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

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

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

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

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



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

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Purpose

This funding opportunity supports unusually innovative intervention research which, if successful, would have a major impact on preventing, reducing, or eliminating health disparities and advancing health equity. Interventions addressing research questions that target social determinants of health (SDOH), which include structural factors and conditions of daily life, are required for this initiative (See NIH SDOH conceptualization here https://www.ninr.nih.gov/researchandfunding/nih-sdohrcc#tabs2). As conceptualized by the NIH, family- and individual-level social and economic circumstances may reflect the downstream effects of SDOH but are not SDOH themselves. As such, applications proposing interventions that address family- and individual-level social and economic circumstances (e.g., food insecurity) alone, without addressing SDOH as conceptualized by NIH, will not be considered responsive to this funding opportunity. Although a formative research phase may be necessary for some projects, an intervention research component addressing SDOH is required. SDOH can be addressed alone or in combination with other determinants of health and as part of a single or multilevel intervention approach.  Applicants may propose interventions addressing disparities in any health condition, disease, or health behavior. 

This initiative invites intervention research focused on transformative research ideas. To be considered transformative, projects should reflect ideas substantially different from traditional concepts and have high potential to lead to major improvements in health through the development, implementation, or dissemination of innovative interventions to address health disparities and health inequities. To accelerate progress in reducing health disparities, this funding opportunity seeks to support interventions that advance or solidify strategies, policies, programs, and environmental changes to address the Nation’s most pressing health challenges. Innovative interventions could take many forms depending on the population of interest and health disparity being addressed. Note that "innovation" can include development and testing of an innovative intervention, new implementation and/or dissemination strategies for evidence-based interventions, and/or creative evaluation of a novel or unusual policy, program, or environmental change to provide insight into their health impacts.

Several key features of this funding opportunity are designed to emphasize that Transformative Research to Address Health Disparities and Advance Health Equity applications are different from conventional, investigator-initiated research applications. These applications focus on the significance of the problem, the novelty of the hypothesis and/or the proposed methodology, and the magnitude of the potential impact rather than on preliminary data. No preliminary data are required for applications submitted in response to this funding opportunity, but could be included if available. Applicants should keep the goal of the Transformative Research to Address Health Disparities and Advance Health Equity initiative in mind throughout the process – to develop, implement, disseminate, and/or evaluate innovative interventions and strategies that address health disparities and that seek to advance health equity.

To support the most innovative and impactful research, the NIH recognizes the need to promote a diverse research workforce. For more information, see NOT-OD-20-031, Notice of NIH’s Interest in Diversity. NIH expects applicant institutions to engage in outreach and recruitment activities to encourage researchers from diverse backgrounds, including individuals from underrepresented racial and ethnic groups, persons with disabilities, and women to apply to participate in the program. In addition, outstanding research is conducted at a broad spectrum of institutions. To support the highest quality research, this funding opportunity encourages applications from the full range of eligible institutions, including those that may serve primarily underrepresented groups, those that may be less research active, and from all domestic geographic locations.

Program Considerations

Consistent with existing NIH practices and applicable law: (1) Funded programs may not use the race, ethnicity, or sex (including gender identity, sexual orientation, or transgender status) of a researcher, trainee, faculty candidate, or other program participants as an eligibility or selection criterion, and (2) NIH does not use the race, ethnicity, or sex of researchers, trainees, faculty, or other program participants in the application review process or funding decisions.  Applicants and award recipients are encouraged to consult with their General Counsel to ensure all applicable laws and regulations are being followed in program design and implementation.
Key Definitions for this NOFO
Social determinants of health (SDOH) are 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. These structural factors include social, economic, and legal forces, systems, and policies that determine opportunities and access to high quality jobs, education, housing, transportation, built environment, information and communication infrastructure, food, and health care; the social environment; and other conditions of daily life. See https://www.ninr.nih.gov/researchandfunding/nih-sdohrcc for additional detail on the NIH SDOH Conceptualization.

Background

Despite scientific and technological discoveries that improved the health of the U.S. population overall, racial and ethnic minority populations and other populations marginalized by society continue to bear a disproportionate burden of disease and premature death. The life expectancy at birth for Black/African American and American Indian/Alaska Native populations is 6 and 11 years lower than for the non-Hispanic White population. Across diseases and conditions, these disparities deepen with a large variance attributed to historical injustices and present social inequities that limit the opportunity of communities and populations to live and maintain lives that are health-promoting. These factors are known as SDOH which shape individual, community, and population health across the life span.

Populations that experience health disparities have higher levels of cumulative exposure to adverse SDOH such as concentrated poverty, lower-quality education and employment opportunities, poor housing affordability, and lower accessibility of healthy food. Health disparity populations also have limited access to health-promoting social conditions, which further limits the optimization of health. Structural factors, rooted in racism, sexism, classism, homophobia, and other discriminatory systems, shape the extent to which conditions of daily life are equitably distributed or unfairly distributed by race, ethnicity, sex, gender identity, socioeconomic position, sexual orientation, or geography, and their intersections. Inequitable exposure to adverse or health-promoting conditions of daily life are underlying causes of persistent and pervasive health disparities.

To make greater progress in fulfilling the NIH mission to enhance health, lengthen life, and reduce illness and disability, innovative and transformative approaches to addressing and removing longstanding barriers to advancing health equity are critical. This requires a sustained focus on addressing adverse SDOH and expanding access to health-promoting SDOH among populations at a health disadvantage. To effectively accomplish this, strong community partnerships are necessary to ensure relevance and resonance of approaches to tackle and ultimately eliminate longstanding and pervasive issues that contribute to poor health outcomes. Community partnerships are essential for developing feasible and acceptable approaches and achieving acceptance, uptake, and sustainability of proposed interventions and strategies. Partnerships within and across sectors such as education, housing, transportation, commerce, agriculture, economic and urban development, justice, human and social services, and public health are critical to advancing the translation of findings into sustainable community- and system-level changes that will have lasting impacts on health and advance health equity.

Research Objectives

Projects are expected to propose exceptionally innovative and transformative activities that are urgently needed to prevent, reduce, or eliminate health disparities and advance health equity. Projects may prospectively test new or adapted interventions (referred to as prospective interventions), evaluate existing or upcoming novel or unusual policy, programmatic, or environmental changes to generate significantly novel insights, or conduct innovative dissemination and implementation research. Research projects must address one or more SDOH as conceptualized by the NIH. SDOH can be addressed alone or in combination with other determinants of health and as part of a single or multilevel intervention approach. As conceptualized by the NIH, family- and individual-level social and economic circumstances may reflect the downstream effects of SDOH but are not SDOH themselves. As such, applications proposing interventions that address family- and individual-level social and economic circumstances (e.g., food insecurity) alone, without addressing SDOH as conceptualized by NIH, will not be considered responsive to this funding opportunity. Studies should be guided by a conceptual framework identifying hypothesized pathways between the intervention or program and outcome(s). All projects should examine the mechanisms by which the intervention alters health and health disparities.

Projects must include a focus on one or more NIH-designated populations that experience health disparities in the US, which includes racial and ethnic minority populations, people with lower socioeconomic status, underserved rural populations, sexual and gender minority populations, people with disabilities, and any subpopulations that can be characterized by the intersection of two or more of these descriptors. As appropriate, studies are encouraged to explicitly examine whether the intervention mitigates differences in health outcomes between health disparity and non-health disparity populations. Given the heterogeneity within health disparity populations, within-group comparisons of intervention effects that allow for discovery of health risk and protective factors are also encouraged.

Innovative approaches to identifying, understanding, and developing strategies for overcoming barriers to the adoption, adaptation, integration, scale-up and sustainability of evidence-based interventions, tools, policies, and guidelines are of interest. Implementation research aims should be guided by equity-oriented theoretical models and frameworks. Projects that focus on de-implementation of interventions that are ineffective, unproven, low-value, or harmful in advancing health equity are also invited. Research that directly tests the effectiveness of SDOH interventions in narrowing health gaps between health disparity and non-health disparity populations is also strongly encouraged.

Community Partnerships: Projects must document or demonstrate throughout the research process meaningful community partnerships to foster the development of feasible and acceptable approaches as well as acceptance, uptake, and sustainability of proposed interventions and strategies. Community partners can include, but are not limited to, those in the housing, transportation, food system, economic development, education, social services, and criminal legal system sectors. Applicants should provide details on the nature and extent of the partnerships by clearly describing the roles of partners and providing evidence of support from partners.

Prospective Interventions to Address SDOH may develop and test the effectiveness of new or adapted interventions in a variety of settings in the U.S., such as neighborhoods, community-based organizations, child welfare and human service settings, workplaces, businesses, stores and restaurants, schools, criminal justice settings, faith-based organizations, public works and facilities, healthcare systems, and recreational settings. Approaches may include group or cluster randomized controlled trial (RCT), stepped wedge RCT, stepped wedge group or cluster RCT, pragmatic RCT, pragmatic trials, adaptive designs (e.g., multiphase optimization strategy [MOST], sequential multiple assignment randomized trials [SMART]), implementation trials (including hybrid effectiveness/implementation designs), and rigorous quasi-experimental designs.

Examples of projects supported in this category include, but are not limited to, studies that develop and evaluate the effectiveness of interventions at community-, systems-, and/or population levels to improve health or reduce health disparities by:

• Improving community conditions through community revitalization investment projects
• Improving economic stability, such as through increased job opportunities or quality employment
• Improving housing access, quality, or affordability
• Improving education quality and school environments
• Reducing community-level violence, including firearm violence
• Improving the availability or quality of green spaces or recreational spaces
• Improving community childcare availability together with providing access to parental support groups
• Improving nutritious food availability in the community in addition to providing primary care-based nutritional counseling to individuals

Evaluation of Existing or Upcoming Interventions may examine policies, programs, system changes, or environmental changes that are existing or upcoming in the U.S. to address SDOH (structural factors or conditions of daily life at the community-, systems-, and/or population levels) (regardless of NIH funding) by states/territories, cities, counties, tribal communities, healthcare systems, public health departments, school systems, employers, or other organizations. Projects including multiple sites, locations, or settings are strongly encouraged to allow for the analysis of variability across and within settings. Studies that compare outcomes across populations in the U.S. with other countries are also allowed, if the comparison elucidates intervention mechanisms to reduce health disparities in the U.S. In addition to examination of individual level impacts as primary outcomes, examination of secondary outcomes that address unintended consequences of a policy or program, degree of implementation (including acceptance, uptake, spread, and sustainability), and implementation barriers and facilitators, are strongly encouraged. 

Examples of projects supported in this category include, but are not limited to studies that evaluate impacts on health and health disparities of:

• Federal, tribal, state, local, or organizational demonstration projects aimed at addressing SDOH
• Tribal policies or programs aimed to address SDOH among American Indian/Alaska Native populations
• New standards of care, changes in health insurance coverage, expansion of access to social services, and other factors that influence SDOH
• Programs or policies designed to improve access, quality, or affordability of housing, transportation, education, and food on health within communities
• Infrastructure changes related to housing, transportation, the food environment, or the built environment
• Programs, policies, or environmental changes targeting SDOH in addition to factors targeting individual or family circumstances such as housing instability, transportation access, nutrition insecurity
• Community economic development policy or program in addition to job training for individuals
• Program or policy to increase community availability of affordable housing, while also implementing screening and referrals for housing insecurity in healthcare settings

Study Designs: Randomization may not be possible for all intervention studies, e.g., where it is not possible to assign participants to high versus low discrimination conditions or in small sample sizes where cross intervention contamination is likely to occur or be a problem. Alternative rigorous research designs that provide robust evidence of intervention effectiveness include quasi-experimental designs, such as multiple baseline or repeated measures design or interrupted time series design. Also, hybrid effectiveness-implementation designs allow observational investigation of implementation processes while also testing intervention effectiveness. Investigators should justify their research and analytic design selection and provide adequate evidence of their ability to execute a rigorous and appropriate analysis of randomized or non-randomized study data.

Non-Responsive Applications
The following types of studies will be considered non-responsive for this announcement and will not be reviewed:

• Projects that do not examine an intervention that addresses one or more SDOH as conceptualized as structural factors and conditions of daily life. Projects that intervene solely at the individual or family level will not be considered responsive to this funding opportunity.
• Projects that do not focus on one or more NIH-designated populations that experience health disparities in the US.
• Projects that do not include a community partnership.
• Projects that do not include a Plan for Enhancing Diverse Perspectives.
• Construction and major renovations costs are unallowable through this RFA. Applications that propose to use grant funds to support construction or major alteration and renovation projects will be considered non-responsive.

Areas of Interest of Participating Institutes, Centers, and Offices (ICOs)

National Institute of Environmental Health Sciences (NIEHS)

NIEHS’ mission is to discover how the environment affects people in order to promote healthier lives and has long worked to reduce environmental health disparities and promote environmental justice. NIEHS is interested in innovative intervention research that addresses the interaction of SDOH with chemical and other environmental exposures that compromise health and contribute to health disparities.  Examples of environmental exposures which are considered of primary interest for NIEHS include but are not limited to: industrial chemicals or manufacturing byproducts, metals, pesticides, herbicides, air pollutants and other inhaled toxicants, particulates, or fibers, fungal, and bacterial or biologically derived toxins. Applicants are strongly encouraged to reach out to the Scientific Contact in the NOFO to discuss if the application fits the NIEHS mission. Applications responsive to NIEHS are required to clearly identify the environmental exposure(s) of interest and describe the intersection of the exposure(s) with SDOH.  The use of a conceptual model demonstrating the relationship of SDOH with the environmental exposure(s) of interest is highly encouraged. While the Transformative Research to Address Health Disparities and Advance Health Equity initiative supports the evaluation of existing or upcoming interventions, NIEHS is particularly interested in: 1) prospective interventions that develop and test interventions addressing the intersection of social and environmental determinants of health at multiple levels and 2) implementation research (including hybrid effectiveness-implementation studies) focused on strategies to adopt and integrate evidence-based interventions that eliminate environmental health disparities and advance environmental health equity. For applications proposing prospective interventions and implementation research, the use of implementation science frameworks is strongly suggested to promote acceptability, scalability, and sustainability. 

Office of Disease Prevention (ODP)

The ODP is the lead office at the NIH responsible for assessing, facilitating, and stimulating research in disease prevention. In partnership with the 27 NIH Institutes and Centers, the ODP strives to increase the scope, quality, dissemination, and impact of NIH-supported prevention research. The ODP is interested in providing co-funding support for research that has strong implications for disease and injury prevention and health equity and that include innovative and appropriate research design, measurement, and analysis methods. For this RFA, ODP is interested in multi-site and/or multi-sectoral interventions that address common risk factors for morbidity and mortality among populations that experience health disparities, including tobacco use, overweight/obesity, poor diet, physical inactivity, alcohol misuse, drug misuse, risky sexual behavior, injury and violence, infectious disease, and environmental health. For additional information about ODP’s research priorities and interests, please refer to the ODP Strategic Plan for Fiscal Years 2024–2028.

Plan for Enhancing Diverse Perspectives (PEDP)

The NIH recognizes that teams comprised of investigators with diverse perspectives working together and capitalizing on innovative ideas and distinct viewpoints outperform homogeneous teams. There are many benefits that flow from a scientific workforce rich with diverse perspectives, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved populations participate in, and benefit from research, and enhancing public trust.

To support the best science, the NIH encourages inclusivity in research guided by the consideration of diverse perspectives. Broadly, diverse perspectives can include but are not limited to the educational background and scientific expertise of the people who perform the research; the populations who participate as human subjects in research studies; and the places where research is done.

This NOFO requires a Plan for Enhancing Diverse Perspectives (PEDP), which will be assessed as part of the scientific and technical peer review evaluation.  Assessment of applications containing a PEDP are based on the scientific and technical merit of the proposed project. Consistent with federal law, the race, ethnicity, or sex of a researcher, award participant, or trainee will not be considered during the application review process or when making funding decisions.  Applications that fail to include a PEDP will be considered incomplete and will be administratively withdrawn before review.

The PEDP will be submitted as Other Project Information as an attachment (see Section IV).  Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP Guidance materials.

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

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Governments

• Eligible Agencies of the Federal Government
• U.S. Territory or Possession

Other

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

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

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

Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

Applicant organizations must complete and maintain the following registrations as described in the How to Apply- Application Guide to be eligible to apply for or receive an award. All registrations must be completed prior to the application being submitted. Registration can take 6 weeks or more, so applicants should begin the registration process as soon as possible. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information.

• System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
  • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
  • Unique Entity Identifier (UEI) - A UEI is issued as part of the SAM.gov registration process. The same UEI must be used for all registrations, as well as on the grant application.
• eRA Commons - Once the unique organization identifier is established, organizations can register with eRA Commons in tandem with completing their Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
• Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with their organization to develop an application for support. Individuals from diverse backgrounds, including individuals from underrepresented racial and ethnic groups, individuals with disabilities, and women are always encouraged to apply for NIH support. See, Reminder: Notice of NIH's Encouragement of Applications Supporting Individuals from Underrepresented Ethnic and Racial Groups as well as Individuals with Disabilities, NOT-OD-22-019 and Notice of NIH's Interest in Diversity, NOT-OD-20-031.

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

The NIH will not accept duplicate or highly overlapping applications under review at the same time, per NIH Grants Policy Statement Section 2.3.7.4 Submission of Resubmission Application. This means that the NIH will not accept:

• A new (A0) application that is submitted before issuance of the summary statement from the review of an overlapping new (A0) or resubmission (A1) application.
• A resubmission (A1) application that is submitted before issuance of the summary statement from the review of the previous new (A0) application.
• An application that has substantial overlap with another application pending appeal of initial peer review (see NIH Grants Policy Statement 2.3.9.4 Similar, Essentially Identical, or Identical Applications).

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

Letter of Intent

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:

[email protected]

Page Limitations

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

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

Plan for Enhancing Diverse Perspectives (PEDP)

• In an "Other Attachment" entitled "Plan for Enhancing Diverse Perspectives," all applicants must include a summary of actionable strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity. 
• Applicants should align their proposed strategies for PEDP with the research strategy section, providing a holistic and integrated view of how enhancing diverse perspectives and inclusivity are buoyed throughout the application.
• The PEDP will vary depending on the scientific aims, expertise required, the environment and performance site(s), as well as how the project aims are structured.
• The PEDP may be no more than 2 pages in length and should include:
  • Actionable strategies using defined approaches for the inclusion of diverse perspectives in the project;
  • Description of how the PEDP will advance the scientific and technical merit of the proposed project;
  • Anticipated timeline of proposed PEDP activities;
  • Evaluation methods for assessing the progress and success of PEDP activities.

Examples of items that advance inclusivity in research and may be appropriate for a PEDP can include, but are not limited to:

• Partnerships with different types of institutions and organizations (e.g., research-intensive; undergraduate-focused; HBCUs; emerging research institutions; community-based organizations).
• Project frameworks that enable communities and researchers to work collaboratively as equal partners in all phases of the research process.
• Outreach and planned engagement activities to enhance recruitment of individuals from diverse groups as human subjects in clinical trials, including those from underrepresented backgrounds.
• Description of planned partnerships that may enhance geographic and regional diversity.
• Outreach and recruiting activities intended to diversify the pool of applicants for research training programs, such as outreach to prospective applicants from groups underrepresented in the biomedical sciences, for example, individuals from underrepresented racial and ethnic groups, those with disabilities, those from disadvantaged backgrounds, and women.
• Plans to utilize the project infrastructure (i.e., research and structure) to enhance the research environment and support career-advancing opportunities for junior, early- and mid-career researchers.
• Transdisciplinary research projects and collaborations among researchers from fields beyond the biological sciences, such as physics, engineering, mathematics, computational biology, computer and data sciences, as well as bioethics.

Examples of items that are not appropriate in a PEDP include, but are not limited to:

• Selection or hiring of personnel for a research team based on their race, ethnicity, or sex.
• A training or mentorship program limited to certain researchers based on their race, ethnicity, or sex.

For further information on the Plan for Enhancing Diverse Perspectives (PEDP), please see PEDP Guidance materials.

SF424(R&R) Senior/Key Person Profile

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

R&R or Modular Budget

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

PEDP implementation costs:

Applicants may include allowable costs associated with PEDP implementation (as outlined in the Grants Policy Statement section 7): https://grants.nih.gov/grants/policy/nihgps/html5/section_7/7.1_general.htm.

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Specific Aims: In developing your specific aims, please consider the following:

What is the challenge and/or opportunity that is the focus of your proposed research? Why is this significant for advancing health equity? What is the overall research approach for addressing the challenge or leveraging the opportunity? Does the proposed research meaningfully address SDOH – alone or in combination with other factors? What are the most innovative aspects of your application? If successful, what impact would the research have on reducing health disparities and advancing health equity?

What is the fundamental new insight that is motivating the proposed research? What is the underlying logic or rationale that provides support for pursuing this insight despite little or no preliminary data?

Research Strategy: In addition to the instructions in the Application Guide, please consider the following when developing your Research Strategy:

Significance: Describe the SDOH and population experiencing health disparities that the research will address. Also describe why and how the proposed research is important to advancing health equity. Describe briefly the innovative aspects of the proposed research that illuminate its transformative potential. Describe why the proposed research is well suited to the goals of the Transformative Research to Address Health Disparities and Advance Health Equity funding opportunity.

Innovation: Describe how your proposed research is unusually innovative and transformative compared to current approaches, paradigms, practices, or perspectives.

Approach: Though preliminary data are not required, if preliminary data are provided, they will be evaluated. In addition to providing details regarding overall strategy, methodology, and analyses, describe the underlying logic or rationale for pursuing this project in the manner proposed. Summarize what you believe to be the major challenges or risks in the project and alternate approaches that may need to be pursued. Describe your approach for ensuring meaningful engagement with relevant community partners. 

Timeline: The Transformative Research to Address Health Disparities and Advance Health Equity project must be designed to have deliverables by the end of the project period that have the potential for transformative impact. The project should not be framed as initiating a line of research that will have the potential for transformative impact only after subsequent periods of support. Provide a timeline within the project period for the proposed research indicating points where intermediate objectives will be assessed, the measurable outcomes that will be used to monitor progress, and the timing and process for reaching decisions regarding the course and direction of the continuing research effort. Given the high degree of risk involved in applications submitted under the Transformative Research to Address Health Disparities and Advance Health Equity program, it is anticipated that investigators will need to continually reassess approaches based on intervention outcomes and potentially alter course to meet project goals. Possible alternative paths that may be followed at critical junctures in the project plan should be indicated on the timeline.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply- Application Guide.

Other Plan(s): 

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

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

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

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

PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form

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

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

See Part 2. Section III.1 for information regarding the requirement for obtaining a unique entity identifier and for completing and maintaining active registrations in System for Award Management (SAM), NATO Commercial and Government Entity (NCAGE) Code (if applicable), eRA Commons, and Grants.gov

4. Submission Dates and Times

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

Organizations must submit applications to Grants.gov (the online portal to find and apply for grants across all Federal agencies). Applicants must then complete the submission process by tracking the status of the application in the eRA Commons, NIH’s electronic system for grants administration. NIH and Grants.gov systems check the application against many of the application instructions upon submission. Errors must be corrected and a changed/corrected application must be submitted to Grants.gov on or before the application due date and time.  If a Changed/Corrected application is submitted after the deadline, the application will be considered late. Applications that miss the due date and time are subjected to the NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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

Information on the submission process and a definition of on-time submission are provided in the How to Apply-Application Guide.

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

Pre-award costs are allowable only as described in the NIH Grants Policy Statement Section 7.9.1 Selected Items of Cost.

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

Applications must include a PEDP submitted as Other Project Information as an attachment. Applications that fail to include a PEDP will be considered incomplete and will be administratively withdrawn before review.

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.

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

Any instructions provided here are in addition to the instructions in the policy.

Section V. Application Review Information

1. Criteria

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

For this particular NOFO, note the following:

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved, in consideration of the following scored review criteria and additional review criteria (as applicable for the project proposed).  An application does not need to be strong in all categories to be judged likely to have a major scientific impact. As part of the overall impact score, reviewers should consider and indicate how the Plan for Enhancing Diverse Perspectives affects the scientific merit of the project.

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

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

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by the Center for Scientific Review, in accordance with NIH peer review 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, consistent with applicable law.

• Scientific and technical merit of the proposed project, including the PEDP, as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

Please note that reviewers will not consider race, ethnicity, age, or gender of a researcher, award participant, or trainee, even in part, in providing critiques, scores, or funding recommendations. NIH will not consider such factors in making its funding decisions.

If the application is under consideration for funding, NIH will request "just-in-time" information from the applicant as described in the NIH Grants Policy Statement Section 2.5.1. Just-in-Time Procedures. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding.

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

3. Anticipated Announcement and Award Dates

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

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

Section VI. Award Administration Information

1. Award Notices

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

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

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

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

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

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

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

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

2. Administrative and National Policy Requirements

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

• The rules listed at 2 CFR Part 200, Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards.
• All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the terms and conditions in the Notice of Award (NoA). The NoA includes the requirements of this NOFO. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities.
• If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website.
  • HHS recognizes that NIH research projects are often limited in scope for many reasons that are nondiscriminatory, such as the principal investigator’s scientific interest, funding limitations, recruitment requirements, and other considerations. Thus, criteria in research protocols that target or exclude certain populations are warranted where nondiscriminatory justifications establish that such criteria are appropriate with respect to the health or safety of the subjects, the scientific study design, or the purpose of the research. For additional guidance regarding how the provisions apply to NIH grant programs, please contact the Scientific/Research Contact that is identified in Section VII under Agency Contacts of this NOFO.

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

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

Successful recipients under this NOFO agree that:

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

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

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

Successful recipients under this NOFO agree that:

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

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

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

The following special terms of the award are in addition to, and not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB) administrative guidelines, U.S. Department of Health and Human Services (DHHS) grant administration regulations at 2 Part CFR 200, and other HHS, PHS, and NIH grant administration policies.

The administrative and funding instrument used for this program will be the cooperative agreement, an "assistance" mechanism (rather than an "acquisition" mechanism), in which substantial NIH programmatic involvement with the recipients is anticipated during the performance of the activities. Under the cooperative agreement, the NIH's purpose is to support and stimulate the recipients' activities by involvement in and otherwise working jointly with the award recipients in a partnership role; it is not to assume direction, prime responsibility, or adopt a dominant role in the activities. Consistent with this concept, the dominant role and prime responsibility resides with the recipients for the project as a whole, although specific tasks and activities may be shared among the recipients and the NIH as defined below.

The PD(s)/PI(s) will have primary responsibility for:

• Providing scientific leadership for all aspects of the study, including planning, any modification of study design, the conduct of the study, quality control, data analysis and interpretation, preparation of publications, dissemination of data, tools, and technologies, and collaboration with other investigators.
• Agreeing to accept close coordination, cooperation, and participation of NIH staff in those aspects of scientific and technical management of the study as stated in these terms and conditions.
• Finalizing study design milestones, including a robust statistical plan for analysis, with NIH staff.
• Upon implementation of the study, following the procedures required by the agreed-upon study design regarding study conduct and monitoring, participant management, data collection, quality control, and statistical analysis.
• Providing summaries of progress toward goals and milestones at least yearly, as requested by NIH. The milestones will be reviewed annually (and at other times, if necessary), and new milestones will be negotiated, as needed by working with the NIH staff as appropriate.
• Retaining custody of and having primary rights to the data developed under these awards, subject to Government rights of access consistent with current HHS, PHS, and NIH policies.
• Managing involvement of industry or any other third party in the study. Except for licensing of patents or copyrights, support or involvement of any third party will occur only following notification of and concurrence by the NIH.
• Making all study materials, procedure manuals, and final datasets available in the public domain, managed by the recipient institution. Recipients are expected to publish and publicly disseminate results, data, and other products of the study, concordant with NIH governance policies and protocols. Publications and oral presentations of work performed under this agreement will require appropriate acknowledgment of support by the NIH and the awarding IC.
• Obtaining prior written approval of the awarding IC Grants Management Specialist, in consultation with the Program Officer and Project Scientist, for changes in any of the key personnel identified in the Notice of Grant Award. 

NIH staff have substantial programmatic involvement that is above and beyond the normal stewardship role in awards, as described below.

The NIH Project Scientist will:

• Consult with the PD(s)/PI(s) regarding study design milestones prior to finalizing the study design and as needed thereafter.
• Serve as a resource to provide scientific/programmatic support by providing input on experimental and clinical approaches and study protocols, and advising in the management and operational aspects of study development and implementation.
• Provide scientific and programmatic support to the PD(s)/PI(s) as the Project Scientist deems necessary, including contributing to data analysis, key personnel selection, and promoting the availability of data and resources.
• Participate in teleconferences or other discussions with PDs/PIs to monitor study development and implementation progress, adherence to the study protocol, the conduct of the study, and recruitment and retention of study participants.
• Review the progress of the study through consideration of routine reporting, site visits, oversight committee recommendations, etc. This review may include, but not be limited to, compliance with the study protocol, achievement of participant enrollment targets, and the timeliness and quality of data reporting.
• Periodically review reports of study progress. NIH staff may use information obtained from the data for the preparation of internal reports on the activities of the study. 

The Project Scientist will not make decisions about the funding of this project and will not be involved in any special reviews of the project that make recommendations about funding.

The NIH Program Official will:

• Carry out a continuous review of all activities to ensure that the objectives are being met and that all regulatory, fiscal, and administrative matters are handled according to NIH and IC guidelines.
• Have the option to withhold support to a participating institution if technical performance requirements/milestones are not met.
• Conduct special reviews of the project as the Program Official deems necessary. NIH may engage outside experts to assist in these reviews. If concerns about the project arise and are not resolved, NIH may reduce or restrict the budget or reduce the term of support to phase out the project.
• An agency program official or IC program director will be responsible for the normal scientific and programmatic stewardship of the award and will be named in the notice of award.

The NIH reserves the right to terminate or curtail a study or any portion of a project in the event of (a) substantive changes in the project not approved in advance, (b) use of funds for activities not within the scope of the award, (c) failure to make sufficient progress toward the project milestones, (d) failure to comply with the terms and conditions of the award or establish necessary statutory, regulatory, policy approval required for conducting the project, or (e) ethical or conflict of interest issues.

Joint Responsibilities:

No joint responsibilities.  All responsibilities and activities assigned to PI/PDs and NIH staff (PO, SDO, SD) are separate and distinct.

Dispute Resolution:

Any disagreements that may arise in scientific or programmatic matters (within the scope of the award) between award recipients and the NIH may be brought to Dispute Resolution. A Dispute Resolution Panel composed of three members will be convened. Members will be: a designee chosen by the PD/PI, one NIH designee, and a third designee with expertise in the relevant area who is chosen by the other two; in the case of individual disagreement, the first member may be chosen by the individual awardee. This special dispute resolution procedure does not alter the awardee's right to appeal an adverse action that is otherwise appealable in accordance with PHS regulation 42 CFR Part 50, Subpart D and DHHS regulation 45 CFR Part 16.

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

4. Reporting

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

• Awardees will provide updates at least annually on implementation of the PEDP.

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]

Julia Seay, PhD
National Institute of Nursing Research (NINR)
Telephone: 240-328-4512
Email: [email protected]

Deidra Roach, M.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-5820
Email: [email protected]

Ashlinn Quinn, PhD.
NIEHS - National Institute of Environmental Health Sciences
Phone: 984-287-4647 or 240-961-8619
Email: [email protected]

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

Xincheng Zheng (Ted), PhD
NIAMS - NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES
Phone: 301-594-4953
E-mail: [email protected]

Center for Scientific Review (CSR)
[email protected]
 

Jenna Briggs
National Institute of Nursing Research (NINR)
Telephone: 301-480-0639
Email: [email protected]

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: [email protected]

LaTavia Miller
NIEHS - National Institute of Environmental Health Sciences
Phone: 984-287-4525
Email: [email protected]

Erik Edgerton
NIAMS - NATIONAL INSTITUTE OF ARTHRITIS AND MUSCULOSKELETAL AND SKIN DISEASES
Phone: 301-594-7760
E-mail: [email protected]

Section VIII. Other Information

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 2 CFR Part 200.