Opportunity Information: Apply for PAR 15 194
Apply for PAR 15 194
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NeuroNEXT Small Business Innovation in Clinical Trials Direct to Phase II (U44)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.853 Extramural Research Programs in the Neurosciences and Neurological Disorders.
- This funding opportunity was created on Apr 29, 2015 and posted on Apr 29, 2015.
- Applicants must submit their applications by Dec 2, 2016. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Small businesses.
- Other Eligible Applicants include the following Non domestic (non U.S.) Entities (Foreign Institutions) are not eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, may be allowed.
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Opportunity Summary:
NeuroNEXT Small Business Innovation in Clinical Trials Direct to Phase II (U44) (Funding Opportunity Number PAR 15-194) was a National Institutes of Health (NIH) funding opportunity, administered through the National Institute of Neurological Disorders and Stroke (NINDS), aimed specifically at U.S.-eligible small businesses that wanted to move an investigational neurological therapy into an exploratory clinical trial without going through a separate Phase I SBIR/STTR step. The mechanism was a cooperative agreement (U44), which generally means the NIH expects to have substantial scientific and programmatic involvement during the project, rather than acting only as a passive funder. The overall intent was to help small companies generate early human data that can justify and properly design later, larger clinical studies, particularly in areas aligned with NINDS priorities.
The FOA supported exploratory clinical trials of investigational agents across several intervention types, including drugs, biologics, devices, and surgical therapies. The emphasis was on trials that meaningfully inform the next stage of development: collecting safety, feasibility, dosing, signal-finding, biomarker, or other clinically relevant data that strengthen the rationale for subsequent studies and help shape their design. In practical terms, this opportunity was meant to bridge a common gap for small businesses in neurotherapeutics development: getting from promising preclinical or early translational work to credible, actionable clinical evidence that can support a larger efficacy-focused trial or other pivotal development steps.
A key framing requirement was that the disease area and clinical focus needed to fit within the NINDS strategic plan and clinical research interests. Applicants were directed to align proposed trials with NINDS’s stated areas of emphasis (referenced through the NINDS funding areas webpage). This is important because it signals that NINDS was not looking for any clinical trial broadly related to neurology, but rather projects that clearly connected to NINDS mission priorities and the institute’s targeted neurological disorders and research goals. The program sat within the NIH Health funding activity category and was listed under CFDA 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders).
Eligibility was limited to small businesses, and the FOA explicitly stated that non-U.S. (foreign) institutions were not eligible to apply. In addition, non-U.S. components of U.S. organizations were not eligible. However, the announcement noted that “foreign components,†as defined by the NIH Grants Policy Statement, could be allowable in some cases, which typically means a U.S. applicant could potentially include certain well-justified international elements (for example, specific activities, collaborations, or resources abroad) if permitted under NIH policy and if clearly necessary to the project. The opportunity did not require cost sharing or matching, which reduces the financial barrier for small businesses that might not have significant non-dilutive funds available.
From an administrative timeline standpoint, the FOA was posted and created on April 29, 2015, with an original and final closing date of December 2, 2016, and it was later archived on January 2, 2017. That means it was time-limited and is no longer open for applications, but it remains a useful reference for understanding how NINDS structured small business clinical trial support within the NeuroNEXT context during that period.
For applicants and interested parties who wanted the full details, NIH provided an additional information link to the full FOA text hosted on the NIH grants site (grants.nih.gov). The contact information included the NIH Office of Extramural Research (OER) webmaster email for technical issues accessing or linking to the announcement, which indicates that the provided contact was primarily for web-access and announcement retrieval support rather than scientific or programmatic questions.
In summary, PAR 15-194 was designed to push small business-led neurological interventions into early-stage clinical testing under a cooperative agreement structure, with the explicit goal of producing credible exploratory trial data that would enable better-designed subsequent clinical studies, and with topic alignment to NINDS strategic priorities as a core expectation.
Frequently Asked Questions (FAQs)
What is the NeuroNEXT Small Business Innovation in Clinical Trials Direct to Phase II (U44) opportunity?
It was an NIH funding opportunity (Funding Opportunity Number PAR 15-194) administered by the National Institute of Neurological Disorders and Stroke (NINDS). It was designed for eligible U.S. small businesses to move an investigational neurological therapy into an exploratory clinical trial using a Direct to Phase II approach, without needing a separate Phase I SBIR/STTR step.
Which NIH institute administered this funding opportunity?
NINDS (National Institute of Neurological Disorders and Stroke) administered this opportunity under the NIH umbrella.
What does the "Direct to Phase II" approach mean in this FOA?
Within the context described, "Direct to Phase II" meant the FOA was intended to support an exploratory clinical trial without requiring the applicant to go through a separate Phase I SBIR/STTR award first.
What award mechanism was used (U44), and what does that imply?
The mechanism was a cooperative agreement (U44). A cooperative agreement generally indicates NIH anticipated substantial scientific and programmatic involvement during the project rather than acting only as a passive funder.
What types of clinical trials were supported?
The FOA supported exploratory clinical trials intended to inform the next stage of development. The emphasis was on generating data such as safety, feasibility, dosing, signal-finding, biomarker results, or other clinically relevant evidence to strengthen the rationale for subsequent studies and help shape their design.
What kinds of investigational interventions could be tested?
The FOA covered investigational neurological therapies across several intervention types, including drugs, biologics, devices, and surgical therapies.
What was the main purpose of funding these exploratory trials?
The stated intent was to help small companies generate early human data that could justify and properly design later, larger clinical studies, especially in areas aligned with NINDS priorities.
How was topic fit determined for this opportunity?
A key requirement was that the disease area and clinical focus fit within the NINDS strategic plan and clinical research interests. Applicants were directed to align proposed trials with NINDS stated areas of emphasis (referenced through the NINDS funding areas webpage).
Does this opportunity support any neurology-related clinical trial?
No. The description makes clear NINDS was not seeking any clinical trial broadly related to neurology; projects needed to clearly connect to NINDS mission priorities and targeted neurological disorders and research goals.
Who was eligible to apply?
Eligibility was limited to small businesses, and the opportunity was aimed specifically at U.S.-eligible small businesses.
Are non-U.S. (foreign) institutions eligible to apply?
No. The FOA explicitly stated that non-U.S. (foreign) institutions were not eligible to apply.
Can non-U.S. components of U.S. organizations participate?
No. The FOA stated that non-U.S. components of U.S. organizations were not eligible.
Are any international elements allowed at all?
The announcement noted that "foreign components," as defined by the NIH Grants Policy Statement, could be allowable in some cases. This typically means a U.S. applicant could potentially include certain well-justified international elements (such as specific activities, collaborations, or resources abroad) if permitted under NIH policy and clearly necessary to the project.
Was cost sharing or matching required?
No. The opportunity did not require cost sharing or matching.
What was the funding activity category and CFDA listing?
The program was within the NIH Health funding activity category and was listed under CFDA 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders).
When was PAR 15-194 posted, and when did it close?
The FOA was posted and created on April 29, 2015. It had an original and final closing date of December 2, 2016.
Is this funding opportunity still open?
No. It was later archived on January 2, 2017, and is no longer open for applications.
Where could applicants find the full FOA details?
NIH provided an additional information link to the full FOA text hosted on the NIH grants site (grants.nih.gov).
What contact information was provided, and what was it intended for?
The contact information included the NIH Office of Extramural Research (OER) webmaster email for technical issues accessing or linking to the announcement. This indicates the provided contact was primarily for web-access and announcement retrieval support rather than scientific or programmatic questions.
What development gap was this opportunity trying to address for small businesses?
It was intended to bridge a common gap in neurotherapeutics development for small businesses: moving from promising preclinical or early translational work to credible, actionable clinical evidence that can support a larger efficacy-focused trial or other pivotal development steps.
What kinds of outcomes were expected from supported trials?
Supported trials were expected to produce credible exploratory trial data (for example, safety, feasibility, dosing, signal-finding, biomarker, or other clinically relevant data) that would enable better-designed subsequent clinical studies.
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