Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Minority Health and Health Disparities (NIMHD)

National Eye Institute (NEI)

National Institute on Aging (NIA)

National Institute of Biomedical Imaging and Bioengineering (NIBIB)

National Institute of Mental Health (NIMH)

National Library of Medicine (NLM)

National Cancer Institute (NCI)

All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.

Sexual and Gender Minority Research Office (SGMRO)

Funding Opportunity Title
Leveraging Health Information Technology (Health IT) to Address and Reduce Health Care Disparities (R01 Clinical Trial Optional)
Activity Code

R01 Research Project Grant

Announcement Type
Reissue of PAR-19-093
Related Notices

See Notices of Special Interest associated with this funding opportunity

NOT-OD-22-190 - Adjustments to NIH and AHRQ Grant Application Due Dates Between September 22 and September 30, 2022

  • April 21, 2022 - Notice of Correction to PAR-22-145. See Notice NOT-MD-22-017.
  • April 20, 2022 - Notice of NCI's participation on PAR-22-145. See Notice NOT-CA-22-082.
  • Funding Opportunity Announcement (FOA) Number
    PAR-22-145
    Companion Funding Opportunity
    None
    Assistance Listing Number(s)
    93.307, 93.242, 93.879, 93.867, 93.286, 93.866, 93.393
    Funding Opportunity Purpose

    This funding opportunity announcement (FOA) seeks to support research that examines the impact of leveraging health information technology (health IT) to reduce disparities in access to and utilization of health care services, patient-clinician communication, and health outcomes for populations that experience health disparities in the U.S.

    Key Dates

    Posted Date
    March 31, 2022
    Open Date (Earliest Submission Date)
    May 05, 2022
    Letter of Intent Due Date(s)

    30 days prior to the application due date

    The following table includes NIH standard due dates marked with an asterisk.
    Application Due Dates Review and Award Cycles
    New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
    June 05, 2022 * July 05, 2022 * September 07, 2022 * November 2022 January 2023 April 2023
    October 05, 2022 * November 05, 2022 * January 07, 2023 * March 2023 May 2023 July 2023
    February 05, 2023 * March 05, 2023 * May 07, 2023 * July 2023 October 2023 December 2023
    June 05, 2023 * July 05, 2023 * September 07, 2023 * November 2023 January 2024 April 2024
    October 05, 2023 * November 05, 2023 * January 07, 2024 * March 2024 May 2024 July 2024
    February 05, 2024 * March 05, 2024 * May 07, 2024 * July 2024 October 2024 December 2024
    June 05, 2024 * July 05, 2024 * September 07, 2024 * November 2024 January 2025 April 2025
    October 05, 2024 * November 05, 2024 * January 07, 2025 * March 2025 May 2025 July 2025
    February 05, 2025 * March 05, 2025 * May 07, 2025 * July 2025 October 2025 December 2025

    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.

    Expiration Date
    May 08, 2025
    Due Dates for E.O. 12372

    Not Applicable

    Required Application Instructions

    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.


    4. Table of Contents

    Part 2. Full Text of Announcement

    Section I. Funding Opportunity Description

    Funding Opportunity Purpose:

    This funding opportunity announcement (FOA) seeks to support research that examines the impact of leveraging health information technology (health IT) to reduce disparities in access to and utilization of health care services, quality of care, patient-clinician communication, and health outcomes for populations that experience health disparities in the U.S.

    Background

    The digitization of the U.S. health care systems continues to be a priority for health care systems and federal policy agencies given the expected capabilities enabled by health Information Technology (health IT) to improve individual and population health and reduce health care disparities. The 2020-2025 Federal Health IT Strategic Plan outlines a vision of health IT to improve population health, access, equity, safety, and reduce costs via health IT capabilities such as public health surveillance, telehealth, and remote monitoring (e.g., wearables; web enabled medical devices). The interoperability of electronic health information (EHI) and reducing clinician burden in documentation tasks remains a focus. Solutions that leverage health IT tools such as patient registries, electronic health records (EHRs), patient portals/patient health records (PHRs), clinical decision support (CDS) modules within EHRs, electronic reminders for guideline recommended evaluations, and machine learning/artificial intelligence (ML/AI) are transforming the healthcare infrastructure and hold promise for advancing health equity. For example, health IT is considered an important lever for addressing challenges in healthcare associated with social determinants of health (SDoH). The emphasis on capturing and integrating standardized measures of demographic data and SDoH in EHRs and implementing CDS to inform care plans to improve outcomes for populations that experience health disparities, as well as preventive care, population health management, and disease management, fits with the growing shift to value-based care that incentivize health systems to improve quality of care and patient outcomes

    To date, the limited research indicates that health IT tools may yield health benefits for populations that experience health disparities – such as racial and ethnic minorities, the socioeconomically disadvantaged, underserved rural populations, and sexual and gender minorities – by enhancing patient engagement, emphasizing patient satisfaction and quality of care, improving implementation of clinical guidelines, promoting patient safety in managing medication prescriptions, and reducing adverse outcomes. More studies are needed to examine the impact of health IT adoption on racial/ethnic disparities in health outcomes and in promoting health equity in clinical settings. Investigation of evidence-based strategies of how best to capture demographic data and SDoH in a standardized way in EHRs/CDS and utilize that information in an actionable way to address health disparities, and not further exacerbate disparities associated with SDoH is needed. Applicants are strongly encouraged to assess social determinants of health using measures available in the Social Determinants of Health Collection of the PhenX Toolkit (www.phenxtoolkit.org), as appropriate. Other research opportunities that warrant exploration include evidence-based approaches to promote equitable access to health IT tools and resources that protect patients that experience health disparities from discrimination, stigma, bias, and exploitation based on their health IT information; strategies to develop the digital health literacy competencies of populations affected by health disparities to allow them to fully benefit from accessing their electronic health information and understand issues of participating in research studies, informed consent for use of clinical data for research, and privacy in the management of their care; impact evaluations to examine the use of ML/AI algorithms embedded in EHRs/CDS to inform disease risk assessment, screening, diagnoses, and treatment decisions with populations that experience health disparities, and assessment of data quality and potential biases of these data sets, developed algorithms and implementation to prevent adverse consequences for populations that experience health disparities.

    The U.S. digital health care ecosystem has become ever more relevant in prevention efforts to mitigate the spread of the COVID-19 virus and for managing secondary effects (e.g., behavioral health challenges; disruptions in the provision and access to treatment provided in health care settings) associated with the COVID-19 pandemic. This evolving environment offers a significant opportunity to understand the challenges of developing and implementing robust and responsive evidence-based health IT systems/approaches to meet the health needs of populations that experience health disparities during public health emergencies. These populations often have a disproportionate burden of chronic diseases, require more complex care because of co-morbidities, and are more susceptible to the negative consequences of the pandemic. Comparative effectiveness studies of digital clinical interventions that can be embedded in the healthcare system via health IT tools as compared to in person or usual care to address the secondary effects of the pandemic on populations that experience health disparities are needed.

    The pandemic resulted in both an increase in implementation of telehealth and health care models that integrate patient generated health data (PGHD) to provide patient care from a distance in the ambulatory setting or in the hospital-at-home programs. Findings from a recent environmental scan report by AHRQ (https://digital.ahrq.gov/sites/default/files/docs/citation/pghd-environmental-scan.pdf) noted a gap in evidenced-based care guidance for ambulatory care practices of how to effectively make use of PGHD to impact patient outcomes. Ambulatory care practices that can access these data in EHRs would potentially improve patient outcomes, care coordination, quality, and cost effectiveness. Clinicians and researchers can utilize these data to prevent and manage acute care and chronic conditions as well as improve risk prediction and diagnoses. While integration of PGHD into EHRs is promising, unintended consequences (e.g., overreporting of symptoms; data overload;) for populations who experience health care disparities is a concern. Suboptimal engagement with digital health tools, low digital health literacy, and lack of access to broadband internet or a smartphone with unlimited data plans can potentially exclude some of these patients- including older adults. Thus, studies will need to be designed with these considerations in mind to ensure findings are applicable to populations that experience health disparities. Evidence-based solutions to manage barriers such as access to broadband for patients in rural areas, interpreters for patients with limited English proficiency, and support for patients with disabilities are needed. Rigorous studies are also needed to address challenges such as clinician and patient increased burden, caregiver burden, poor usability, circumstances under which utilization is more appropriate, and workflow integration faced by clinicians to effectively utilize PGHD in clinics.

    The rapid use of telehealth in response to the COVID-19 pandemic resulted both as a means of necessity to prevent virus spread and to the temporary regulatory waivers issued by the Centers for Medicare and Medicare Services to broaden access and payment for a wider range of telehealth services. This rapid increase provides an opportunity to understand the impact of telehealth policies on health equity and access to care for populations that experience health disparities.

    Other research opportunities that warrant exploration include evidence-based approaches to promote equitable access to health IT tools and resources that protect patients that experience health disparities from discrimination, stigma, bias, and exploitation based on their health IT information. For example, strategies to develop the digital health literacy competencies that allow patients from populations that experience health disparities to fully benefit from accessing their electronic health information and understand issues of participating in research studies, informed consent for use of clinical data for research, and privacy in the management of their care are needed. Impact evaluations to examine the use of ML/AI algorithms embedded in EHRs/CDS to inform disease risk assessment, screening, diagnoses, and treatment decisions as well as assessment of data quality and potential biases of these data sets, developed algorithms and implementation to prevent adverse consequences for populations that experience health disparities are needed.

    Research Objectives

    This funding opportunity announcement (FOA) seeks to support multidisciplinary research that examines the impact of leveraging health information technology (health IT) to reduce disparities in access to care, quality of care, patient-clinician communication, and health outcomes for populations that experience health disparities in the U.S. Projects should include a focus on one or more NIH-designated health disparity populations in the United States, which include Blacks/African Americans, Hispanics/Latinos, American Indians/Alaska Natives, Asians, Native Hawaiians and Pacific Islanders, socioeconomically disadvantaged populations of any race, underserved rural populations, and sexual and gender minorities living in the 50 states, the District of Columbia, tribal lands, and the U.S. territories. Projects that include populations that identify across more than one population with health disparities are encouraged. Projects should involve collaborations from relevant stakeholders, health disparity population groups such as academic researchers, administrators and leaders of healthcare systems or clinics, clinicians caring for the patients from populations that experience health disparities, and patient advisory and advocacy groups.

    Research encouraged under this FOA includes multi-level (e.g., patient, clinician, and health care system) approaches to develop interventions that leverage health IT tools to improve the health outcomes of populations that experience health disparities. Please refer to the NIMHD Research Framework for additional detail. Lessons learned through this initiative can help build the research evidence regarding health IT approaches to improve health outcomes for populations that experience health disparities.

    Applicants are strongly encouraged to assess social determinants of health as appropriate using the measures available in the Social Determinants of Health Collection of the PhenX Toolkit previously vetted by the NIMHD led workgroup.

    Research Methodology

    This funding opportunity announcement (FOA) seeks to support the use of clinical trials, comparative effectiveness research, observational studies, and implementation science to examine the impact of leveraging health information technology (health IT) to reduce disparities in access to care, quality of care, patient-clinician communication, and health outcomes for populations that experience health disparities in the U.S.

    Projects that focus exclusively on mHealth interventions at the patient level (e.g., the use of fitness related mobile applications), in the absence of incorporation of health IT elements within a healthcare system, would not be considered a priority in this FOA.

    Projects that examine the financing of health care or the cost and efficiency of health care service delivery, without linking such economic analysis to measurable health outcomes, are considered outside of NIH's mission, and will not be supported. See NOT-OD-16-025 for more information.

    National Institute on Aging (NIA) is interested in:

    • Studies that utilize the NIA Framework on Health Disparities to evaluate health IT interventions among older adults.
    • Studies that can identify and facilitate the integration of core data elements related to social determinants of health and adverse childhood experiences, and family-level data of relevance to patient health, safety, and risks and that would be relevant to care plan implementation (for both chosen and biological families).
    • Development of EHR-integrated family-centered goal-setting andadvance care and financial planning tools.
    • Research that can improve the detection of bias in phenotypingalgorithms in diagnosis and clinical care plans.
    • Integration of cohort-sensitive sexual orientation and gender identity measures in the development of care plans for older adults.
    • Research that can assess the quality and extent to which EHR clinical communication informs clinical testing, diagnostic and treatment decision making, care plan adherence, and patient outcomes, for clinical communications involving patients and/or caregivers.
    • Evaluation of health IT interventions among people living with Alzheimer’s Disease and Related Dementias.
    • Health IT interventions that leverage health IT to reduce disparities among people living with Alzheimer’s Disease and Related Dementias.

    NIMHD Areas of Special interests include but are not limited to the following:

    • Interventions that address the utility and impact of including SDoH and community level geocoded data and/or perceived community level measures in EHRs on the health outcomes of populations affected by health disparities.
    • Evaluation of when in the clinical workflow would SDoH and community level geocoded data in EHRs have the most beneficial impact on health outcomes and evaluation of unintended adverse effects (e.g., stigma) of incorporating SDoH in EHRs.
    • Interventions that address the addtional health literacy and numeracy demands of EHR driven conversations on shared decision making, quality of patient-clinician communication, and health outcomes; types of interventions and personalize tailoring needed to foster engagement of patients with EHR portals for communication and access to PHRs to encourage informed shared decisions and quality of communication between patient and clinician in a sustained and relevant way.
    • Examination of the differences in adoption rates of patient access to portals for communication and review of PHRs-including addressing reasons (e.g., distrust of medical research, privacy) - among older users, rural residents, low-income patients, persons with LEP and/or limited health literacy, and racial/ethnic minority patients.
    • The unintended consequences of EHR use on patient – clinician and clinician-clinician communication and relationships, and health outcomes among populations affected by health disparities; The impact of using automated algorithms (ML/AI) to inform disease risk assessment, detection, diagnoses, and treatment decision-making on disparities in healthcare quality or outcomes.
    • Interventions to utilize patient generated health data (PGHD) which can include NIH patient-reported outcomes measures, (e.g., www.nihpromis.org), in ambulatory care practices to improve health outcomes.
    • Interventions to address clinician and patient burden, caregiver burden, poor usability, and workflow integration faced by clinicians to effectively utilize PGHD in clinics.
    • Evaluation of telehealth policies (e.g., regulatory waivers issued by the Centers for Medicare and Medicare Services; Accountable Care Organization/ACO payment model; credentialing of clinicians/care team delivering telehealth services) on access to care.
    • Impact of telehealth care delivery models on quality of care, health outcomes, healthcare utilization, patient self-management/decision making, and costs.
    • Interventions to address the challenges, including SDoH and health literacy, that can impact telehealth engagement and adherence to treatment plans.
    • Multi-level (patient, caregivers or support system of patient, clinicians, and health care system) interventions that leverage health IT to improve the care of complex chronic diseases in diverse primary care settings – including safety net clinics and patient-centered medical home (PCMH).
    • Intervention studies of leveraging health IT for quality improvement in less resourced primary care practices.
    • Intervention studies of EHRs/CDS use to manage care in diverse settings (e.g., small practices, rural settings, safety net clinics) and the usability of these tools to determine what is working &and what is missing in reducing disparities in quality of care and outcomes, as well as to improve patient safety (e.g., identification of patients at risk for medication errors/care delays; reduction of diagnostic errors; patients at risk of low or inadequate adherence to medical therapy; patients at increased risk of drug-drug interactions and medication adverse events).
    • Enable interoperability of health IT tools (e.g., mobile apps, wearables, and other devices) with EHR systems to support the integration across high and low-resource clinical settings, health care systems- including communication between different segments of health care such as pharmacy chains with providers- to screen, communicate, share data, and enhance decision support for patients and providers.
    • Advance human-centered design methodologies/novel approaches of tailoring innovations to fit end-users to develop multilevel communication tools to translate, transcribe, and analyze patient information into digital platforms.

    Specific Areas of Research Interest for National Cancer Institute (NCI)

    The National Cancer Institute encourages applications designed to study the impact of leveraging health IT tools (including, but not limited to, electronic medical records, patient portals, telehealth, and digital health tools, if data are linked to health system tools following the scope of this PAR) to reduce cancer health disparities and promote health equity. NCI is interested in research across the cancer control continuum, including cancer prevention, detection, diagnosis, treatment, survivorship, or end-of-life. Studies that incorporate two or more of the following levels of influence on cancer control outcomes are a priority: individual (patient, caregiver, clinical provider), family, clinical team, health care institution, community, and policy environment. Studies should focus on improving cancer-related health communication; healthcare delivery processes including coordination of cancer care, collaboration and other teamwork processes; behavioral and health outcomes; access to care across the cancer control continuum; or quality of cancer-related care among populations affected by cancer health disparities. Studies that examine whether health IT tools can be leveraged to address structural barriers to equitable cancer care are within scope. Studies that examine the efficacy, acceptability, and implementation of health IT tools to reduce digital, communication, and health inequalities, with consideration for usability and clinical workflow integration in cancer-related care, are encouraged.Studies that evaluate patient-centered, clinician and patient facing health IT to improve cancer-related outcomes and healthcare services are also encouraged. Studies may examine the adoption and adaptation of cancer-focused evidence-based interventions in health IT platforms or the scale up and implementation of cancer-focused evidence-based health IT interventions. NCI encourages intervention components to be clearly specified and guided by theory, and disparities and inequalities defined within the scope of this PAR. Mixed methods study designs and practitioner engaged approaches are within scope. NCI encourages studies to consider the influence of social determinants of health (e.g., broadband access, health literacy, healthcare access, structural racism and bias) on health IT interventions, and efforts to mitigate unintended consequences for health IT interventions to exacerbate health inequalities.

    Note, NCI’s definition for health disparities and health equity: https://cancercontrol.cancer.gov/hdhe/about/background

    Specific Areas of Research Interest for National Eye Institute (NEI)

    The National Eye Institute (www.nei.nih.gov) supports basic and clinical research into diseases and disorders of the visual system and the special needs of people with impaired vision or who are blind. NEI is particularly interested in research of improved methods for delivering vision care and rehabilitation in underserved populations including people in urban and rural settings. Research topics may include but are not limited to telemedicine, screening and automated diagnosis, medication adherence, quality of life, and rehabilitation strategies for those with vision loss.

    NEI would only support clinical trial applications for this FOA that fulfill the NIH requirements for either a mechanistic or minimal risk trials. A mechanistic trial is designed to understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention. A minimal risk trial is one in which the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

    Specific Areas of Research Interest for National Institute of Mental Health (NIMH) in the Division of Services and Intervention Research (DSIR)

    NIMH encourages research that addresses the institute’s scientific priorities, including the National Advisory Mental Health Council workgroup report on Opportunities and Challenges of Developing Information Technologies on Behavioral and Social Science Clinical Research and NOT-MH-18-031. NIMH encourages research that is aligned with these recommended areas for domestic non-AIDS and AIDS-related mental health research. All applications to NIMH involving clinical trials are expected to follow the NIMH mechanism-based, experimental therapeutics approach to intervention development and testing (see Support for Clinical Trials at NIMH and contact NIMH program staff for more information about NIMH clinical trials practices and research priorities).

    NIMH encourages a deployment-focused model of intervention and services design and testing that takes into account the perspective of relevant stakeholders (e.g., service users, providers, administrators, payers) and the key characteristics of the settings (e.g., resources, including workforce capacity; existing clinical workflows) that are intended to implement mental health interventions. This attention to end-user perspectives and characteristics of intended clinical and/or community practice settings is intended to ensure the resultant interventions and service delivery strategies are acceptable to consumers and providers, the approaches are feasible and scalable in the settings where individuals are served, and the research results will have utility for end users.

    NIMH’s DSIR areas of interest include, but are not limited to, research focused on the following:

    • evaluating health IT tools to address disparities in the early detection and treatment of mental illnesses and suicide risk.
    • optimizing and testing health IT tools to address factors perpetuating disparities in mental health service access, engagement, quality, and health outcomes across diverse settings.
    • evaluating health IT tools to improve equity in the detection and treatment of the general health of people with serious mental illness and to address disparities in premature mortality in this population.
    • examining health IT tools to help promote equity in the rapid identification of people with early psychosis and to facilitate timely engagement in evidence-based Coordinated Specialty Care.
    • developing and testing health IT tools that support shared decision making to improve equity in the availability and delivery of appropriate, high quality mental health care.
    • optimizing the integration of information regarding psychiatric/suicide risk, including crisis services information (e.g., emergency services (ED or 911) or crisis center encounters and assessments; safety plans; precipitating stressors such as housing or food insecurity, etc.) to improve coordination, continuity, and overall quality of mental health services.
    • examining the impact of integrating individual- and/or community-level SDoH in heath IT systems on the mental health services outcomes of populations affected by heath disparities.
    • examining sources of bias in ML/AI applications and related approaches that utilize health information and other data and developing strategies to facilitate accuracy and fairness in predictive algorithms and other AI-based health IT tools to improve disparities in mental health services outcomes and related morbidity and mortality (e.g., suicide).
    • developing and testing stakeholder-informed decision-making tools, and evaluating the implementation, adoption, and systems integration of ML/AI algorithms within existing clinic workflows (e.g., for detection and treatment of mental disorders, comorbidities such as substance use, and suicide risk) to reduce health care inequalities.
    • leveraging health IT data by integrating additional data sources (e.g., geolocation data, social media streams) to investigate of the role of social (e.g., stigma), economic (e.g., employment), and structural factors (e.g., structural racism and discrimination, geographic and neighborhood factors) on the uptake of HIV testing, preexposure prophylaxis (PrEP) and other biomedical HIV prevention strategies among individuals from high-incidence populations.
    • investigating health IT tools, including the ongoing identification, mitigation, and elimination of implicit biases, to optimize PrEP access, uptake, and retention in hard-to-reach populations.
    • optimizing telehealth care delivery models to increase access to HIV prevention and care services in underserved populations.
    • leveraging patient perspectives in evaluating the implementation, adoption, and systems integration of ML/AI algorithms within existing HIV clinic workflows to reduce health care inequalities.
    • leveraging health IT data by integrating additional data sources (e.g., geolocation data, social media streams) to investigate of the role of social (e.g., stigma), economic (e.g., employment), and structural factors (e.g., structural racism and discrimination, geographic and neighborhood factors) on the uptake of antiretroviral therapy (adherence or persistence) among people living with HIV from marginalized communities.
    • examining health IT tools used to assess, monitor, and support antiretroviral adherence and treatment that considers privacy, confidentiality, and equitable access for people living with HIV.
    • examining the impact of using ML/AI algorithms to inform HIV risk assessments, diagnoses, and treatment decision-making on disparities in healthcare quality or outcomes.

    Specific Areas of Research Interest for The National Library of Medicine (NLM)

    • The National Library of Medicine (NLM) is interested in submissions that incorporate innovative biomedical informatics and data science approaches that harness the digital healthcare ecosystem and have 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 approaches (e.g., clinical decision support systems and machine learning/artificial intelligence applications) that account for systematic biases and blind spots in health data and leads to tools and approaches that are accurate for all patient populations

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

    Section II. Award Information

    Funding Instrument

    Grant: A support mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity.

    Application Types Allowed
    New
    Renewal
    Resubmission

    The OER Glossary and the SF424 (R&R) Application Guide provide details on these application types. Only those application types listed here are allowed for this FOA.

    Clinical Trial?

    Optional: Accepting applications that either propose or do not propose clinical trial(s).

    Funds Available and Anticipated Number of Awards

    The number of awards is contingent upon NIH appropriations and the submission of a sufficient number of meritorious applications.

    Award Budget
    Application budgets are not limited but need to reflect the actual needs of the proposed project.
    Award Project Period

    The scope of the proposed project should determine the project period. The maximum project period is 5 years. 

    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

    Eligible Organizations

    Higher Education Institutions

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

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

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

    Nonprofits Other Than Institutions of Higher Education

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

    For-Profit Organizations

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

    Local Governments

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

    Federal Governments

    • U.S. Territory or Possession

    Other

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

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

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

    Foreign components, as defined in the NIH Grants Policy Statement, are not allowed. 

    Required Registrations

    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. SAM registrations prior to fall 2021 were updated to include a UEI. For applications due on or after January 25, 2022, the UEI must be provided on the application forms (e.g., FORMS-G); the same UEI must be used for all registrations, as well as on the grant application.
      • Dun and Bradstreet Universal Numbering System (DUNS) – Organization registrations prior to April 2022 require applicants to obtain a DUNS prior to registering in SAM. By April 2022, the federal government will stop using the DUNS number as an entity identifier and will transition to the Unique Entity Identifier (UEI) issued by SAM. Prior to April 2022, after obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
    • eRA Commons - Once the unique organization identifier (DUNS prior to April 2022; UEI after April 2022) is established, organizations can register with eRA Commons in tandem with completing their full SAM and 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.

    Eligible Individuals (Program Director/Principal Investigator)

    Any individual(s) with the skills, knowledge, and resources necessary to carry out the proposed research as the Program Director(s)/Principal Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to develop an application for support. Individuals from underrepresented racial and ethnic groups as well as individuals with disabilities are always encouraged to apply for NIH support.

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

    2. Cost Sharing

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

    3. Additional Information on Eligibility

    Number of Applications

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

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

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

    Section IV. Application and Submission Information

    1. Requesting an Application Package

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

    2. Content and Form of Application Submission

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

    Page Limitations

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

    Instructions for Application Submission

    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.

    SF424(R&R) Senior/Key Person Profile

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

    R&R or Modular Budget

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

    R&R Subaward Budget

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

    PHS 398 Cover Page Supplement

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

    PHS 398 Research Plan

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

    Research Strategy. Describe how the project will contribute to understanding the impact of leveraging health technology (health IT) to reduce health disparities among  populations affected by health disparities. Identify populations affected by health disparities  included in the study and provide a rationale for this population focus. Describe how the project uses a multidisciplinary approach, including integration of the disciplines and expertise of the research team, to understand the challenges of leveraging health IT to reduce disparities in access to care, delivery of higher quality of care, improving patient – clinician communication, and health outcomes for minority health and populations affected by health disparities in the U.S.  If there are foreign component(s), describe how the proposed activities at foreign sites will improve minority health and/or help reduce health disparities in the United States.

    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.

    The following modifications also apply:

    • All applications, regardless of the amount of direct costs requested for any one year, should address a Data 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 fieldof 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 (DUNS number or UEI as required) provided on the application is the same number 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.

    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.

    In addition, for applications involving clinical trials:

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

    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.

    Overall Impact

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

    Scored Review Criteria

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

     

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

    In addition, for applications involving clinical trials

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

     

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

    In addition, for applications involving clinical trials

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

     

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

    In addition, for applications involving clinical trials

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

     

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

    If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/gender, race, and ethnicity, as well as the inclusion or exclusion of individuals of all ages (including children and older adults), justified in terms of the scientific goals and research strategy proposed?

    In addition, for applications involving clinical trials

    Does the application adequately address the following, if applicable

    Study Design

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

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

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

    Data Management and Statistical Analysis

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

     

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

    In addition, for applications involving clinical trials

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

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

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

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

    Additional Review Criteria

    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.

     

    Specific to applications involving clinical trials

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

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

     

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

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

     

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

     

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

     

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

     

    For Resubmissions, the committee will evaluate the application as now presented, taking into consideration the responses to comments from the previous scientific review group and changes made to the project.

     

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

     

    Not applicable

    Additional Review Considerations

    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.

     

    Not applicable

     

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

     

    Reviewers will comment on whether the following Resource Sharing Plans, or the rationale for not sharing the following types of resources, are reasonable: (1) Data Sharing Plan; (2) Sharing Model Organisms; and (3) Genomic Data Sharing Plan (GDS).

     

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

     

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

    2. Review and Selection Process

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

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

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

    Applications will be assigned on the basis of established PHS referral guidelines to the appropriate NIH Institute or Center. Applications will compete for available funds with all other recommended applications. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
    • Scientific and technical merit of the proposed project as determined by scientific peer review.
    • Availability of funds.
    • Relevance of the proposed project to program priorities.

    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:

    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 must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identify, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. 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.

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

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

    Cooperative Agreement Terms and Conditions of Award

    Not Applicable

    3. Reporting

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

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

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

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

    Section VII. Agency Contacts

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

    Application Submission Contacts

    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: http://grants.nih.gov/support/ (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: GrantsInfo@nih.gov (preferred method of contact)
    Telephone: 301-637-3015

    Grants.gov Customer Support (Questions regarding Grants.gov registration and Workspace)
    Contact Center Telephone: 800-518-4726
    Email: support@grants.gov

    Scientific/Research Contact(s)

    Yewande A. Oladeinde, Ph.D.
    National Institute on Minority Health and Health Disparities (NIMHD)
    Telephone: 301-402-4307
    Email: yewande.oladeinde@nih.gov

    April Oh, Ph.D., MPH

    National Cancer Institute (NCI)

    Telephone: 240-276-6709

    Email: April.oh@mail.nih.gov

    NLM - NATIONAL LIBRARY OF MEDICINE
    Phone: 301.761.6249
    E-mail: sufianm@mail.nih.gov

    Christine M. Ulbricht, Ph.D.
    National Institute of Mental Health (NIMH)
    Telephone: 301-480-6928
    Email: christine.ulbricht@nih.gov

    James Gao
    NEI - NATIONAL EYE INSTITUTE
    Phone: 301.594.6074
    E-mail: james.gao@nih.gov

    Lori A J. Scott-Sheldon, Ph.D.

    National Institute on Mental Health (NIMHD).

    Telephone: 301-792-2309

    Email: lori.scott-sheldon@nih.gov.

    Christopher Barnhart, PhD
    Sexual & Gender Minority Research Office (SGMRO)
    Telephone: 301-594-8983
    Email: christopher.barnhart@nih.gov

    Meryl Sufian
    NLM - NATIONAL LIBRARY OF MEDICINE
    Phone: 301.761.6249
    E-mail: sufianm@mail.nih.gov

    Tiffani Bailey Lash
    National Institute of Biomedical Imaging and Bioengineering (NIBIB)
    Phone: 301-451-4778
    E-mail: baileyti@mail.nih.gov

    Priscilla Novak, PhD MPH
    Program Official
    Email: Priscilla.Novak@nih.gov
    Phone 301-496-3136
    Division of Behavioral and Social Research
    National Institute on Aging

    Christine M. Ulbricht, Ph.D.
    National Institute of Mental Health (NIMH)
    Telephone: 301-480-6928
    Email: christine.ulbricht@nih.gov

    James Gao
    NEI - NATIONAL EYE INSTITUTE
    Phone: 301.594.6074
    E-mail: james.gao@nih.gov

    Heather D'Angelo, Ph.D.
    National Cancer Institute (NCI)
    Telephone: 240-276-6597
    Email: heather.dangelo@nih.gov 

    Peer Review Contact(s)

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

    Financial/Grants Management Contact(s)

    Priscilla Grant, J.D.

    National Institute on Minority Health and Health Disparities (NIMHD)
    Telephone: 301-594-8412
    Email: grantp@mail.nih.gov


    Crystal Wolfrey

    National Cancer Institute

    Telephone: 240-276-6277

    Email: wolfreyc@gab.nci.nih.gov

    Katie Ellis
    National Institute of Biomedical Imaging and Bioengineering (NIBIB)
    Phone: 301-451-4791
    E-mail: kellis@mail.nih.gov

    Terri Jarosik
    National Institute of Mental Health (NIMH)
    Telephone: 301-443-3858
    Email: tjarosik@mail.nih.gov

    Karen Robinsonsmith
    NEI - NATIONAL EYE INSTITUTE
    Phone: (301) 451-2020
    E-mail: kyr@nei.nih.gov

    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.

    Authority and Regulations

    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.

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