Part 1. Overview Information

Key Dates

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

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

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

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

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

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

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



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

Part 2. Full Text of Announcement

Section I. Notice of Funding Opportunity Description

Sleep is an important determinant of overall health and is required to support well-being across the lifespan. For the purposes of this initiative, sleep deficiencies include: insufficient sleep duration; poor sleep efficiency, quality, timing, or regularity; as well as sleep/circadian disorders. These deficiencies occur disproportionately among populations that experience health disparities. Sleep deficiencies are associated with a wide variety of health disparities, including those observed in hypertension, stroke, diabetes, liver disease, cancer, obesity, and poorer cognitive, emotional, and social functioning. Conversely, healthy sleep is a protective factor for overall quality of life and adverse health outcomes, and successful treatment of sleep disorders (e.g., via CPAP for obstructive sleep apnea) has been associated with improvements in cardiometabolic health and quality of life.

Sleep health disparities are prevalent in the United States. According to the Centers for Disease Control and Prevention (CDC), the prevalence of age-adjusted recommended sleep duration of 7 or more hours is lower for Native Hawaiians and Pacific Islanders, African American or Black individuals, and American Indians and Alaska Natives, compared with White, Latino, and Asian adults.  For some of these populations, these sleep disparities emerge early in life and persist over time. For example, among children aged 4 months to 14 years, insufficient sleep duration is highest in African American or Black children compared to all other racial and ethnic groups. Sleep deficiencies also occur more commonly among unemployed compared to employed adults, as well as among those with high school diplomas only compared to those with college degrees. Recent evidence also suggests that sexual and gender minority (SGM) individuals experience sleep health disparities compared to heterosexual and cisgender individuals, at least in part due to influences of stigma, minority stressors such as discrimination (including that resulting from having intersecting minoritized identities), and mental health challenges and substance use disorders, which also influence sleep health. In sum, the same populations that are most impacted by conditions with known health disparities also experience sleep deficiencies at disproportionate rates.

Emerging research has shed light on the factors and mechanisms influencing sleep health and sleep health disparities that can be targeted in intervention research to reduce sleep health disparities. Determinants of sleep health disparities occur across multiple levels and domains of influence (see the NIMHD Research Framework) and may interact with one another to affect sleep health. For example, individual-level factors such as occupation, immigrant status, experiences with discrimination, or sleep health literacy/awareness; interpersonal-level factors such as family beliefs about sleep health, household chaos, or working non-traditional hours; community-level factors such as heat, light, or noise exposure or exposure to neighborhood violence; and societal-level factors such as school start times or exposure to climate-change-related disasters, can all affect individuals’ ability to achieve healthy sleep and contribute to sleep health disparities. Populations that experience health disparities may also lack access to evidence-based medical treatment for sleep disorders. While currently, interventions that directly address sleep health disparities are limited, examples such as interventions for obstructive sleep apnea among African American or Black adults have demonstrated the efficacy of tailored interventions that address barriers at multiple levels (e.g., awareness, health care access, mistrust of healthcare system, language barriers). Existing evidence also supports delaying school start times as a structural-level intervention that may improve health outcomes among minoritized adolescents. Similar efforts are needed that address the full range of sleep deficiencies in populations experiencing health disparities.

Given this background, there is a critical need for intervention research, conducted in a variety of settings and contexts, that promotes sleep health among underserved populations and reduces sleep health disparities. Interventions should address social and environmental determinants of health including the sleep environment, consider life stage of the target population, and be designed with the needs of populations and communities experiencing poor sleep health in mind. Because the causes of sleep health disparities are complex and occur across multiple levels and domains, interventions to reduce sleep health disparities and improve sleep health among populations that experience health disparities must take these complexities and multiple levels into consideration.

Research Objectives

The overall of objective of this initiative is to support the development and testing of non-pharmacological interventions conducted across multiple levels and domains of influence to promote sleep health, treat sleep disorders, reduce sleep health disparities, and/or examine sleep as a modifiable health factor to reduce disparities for other health outcomes. This initiative emphasizes promoting interventions to improve sleep health via addressing one or more behavioral, social, environmental, or structural determinant(s) of sleep health or deficiencies. 

Interventions should be based on conceptual models that propose mechanisms of action and pathways explaining sleep health or sleep health disparities, and must focus on one or more NIH-designated populations that experience health disparities in the U.S. and its territories (Black or African American, Hispanic or Latino, American Indian and Alaska Native, Asian, or Native Hawaiian and Pacific Islander persons, socioeconomically disadvantaged populations, underserved rural populations, sexual and gender minority [SGM] individuals, and persons living with disabilities). Projects that focus on rural populations, SGM individuals, or persons living with disabilities should prioritize examining the intersections with race and ethnicity or socioeconomic disadvantage. Since sleep disparities begin in early life and occur across the lifespan, interventions across the life course are encouraged, as well as those that consider key life transition points known to co-occur with changes in sleep (e.g., the pre/peri/postnatal periods, parenthood, or during periods of unemployment). Interventions may consider multiple facets of sleep health, including sleep quality, quantity, efficiency, and timing. The expectation is that improving sleep health and treating sleep disorders will not only help individuals feel better, but also may translate to improvements and reduce disparities in other health outcomes (e.g., cardiovascular disease, mental health).

Studies supported under this PAR are encouraged to engage meaningfully and work closely with communities affected by sleep health disparities to inform study design, analysis, and dissemination. Randomized controlled trials may not always be feasible when studying sleep disparities. Still, it is imperative that research studies have sufficient rigor to ensure confidence in results. Investigators may select other research designs that will provide robust evidence of intervention effectiveness, including quasi-experimental designs, such as an interrupted time series design, or stepped-wedge cluster randomized designs in which all subjects receive the intervention. Further, hybrid effectiveness-implementation designs are encouraged that support early investigation of implementation processes while also testing intervention effectiveness. Intervention designs that lack comparison conditions or sites (e.g., an intervention implemented in a single clinic or school) are strongly discouraged. Investigators should justify their research design selection and provide adequate details for their ability to execute a rigorous and appropriate analysis of study data. Investigators are strongly encouraged to employ a common set of tools and resources that will promote the collection of comparable data on social determinants of health (SDOH) across studies. Studies should incorporate measures from the Core and Specialty collections that are available in the SDOH Collection of the PhenX Toolkit (www.phenxtoolkit.org). Applicants are also encouraged to carefully measure functional and global symptoms, including depression, anxiety, level of energy, feeling sleepy, etc., and to use objective (e.g., using wearable devices), in addition to self-report, measures of sleep.

Specific Areas of Research Interest

Intervention research topics of interest for this NOFO include, but are not limited to:

• Improving sleep health awareness, early detection of poor sleep and sleep disorders, and early intervention, in clinical and other settings to promote sleep quality and/or duration
• Population-level interventions focused on policies and practices to promote healthy sleep (e.g., delayed school start times, workplace interventions)
• Approaches that incorporate environmental and social determinants of health to address sleep health disparities, such as interventions addressing the home, work, or neighborhood built environment
• Prevention of sleep health disparities across the lifespan or at key life course transition points, such as during early childhood, adolescence, periods of unemployment, pre/peri/postnatal periods, parenthood, and in older adults
• Adapt and develop evidence-based, culturally appropriate, and/or community-engaged interventions for populations that experience health disparities including specific vulnerable populations, such as shift workers
• Investigate sleep as primary prevention for health outcomes with observed health disparities, such as cardiovascular disease, obesity, cancer outcomes, mental health conditions, and substance use disorders
• Determine whether sleep mediates or modifies intervention effectiveness for health outcomes with observed disparities (e.g., whether sleep mediates or moderates the effects of a physical activity intervention on mental health outcomes)
• Implementation of CPAP among persons with a confirmed diagnosis of obstructive sleep apnea to promote adherence and evaluate response among populations with health disparities
• Studies examining health behavior change (e.g., physical activity, nutrition, alcohol use, modifying caffeine intake, improving sleep hygiene practices) to improve sleep health among populations experiencing health disparities
• Strategies to mitigate the negative effects of climate change-related factors on sleep health, such as natural disasters, displacement, poor air quality, and extreme heat
• Family level strategies to improve sleep environment and quality especially when room sharing occurs or in multigenerational living arrangements
• Provider-based strategies to promote healthy sleep guidance and test appropriate interventions within clinical settings

Other IC-Specific Interests

National Cancer Institute (NCI)

Sleep health has been linked to cancer risk and reduced quality of life for cancer survivors. Research also indicates sleep health can interact with other cancer-related risk factors such as physical activity, substance use, diet, and obesity. Additionally, minoritized, disadvantaged, and underserved populations generally report less sleep and/or lower quality sleep on a number of dimensions, and bear a disproportionate burden of cancer compared to other groups.

NCI is interested in a wide variety of interventions across levels of analysis, the cancer continuum, and the lifespan. This may include multi-level interventions as well as interventions at a specific level of analysis from the individual to the population.

Research topics include, but are not limited to:

• Prevention of sleep health disparities in cancer survivors and/or caregivers, particularly at key cancer care transitions such as during diagnosis, treatment, and recovery.
• Improving sleep health awareness and early detection of poor sleep and sleep disorders in cancer care settings.
• Assessing the impact of sleep interventions on side effects and/or late effects of cancer treatments (e.g., chemotherapy-induced cognitive decline) in populations experiencing cancer or sleep health disparities.
• Supporting sleep health as an outcome in patients undergoing cancer treatment and advancing our understanding of their influence on reducing side effects and enhancing quality of life.
• Examining mechanisms or biomarkers of sleep and cancer (e.g., immune function and inflammatory processes) to advance our understanding of cancer disparities.
• Adapting or developing evidence-based, culturally appropriate sleep interventions for populations experiencing cancer disparities.
• Investigating sleep as primary prevention for cancer-related outcomes in populations experiencing cancer disparities.
• Determining whether sleep mediates or modifies the effectiveness of interventions to to improve cancer-related health outcomes in populations experiencing cancer disparities
• Intervention studies that examine mechanisms or biomarkers of sleep and cancer (e.g., immune function and inflammatory processes) in order to advance our understanding of cancer disparities.
• Interventions to improve sleep behavior in order to indirectly target other cancer risk factors, such as tobacco or alcohol use, obesity and physical activity.
• Improving sleep health in long-term cancer survivors.
• Interventions that support sleep health in patients undergoing cancer treatment and advance our understanding of their influence on reducing side effects and enhancing quality of life.
• Since dimensions of sleep health, including sleep quality and quantity, vary between population groups and across the lifespan, NCI also encourages intervention projects that  support improvements in measurement techniques, such as ensuring that sleep instruments are validated for the populations studied, and simultaneously capturing measurement of multiple sleep health dimensions.

National Institute on Aging (NIA)

NIA supports mechanism-based intervention research to prevent, reduce, or eliminate health disparities and inequities over the life course, especially among older adults and people living with Alzheimer’s disease and Alzheimer’s disease related dementias (AD/ADRD), as well as their caregivers. Applicants are encouraged to consider the priorities outlined in  NIA’s strategic directions for health disparities research and in the  AD+ADRD Research Implementation Milestones related to health disparities, and those reflected within  NIA’s Health Disparities framework.

Similarly, NIA encourages applicants to draw upon the NIH Stage Model for Behavioral Intervention Development, which offers a framework to: (1) support development and testing of effective interventions that are defined by their principles and (2) ensure that efficacious interventions can be administered in the community or in health systems with fidelity to the intervention’s principles. This includes the development, testing, and validation of scalable training materials and procedures so that these interventions can be delivered with fidelity in community settings or health systems. In keeping with the Stage Model, applications should propose contemporary analytic techniques to evaluate mechanisms by which the focal intervention impacts health and health disparities.

In addition, NIA’s commitment to palliative care research encourages holistic interdisciplinary research focused on improving the quality of life for persons with serious illness. Research that seeks to understand and address disparities in access, quality, and use of palliative care is highly encouraged.

Examples of research areas that would be of interest to NIA include but are not limited to:

• Interventions at the individual, dyad, family, or community level to improve sleep health and disparities for older adults, people living with AD/ADRD, or their caregivers.
• Interventions designed to mitigate potential sleep disruptions caused by transitions of later life, including retirement, bereavement, divorce, re-partnering, caregiving, children exiting or reentering the home, residential changes, etc.
• Implementation strategies to expand the reach of evidence-based sleep interventions to older adults who experience health disparities.
• Interventions to improve sleep among older adults with the potential to prevent or slow the trajectory of cognitive decline or impairment or accelerated aging.
• Potential biological pathways and mechanisms of non-pharmacological interventions, including diet/nutrition, exercise, music, and meditation that may affect sleep health or reduce sleep health disparities, or in the context of sleep interventions to reduce disparities for other health outcomes among populations including older adults that experience health disparities.
• Multicomponent interventions that address sleep disorders as part of symptom burden clusters in individuals receiving palliative or end of life care.

National Institute of Neurological Disorders and Stroke (NINDS)

The National Institute of Neurological Disorders and Stroke (NINDS) supports research to understand interventions of biologic, environmental, social, and healthcare system factors to promote sleep health, eliminate sleep health disparities, and examine sleep as a modifiable factor to reduce inequities associated with neurological/neuromuscular diseases. Some priority disease areas include (but are not limited to) stroke and other cerebrovascular diseases, epilepsy, migraine, nervous system infections, spinal cord injury, headache, Parkinson's disease and other neurodegenerative disorders, brain trauma, neurodevelopmental disorders, neuromuscular conditions (e.g., muscular dystrophies, myasthenia gravis) and the neurological consequences of HIV/AIDS. Investigators are strongly encouraged to discuss their research plans with NINDS Scientific/Research contacts prior to submitting their application. Research activities outside of the NINDS mission, or traditionally supported by another NIH Institute or Center, will not be considered through this program. Investigators are encouraged to incorporate community engagement strategies when appropriate.

Clinical trials are research studies in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. Applicants considering submitting a clinical trial should review the NINDS Clinical Trial policy (https://www.ninds.nih.gov/current-research/research-funded-ninds/clinical-research). For this funding announcement, only intervention research that meet the definition of mechanistic clinical trials and Basic Experimental Studies with Humans (BESH) will be supported by NINDS:

Mechanistic trials, defined as studies designed to understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention (i.e., HOW an intervention works, but not IF it works or is safe).

Basic Experimental Studies Involving Humans (BESH), defined as basic research studies involving humans that seek to understand the fundamental aspects of phenomena that also fall under the NIH definition of a clinical trial.

Research topics of interest for this NOFO include, but are not limited to:

• Demonstration of successful community engagement with populations defined by the NIH that experience health disparities (HDP) on interventions related to sleep disparities, as evidenced by development of sustainable community/research partnerships, buy-in surveys and meaningful community engagement metrics (see: the National Academy of Medicine’s Advancing Health Equity and Systems Transformation through Community Engagement) as related to NINDS mission
• Community-tailored outreach to NIH-defined HDP for intervention research, focused on recruitment, retention, and inclusion strategies to ensure future statistically robust and feasible sleep-related trials that fall within NINDS mission
• Creation and use of standardized and validated tools and metrics for assessing specific (multi-level and socioecological) drivers of neurological health disparities as it relates to sleep
• Establishing collaborative research team(s) with expertise in health disparities, community engagement and neurological sleep disparities and commensurate knowledge/education in cultural humility, equity and inclusion
• Development of community-driven, evidence-based interventions to reduce sleep-related neurological health disparities for one or more populations that experience health disparities that take into account: uptake and sustainability, Social Determinants of Health barriers, cultural and linguistic adaptations tailored to the population(s) of interest up to the point of clinical trial readiness

Applications for clinical trials that seek to answer specific questions about safety, tolerability, clinical efficacy, effectiveness, clinical management, and/or implementation of pharmacologic, behavioral, biologic, surgical, or device (invasive or non-invasive) interventions, preventive, therapeutic, and services interventions are important to the NINDS, but will not be supported under this NOFO. Please refer to https://www.ninds.nih.gov/Funding/Find-Funding-Opportunities to find the appropriate NIH or NINDS-specific NOFO for such clinical trials. Applicants are strongly advised to consult with NINDS prior to submitting an application to this NOFO to determine the appropriate funding. 

NINDS, as part of NIH, strives for rigor and transparency in all research it funds. For this reason, NINDS explicitly emphasizes the NIH application instructions related to rigor and transparency, https://grants.nih.gov/policy/reproducibility/guidance.htm, and provides additional guidance to the scientific community, https://www.ninds.nih.gov/Funding/grant_policy. The proposed clinical study must be based on robust and rigorous supporting data (e.g., from non-clinical in vivo and/or in vitro studies or preliminary clinical studies) that demonstrate that there is an adequate scientific foundation to justify the proposed trial. The proposed trial design must also use rigorous and transparent approaches. Additionally, the NINDS encourages the use of common data elements (see NINDS CDE Project: https://www.commondataelements.ninds.nih.gov/). A letter of intent and communication with NINDS program staff prior to submission of an application is strongly encouraged.

National Institute on Alcohol Abuse and Alcoholism (NIAAA)

The mission of the NIAAA is to generate and disseminate fundamental knowledge about the effects of alcohol on health and well-being, and apply that knowledge to improve diagnosis, prevention, treatment and recovery of alcohol-related problems, including alcohol use disorder and alcohol-associated organ damage, across the lifespan. NIAAA supports basic and/or translational research in a wide range of alcohol research scientific areas including genetics, neuroscience, epidemiology, prevention, and treatment. For clinical trials, the applicant should have an existing alcohol research clinical trial or a history of experience conducting clinical trials that examine alcohol-related outcomes.

Research shows that diverse teams working together outperform homogenous teams. Scientists and trainees from diverse backgrounds and with different life experiences bring different perspectives, creativity, and individual enterprise to address complex scientific problems. Diverse teams of scientists will lead the way to develop more innovative inclusive research that will more broadly enhance public health. Fostering diversity by addressing underrepresentation in the scientific research workforce is a key component of the NIH strategy to identify, develop, support, and maintain the quality of our scientific workforce. It is expected that the Alcohol Research Centers will include a diverse group of scientists, including individuals from underrepresented backgrounds as per NOT OD 20-031 (Notice of NIH's Interest in Diversity). NIAAA is especially interested in enhancing representation from racial, ethnic and gender minorities and early-stage investigators.

NIAAA is interested in studies proposing to examine sleep as a modifiable factor to reduce disparities for alcohol treatment outcomes and also studies examining non-pharmacological interventions to modify alcohol consumption to improve sleep health and reduce sleep health disparities.

Research topics include, but are not limited to:

? Evaluation, dissemination, implementation, and sustainability of evidence-based screening strategies, psychoeducation, and interventions for comorbid AUD and sleep disorders.

? Test novel approaches (e.g., sequential, multiple assignment, randomized trials–[SMART] trials) to adapt interventions at the individual level and/or to account for AUD/sleep comorbidity and cultural factors specific to diverse groups in AUD treatment.

? Development and adaptation of culturally grounded interventions and psychoeducation strategies to address barriers to treatment and health services for individuals with AUD and sleep disorders.

? Determine modifiers (e.g., social/cultural factors, other mental health comorbidity) that may influence longer term recovery outcomes for individuals with sleep/AUD comorbidity.

? Apply new technology (e.g., mobile devices, computer, web-based applications) to evidence-based behavioral health approaches to improve the effectiveness of novel interventions to reach remote and underserved, vulnerable populations.

? Evaluate the role of sleep disorders and social/cultural factors in treatment accessibility, effectiveness, and long-term recovery of AUD.

NHLBI

NHLBI will accept mechanistic clinical trials defined as mechanistic studies that that meet NIH’s definition of a clinical trial and that have the primary goal of understanding how an intervention works:

• Mechanistic studies are designed to understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention (the goal must not be to evaluate safety, pharmacokinetics or pharmacodynamics, efficacy, or clinical trial feasibility)
• fundamental or basic experimental studies involving humans (BESH) that do not have specific processes or products in mind
• hybrid applications, i.e., applications that propose non-interventional fundamental science aims along with the mechanistic or BESH clinical trial(s)
• Studies using surrogate or clinical outcomes for the purpose of providing preliminary proof of an expected effect (these must not be efficacy studies, see next section) of the proposed mechanistic and fundamental or basic experimental study

The following types of clinical trials are not allowed and will not be accepted by NHLBI under this NOFO:

• Early Phase Clinical Trials for Therapeutics and/or Diagnostics
• Studies to develop or conduct tests of the clinical efficacy/effectiveness of treatments.
• Studies that have safety, clinical efficacy, clinical management, and/or implementation goals.

Applicants are strongly encouraged to consult the NHLBI Scientific/Research Contact listed below prior to submission in order to confirm the NOFO to which the application should be submitted. Applicants are also encouraged to refer to the NHLBI Clinical Trial Funding Opportunities webpage.

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

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

Section II. Award Information

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

Section III. Eligibility Information

1. Eligible Applicants

Higher Education Institutions

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

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

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

Nonprofits Other Than Institutions of Higher Education

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

For-Profit Organizations

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

Local Governments

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

Federal Governments

• 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 Organizations) 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 How to Apply - 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. Failure to complete registrations in advance of a due date is not a valid reason for a late submission, please reference NIH Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications for additional information

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

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

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

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

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

2. Cost Sharing

This NOFO does not require cost sharing as defined in the NIH Grants Policy Statement NIH Grants Policy Statement Section 1.2 Definition of Terms.

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 NIH Grants Policy Statement Section 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 NIH Grants Policy Statement 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 NOFO. 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 How to Apply - Application Guide except where instructed in this notice of funding opportunity to do otherwise. Conformance to the requirements in the How to Apply - Application Guide is required and strictly enforced. Applications that are out of compliance with these instructions may be delayed or not accepted for review.

Page Limitations

All page limitations described in the How to Apply – Application Guide and the Table of Page Limits must be followed.

The following section supplements the instructions found in the How to Apply – Application Guide and should be used for preparing an application to this NOFO.

SF424(R&R) Cover

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Project/Performance Site Locations

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Other Project Information

All instructions in the How to Apply - Application Guide must be followed.

SF424(R&R) Senior/Key Person Profile

All instructions in the How to Apply - Application Guide must be followed.

R&R or Modular Budget

All instructions in the How to Apply - Application Guide must be followed.

R&R Subaward Budget

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Cover Page Supplement

All instructions in the How to Apply - Application Guide must be followed.

PHS 398 Research Plan

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

• Describe how the project intervenes on a causal mechanism or pathway to reduce sleep disparities and/or intervenes on sleep or circadian-related mechanisms that contribute to another health condition for which health disparities are observed.
• Describe how the research focuses on health disparities among U.S. racial or ethnic minority and low socioeconomic status populations, or focus on the intersection of race/ethnicity and/or lower SES for underserved rural residents, sexual and gender minority populations, or persons living with disabilities.
• Describe how the composition of the research team has the appropriate breadth and inclusiveness of expertise and disciplines (such as social science, health disparities or sleep research expertise).
• If there are foreign component(s), describe how the proposed activities at foreign sites will contribute to the knowledge that will improve minority health and/or help to reduce or eliminate health disparities in the United States.

Resource Sharing Plan: Individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the How to Apply - Application Guide.

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

All instructions in the How to Apply - Application Guide must be followed, with the following additional instructions:

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

Appendix: Only limited Appendix materials are allowed. Follow all instructions for the Appendix as described in the How to Apply - Application Guide.

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

PHS Human Subjects and Clinical Trials Information

When involving human subjects research, clinical research, and/or NIH-defined clinical trials (and when applicable, clinical trials research experience) follow all instructions for the PHS Human Subjects and Clinical Trials Information form in the How to Apply - 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 How to Apply - 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 How to Apply - Application Guide must be followed.

PHS Assignment Request Form

All instructions in the How to Apply - Application Guide must be followed.

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

See Part 2. 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. 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 Grants Policy Statement Section 2.3.9.2 Electronically Submitted Applications.

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 How to Apply – 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 Section 7.9.1 Selected Items of Cost.

7. Other Submission Requirements and Information

Applications must be submitted electronically following the instructions described in the How to Apply - Application Guide. Paper applications will not be accepted.

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

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

Important reminders:

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

The applicant organization must ensure that the unique entity identifier provided on the application is the same identifier used in the organization’s profile in the eRA Commons and for the System for Award Management. Additional information may be found in the How to Apply - 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.

For this particular announcement, note the following:

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

Reviewers will provide an overall impact score to reflect their assessment of the likelihood for the 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.

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

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

2. Review and Selection Process

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

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

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

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

• Scientific and technical merit of the proposed project as determined by scientific peer review.
• Availability of funds.
• Relevance of the proposed project to program priorities.

3. Anticipated Announcement and Award Dates

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

Information regarding the disposition of applications is available in the NIH Grants Policy Statement Section 2.4.4 Disposition of Applications.

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. This request is not a Notice of Award nor should it be construed to be an indicator of possible funding. 

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

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

Any application awarded in response to this NOFO 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:

• Federalwide Standard Terms and Conditions for Research Grants
• Prohibition on Certain Telecommunications and Video Surveillance Services or Equipment
• Acknowledgment of Federal Funding

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

If a recipient receives an award, the recipient must follow all applicable nondiscrimination laws. The recipient agrees to this when registering in SAM.gov. The recipient must also submit an Assurance of Compliance (HHS-690). To learn more, see the Laws and Regulations Enforced by the HHS Office for Civil Rights website.

HHS recognizes that NIH 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 NOFO.

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 System for Award Management (SAM.gov) requirements. SAM.gov requires Federal agencies to review and consider information about an applicant in the designated integrity and performance system (currently SAM.gov) prior to making an award. An applicant can review and comment on any information in the responsibility/qualification records available in SAM.gov. NIH will consider any comments by the applicant, in addition to the information available in the responsibility/qualification records in SAM.gov, 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 2 CFR Part 200.206 “Federal awarding agency review of risk posed by applicants.” This provision will apply to all NIH grants and cooperative agreements except fellowships.

Not Applicable

3. Data Management and Sharing

Consistent with the 2023 NIH Policy for Data Management and Sharing, when data management and sharing is applicable to the award, recipients will be required to adhere to the Data Management and Sharing requirements as outlined in the NIH Grants Policy Statement. Upon the approval of a Data Management and Sharing Plan, it is required for recipients to implement the plan as described.

4. Reporting

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

A final RPPR, invention statement, and the expenditure data portion of the Federal Financial Report are required for closeout of an award, as described in the NIH Grants Policy Statement. NIH NOFOs 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 2 CFR Part 200.301.

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

In accordance with the regulatory requirements provided at 2 CFR Part 200.113 and Appendix XII to 2 CFR Part 200, recipients that have currently active Federal grants, cooperative agreements, and procurement contracts from all Federal awarding agencies with a cumulative total value greater than $10,000,000 for any period of time during the period of performance of a Federal award, must report and maintain the currency of information reported in the System for Award Management (SAM) about civil, criminal, and administrative proceedings in connection with the award or performance of a Federal award that reached final disposition within the most recent five-year period.  The recipient must also make semiannual disclosures regarding such proceedings. Proceedings information will be made publicly available in the designated integrity and performance system (Responsibility/Qualification in SAM.gov, formerly 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 2 CFR Part 200 – Award Term and Condition for Recipient Integrity and Performance Matters.

Section VII. Agency Contacts

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

eRA Service Desk (Questions regarding ASSIST, eRA Commons, application errors and warnings, documenting system problems that threaten submission by the due date, and post-submission issues)

Finding Help Online: https://www.era.nih.gov/need-help (preferred method of contact)
Telephone: 301-402-7469 or 866-504-9552 (Toll Free)

General Grants Information (Questions regarding application instructions, application processes, and NIH grant resources)
Email: 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

Arielle S. Gillman, PhD, MPH
Division of Integrative Biological and Behavioral Sciences
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-435-0060
Email: arielle.gillman@nih.govmailto:nancy.jones@nih.gov

Nancy L. Jones, PhD, MA
Division of Community Health and Population Sciences
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-594-8945
Email: nancy.jones@nih.gov

Lynne S. Padgett, PhD FAPOS
Division of Clinical and Health Services Research
National Institute on Minority Health and Health Disparities (NIMHD)
Telephone: 301-827-5511
Email: lynne.padgett@nih.gov

Todd S. Horowitz
National Cancer Institute
Telephone: 240-276-6963
Email: todd.horowitz@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

Janet (Yejun) He, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-9964
Email: hey@ninds.nih.gov

Richard T. Benson, M.D., Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-827-9071
Email: Richard.benson@nih.gov

Mariela Shirley, Ph.D.
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Telephone: 301-402-9389
Email: shirleym@mail.nih.gov

Elise Rice, Ph.D.
Division of Behavioral and Social Research
National Institute on Aging (NIA)
Telephone: 301-496-5752
Email: elise.rice@nih.gov 

Alexis Bakos, Ph.D., M.P.H., R.N.
Division of Geriatrics and Clinical Gerontology
National Institute on Aging (NIA)
Telephone: 301-480-8538
Email: alexis.bakos@nih.gov

Shilpy Dixit, PhD
NHLBI - NATIONAL HEART, LUNG, AND BLOOD INSTITUTE
Phone: none
E-mail: shilpy.dixit@nih.gov

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

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

Crystal Wolfrey
National Cancer Institute (NCI)
Telephone: 240-276-6277
Email: crystal.wolfrey@mail.nih.gov

Randi Freundlich
National Institute of Nursing Research (NINR)
Telephone: 301-594-5974
Email: freundlichr@mail.nih.gov

Chief Grants Management Officer
National Institute of Neurological Disorders and Stroke (NINDS)
Email: ChiefGrantsManagementOfficer@ninds.nih.gov

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

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

Anthony Agresti
NHLBI - NATIONAL HEART, LUNG, AND BLOOD INSTITUTE
Phone: 301-827-8014
E-mail: agrestia@nhlbi.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.

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 2 CFR Part 200.