Part 1. Overview Information

Key Dates

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

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

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

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

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

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

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



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

Part 2. Full Text of Announcement

Section I. Funding Opportunity Description

Background and Purpose

The NIH UNITE initiative was established to identify and address structural racism within the NIH-supported and the greater scientific community. The aims are to establish an equitable and civil culture and reduce barriers to racial equity (Collins, et al., Cell 2021, Bernard, et al., Nature Medicine 2021). UNITE is comprised of five committees with separate but coordinated objectives on tackling the problem of racism and discrimination in science, while developing methods to promote diversity and inclusion.

NIH recognizes that scientists who assume additional academic service, outreach, and mentoring duties to promote Diversity, Equity, Inclusion, and Accessibility (DEIA) are not always appropriately recognized or rewarded for these activities and thus this work can significantly inhibit the individual’s scientific research career. The ReWARD program provides funding for the scientific research and DEIA activities of Program Directors/Principal Investigators (PDs/PIs) who have a record of making significant, sustained, and impactful contributions to enhancing DEIA and who are not a PD/PI on an NIH research project grant at the time of the award. PDs/PIs of active major NIH research grants are encouraged to determine if they are eligible for the NIH DEIA mentorship supplement program. The ReWARD program is intended for individuals with a balanced approach to advancing scientific research and promoting DEIA. PDs/PIs who intend to devote their funded efforts almost exclusively to scientific research are encouraged to apply for the parent R01. PDs/PIs who intend to devote their funded efforts almost exclusively to DEIA activities or to propose activities on the scale of an institutional training program are encouraged to explore the variety of funding opportunities offered to enhance diversity in the biomedical research workforce.

The ReWARD program will support scientific research in areas related to the programmatic interests of one or more of the participating NIH Institutes and Centers (ICs) and ongoing DEIA activities focused on enhancing diversity in the biomedical research enterprise within the United States and territories. Note that the biomedical research enterprise includes a range of research, including basic science, behavioral, social science, and translational and clinical research and will be described hereafter as biomedical research. The long-term goal of this program is to enhance diversity in the biomedical research workforce.

Need for the Program

Promoting diversity in the extramural scientific workforce is critical to the success of the NIH mission and is consistent with the mandates of the 21st Century Cures Act. While scientific workforce diversity is integral to the NIH mission, expanding the pool of academic investigators from nationally underrepresented backgrounds in the biomedical research workforce has remained an elusive goal (see Policy Supporting Next Generation Researchers Initiative). For example, while the United States has seen a significant increase in the number of Ph.D. degrees in the biomedical sciences earned by scientists from historically underrepresented racial and ethnic groups in the biomedical research workforce, corresponding increases in the ranks of the faculty in basic science departments (Gibbs, et al., eLife 2016; Valantine, Lund & Gammie, CBE-Life Sciences Education, 2016) or NIH-funded investigators (Hoppe et al, 2019; Lauer, 2020) have not occurred. Similarly, women have earned a majority of biomedical Ph.Ds. since 2008 (NSF data), but only approximately 1/3 of NIH-funded PD/PIs are women (NIH Databook).

Scientists who assume substantial academic service, outreach, and mentoring duties to promote DEIA often experience career setbacks and difficulty supporting their research efforts because of the time they devote to their substantial DEIA efforts (Rodr guez et al., 2015; Gewin 2020; Faucett et al., 2022) . Supporting and recognizing DEIA efforts are likely to increase the retention of individuals from underrepresented groups in the biomedical research workforce. For example, studies suggest that underrepresented researchers who experience the altruistic or communal value of conducting biomedical research feel more psychologically involved with their research over time and this may contribute to retention (Diekman et al., 2010; Thoman et al, 2015). In addition, many successful DEIA-promoting programs are located at under-resourced institutions that serve students from diverse backgrounds. These institutions generally have lower levels of funding from NIH than do higher-resourced institutions. A program to promote the research projects of PDs/PIs who make significant contributions to DEIA efforts may serve the dual purposes of broadening the pool of researchers conducting biomedical research as well as the research settings in which NIH-funded biomedical investigations are conducted, while at the same time enabling these researchers and institutions to continue or expand their important DEIA activities. Broadening the institutions that participate in NIH-funded research would also increase access to research experiences for students from across the country, which would increase the pool of talented researchers available to the Nation in the future, including from groups currently underrepresented in biomedical research.

Program Considerations

ReWARD funding will support research in areas related to the programmatic interests of one or more of the participating NIH Institutes and Centers (see below) and ongoing DEIA activities focused on enhancing diversity in the biomedical research enterprise within the United States and territories. NIH intends to support ReWARD renewals through future re-issuances of this funding announcement.

NIH encourages institutional support of individuals who receive ReWARD funding (e.g., through protected time for the proposed activities, additional staff, resources and/or infrastructure enhancements) and requires an institutional letter of support (see Letters of Support in Part 2. Section IV.2).

Because this funding is intended for individuals with no current NIH research project grant funding at the time of the award (e.g., individuals who may have faced career setbacks or delays), PDs/PIs applying to the ReWARD program are not expected to have extensive publications and preliminary data. However, investigators should have robust research aims and strategies that are rigorous, feasible, and likely to push forward the boundaries of scientific discovery. DEIA activities that focus solely on research mentoring or training within the PD/PI's normal duties, are not likely to rise to the level of significant, sustained, and/or impactful DEIA contributions supported within the goals of this program.

The NIH recognizes that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogeneous teams. There are many benefits that flow from a diverse scientific workforce, 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, NIH encourages inclusivity in research. Examples of structures that promote diverse perspectives include but are not limited to:

• Transdisciplinary research projects and collaborations among researchers from fields such as behavioral/social sciences, computational biology, physics, engineering, mathematics, computer and data sciences, as well as bioethics.
• Engagement from different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).
• Individual applications and partnerships that enhance geographic and regional heterogeneity.
• Investigators and teams composed of researchers at different career stages.
• Training and mentoring opportunities encouraging participation of individuals from diverse backgrounds, including those from groups traditionally underrepresented in the biomedical, behavioral, and clinical research workforce (see NOT-OD-20-031), such as underrepresented racial and ethnic groups, those with disabilities, those from disadvantaged backgrounds, and women.
• Project-based opportunities to enhance the research environment to benefit early- and mid-career investigators.

This FOA requires a Plan for Enhancing Diverse Perspectives (PEDP) as part of the application (see further below). Applicants are strongly encouraged to read the FOA instructions carefully. Applications must include a PEDP submitted as an Other Attachment on the Other Project Information form (see Section IV).

Specific Areas of Research Interest

NCCIH will support research that is well aligned with the NCCIH Strategic Plan. Research areas funded by the institute broadly fall into three therapeutic areas, including nutritional, psychological, and physical approaches. These may include the array of chemical space occupied by natural products derived from plants, fungi, bacteria, marine organisms, or animals; as well as mind and body approaches such as yoga, massage therapy, meditation, mindfulness-based stress reduction, spinal/joint manipulation, acupuncture, and music-based interventions. NCCIH is interested in research that takes a transdisciplinary approach that integrates natural, social, and health sciences and transcends traditional boundaries to investigate the multifactorial process of whole person health restoration. Applications proposing a clinical trial must follow the Consolidated Notice on NCCIH Clinical Trials Policies as only mechanistic clinical trials will be accepted by NCCIH through this FOA.

Potential applicants are strongly encouraged to consult with the NCCIH Scientific Research staff listed below prior to developing and submitting an application.

NEI will support applications that address or seek fundamental knowledge related to visual function, including but not limited to cellular and molecular neuroscience, imaging, genetics, development, basic and translational research on vision including how the visual system works from the eyes to the brain in health and disease. NEI encourages an emphasis on understanding and addressing health disparities that are experienced by vulnerable populations. NEI will not support clinical trials that are greater than minimal risk on this funding opportunity. Minimal risk is defined as the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. Please refer to https://www.nei.nih.gov/grants-and-training/funding-opportunitiesto find the appropriate NIH or NEI-specific FOA for clinical trials. All investigators are encouraged to contact the NEI Scientific Program Officer in advance of submission.

NHGRI supports resources, approaches, and technologies that accelerate genomic research focused on the structure and biology of genomes; the genomics of disease; the implementation and effectiveness of genomic medicine; computational genomics and data science; the impact of genomic technology, advances, and implementation on health disparities and health equity; and ethical, legal, and social issues related to genomic advances. NHGRI recognizes the importance of diversity in the genomic workforce, without which the promise of genomics cannot be fully achieved.

In general, NHGRI supports studies that provide generalizable methods and knowledge. Approaches that are comprehensive across the genome or are generalizable across variants, tissues, diseases, or function may be in scope for NHGRI to the extent they address priority areas described in the NHGRI 2020 Strategic Vision and on the web pages for the research mission of NHGRI’s Extramural Divisions and Offices:

• Division of Genome Sciences
• Division of Genomic Medicine
• Ethical, Legal, and Social Implications Research Program
• Office of Genomic Data Science
• Training, Diversity and Health Equity Office

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

NIBIB interests include the development and integration of advanced bioengineering, sensing, imaging, and computational technologies for the improvement of human health and medical care. An application is not within the NIBIB mission if its principal focus is the development of a technology with the goal of understanding basic biological function or pathological mechanisms. Additionally, NIBIB only supports projects developing platform technologies that are applicable to a broad spectrum of disorders and diseases. However, applicants may propose research that utilizes only a single tissue, organ, or physiological condition as a model system to facilitate the development of what is expected to be a more broadly applicable enabling technology. Potential applicants are encouraged to contact the appropriate Program Director in their scientific program area of interest to determine if their research fits within the NIBIB mission.

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

NIDA supports innovative research addressing critical issues of neuroscience, genetics, behavior, prevention, treatment, epidemiology, etiology, health services, HIV/AIDS, and co-occurring opportunistic infections (e.g., viral hepatitis C, tuberculosis, sexually transmitted infections) associated consequences in substance-using populations, medication development, or other research areas relevant to drug abuse. NIDA priorities are further described in the NIDA Strategic Plan (see Director's Message | National Institute on Drug Abuse (NIDA) (nih.gov) ) and on the NIDA Notice of Special Interest webpage (see Search All Funding Opportunities | National Institute on Drug Abuse (NIDA) (nih.gov) ). Applicants are encouraged to contact a program official to discuss the proposed application.

NIDCD supports biomedical research, behavioral research, and research training in the normal and disordered processes of hearing, balance, taste, smell, voice, speech, and language. Applicants are strongly encouraged to learn more about NIDCD’s mission areas at Extramural Research. NIDCD’s priorities are further described in NIDCD’s 2023-2027 Strategic Plan . Potential applicants are strongly encouraged to discuss their research plans with Program Staff in relevant areas.

NIDCR supports research and research training to advance fundamental knowledge about dental, oral, and craniofacial (DOC) health and disease, and to translate these findings into prevention, early detection, and treatment strategies that improve overall health for all individuals and communities across the lifespan. Strategic Priorities are laid out in NIDCR Strategic Plan 2021-2026. Of particular interests for this FOA are:

1. Innovations in DOC disease prevention, early detection and diagnosis, and precision treatment
2. Implementation of evidence-based discoveries into sustained clinical practices to reduce health disparities and inequities
3. Support for future generations of DOC researchers and oral health professional scholars to address unmet clinical needs by capturing emergent scientific and technological advances
4. Partnerships across sectors to develop and sustain a diverse and robust research workforce in DOC sciences

Through this FOA, NIDCR may support clinical trials only of minimal risk to study participants, and for assessing feasibility and acceptability of the trial design. All potential applicants are encouraged to contact NIDCR Scientific/Research Contact listed in this FOA.

NIGMS supports basic research that increases our understanding of biological processes and lays the foundation for advances in disease diagnosis, treatment, and prevention. NIGMS' research mission is aimed at understanding the principles, mechanisms, and processes that underlie living organisms, often using research models. NIGMS does not support research that is relevant to the diseases, organ systems, or stages of life within the mission areas of other NIH Institutes and Centers. NIGMS accepts investigator-initiated applications for clinical trials using the R01 mechanism with the following considerations and limitations (see NOT-GM-22-027 and Investigator-Initiated Applications for Clinical Trials (R01) for further details).

NIH BRAIN Initiative is aimed at revolutionizing our understanding of the human brain, by accelerating the development and application of innovative technologies. Grant applications that fall into one or more of the seven high-priority research areas, including neuroethics, will be considered for funding. Research projects that develop new tools and approaches in the following areas are of particular interest:

• Discovering cell type diversity in the brain
• Mapping brain circuits at multiple scales
• Monitoring the brain in action
• Demonstrating causality between brain activity and behavior,
• Developing new theoretical and data analysis tools to understand brain function
• Developing innovative technologies to understand the human brain specifically
• Neuroethics

NIMH supports research on topics that include but are not limited to basic neuroscience and behavioral science; translational application of brain and behavior relationships in healthy and diseased states; and preventive, treatment and services interventions. Applications considered for funding by the NIMH must fall within the areas of priority detailed in the NIMH Strategic Plan and the NIMH Strategic Research Priorities. It is recommended that investigators contact NIMH Scientific/Research staff well in advance of submitting applications to discuss the match to NIMH priorities.

NIMH supports mechanistic clinical trials that focus on biomarker studies that may provide information about physiological function, target engagement of therapeutics, and/or the impact of therapeutic responses. These types of studies do not have as a primary aim to establish the efficacy or effectiveness of the intervention. NIMH also supports clinical trials involving preventive, therapeutic, and services interventions. All applications that propose clinical trials are expected to comport with NIMH’s experimental therapeutics approach to intervention development and testing. That is, the scope of work must include specification of targets/mechanisms and assessment of intervention induced changes in the presumed targets/mechanisms that are hypothesized to account for the intervention’s outcomes. In this manner, the results of the trial will advance knowledge regarding therapeutic change mechanisms and be informative regardless of trial outcomes (e.g., in the event of negative results, information about whether the intervention was successful at engaging its targets can facilitate interpretation).

See the Consolidated Notice on NIMH Clinical Trials Policies , NOT-MH-20-105, for a summary of NIMH’s policies on support for clinical trials. Applications that do not comport with MH Clinical Trials Policies will not be accepted.

NIMHD supports the study of many aspects of minority health and health disparities from biological and population sciences to clinical, behavioral, and translational research, as well as research on health care services, health systems and workforce development. NIMHD focuses on the full continuum of causes of health disparities and the interrelation of these causes. NIMHD projects must include a focus on one or more of the following populations that NIH designated as experiencing health disparities in the United States and its territories: African Americans, Latinos/Hispanics, American Indians and Alaska Natives, Asian Americans, Native Hawaiians and Pacific Islanders, less privileged socioeconomic groups, underserved rural populations, and sexual and gender minorities. NIMHD encourages projects that use approaches encompassing multiple domains of influence (e.g., biological, behavioral, sociocultural, environmental, physical environment, health system) and multiple levels of influence (e.g., individual, interpersonal, family, peer group, community, societal) to understand and address health disparities (see the NIMHD Research Framework for more information). Studies using animal models or exclusively basic science, or studies based outside the U.S. or its territories will not be supported by NIMHD under this FOA.

NINDS will support applications that address or seek fundamental knowledge about the brain and nervous system by supporting and conducting research on the healthy and diseased brain, spinal cord, and peripheral nerves and to use that knowledge to reduce the burden of neurological disease. NINDS supports basic, translational, and clinical research. NINDS also encourages activities focused on understanding and addressing disparities in neurologic health, healthcare, and health outcomes in disparate populations, including racial and ethnic minorities, the geographically disadvantaged, sex and gender minorities, and others who have been historically underserved, marginalized, and adversely affected by persistent inequality and socioeconomic disadvantage. NINDS generally expects a minimum effort of 2.4 calendar months (or 20% effort) towards research on an R01.

Clinical trials that seek to answer specific questions about safety, tolerability, clinical efficacy, effectiveness, clinical management, and/or implementation of pharmacologic, behavioral, biologic, surgical, or device (invasive or non-invasive) interventions, preventive, therapeutic, and service interventions will not be supported under this FOA. Please refer to https://www.ninds.nih.gov/Funding/Find-Funding-Opportunities to find the appropriate NIH or NINDS-specific FOA for such clinical trials. In many cases, small interventional trials exploring an intervention are within the scope of PAR-21-236: NINDS Exploratory Clinical Trials (U01 Clinical Trial Required). However, applicants are strongly encouraged to speak with the assigned Scientific/Research Contact prior to application. Only applications that fall within the scientific mission of the NINDS will be considered for funding (https://www.ninds.nih.gov/About-NINDS/Who-We-Are/Mission) and the NINDS Strategic Plan.

NLM supports research that incorporates innovative biomedical informatics and data science approaches that harness the digital healthcare ecosystem and has the potential to reduce health disparities while improving access to care, continuity of care, and/or health outcomes. Further, NLM is interested in research that leverages health data and develops novel approaches (e.g., clinical decision support systems; machine learning/artificial intelligence) that account for systematic biases and blind spots in health data and the development of tools and approaches that may be tailored for diverse populations.

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

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Governments

• 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 Institutions) are not eligible to apply.

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

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

Applicant Organizations

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

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

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

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

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

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

This FOA is open to all eligible PDs/PIs who have a track record of making significant, sustained, and impactful contributions to enhancing DEIA in the biomedical research enterprise and who are not at the time of award a PD/PI on an NIH research project grant (RPG).

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

Page Limitations

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

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

SF424(R&R) Cover

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

SF424(R&R) Project/Performance Site Locations

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

SF424(R&R) Other Project Information

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

Other Attachments: The application must include the following 2 attachments. Applications lacking the 2 attachments will not be reviewed. Please use the filenames suggested below. The filename provided for each document added to the section Other Attachments will be the name used for the bookmark in the electronic application in eRA Commons.

1. Diversity Statement (2-page maximum):The application must include a diversity statement from the PD/PI applying for the R01 award. The Diversity Statement provides an opportunity to expand upon, but not duplicate information in the biosketch. The Diversity Statement should include a detailed description of the PD/PI's commitment to diversity as well as any past or present activities to enhance DEIA in the biomedical research enterprise such as activities to support individuals from diverse backgrounds, including those from groups underrepresented in the biomedical research workforce (e.g., certain racial/ethnic groups, persons with disabilities, students from disadvantaged backgrounds, women, as described in the NIH Notice of Interest in Diversity). The statement should describe the outcomes and impact of past DEIA activities. Of particular interest are activities related to addressing structural and systemic barriers that limit the diversity and inclusivity of the biomedical research enterprise.

DEIA activities that focus solely on research mentoring or training within the PD/PI's normal duties, are not likely to rise to the level of significant, sustained, and/or impactful DEIA contributions supported within the goals of this program. The statement may include evidence of working effectively with scientists from a wide variety of backgrounds, promoting inclusive, safe, equitable and accessible scientific biomedical research environments.

This attachment should be titled Diversity Statement. Applications lacking a Diversity Statement will not be reviewed.

2. Plan for Enhancing Diverse Perspectives (PEDP) (1-page maximum): All applications must include a summary of strategies to advance the scientific and technical merit of the proposed project through expanded inclusivity. The PEDP should provide a holistic and integrated view of how enhancing diverse perspectives is viewed and supported throughout the application and can incorporate elements with relevance to any review criteria (significance, investigator(s), innovation, approach, and environment) as appropriate. Where possible, applicant(s) should align their description with these required elements within the research strategy section. 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 should include a timeline and milestones for relevant components that will be considered as part of the review.

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

• Discussion of engagement with different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).
• Description of any planned partnerships that may enhance geographic and regional diversity.
• Plan to enhance recruiting of women and individuals from groups traditionally under-represented in the biomedical, behavioral, and clinical research workforce.
• Proposed monitoring activities to identify and measure PEDP progress benchmarks.
• Plan to utilize the project infrastructure (i.e., research and structure) to support career-enhancing research opportunities for junior, early- and mid-career researchers.
• Description of any training and/or mentoring opportunities available to encourage participation of students, postdoctoral researchers and co-investigators from diverse backgrounds, including those from underrepresented groups.
• Plan to develop transdisciplinary collaboration(s) that require unique expertise and/or solicit diverse perspectives to address research question(s).
• Publication plan that enumerates planned manuscripts and proposed lead authorship.
• Outreach and planned engagement activities to enhance recruitment of individuals from diverse groups as research participants including those from under-represented groups in research.

For further information on the Plan for Enhancing Diverse Perspectives (PEDP), please see https://braininitiative.nih.gov/about/pedp-key-elements-and-examples.

This attachment should be titled Plan for Enhancing Diverse Perspectives. Applications lacking the PEDP will not be reviewed.

SF424(R&R) Senior/Key Person Profile

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

Biographical Sketch: In addition to the instructions, the PD/PI should describe the following in the biosketch:

• Leadership roles in DEIA activities
• Honors, awards, recognition for DEIA activities
• Service-oriented DEIA efforts beyond the requirements of being a biomedical Principal Investigator
• A description of any career setbacks or delays because of DEIA activities or issues.

The DEIA information included in the biosketch may be expanded upon in the Diversity Statement attachment.

R&R or Modular Budget

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

The application should describe the allowable costs associated with the research project and DEIA activities. For the PEDP implementation costs, applicants may include allowable costs associated with PEDP implementation (as outlined in the Grants Policy Statement section 7).

R&R Subaward Budget

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

PHS 398 Cover Page Supplement

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

PHS 398 Research Plan

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

Specific Aims: In addition to the scientific specific aims in alignment with a participating ICO's research mission, succinctly list the specific aim(s) of the DEIA proposed activities (e.g., training, mentoring, networking, cohort-building, career development, or psychosocial intervention to support entry and persistence of individuals from diverse backgrounds, including those from underrepresented groups in the biomedical research enterprise). DEIA activities must focus on enhancing diversity in the biomedical research enterprise within the United States and territories. State concisely the broader goals of the proposed DEIA activities and summarize the expected outcome(s), including the impact that the results of the proposed activities will have on the biomedical research enterprise.

Research Strategy: Preliminary data (i.e., data not yet published by the PD/PI) for the proposed scientific research are neither expected nor required. The feasibility of the proposed research may be demonstrated through literature citations or data from sources other than the PD/PI's original research.

In addition to the scientific research strategy focusing on the specific aims in alignment with a participating ICO's mission, include the strategy for effectively maintaining or implementing the DEIA activities to achieve the stated DEIA specific aim(s). The DEIA strategy should follow the format detailed in the SF424 (R&R) Application Guide.

Letters of Support: The application must contain an institutional letter of support from the Department Chair, Dean or equivalent leadership official. This letter should describe the following:

• The institutional commitment to DEIA initiatives for example:
  • Institutional DEIA goals and the support structures for DEIA initiatives
  • How DEIA service is recognized during promotion and tenure
  • How DEIA service is recognized by campus-wide acknowledgment of achievement
• That the time and effort requested by the applicant for the proposed research and DEIA activities will be provided.

Additional institutional support to the PD/PI may also be described, for example:

• Mentoring for PD/PI
• Other types of support (e.g., laboratory and/or office space, administrative staff time, funding to attend scientific conferences).
• Professional skills development and networking opportunities (e.g., leadership programs, communication workshops, mentoring workshops, additional opportunities for networking, especially with institutional leadership)

Applications lacking the institutional letter will not be reviewed.

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

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

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

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

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the SF424 (R&R) Application Guide.

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

PHS Human Subjects and Clinical Trials Information

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

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

Study Record: PHS Human Subjects and Clinical Trials Information

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

Delayed Onset Study

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

PHS Assignment Request Form

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

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

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

4. Submission Dates and Times

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

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

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

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

5. Intergovernmental Review (E.O. 12372)

This initiative is not subject to intergovernmental review.

6. Funding Restrictions

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

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

7. Other Submission Requirements and Information

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

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

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

Important reminders:

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

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

See more tips for avoiding common errors.

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

Applications must include the following attachments as Other Attachments on the SF424(R&R) Other Project Information form: (1) a Diversity Statement and (2) a PEDP. Applications must also include an institutional letter of support submitted as a Letter of Support on the PHS 398 Research Plan form. Applications that fail to include these 3 documents will be considered incomplete and will be withdrawn before review.

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

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

Post Submission Materials

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

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.

Specific to this FOA:

• The application need not have extensive background materials or preliminary information for the scientific research plan. Accordingly, reviewers will emphasize the conceptual framework, the level of innovation, and the potential to significantly advance scientific knowledge or understanding. Appropriate justification for the proposed work can be provided through literature citations, data from other sources, or, when available, from investigator-generated data.
• Reviewers should assess the candidate's demonstrated track record and proposed plans with respect to advancing and promoting DEIA in the biomedical research enterprise in the United States and territories and the PD/PI’s institutional context (e.g., resources, teaching requirements). Because this funding is intended for individuals who may have faced career setbacks or delays because of DEIA activities, and in some cases, institutional context, reviewers should note that applicants should not be expected to have extensive publications but should instead be evaluated on whether their aims and strategies are rigorous and feasible and the scientific question(s) are likely to advance the field of study. Similarly, early career stage applicants may not have yet published independently as senior or corresponding authors, and the absence of these publications should not be viewed as a weakness. Applications should be evaluated with respect to the PD/PI’s career stage and any career setbacks due to DEIA activities.

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 proposed activities to make rigorous and useful/significant scientific contributions to the research field(s) involved including its impact on DEIA in the biomedical research workforce. The ReWARD program is intended for individuals with a balanced approach to advancing scientific research and promoting DEIA. Applications should be strong in both areas overall to be considered meritorious.

Reviewers will consider each of the review criteria below in relation to the program objectives and give a separate score for each. An application does not need to be strong in all categories to be judged as a high impact. For example, an application describing a solid and interesting scientific research project not viewed as paradigm-shifting, but including a highly innovative plan to enhance DEIA, may be considered strong in "Innovation".

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

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

2. Review and Selection Process

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

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

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

Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions consistent with applicable law:

• 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.
• Portfolio balance, including regional and institutional distribution.
• Breadth of impact of DEIA activities on the institutional, regional and/or national biomedical research workforce.

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

Recipients must comply with any funding restrictions described in Section IV.6. Funding Restrictions. Selection of an application for award is not an authorization to begin performance. Any costs incurred before receipt of the NoA are at the recipient's risk. These costs may be reimbursed only to the extent considered allowable pre-award costs.

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

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

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

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

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

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

2. Administrative and National Policy Requirements

All NIH grant and cooperative agreement awards include the NIH Grants Policy Statement as part of the NoA. For these terms of award, see the NIH Grants Policy Statement Part II: Terms and Conditions of NIH Grant Awards, Subpart A: General and Part II: Terms and Conditions of NIH Grant Awards, Subpart B: Terms and Conditions for Specific Types of Grants, Recipients, and Activities, including of note, but not limited to:

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

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

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

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

• Recipients of FFA must ensure that their programs are accessible to persons with limited English proficiency. For guidance on meeting the legal obligation to take reasonable steps to ensure meaningful access to programs or activities by limited English proficient individuals see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/fact-sheet-guidance/index.html and https://www.lep.gov.
• For information on an institution’s specific legal obligations for serving qualified individuals with disabilities, including providing program access, reasonable modifications, and to provide effective communication, see https://www.hhs.gov/civil-rights/for-individuals/disability/index.html.
• HHS funded health and education programs must be administered in an environment free of sexual harassment, see https://www.hhs.gov/civil-rights/for-individuals/sex-discrimination/index.html. For information about NIH's commitment to supporting a safe and respectful work environment, who to contact with questions or concerns, and what NIH's expectations are for institutions and the individuals supported on NIH-funded awards, please see https://grants.nih.gov/grants/policy/harassment.htm.
• For guidance on administering programs in compliance with applicable federal religious nondiscrimination laws and applicable federal conscience protection and associated anti-discrimination laws see https://www.hhs.gov/conscience/conscience-protections/index.html and https://www.hhs.gov/conscience/religious-freedom/index.html.

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

In accordance with the statutory provisions contained in Section 872 of the Duncan Hunter National Defense Authorization Act of Fiscal Year 2009 (Public Law 110-417), NIH awards will be subject to the Federal Awardee Performance and Integrity Information System (FAPIIS) requirements. FAPIIS requires Federal award making officials to review and consider information about an applicant in the designated integrity and performance system (currently FAPIIS) prior to making an award. An applicant, at its option, may review information in the designated integrity and performance systems accessible through FAPIIS and comment on any information about itself that a federal agency previously entered and is currently in FAPIIS. The Federal awarding agency will consider any comments by the applicant, in addition to other information in FAPIIS, in making a judgment about the applicant’s integrity, business ethics, and record of performance under Federal awards when completing the review of risk posed by applicants as described in 45 CFR Part 75.205 and 2 CFR Part 200.206 Federal awarding agency review of risk posed by applicants. This provision will apply to all NIH grants and cooperative agreements except fellowships.

Not Applicable

3. Data Management and Sharing

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

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

4. Reporting

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

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH FOAs outline intended research goals and objectives. Post award, NIH will review and measure performance based on the details and outcomes that are shared within the RPPR, as described at 45 CFR Part 75.301 and 2 CFR Part 200.301.

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

In accordance with the regulatory requirements provided at 45 CFR 75.113 and 2 CFR Part 200.113 and Appendix XII to 45 CFR Part 75 and 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period. The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (currently FAPIIS). This is a statutory requirement under section 872 of Public Law 110-417, as amended (41 U.S.C. 2313). As required by section 3010 of Public Law 111-212, all information posted in the designated integrity and performance system on or after April 15, 2011, except past performance reviews required for Federal procurement contracts, will be publicly available. Full reporting requirements and procedures are found in Appendix XII to 45 CFR Part 75 and 2 CFR Part 200 Award Term and Condition for Recipient Integrity and Performance Matters.

In carrying out stewardship of grant programs, NIH will periodically evaluate the ReWARD program, employing the representative measures identified below. In assessing the effectiveness of research project grant investments, NIH may use information from progress reports and public databases, PD/PIs, and from participants themselves. Where necessary, PD/PIs and participants may be appropriately contacted after the completion of the grant period for updates on participants subsequent outcomes.

The overall evaluation of the program will be based on metrics that may include, but are not limited to, the following:

Characteristics of the applicant and awardee pool for the program, such as:

• DEIA activities
• Geographic distribution
• Investigator demographics
• Institution types
• Scientific topics of supported research

Indicators of scientific accomplishments/productivity, such as:

• Outcomes of individuals involved in the DEIA activities
• Peer-reviewed research publications and citations
• Presentations at scientific conferences (talks, posters, etc.)
• Patent activity among grantees

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]

Kristy Nicks, Ph.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Phone:301-827-3354
E-Mail: [email protected]

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

Aria Crump
National Institute on Drug Abuse (NIDA)
Phone: 301-443-6504
E-mail: [email protected]

Sundania Jw Wonnum, PhD
National Institute on Minority Health and Health Disparities (NIMHD)
Phone: 301-402-1366
E-mail: [email protected]

Utibe R. Bickham-Wright, PhD
National Institute on Minority Health and Health Disparities (NIMHD)
Phone: 301-402-1366
E-mail: [email protected]

Lillian Shum, PhD
National Institute of Dental & Craniofacial Research (NIDCR)
Phone: 301-594-0618
E-mail: [email protected]

Patrick C. Still, Ph.D.
National Center for Complementary and Integrative Health (NCCIH)
Phone: 301-682-1895
Email: [email protected]

Michelle Jones-London, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-451-7966
Email: [email protected]

Susan L Sullivan
National Institute on Deafness and Other Communication Disorders (NIDCD)
Phone: 301-496-8683
E-mail: [email protected]

Meryl Sufian, PhD
National Library of Medicine
Phone: 301-496-4671
Email: [email protected]

Brittany Haynes
National Institute of Mental Health (NIMH)
Phone: (301) 496-2767
Email: [email protected]

Neeraj Agarwal
National Eye Institute (NEI)
Phone: 301-435-8155
E-mail: [email protected]

Elizabeth Powell, PhD
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-0786
Email: [email protected]

Albert Avila
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Phone: 301-496-8804
E-mail: [email protected]

Regine Douthard, MD, MPH
Office of Research on Women's Health (ORWH)
Phone: 301-451-2729
E-mail: [email protected]

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

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

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

Melissa M Smarr, PhD
National Institute of Environmental Health Sciences (NIEHS)
Phone: 984-287-4507
E-mail: [email protected]

Brett Miller, PhD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Telephone: 301-496-9849
Email: [email protected]

Center for Scientific Review (CSR)
Email: [email protected]

Justin Rosenzweig
National Institute of General Medical Sciences (NIGMS)
Email: [email protected]

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

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

Gabriel Hidalgo, MBA
National Institute of Dental & Craniofacial Research (NIDCR)
Phone: 301-827-4630
E-mail: [email protected]

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

Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email: [email protected]

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

Andrea Culhane
National Library of Medicine (NLM)
Phone: 301-402-0069
E-mail: [email protected]

Tamara Kees
National Institute of Mental Health (NIMH)
Phone: (301) 443-8811
E-mail: [email protected]

Karen Robinson-Smith
National Eye Institute (NEI)
Phone: 301-435-8178
E-mail: [email protected]

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

Leslie Littlejohn
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Phone: (301) 594-2545
E-mail: [email protected]

Deanna L Ingersoll
National Human Genome Research Institute (NHGRI)
Phone: 301-435-7858
E-mail: [email protected]

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

Margaret Young
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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 45 CFR Part 75 and 2 CFR Part 200.