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.Apply for PAR 17 479
- 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.
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Frequently Asked Questions (FAQs)
What is the NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) for Clinical Trials and Clinical Research (R44)?
This is a National Institutes of Health (NIH) funding opportunity administered by the National Institute of Neurological Disorders and Stroke (NINDS). It uses the SBIR R44 grant mechanism to provide renewal-level Phase IIB support for projects that need additional resources beyond a standard SBIR Phase II award to run clinical trials or related clinical research and move closer to commercialization.
What is the main purpose of this Phase IIB funding?
The main purpose is to help small businesses push promising neuroscience-focused technologies beyond the typical SBIR Phase II stage by funding expensive, later-stage clinical trials or clinical research needed to demonstrate real-world safety, effectiveness, and value. The goal is to bring products closer to market entry, regulatory milestones, broader adoption, or acquisition/licensing.
Who is this opportunity intended to support?
It is intended to support U.S. small business concerns that meet SBIR requirements and already have NIH SBIR or STTR Phase II support for the project, but now need additional funding to complete the clinical work required for translation and commercialization.
Is prior NIH SBIR or STTR Phase II support required?
Yes. The program targets projects that have already been supported through an NIH SBIR or STTR Phase II award and require additional Phase IIB resources to conduct clinical trials or related clinical research.
What kinds of research activities does this FOA focus on?
The FOA focuses on clinically oriented work, including clinical trials and related clinical research, aimed at generating evidence that supports translation into patient care and eventual commercialization (rather than remaining at a proof-of-concept or preclinical stage).
What scientific areas and diseases must the project address?
The scientific scope must align with the mission and priorities of NINDS, meaning the work should address neurological disorders, stroke, or related areas consistent with NINDS priorities.
What types of products or interventions can be supported?
Eligible projects can include drugs and biologics, medical devices, diagnostics, and other technologies. The scope also includes surgical approaches as well as behavioral or rehabilitation therapies, as long as the work is clinically oriented and supports translation and commercialization.
How is this different from a standard SBIR Phase II award?
This Phase IIB mechanism is designed to provide extra runway for costly later-stage clinical work that is often too expensive to cover under a typical Phase II budget. It is meant to fund clinical trials or clinical research needed to demonstrate safety, effectiveness, and value so a product can approach market readiness.
Does the FOA emphasize commercialization readiness?
Yes. A central feature is a strong emphasis on commercialization readiness, including a clear pathway to market, a business rationale, and a credible plan for financing beyond NIH support.
Is a Commercialization Plan required?
Yes. Applicants are required to submit a Commercialization Plan consistent with NIH SBIR Phase II application requirements. The plan must explain the pathway to market, the business rationale, and how the project will be financed beyond NIH funding.
Does the FOA expect third-party investment or strategic partnerships?
Yes. 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, such as venture investors, corporate partners, or other non-federal backers.
How much third-party funding is expected relative to the requested NINDS funding?
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.
What counts as evidence of outside support or investor interest?
Applicants should be prepared to document investor interest or partner commitments using materials such as letters of support, strategic partner commitments, or other concrete evidence that external stakeholders are willing to share the financial risk of the clinical-stage work.
Who is eligible to apply?
Eligibility is limited to U.S. small business concerns that meet SBIR requirements because this is an SBIR R44 grant mechanism.
Are foreign (non-U.S.) institutions eligible to apply?
No. Foreign institutions (non-U.S. entities) are not eligible to apply.
Can a U.S. small business include non-U.S. components in the project?
Non-U.S. components of U.S. organizations are not eligible. However, the FOA notes that foreign components (as defined under the NIH Grants Policy Statement) may be allowed in some cases. This generally means specific project elements may be performed abroad if well-justified and consistent with NIH policy, while the applicant organization remains an eligible U.S. small business.
What NIH institute administers this opportunity?
This opportunity is administered by the National Institutes of Health (NIH) through the National Institute of Neurological Disorders and Stroke (NINDS).
What is the grant mechanism used for this opportunity?
The mechanism is SBIR R44, described as NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) for Clinical Trials and Clinical Research.
What is the funding category and assistance listing information provided?
The opportunity is in the health funding category and is associated with CFDA 93.853.
What is the FOA identifier referenced in the provided information?
The provided source data identifies this funding opportunity as PAR-17-479.
When was this opportunity created and what was the original closing date?
It was created on September 11, 2017, and the original closing date listed is January 5, 2018.
Does the provided information specify an award ceiling or the number of awards?
No. The source data provided does not specify an award ceiling or the expected number of awards.
What outcomes is NINDS trying to accelerate with this Phase IIB support?
The intent is to accelerate movement from NIH-funded development into the commercial marketplace by supporting the clinical work needed for market readiness and by driving meaningful engagement from investors and strategic partners.
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