NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) for Clinical Trials and Clinical Research (R44 Clinical Trial Optional) | PAR 18 665

Opportunity Information: Apply for PAR 18 665

NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) for Clinical Trials and Clinical Research (R44 Clinical Trial Optional), funding opportunity number PAR-18-665, is an NIH small business grant program designed to help SBIR/STTR Phase II projects move from late-stage development into commercialization by paying for the expensive clinical work that often stands between a promising prototype and a product that can realistically enter the market. It is specifically aimed at small business concerns that already completed an NIH SBIR or STTR Phase II award and now need additional, follow-on support to run clinical trials or other clinical research activities that are necessary to demonstrate safety, performance, and real-world value.

The scientific scope has to align with the mission of the National Institute of Neurological Disorders and Stroke (NINDS), meaning the product under development must address neurological disorders, stroke, or related nervous system conditions in a way that fits NINDS priorities. The FOA is broad in terms of what kinds of health technologies it will consider: drugs and biologics are eligible, as are medical devices and diagnostics. It also explicitly allows evaluation of non-pharmacologic interventions such as surgical approaches, behavioral therapies, and rehabilitation strategies, as long as the work is clinical in nature and clearly supports the path to a commercially viable product.

A central feature of this Phase IIB mechanism is its emphasis on commercialization readiness and private-sector validation. NINDS is trying to reduce the so-called "valley of death" between NIH-funded development and market entry by encouraging applicants to bring in third-party investors or strategic partners. In practical terms, the application must include a Commercialization Plan (required under the SF424 SBIR Phase II instructions) that lays out the business case for the product, the regulatory and reimbursement strategy where applicable, the competitive landscape, and the concrete steps the company will take to reach market. That plan must also describe outside funding that has already been secured or is expected during the project period.

The FOA sets a strong expectation that independent third-party funding will match or exceed the amount requested from NINDS across the Phase IIB project period. This is not described as a minor preference; it is positioned as a key element of the program logic, signaling that NINDS wants to see meaningful external commitment as evidence that the project is commercially credible and that the company has a realistic financing strategy beyond federal support.

Eligibility is limited to U.S. small businesses. Foreign institutions cannot apply, and non-U.S. components of U.S. organizations are not eligible to apply. However, "foreign components" as defined in the NIH Grants Policy Statement may be allowed in some cases, which typically means certain well-justified elements of the work may be performed outside the U.S. if permitted under NIH policy and appropriately documented.

Administratively, this is a discretionary grant program under NIH, within the health funding activity category (CFDA 93.853). The opportunity was created on February 15, 2018, and the original closing date listed is April 5, 2021. The FOA title includes "Clinical Trial Optional," which indicates the mechanism can support clinical trials, but proposals may also be appropriate for other forms of clinical research that advance the product toward commercialization, depending on the specific aims and the development stage of the technology.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) for Clinical Trials and Clinical Research (R44 Clinical Trial Optional)" 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 2018-02-15.
• 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 18 665

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