Innovations for Healthy Living - Improving Minority Health and Eliminating Health Disparities (R43/R44 - Clinical Trial Optional)

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Description

This opportunity invites U.S. small businesses to apply for Small Business Innovation Research (SBIR) grants (R43/R44) to develop and commercialize innovative products, processes, or services that aim to improve minority health and/or reduce and ultimately eliminate health disparities in populations that experience such disparities in the United States. Projects may include technology, services, or interventions that are effective, affordable, and culturally acceptable, and may propose clinical trials (optional).

Participating NIH Institutes and Centers include NIMHD, NHLBI, NIA, NIBIB, NIDCR, NIDDK, NINDS, NINR, NCATS, and NIAAA, each with specific areas of interest (see NOFO for details).

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Due Dates

• June 10, 2025
• December 9, 2025
• June 10, 2026
• December 9, 2026

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 6 months.
• Phase II: Up to $2,045,816 total costs for up to 2 years.
• Waivers: Some topics may be eligible for higher caps (e.g., up to $500,000 for Phase I and $2.5M for Phase II for NIA). See the current list of approved topics and contact program officials if requesting above the standard cap.
• Number of Awards: Varies by participating NIH Institute/Center; see NOFO for anticipated numbers and budgets.

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Eligibility

• Applicant: Only United States small business concerns (SBCs) are eligible. Must be organized for profit, have a place of business in the U.S., and meet SBA size standards (≤500 employees).
• Ownership: Must be >50% owned and controlled by U.S. individuals or qualifying entities. Special rules apply for venture capital, hedge fund, or private equity ownership.
• Foreign Entities: Non-U.S. organizations are not eligible. Foreign components may be allowed if well-justified.
• SBIR Benchmarks: Applicants must meet SBIR Phase I to Phase II transition and commercialization benchmarks if they have significant prior SBIR/STTR awards.
• PI Requirements: The primary employment of the PD/PI must be with the small business at the time of award and during the project.

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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, and Grants.gov.
• Letter of Intent: Strongly encouraged, due 30 days before the application deadline.
• Application Guide: Follow the SBIR/STTR Application Guide and the specific NOFO instructions.
• Required Attachments: SBIR Application Certification (if majority-owned by multiple VCOCs, hedge funds, or private equity firms), Data Management and Sharing Plan, and other standard NIH forms.
• Clinical Trials: Applications may include or exclude clinical trials.
• Review: Peer review will consider significance, innovation, approach, investigator(s), environment, and commercialization potential.

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Additional Information

• Research Focus: Projects must explicitly address minority health or health disparities. Applications not addressing these will not be reviewed.
• Areas of Interest: See NOFO for detailed, institute-specific priorities (e.g., heart/lung/blood/sleep health, aging, oral health, diabetes, digital health, AI, big data, etc.).
• Budget: Propose a budget appropriate for the work; contact program officials if exceeding standard caps.
• Data Rights: SBIR/STTR recipients may retain data rights for up to 20 years.
• Foreign Disclosure: Applicants must comply with new foreign disclosure requirements for all owners and key personnel.
• Multiple Applications: Allowed if scientifically distinct; no duplicate or overlapping applications.

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External Links

• Full NOFO and Application Instructions (NIH)
• Grants.gov Opportunity Page
• NIH SBIR/STTR Application Guide (PDF)
• NIMHD Research Framework
• NIH SBIR/STTR Program Overview
• NIH Data Management and Sharing Policy

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Contact Information

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

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