Funder: National Institutes of Health
Due Dates: August 6, 2025 (Letter of Intent) | September 5, 2025 (Application)
Funding Amounts: Up to $3,945,657 total costs (direct, indirect, fee) for up to 3 years; lower caps for some NIH Institutes (see below).
Summary: Supports small businesses with recent NIH SBIR/STTR Phase II/IIb awards to advance products to commercialization through technical assistance and late-stage R&D, requiring at least one clinical trial.
Key Information: Only U.S. small businesses with an active or recent (within 36 months) NIH SBIR/STTR Phase II/IIb award are eligible; clinical trial is required.
Description
This opportunity from the National Institutes of Health (NIH) is designed to help U.S. small businesses bridge the gap between SBIR/STTR Phase II/IIb funding and full commercialization of biomedical products. The program provides support for technical assistance and late-stage research and development activities not typically funded under standard Phase II/IIb grants, with a mandatory requirement to propose at least one clinical trial. The goal is to facilitate the transition of promising technologies to the market by supporting activities such as regulatory strategy, manufacturing scale-up, clinical studies, and more.
Due Dates
- Letter of Intent: August 6, 2025 (30 days prior to application due date)
- Application Deadline: September 5, 2025 (by 5:00 PM local time of applicant organization)
- Future cycles: Standard NIH SBIR/STTR due dates may apply; check the NIH due dates page for updates.
Funding Amount
- Maximum budget: Up to $3,945,657 total costs (direct, indirect, and fee) for the entire project period (up to 3 years).
- Institute-specific caps:
- National Institute on Deafness and Other Communication Disorders (NIDCD): $1,750,000 total costs per year.
- National Eye Institute (NEI): $750,000 total costs across all years.
- National Heart, Lung, and Blood Institute (NHLBI): $500,000 total costs across all years.
- Project period: Up to 3 years.
- Number of awards: Contingent on NIH appropriations and the number of meritorious applications.
Eligibility
- Applicant type: Only U.S. small business concerns (SBCs) with an active or recently active (within the last 36 months) NIH SBIR or STTR Phase II or Phase IIB award are eligible.
- Ownership: Must be organized for profit, have a place of business in the U.S., and meet SBIR/STTR ownership and size requirements (generally ≤500 employees).
- Clinical trial: At least one clinical trial is required in the proposed project.
- Foreign entities: Non-U.S. organizations are not eligible; foreign components may be allowed if justified.
- Other: Only one CRP award per project is allowed. Applicants may submit more than one application if each is scientifically distinct.
Application Process
- Letter of Intent: Strongly encouraged, but not required. Should include project title, PI and key personnel, institutions, and funding opportunity number. Send to the relevant NIH Institute/Center contact.
- Application submission: Use NIH ASSIST, Grants.gov Workspace, or an institutional system-to-system solution.
- Required registrations: SAM, SBA Company Registry, eRA Commons, and Grants.gov.
- Application components: Follow the SBIR/STTR Application Guide and the specific instructions in the funding announcement.
- Key sections: Specific Aims, Research Strategy, Commercialization Plan, Project Management Plan, Regulatory Plan, Fundraising Plan, and a CRP Progress Report.
- Budget: Justify all costs; no cost sharing required. Filing fees for patents or FDA submissions are not allowed.
- Outsourcing: Significant portions of work may be subcontracted, but the SBC must maintain oversight and management.
Additional Information
- Scope of activities: May include regulatory strategy, manufacturing scale-up, independent replication of studies, IND-enabling studies, clinical studies, and more.
- No separate TABA funding: CRP applicants cannot request separate Technical and Business Assistance (TABA) funding.
- Review criteria: Emphasis on commercialization potential, technical merit, project management, and the ability to advance the product to market.
- Institute-specific interests: Some NIH Institutes have specific budget caps or programmatic priorities; applicants are encouraged to contact the relevant program officer early.
- Reporting: Annual progress and financial reports required; data management and sharing plan required.
External Links
Contact Information
- General Grants Info: GrantsInfo@nih.gov | 301-480-7075
- eRA Service Desk: https://www.era.nih.gov/need-help | 301-402-7469 or 866-504-9552
For additional contacts (including financial/grants management), see the full announcement Section VII.