Technologies for Improving Minority Health and Eliminating Health Disparities (R41/R42- Clinical Trial Optional)

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Description

This opportunity invites U.S. small business concerns (SBCs) to apply for Small Business Technology Transfer (STTR) grants (R41/R42) to develop products, processes, or services for commercialization that aim to improve minority health and/or reduce and ultimately eliminate health disparities in one or more NIH-defined populations. Projects should result in effective, affordable, and culturally acceptable technologies, with a strong potential for real-world impact and commercialization.

The program is supported by multiple NIH institutes, including the National Institute on Minority Health and Health Disparities (NIMHD), National Institute of Biomedical Imaging and Bioengineering (NIBIB), National Institute of Dental and Craniofacial Research (NIDCR), National Institute of Neurological Disorders and Stroke (NINDS), National Institute of Nursing Research (NINR), and the National Center for Advancing Translational Sciences (NCATS).

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Due Dates

• June 10, 2025: New, Renewal, Resubmission, Revision (including AIDS-related)
• December 9, 2025: New, Renewal, Resubmission, Revision (including AIDS-related)
• June 10, 2026: New, Renewal, Resubmission, Revision (including AIDS-related)
• December 9, 2026: New, Renewal, Resubmission, Revision (including AIDS-related)

All applications are due by 5:00 PM local time of the applicant organization. Letters of intent are encouraged 30 days prior to the application due date.

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Funding Amount

• Phase I: Up to $306,872 total costs for up to 1 year.
• Phase II: Up to $2,045,816 total costs for up to 2 years.
• Institute-specific anticipated funding:
  • NIMHD: up to $1,000,000 (3–4 awards)
  • NIDCR: up to $250,000 (1 award)
  • NCATS: up to $1,000,000 (1–3 awards)
  • NIBIB: up to $300,000 (1 award)
• Higher budgets may be considered for specific topics with prior approval; see NIH budget waivers.
• Project duration: Phase I (up to 1 year), Phase II (up to 2 years).

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Eligibility

• Applicant type: Only U.S. small business concerns (SBCs) are eligible.
  • Must be organized for profit, have a place of business in the U.S., and operate primarily within the U.S.
  • Must be more than 50% owned and controlled by U.S. citizens or permanent resident aliens, or by other eligible small businesses.
  • Must have no more than 500 employees.
  • Small businesses majority-owned by multiple venture capital operating companies, hedge funds, or private equity firms are not eligible for STTR.
• Foreign organizations: Not eligible. Foreign components may be allowed only in rare, well-justified cases.
• Principal Investigator (PI): May be employed by the SBC or the partnering non-profit research institution, but must have a formal appointment with the SBC and commit at least 10% effort.
• Multiple applications: Allowed if each is scientifically distinct.
• Clinical trials: Optional (applications may or may not propose a clinical trial).

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Application Process

• Submission: Applications must be submitted electronically via Grants.gov or NIH ASSIST.
• Required registrations: SAM, SBA Company Registry, eRA Commons, Grants.gov.
• Letter of intent: Strongly encouraged, due 30 days before the application deadline.
• Application instructions: Follow the NIH SBIR/STTR Application Guide and the specific funding announcement.
• Key application components:
  • Project summary/abstract
  • Research strategy (must address how the technology will improve minority health or reduce health disparities)
  • Commercialization plan (for Phase II and Fast-Track)
  • Data Management and Sharing Plan (required for all applicants)
  • Letters of support (including from consultants, collaborators, and, for STTR, the partnering research institution)
  • Budget and justification
• Appendices: Limited; see FOA for allowable materials.
• Review criteria: Significance, innovation, approach, investigator(s), environment, and commercialization potential.

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Additional Information

• Scope: Projects must explicitly address minority health or health disparities in NIH-defined populations. Applications not responsive to this focus will not be reviewed.
• Research areas of interest include, but are not limited to:
  • Technologies for disease self-management, care coordination, and communication in underserved communities
  • Culturally attuned behavioral interventions and health promotion tools
  • Tools for measuring social/environmental exposures and integrating social determinants of health
  • Mobile health, telehealth, and digital health solutions for minority and underserved populations
  • Data science, AI, and big data tools to address health disparities
  • Educational technologies for health literacy and science education
  • Infrastructure and workforce development tools to expand access to care and research
• Institute-specific interests: See the full FOA for details on each participating institute’s priorities and restrictions (e.g., NIDCR does not support clinical trials under this mechanism).
• Foreign disclosure: All applicants must comply with strict disclosure requirements regarding foreign relationships and affiliations. See NIH guidance.
• Security review: NIH will assess security risks related to foreign ties; certain relationships may disqualify applicants.

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External Links

• Full Funding Opportunity Announcement (NIH)
• NIH SBIR/STTR Application Guide
• NIH SBIR/STTR Program Overview
• NIMHD Research Framework
• NIH Data Management and Sharing Policy
• NIH Grants Policy Statement
• NIH SBIR/STTR Budget Waivers
• Grants.gov Opportunity Listing

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Contact Information

For additional contacts and the most up-to-date information, see the full FOA contact section.

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