NINDS Exploratory Clinical Trials for Small Business (R43/R44 Clinical Trial Required) | PAR 23 311

Opportunity Information: Apply for PAR 23 311

The NINDS Exploratory Clinical Trials for Small Business (R43/R44 Clinical Trial Required), PAR-23-311, is an NIH SBIR funding opportunity designed specifically to help small businesses run investigator-initiated exploratory clinical trials that align with the mission of the National Institute of Neurological Disorders and Stroke (NINDS). The core aim is to move promising neurological products into early-stage human testing by providing grant support for clinical studies that can generate the initial evidence needed to de-risk a technology and guide the next stages of development. Because it is labeled "Clinical Trial Required," applicants are expected to propose a project that includes an actual clinical trial rather than only preclinical work or purely observational clinical research.

This FOA supports a wide range of intervention and product types as long as they are relevant to neurological disorders and stroke. Projects may evaluate drugs and small molecules, biologics, medical devices, and diagnostics, and it can also support clinical testing of surgical approaches, behavioral interventions, and rehabilitation therapies. In practical terms, the opportunity is meant for companies that already have a sufficiently mature candidate (for example, a device prototype ready for clinical use, a therapeutic with an appropriate clinical-grade supply and supporting data, or a diagnostic ready for prospective evaluation) and now need funding to run an exploratory trial to assess feasibility, safety, early signals of efficacy, usability, or performance in the intended use setting.

Only SBIR Phase II and Fast-Track applications are supported. A standard SBIR Phase I application is not accepted on its own under this announcement; Phase I is only allowed if it is submitted as part of a Fast-Track application that bundles Phase I and Phase II into a single combined submission with distinct milestones and aims for each phase. This structure signals that NINDS is prioritizing projects that are beyond the earliest concept stage and are positioned to enter or already be in clinical evaluation, rather than projects that are still primarily focused on proof-of-concept bench work. The mechanism types referenced in the title, R43 and R44, correspond to SBIR Phase I (R43) and SBIR Phase II (R44), but under this FOA the emphasis is on Phase II and Fast-Track pathways that lead into Phase II-level clinical execution.

Eligibility is limited to small businesses, consistent with the SBIR program. Foreign institutions (non-U.S. entities) are not eligible to apply, and non-domestic components of U.S. organizations are also not eligible. However, "foreign components" as defined by NIH policy may be allowed in some circumstances, which typically means a U.S. small business could potentially include certain well-justified activities performed outside the U.S. if NIH policy permits and the application clearly explains why that component is necessary and how oversight, compliance, and data integrity will be maintained. The administering agency is the National Institutes of Health, and the relevant CFDA (assistance listing) number is 93.853, which corresponds to NINDS.

Administratively, the opportunity is a discretionary grant program with an original closing date listed as 2026-09-05, and it was created on 2023-11-27. The notice is a reissue of PAR-21-266, meaning it continues an existing NINDS program line with updated dates and potentially refreshed details while keeping the same general purpose: supporting small businesses that are ready to run exploratory clinical trials in neurology and stroke. The source data provided does not list an award ceiling or the expected number of awards, so applicants typically need to consult the full FOA text and related NIH SBIR guidance to understand budget expectations, allowable costs, and any institute-specific preferences around trial scope, milestones, and commercialization planning.

In summary, PAR-23-311 is best read as a pathway for U.S. small businesses to obtain SBIR funding to conduct early clinical testing of neurological or stroke-related products, with the clear expectation that the proposed work includes a clinical trial and that the project is mature enough for Phase II or a Fast-Track trajectory.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NINDS Exploratory Clinical Trials for Small Business (R43/R44 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 2023-11-27.
• Applicants must submit their applications by 2026-09-05. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Small businesses.

Apply for PAR 23 311

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