NINDS Exploratory Clinical Trials for Small Business (R44) - Clinical Trial Required | PAR 18 618

Opportunity Information: Apply for PAR 18 618

The grant opportunity titled "NINDS Exploratory Clinical Trials for Small Business (R44) - Clinical Trial Required" (Funding Opportunity Number PAR-18-618) is a National Institutes of Health (NIH) program run through the National Institute of Neurological Disorders and Stroke (NINDS). Its main goal is to fund investigator-initiated exploratory clinical trials led by small businesses using the Small Business Innovation Research (SBIR) mechanism. In practical terms, it is designed as a pathway for a qualifying small business to move a neuroscience-related product into early clinical testing when that work directly supports NINDS mission areas.

This FOA is specifically focused on clinical trials and requires that the proposed work includes a clinical trial component. The scope is broad in terms of what types of interventions or technologies can be studied, as long as they align with NINDS priorities in neurological disorders and stroke. Eligible projects may evaluate drugs or biologics, medical devices, and diagnostics, and the announcement also allows for studies of surgical approaches, behavioral interventions, and rehabilitation therapies. The emphasis on "exploratory" clinical trials generally signals early-stage clinical evaluation, such as initial testing of feasibility, safety, dosing, device performance, proof of concept, or early signals of clinical activity, rather than large confirmatory trials.

From a funding mechanism standpoint, the opportunity supports only SBIR Phase II and SBIR Fast-Track applications under the R44 activity code. Standalone SBIR Phase I applications are not accepted under this program; however, Phase I work may be included if it is submitted as part of a Fast-Track application, which combines Phase I and Phase II into a single, continuous submission with defined milestones for progression. This structure is meant to accommodate small businesses that are ready to advance beyond basic feasibility and into development and clinical evaluation, while still providing a route for those who need an initial Phase I stage as part of a unified plan.

Eligibility is limited to small businesses. Non-U.S. (foreign) institutions are explicitly not eligible to apply, and non-domestic components of U.S. organizations are also not eligible. At the same time, the FOA notes that "foreign components" as defined by the NIH Grants Policy Statement may be allowed, which typically means certain discrete elements of the project could occur outside the U.S. if they are justified and meet NIH policy requirements, even though the applicant organization itself must be an eligible U.S. small business. Because NIH rules on foreign components can be nuanced, applicants are expected to consult the FOA and NIH policy language carefully to confirm what is permissible for their specific project design.

Administratively, this is a discretionary grant program in the health funding category (CFDA 93.853). The opportunity record indicates an original closing date of 2021-04-05 and a creation date of 2018-02-01. The summary provided does not list an award ceiling or expected number of awards, which often means applicants need to refer to the full FOA or related NIH budget guidance to understand typical budget ranges, project periods, and any institute-specific limits or expectations. Overall, the opportunity is a targeted SBIR pathway for small businesses that have a neuroscience-focused product and are prepared to conduct an early clinical trial under NINDS alignment, using either Phase II or a Fast-Track Phase I/II approach.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NINDS Exploratory Clinical Trials for Small Business (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 2018-02-01.
• Applicants must submit their applications by 2021-04-05. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Small businesses.

Apply for PAR 18 618

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