NINDS Exploratory Clinical Trials for Small Business (R41/R42 Clinical Trial Required) | PAR 21 267

Opportunity Information: Apply for PAR 21 267

This grant opportunity, titled "NINDS Exploratory Clinical Trials for Small Business (R41/R42 Clinical Trial Required)" (PAR-21-267), is a National Institutes of Health (NIH) program run through the National Institute of Neurological Disorders and Stroke (NINDS). It is designed specifically to support small business-led projects that are ready to move an intervention into an exploratory clinical trial stage, using the Small Business Technology Transfer (STTR) mechanism. The core intent is to give Small Business Concerns a clear funding pathway to run investigator-initiated exploratory clinical trials that advance products and technologies aligned with NINDS mission priorities in neurological disorders and stroke.

The scope of what can be tested is broad, as long as it clearly connects to NINDS program interests and has a legitimate clinical trial component. Projects may evaluate drugs or other therapeutics, biologics, medical devices, or diagnostics. NINDS also allows exploratory clinical trials involving surgical approaches, behavioral interventions, rehabilitation therapies, and related treatment strategies, provided the work is structured as a clinical trial and is positioned as a product- or intervention-focused development effort rather than basic discovery research. In practice, applicants would be expected to present a credible plan for testing safety, feasibility, preliminary signals of effectiveness, or other early clinical outcomes appropriate for an exploratory trial, along with operational details that show the trial can realistically be executed.

A defining feature of this FOA is that it is explicitly "clinical trial required," meaning the application must include a clinical trial as the primary activity rather than treating a clinical trial as optional or incidental. This typically implies that applicants need to propose a trial-ready intervention, identify the target patient population, define endpoints and statistical considerations appropriate to an exploratory design, and address regulatory and compliance expectations that come with human subjects research. Since the mechanism is STTR, the project also needs to reflect the STTR model: a small business partnering with a research institution, with a meaningful collaborative R&D relationship and appropriate allocation of work between the small business and the partnering research organization.

In terms of application types, this program only supports STTR Phase II and STTR Fast-Track applications. A standalone STTR Phase I application is not supported under this announcement; Phase I is only accepted when it is bundled into a Fast-Track submission that proposes a Phase I and Phase II effort together. That structure signals that NINDS is aiming this program at teams that are either already beyond the earliest proof-of-concept work (Phase II) or have a tightly integrated plan to progress quickly from early-stage development into a more advanced clinical testing and commercialization trajectory (Fast-Track). Conceptually, this emphasizes later readiness and a clearer near-term path to clinical execution compared with programs that primarily fund early feasibility or preclinical exploration.

Eligibility is limited to small businesses, consistent with STTR rules, and the FOA is restrictive with respect to foreign participation. Non-U.S. (foreign) institutions are not eligible to apply directly, and non-U.S. components of U.S. organizations are also not eligible to apply under this opportunity. That said, foreign components may be permitted in certain circumstances as defined by the NIH Grants Policy Statement, which generally means a U.S.-based applicant might include a foreign element only when it is well-justified and allowed under NIH policy, rather than making the foreign entity the applicant or a primary organizational component. In short, the applicant organization must be a qualifying U.S. small business, and the project should be structured so that the core work is led and managed domestically, with any foreign involvement treated as exceptional and policy-compliant rather than central.

Administratively, the opportunity is categorized as a discretionary grant program under CFDA 93.853. It was created on 2021-07-16 and lists an original closing date of 2023-11-26 in the provided record. The notice is a reissue of an earlier funding announcement (PAR-18-617), which typically indicates continuity in program intent while reflecting updated NIH or institute policies, forms, or review expectations. While the record you provided does not specify an award ceiling or expected number of awards, applicants should generally plan to align budgets and timelines with STTR Phase II and Fast-Track norms and with the real costs of conducting an exploratory clinical trial, including clinical operations, data management, monitoring, regulatory work, participant recruitment, and safety oversight.

Overall, the program is best understood as an NIH/NINDS translational funding lane for small businesses that are ready to run an early-stage clinical trial on a neurological intervention or enabling technology. It prioritizes projects that are product-centered, clinically executable, and aligned with NINDS disease and mission areas, while using the STTR partnership model to combine small business development capabilities with research-institution expertise needed to conduct rigorous, compliant clinical testing.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NINDS Exploratory Clinical Trials for Small Business (R41/R42 Clinical Trial Required)" 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 2021-07-16.
• Applicants must submit their applications by 2023-11-26. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Small businesses.

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