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 Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute on Drug Abuse (NIDA)

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.

Division of Program Coordination, Planning and Strategic Initiatives, Office of Disease Prevention (ODP)
Office of Behavioral and Social Sciences Research (OBSSR)
Office of Research on Women's Health (ORWH)

Funding Opportunity Title
Health Services Research on Minority Health and Health Disparities (R01- Clinical Trial Optional)
Activity Code

R01 Research Project Grant

Announcement Type

Reissue of PAR-18-286

Related Notices

None

Funding Opportunity Announcement (FOA) Number
PAR-20-310
Companion Funding Opportunity

None

Catalog of Federal Domestic Assistance (CFDA) Number(s)

93.307; 93.273; 93.279; 93.313

Funding Opportunity Purpose

The purpose of this Funding Opportunity Announcement (FOA) is to encourage innovative health services research that can directly and demonstrably contribute to the improvement of minority health and/or the reduction of health disparities at the health care system-level as well as within clinical settings.

Key Dates

Posted Date
September 30, 2020
Open Date (Earliest Submission Date)
October 27, 2020
Letter of Intent Due Date(s)

Not Applicable

Application Due Date(s)

November 27, 2020; March 17, 2021; November 17, 2021; March 17, 2022; November 17 2022; February 17, 2023.

All applications are due by 5:00 PM local time of applicant organization. All types of non-AIDS applications allowed for this funding opportunity announcement are due on the listed date(s).

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.

AIDS Application Due Date(s)

November 27, 2021; March 17, 2021; November 17, 2021; March 17, 2022; November 17, 2022; March 17, 2023.

All applications are due by 5:00 PM local time of applicant organization. All types of AIDS and AIDS-related applications allowed for this funding opportunity announcement are due on the listed date(s).

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.

Scientific Merit Review

March, 2021; June, 2021; March, 2022; June, 2022; March, 2023; June, 2023.

Advisory Council Review

May, 2021; October, 2021; May, 2022; October, 2022; May, 2023; October, 2023.

Earliest Start Date

July, 2021; December, 2021; July, 2022; December, 2022; July, 2023; December, 2023.

Expiration Date
March 28, 2023
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

Purpose

Although scientific and technological discoveries have improved the health of the U.S. population overall, racial/ethnic minority populations, sexual and gender minority populations, socioeconomically disadvantaged populations, and underserved rural populations, continue to experience a disproportionate burden of disease and risk factors, unmet health care needs and other adverse health conditions.

As the Nation’s steward of biomedical and behavioral research, NIH has devoted considerable resources to characterize the root causes of health disparities, uncovering a complex web of interconnected and overlapping factors (i.e., biological, behavioral, environmental, and societal). As an important next step, research is needed that capitalizes upon knowledge about causal pathways to directly and demonstrably contribute to the reduction of health disparities. Of importance is research that moves beyond an exclusive focus on the health status of individuals to examine and address how larger systemic factors cause, sustain, or minimize health disparities in communities, regions, and the Nation as a whole. Disparities in health care are a clear contributor to disparities in health outcomes. Differences in health care utilization patterns and quality of care indicators between populations affected by health disparities and the general population have been well documented. More work is needed to understand how best to eliminate these inequities by understanding the causal mechanisms and evaluating the effectiveness of interventions. In addition, with the emerging Coronavirus disease 2019 (COVID-19) pandemic, differences in health care utilization patterns and quality of care need to be reevaluated and interventions to reduce health disparities generated by this pandemic and improve minority health need to be developed and evaluated.

The purpose of this FOA is to encourage health services research that can directly contribute to the improvement of minority health and/or the reduction of health disparities, while taking into consideration the interaction between system-level healthcare, individual clinical care and social determinants of health, including the role of structural systemic factors, place and neighborhood factors. The focus of this FOA is on all services provided in the healthcare setting where individuals from health disparity populations seek care with a clinician for preventive services, chronic disease management, urgent symptomatic care, emergency care, and hospital care. These health services do include tele-medicine or virtual or remote encounters and home visits.

Research Objectives

The overarching purpose of this FOA is to promote research to generate new knowledge to improve health care access, delivery, utilization and quality, and health outcomes of racial and ethnic minority populations and other groups affected by health disparities. Research encouraged under this FOA includes the examination of population-specific clinical presentation and/or manifestation of diseases and their complications within the context of health care settings; services within health care systems and non-clinical settings linked to health care systems (e.g. personal residences, school-based health centers, the workplace, and criminal justice settings); etiologies and reduction of health care disparities; structure and organization of health care systems and coordination of health care; impact of healthcare and non-healthcare policies on health care and health disparities; and system-wide interventions or multi-level interventions. Projects may address health services pertaining to health promotion, screening for disease or risk factors, prevention at any level, diagnosis and the treatment of particular health conditions (including chronic diseases, mental and substance abuse disorders, and infectious diseases such the 2019 Novel Coronavirus), specific segments of populations affected by health disparities (e.g. pregnant women, children, persons with disabilities, older adults), or more general indicators (e.g., access to primary care services or specialty care) that may not be condition-specific. Projects may include observational/descriptive, or interventional studies (including randomized clinical trials, pragmatic trials and others) and may involve primary data collection and/or secondary analysis of existing datasets. Projects should involve the use of relevant health system-level data in some way. Projects should include a focus on one or more NIH-designated US populations affected by health disparities, which include Blacks/African Americans, Hispanics/Latinos, American Indians/Alaska Natives, Asian Americans, Native Hawaiians and other Pacific Islanders, socioeconomically disadvantaged populations, underserved rural populations, and sexual and gender minorities. Projects that include populations that identify across more than one health disparity group are encouraged.

Applications Not Responsive to the FOA

The primary interest of this FOA is research on system-wide health services research that encompasses the diversity of individuals served within these health care systems. It is expected that projects will include patient or participant samples that are representative of the population served by the health care system(s) to be studied. Examples of projects that will not be considered responsive to this FOA include:

  • Projects that recruit participants from health care systems but do not involve the examination of the organization, processes of care, or service delivery of those systems.
  • Projects that rely exclusively on patient-reported data.
  • 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 (https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-025.html) for more information.

Note: Non-responsive applications will not be reviewed. Applicants are encouraged to reach out to scientific contacts for this FOA to discuss responsiveness.

Research Methodology

Examples of research methods could include, but are not limited to:

  • Cluster-randomized, randomized or practical clinical trials of the effectiveness of new or existing technologies (e.g., telehealth), non-technological interventions, and multi-level interventions that involve broad inclusion of patients from health disparity populations and addresses a disease or condition that disproportionately impacts health disparity populations (e.g., infectious diseases such as COVID-19, chronic diseases such as cancer, diabetes, cardiovascular conditions, asthma, and others, mental health/substance abuse disorders including perinatal depression, and maternal and infant mortality).
  • Studies that involve primary data collection to study emerging challenges to the health care system.
  • Use of large-scale longitudinal data sets, data mining techniques, registries, and integration of quantitative and qualitative analytical frameworks and techniques to address and inform implementation of interventions addressing health services research in minority health and health disparities.
  • Prospective studies evaluating patient-clinician communication factors in the care of patients from health disparity populations across the spectrum of clinical care.
  • Decision science modeling and analysis, including system dynamics modeling, network analysis, and agent-based modeling to investigate social determinants of health and how clinical care interacts with other sectors (e.g., housing, food insecurity, employment) to influence health outcomes for health disparity populations.
  • Models that hierarchically connect information at different levels of NIMHD's research framework and differentiate between individual and structural factors.
  • Partitioning and decomposition methods that have a high potential in identifying causes of health care and health disparities.
  • Prospective or retrospective studies of the adoption, implementation, and sustainability of healthcare and non-healthcare policies and their interaction with programs and contextual factors, and assessment of their influence on health disparities.
  • Participatory engagement of stakeholders (hospitals, clinical facilities, patients and caregivers, medical groups, clinicians, clinical care teams, community groups, administrators, policymakers) in the formulation of the research and to the extent necessary, in the implementation of the research.
  • The ability to conduct subpopulation analysis to determine which interventions work best for specific population groups (e.g. Hispanic or Latino subpopulations, Asian subpopulations, Pacific Islander subpopulations), including medically underserved and under-represented groups with the intent to focus on reduction of health disparities.
  • Economic evaluations of interventions (e.g., cost-effectiveness and cost-benefit analyses).
  • Multi-level interventions that address system, clinician, patient and community factors are of interest and encouraged.

Areas of Research Interest

Research topics of interest include but are not limited to:

  • Research to understand and address population-specific clinical presentation and/or manifestation of diseases, and their complications and differences in response to treatment among populations affected by health disparities. For example, identifying optimal screening criteria to determine disease risk, tailoring disease management strategies or biomarkers, based on clinical presentation of diseases and their complications, or findings from interventions or clinical trials assessing differences in response to treatment (e.g., precision medicine).
  • Studies of strategies to ensure that populations affected by health disparities receive preventive, screening, diagnostic and treatment services consistent with national evidence-based recommendations in clinical settings (including rural health care settings), especially for conditions of greatest burden, such as but not limited to diabetes mellitus, coronary artery disease, cancer, cerebrovascular disease, cognitive impairment or dementia, asthma, mental and substance use disorders, perinatal physical and mental health complications, and infectious diseases such as the 2019 Novel Coronavirus Pandemic.
  • Studies of strategies to ensure that vulnerable groups (e.g., pregnant women, women with severe maternal physical and mental morbidity, infants and children with complex medical care needs, older adults, persons with disabilities) within populations affected by health disparities receive preventive, screening, diagnostic, and treatment services consistent with national evidence-based recommendations, and recommended support services outside clinical settings.
  • Studies of strategies to effectively identify and treat common risk factors or causes of maternal and infant mortality and severe maternal physical and mental health morbidity in populations affected by health disparities.
  • Studies of strategies to improve patient safety and reduce medical errors, including adverse events related to medications, devices and medical and/or surgical procedures, in populations affected by health disparities.
  • Studies on the effects of emerging infectious diseases such as the COVID-19 pandemic on disparities in health care utilization and health outcomes among medically vulnerable populations such as institutionalized and non-institutionalized older adults; persons with chronic conditions, mental health and/or substance abuse disorders, complex medical needs, and/or with compromised immune system function; and pregnant women. In addition, examine the effects of these infectious diseases on disparities in health care utilization and health outcomes among socially vulnerable populations such as the homeless, the recently incarcerated, immigrants, persons with disabilities, and children.
  • Studies on the effects of the COVID-19 pandemic on disparities in access to care and quality of care for health disparity populations, taking into account how it impacts the structure and organization of different health care systems that serve health disparity populations, including those living in rural areas.
  • Development and assessment of innovative preventive or health promotion interventions (e.g., health education, wellness programs, early screening, immunizations/vaccinations) delivered within the health care system, including underserved rural health care settings, and targeting populations affected by health disparities.
  • Research on innovative models of health care delivery in rural areas and their impact on health outcomes. Examples include integration and coordination of delivery of services between rural community health clinics and larger health care hubs, use of telehealth or other telecommunication to coordinate care between local primary clinics and nearest large health care system, coordination and communication between stand-alone emergency rooms, birth centers and other stand-alone services and regional health care hubs, and integration of pharmacies and other community resources (e.g., fire stations, schools) in health promotion strategies.
  • Assessment of initiatives that integrate social determinants of health with other health care data and their impact on health care access and health outcomes of populations affected by health disparities.
  • Studies of strategies to improve the quality of health care for populations affected by health disparities, including emerging innovative strategies such as but not limited to evidence-based health care safety bundles for specific conditions, health improvement collaboratives, and innovative primary care models.
  • Research to understand factors that trigger, facilitate, or deter engagement/partnership of patients from populations affected by health disparities in clinical care across the care cascade (screening, diagnosis, engagement in care, treatment adherence), and assessment of the impact of interventions to enhance patient engagement on health outcomes.
  • Research to identify patterns and elucidate mechanisms for different patterns of health care utilization, quality, and outcomes in populations affected by health disparities.
  • Assessment of the impact of the structure and organization of health care systems on health services utilization and health outcomes, including strategies to increase health equity.
  • Assessment of interventions to reduce clinician and/or health care system bias and examining how these interventions impact quality of care, patients’ health outcomes, and health and health care disparities.
  • Analysis of how racism and other types of discrimination at multiple levels (structural, institutional, and personally mediated) in the health care system influence minority health and/or health disparities in relation to outcomes.
  • Incorporation of specific research tools or methodologies into system-level service delivery practices that identify or measure patient-reported outcomes, such as health-related quality of life, preference-based decision making, functional status, symptoms, and adherence in populations affected by health disparities, within the context of assessing clinical and/or services outcomes.
  • Analysis of initiatives to increase the supply of and access to health care practitioners (including allied health professionals, paraprofessionals or peer-led health services) in medically underserved areas, including underserved rural areas.
  • Studies of strategies to manage, finance, and deliver health care to improve minority health or reduce health disparities.
  • Analysis of local, state, or national healthcare and non-healthcare policies that increase or reduce health care and health disparities, such as those related to insurance coverage or reimbursement, sick leave policies, family and medical leave policies, language access policies, and the organization of government-run or -funded health care services.
  • Research to examine the role of federal, state and local policies in different sectors (e.g., health care, labor, transportation, housing) in exacerbating or reducing the impact of the COVID-19 pandemic, chronic medical conditions, or other diseases that have disproportionate effects on minority health and health disparities.
  • Research to understand or improve formal care for populations affected by health disparities in community-based mental health and drug treatment settings, including clinics, private practice settings, residential treatment facilities, and detoxification centers.
  • Studies of strategies to implement health promotion, prevention, screening, early detection, and diagnostic interventions, as well as effective treatments.
  • Studies of clinical procedures or guidelines into existing care systems such clinician or health care system decision-making about advanced ventilatory support for patients with severe advanced COVID-19 or other acute severe diseases with high mortality.
  • Studies that evaluate community-level strategies by health care systems to address social determinants of health and reduce health disparities, including intersectoral partnerships with social services, urban planning, transportation, criminal justice system, and community service organizations.
  • Studies of the implementation of multiple evidence-based practices within community or clinical settings to meet the needs of patients with complex medical needs.

Specific Areas of Research Interest for NIAAA:

  • Evaluation of screening, brief intervention, and referral to treatment (SBIRT) and treatment retention and relapse rates in health disparity populations and identifying strategies for improving these.
  • Assessment of stigma and bias as they relate to healthcare quality, health systems delivery, and access to care in health disparity populations, their impact, and interventions to address this impact.
  • Analysis of differences in rates of fetal exposure to alcohol and FASD between health disparity populations and identifying strategies for reducing prenatal exposure in health disparity populations.
  • Evaluation of the ways in which dissemination and implementation of evidence-based strategies for prevention and treatment of alcohol-related problems may be tailored to improve outcomes in health disparity populations.
  • Evaluation of how the determinants of health disparities (i.e., environmental, social, biological/genetic, psychosocial, and economic) are associated with disparities in healthcare quality, health systems delivery, and access to care in health disparity populations.

Specific Areas of Research Interest for ODP:

The Office of Disease Prevention (ODP) serves as the liaison office for the NIH to the USPSTF. As such, the ODP encourages trans-NIH collaborations to address prevention research gaps. For example, the U.S. Preventive Services Task Force has recommended lung cancer screening with low radiation dose CT (LDCT) for adults at increased risk since 2013. But uptake of this recommended preventive service in the population eligible for screening is very low. An estimated 136,000 people are expected to die of lung cancer disease in 2020, and the burden of lung cancer is higher in African Americans, in members of other minority groups, and in adults ages 65 and older. Thus, the NIH ODP is interested in implementation research studies that identify effective ways to increase discussions about and encourage appropriate use of LDCT screening among NIH-designated U.S. health disparity populations affected by health disparities, especially African American (see https://www.nimhd.nih.gov/about/overview/ for more information about NIH-designated U.S. disparity populations).

One of the Office of Disease Prevention’s strategic priority areas is to promote the best available methods in prevention research. The ODP encourages applications using interventions or observational research designs that have strong implications for disease prevention and make use of innovative design, measurement, and analytic methods. In the context of this FOA, examples of research areas of interest include, but are not limited to:

  • Hybrid implementation science-based studies that test novel approaches to implement evidence-based clinical guideline recommendations for lung cancer screening with low radiation dose CT (LDCT) in adults from U.S. health disparity populations with increased risk (e.g., African Americans ages 65 and older).
  • Studies to integrate and/or improve understanding of how to effectively tailor the implementation of evidence-based home visiting, community health worker, and patient navigation programs to adequately address chronic health issues in underserved populations.
  • Research that focuses on strategies for increasing adoption of shared-decision making curricula among medical, nursing, and allied health professionals in clinical or community settings.
  • Studies to further refine and integrate evidence-based point of care diagnostics and digital screening tools for early and accurate disease detection.
  • Studies to optimize and scale up delivery of proven-effective digital technologies (e.g., smartphones, text messaging, etc.) that extend the reach and uptake of established digital health interventions to improve health and healthcare delivery in medically underserved geographic areas and populations.

Design, Analysis, and Sample Size Considerations for Studies to Evaluate Interventions:

Investigators seeking to evaluate the effect of an intervention on a health-related biomedical or behavioral outcome may propose a study design in which (1) groups or clusters are assigned to study arms and individual observations are analyzed to evaluate the effect of the intervention, or (2) participants are assigned individually to study arms but receive at least some of their intervention in a group format or through a shared facilitator. Designs that might be proposed include parallel group- or cluster-randomized trials, stepped-wedge group- or cluster- randomized trials, individually randomized group-treatment trials, multiple baseline designs, time-series designs, and other quasi-experimental designs. Whenever participants are assigned in groups or clusters (e.g., families, clinics, schools, worksites, communities), or participants receive some part of their intervention in a group format or through a shared facilitator, and observations on individual participants are analyzed for between-group effects, special methods are required for analysis and sample size. Applicants will need to show that their methods are appropriate given their plans for assignment of participants and delivery of interventions. Additional information is available at https://researchmethodsresources.nih.gov/.

Applications must also be relevant to the objectives of at least one of the participating NIH Institutes and Centers (IC) listed above. ODP does not award grants. Please contact the relevant IC program contact listed for questions related to IC research priorities and funding.

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)

Need help determining whether you are doing a clinical trial?

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.

  • Dun and Bradstreet Universal Numbering System (DUNS) - All registrations require that applicants be issued a DUNS number. 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.
  • 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.
  • eRA Commons - Applicants must have an active DUNS number to register in eRA Commons. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration, but 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 DUNS number and 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.  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 NOT-OD-11-101).

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:

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.

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 Component of the SF424(R&R) Application Package. 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 DUNS number it provides 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 and responsiveness by components of participating organizations, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

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. 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.

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.

Significance

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

 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 the trial needed to advance scientific understanding?

Investigator(s)

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

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

Innovation

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

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

Approach

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

If the project involves human subjects and/or NIH-defined clinical research, are the plans to address 1) the protection of human subjects from research risks, and 2) inclusion (or exclusion) of individuals on the basis of sex/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 proposing clinical trials: Does the application adequately address the following, if applicable:

Study Design

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

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

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

Data Management and Statistical Analysis

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

Environment

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

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.

 Study Timeline

Specific to applications proposing clinical trials: Is the study timeline described in detail, taking into account start-up activities, the anticipated rate of enrollment, and planned follow-up assessment? Is the projected timeline feasible and well justified? Does the project incorporate efficiencies and utilize existing resources (e.g., CTSAs, practice-based research networks, electronic medical records, administrative database, or patient registries) to increase the efficiency of participant enrollment and data collection, as appropriate? Are potential challenges and corresponding solutions discussed (e.g., strategies that can be implemented in the event of enrollment shortfalls?

Protections for Human Subjects

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

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

Inclusion of Women, Minorities, and Individuals Across the Lifespan

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

Vertebrate Animals

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

Biohazards

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

Resubmissions

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.

Renewals

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

Revisions

For Revisions, the committee will consider the appropriateness of the proposed expansion of the scope of the project. If the Revision application relates to a specific line of investigation presented in the original application that was not recommended for approval by the committee, then the committee will consider whether the responses to comments from the previous scientific review group are adequate and whether substantial changes are clearly evident.

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.

Applications from Foreign Organizations

  Not applicable.

Select Agent Research

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

Resource Sharing Plans

Reviewers will comment on whether the 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).

Authentication of Key Biological and/or Chemical Resources:

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

Budget and Period of Support

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

2. Review and Selection Process

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by 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 grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. 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.

Additionally, ICs may specify any special reporting requirements for the proposed clinical trial to be included under IC-specific terms and conditions in the NoA. For example: If the proposed clinical trial has elevated risks, ICs may require closer programmatic monitoring and it may be necessary to require the awardee to provide more frequent information and data as a term of the award (e.g., to clarify issues, address and evaluate concerns, provide documentation). All additional communications and information related to programmatic monitoring must be documented and incorporated into the official project file. 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 of all trials whether required under the law or not. For more information, seehttp://grants.nig.gov/ClinicalTrials_fdaaa/.

Institutional Review Board or Independent Ethics Committee Approval: Grantee institutions must ensure that the application as well as all protocols are reviewed by their IRB or IEC. To help ensure the safety of participants enrolled in NIH-funded studies, the awardee 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 athttp://grants.nih.gov/grants/policy/hs/data_safety.htmand 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, Grantees, and Activities. More information is provided at Award Conditions and Information for NIH Grants.

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. This includes ensuring programs are accessible to persons with limited English proficiency. 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 http://www.hhs.gov/ocr/civilrights/understanding/section1557/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 “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, awardees 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.

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for awardees of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All awardees 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 $25,000.  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 Appendix XII to 45 CFR Part 75, 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 – Award Term and Conditions 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: 301-945-7573

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)

Please direct all inquiries to the contacts in Section VII of the listed funding opportunity announcements with the following additions/substitutions:

NIMHD

Rada K. Dagher, PhD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-451-2187
rada.dagher@nih.gov (mailto:rada.dagher@nih.gov)

NIAAA

Laura E. Kwako, PhD
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-451-8507
Email: laura.kwako@nih.gov

NIDA

Minnjuan Flournoy-Floyd, Ph.D.
National Institute on Drug Abuse (NIDA)
Telephone: 301-827-6474
Email: minnjuan.flournoyfloyd@nih.gov

ODP

Melissa C. Green Parker, PhD
Office of Disease Prevention (ODP)
Telephone: 301-480-1161
Email: melissa.greenparker@nih.gov

OBSSR

Dara R. Blachman-Demner, Ph.D.
Office of Behavioral and Social Sciences Research (OBSSR)
Telephone: 301-496-8522
Email: dara.blachman-demner@nih.gov

OBSSR does not award grants. Please contact one of the IC program contacts listed above for questions regarding funding interest.

ORWH

Damiya E. Whitaker, Psy.D.
Office of Research on Women's Health (ORWH)
Telephone: 301-451-8206
Email: damiya.whitaker@nih.gov (mailto:damiya.whitaker@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
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8412
Email: pg38h@nih.gov

Judy Fox
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4704
Email: jfox@mail.nih.gov

Edith Davis
National Institute on Drug Abuse (NIDA)
Telephone: 301-827-6697
Email: edavis1@nida.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.


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