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.Apply for PAR 21 265
- 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.
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FAQs: NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) for Clinical Trials and Clinical Research (R44 Clinical Trial Optional), PAR 21-265
What is PAR 21-265?
PAR 21-265 is a National Institutes of Health (NIH) funding opportunity from the National Institute of Neurological Disorders and Stroke (NINDS) that provides renewal awards for previously funded SBIR or STTR Phase II projects. It is designed to help small businesses move mature projects into a Phase IIB-like stage focused on generating clinical evidence needed to support commercialization.
What is the main goal of this NINDS SBIR Phase IIB renewal award?
The main goal is to support clinically meaningful evidence generation (through clinical trials and/or clinical research) that advances a product toward regulatory acceptance, clinical adoption, and commercialization. The opportunity targets projects that have already completed earlier SBIR/STTR Phase II development milestones and now need resources to perform clinical evaluation.
Is this opportunity new or related to an earlier program?
This funding opportunity is a reissue of an earlier announcement (PAR-18-665) and keeps the same overall intent: extending Phase II work into a Phase IIB-like period where clinical evidence generation becomes central.
Which NIH institute is offering this opportunity, and what areas does it focus on?
The opportunity is offered by NINDS. Projects are expected to align with the NINDS mission, meaning they should address neurological disorders and stroke and propose work that supports clinical evaluation and commercialization readiness within that scope.
What kinds of products or interventions can be supported?
The FOA is broad and can support clinical evaluation of drugs and biologics, medical devices, and diagnostics. It also explicitly includes non-pharmacologic approaches such as surgical interventions, behavioral therapies, and rehabilitation therapies, as long as the proposed work is focused on collecting clinically meaningful data that moves the product toward the market.
Does the award support clinical trials?
Yes. The mechanism is listed as R44 (SBIR) with "clinical trial optional" language. That means the opportunity can accommodate applications that include clinical trials when they are appropriate for the product stage and project aims, as well as clinical research activities that may not meet the NIH definition of a clinical trial.
Who is eligible to apply?
Eligibility is limited to small business concerns consistent with SBIR rules. This opportunity is intended specifically for companies with promising projects that were previously funded under SBIR or STTR Phase II and are ready to extend that work into a Phase IIB-like clinical evidence-generation stage.
Are non-U.S. companies or foreign institutions eligible to apply?
No. 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.
Can any part of the project be performed outside the United States?
Possibly. While the applicant organization must be U.S.-based and eligible as an SBIR small business, foreign components (as defined by NIH policy) may be allowable in some cases. This generally refers to discrete parts of the work performed outside the U.S. when well-justified and compliant with NIH policy.
What makes this opportunity different from earlier-stage SBIR funding?
This renewal award is positioned for later-stage projects that have already achieved earlier proof-of-concept and development milestones and now need support for clinical evidence generation. The emphasis shifts strongly toward clinical trials/clinical research and commercialization readiness rather than early technical feasibility.
Is a Commercialization Plan required?
Yes. Applicants must submit a Commercialization Plan consistent with SBIR Phase II requirements under the SF424 instructions. The plan is treated as a substantive part of the application, not a formality.
What should the Commercialization Plan cover based on the information provided?
Based on the provided description, the plan is expected to explain how the company will reach the market, including target indications and customer segments, regulatory and reimbursement pathways, and how the proposed clinical work reduces technical, clinical, and business risk. It should also describe third-party investor or partner funding that is already secured and/or anticipated during the project period.
How important is third-party (non-federal) funding or partnership for this award?
It is a central feature of the opportunity. NINDS emphasizes commercialization readiness and outside partnership and structures the FOA to encourage, and effectively expect, third-party support such as independent investors or strategic partners. The aim is to bridge NIH-supported development into the commercial ecosystem.
Is there an expectation for matching funds?
Yes. The FOA signals a strong expectation that the amount of independent third-party funding will match or exceed the NINDS funds requested across the Phase IIB project period. This underscores NINDS's intent to co-fund late-stage clinical efforts alongside external stakeholders.
What activity mechanism is used for this opportunity?
The activity mechanism is R44 (SBIR), and it is described as "clinical trial optional," allowing applications that include clinical trials when appropriate.
How is this opportunity categorized administratively?
It is a discretionary NIH grant opportunity categorized under health with CFDA 93.853.
What is the closing date listed for this opportunity?
The original closing date listed in the provided information is 2024-04-05.
When was this opportunity record created?
The record creation date shown in the provided information is 2021-07-15.
Is the award ceiling or number of expected awards provided?
No. Based on the provided source data, an award ceiling and the expected number of awards are not specified.
What types of projects appear most competitive based on the description?
Projects that are mature enough to justify clinical evaluation and that present a credible, well-supported path to commercialization. The description highlights the importance of clinically meaningful data generation, a strong Commercialization Plan, and meaningful third-party commitment that is expected to match or exceed the requested NINDS funding.
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