Opportunity Information: Apply for PAR 21 266
The NINDS Exploratory Clinical Trials for Small Business (R43/R44 Clinical Trial Required), funding opportunity number PAR-21-266, is an NIH SBIR grant program designed specifically to help U.S. small businesses run investigator-initiated exploratory clinical trials that align with the mission of the National Institute of Neurological Disorders and Stroke (NINDS). In practical terms, this opportunity is meant to move promising, product-focused neuroscience innovations into early-stage human testing, where the goal is usually to generate credible clinical signals, feasibility data, and other evidence that can justify larger, later-stage trials or support a regulatory and commercialization path.
This FOA supports projects centered on products and interventions relevant to neurological disorders and stroke, broadly interpreted within NINDS priorities. The scope is intentionally wide in terms of what can be tested, as long as it fits NINDS goals and is ready for an exploratory clinical trial. Applicants may propose evaluation of therapeutics such as drugs and biologics, medical devices, and diagnostics, and the announcement also explicitly allows surgical approaches as well as behavioral and rehabilitation therapies. The common thread is that the proposed work must involve a clinical trial and must be positioned as exploratory, meaning it is typically earlier and more hypothesis-generating or feasibility-focused than a definitive, pivotal trial.
From an eligibility and mechanism standpoint, the program is limited to SBIR applicants that are Small Business Concerns. It does not function as a general academic or nonprofit clinical trial mechanism; it is aimed at small companies pursuing innovation with a clear product development trajectory. Importantly, the FOA only supports SBIR Phase II and SBIR Fast-Track applications. A standalone SBIR Phase I application is not accepted under this announcement; Phase I is only allowed if it is submitted as part of a Fast-Track application (which bundles Phase I and Phase II in a single submission with defined milestones and a transition plan). That structure signals that NINDS expects applicants to be relatively advanced in development readiness, with a plausible near-term path to conducting a clinical study and generating decision-quality data.
There are also notable restrictions related to foreign participation. Non-domestic (non-U.S.) entities, including foreign institutions, are not eligible to apply. In addition, non-domestic components of U.S. organizations are not eligible to apply. However, foreign components as defined under the NIH Grants Policy Statement may be permitted, which generally means limited, well-justified foreign involvement could be allowable in some cases, subject to NIH rules and approval, but the applicant organization itself must be a U.S. small business and the project cannot be structured around non-U.S. organizational components.
Administratively, this is a discretionary grant program under NIH within the health funding activity category, associated with CFDA number 93.853. The opportunity was created on 2021-07-15 and lists an original closing date of 2023-11-27 in the provided record. While the listing does not state an award ceiling or expected number of awards, the main takeaway is that it is a targeted NINDS SBIR pathway for small businesses ready to conduct exploratory clinical trials on neurologically relevant products, using Phase II or Fast-Track structures and following NIH rules on eligibility and foreign involvement.Apply for PAR 21 266
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NINDS Exploratory Clinical Trials for Small Business (R43/R44 Clinical Trial Required)" 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 2023-11-27. (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 Exploratory Clinical Trials for Small Business (R43/R44 Clinical Trial Required) - PAR-21-266
What is this funding opportunity?
This is an NIH Small Business Innovation Research (SBIR) grant opportunity from the National Institute of Neurological Disorders and Stroke (NINDS) called "NINDS Exploratory Clinical Trials for Small Business (R43/R44 Clinical Trial Required)." The funding opportunity number is PAR-21-266, and it is designed to support U.S. small businesses that want to run investigator-initiated exploratory clinical trials aligned with the NINDS mission.
What is the main purpose of PAR-21-266?
The purpose is to help move promising, product-focused neuroscience innovations into early-stage human testing. Projects are expected to generate practical early clinical evidence such as feasibility data, credible clinical signals, and other decision-quality results that can justify larger later-stage trials or support regulatory and commercialization planning.
Who is this program intended for?
This program is intended for SBIR applicants that qualify as U.S. Small Business Concerns. It is not described as a general mechanism for academic institutions or nonprofits to run clinical trials; it is specifically aimed at small companies advancing innovations with a product development trajectory.
What kinds of projects are supported?
The FOA supports projects centered on products and interventions relevant to neurological disorders and stroke, broadly interpreted within NINDS priorities. The scope is intentionally wide as long as the proposed work fits NINDS goals and is ready for an exploratory clinical trial.
Does the proposed research have to include a clinical trial?
Yes. The opportunity is explicitly described as "Clinical Trial Required," and the supported work must involve a clinical trial.
What does "exploratory clinical trial" mean in the context of this FOA?
In this context, "exploratory" generally means early-stage, feasibility-focused, and/or hypothesis-generating human testing rather than a definitive or pivotal trial. The intent is typically to generate early clinical evidence that can support the next major development step.
What types of interventions can be evaluated?
Applicants may propose evaluation of a wide range of interventions and products, including therapeutics (such as drugs and biologics), medical devices, diagnostics, surgical approaches, behavioral therapies, and rehabilitation therapies, as long as the work aligns with NINDS goals and is positioned for an exploratory clinical trial.
What SBIR phases and application types are allowed under PAR-21-266?
This FOA supports SBIR Phase II and SBIR Fast-Track applications. A standalone SBIR Phase I application is not accepted under this announcement.
Can a Phase I project be included at all?
Yes, but only if Phase I is included as part of an SBIR Fast-Track application (a single submission that bundles Phase I and Phase II with defined milestones and a transition plan).
What does the FOA structure imply about project readiness?
Because the FOA does not accept standalone Phase I applications and focuses on Phase II or Fast-Track, it signals that NINDS expects applicants to be relatively advanced in development readiness, with a plausible near-term path to conducting a clinical study and producing data that supports key go/no-go decisions.
Are non-U.S. organizations eligible to apply?
No. Non-domestic (non-U.S.) entities, including foreign institutions, are not eligible to apply.
Can a U.S. organization include non-U.S. components?
The FOA states that non-domestic components of U.S. organizations are not eligible to apply. However, it also notes that foreign components (as defined under the NIH Grants Policy Statement) may be permitted in some cases. Any foreign involvement would need to be limited, well-justified, and consistent with NIH rules, while the applicant organization itself must be a U.S. small business.
Is this an academic or nonprofit clinical trial mechanism?
No. Based on the description provided, this program is an NIH SBIR pathway targeted to U.S. small businesses and does not function as a general academic or nonprofit clinical trial funding mechanism.
Which NIH institute is sponsoring this opportunity?
The opportunity is associated with the National Institute of Neurological Disorders and Stroke (NINDS), and proposed projects must align with the NINDS mission and priorities.
What is the funding mechanism used?
The mechanism is NIH SBIR using the R43/R44 activity codes (SBIR), with clinical trial required, and limited to Phase II and Fast-Track under this announcement.
What is the CFDA number associated with this opportunity?
The opportunity is associated with CFDA number 93.853.
When was this opportunity created, and what closing date is listed?
The record provided states the opportunity was created on 2021-07-15 and lists an original closing date of 2023-11-27.
Does the listing provide an award ceiling or expected number of awards?
No. Based on the information provided, the listing does not state an award ceiling or the expected number of awards.
What are the key takeaways for potential applicants?
The key points are that this is a targeted NINDS SBIR pathway for U.S. small businesses that are ready to conduct exploratory clinical trials on neurologically relevant products. Applications must be submitted as SBIR Phase II or SBIR Fast-Track (no standalone Phase I), and eligibility is limited to U.S. small business applicants while following NIH rules and restrictions on foreign participation.
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