NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) for Pre-Clinical Research (R44) | PAR 17 480

Opportunity Information: Apply for PAR 17 480

The National Institute of Neurological Disorders and Stroke (NINDS), part of the National Institutes of Health (NIH), offered this Funding Opportunity Announcement (FOA) to provide renewal-style funding for certain Small Business Innovation Research (SBIR) Phase II projects that need a larger, later-stage push before they can realistically reach commercialization. The opportunity is formally titled "NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) for Pre-Clinical Research (R44)" and is designed for small business concerns that already have NIH SBIR or STTR Phase II results and now need additional support to move the work into the next development stage. In practical terms, it targets projects approaching key preclinical milestones where additional funding can help bridge the common gap between a successful Phase II and a commercially viable product, service, or tool.

A major focus of this FOA is de-risking and advancing technologies that either (1) are headed toward approval by a federal regulatory agency, or (2) involve development of complex research tools that require substantial refinement, validation, or scaling before they will be widely usable or market-ready. This means the program is oriented toward activities that are closer to product development than basic discovery, especially where there are clear downstream requirements like reproducibility, quality systems, performance testing, and preparatory work needed to support later regulatory submissions or real-world deployment. By emphasizing preclinical research at this Phase IIB stage, the FOA is essentially trying to fund the kind of rigorous, expensive, and time-consuming work that often determines whether a promising neuroscience innovation can actually progress into the clinic or the marketplace.

Another central feature is the strong expectation of meaningful private-sector or third-party participation. NINDS uses this initiative to encourage partnerships between NIH SBIR/STTR awardees and independent third-party investors and/or strategic partners (for example, venture capital, angel investors, corporate partners, foundations providing independent investment-like support, or other non-federal sources aligned with commercialization). Applicants are required to submit a Commercialization Plan, consistent with NIH SBIR Phase II application instructions, and that plan must spell out the commercialization strategy and clearly describe third-party funding that has already been secured or is expected during the project period. The FOA explicitly states an expectation that the amount of independent third-party funding will be at least equal to, and ideally greater than, the amount of NINDS funding requested over the SBIR Phase IIB project period. In other words, this program is structured as a leverage mechanism: NIH funds are intended to complement and attract non-federal capital, signaling that the project has outside validation and a credible route to market.

Eligibility is limited to small businesses, reflecting the SBIR program structure, and the award mechanism is an NIH grant under the R44 activity code. Foreign institutions are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible. However, the FOA notes that foreign components, as defined in the NIH Grants Policy Statement, may be allowed in some circumstances, meaning certain project elements could potentially be carried out abroad if they meet NIH policy requirements and are justified within the application. The funding opportunity is categorized as discretionary and falls under the health funding activity category, with CFDA number 93.853. The opportunity number is PAR-17-480, and it was created on September 11, 2017, with an original closing date listed as January 5, 2021.

Overall, this FOA functions as a targeted extension and commercialization bridge for neuroscience-related SBIR/STTR Phase II projects that are not yet ready to launch commercially but have progressed far enough that additional, milestone-driven development funding could meaningfully accelerate them. The program emphasizes practical readiness, investor or partner alignment, and a clear commercialization pathway, using required planning and expected third-party investment to ensure that funded projects have both technical momentum and market-facing credibility.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) for Pre-Clinical Research (R44)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.853.
• This funding opportunity was created on 2017-09-11.
• Applicants must submit their applications by 2021-01-05. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Small businesses.

Apply for PAR 17 480

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: