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Grant Details

https://www.grants.gov/search-results-detail/357572

Grant Analysis

Purpose & Target

The core objective of this grant is to support non-pharmacological interventions aimed at promoting sleep health, reducing sleep health disparities, and investigating sleep's role as a modifiable factor to lessen disparities in other health outcomes. It targets a broad range of organizations, including higher education institutions, non-profits, for-profits (including small businesses), and various government entities. This is a SECTOR-SPECIFIC grant focused on health research. The geographic scope for research impact is primarily on populations in the U.S. and its territories. Key filtering criteria for applicants include a focus on non-pharmacological interventions, addressing sleep health disparities, and the R01 grant type, with clinical trials being optional but subject to specific limitations. This is a recurring grant opportunity with multiple application deadlines until 2027.

Financial Structure

  • Budget: Application budgets are not limited but must reflect the actual needs of the proposed project.
  • Cost Sharing: Not required.
  • Minimum Funding: Not specified.
  • Maximum Funding: Not specified.
  • Currency: USD (implied).
  • Funding Rate: Not specified (typical for NIH R01 grants covers eligible direct costs plus indirect costs).
  • Pre-award Costs: Allowable as described in the NIH Grants Policy Statement.
  • Budget Limitations: Requests of $500,000 or more in direct costs in any single year (excluding consortium F&A) require contacting a Scientific/Research Contact at least 6 weeks before submission.
  • Mandatory Disclosure: Recipients are required to submit any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award.

Eligibility Requirements

Organization Type
  • Eligible:
    • Higher Education Institutions: Public/State Controlled, Private
    • Nonprofits: 501(c)(3) IRS Status (other than higher education), without 501(c)(3) IRS Status (other than higher education)
    • For-Profit Organizations: Small Businesses, Other than Small Businesses
    • Local Governments: State, County, City or Township, Special District, Federally Recognized Indian/Native American Tribal Governments, Other Indian/Native American Tribal Governments
    • Federal Governments: Eligible Agencies
    • 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
  • Not Eligible:
    • Non-domestic (non-U.S.) Entities (Foreign Organizations)
    • Non-domestic (non-U.S.) components of U.S. Organizations
Geographic Location
  • Applicants must be based in the U.S.
  • Research must focus on populations that experience health disparities in the U.S. and its territories.
  • Foreign components of U.S. organizations are allowed.
Registrations & Certifications
  • Required prior to application submission:
    • System for Award Management (SAM) registration (active, renewed annually).
    • NATO Commercial and Government Entity (NCAGE) Code (for foreign organizations registering in SAM, if applicable).
    • Unique Entity Identifier (UEI) (issued via SAM.gov).
    • eRA Commons account (for organization, including at least one Signing Official and one Program Director/Principal Investigator).
    • Grants.gov registration (requires active SAM registration).
  • Program Directors/Principal Investigators (PDs/PIs) must have an eRA Commons account affiliated with the applicant organization.
Cost Sharing
  • Cost sharing is not required.
Clinical Trials
  • Clinical trials are optional, but specific types may be excluded by participating NIH Institutes:
    • National Institute of Neurological Disorders and Stroke (NINDS): Only mechanistic clinical trials and Basic Experimental Studies with Humans (BESH) are supported. Clinical trials focusing on safety, tolerability, efficacy, effectiveness, clinical management, or implementation are not supported under this NOFO.
    • National Heart, Lung, and Blood Institute (NHLBI): Only mechanistic clinical trials and BESH are supported. Early Phase Clinical Trials for Therapeutics/Diagnostics and studies testing clinical efficacy/effectiveness are not allowed.
    • National Institute on Alcohol Abuse and Alcoholism (NIAAA): Applicants for clinical trials should have existing alcohol research clinical trial experience or a history of conducting clinical trials examining alcohol-related outcomes.
Application Limits
  • Applicant organizations may submit more than one application, provided that each application is scientifically distinct.
  • Duplicate or highly overlapping applications are not accepted if already under review.

Application Process

Application Submission Timeline
  • Open Date (Earliest Submission Date): January 05, 2025.
  • Latest Application Due Date: June 05, 2027, by 5:00 PM local time of applicant organization.
  • Other regular application due dates: February 05, 2025; June 05, 2025; October 05, 2025; February 05, 2026; June 05, 2026; October 05, 2026; February 05, 2027.
  • For AIDS applications, specific due dates are available, with the latest being July 05, 2027.
  • If a due date falls on a weekend or Federal holiday, the deadline is automatically extended to the next business day.
  • Funding Opportunity Expiration Date: September 08, 2027.
Application Procedure
  • Applicants must access the application package through ASSIST, Grants.gov Workspace, or an institutional system-to-system (S2S) solution.
  • Follow the instructions in the 'Research (R) Instructions in the How to Apply - Application Guide', supplemented by this Notice of Funding Opportunity (NOFO).
  • Applications must be submitted electronically through Grants.gov.
  • Applicants must track the status of their application in the eRA Commons.
  • Errors identified during submission must be corrected and a changed/corrected application resubmitted to Grants.gov on or before the due date and time.
  • For requests of $500,000 or more in direct costs in any year, applicants must contact a Scientific/Research Contact at least 6 weeks before submitting the application.
Required Documentation
  • SF424(R&R) Cover
  • SF424(R&R) Project/Performance Site Locations
  • SF424(R&R) Other Project Information
  • SF424(R&R) Senior/Key Person Profile
  • R&R or Modular Budget
  • R&R Subaward Budget
  • PHS 398 Cover Page Supplement
  • PHS 398 Research Plan (must describe intervention's causal mechanism and research team's expertise)
  • Resource Sharing Plan
  • Other Plan(s), including a Data Management and Sharing Plan (required for all applications generating scientific data)
  • PHS Human Subjects and Clinical Trials Information form (if human subjects involved)
  • PHS Assignment Request Form
  • Limited Appendix materials are allowed (e.g., blank questionnaires/surveys; no publications).
Project Period
  • The maximum project period is 5 years.
Reporting & Compliance Post-Award
  • Recipients must submit the Research Performance Progress Report (RPPR) annually and provide financial statements.
  • A final RPPR, invention statement, and expenditure data portion of the Federal Financial Report are required for award closeout.
  • ClinicalTrials.gov registration and results reporting are expected for all clinical trials.
  • Recipient institutions must ensure all protocols involving human subjects are reviewed and approved by their Institutional Review Board (IRB) or Independent Ethics Committee (IEC).
  • Oversight and monitoring of all NIH-conducted or -supported human biomedical and behavioral intervention studies (clinical trials) are required for data safety and integrity.
  • Compliance with Investigational New Drug (IND) or Investigational Device Exemption (IDE) requirements is necessary for relevant clinical research projects.

Evaluation Criteria

Overall Impact
  • Reviewers will provide an overall impact score reflecting their assessment of the likelihood for the project to exert a sustained, powerful influence on the research field(s) involved.
Scored Review Criteria
  • Importance of the Research (Significance and Innovation):
    • Addresses a critical need for intervention research in sleep health disparities.
    • Proposes innovative non-pharmacological interventions.
    • Focuses on NIH-designated populations experiencing health disparities.
  • Rigor and Feasibility (Approach):
    • Employs rigorous research designs (e.g., quasi-experimental, stepped-wedge cluster randomized, hybrid effectiveness-implementation).
    • Avoids designs lacking comparison conditions or sites.
    • Incorporates measures from the PhenX Toolkit for Social Determinants of Health (SDOH).
    • Utilizes objective measures (e.g., wearable devices) in addition to self-report for sleep.
    • Describes how the project intervenes on a causal mechanism or pathway to reduce sleep disparities or related health disparities.
  • Expertise and Resources (Investigator(s) and Environment):
    • The research team demonstrates appropriate breadth of expertise and disciplines (e.g., social science, health disparities, sleep research expertise).
    • The PD(s)/PI(s) possess the necessary skills, knowledge, and resources.
    • If foreign component(s) are involved, their contribution to improving minority health and/or helping to reduce or eliminate health disparities in the United States is clear.
Additional Review Criteria (Considered but not scored)
  • Protections for Human Subjects.
  • Vertebrate Animals (if applicable): Evaluation of procedures, justifications for use and species, interventions to minimize discomfort, and justification for euthanasia method.
  • Biohazards (if applicable): Assessment of hazardous materials/procedures and proposed protection.
  • Resubmissions: Evaluation of the full application as now presented.
  • Renewals: Evaluation of progress made in the last funding period.
  • Revisions: Evaluation of the appropriateness of the proposed expansion of the project scope.
Additional Review Considerations (Considered but do not impact overall score)
  • Authentication of Key Biological and/or Chemical Resources: Plans for identifying and ensuring the validity of these resources.
  • Budget and Period of Support: Evaluation of whether the budget and requested period are fully justified and reasonable in relation to the proposed research.
Funding Decisions
  • Decisions will be based on:
    • 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.

Compliance & Special Requirements

Regulatory Compliance
  • Adherence to the NIH Grants Policy Statement.
  • Compliance with 2 CFR Part 200, 'Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards'.
  • Compliance with all applicable nondiscrimination laws (recipients agree to this upon SAM.gov registration).
  • Compliance with Sections 301 and 405 of the Public Health Service Act, and 42 CFR Part 52.
  • Compliance with all federal statutes and regulations relevant to federal financial assistance.
Data Protection & Security
  • Compliance with the 2023 NIH Policy for Data Management and Sharing.
  • Implementation of the approved Data Management and Sharing Plan is required.
  • For activities involving health IT, recipients must use health IT that meets standards and implementation specifications adopted in 45 CFR part 170, Subpart B, if such standards can support the activity.
  • When health IT is used for eligible clinicians in ambulatory settings or hospitals, it must be certified under the ONC Health IT Certification Program if certified technology can support the activity.
  • For entities with ongoing access to HHS systems or data (including PII/PHI), plans and procedures modeled after the NIST Cybersecurity framework must be developed to protect HHS systems and data.
Ethical Standards
  • Strict adherence to protections for human subjects, including obtaining IRB or IEC approval.
  • Data and Safety Monitoring Requirements for clinical trials to ensure participant safety and data integrity.
  • Mandatory disclosure of any information related to violations of federal criminal law involving fraud, bribery, or gratuity violations potentially affecting the federal award.
Unique Aspects & Strategic Opportunities
  • Non-pharmacological Focus: The grant exclusively supports non-pharmacological interventions.
  • Social and Environmental Determinants: Strong emphasis on addressing social and environmental determinants of sleep health disparities.
  • Lifespan Approach: Interventions are encouraged across the entire lifespan and at key life transition points (e.g., early childhood, adolescence, unemployment, prenatal periods, parenthood, older adulthood).
  • Community Engagement: Applicants are strongly encouraged to engage meaningfully and work closely with communities affected by sleep health disparities to inform study design, analysis, and dissemination, and to address implementation processes.
  • Research Design Flexibility: While rigorous evidence is required, the NOFO supports alternative research designs such as quasi-experimental (e.g., interrupted time series, stepped-wedge cluster randomized designs) and hybrid effectiveness-implementation designs, acknowledging that randomized controlled trials may not always be feasible.
  • Standardized Data Collection: Encourages the use of the PhenX Toolkit for collecting comparable data on Social Determinants of Health (SDOH).
  • Objective Measures: Encourages the use of objective measures (e.g., wearable devices) in addition to self-report for sleep data.
  • Interdisciplinary Collaboration: Explicitly encourages research teams with a broad range of expertise and disciplines (e.g., social science, health disparities, sleep research).
  • Foreign Components: While foreign organizations cannot apply directly, foreign components of U.S. organizations are allowed, provided they contribute to improving minority health or reducing health disparities in the U.S.

Grant Details

sleep health health disparities non-pharmacological interventions social determinants of health health outcomes public health minority health african american health native american health alaska native health pacific islander health clinical trials behavioral interventions social interventions environmental interventions research project grant r01 national institutes of health nih nimhd nhlbi nia niaaa ninds ninr nci cancer aging neurological disorders alcohol use disorder nursing research community engagement data sharing human subjects research us government funding disease prevention chronic disease mental health cardiovascular disease obesity diabetes cancer prevention neurology gerontology addiction nursing biological mechanisms social mechanisms behavioral mechanisms health services research quasi-experimental design hybrid implementation phenx toolkit wearable devices public health policy workplace interventions school interventions urban planning rural health underserved populations health equity lifespan research maternal health paternal health child health adolescent health older adults alzheimer's disease caregiver support palliative care risk factors sleep quality sleep quantity circadian rhythms sleep disorders insomnia sleep apnea sleep hygiene stress reduction physical activity nutrition substance use data management cybersecurity federal grants public-private partnerships research development health promotion
Interventions to Reduce Sleep Health Disparities (R01 - Clinical Trials Optional)
PAR-24-330
National Institutes of Health (NIH)
UNIVERSITY NGO ENTERPRISE PUBLIC OTHER
US
HEALTHCARE SOCIAL EDUCATION OTHER
DEVELOPMENT PILOT_PROJECTS RESEARCH_DEVELOPMENT
OTHER
SDG3 SDG10 SDG17
FUNDING RESEARCH_DEVELOPMENT CAPACITY_BUILDING
None
None
None
USD
None
June 5, 2027, 5 p.m.
July 2027 - October 2027