Funder: National Institutes of Health
Due Dates: September 5, 2024 | January 5, 2025 | April 5, 2025 | September 5, 2025
Funding Amounts: Phase I: up to $306,872 (6 months) | Phase II: up to $2,045,816 (2 years); higher budgets possible for select topics
Summary: Supports U.S. small businesses to conduct innovative R&D aligned with NIH/CDC missions, requiring at least one clinical trial per application.
Key Information: Only applications proposing clinical trials are eligible; strict eligibility and disclosure requirements apply.
Description
This opportunity invites U.S. small businesses to apply for Small Business Innovation Research (SBIR) grants to develop and commercialize innovative technologies or products that address the research and development missions of the National Institutes of Health (NIH) and Centers for Disease Control and Prevention (CDC). All applications must propose at least one clinical trial. Projects should align with the scientific priorities of one or more participating NIH Institutes or CDC Centers.
The SBIR program is designed to stimulate technological innovation, strengthen the role of small businesses in federal R&D, and increase commercialization of innovations. This solicitation supports Phase I (feasibility), Phase II (development), Fast-Track (combined Phase I/II), Direct-to-Phase II (NIH only), and Phase IIB (additional development) applications.
Due Dates
- September 5, 2024
- January 5, 2025
- April 5, 2025
- September 5, 2025
All applications are due by 5:00 PM local time of the applicant organization. These are standard NIH SBIR due dates; applicants are encouraged to apply early.
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
- Phase IIB: Budget limits vary by Institute/Center and topic
- Higher budgets: May be allowed for specific topics with NIH approval (see list of approved topics for budget waivers)
Applicants should propose a budget and duration appropriate for the project scope. Contact program officials for guidance if requesting above-standard budgets.
Eligibility
- Applicant: U.S. small business concern (SBC) with ≤500 employees, organized for profit, and located in the U.S.
- Ownership: Must be >50% owned and controlled by U.S. individuals or qualifying entities; certain venture capital ownership structures are allowed for SBIR (not STTR).
- Principal Investigator: Must be primarily employed by the small business at the time of award and during the project.
- Foreign entities: Not eligible; foreign components may be allowed if justified.
- Multiple applications: Permitted if each is scientifically distinct.
- Performance benchmarks: Companies with significant prior SBIR/STTR awards must meet transition and commercialization benchmarks.
See the full eligibility criteria for details.
Application Process
- Submission: Applications must be submitted electronically via Grants.gov, NIH ASSIST, or an institutional system-to-system solution.
- Required registrations: SAM, SBA Company Registry, eRA Commons, and Grants.gov (may take 6+ weeks).
- Application guide: Follow the SBIR/STTR Application Guide and all instructions in the funding announcement.
- Clinical trial documentation: Must include a detailed clinical trial plan using the PHS Human Subjects and Clinical Trials Information form.
- Data management: All applicants must submit a Data Management and Sharing Plan.
- Disclosures: Applicants must comply with foreign relationship disclosure requirements and submit additional certifications if majority-owned by venture capital, hedge funds, or private equity.
Additional Information
- Scope: Projects must be relevant to the missions of participating NIH Institutes or CDC Centers. See SBIR/STTR Program Descriptions and Research Topics.
- Clinical trial requirement: Only applications proposing at least one clinical trial are eligible under this announcement. For non-clinical trial SBIRs, see PA-24-245.
- Review criteria: Scientific merit, innovation, significance, approach, investigator qualifications, environment, and commercialization potential (for Phase II/Fast-Track).
- No cost sharing required.
- Foreign components: Allowed only if well justified and necessary for the project.
- Reporting: Annual and final progress, invention, and financial reports required.
External Links
Contact Information