NINDS Exploratory Clinical Trials for Small Business (SBIR R44) | Apply Online

Opportunity Summary:

The NINDS Exploratory Clinical Trials for Small Business (SBIR R44) opportunity (Funding Opportunity Number PAR-12-073) is a National Institutes of Health (NIH) grant program designed specifically to help eligible small business concerns move promising neurological products into investigator-initiated exploratory clinical trials. The core intent of the announcement is to give small companies a clear funding path to run early, exploratory human studies that generate the kind of clinical evidence needed to advance development decisions, support later-stage trials, and reduce technical and regulatory uncertainty. The clinical trials supported under this program must align with the mission and priorities of the National Institute of Neurological Disorders and Stroke (NINDS), meaning the work should address diseases, disorders, or injuries of the brain, spinal cord, peripheral nerves, or related neuromuscular systems in a way that fits NINDS program goals.

The FOA is broad in the kinds of interventions and technologies it will consider, as long as they are relevant to NINDS. It allows exploratory clinical trials that evaluate drugs and small molecules, biologics, medical devices, and diagnostics, and it also allows clinical testing of surgical approaches, behavioral interventions, and rehabilitation therapies. In other words, it is not limited to one modality or product category; it is aimed at enabling small businesses to test clinically meaningful innovations across the range of neurological care and research. Because the focus is on exploratory clinical trials, the expectation is generally that projects will be structured to answer early clinical questions such as feasibility, safety signals, dosing/parameter selection, proof-of-concept, biomarker performance, usability, or other data needed to justify and design subsequent pivotal studies.

A key structural restriction of this program is that it supports only SBIR Phase II and Fast Track applications. Standalone Phase I applications are not supported under this announcement, but Phase I can be included if the applicant uses the Fast Track mechanism (which combines Phase I and Phase II in a single coordinated application with defined milestones for transition). This means the program is oriented toward projects that are beyond the earliest concept stage and are ready for, or approaching, clinical evaluation with a credible development plan. The funding instrument type is a grant, the activity category is Health, and the CFDA number listed is 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders).

Eligibility is limited to small businesses, consistent with SBIR requirements, and the posting indicates there is no cost sharing or matching requirement, which can be important for small companies trying to preserve capital while generating clinical data. The award ceiling shown in the provided listing is $150,000, though applicants typically need to confirm budget rules and any NIH policy updates by reviewing the full FOA text because SBIR budget guidance can depend on project scope, justification, and NIH-specific limits or waivers.

From an administrative standpoint, the opportunity was originally posted on January 11, 2012, with the record showing an original closing date of January 7, 2015, and a current closing date of May 7, 2015, after which it was archived on June 6, 2015. The administering agency is the National Institutes of Health, with NINDS as the sponsoring institute. Applicants who need the full announcement details were directed to the NIH Grants Guide page for PAR-12-073, and the listing provides NIH Office of Extramural Research (OER) webmaster contact emails for technical access or linking problems.

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Previous opportunity: NINDS Exploratory Clinical Trials for Small Business (STTR R42)

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