It is critical that applicants follow 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 the 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.

Part 1. Overview Information
Part 2. Full Text of the Announcement

Section I. Funding Opportunity Description
Section II. Award Information
Section III. Eligibility Information
Section IV. Application and Submission Information
Section V. Application Review Information
Section VI. Award Administration Information
Section VII. Agency Contacts
Section VIII. Other Information

Although scientific and technological advances have improved the health and wellbeing of the U.S. population overall, racial and ethnic minorities, socioeconomically disadvantaged, underserved rural and sexual and gender minority populations continue to experience a disproportionate share of many acute or chronic diseases and adverse health outcomes. It is critical to address health disparities and improve health for all Americans.

Several characteristics make addressing health disparities an especially challenging problem. The challenges lie in the interactions of influences at various levels (e.g., individual, interpersonal, family, community, societal), the diversity of the relevant mediators (e.g., exposures, resilience factors), and the multiple interacting mechanisms involved (e.g., biological, behavioral, environmental, sociocultural, and healthcare system). The array of determinants of health across levels and domains are depicted in the NIMHD Research Framework (https://www.nimhd.nih.gov/about/overview/research-framework.html). Systems science considers different components within complex systems across multiple levels to help understand their interactions and influences. The focus on single, independent risk factors often fails to capture the complexity of interactions between diverse factors in subtle, bidirectional, or non-linear ways to strongly influence overall behaviors and health outcomes. The dynamic relationship that unfolds when considering contextual factors that contribute to health inequities, such as neighborhood segregation, housing insecurity, food insecurity, neighborhood safety, social networks, and community disempowerment, cannot be fully captured with currently available data and analytic methods. Simulation Modeling and Systems Science (SMSS) provides avenues for modeling relevant multiple processes, testing plausible scenarios, understanding the magnitude of intended and unintended consequences of specific interventions, and having the option to adjust and refine simulated intervention designs prior to actual implementation testing in the real world. SMSS approaches have been used to guide interventions in clinical preventive care, disaster planning, and for analyzing national health reform strategies. They have also been used to model potential public health outcomes in cases where it is not feasible to test various intervention strategies on real populations, particularly where interventions may involve factors far upstream from health outcomes, such as societal causes embedded in political, legal, economic and cultural factors.

The importance of using SMSS to address population health has been highlighted in Institute of Medicine (IOM) reports, including: For the Public's Health: The Role of Measurement in Action and Accountability (2011) and Bridging the Evidence Gap in Obesity Prevention: A Framework to Inform Decision Making (2010). Moreover, results from simulation models developed under NCI's Cancer Intervention and Surveillance Modeling Network (CISNET) were used to inform guidelines issued by the U.S. Preventive Services Task Force (e.g., breast cancer screening and colorectal cancer screening). However, SMSS have not been widely adopted in health disparities research to help understand the causes of disparities, guide efficient interventions, and/or inform policy making.

Although no simulation models can replace real world settings or scenarios, many are becoming indispensable for decision making, such as national or local pandemic planning, and can have a profound impact on health policies relevant to minority health and health disparities. The field of SMSS may help to guide health disparities research, in identifying causal inference and what types of situations will be most amenable to research, policy, and practice interventions and in implicating where leverage may be best applied for any health disparity population. Electronic health records, mobile health technologies, smart devices, sensors, and high-end laboratory technologies have greatly expanded the availability of rich data for more accurate simulation and modeling under the systems perspective. Many innovative methods have been developed to help harmonize disparate data across diverse sources and guide informed decision making. Traditional study design and statistical methods need to be rethought in the context of big data and high-performance computing to tackle disparities among diverse populations including those with limited and small samples. Thus, it is important to advance SMSS using new big data technologies to understand the etiology of health disparities and guide intervention development and implementation.

SMSS are also highly relevant to late-stage translation research because they integrate information and evidence from various sources such as epidemiology, clinical guidelines, sociology, behavioral science, psychology, neuroscience, and economics, to formulate complex predictive models. The etiology, pathways, and mechanisms that result in health disparities mimic a complex adaptive system. Models of health disparities seek to illuminate critical elements and intervention points that can tip the system for improved health or provide insights into why health has not improved. Modeling multi-level interventions is important for addressing how the interactions and influences of health determinants function. SMSS offer an opportunity to explore the potentially complex influences on population health at each intervention level; within the classic implementation research paradigm this analysis is cost prohibitive. SMSS provide the platform to explore the space of possible combinations of interventions, integrate information, uncover synergies, and provide close-to-real-world predictions to guide decision making. Of importance is the ability to identify unanticipated implementation research strategies that may yield high return. SMSS approaches can answer the critical questions of what works, under what conditions, what strategies and combinations of strategies will yield innovative ways to address disparities. Also, other significant questions include: why something did not work as anticipated, and how could the intervention be modified to be more effective in addressing disparities.

• Foster trans-disciplinary partnerships and collaborations in understanding the etiology and causal pathways of health disparities using SMSS
• Use SMSS to identify modifiable barriers and cost-effective factors to reduce and eventually eliminate health disparities
• Provide evidence-based simulation or prediction of the impact of effective or ineffective health disparities interventions delivered in real-world settings
• Promote big data harmonization and novel analytic methods in SMSS to address minority health and health disparities

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

• System dynamics
• Network analysis
• Agent-based modeling
• Microsimulation
• Discrete event analysis
• Markov modeling

Applications should be relevant to the objectives of the funding opportunity announcement and to at least one of the participating institutes and offices' research interests. Researchers are strongly encouraged to review the general research interests of the participating ICs.

NIMHD is interested in several research priorities that could have significant impact on understanding and addressing minority health and health disparities using simulation modeling and systems science. The research must focus on one or more minority or health disparity populations (African Americans/Blacks, Hispanics/Latinos, American Indians/Alaska Natives, Asians, Native Hawaiians and Other Pacific Islanders, socioeconomically disadvantaged populations, underserved rural populations, and sexual and gender minority populations).

Examples of potential topic areas include but are not limited to:

• Models to explore mechanisms and pathways of health disparities using multiple socioecological levels
• Predictive models to improve clinical care coordination and integrate patient-centered health services for minority and health disparity populations
• Simulation modeling to identify and verify most appropriate population-specific screening or detection strategies on chronic diseases prevention
• Simulation modeling to identify and verify most appropriate population-specific evaluation and treatment strategies of chronic diseases that disproportionately affect disparity populations
• Models to inform improved multilevel, multi-factorial randomized controlled, comparative effectiveness, or pragmatic intervention designs aimed at addressing health disparities
• SMSS to improve implementation and dissemination of evidence-based primary care practice in rural and underserved communities
• Simulation modeling using big data and information technology for national and local disparity surveillance and monitoring

National Heart, Lung, and Blood Institute (NHLBI)

The NHLBI provides global leadership for a research, research training, and education program to promote the prevention and treatment of heart, lung, blood, and sleep diseases and enhance the health of all individuals so that they can live longer and more fulfilling lives. The NHLBI seeks applications that will address questions relevant to the NHLBI mission and should align with the NHLBI's Strategic Vision. The NHLBI has significant interests in implementation research for the prevention, control, and treatment of heart, lung, blood, and sleep disorders, particularly research that addresses the implementation of proven-effective, evidence-based interventions in clinical, community, and/or other settings; addresses impediments to uptake, scale up, and sustainability in various contexts; and/or examines disparities in disease burden, models possible treatment paradigms. Examples of potential topic areas include, but are not limited to:

• Studies modeling the effectiveness and cost-effectiveness of dissemination or implementation strategies to reduce health inequities in heart, lungs, blood or sleep disorders, and improve quality of care among rural, minority, low literacy and other underserved populations.
• Studies modeling the implementation of multiple evidence-based practices within community or clinical settings to meet the needs of complex patients and diverse systems of care within heart, lung, blood and sleep disorders.
• Studies modeling the magnitude and/or burden of HLBS diseases and disorders in global populations; simulation modeling and systems science studies to characterize global health inequities in heart, lung, blood and/or sleep disorders; modeling studies aimed at improving the quality of care among global populations in various settings (e.g., rural, minority, low literacy and other underserved populations) for HLBS diseases and disorders.
• Comparison studies of HLBS diseases and disorders between US and global populations simulating possible scenarios that could lead to significant reductions in disease burden for heart, lung, blood, and/or sleep disorders.
• Systems science studies to inform key implementation steps and challenges on decision models that assist states and communities in their efforts to promote effective implementation and dissemination of multi-pronged and coordinated approaches to promote prevention of heart, lung, blood, or sleep diseases and conditions
• Simulation modeling to identify key determinants for effective evidence-based interventions for heart, lung, blood, or sleep diseases (e.g., asthma, COPD, hypertension, Sickle Cell Disease, etc.) and their impact on morbidity, mortality, and cost of treatment per recommended guidelines.
• Studies modeling complex social/environmental heart, lung, blood, sleep health behaviors (e.g., diet, smoking, etc.) to identify underlying mechanisms and key leverage points for evidence-based interventions.
• Studies that model implementation of interventions targeting the same heart, lung, blood, or sleep risk factors, but that use different strategies (e.g., mass media campaigns vs. policy regulation, etc.) and which predict the critical elements for successful implementation of each intervention approach.

NCI is interested in modeling efforts that focus on explaining why disparities exist, how disparities can be alleviated in the future, what combination of cancer control activities (which are considered optimal for the general population) can be more appropriately tailored for the needs in specific populations. Of additional interest is the potential population impact of programs and interventions which have shown promise to reduce disparities in specific studies. While disparities will typically be studied in terms of standard racial/ethnic characterizations, modelers are encouraged to utilize data sources that will enable modeling in terms of other important factors such as income/education, insurance status, and geography (e.g., rural vs. urban). Applications are especially encouraged which link the upstream antecedents of disparities to the long term downstream outcomes. NCI’s interest focuses on modeling in two related domains:

• The upstream behavioral (including observable behavior, cognition and affective factors), geographic, cultural, political, economic, and organizational antecedents of disparities in smoking rates, obesity, and other risk factors; screening rates, follow-up to abnormal screening, treatment, and quality of care related to healthcare access and delivery; genetic predispositions and gene by environment interactions.
• The downstream consequences of disparities in cancer incidence, prevalence and mortality resulting from differences in behavioral risk factors, healthcare access and delivery, and genetic predispositions.

National Institute on Aging (NIA)

NIA is interested in using simulation modeling and systems science to understand aging changes across the lifespan or diagnosis and management of medical conditions common among the elderly. Examples of potential topic areas include those from NIHMD with specific aging focus but are not limited to:

• Predictive models to improve clinical care coordination and integrate patient-centered geriatric health services for older adults from racial and ethnic minority and disadvantaged populations.
• Models to inform improved multilevel, multi-factorial randomized controlled, comparative effectiveness, or pragmatic clinical trial intervention designs aimed at addressing health disparities in aging and life expectancy, especially in racial and ethnic minorities and socioeconomically disadvantaged groups
• Systems science to improve implementation and dissemination of evidence-based primary care and geriatrics practice in older adults from rural and underserved communities
• Simulation modeling using big data technology for disparity surveillance and reduction
• Understand environmental factors and related biological mechanisms that diminish health and reduce life expectancy for populations that experience health disparities
• Develop strategies to increase life expectancy and health span among aging adults and improve the health status of older adults from underserved and disadvantaged populations
• Research that explains the role of stress and/or resilience in the pathway linking environmental, sociocultural, and psychological and/or behavioral factors to health outcomes (e.g. mortality, cognitive impairment, multiple chronic conditions, disability, and quality of life) through biological pathways that include cellular and molecular mechanisms of biological aging (e.g. inflammation, immune-senescence, genetics/epigenetics), metabolic, cardiovascular, and neurobiological pathways(e.g. neuroimmune, neuroendocrine, and autonomic/sympathetic).

NIDCD is interested in supporting simulation modeling and systems science (SMSS) research projects to advance understanding of hearing impairment and other communication disorders that can lead to disparities and inequities in access and utilization of health care, rehabilitation treatments, and knowledge of preventive measures. Hearing impairment and other communication disorders are not rare in the U.S. population a conservative estimate is that 46 million Americans experience one or more communication disorders. Since communication disorders make the basic components of communication (sensing, interpreting, and responding to people and things in our environment) challenging, these disorders can not only compromise physical health, but also affect the emotional, social, recreational, educational, and vocational aspects of life. The effects often ripple out to affect families and social networks, including those at work and school. The total economic impact of communication disorders addressed by the NIDCD mission areas of hearing, balance, smell, taste, voice, speech and language with regards to quality of life and unfulfilled potential is substantial. The prevalence of communication disorders is expected to increase as the population ages, survival rates of medically fragile infants improve, and the numbers of children and adults affected by traumatic injuries and diseases increase. Examples of potential topic areas include but are not limited to:

• Predictive models to identify strategies and interventions that may be effective in reducing disparities and inequities and to assess the range of effects that may be associated with implementing such strategies and interventions;
• Multi-level models that illuminate interactions among distinct systems that increase or reduce disparity/inequity outcomes, potentially encompassing influences such as those exerted through education, neighborhood, family, cultural, religious, commercial, media, regulatory, and/or health care systems.
• Models that identify factors that create or exacerbate disparities and inequities in access to screening, intervention, referral to treatment, treatment for hearing impairment (including tinnitus and hyperacusis), balance/vestibular disorders, smell or taste impairment (including dysgeusia or phantosmia), and disorders of voice, speech and language.
• Examine existing and develop better aural rehabilitation strategies across the lifespan, including how aural rehabilitation strategies are affected by treating comorbid conditions that influence success, such as co-occurring issues in underserved children and adults from differing socio-cultural backgrounds with regards to hearing impairment, which may also be associated with cognitive decline (e.g., dementia), or chronic illness (e.g., diabetes).
• Implement practical approaches to screening for chemosensory disorders, i.e., the incidence, prevalence and associated risk factors for taste and smell loss and dysfunction. There is a need to integrate the use of standardized chemosensory measurement into the health care system (particularly for older adults) to facilitate appropriate advice, warnings and precautionary instructions that should be given to patients who suffer from chronic difficulty with odor identification or disturbances in smell perception (e.g., phantosmia) and taste loss or altered perception (e.g., dysgeusia). These problems likely have varying distributions and impact across minority and disadvantaged sectors of the population.

NIDA is interested in several research priorities that could have significant impact on understanding and addressing minority health and health disparities using simulation modeling and systems science.

• Studies modeling the effectiveness and cost-effectiveness of dissemination or implementation strategies to reduce health inequities in substance use disorder treatment and improve quality of treatment among rural, minority, and other underserved populations.
• Studies modeling the implementation of multiple evidence-based practices within community or clinical settings to meet the needs of complex patients and diverse systems of care in addiction.
• Systems science studies to inform key implementation steps and challenges on decision models that assist states and communities in their efforts to promote effective implementation and dissemination of multi-pronged and coordinated approaches to promote prevention and evidence-based treatment (e.g., Medication Assisted Treatment for opioid use disorders) of addiction.
• Simulation modeling to identify key determinants for effective evidence-based interventions for addiction (e.g., combination of behavioral treatments with medication assisted treatment) and their impact on morbidity, mortality, and cost of treatment.
• Studies modeling complex social/environmental factors that influence addiction to identify underlying mechanisms and key leverage points for evidence-based interventions.
• Studies that model implementation of interventions targeting the same addiction risk behaviors, but that use different strategies (e.g., mass media campaigns vs. policy regulation, etc.) and which predict the critical elements for successful implementation of each intervention approach.
• Predictive models to improve clinical care coordination and integrate patient-centered addiction services in primary care to reduce disparities.
• Predictive models to improve care coordination and integrate patient-centered addiction services in settings such as criminal justice and child welfare to reduce disparities.
• Multi-level models that illuminate interactions between or among distinct systems that contribute to (or attenuate) disparity/inequity outcomes, potentially encompassing influences such as those exerted through education, neighborhood, family, cultural, religious, commercial, media, regulatory, and/or health care systems.

NIMH has specific interest in improving the mental health outcomes of underserved populations. NIMH is also participating in modeling approaches that support the National Action Alliance for Suicide Prevention s efforts to reduce the suicide rate by 20% by 2025. Because many underserved populations often experience greater suicide risk, and less service access and engagement, simulation modeling of potential improvements for underserved populations could identify the most promising pathways to reduce suicide deaths and associated mental health problems. Simulation modeling approaches could include, but are not limited to:

• Predictive models to improve case identification of individuals with mental illness, suicide risk, treatment response or non-response, and other relevant outcomes in representative populations of diverse racial/ethnic, geographic and socioeconomic groups
• Microsimulation modeling to assess the expected benefits and costs of the implementation of efficacious mental health interventions to reduce the burden of mental disorders and suicide across diverse racial ethnic, geographic and socioeconomic groups.
• Use simulation to identify key gaps in existing evidence regarding efficacy, effectiveness, and efficiency of certain mental health interventions among diverse groups, such that research to fill these gaps would have high clinical and public health value, particularly in reducing mental health disparities.

NLM is interested in research projects that incorporate innovative biomedical informatics and data sciences approaches into simulation modeling and systems science to reduce health disparities across all segments of the U.S. population. NLM is interested in SMSS research projects that are generalizable across multiple biomedical domains. Examples of potential topic areas include but are not limited to:

• Predictive modeling using EHR data for disparity surveillance and reduction
• SMSS studies that address improving disaster planning for diverse populations
• Simulation modeling for biosurveillance in rural, minority, and other underserved populations
• Simulation modeling of decision factors for health decisions of consumers and patients, to reduce health disparities

OBSSR is interested in advancing research that aligns with its 2017-2021 scientific priorities

(https://obssr.od.nih.gov/about-us/2017-strategic-plan/scientific-priorities/)

This includes simulation research that (1) improves the linkages between basic and applied BSSR; (2) Enhances methods and measures leading to a more cumulative and integrated approach to BSSR and (3) facilitate BSSR into health research and practice.

Office of Disease Prevention (ODP)

The ODP is interested in co-funding simulation modeling and systems science research projects to identify combinations of preventive interventions that, if implemented and disseminated broadly, could reduce health disparities for a wide variety of preventable conditions in a state or region, or across the country. The ODP is particularly interested in evaluating multi-level interventions in the context of these simulation modeling and systems science research projects. Of greatest interest would be applications focused on estimating reductions in health disparities for the leading and actual causes of death.

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

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

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)

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)
• U.S. Territory or Possession

Other

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

Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.
Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Applicant Organizations

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

• 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) (formerly CCR) 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.
• eRA Commons - Applicants must have an active DUNS number and SAM registration in order to complete the eRA Commons registration. Organizations can register with the eRA Commons as they are working through their SAM or Grants.gov registration. 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.

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.

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

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).

Buttons to access the online ASSIST system or to download application forms 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.

It is critical that applicants follow 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.

For information on Application Submission and Receipt, visit Frequently Asked Questions Application Guide, Electronic Submission of Grant Applications.

Although a letter of intent is not required, is not binding, and does not enter into the review of a subsequent application, the information that it contains allows IC staff to estimate the potential review workload and plan the review.

By the date listed in Part 1. Overview Information, prospective applicants are asked to submit a letter of intent that includes the following information:

• Descriptive title of proposed activity
• Name(s), address(es), and telephone number(s) of the PD(s)/PI(s)
• Names of other key personnel
• Participating institution(s)
• Number and title of this funding opportunity

The letter of intent should be sent to:

Andrew Louden, PhD
National Institute on Minority Health and Health Disparities
Telephone: 301-594-9009
Email: Andrew.Louden@nih.gov

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

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

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

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

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

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

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

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

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

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.

Appendix:

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

Form only available in FORMS-D application packages for use with due dates on or before January 24, 2018.

When conducting clinical research, follow all instructions for completing PHS Inclusion Enrollment Report as described in the SF424 (R&R) Application Guide.

Use only for applications with due dates on or after January 25, 2018. When involving NIH-defined human subjects research, clinical research, and/or 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

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

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

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

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.

This initiative is not subject to intergovernmental review.

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.

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 Applying Electronically. If you encounter a system issue beyond your control that threatens your ability to complete the submission process on-time, you must follow the Guidelines for Applicants Experiencing System Issues. 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 NIMHD, NIH. Applications that are incomplete, non-compliant and/or nonresponsive will not be reviewed.

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.

Important Update: See NOT-OD-18-228 for updated review language for due dates on or after January 25, 2019.

Only the review criteria described below will be considered in the review process. As part of the NIH mission, all applications submitted to the NIH in support of biomedical and behavioral research are evaluated for scientific and technical merit through the NIH peer review system.

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

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

Does the project address an important problem or a critical barrier to progress in the field? Is there a strong scientific premise for the project? 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?Does the application address a critical minority health or health disparities issue with potential to make a significant contribution to the field?

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?Does the investigative team have multidisciplinary expertise including disparities research and simulation modeling?

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?

Are the overall strategy, methodology, and analyses well-reasoned and appropriate to accomplish the specific aims of the 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 children, justified in terms of the scientific goals and research strategy proposed? Is the selected SMSS methodology appropriate for the minority health or health disparities questions to be addressed?

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?

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.

For research that involves human subjects but does not involve one of the six 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 six 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 children 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.

Not Applicable

Not Applicable

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.

Applications will be evaluated for scientific and technical merit by (an) appropriate Scientific Review Group(s) convened by 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:

• 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.
• Will receive a written critique.

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.
• Geographic distribution and/or regionality of research impact.

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.

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.

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 law. This means that recipients of HHS funds must ensure equal access to their programs without regard to a person’s race, color, national origin, disability, age and, in some circumstances, sex and religion. This includes ensuring your programs are accessible to persons with limited English proficiency. 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. HHS provides general guidance to recipients of FFA on meeting their legal obligation to take reasonable steps to provide meaningful access to their programs by persons with limited English proficiency. Please see https://www.hhs.gov/civil-rights/for-individuals/special-topics/limited-english-proficiency/index.html. The HHS Office for Civil Rights also provides guidance on complying with civil rights laws enforced by HHS. Please see http://www.hhs.gov/ocr/civilrights/understanding/section1557/index.html; and https://www.hhs.gov/civil-rights/for-providers/laws-regulations-guidance/index.html. Recipients of FFA also have specific legal obligations for serving qualified individuals with disabilities. Please see http://www.hhs.gov/ocr/civilrights/understanding/disability/index.html. Please contact the HHS Office for Civil Rights for more information about obligations and prohibitions under federal civil rights laws at https://www.hhs.gov/ocr/about-us/contact-us/index.html or call 1-800-368-1019 or TDD 1-800-537-7697. Also note it is an HHS Departmental goal to ensure access to quality, culturally competent care, including long-term services and supports, for vulnerable populations. For further guidance on providing culturally and linguistically appropriate services, recipients should review the National Standards for Culturally and Linguistically Appropriate Services in Health and Health Care at http://minorityhealth.hhs.gov/omh/browse.aspx?lvl=2&lvlid=53.

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

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.

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons registration, submitting and tracking an application, documenting system problems that threaten submission by the due date, 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)

Grants.gov Customer Support (Questions regarding Grants.gov registration and submission, downloading forms and application packages)
Contact Center Telephone: 800-518-4726
Email: support@grants.gov

GrantsInfo (Questions regarding application instructions and process, finding NIH grant resources)
Email: GrantsInfo@nih.gov (preferred method of contact)
Telephone: 301-945-7573

Andrew Louden, PhD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-9009
Email: Andrew.Louden@nih.gov

Gregory Bloss, M.A., M.P.P.
National Institute on Alcohol Abuse and Alcoholism
Telephone: 301-443-3865
Email: Gregory.Bloss@nih.gov

Cerise Elliott, PhD
National Institute on Aging (NIA)
Telephone: 301-496-9350
Email: elliottce@mail.nih.gov

Eric (Rocky) Feuer
National Cancer Institute (NCI)
Phone: 240-276-6772
Email: feuerr@mail.nih.gov

Howard Hoffman, M.A.
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-402-1843
Email: hoffmanh@mail.nih.gov

Elizabeth Neilson, Ph.D, M.P.H., M.S.N.
Office of Disease Prevention (ODP)
Telephone: 301-827-5578
Email: NeilsonE@mail.nih.gov

Jane L. Pearson, PhD
National Institute of Mental Health
Telephone: 301-443-3598
Email: jpearson@nih.gov

Emmanuel Peprah, Ph.D.
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-496-1051
Email: emmanuel.peprah@nih.gov

Hua-Chuan Sim, MD,
National Library of Medicine,
Telephone: 301-594-4882
Email: simh@mail.nih.gov

Michael Spittel,
Office of Behavioral and Social Sciences Research (OBSSR)
Telephone: 301-451-4286
Email: spittelm@mail.nih.gov

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

Tisha R. A. Wiley, PhD
National Institute on Drug Abuse (NIDA)
Telephone: 301-594-4381
Email: tisha.wiley@nih.gov

Gregory Bloss, M.A., M.P.P.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-443-4734
Email: Gregory.Bloss@nih.gov

Grace C.Y. Peng, PhD
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4778
Email: grace.peng@nih.gov

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

Priscilla Grant, JD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8412
Email: pg38h@nih.gov

John Bladen
National Institute on Aging (NIA)
Telephone: 301-402-7730
Email: jbladen@mail.nih.gov

Rebecca Claycamp
National Institute of Mental Health
Telephone: 301-443-2811
Email: rclaycam@mail.nih.gov

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

Sean Hine
National Cancer Institute (NCI)
Telephone: 240-276-6291
Email: hines@mail.nih.gov

Teresa Farris Marquette
National Heart, Lung, and Blood Institute (NHLBI)
Telephone: 301-435-0172
Email: tm275a@nih.gov

Dwight Mowery
National Library of Medicine (NLM)
Telephone: 301-496-4221
Email: moweryd@mail.nih.gov

Christopher Myers
National Institute on Deafness and Other Communication Disorders (NIDCD)
Telephone: 301-435-0713
Email: Myersc@mail.nih.gov

Cheryl Nathaniel
National Institute on Drug Abuse (NIDA)
Telephone: 202-526-0108
Email: nathanic@nida.nih.gov

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

James Huff
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Telephone: 301-451-4786
Email: james.huff@nih.gov

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

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and under Federal Regulations 42 CFR Part 52 and 45 CFR Part 75.