NINDS Competing Renewal Awards of SBIR Phase II Grants (Phase IIB) for Exploratory Clinical Trials (SBIR R44) | Apply Online

Opportunity Summary:

The opportunity titled "NINDS Competing Renewal Awards of SBIR Phase II Grants (Phase IIB) for Exploratory Clinical Trials (SBIR R44)" (Funding Opportunity Number PAR-12-075) is a National Institutes of Health (NIH) funding announcement from the National Institute of Neurological Disorders and Stroke (NINDS). It is a discretionary grant program under the Small Business Innovation Research (SBIR) mechanism, specifically using the SBIR Phase IIB/competing renewal structure (R44). In practical terms, this FOA is meant for small businesses that already completed an NIH SBIR Phase II project and now need additional support to move a promising technology into an exploratory clinical trial stage, bridging the gap between late-stage development and commercialization.

The core purpose is to fund exploratory clinical trials that advance products aligned with NINDS's mission in neurological disorders and stroke. The FOA is intentionally broad about the types of interventions and technologies that can be tested, as long as they fit NINDS priorities. Proposed clinical trials may involve drugs or other pharmacologic agents, biologics, medical devices, diagnostics, and also non-product interventions such as surgical approaches, behavioral treatments, or rehabilitation therapies. The emphasis is on clinical testing that helps determine whether the product or therapy is ready for the next steps on the path to market, including collecting early evidence of safety, feasibility, and signals of clinical activity that can support later, larger trials or regulatory and commercialization decisions.

A central theme of this announcement is that clinical trials are expensive and often difficult for small companies to finance on their own. Because of that, the FOA is designed not only to provide NIH support, but also to encourage the transition to commercialization by promoting partnerships between NIH SBIR awardees and third-party investors and/or strategic partners. The underlying idea is that Phase IIB should help de-risk the technology enough to attract private capital or corporate collaboration, and at the same time demonstrate that the business has a credible commercialization plan and the external support needed to carry a clinical program forward.

Eligibility is limited to small business concerns, consistent with SBIR rules. There is no cost sharing or matching requirement listed for this opportunity, meaning applicants are not required to provide matching funds as a formal condition of the award. The funding activity category is health, and the CFDA number associated with it is 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders), reinforcing that the work must fall within NINDS's scientific and public health scope.

Key dates from the record show the FOA was posted and created on January 11, 2012, with an original and current closing date of September 7, 2013, and an archive date of October 8, 2013. That indicates this particular announcement is historical rather than currently open, but it still serves as a clear example of how NINDS structures Phase IIB SBIR support for clinical-stage translation. For those looking for the full announcement text and details that would normally include application instructions, review criteria, and specific program requirements, the listing provides an additional information link: http://grants.nih.gov/grants/guide/pa-files/PAR-12-075.html.

For help accessing or linking to the announcement, the contact listed is the NIH Office of Extramural Research (OER) Webmaster at FBOWebmaster@OD.NIH.GOV, which is primarily a technical contact for announcement access issues rather than a scientific/program contact.

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Next opportunity: NINDS Competing Renewal Awards of SBIR Phase II (Phase IIB) Grants (SBIR R44)

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