NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) for Clinical Trials and Clinical Research (R44 Clinical Trial Optional) | PAR 24 221

Opportunity Information: Apply for PAR 24 221

The NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) for Clinical Trials and Clinical Research (PAR-24-221) is a National Institutes of Health grant opportunity designed to help small businesses push previously funded NIH SBIR/STTR Phase II projects further along the path to commercialization. The core purpose is to provide additional resources for the kind of clinical work that often sits between a successful Phase II effort and a market-ready product, especially when the next steps require expensive and time-consuming clinical trials or other clinical research activities.

This FOA is specifically tied to the mission of the National Institute of Neurological Disorders and Stroke (NINDS), meaning proposed projects need to clearly align with NINDS priorities in neurological disorders and stroke-related science and care. The supported technologies and interventions can be broad as long as they fit that mission: therapeutics such as drugs and biologics, medical devices, and diagnostics are all within scope, and the program can also cover clinical evaluation of surgical approaches, behavioral interventions, rehabilitation therapies, or related clinical strategies. The mechanism is an SBIR Phase IIB renewal-style award under the R44 activity, and the clinical trial component is described as optional in the title, reflecting that applications may propose clinical trials or other forms of clinical research depending on what is appropriate for the product and its development stage.

A major emphasis of this opportunity is bridging the financing gap that commonly appears when a small business needs to run clinical studies to satisfy regulatory expectations, demonstrate real-world clinical value, or de-risk the technology enough to attract buyers, licensees, or later-stage investors. Because these activities are capital-intensive, NINDS is using this FOA to encourage meaningful partnerships between NIH-funded SBIR/STTR companies and independent third-party investors and/or strategic partners. In practical terms, the program is not only funding science; it is trying to accelerate commercialization readiness by ensuring there is credible external market validation and financial commitment alongside the NIH dollars.

A required element of the application is a Commercialization Plan, consistent with SBIR Phase II application requirements under the SF424 instructions. For this particular FOA, the Commercialization Plan is not a formality; it is central to the program’s intent. Applicants are expected to describe the project’s commercialization pathway and, critically, to document independent third-party investor funding that has already been secured or that is anticipated during the project period. The expectation is that the level of this independent third-party support will be at least equal to, and ideally exceed, the amount of NINDS funding requested over the Phase IIB project period. This matching expectation signals that NINDS wants to see strong external buy-in and a realistic plan for moving beyond NIH support into a sustainable commercial development track.

Eligibility is limited to small businesses, consistent with the SBIR program. Foreign organizations are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible to apply. However, foreign components, as defined by the NIH Grants Policy Statement, may be allowed in some circumstances, which typically means certain discrete project elements could potentially be performed abroad if justified and allowable under NIH policy, even though the applicant organization itself must be domestic and eligible.

Administratively, this is a discretionary grant opportunity offered by NIH in the health funding activity category, associated with CFDA 93.853. The opportunity was created on 2024-06-20 and lists an original closing date of 2027-04-05, indicating a multi-year window in which applications may be accepted according to the FOA’s submission cycles. The award ceiling and expected number of awards are not specified in the provided source data, so applicants would need to rely on the full FOA details and current NIH/NINDS guidance for budget expectations, allowable costs, and typical award sizes.

Overall, PAR-24-221 is best understood as a scale-up and de-risking program for SBIR-funded neurological products that are ready for the next clinical and commercial step. It targets projects that have already demonstrated enough promise to earn NIH Phase II support and now need additional clinical evidence and a stronger financing and partnership structure to realistically reach the market.

• 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 Clinical Trials and Clinical Research (R44 Clinical Trial Optional)" 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 2024-06-20.
• Applicants must submit their applications by 2027-04-05.
• Eligible applicants include: Small businesses.

Apply for PAR 24 221

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