Interventions to Reduce Sleep Health Disparities (R01 - Clinical Trials Optional)

Interventions to Reduce Sleep Health Disparities (R01 - Clinical Trials Optional) is sponsored by NIH Office of Disease Prevention (ODP). Funds interventions to reduce sleep health disparities.

PAR-24-330: Interventions to Reduce Sleep Health Disparities (R01 - Clinical Trials Optional) This funding opportunity was updated to align with agency priorities. Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. 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 Heart, Lung, and Blood Institute ( NHLBI ) National Institute on Alcohol Abuse and Alcoholism ( NIAAA ) National Institute of Neurological Disorders and 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 Behavioral and Social Sciences Research ( OBSSR ) Funding Opportunity Title Interventions to Reduce Sleep Health Disparities (R01 - Clinical Trials Optional) R01 Research Project Grant April 06, 2026 - Implementation of Changes for Basic Experimental Studies with Humans. See Notice NOT-OD-26-067 .

January 28, 2026 - NIH Removing AIDS Application Due Dates from NOFOs. See Notice NOT-OD-26-029 . March 31, 2025 - This funding opportunity was updated to align with agency priorities.

Carefully reread the full funding opportunity and make any needed adjustments to your application prior to submission. April 4, 2024 - Overview of Grant Application and Review Changes for Due Dates on or after January 25, 2025. See Notice NOT-OD-24-084 .

August 31, 2022 - Implementation Changes for Genomic Data Sharing Plans Included with Applications Due on or after January 25, 2023. See Notice NOT-OD-22-198 . August 5, 2022 - Implementation Details for the NIH Data Management and Sharing Policy.

See Notice NOT-OD-22-189 . Funding Opportunity Number (FON) Companion Funding Opportunity See Section III. 3.

Additional Information on Eligibility. Assistance Listing Number(s) 93. 307, 93.

273, 93. 233, 93. 837, 93.

838, 93. 839, 93. 840, 93.

853, 93. 866, 93. 361, 93.

399 Funding Opportunity Purpose The purpose of this initiative is to support non-pharmacological interventions to promote sleep health, reduce sleep health disparities, and examine sleep as a modifiable factor to reduce disparities for other health outcomes among populations that experience health disparities.

Funding Opportunity Goal(s) Health Disparities Research Project Grants (RPG), including those to be supported by this initiative on interventions to reduce sleep health disparities, support innovative projects to enhance our understanding of biological mechanisms, social, behavioral, and health services that can directly and demonstrably contribute to the improvement in minority health and the elimination of health disparities.

Open Date (Earliest Submission Date) The following table includes NIH standard due dates marked with an asterisk. Renewal / Resubmission / Revision (as allowed) AIDS - New/Renewal/Resubmission/Revision, as allowed 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.

Required Application Instructions 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 Application Guide and the NOFO) 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.

Use the NIH ASSIST system to prepare, submit and track your application online. 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. Workspace to prepare and submit your application and eRA Commons to track your application. Part 1.

Overview Information 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.

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, 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, 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 systems-level intervention that may improve health outcomes among 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.

The overall 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.

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 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 environmental hazards on sleep health, such as 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. 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 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 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 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 disparities 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 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).

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 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 Development of community-driven, evidence-based interventions to reduce sleep-related neurological health disparities for one or more populations that experience health disparities that consider: uptake and sustainability, Social Determinants of Health barriers, 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.

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 other factors specific to 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 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 factors in treatment accessibility, effectiveness, and long-term recovery of AUD.

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) hybrid applications, i.e., applications that propose non-interventional fundamental science aims along with the mechanistic 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 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. National Institute of Nursing Research (NINR) The National Institute of Nursing Research (NINR) supports research aligned with our mission and strategic priorities, conducted by scientists from any discipline.

NINR discovers solutions to health challenges through the lenses of social determinants of health, population and community health, prevention and health promotion, and systems and models of care.

Drawing on the strengths of nursing’s holistic, contextualized perspective, core values, and broad reach, NINR funds multilevel and cross-sectoral research that examines the factors that impact health across the many settings in which nurses practice, including homes, schools, workplaces, clinics, justice settings, and the community.

Investigators proposing NIH-defined clinical trials may refer to the Research Methods Resources website for information about developing statistical methods and study designs. See Section VIII. Other Information for award authorities and regulations.

Section II. Award Information Grant: A financial assistance mechanism providing money, property, or both to an eligible entity to carry out an approved project or activity. Application Types Allowed The OER Glossary and the How to Apply Application Guide provide details on these application types.

Only those application types listed here are allowed for this NOFO. 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. Application budgets are not limited but need to reflect the actual needs of the proposed project. 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 NOFO. Section III.

Eligibility Information Higher Education Institutions Public/State Controlled Institutions of Higher Education Private Institutions of Higher Education 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 (Other than Small Businesses) City or Township Governments Special District Governments Indian/Native American Tribal Governments (Federally Recognized) Indian/Native American Tribal Governments (Other than Federally Recognized).

Eligible Agencies of the Federal Government U.S. Territory or Possession 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 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. NIH will no longer issue awards (i.e., new, renewal, or non-competing continuation) to domestic or foreign entities that involve foreign subawards/subcontracts. All NIH-funded research involving foreign subawards/subcontracts must be submitted in response to a NOFO that is specifically designated for funded international collaborations.

See NIH Grants Policy Statement 16. 8 Collaborative International Research Awards. Applications involving foreign subawards/subcontracts submitted in response to this NOFO will be deemed noncompliant and will not be considered for funding.

This policy applies to all monetary international collaborations resulting in foreign subawards/subcontracts, however, it does not preclude unfunded international collaborations or foreign components, funding for foreign consultants, or procurement of unique equipment or supplies from foreign vendors. Foreign components, as defined in the NIH Grants Policy Statement , are allowed.

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 the 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.

All PD(s)/PI(s) must be registered with ORCID. The personal profile associated with the PD(s)/PI(s) eRA Commons account must be linked to a valid ORCID ID. For more information on linking an ORCID ID to an eRA Commons personal profile see the ORCID topic in our eRA Commons online help.

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 their organization to develop an application for support. For institutions/organizations proposing multiple PDs/PIs, visit