NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) for Pre-Clinical Research (R44 Clinical Trial Not Allowed) | PAR 24 222

Opportunity Information: Apply for PAR 24 222

NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) for Pre-Clinical Research (R44 Clinical Trial Not Allowed) is a National Institutes of Health (NIH) funding opportunity designed to help small businesses push promising neuroscience-related technologies past a common bottleneck that happens after SBIR or STTR Phase II support ends. Many projects that look strong at the end of Phase II still need substantial additional resources to reach the point where a product can be cleared by regulators, manufactured reliably, and positioned for real-world adoption. This gap, often called the "Valley of Death," is especially challenging for medical biotechnology products because the work needed to de-risk a technology for investors, partners, and regulators can be expensive and time-consuming even before any clinical testing begins.

The core purpose of this program is to provide a Phase IIB competing renewal pathway for previously funded NINDS SBIR or STTR Phase II projects, with an emphasis on achieving the next major, commercialization-relevant milestones. In practical terms, that means supporting the additional pre-clinical research and development activities that are necessary to move a technology closer to market entry. The program is aimed at technologies that will ultimately require federal regulatory approval (for example, products that must meet FDA expectations) as well as complex research tools that may not follow the same regulatory route but still face significant technical, validation, and market-readiness hurdles before customers will adopt them at scale.

A major theme of this opportunity is encouraging applicants to build credible commercialization momentum by forming partnerships with third-party investors and/or strategic partners. NINDS is explicitly trying to facilitate the transition from government-backed early development to the stage where private capital, industry partnerships, or other independent sources of support can drive the product the rest of the way. Applicants are strongly encouraged to secure independent third-party funding throughout the Phase IIB project period, signaling that NINDS expects Phase IIB projects to be run with a commercialization mindset, where the company is simultaneously advancing the science, reducing risk, and lining up the resources and relationships needed to bring the product to market.

This FOA is specifically for pre-clinical research under an R44 grant mechanism, and clinical trials are not allowed under this announcement. That restriction matters because it clarifies the type of work NINDS expects to fund: pre-clinical experiments, non-clinical validation, engineering and design refinement, reproducibility and robustness studies, development of manufacturability plans, development of quality systems approaches as appropriate, and other activities that strengthen a regulatory and commercialization package prior to initiating clinical studies under a different funding pathway. The overall idea is to support the work that makes a future clinical or market step feasible and investable, rather than paying for human-subject testing under this particular award.

Eligibility is limited to small businesses, consistent with SBIR/STTR goals. Foreign organizations (non-U.S. entities) are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible. However, "foreign components" as defined in the NIH Grants Policy Statement may be allowed in some cases, which generally means certain discrete project elements may be performed outside the U.S. only if they meet NIH rules and are well justified, rather than having the applicant or core performing entity based abroad.

Administratively, this is an NIH discretionary grant opportunity from the National Institutes of Health, aligned with the health funding activity category and listed under CFDA number 93.853. The funding opportunity number is PAR-24-222, and the original closing date is April 5, 2027. The notice does not provide an award ceiling or expected number of awards in the provided source details, which often means applicants should rely on the full FOA text and NIH budget guidance to understand typical award sizes, allowable costs, and the review criteria that will determine competitiveness.

In short, this NINDS Phase IIB renewal opportunity is meant for small businesses that have already completed an NINDS-supported SBIR/STTR Phase II project and now need additional pre-clinical funding to hit the next key milestones on the path to commercialization. It places special weight on bridging the post-Phase II financing gap by pushing companies to secure third-party support and build real partnerships, while keeping the scope firmly in the pre-clinical domain and excluding clinical trials under this FOA.

• 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 Clinical Trial Not Allowed)" 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 2024-06-21.
• Applicants must submit their applications by 2027-04-05.
• Eligible applicants include: Small businesses.

Apply for PAR 24 222

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