Department of Health and Human Services

Part 1. Overview Information

Participating Organization(s)

National Institutes of Health (NIH)

Components of Participating Organizations

National Institute on Minority Health and Health Disparities (NIMHD)

National Eye Institute (NEI)

National Institute on Aging (NIA)

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

National Institute on Deafness and Other Communication Disorders (NIDCD)

National Institute on Drug Abuse (NIDA)

National Institute of Nursing Research (NINR)

National Cancer Institute (NCI)

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

Office of Research on Women's Health (ORWH)

Funding Opportunity Title
Health Care Models for Persons with Multiple Chronic Conditions from Populations that Experience Health Disparities: Advancing Health Care towards Health Equity (R01 - Clinical Trials Optional)
Activity Code

R01 Research Project Grant

Announcement Type
New
Related Notices

See Notices of Special Interest associated with this funding opportunity

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

Funding Opportunity Announcement (FOA) Number
PAR-22-092
Companion Funding Opportunity
None
Assistance Listing Number(s)
93.307, 93.866, 93.393, 93.867, 93.846, 93.279, 93.173, 93.313, 93.361
Funding Opportunity Purpose

This initiative will support innovative, collaborative, and multi-disciplinary research designed to study the effective adaptation, integration, and implementation of recommended guidelines of care of persons with multiple chronic conditions (MCCs) from populations that experience health disparities. Projects would be expected to involve more than one component and/or more than one level of influence within existing or newly proposed health care models. The goal of this initiative is attainment of optimal treatment and health outcomes goals to advance health care towards health equity.

Key Dates

Posted Date
January 11, 2022
Open Date (Earliest Submission Date)
February 17, 2022
Letter of Intent Due Date(s)

30 days prior to the application due date.

The following table includes NIH standard due dates marked with an asterisk.
Application Due Dates Review and Award Cycles
New Renewal / Resubmission / Revision (as allowed) AIDS Scientific Merit Review Advisory Council Review Earliest Start Date
March 18, 2022 March 18, 2022 May 07, 2022 * July 2022 October 2022 September 2022
June 05, 2022 * July 05, 2022 * September 07, 2022 * November 2022 January 2023 April 2023
February 05, 2023 * March 05, 2023 * May 07, 2023 * July 2023 October 2023 December 2023
June 05, 2023 * July 05, 2023 * September 07, 2023 * November 2023 January 2024 April 2024
February 05, 2024 * March 05, 2024 * May 07, 2024 * July 2024 October 2024 December 2024
June 05, 2024 * July 05, 2024 * September 07, 2024 * November 2024 January 2025 April 2025

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

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

Expiration Date
September 08, 2024
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

Key Definitions

The term "populations that experience health disparities" refers to NIH-designated U.S. health disparity populations which currently includes 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 (https://www.nimhd.nih.gov/about/overview/).

The term “health care models” refers to the different existing or newly proposed models of patient-centered care. Examples of existing health care models include the Chronic Care Model, the eHealth Enhanced Chronic Care Model, the Community-Based Transition Model, the Nurse Management Model, the Home-Based Model, the Integrated Delivery Systems Model, the Patient-Centered Model and the Value-Based Care Models.

The term “multi-component” refers to the different components of the health care models (e.g., health care system organization, clinician decision support, clinical information system, patient self-management support, delivery system design, and others).

The term “multi-level” refers to the multi-dimensional framework of determinants relevant to understand minority health and address health disparities. This concept is further described under the NIMHD Research Framework (https://www.nimhd.nih.gov/about/overview/research-framework/).

Background

The increasing prevalence of U.S. adults with multiple chronic conditions (MCCs) has posed several clinical and public health challenges, especially in providing preventive services, increasing awareness among those at highest risk, attaining optimal treatment and control of coexisting MCCs, and subsequently preventing fatal or disabling complications. The proportion of U.S. adults with MCCs has also continued increasing, and it is estimated be 42% or higher, varies by U.S. state, and is higher among adults aged 65 years and older, although the proportion of adults younger than 65 with MCCs has been steadily increasing. The prevalence of MCCs could be twice as high among persons living in poverty compared to those living at 400% or more of poverty level. Adults from some racial or ethnic minority populations have experienced a greater increase in prevalence of MCCs, especially those aged 45-64 years, compared to Whites. In addition, the rate of preventable hospitalizations and visits to the emergency department related to individual chronic conditions such as pulmonary diseases, hypertension, diabetes, cardiovascular diseases, and to MCCs tends to be higher among populations that experience health disparities, including racial or ethnic minorities, those without health insurance or optimal health insurance coverage, and some rural communities. The significant costs associated with these preventable events deepens the financial hardship experienced by many of these patients and their families, which could also be experiencing disabling complications associated with MCCs.

Over the last two decades, there has been a loud chorus of calls for fundamental change in the care of persons with chronic diseases in the U.S. Workgroups led by the National Academy of Medicine (formerly the Institute of Medicine) and HHS have identified challenges associated with the attainment of recommended care goals for persons with MCCs, including: delivery system issues (for example, lack of or suboptimal care coordination, integration of primary and specialty care, and subspecialty referrals); limited understanding on the best integration or prioritization of guidelines of care within the context of coexisting conditions or risk factors, and the risk of polypharmacy and undesirable adverse events; patient-centered priorities (for example, patient’s expected outcomes, quality of life, out-of-pocket affordability); and payment or reimbursement issues for clinicians and health care systems (for example, lack of reimbursement for some services). Also, the frequent exclusion of persons with MCCs from clinical trials precludes the generation of necessary evidence that would inform the optimal integration of new treatments into real-life clinical settings. At the same time, strategies to address these challenges, include “facilitating research to fill knowledge gaps”, and “scaling up interventions that reach all people”, and especially “disadvantaged populations disproportionately affected by chronic illness”.

Several health care models have been proposed that intend to incorporate broad approaches to the management of chronic diseases. The Chronic Care Model (CCM) emphasizes the central role of productive interactions between the patient and the health care team and proposes the integration of six elements -health care organization, community resources, patient self-management support, delivery system design, health care provider decision support, and clinical information system. The CCM catapulted the proposal of other health care models (for example, the eHealth Enhanced Chronic Health Care Model, the Community-Based Transition Model, the Model for Developing Complex Interventions in Nursing, the Home-Based Model, the Integrated Delivery Systems Model, Team-Based Care, Family Management Framework, and others, in which components of the CCM have been expanded or enhanced. More recently, the Value-Based Care Model (VBCM) has gained increasing interest. In the VBCM, value (or value proposition) is defined as health outcomes (or quality of care) achieved per dollars spent. It has been proposed that under the VBCM the integration or organization of multi-disciplinary or multi-specialty care for co-existing chronic conditions, the assessment of costs and health outcomes, and the integration of health care information technology platforms that are patient-centered and support easy management of medical data could lead to an effective value-based health care system.

Some of the health care models mentioned above, or interventions in some of their components, have demonstrated improvements in disease-specific health outcomes or the facilitation of care coordination. Nonetheless, the impact of these models on attaining optimal control and prevention of complications associated with MCCs has not been fully tested or evaluated. Very importantly, an underlying commonality to many of these models is the focus on payment or cost-reduction as a central or primary trigger around which interventions are implemented. However, attainment of optimal health outcomes as a central goal (instead of cost reduction being the main aim) in any model needs further study. Moreover, there has not been enough research evaluating the impact of these different health care models on health outcomes such as reduction of preventable complications, prevention of hospitalizations or readmissions, improved quality of life, proactive health care delivery, engagement and effect on patient caregivers and representatives, and direct and indirect health care costs for persons with MCCs from populations that experience health disparities.

Research Objectives

The overarching goal of this FOA is to support innovative, multidisciplinary, and multi-level and/or multi-component research through existing or newly proposed health care models designed to optimize the care of persons with MCCs from U.S. populations that experience health disparities through the adaption, integration, and implementation of evidence-based or recommended guidelines of care for different and coexisting chronic conditions with a holistic perspective, and focused on attaining optimal health outcomes as the primary goal. The integration/implementation of multiple guidelines of care should be set to accomplish optimal treatment and recommended health outcomes goals to reach health equity, and not merely demonstrating improvement in health outcomes.

For the purpose of this FOA, chronic diseases of interest are those that have the highest prevalence and/or are associated with the greatest burden of morbidity, disability, and/or mortality among populations that experience health disparities. These diseases/conditions include: obesity, diabetes and its complications, cardiovascular diseases (include coronary artery disease, heart failure, peripheral vascular disease, and stroke), cardiometabolic disease risk factors (e.g., hypertension, hypercholesterolemia/dyslipidemia, tobacco smoking, prediabetes), cancer and its complications and risk factors, chronic respiratory diseases -especially chronic obstructive pulmonary disease and asthma-, sleep disordered breathing, cognitive decline (including Alzheimer’s disease and related dementias), chronic liver disease and cirrhosis, substance use disorders, chronic kidney disease (including end-stage renal disease), osteoarthritis and other chronic musculoskeletal diseases, mental health conditions (including anxiety and depression), diseases and disorders of the visual system, and diseases and disorders of the auditory system, including deafness and other communication disorders.

Studies would be expected to be performed in clinical/health care settings that provide health care to and include in the research design sufficiently diverse patient populations (for example, >50% patients from populations that experience health disparities), thus allowing appropriate health outcomes/health equity comparison analyses. Ideally, more than one population that experiences health disparities would be represented in the patient population of interest, unless geography or other circumstances would posit limitations to do so. Limited-resource institutions and health care settings are of high-priority under this initiative. Research teams could include investigators from both limited-resource and high-resource institutions. Within the context of such partnerships, is expected that investigators from limited-resourced institutions will assume primary responsibility for the study design and execution, while investigators from high-resource institutions are expected to provide scientific expertise and technical assistance to less research-intensive institutions to successfully execute research activities. Given that the bulk of research activities will take place in limited-resource institutions and health care settings, it is expected that at least 60% of direct costs will be directed to those institutions and personnel. In addition, investigators from limited-resource institutions who are assuming primary responsibilities should be assured key personnel status. Although most studies on MCCs have focused on adults, some studies have highlighted the increasing prevalence of children with chronic diseases, especially asthma, and their unique health care needs. Therefore, projects focused on the health care of children with MCCs are also of interest.

Under this FOA, research may take place within the context of at several potential scenarios involving existing health care models within established health care settings, or studies involving the proposal of new health care models. Within the context of existing health care models, examples of research projects include pilot interventions or small-scale projects integrating recommended or evidence-based guidelines of care for more than one chronic condition by involving more than one element or component of the existing models. These components may include health care organization and intercommunication, connection with community resources, patient self-management support, clinical information systems, clinicians intercommunication, access and affordability of necessary pharmacotherapy, case management, and others, or more than one level of influence (per NIMHD’s Research Framework). Larger-scale studies for which pilot data or small-scale success have been documented, or the comparison of the effect of different health care models on health outcomes (for example, comparing an experimental model or interventions within a model with a standard model), are also examples of research projects within established health care models. Proposed multi-component or multi-level interventions should move beyond already studied interventions such as those solely based on a single component such as patient navigation. Within the context of new health care models, research projects could include pilot tests of the implementation of guidelines of care through the combination of elements or components from different models or propose completely brand-new health care models.

Considering the complexities of health care and gaps in research demonstrating the impact of different health care models on health outcomes for persons with MCCs in the U.S., and especially those from populations that experience health disparities, it is imperative to think what can be done differently. Within this context, attaining optimal health outcomes based on evidence-based guidelines and patient-centered goals through health care models that adapt to patients’ health care needs, personal goals, resources, and limitations is the primary aim of this initiative. Examples include but are not limited to personal health outcomes that patients hope to achieve, especially related to health insurance coverage, out-of-pocket expenses, lost wages, time that health care would demand, physical/mental function and independence, well-being, life expectancy, social/occupational engagement, burden of diagnostic/surveillance tests or procedures or treatment, and complexity of self-management tasks), In addition, examples of strategies that need to be tested within the context of care of patients from populations with health disparities include the seamless integration of multiple levels of health care professionals and supportive personnel in a comprehensive and holistic care plan; algorithms and decision support tools for clinicians; and strategies that prevent unnecessary readmissions that account for the natural recovery of the underlying chronic diseases, incorporate early outpatient follow-up after hospital discharge, telehealth, or home-based rehabilitation or clinician visits. Furthermore, understanding the feasibility, affordability and sustainability of such models would be critical for their long-term success.

The initiative will support interventions (especially multi-component or multi-level interventions), clinical trials (including cluster-randomized trials, pragmatic trials), natural experiments (e.g., impact of health care and non-health care policies), mixed-methods, quasi-experimental studies, time-series quality improvement studies, and evaluation of proposed interventions within existing health care models or newly proposed health care models.

Recipients under this initiative would be expected to use common data elements (CDEs) for patient demographics and social determinants of health (refer to the Phen-X Toolkit), as well as for clinical conditions measurements or assessments and clinical outcomes.

Specific Areas of Interest

Areas of interest include but are not limited to:

  • Multi-component, multi-level studies in existing or newly proposed health care models that explore the integration of guidelines of care, and its impact on attaining optimal health outcomes and increasing health equity based on:
    • Patients’ characteristics: for example, age, sex/gender, race and ethnicity, socioeconomic status, sexual orientation and gender identity, geographic location, pregnancy status, state of progression of coexisting chronic diseases (e.g., newly diagnosed compared to advanced disease stage), insurance health status and coverage and other measures of the social determinants of health (as described and listed in the Phen-X Toolkit), unique health risk or protective factors (e.g., experienced by the patients’ heritage group or country of origin, or communities where patients live)
    • Health care settings’ characteristics: for example, urban or rural location, resources, personnel, U.S. region (states or territories)
  • Studies that compare the effect of different health care models or interventions within their components on health outcomes and quality of care or quality improvement
  • Studies that evaluate clinician decision-making and/or health care system strategies on prioritizing or integrating guidelines of care
  • Studies that explore the intercommunication among clinicians (e.g., primary health care clinician-specialists, specialist-specialist) around recommended guidelines of care and clinical decision-making, and test and evaluate approaches that synergize communication and reduce contradictory recommendations.
  • Research on strategies to integrate guidelines of care and enhance care coordination for patients at greater risk for non-adherence or adverse events, including persons with cognitive impairment, and/or complex illnesses and health regimens, and/or challenging housing or work-related conditions
  • Studies that test and evaluate hybrid health care models [for example, combination of health care setting and a non-health care setting (e.g., workplace), or group-based models of care (e.g., Centering Pregnancy)]
  • Studies that test and evaluate interventions that promote proactive health care delivery and how this enhances patient self-management, agency and ability to express opinions; timely continuity of care and referral to needed specialty care and avoidance of unnecessary consultations or emergency room visits; patient/caregiver-clinician shared decision making; care coordination; and/or shared patient care in health care settings with limited resources and clinical personnel. The role of health information technology, including telehealth, in proactive health care delivery is of interest.
  • Studies that identify and evaluate the impact of contextual factors outside of the clinical/health care settings on the effectiveness of health care models. Some of these contextual factors include:
    • Ongoing community interventions; community resources and services
    • Transportation, housing, and other sectors
    • Local, state, and federal health care and non-health care policies (e.g., laws/policies regarding insurance coverage, eligibility for services, workplace safety, sick leave)
  • Studies that evaluate the impact of differences or changes in individual health care insurance coverage on access to and affordability of needed pharmacotherapy and self-monitoring devices and supplies, utilization of and quality of health care services, timely evaluation by subspecialists, and other services.
  • Research that tests and evaluates health care coordination between traditional and alternative settings (e.g., pharmacies, fire stations, school-based clinics, senior centers, and other community resources) and its impact on utilization of and quality of health care services, and/or health outcomes.
  • Health economic sub-analyses (embedded into primary studies, and not limited to) on:
    • The sustainability of the simultaneous integration or full implementation of multiple guidelines of care for MCCs, including actual and/or projected health care costs. In addition to health care provider payment/reimbursement and medications, health care costs should account for all services (including self-management devices and supplies) needed to accomplish the full integration/implementation
    • Attainment of optimal treatment and health outcomes goals to reach health equity
    • Prevention of adverse events, including hospitalizations, visits to the emergency department and other complications
    • Availability and prompt referral and evaluation by subspecialists within the context of health care payer policies on coverage of and payment for services, health care system protocols and processes, and payment models
    • Comparison of health care costs and sustainability across different health care models

Other Institutes' Specific Research Interests:

National Institute on Aging (NIA)

NIA has an interest in the use of innovative models of care that are effective when the person living with chronic conditions also has Alzheimer’s Disease or a Related Dementia, and whether such models change outcomes such as cost, quality, access, or care coordination for people with MCCs and Alzheimer’s Disease or a related dementia.

NIA has an interest in the use of innovative models of care for Medicare beneficiaries with MCCs.

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

The mission of the National Institute of Arthritis and Musculoskeletal and Skin Diseases is to support research into the causes, treatment, and prevention of arthritis and musculoskeletal and skin diseases. In the context of this FOA, the NIAMS is interested in the use of innovative health care models, on both individual and community levels, to reduce and encourage elimination of health disparities in patients with MCCs within the NIAMS mission relevant diseases. Research areas include rheumatology, orthopaedics, dermatology, metabolic bone diseases, heritable disorders of bone and cartilage, inherited and inflammatory muscle diseases, and sports and rehabilitation medicine. Clinical trial applications will only be supported by NIAMS if submitted to a NIAMS clinical trial-specific FOAs. A current list of active NIAMS clinical trials FOAs is available at https://www.niams.nih.gov/grants-funding/conducting-clinical-research/grants. Applicants are encouraged to discuss potential applications with the appropriate NIAMS program director.

National Eye Institute (NEI)

The National Eye Institute (www.nei.nih.gov) supports basic and clinical research into diseases and disorders of the visual system and the special needs of people with impaired vision or who are blind. NEI is particularly interested in research of improved methods for delivering vision care and rehabilitation in underserved populations including people in urban and rural settings with MCC. Research topics may include but are not limited to telemedicine, screening and automated diagnosis, medication adherence, quality of life, and rehabilitation strategies for those with vision loss. NEI would only support clinical trial applications for this FOA that fulfill the NIH requirements for either a mechanistic or minimal risk trials. A mechanistic trial is designed to understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention. A minimal risk trial is one in which the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

National Cancer Institute (NCI)

NCI Division of Cancer Prevention (DCP)

DCP leads, supports, and promotes rigorous, innovative research and training to prevent cancer and its consequences, to improve the health of all people. DCP is interested in research that supports its mission by using innovative models of care to improve the health of individuals with multiple chronic conditions from populations that experience health disparities (as defined above under “Key Definitions” as well as adolescents and young adults and older adults).

Examples of research areas of interest to DCP in these populations include but are not limited to models of care and strategies that:

  • Promote and facilitate adherence to current cancer prevention, screening, and surveillance guidelines among cancer survivors
  • Enable “bundling” of cancer prevention, screening, and surveillance approaches in the home or at accessible point of care locations
  • Promote and facilitate adherence to current cancer prevention, screening, and/or surveillance guidelines among individuals at average or greater than average risk for cancer
  • Reduce the cumulative effect of the burden of cancer and other comorbidities anywhere along the cancer care continuum
  • Reduce cancer treatment-related toxicities
  • Facilitate virtual or remote management of cancer treatment-related toxicities
  • Address the special needs that are unique to cancer survivors
  • Increase clinical trial participation in individuals anywhere along the cancer prevention and care continuum
  • Improve health-related quality of life and reduce symptom burden in individuals with cancer
  • Promote access to non-pharmacologic approaches to pain and symptom management in individuals with cancer

Division of Cancer Control & Population Sciences (DCCPS)

The mission of the NCI Division of Cancer Control & Population Sciences (DCCPS) is to reduce risk, incidence, and deaths from cancer as well as enhance the quality of life for cancer survivors. DCCPS is interested in supporting research that develops, evaluates, and/or identifies key components of care delivery models designed to improve cancer-related outcomes for individuals with MCCs, their caregivers, and communities. Examples of research areas of interest to DCCPS include, but are not limited to, models of care and strategies that:

  • Facilitate team-based care and coordination of care across specialties and care settings over time for individuals with cancer and other chronic conditions.
  • Incorporate novel digital health or clinical informatics tools or features and evaluates impact on cancer-related outcomes and cancer-related health or healthcare inequities.
  • Examine the effects of care delivery models and strategies on outcomes such as care access, quality, utilization, costs, care-related financial distress, and related inequities.
  • Identify facilitators and barriers to the implementation, adaptation, sustainment, and equitable participation in or access to care delivery models that include a focus on cancer prevention, screening and surveillance, diagnosis and treatment planning, cancer treatment, survivorship, and/or end of life care for people with multiple chronic conditions.
  • Identify or develop and test key care model features and functions that facilitate equitable access to, participation in, and outcomes among NIH-designated U.S. health disparity populations.
  • Focus on issues related to first-line cancer therapy and follow-up care due to concordant and discordant clusters of multiple chronic conditions and how either facilitate or hinder effective health management for cancer survivors
  • Include development, validation, or integration of patient-reported outcome measures of symptoms and functioning for use in cancer populations with MCCs
  • Develop or validate methods to manage symptoms or patient-reported functional deficits when the deficits can be attributed to more than one chronic condition
  • Use a social determinants of health approach to address barriers to symptom management and evaluate quality of life of racial and ethnic minorities or older adults with MCCs
  • Target older cancer patients/survivors with multimorbidity and high levels of complexity

Applicants are encouraged to discuss potential applications with an NCI Program Contact for this announcement or other appropriate NCI Program Director.

National Institute of Nursing Research (NINR)

NINR supports research that builds the scientific foundation for policy and practice across clinical and community settings, and advances the prevention, detection, and management of disease and disability. Drawing on nursing’s holistic perspective, NINR supports observational, intervention, and translational research that integrates factors at multiple levels to identify their role in health, health improvement and health inequities in varied settings. These settings include hospitals and clinics, people’s homes, schools, workplaces, long-term care facilities, justice settings, and communities.

For this PAR, NINR is especially interested in research related to multiple chronic conditions that tests models of care including those listed in the PAR as well as Nurse-managed Health Center Models.

Research is encouraged in these areas:

  • Barriers and facilitators to the implementation of models at multiple levels: interpersonal, institutional, community, and policy.
  • Identifying and addressing social and economic needs (e.g. unemployment, homelessness, transportation, etc.) as part of holistic care for individuals with multiple chronic conditions.
  • Studies (e.g. natural experiments) evaluating how changes in local, state, and federal health care and non-health care policies (e.g. laws/policies regarding insurance coverage, eligibility for services, workplace safety, sick leave) influence the effectiveness of components within existing health care models or new models of health care.
  • Transition Care Models that promote collaborative team efforts from physicians, pharmacists, nurses, community health workers, and other health professionals, businesses, and organizations to form a network to improve healthcare for populations with multiple chronic conditions experiencing health disparities.

National Institute on Deafness and Other Communication Disorders (NIDCD)

The National Institute on Deafness and Other Communication Disorders (NIDCD) welcomes applications in which disordered communication processes, including diseases or conditions affecting hearing, balance, taste, smell, voice, speech, and language, are a component of the MCCs being examined within populations who experience health disparities. Populations of interest include both pediatric and adult. Examples include, but are not limited to:

  • Intervention work (including screening) that evaluates the effect, feasibility, and accessibility of interventions to improve health care and outcomes in people with cognitive deficits and hearing, balance/vestibular, chemosensory (taste and smell), or voice, speech, and language impairment.
  • Evaluating the effectiveness of the provision of services and outcomes for populations that experience health disparities with hearing, other sensory or communication disorders and MCCs.
  • Development and evaluation of tools that enhance application of multimorbidity measurement and care management into primary care settings for populations with hearing, other sensory or communication disorders.
  • Longitudinal studies in diverse, underserved, and vulnerable populations that examine chronic condition onset and trajectory in conjunction with hearing, other sensory or communication disorders.
  • Identification of effective practices that address special health care needs for populations that experience health disparities with hearing, other sensory or communication disorders and MCCs.

The Office of Research on Women’s Health (ORWH)

The ORWH is part of the Office of the Director of NIH and works in partnership with the 27 NIH Institutes and Centers to ensure that women's health research is part of the scientific framework at the NIH and is supported in the larger scientific community. ORWH uses a multidimensional framework to represent the intersection of factors that underlie patterns of disease and determinants of health outcomes in populations. Biomedical research that considers sex and gender influences, alongside race, ethnicity, social class, and other biopsychosocial and cultural factors, will enhance understanding and inform community-based strategies and healthcare practices most likely to result in improvement of health outcomes and resources for all segments of the population. A growing body of work notes a higher level of chronic disease burden, earlier onset of multimorbidity and the compounding effects of multimorbidity alongside greater risk of poorer multimorbidity trajectory among racial and ethnic minority groups. Given the increased recognition of health and healthcare disparities, interventional research will need to leverage multicomponent care models to optimally manage the health of persons with MCCs from such populations. Applications proposing approaches which consider individual and higher-level determinants of health/healthcare disparities and explore the intersectionality of sex, gender, race and other biopsychosocial factors in the implementation and evaluation of evidenced-based models are of particular interest. For additional guidance on areas of interest to the ORWH, please refer to the 2019-2023 Trans-NIH Strategic Plan for the Health of Women on the ORWH website (https://www.nih.gov/women/strategicplan).”

The following types of projects are not considered responsive to this FOA, and will not be reviewed.

  • Studies without a focus on one or more U.S. populations that experience health disparities
  • Research that is exclusively qualitative
  • Research that is exclusively based on retrospective analyses
  • Studies that do not address or focus on the care of more than one chronic disease
  • Studies that implement care or an intervention on one chronic disease and propose testing the influence of that intervention on another chronic disease
  • Projects that test interventions that do not involve more than one component or more than one level (e.g., an intervention that consists entirely of patient navigation or community health workers' services)
  • Projects that prospectively test evidence-based interventions in understudied populations without modification to intervention content, delivery, or implementation
  • Studies focused on improvement on health outcomes without aiming at reaching health equity
  • Projects or collaborators outside of the United States and its territories
  • Observational studies focused on the study of prevalence and incidence of chronic diseases or their complications
  • Studies focused on identifying, describing and/or explaining health disparities in any given database or population

Applicants are strongly encouraged to reach out to the relevant scientific contacts to discuss whether their applications align with the goals of this FOA.

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
Resubmission
Revision

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 Government

  • U.S. Territory or Possession

Other

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

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

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

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

Required Registrations

Applicant organizations

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

  • System for Award Management (SAM) – Applicants must complete and maintain an active registration, which requires renewal at least annually. The renewal process may require as much time as the initial registration. SAM registration includes the assignment of a Commercial and Government Entity (CAGE) Code for domestic organizations which have not already been assigned a CAGE Code.
    • NATO Commercial and Government Entity (NCAGE) Code – Foreign organizations must obtain an NCAGE code (in lieu of a CAGE code) in order to register in SAM.
    • Unique Entity Identifier (UEI)- A UEI is issued as part of the SAM.gov registration process. SAM registrations prior to fall 2021 were updated to include a UEI. For applications due on or after January 25, 2022, the UEI must be provided on the application forms (e.g., FORMS-G); the same UEI must be used for all registrations, as well as on the grant application.
    • Dun and Bradstreet Universal Numbering System (DUNS) – Organization registrations prior to April 2022 require applicants to obtain a DUNS prior to registering in SAM. By April 2022, the federal government will stop using the DUNS number as an entity identifier and will transition to the Unique Entity Identifier (UEI) issued by SAM. Prior to April 2022, after obtaining a DUNS number, applicants can begin both SAM and eRA Commons registrations. The same DUNS number must be used for all registrations, as well as on the grant application.
  • eRA Commons - Once the unique organization identifier (DUNS prior to April 2022; UEI after April 2022) is established, organizations can register with eRA Commons in tandem with completing their full SAM and Grants.gov registrations; all registrations must be in place by time of submission. eRA Commons requires organizations to identify at least one Signing Official (SO) and at least one Program Director/Principal Investigator (PD/PI) account in order to submit an application.
  • Grants.gov – Applicants must have an active SAM registration in order to complete the Grants.gov registration.

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

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

Eligible Individuals (Program Director/Principal Investigator)

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

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

2. Cost Sharing

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

3. Additional Information on Eligibility

Number of Applications

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

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

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

Section IV. Application and Submission Information

1. Requesting an Application Package

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

2. Content and Form of Application Submission

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

Letter of Intent

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

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

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

The letter of intent should be sent to:

Larissa Avilés-Santa, MD, MPH
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301 827 6924
Email: avilessantal@nih.gov

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

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

See more tips for avoiding common errors.

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

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 this 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?

Specific to this FOA:

In applications where a pilot test is proposed, can the design of the study be expected to generate results that provide insight to whether the testing approach should be pursued further? If a large scale intervention is planned, do pilot data and/or published studies provide sufficient support for pursuing the intervention on the proposed scale?

In addition, for applications involving clinical trials

Does the application adequately address the following, if applicable

Study Design

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

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

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

Data Management and Statistical Analysis

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

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 involving clinical trials

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

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

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

Not Applicable

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 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 submitted in response to this FOA. Following initial peer review, recommended applications will receive a second level of review by the appropriate national Advisory Council or Board. The following will be considered in making funding decisions:
  • Scientific and technical merit of the proposed project as determined by scientific peer review.
  • Availability of funds.
  • Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

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

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

Section VI. Award Administration Information

1. Award Notices

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

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

Recipients must comply with any funding restrictions described in Section IV.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.

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

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

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

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

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

2. Administrative and National Policy Requirements

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

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

Should the applicant organization successfully compete for an award, recipients of federal financial assistance (FFA) from HHS must administer their programs in compliance with federal civil rights laws that prohibit discrimination on the basis of race, color, national origin, disability, age and, in some circumstances, religion, conscience, and sex (including gender identify, sexual orientation, and pregnancy). This includes ensuring programs are accessible to persons with limited English proficiency and persons with disabilities. The HHS Office for Civil Rights provides guidance on complying with civil rights laws enforced by HHS. Please see https://www.hhs.gov/civil-rights/for-providers/provider-obligations/index.html and https://www.hhs.gov/civil-rights/for-individuals/nondiscrimination/index.html

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

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

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

Cooperative Agreement Terms and Conditions of Award

Not Applicable

3. Reporting

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

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

The Federal Funding Accountability and Transparency Act of 2006 (Transparency Act), includes a requirement for recipients of Federal grants to report information about first-tier subawards and executive compensation under Federal assistance awards issued in FY2011 or later.  All recipients of applicable NIH grants and cooperative agreements are required to report to the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov on all subawards over $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: 301-637-3015

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

Scientific/Research Contact(s)

Larissa Avilés-Santa, MD, MPH
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301 827 6924
Email: avilessantal@nih.gov

Priscilla Novak, Ph.D.
National Institute On Aging (NIA)
Phone: 301-496-3136
E-mail: priscilla.novak@nih.gov

Karen Huss, PhD, RN, ANP-BC, FAAN, FAAAAI, FAHA
National Institute of Nursing Research (NINR)
Telephone: 301-594-5970
Email: hussk@mail.nih.gov
 

Julia Beth Zur
National Institute On Drug Abuse (NIDA)
Phone: 301-443-2261
E-mail: julia.zur@nih.gov

Xincheng Zheng (Ted), M.D., Ph.D.
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Tel: (301) 594-4953
Email: zhengx4@mail.nih.gov 

Jimmy Toan Le
National Eye Institute (NEI)
Phone: 301-435-8160
E-mail: jimmy.le@nih.gov

Ellen Richmond, MS, GNP-BC
National Cancer Institute (NCI)
Division of Cancer Prevention (NCI DCP)
Telephone: (240) 276-7043
Email: richmone@mail.nih.gov  

Sallie Weaver, PhD, MHS
National Cancer Institute (NCI)
Division of Cancer Control & Population Sciences (NCI DCCPS)
Telephone: (240) 276-6254
Email: sallie.weaver@nih.gov  

Howard J. Hoffman
National Institute On Deafness And Other Communication Disorders (NIDCD)
Phone: 240-506-1974
E-mail: hoffmanh@mail.nih.gov

Damiya Eve Whitaker
Office Of Research On Women's Health (ORWH)
Phone: 301-451-8206
E-mail: 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, JD
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: (301) 594-8412
Email: grantp@mail.nih.gov

Ryan Blakeney
National Institute On Aging (NIA)
Phone: 301-451-9802
E-mail: blakeneyr@mail.nih.gov

Kelli Oster
National Institute of Nursing Research (NINR)
Telephone: 301-594-2177
Email: osterk@mail.nih.gov
 

Pamela G Fleming
National Institute On Drug Abuse (NIDA)
Phone: 301-480-1159
E-mail: pfleming@mail.nih.gov

Erik Edgerton
National Institute Of Arthritis And Musculoskeletal And Skin Diseases (NIAMS)
Phone: 301-594-7760
E-mail: erik.edgerton@nih.gov

Karen Robinsonsmith
National Eye Institute (NEI)
Phone: (301) 451-2020
E-mail: kyr@nei.nih.gov

Crystal Wolfrey
National Cancer Institute
Telephone: 240-276-6277
Email: wolfreyc@mail.nih.gov
 

Christopher Myers
National Institute On Deafness And Other Communication Disorders (NIDCD)
Phone: (301) 435-0713
E-mail: myersc@nidcd.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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