of the AC, the center is expected to become an institution-wide resource for increasing capacity to conduct environmental health disparities and environmental justice research.

Investigator Development Core

The main objectives of the Investigator Development Core (IDC) are to 1) train early career investigators, to conduct research examining and addressing environmental health disparities through an environmental justice lens and 2) build research capacity at institutions working directly with communities experiencing environmental health disparities. All applicants must propose a pilot project program supporting small-scale, innovative research projects. Pilot project programs will provide up to $50,000 in direct costs per a project each year for a minimum of 3 projects annually (typically beginning in Year 2). Pilot projects may last up to 2 years. Pilot project awardees must be early career investigators, junior career faculty, or postdoctoral fellows who are early-stage investigators as defined by NIH (more info on early stage investigator status: https://grants.nih.gov/policy/early-stage/index.htm). IDC personnel are expected to support the pilot project awardees through training and mentorship to ensure successful completion of projects, dissemination of results, and subsequent grant proposals and submissions. The pilot projects should aim to produce preliminary data to address environmental health disparities and lead to scalable multidisciplinary research using multilevel, multidomain approaches. Grantees are encouraged to collaborate with the Community Engagement and Dissemination Core in the development of pilot projects to ensure a community-informed, environmental justice lens. The IDC will also develop infrastructure and build capacity to establish or expand consortium partnerships with other biomedical and behavioral institutions (designated or otherwise; see Section III.1, Eligible Applicants, below) that conduct environmental justice and health disparities research, including NIH resource limited institutions. The IDC may also support other types of activities, including, but not limited to, internal workshops, boot camps, conferences, seminars, brownbag series, and working groups, that support professional development leading to successful grant applications, mentoring during research activities, and dissemination of results via publications and conference presentations.

Community Engagement and Dissemination Core

The goal of the Community Engagement and Dissemination Core (CEDC) is to establish and sustain equitable and collaborative partnerships with communities experiencing environmental health disparities. Community partnerships are crucial for developing feasible and acceptable approaches to address longstanding and pervasive environmental health disparities. The overall goal of these partnerships is to promote health equity through bi-directional communication of community concerns with center leadership and facilitate the uptake and translation of knowledge gained through the research projects. Each center is required to have a community advisory board, comprised of local community members and other strategic partners, that meets every 6 months (at minimum) to provide feedback on and inform center activities. Community members may include but are not limited to clinicians, health systems, state and local public health agencies, school systems, community-based organizations, and faith-based organizations and are encouraged to be active members of center research teams. CEDC activities should be conducted with cultural humility and leverage local strengths, knowledge, and resiliency to advance scientific knowledge, inform interventions that address environmental health disparities, and contribute to improved public health. Examples of CEDC activities include but are not limited to 1) translating research findings to benefit community partners and inform improved diagnosis, health care, intervention, and prevention strategies. 2) training community members and academics in community engaged participatory research methods. 3) developing and implementing strategies to improve the environmental health literacy of the local community, academics, policymakers, and healthcare/public health professionals. 4) conducting partner-led evaluation of core activities and their contributions to the overall mission of the center. The CEDC will be responsible for disseminating the center activities to community members, partner organizations, relevant service organizations, policymakers, healthcare/public health professionals and the public. Broader dissemination efforts include but are not limited to 1) local presentations of pilot and center research projects. 2) strategic planning to translate research findings into sustainable community and system-level changes. 3) regular meetings to highlight, share, and prioritize center responses to community-identified environmental health concerns. Final materials developed by the CEDC must be uploaded to the NIEHS Partnerships for Environmental Public Health (PEPH) Resource Center: https://connect.niehs.nih.gov/peph/ to facilitate translation and communication of environmental health research to other community-university teams.

Research Projects

Research Project(s) should address research questions relevant to reducing environmental health disparities and promoting environmental justice. One to two research projects may be proposed and may vary in scale and scope, yet all research projects combined should total no more than $550,000 in annual direct costs annually for five years. Research projects may be observational studies, exploratory/developmental projects, interventions, or clinical trials: https://grants.nih.gov/policy/clinical-trials/definition.htm, and are encouraged to use a multidisciplinary, multilevel, multidomain approach and framework (see the NIMHD Research Framework) and include a focus on one or more population(s) experiencing environmental health disparities. All projects should address health outcomes associated with significant morbidity and mortality among the population(s) of interest. The scope of proposed research projects may be full-scale studies or exploratory/developmental projects. 

If more than one research project is proposed, one project must be an intervention research study. If non-intervention studies are proposed, applicants are encouraged to provide baseline measures of exposures and a plan of how project results will inform future interventions. For intervention research projects, studies are expected to partner with communities to strategize on how to address, mitigate, reduce, or alleviate environmental health disparities as well as promote uptake and sustainability. Use of implementation science frameworks and methods is strongly encouraged to support the adoption, integration, uptake, scale-up, and sustainability of the projects. Studies can take many forms depending on the population of interest and environmental health disparity being addressed. Possible study designs include but are not limited to development and testing of an environmental justice intervention, implementation and/or dissemination strategies for evidence-based/informed interventions, evaluation of policies and/or programs, and local/system level environmental changes to address environmental health disparities. More on the application of implementation science to environmental health can be found on the NIEHS Advancing Environmental Health Equity through Implementation Science workshop website: https://www.niehs.nih.gov/news/events/pastmtg/2022/eheworkshop2022. Studies are encouraged to leverage existing data sets and NIH and Federal resources (e.g., diverse cohort studies, the Environmental Influences on Child Health Outcomes (ECHO) Program Study, PhenX SDOH toolkit: https://www.nimhd.nih.gov/resources/phenx/; Environmental Justice Screen: https://www.epa.gov/ejscreen), when possible. Use of common data elements such as PhenX SDOH allows the centers to aggregate data across participant communities and populations and link their research data with external sources.

Community partnerships are essential for developing feasible and acceptable approaches to address longstanding and pervasive environmental health issues leading to poorer health outcomes. Proposed studies should build the capacity of community partners and include them as active members of research teams. Community partners should be essential partners with research projects, provide insight into local issues and leverage local resources in the development of research questions and the translation of scientific findings into locally appropriate language(s) and effective delivery formats. Expected research outcomes should translate into tangible environmental justice focused action such as but not limited to increasing awareness of environmental exposures, environmental justice education for health care providers, environmental exposure prevention measures, and/or mitigation strategies to reduce environmental exposures.

Research projects are encouraged to include early career researchers. The research team may include senior and junior faculty, pre- and post-doctoral and other trainees, and community members, all with appropriate justification.

Applicants can leverage the ECHO Program de-identified public-use Cohort data on NICHD’s Data and Specimen Hub (DASH) at https://dash.nichd.nih.gov/study/424643. ECHO’s mission is to enhance the health of children for generations to come, and its goal is to understand the effects of a broad range of early environmental influences on child health and development. ECHO data provides information on 63,215 ECHO Cohort participants with wide geographic, socioeconomic, racial, and ethnic diversity. The data include an array of information about demographics, pregnancy and birth data, and for the child and during pregnancy, child strengths and difficulties questionnaire, perceived stress scale, caregiver general cognition, child blood pressure, early childhood education, gender identity, public assistance, environmental exposures—including data about household chemicals—and bioassay results regarding chemicals such as flame retardants, metals and metalloids, tobacco metabolites, fungicides and herbicides, and other analytes.

Applicants are encouraged to partner with other funded EHD centers and leverage NIH investments aligned with this topic.

Applicants are expected to provide a center-based evaluation plan that includes expected inputs, outputs, outcomes, and impacts for the center’s work. The NIEHS PEPH Evaluation Metrics Manual, https://www.niehs.nih.gov/research/supported/translational/peph/metrics, can serve  as a resource for applicants in developing and implementing an evaluation plan for environmental health disparities projects. Applicants are encouraged to include evaluation scientific expertise on the study team.

All data collected is required to be shared per the NIH Data Management and Sharing Policy: https://sharing.nih.gov/data-management-and-sharing-policy.

Specific Areas of Research Interest

Specific research topics may include but are not limited to the following among populations experiencing health disparities:

• Develop models to evaluate the interaction or cumulative impacts of various environmental exposures (chemical, physical, and/or biological stressors) with different SDOH on health outcomes.
• Examine drivers for differential exposures (including the social, built, and physical environment) to better understand how environmental contributions disproportionately impact health among populations with multiple marginalized statuses (e.g., immigrants living in rural areas, persons who are racial and ethnic minorities that are also unhoused).
• Develop implementation research with community partners to create and test strategies to promote the adoption, integration, uptake, scale-up, and spread of evidence-based/informed interventions for reducing or preventing harmful environmental exposures.
• Test multilevel EHD interventions incorporating Indigenous Knowledges to promote American Indian/Alaskan Native, Native Hawaiian and Pacific Islander well-being, resilience, and connection to lands and waters.
• Develop and test environmental justice focused interventions addressing upstream SDOH among immigrant communities.
• Develop and test models which bolster health through understanding community strengths, environmental exposures, resiliency, and chronic disease risks to help communities recover from extreme weather events or heat exposure due to climate change.
• Implement structural interventions to prevent and address long-term environmental health disparities and factors related to maternal and child health disparities across the life course and across generations.
• Develop systems level (e.g., healthcare, workplace, or school) and policy interventions to address place-based disparities in communities disproportionately affected by environmental exposures exacerbated by climate change.
• Examine the impacts of resource extraction (e.g., unconventional oil and gas development, hydraulic fracking, logging, mining) on water or air quality exposures leading to health disparities among populations such as local Tribal and low-income, rural communities.
• Examine environmental exposures through use of personal care or cleaning products and their effects on maternal, child, and reproductive health and cancer outcomes.
• Test strategies to improve mental health symptoms, reduce anxiety and depression, and/or support management of substance use disorders within communities experiencing adverse environmental exposures while considering environmental factors and SDOH.
• Develop and test strategies to reduce pesticide and/or other adverse environmental exposures and their health impacts among workers or communities who are disproportionately exposed such as farmworkers, veterans, first responders, skilled laborers, the rural poor, and children and families.
• Examine the impacts of industrial agricultural activity on water or air quality exposures leading to health disparities among populations such as rural communities and farmworkers.
• Implement qualitative and mixed methods approaches (e.g., historical, ethnographic, and case studies) to identify, describe, and measure community strengths, resilience, place-based stressors, trust/distrust with scientific information sources, and local knowledge on health outcomes.
• Integrate geographic information systems (GIS) technologies with environmental, demographic, and population data to more accurately identify communities who are disproportionately exposed to environmental exposures and experience adverse SDOH and health outcomes.
• Investigate how environmental exposures and SDOH may lead to accelerated aging and increased risk for chronic disease(s) such as cancer across the life course.

National Institute on Aging (NIA)

NIA is interested in understanding the behavioral, biological, chemical, genomic and environmental (GxE), socioecological and toxicological processes related to environmental factors and exposures over the life course that affect the health and wellbeing of older individuals, including those living with Alzheimer’s Disease and Alzheimer’s Disease Related Dementias (AD/ADRD), as examined in human and/or animal models. Applicants are encouraged to consider innovative methods and research designs to facilitate studies examining environmental health disparities within groups (e.g., racial/ethnic) as well as between groups, recognizing that both between and within-group heterogeneity in individuals’ access to resources and their lived experiences impact their health and wellbeing. This includes exposures that impact susceptibility and/or resilience to AD/ADRD and their precursors (e.g. mild cognitive impairment, etc.). Applicants should reference the NIA Health Disparities Research Framework and the NIH Stage Model for Behavioral Intervention Development. Research topics of interest include, but are not limited to:

• Effects of environmental factors or changing environmental hazards on the health of midlife and older adults, including those from different racial, ethnic, and sexual and gender minority groups, those living with disabilities, and those from socially disadvantaged backgrounds. Environmental hazards can include particulate matter and heightened amounts of air pollutants (including ultrafine particles); endocrine disrupters; volatile organic chemicals (VOCs) and other emerging contaminants arising from personal care products; industrial manufacturing; automotive traffic; changes in pesticide or herbicide application practices; other agricultural practices; excessive indoor and outdoor temperature extremes; disasters including wildfires and other extreme events.
• Effects of environmental exposures or changing environmental hazards on health and/or well-being, rate of aging, and aging-related physiological processes, and functional abilities in humans or other animal models across the life span. Physiological processes may include immune function, metabolism, circadian rhythms, etc. Other animal models may include domestic, captive, or wild populations.
• Effects of environmental factors or changing environmental hazards on midlife and older adults’ management of health conditions (e.g., diabetes, cholesterol, weight management, various types of arthritis, etc.), comorbidities, or cognitive decline and resilience to these outcomes.
• Effects of environmental factors or changing environmental hazards on midlife and older adults’ emotional, social, and financial well-being that may be affected by changes in the social, natural, and built environment.
• The contribution of environmental factors or changing environmental hazards to social structure and social adversity, and their effects on aging processes across the life course, in studies of humans and/or animal models.
• Interactions or additive effects of environmental exposures or changing environmental hazards on molecular, cellular, toxicologic, and physiological perturbations that impact health and/or well-being across the lifespan.
• Interactions or additive effects of environmental exposures or changing environmental hazards on affective, social, behavioral, and cognitive functions (including brain health) over the life course.
• Evidence-based health policies that can help prevent illness, or those that can help promote and sustain adopting preventive measures to mitigate overall rates of mortality or morbidity that are associated with, or caused by, environmental hazards.
• Interventions to facilitate disaster preparedness, foster resilience, or otherwise mitigate the effects of environmental hazards on the health and wellbeing of midlife and older adults, people living with dementia, and the individuals or communities who care for them.
• Interventions to improve access to healthy and sustainable environments for midlife and older adults, people living with dementia, and their caregivers.

Proposed centers are strongly encouraged to collaborate with existing NIA-supported research infrastructure, including the Research Coordinating Center on the Exposome and Alzheimer's Disease (AD) and AD-Related Dementias (ADRD); and the studies funded under the following initiatives: 1) Understanding Gene-Environment Interactions in Brain Aging and Alzheimer’s Disease (AD) and AD-Related Dementias (ADRD) (RFA-AG-24-021); 2) Quantifying the Impact of Environmental Toxicants on Alzheimer’s Disease (AD) and AD-Related Dementias (ADRD) Risk in Cohort Studies (RFA-AG-24-022); and 3) Quantifying the Impact of Environmental Toxicants on Alzheimer’s Disease (AD) and AD-Related Dementias (ADRD) Risk in Cohort Studies (RFA-AG-24-023).

Research projects are strongly encouraged to make use of NIA longitudinal studies and their resources, including the US Health and Retirement Study (HRS), the International Family of HRS studies, the Harmonized Cognitive Assessment Protocol (HCAP) available in the HRS and several international studies to measure cognitive outcomes to examine between- and within-group health disparities, and the Alzheimer’s Disease Research Centers (ADRCs) cohorts. Additionally, proposals are strongly encouraged to utilize NIA-funded repositories and knowledge portals such as the AD Knowledge Portal and the National Institute on Aging Genetics of Alzheimer’s Disease Data Storage (NIAGADS). Additional NIA-funded data sharing resources can be found here.

Resources for Applicants:

NIH Stage Model for Behavioral Intervention Development

Data Resources for Behavioral and Social Research on Aging

Data Sharing Resources for Researchers

National Cancer Institute (NCI)

NCI seeks to support an EHD Center with a research focus on cumulative risk of environmental exposures (chemical, physical, biological, and social factors) on cancer, stimulating multilevel and/or multidomain SDOH intervention research on environmental exposures and cancer, research to investigate structural and/or environmental racism as a contributor to cancer risk, how climate-related issues impact communities facing environmental justice concerns, and research to improve Indigenous Knowledge. The NCI-awarded EHD Center would enable capacity building, training of early-stage investigators, and infrastructure support to advance pilot and research projects that are scalable and allow for collaboration with communities. In particular, community-engaged approaches that expand partnerships (e.g. cancer coalitions) to develop strategies that could lead to actionable changes and be translated to bring about community and system change for cancer control and prevention are of interest.

NCI’s scientific interests include, but are not limited to:

• Research to understand the impact of the social determinants of health and environmental exposures (physical environment, chemical environment, social environment, and personal (lifestyle) environment), and their interrelationship as contributors and mediators of cancer disparities in communities facing environmental justice concerns.
• Intervention research that will address multi-level and/or multi-domain social determinants of health (e.g., neighborhood and built environment and social and community contexts) and its interaction with environmental exposures to promote cancer control and prevention.
• Research on the disproportionate burden of environmental exposures by investigating the root causes of health disparities in these communities including the role of structural racism and the built environment (e.g., discriminatory housing policies, housing quality, neighborhood disinvestment).
• Research to understand how climate-related issues impact exposure to air pollutants and the health response to air pollution, and current and potential co-exposure to additional chemical and non-chemical stressors.
• Community-engaged approaches and collaborations with inclusion of multigenerational Indigenous Knowledge to understand tribal exposure pathways, higher toxic burdens, and observe and learn from their traditional approaches to protect the environment (e.g., how Tribes use natural resources for food, medicine, recreation, traditions, and cultural practices). 

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

NICHD has specific interests in research that align with the NICHD mission to lead research and training to understand human development, improve reproductive health, enhance the lives of children and adolescents, and optimize abilities for all and within the scope of the NICHD Strategic Plan 2020 (https://www.nichd.nih.gov/about/org/strategicplan).  

National Institute of Nursing Research (NINR)

NINR seeks to support an EHD Center with a focus aligned with our mission and strategic priorities (see: https://www.ninr.nih.gov/aboutninr/ninr-mission-and-strategic-plan) and welcomes applications from eligible PDs/PIs from any discipline. NINR discovers solutions to health challenges through the lenses of health equity, social determinants of health, population and community health, prevention and health promotion, and systems and models of care. Drawing on the strengths of nursing’s holistic, contextualized perspective, core values, and broad reach, NINR funds multilevel and cross-sectoral research that examines the factors that impact health across the many settings in which nurses practice, including homes, schools, workplaces, clinics, justice settings, and the community.

Applications will not be considered as responsive to this RFA if they:

• Include animal models
• Focus on environmental health disparities outside the U.S. and its territories
• Do not focus on NIH-designated populations experiencing health disparities
• Do not propose the required cores and at least one research project
• Do not propose one intervention study if more than one research project is proposed
• Focus solely on climate change and health

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.

Technical Assistance Webinar

NIMHD will conduct a Pre-Application Technical Assistance webinar for prospective applicants on October 22, 2024 11:30am -12:30pm EST. Attendees must register in advance. Registration link: https://nih.zoomgov.com/meeting/register/vJItd-ivqzgrG6euxRq8A0Kmo0WL0-lAn90. Prospective applicants are encouraged to send questions, preferably at least 24 hours prior to the webinar, to the Scientific/Research Contact, Dr. Deborah Linares, [email protected]. A recording of the webinar will be posted on the NIMHD website at www.nimhd.nih.gov.

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 Organization) 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 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 registration; 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 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- Definitions 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 or an institutional system-to-system solution. A button to apply using ASSIST is available in Part 1 of this NOFO. See the administrative office for instructions if planning to use an institutional system-to-system solution.

2. Content and Form of Application Submission

It is critical that applicants follow the Multi-Project (M) Instructions in the How to Apply - Application Guide, except where instructed in this notice of funding opportunity to do otherwise and where instructions in the How to Apply - Application Guide are directly related to the Grants.gov downloadable forms currently used with most NIH opportunities. Conformance to the requirements in the How to Apply - 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:

Dr. Yuijing Liu
Telephone: 301.827.7815
Email: [email protected]

Page Limitations

All page limitations described in the How to Apply- Application Guide and the Table of Page Limits must be followed.

Instructions for the Submission of Multi-Component Applications

The following section supplements the instructions found in How to Apply- Application Guide and should be used for preparing a multi-component application.

Overall Component

When preparing the application, use Component Type ‘Overall’.

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

SF424(R&R) Cover (Overall)

Complete entire form.

PHS 398 Cover Page Supplement (Overall)

Note: Human Embryonic Stem Cell lines from other components should be repeated in cell line table in Overall component.

Research & Related Other Project Information (Overall)

Follow standard instructions.

Project/Performance Site Locations (Overall)

Enter primary site only.

A summary of Project/Performance Sites in the Overall section of the assembled application image in eRA Commons compiled from data collected in the other components will be generated upon submission.

Research and Related Senior/Key Person Profile (Overall)

Include only the Project Director/Principal Investigator (PD/PI) and any multi-PDs/PIs (if applicable to this NOFO) for the entire application.

A summary of Senior/Key Persons followed by their Biographical Sketches in the Overall section of the assembled application image in eRA Commons will be generated upon submission.

Budget (Overall)

The only budget information included in the Overall component is the Estimated Project Funding section of the SF424 (R&R) Cover.

A budget summary in the Overall section of the assembled application image in eRA Commons compiled from detailed budget data collected in the other components will be generated upon submission.

PHS 398 Research Plan (Overall)

Introduction to Application: For Resubmission and Revision applications, an Introduction to Application is required in the Overall component.

Specific Aims: Describe the specific aims for the project as a whole and how the proposed activities will have a measurable impact on understanding and reducing one or more environmental health disparities and promote environmental justice.

Research Strategy: Provide an overview of the proposed center with scientific focus on environmental health disparities and environmental justice, including major goals and objectives, community partners to be engaged, the type of research to be conducted, disciplines involved, and disease/conditions, risk factors, or determinants under study.

Summarize the design, structure, and governance of the center, the features and functions of the proposed cores and how they interact and synergize with each other and with the proposed research projects, and plans and procedures to monitor and assess progress of the center.

Describe how the center will 1) advance the knowledge and science of environmental health disparities and environmental justice, 2) contribute to expanding the development of a workforce for conducting research in the field of environmental health disparities, and 3) facilitate equitable community stakeholder collaborations. To the extent possible, discuss expected improvements, such as reductions in environmental health disparities, that could result from the proposed work, over any relevant baseline for the proposed disease, condition, or significant activity.

Summarize the proposed research projects and explain how they are synergistic with one another and with the cores and pilot project program. Describe plans and procedures to monitor and assess their progress.

Summarize existing linkages with community stakeholders and the principles, policies, and practices that will guide when and how the center will engage with communities and for what purposes. Describe how research findings will be disseminated to the community.

Letters of Support: Applicants must provide a letter from the president, chancellor, dean, or provost to:

• Indicate the commitment of the institution to the center's specific aims and how the center's activities will be integral to the broad institutional vision for reducing and/or mitigating environmental health disparities and promoting environmental justice.
• Specify any institutional support, at the departmental and higher administrative levels, for example, financial support, support for developing early-stage investigators to conduct center research (e.g., access to core facilities, research design and data analysis consultation, etc.), dedicated space, salary support for professional or administrative staff, and interfaces with other grant funded programs, centers, and initiatives.
• Specify any institutional collaborations with local community partners involved in environmental justice efforts. 

All other letters of support, including those for cores and research projects, should be placed together in this section, accompanied by a coversheet that lists each letter, author(s) and their organizational affiliation, and their role on the project. Include letters of support for any collaborative/cooperative arrangements, subcontracts, consultants, community partnerships, etc.

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 items are allowed in the Appendix. Follow all instructions for the Appendix as described in How to Apply- Application Guide; any instructions provided here are in addition to the How to Apply - Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Overall)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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, there must be at least one human subjects study record using the Study Record: PHS Human Subjects and Clinical Trials Information form or a Delayed Onset Study record within the application. The study record(s) must be included in the component(s) where the work is being done, unless the same study spans multiple components. To avoid the creation of duplicate study records, a single study record with sufficient information for all involved components must be included in the Overall component when the same study spans multiple components.

Study Record: PHS Human Subjects and Clinical Trials Information

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

Use the “Other Requested Information” attachment in the Overall component to identify the components in which the work is being done. When completing the PHS Human Subjects and Clinical Trials Information form in the components working on the study, use the “Other Requested Information” attachment to indicate the study details are included in the Overall component. Once the “Other Requested Information” attachment is uploaded, no additional study information is needed in those components.

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 (Overall)

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

Administrative Core 

When preparing your application, use Component Type ‘Administrative Core.’

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

SF424 (R&R) Cover (Administrative Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Administrative Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Administrative Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Administrative Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Administrative Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Administrative Core)

Budget forms appropriate for the specific component will be included in the application package. The PD/PI is expected to attend an annual EHD Centers grantees meeting, held in the Washington DC metropolitan area. Funded early career stage investigators, collaborators or other members of the project team may also attend as warranted. Funds for travel to this meeting should be included in the budget request.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Administrative Core)

Specific Aims: Describe the specific aims for this core and summarize how its activities will support achievement of the proposed center objectives.

Research Strategy: Describe the center's administrative structure and the roles and responsibilities of Administrative Core personnel including scientific leadership. Include a Management Plan describing the governance structure and operations, and the composition and role(s) of any internal or external committees or advisory boards proposed to help manage the proposed activities. Do not name potential members of external advisory committees or boards in the application. Instead, membership should be described in terms of the qualities, characteristics and expertise that will be assembled to form an advisory committee or board.

Describe strategies for overseeing, managing and coordinating the entire range of proposed activities, establishing the appropriate measures for monitoring and accessing progress, and for ensuring that component plans are implemented. Describe plans to promote synergy between the cores, research projects, and pilot project program. Describe any activities intended to stimulate interest in the field of environmental health disparities and environmental justice research and promote the professional development of researchers affiliated with the center. Describe how the center proposes approaches that engage the target community/ies. 

Include an evaluation plan to facilitate ongoing overall project performance and management to ensure successful completion of the stated aims and achievement of desired results and programmatic objectives. Describe how the evaluation will be conducted, principal performance measures and metrics to be used to assess achievement of short- and long-term goals of each core and project, and potential sources of data. The productivity of investigators, including those with pilot projects, should include monitoring related grant applications and awards, dissemination activities (e.g., publications and presentations). The plan should address administrative functioning (process) as well as scientific and developing investigator accomplishments (outcomes). Describe key milestones and expected outcomes for each area, as appropriate.

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. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Administrative Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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.

Investigator Development Core

When preparing your application, use Component Type ‘Investigator Development Core.’

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

SF424 (R&R) Cover (Investigator Development Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Investigator Development Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Investigator Development Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Investigator Development Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Investigator Development Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Investigator Development Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

The Investigator Development Core must support at least 3 pilot projects annually (typically beginning in year 2). The combined direct costs allocated to pilot projects and required to be expended in the Pilot Project Program is up to $150,000 per year. Direct costs for each pilot project may range from a minimum of $25,000 per year to a maximum of $50,000 per year for up to two years. The direct costs and project period for a pilot project may not exceed those for an NIH R03 grant. Pilot projects are may last up to 2 years. 

Funds should not be requested to cover the cost of tuition, fees or stipends for students or trainees. Compensation for services rendered is allowable. Personnel and other costs needed to support the administration of the Pilot Project Program are also allowable Core costs.

PHS 398 Research Plan (Investigator Development Core)

Specific Aims: Describe the specific aims of this core and summarize how it will contribute to 1) expanding and diversifying the scientific workforce for conducting environmental health disparities research that leads towards promoting environmental justice. 2) Training early career investigators to conduct research examining and addressing environmental health disparities through an environmental justice lens. 3) Building research capacity at institutions working directly with communities experiencing environmental health disparities.

Research Strategy: The research strategy should address how the applicant plans to use support from this NOFO to provide development activities above and beyond those already provided by the applicant institution. Provide the following information for the Investigator Development Core:

• Describe a Pilot Project Program for postdoctoral fellows, junior faculty members, and other early-stage investigators, including the pool of potential applicants and how the Core will promote the receipt of pilot project applications.
• Explain how the proposed pilot project program and other core activities will support the training and professional development in environmental justice research of early career investigators.
• Recipients of pilot funds will be expected to receive ongoing advice from EHD Center faculty, meet on a regular schedule, participate in seminars and conduct their research pilot project. These investigators will be expected to work on publications based on their pilot project as well as collaborate on other projects. The goal is to successfully apply for external funding such as mentored K-award or R01 equivalent grant as appropriate to their career level.
• State how the core’s pilot projects and other development activities r espond to the identified needs of environmental justice communities and make research actionable. 
• Describe plans to solicit and review applications, prioritize pilot projects for funding, review their methodology and research performance, and provide support to recipients throughout the pilot project to publication of results and preparation of subsequent grant applications.
• Explain advisory and technical support resources in place to support rigorous research designs, appropriate statistical analysis, and manuscript preparation.
• Indicate any synergies of the Investigator Development Core’s pilot projects and other activities with the activities of the center’s other cores and project(s).
• Describe plans to develop infrastructure and build capacity to establish or expand consortium partnerships with other biomedical and behavioral institutions conducting environmental health disparities and environmental justice research, including limited resource institutions.
• State the scope, eligibility requirements, the limit on dollars available and number of years of support per pilot project, oversight and evaluation procedures, and plans to assure that all pilot projects will comply fully with applicable Federal policies, rules and guidelines for research involving human subjects and live vertebrate animals. 
• Do not include detailed proposals or descriptions of specific pilot projects, as pilot projects should not be selected until after the center grant is awarded.

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. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Investigator Development Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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.

Community Engagement and Dissemination Core 

When preparing your application, use Component Type ‘Community Engagement and Dissemination Core.’

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

SF424 (R&R) Cover (Community Engagement and Dissemination Core)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Community Engagement and Dissemination Core)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Community Engagement and Dissemination Core)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Community Engagement and Dissemination Core)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Community Engagement and Dissemination Core)

• In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Community Engagement and Dissemination Core)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

PHS 398 Research Plan (Community Engagement and Dissemination Core)

Specific Aims: Describe the specific aims for this core and the scientific questions to be addressed with community partners in the field of environmental health disparities.

Research Strategy: The research strategy should address how the applicant plans to use support from this NOFO to provide community engagement and dissemination activities above and beyond those already provided by the applicant institution.

Provide the following information for the Community Engagement and Dissemination Core:

• Explain how this core will serve as a critical bridge between the scientific investigators and communities and other relevant partners who may wish to engage in research and dissemination activities to address local or regional environmental health disparities of concern.
• Identify existing and potential future community partners. 
• State the core leadership and the principles, policies, and practices that will guide its operation. Identify the community advisory board structure and goals. 
• Describe how the proposed research activities of the core and the center overall respond to the needs of the community(ies) involved and reflect relevant cultural aspects and needs of the community.
• State the types of activities to be conducted for timely and appropriate dissemination of information generated by center research projects, pilot projects, and other activities for diverse audiences, including lay community audiences.
• Delineate the expected outcomes of proposed dissemination strategies and activities and how the impact of dissemination efforts will be assessed. 
• Explain how the core will coordinate dissemination activities with community members, partner organizations, and relevant service organizations or policymakers. 
• Describe how stakeholders will share in the decision-making on what, when, how, and to whom findings from research and pilot projects will be presented. 
• Identify strategic planning processes to translate findings into sustainable community and system-level changes at the local level and beyond.
• Describe how the core will oversee engagement of affected community groups and members, provide culturally sensitive translation of research findings to appropriate partners, promote dialogue between center members and identified stakeholders, and build capacity in environmental health literacy and risk prevention.
• Describe clear and measurable objectives, expected products, anticipated impact and significance for environmental public health. Include an evaluation plan and define evaluation tools to measure the impact of core activities (e.g., see the NIEHS Partnerships for Environmental Public Health Evaluation Metrics Manual at: http://www.niehs.nih.gov/pephmetrics). Applications should prioritize short-, mid- and long-term community engagement dissemination activities and explain how they align with the center’s mission and overall objectives. 

Letters of Support:

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. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Community Engagement and Dissemination Core)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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.

Research Project

When preparing your application, use Component Type ‘Research Project.’

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

SF424 (R&R) Cover (Research Project Name)

Complete only the following fields:

• Applicant Information
• Type of Applicant (optional)
• Descriptive Title of Applicant’s Project
• Proposed Project Start/Ending Dates

PHS 398 Cover Page Supplement (Research Project)

Enter Human Embryonic Stem Cells in each relevant component.

Research & Related Other Project Information (Research Project)

Human Subjects: Answer only the ‘Are Human Subjects Involved?’ and 'Is the Project Exempt from Federal regulations?’ questions.

Vertebrate Animals: Answer only the ‘Are Vertebrate Animals Used?’ question.

Project Narrative: Do not complete. Note: ASSIST screens will show an asterisk for this attachment indicating it is required. However, eRA systems only enforce this requirement in the Overall component and applications will not receive an error if omitted in other components.

Project /Performance Site Location(s) (Research Project)

List all performance sites that apply to the specific component.

Note: The Project Performance Site form allows up to 300 sites, prior to using additional attachment for additional entries.

Research & Related Senior/Key Person Profile (Research Project)

• In the Project Director/Principal Investigator section of the form, use Project Role of ‘Other’ with Category of ‘Project Lead’ and provide a valid eRA Commons ID in the Credential field.
• In the additional Senior/Key Profiles section, list Senior/Key persons that are working in the component.
• Include a single Biographical Sketch for each Senior/Key person listed in the application regardless of the number of components in which they participate. When a Senior/Key person is listed in multiple components, the Biographical Sketch can be included in any one component.
• If more than 100 Senior/Key persons are included in a component, the Additional Senior Key Person attachments should be used.

Budget (Research Project)

Budget forms appropriate for the specific component will be included in the application package.

Note: The R&R Budget form included in many of the component types allows for up to 100 Senior/Key Persons in section A and 100 Equipment Items in section C prior to using attachments for additional entries. All other SF424 (R&R) instructions apply.

If one or two Research Projects are proposed, the combined annual direct costs for all Research Projects should not exceed $550,000.

PHS 398 Research Plan (Research Project)

Specific Aims: Describe the specific aims of the research project, emphasizing its relevance to environmental health disparities and environmental justice.

Research Strategy: Provide the following information for each Research Project(s) proposed:

• Describe the roles and responsibilities of all members of the research team. For multiple PD/PI projects, include a multiple PD/PI Leadership Plan. 
• All projects must have a primary focus on one or more populations experiencing environmental health disparities.
• Explain how the proposed project will contribute towards advancing the science of environmental health disparities. 
• State how the project will address environmental justice issues and lead to mitigation/reduction of health disparities. 
• Provide a conceptual model that specifies the determinants and mechanisms of health outcomes to be examined and guides the study design, selection of measures, intervention (if applicable), and data analytic strategy. 
• Identify how the project maps onto the NIMHD Research Framework: http://www.nimhd.nih.gov/ and the NIEHS Translational Research Framework: https://www.niehs.nih.gov/research/programs/translational/framework-details. 
• Explain the multidisciplinary aspects of the project and describe how relevant partners representing populations experiencing health disparities will be engaged. Community-engaged research approaches are encouraged.
• Delineate how study findings can contribute to understanding or addressing environmental justice research on a broad scale, not just at the specific study sites or for local populations.
• Indicate how the study plans to address, mitigate, reduce, or alleviate environmental health disparities as well as promote uptake and sustainability.
• If an intervention study is not proposed, explain how study findings can inform future interventions.
• Applicants are encouraged across Research Projects as applicable, to include CDEs from the Social Determinants of Health Collection of the PhenX Toolkit (www.phenxtoolkit.org).

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. The Data Management and Sharing (DMS) Plan must be provided in the Overall component.

Appendix:

Only limited items are allowed in the Appendix. Follow all instructions for the How to Apply- Application Guide; any instructions provided here are in addition to those in the How to Apply- Application Guide instructions.

PHS Human Subjects and Clinical Trials Information (Research Project)

When involving human subjects research, clinical research, and/or NIH-defined clinical trials 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 a 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.

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) using ASSIST or other electronic submission systems. 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 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.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide. Paper applications will not be accepted.

For information on how applications will be automatically assembled for review and funding consideration after submission, refer to: http://grants.nih.gov/grants/ElectronicReceipt/files/Electronic_Multi-project_Application_Image_Assembly.pdf.

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) and component Project Leads 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.

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 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.

In order to expedite review, applicants are requested to notify the NIMHD Referral Office by email at [email protected] when the application has been submitted. Please include the FON, title, PD/PI name, and title of the application.

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 NIH in support of the NIH mission are evaluated for scientific and technical merit through the NIH peer review system.

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.

Significance

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

Specific to this NOFO: 

• Does the center propose a cohesive and multidisciplinary focus on reducing environmental health disparities and achieving environmental justice? 
• Is there evidence of synergy (degree of interaction, collaborative research opportunities) that will be stimulated to accelerate progress in the field of environmental health disparities research? 
• Does the center propose approaches that engage the target community/ies? If so, is there evidence of established research collaborations with proposed community partners? How feasible and appropriate are the plans for integrating community partners into the center’s research? 
• If applicable, is the plan to report research results to study participants adequate and appropriate?

In addition, for applications involving clinical trials

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

Investigator(s)

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

Specific to this NOFO: 

• To what extent are the investigators from the affected community(ies) or have demonstrated strong ties to them and/or experience collaborating with them? 
• Are members of the community and/or institutions that serve the community included as partners in the research? 
• Do the investigators demonstrate experience and expertise in working with the affected community(ies)?

In addition, for applications involving clinical trials

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

Innovation

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

In addition, for applications involving clinical trials

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

Approach

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

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address:

1) the protection of human subjects from research risks, and
2) inclusion (or exclusion) of individuals on the basis of sex or gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

Specific to this NOFO: 

• To what extent does a coordinated interrelationship exist between research projects and cores, and do these components align with the center's overarching theme? 
• How will the scientific objectives of each research project benefit significantly from interactions with other research projects and cores? 
• How closely are community(ies) voices and needs reflected in the proposed center work? To what extent are local partners involved equitably within the center work?
• To what extent does the center propose approaches that engage the target community(ies)? If so, is there evidence of established research collaborations with proposed community partners? 
• How feasible and appropriate are the plans for integrating community partners into the center’s research? 
• Is the plan to report research results to study participants adequate and appropriate?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

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

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

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

Data Management and Statistical Analysis

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

Environment

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

Specific to this NOFO: To what extent are the institutional commitment and available resources described in the application likely to contribute to the center's success and foster interactions with other scientists across the institution to promote environmental health justice research and reduce environmental health disparities?

In addition, for applications involving clinical trials

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

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

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

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

Additional Review Criteria - Overall

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

Study Timeline

Specific to applications involving clinical trials

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

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

The committee will evaluate the involvement of live vertebrate animals as part of the scientific assessment according to the following three points: (1) a complete description of all proposed procedures including the species, strains, ages, sex, and total numbers of animals to be used; (2) justifications that the species is appropriate for the proposed research and why the research goals cannot be accomplished using an alternative non-animal model; and (3) interventions including analgesia, anesthesia, sedation, palliative care, and humane endpoints that will be used to limit any unavoidable discomfort, distress, pain and injury in the conduct of scientifically valuable research. Methods of euthanasia and justification for selected methods, if NOT consistent with the AVMA Guidelines for the Euthanasia of Animals, is also required but is found in a separate section of the application. For additional information on review of the Vertebrate Animals Section, please refer to the Worksheet for Review of the Vertebrate Animals Section.

Biohazards

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

Resubmissions

Not applicable

Renewals

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

Revisions

Not Applicable

Applications from Foreign Organizations

Not Applicable

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

Overall Impact - Cores

Reviewers will provide one overall impact score to reflect their assessment of the likelihood for the Cores collectively to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following review criteria. Criterion scores will not be provided for the Cores.

Review Criteria - Cores

Reviewers will consider each of the review criteria below in the determination of scientific merit.

Review Criteria - Administrative Core

Reviewers will consider this core for its strengths and weaknesses relative to the points below in the determination of scientific merit.

• Are strategies and approaches to ensure effective overall management and support for the entire range of proposed activities well described, including coordination among cores and research projects, and do they adequately support the likelihood that each component's aims will be achieved within the project period?
• Are the proposed programmatic activities appropriate for enhancing institutional capacity to conduct research on environmental health disparities and to support the professional development of early career investigators in the various disciplines involved?
• Is the organizational and governance structure adequately described and appropriate for supporting the stated aims? 
• Does the management plan adequately describe the composition and roles of any proposed committees or advisory boards to assist in managing proposed activities in terms of the qualities, characteristics and expertise that will be assembled? Are the Core Lead, collaborators, and other key personnel well suited to their proposed roles?
• Does the application include an evaluation plan that incorporates plans for monitoring progress, including appropriate performance targets, objectives, outputs and outcomes? Is the proposed evaluation plan well-conceived and described in sufficient detail to judge its utility for ongoing project management?

Review Criteria - Investigator Development Core

Reviewers will consider this core for its strengths and weaknesses relative to the points below in the determination of scientific merit on supporting research training and professional development, particularly early career investigators. 

• Do the pilot project program and other activities described in this core clearly focus on environmental health disparities and environmental justice, and are they likely to expand opportunities for early career investigators to engage in multidisciplinary and multilevel research in this field? To what extent is the pilot project program likely to encourage early career investigators to propose innovative ideas of importance to environmental health disparities and environmental justice, e.g., in high risk and/or emerging areas?
• How well do the pilot project program and other core activities align with center’s central theme? 
• Do the core’s pilot project program and other activities respond to the identified needs of environmental justice communities and make research actionable?
• Are criteria and procedures for soliciting, submitting, reviewing and selecting pilot projects for funding clearly described and adequately justified in the overall context of the center’s proposed theme, goals and objectives? 
• Are appropriate advisory and technical support resources in place to support rigorous research design and appropriate statistical analyses? 
• Are there appropriate plans and safeguards in place for ensuring compliance with applicable Federal laws, regulations and policies for research involving human subjects for proposed pilot projects?
• Is information about the expected number, distribution, direct costs and duration of pilot projects sufficient to support the potential for success, as well as program scope and impact? 
• Is sufficient time built into pilot projects for evaluating progress and supporting professional development? 
• To what extent are plans for overseeing and mentoring pilot award recipients, including commitment of the identified trainers and mentors, likely to enhance their professional development?
• Does the application clearly describe plans to develop infrastructure and build capacity to establish or expand consortium partnerships with other biomedical and behavioral institutions conducting environmental health disparities and environmental justice research, including limited resource institutions? 

Review Criteria - Community Engagement and Dissemination Core

Reviewers will consider this core for its strengths and weaknesses relative to the points below in the determination of scientific merit on supporting the research education and training of community members from populations experiencing health disparities.

• Is the plan for the core's establishment aligned to the center’s mission, appropriate to the proposed community setting, and adequate for success? 
• Are the proposed activities responsive to the needs of the community(ies) involved, and are they based on or do they reference relevant cultural aspects and needs of the community?
• Does core leadership demonstrate expertise in community engagement, health communication, or other relevant disciplines and have a track record of success with community-engaged research partnerships? Are community and other partner organizations/members clearly defined and appropriate for the proposed activities, and is documentation of their commitment to the project provided? 
• Does the Community Advisory Board have appropriate and broadly representative membership to be successful?
• Are strategies identified to facilitate and strengthen bi-directional dialogue and keep community members and other stakeholders informed about Center activities and research findings? Do plans and approaches for dissemination incorporate locally appropriate language(s) and preferred methods of delivery, and use terminology appropriate for the general public?
• Are there adequate plans to assess the effectiveness of community- and stakeholder-level engagement and dissemination efforts, and to measure the impact of core activities on the community(ies) involved, such as enhancing environmental health literacy or enhancing community capacity to engage in scientific research and mitigating local environmental health exposures?

Overall Impact - Research Project

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

In addition, for applications involving clinical trials:

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

Scored Review Criteria Research Project

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

Significance

• Does the project address an important problem or a critical barrier to progress in the field? Is the prior research that serves as the key support for the proposed project rigorous? 
• If the aims of the project are achieved, how will scientific knowledge, technical capability, and/or clinical practice be improved? How will successful completion of the aims change the concepts, methods, technologies, treatments, services, or preventative interventions that drive this field?
• Will the project advance the knowledge and science of environmental health disparities and environmental justice? 
• To what extent is the project likely to contribute to a better understanding or addressing the role of determinants on environmental health disparities broadly? 
• Is there evidence of synergy for this project from interaction with other components of the center?

In addition, for applications involving clinical trials

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

Investigator(s)

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

In addition, for applications involving clinical trials

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

Innovation

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

In addition, for applications involving clinical trials

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

Approach

• Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the project? 
• Have investigators included plans to address weaknesses in the rigor of prior research that serves as the key support for the proposed project? 
• Have the investigators presented strategies to ensure a robust and unbiased approach, as appropriate for the work proposed? 
• Are potential problems, alternative strategies, and benchmarks for success presented? 
• If the project is in the early stages of development, will the strategy establish feasibility, and will particularly risky aspects be managed? 
• Have the investigators presented adequate plans to address relevant biological variables, such as sex, for studies in vertebrate animals or human subjects?
• If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?
• Is a clear and appropriate conceptual model provided that guides the study design, selection of measures, and data analytic strategy? 
• If the project involves a multidisciplinary study, is there an investigator record for multidisciplinary research and does the project involve appropriate collaborators? 
• To what extent does this project indicate contributions to and benefits to be received through interaction with other projects and cores?
• To what extent does the project address community concerns regarding environmental exposures? 

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable:

Study Design

• Is the study design justified and appropriate to address primary and secondary outcome variable(s)/endpoints that will be clear, informative and relevant to the hypothesis being tested? 
• Is the scientific rationale/premise of the study based on previously well-designed preclinical and/or clinical research? 
• If an intervention is proposed, given the methods used to assign participants and deliver interventions, is the study design adequately powered to answer the research question(s), test the proposed hypothesis/hypotheses, and provide interpretable results?
• Is the trial appropriately designed to conduct the research efficiently? Are the study populations (size, gender, age, demographic group), proposed intervention arms/dose, and duration of the trial, appropriate and well justified? 
• If an intervention is proposed, to what extent does the research project seek to mitigate or address environmental health disparities within the community? If an intervention is not proposed, to what extent does the research project seek to inform future interventions to mitigate or address environmental health disparities within the community?
• Are potential ethical issues adequately addressed? Is the process for obtaining informed consent or assent appropriate? Is the eligible population available? Are the plans for recruitment outreach, enrollment, retention, handling dropouts, missed visits, and losses to follow-up appropriate to ensure robust data collection? Are the planned recruitment timelines feasible and is the plan to monitor accrual adequate? Has the need for randomization (or not), masking (if appropriate), controls, and inclusion/exclusion criteria been addressed? Are differences addressed, if applicable, in the intervention effect due to sex/gender and race/ethnicity?
• Are the plans to standardize, assure quality of, and monitor adherence to, the trial protocol and data collection or distribution guidelines appropriate? Is there a plan to obtain required study agent(s)? Does the application propose to use existing available resources, as applicable?

Data Management and Statistical Analysis

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

Environment

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

In addition, for applications involving clinical trials

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

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

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

Additional Review Criteria Research Project

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

Study Timeline

Specific to applications involving clinical trials

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

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

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

Additional Review Considerations Research Project

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.

Are the project’s proposed research activities responsive to the needs of the community(ies) involved, and are they based on or do they reference relevant cultural aspects and needs of the community? Will the study findings be adequately disseminated?

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the Resource Sharing Plan(s) (e.g., Sharing Model Organisms) or the rationale for not sharing the resources, is reasonable.
Authentication of Key Biological and/or Chemical Resources

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

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by NIMHD, in accordance with NIH peer review policies and practices, 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.

Appeals of initial peer review will not be accepted for applications submitted in response to this NOFO.

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 their 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: Grantee 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).

Prior Approval of Pilot Projects

Recipient-selected projects that involve clinical trials or studies involving greater than minimal risk to human subjects require prior approval by NIH prior to initiation.

• The recipient institution will comply with the NIH Guidance on Changes That Involve Human Subjects in Active Awards and That Will Require Prior NIH Approval.
• The recipient institution will provide NIH with specific plans for data and safety monitoring, and will notify the IRB and NIH of serious adverse events and unanticipated problems, consistent with NIH DSMP policies.

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

3. Data Management and Sharing

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. 

• 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.

NIH recipients/offerors must collect and annually report information on sex or gender race, and ethnicity in progress reports. Refer to this Decision Tree for help determining reporting expectations for different types of studies.

Progress reports should briefly describe status of pilot projects, including data and safety monitoring, and should notify NIH of serious adverse events and unanticipated problems.

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]

Deborah E. Linares, Ph.D., M.A.
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-402-2516
Email: [email protected]

Randy Capps, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-827-5423
Email: [email protected]

Liam O'Fallon, Ph.D.
NIEHS - National Institute of Environmental Health Sciences
Phone: 984-287-3298 or 919-802-6523
Email: [email protected]

Behnoosh Momin, DrPH, MS, MPH
National Cancer Institute (NCI)
Telephone: (240) 789-3981
Email: [email protected]

Leigh A. Willis, PhD, MPH
National Institute of Nursing Research (NINR)
Telephone: 240-687-1634
Email: [email protected]

Emerald Nguyen, Ph.D.
National Institute on Aging (NIA)
Phone: 301-402-7571
Email: [email protected]

Richard Kwok, Ph.D.
National Institute on Aging (NIA)
Phone: 919-627-8892
Email: [email protected]

S. Sonia Arteaga, PhD
Deputy Director
Environmental influences on Child Health Outcomes (ECHO) 
Office of the Director, National Institutes of Health
Telephone: 301-435-1033
Email: [email protected]

Ivan Navarro, PhD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 240-255-8335
Email: [email protected]

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

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

Jenny Greer
NIEHS - National Institute of Environmental Health Sciences
Phone: 984-287-3332
Email: [email protected]

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

Susan A. Toy
National Institute of Nursing Research (NINR)
Telephone: 202-725-8503
Email: [email protected]

Ryan Blakeney
National Institute on Aging (NIA)
Phone: 301-451-9802
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.