NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) for Clinical Trials and Clinical Research (R44) | PAR 17 479

Opportunity Information: Apply for PAR 17 479

The NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) for Clinical Trials and Clinical Research (R44) is a National Institutes of Health funding opportunity designed to help small businesses push promising, neuroscience-focused technologies beyond the standard SBIR Phase II stage and closer to commercialization. The program targets projects that have already been supported through an NIH SBIR or STTR Phase II award and now need additional resources to conduct the clinical trials or related clinical research required to demonstrate real-world safety, effectiveness, and value. Because later-stage clinical work is often too expensive to cover with a typical Phase II budget, this Phase IIB mechanism is meant to provide that extra runway so products can reach the point where they are ready for market entry, regulatory milestones, broader adoption, or acquisition/licensing.

The scientific scope is tied closely to the mission of the National Institute of Neurological Disorders and Stroke (NINDS), meaning the work must address neurological disorders, stroke, or related areas aligned with NINDS priorities. Eligible projects can include a wide range of product types and interventions, including drugs and biologics, medical devices, diagnostics, and other technologies, as well as surgical approaches and behavioral or rehabilitation therapies. The unifying theme is that the proposed work should be clinically oriented and aimed at generating evidence that supports translation into patient care and eventual commercialization, rather than remaining at the proof-of-concept or preclinical development stage.

A central feature of this opportunity is its strong emphasis on commercialization readiness and outside investment. NINDS is using this FOA not only to fund clinical studies, but also to encourage applicants to build credible partnerships with third-party investors and/or strategic partners (for example, venture investors, corporate partners, or other non-federal backers). Applicants are required to submit a Commercialization Plan, consistent with NIH SBIR Phase II application requirements, and that plan must clearly explain the pathway to market, the business rationale, and how the project will be financed beyond NIH support. Importantly, the FOA signals an expectation that independent third-party funding secured already or anticipated during the project period will be at least equal to, and ideally exceed, the amount of NINDS funding requested over the Phase IIB period. In practical terms, applicants should be prepared to document investor interest, strategic partner commitments, letters of support, or other concrete evidence that external stakeholders are willing to share the financial risk of the clinical-stage work.

From an eligibility standpoint, the competition is limited to U.S. small business concerns that meet SBIR requirements, since the FOA is specifically an SBIR R44 grant mechanism. Foreign institutions (non-U.S. entities) are not eligible to apply, and non-U.S. components of U.S. organizations are also not eligible. However, the FOA notes that foreign components, as defined under the NIH Grants Policy Statement, may be allowed in some cases, which typically means discrete elements of the project may be performed abroad if they are well-justified and consistent with NIH policy, but the applicant organization itself must remain an eligible U.S. small business.

Administratively, this is a discretionary grant opportunity administered by NIH under the health funding category, associated with CFDA 93.853 and identified in the provided source data as PAR-17-479. It was created on September 11, 2017, with an original closing date of January 5, 2018. While the source data provided does not specify an award ceiling or the expected number of awards, the overall intent is clear: provide renewal-level Phase IIB SBIR support to fund clinical trials and clinical research that are necessary but expensive, and do so in a way that accelerates movement from NIH-funded development into the commercial marketplace through meaningful investor and partner engagement.

• 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)" 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 2017-09-11.
• Applicants must submit their applications by 2018-01-05. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Small businesses.

Apply for PAR 17 479

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