NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) for Clinical Trials and Clinical Research (R44 Clinical Trial Optional) | PAR 21 265

Opportunity Information: Apply for PAR 21 265

The NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) for Clinical Trials and Clinical Research (R44 Clinical Trial Optional), PAR 21-265, is a National Institutes of Health funding opportunity designed to help small businesses move promising, previously funded SBIR or STTR Phase II projects closer to commercialization. In practical terms, it targets projects that have already cleared the earlier proof-of-concept and development milestones under NIH small business programs and now need additional resources to run the kinds of clinical trials and clinical research activities that are often required before a product can reach the market. The program is a reissue of an earlier announcement (PAR-18-665), keeping the same overall intent: extend Phase II work into a Phase IIB-like stage where clinical evidence generation becomes the central focus.

The scientific and product scope is tied directly to the mission of the National Institute of Neurological Disorders and Stroke (NINDS). Applicants are expected to be developing technologies or interventions relevant to neurological disorders and stroke, and the FOA is broad about what types of products and approaches qualify. It can support clinical evaluation of drugs and biologics, medical devices, and diagnostics, and it also explicitly includes non-pharmacologic approaches such as surgical interventions, behavioral therapies, and rehabilitation therapies. The key is that the work proposed in the renewal award is aimed at collecting clinically meaningful data that advances the product toward regulatory acceptance, clinical adoption, and ultimately commercialization.

A central feature of this opportunity is its emphasis on commercialization readiness and outside partnership. NINDS recognizes that clinical trials are expensive and can be difficult to fund with grant dollars alone, particularly at the stage where a company is trying to de-risk a product enough to attract broader market investment. To address this, the FOA is structured to encourage (and effectively expects) applicants to bring in third-party support, such as independent investors or strategic partners. The intent is to create a bridge from NIH-supported development into the commercial ecosystem by aligning federal support with private capital or other non-federal backing.

Because commercialization is a core goal, applicants must submit a Commercialization Plan as part of the application package, consistent with SBIR Phase II requirements under the SF424 instructions. This plan is not just a formality; it is expected to lay out how the company will reach the market, what the target indications and customer segments are, what the regulatory and reimbursement pathways look like, and how the clinical work proposed in the award will reduce technical, clinical, and business risk. Importantly, the plan should also describe any third-party investor funding already secured and/or anticipated during the project period. The FOA signals a strong expectation that the amount of this independent third-party funding will match or exceed the NINDS funds requested across the Phase IIB project period, underscoring that NINDS wants to co-fund late-stage clinical efforts alongside external stakeholders rather than act as the sole source of capital.

Eligibility is limited to small business concerns, consistent with SBIR rules, and the opportunity is explicitly not open to non-U.S. entities. Foreign institutions cannot apply, and non-domestic components of U.S. organizations are also not eligible. However, foreign components (as NIH defines them in the NIH Grants Policy Statement) may be allowed in some cases, which typically means discrete parts of the project may be performed outside the U.S. if well-justified and compliant with NIH policy, even though the applicant organization itself must be U.S.-based and eligible as an SBIR small business.

From an administrative standpoint, this is a discretionary grant opportunity under the NIH, categorized under health (CFDA 93.853). The activity mechanism is R44 (SBIR), with clinical trial optional language, meaning the mechanism can accommodate applications that include clinical trials when appropriate for the project stage and aims. The original closing date listed for this opportunity is 2024-04-05, and the record shows a creation date of 2021-07-15. While an award ceiling and expected number of awards are not specified in the provided source data, the overall framing makes clear that NINDS is prioritizing projects that are mature enough to justify clinical evaluation and that have a credible, well-supported path to commercialization backed by meaningful third-party commitment.

• 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 2021-07-15.
• Applicants must submit their applications by 2024-04-05. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Small businesses.

Apply for PAR 21 265

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: