Opportunity Information: Apply for PAR 14 252
Apply for PAR 14 252
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIH StrokeNet Small Business Innovation Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention (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 Jun 6, 2014 and posted on Jun 6, 2014.
- Applicants must submit their applications by Sep 7, 2017. (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 Only United States small business concerns (SBCs) are eligible to submit applications for this opportunity. A small business concern is one that, at the time of award of Phase I and Phase II, meets all of the following criteria 1. Is organized for profit, with a place of business located in the United States, which operates primarily within the United States or which makes a significant contribution to the United States economy through payment of taxes or use of American products, materials or labor 2. Is in the legal form of an individual proprietorship, partnership, limited liability company, corporation, joint venture, association, trust or cooperative, except that where the form is a joint venture, there must be less than 50 percent participation by foreign business entities in the joint venture 3. (i) SBIR and STTR. Be a concern which is more than 50 directly owned and controlled by one or more individuals (who are citizens or permanent resident aliens of the United States), other business concerns (each of which is more than 50 directly owned and controlled by individuals who are citizens or permanent resident aliens of the United States), or any combination of these OR (ii) SBIR only. Be a concern which is more than 50 owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these. No single venture capital operating company, hedge fund, or private equity firm may own more than 50 of the concern OR (iii) SBIR and STTR. Be a joint venture in which each entity to the joint venture must meet the requirements set forth in paragraph 3 (i) or 3 (ii) of this section. A joint venture that includes one or more concerns that meet the requirements of paragraph (ii) of this section must comply with 121.705(b) concerning registration and proposal requirements. 4. Has, including its affiliates, not more than 500 employees. If the concern is more than 50 owned by multiple venture capital operating companies, hedge funds, private equity firms, or any combination of these falls under 3 (ii) or 3 (iii) above, see Section IV. Application and Submission Information for additional instructions regarding required application certification.
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Opportunity Summary:
The NIH StrokeNet Small Business Innovation Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention (U44) funding opportunity (PAR 14-252) was a National Institutes of Health (NIH) Small Business Innovation Research (SBIR) cooperative agreement designed to help U.S. small businesses move promising stroke-related innovations into human testing. The focus was on clinical research that could meaningfully improve stroke prevention, acute treatment, or recovery, with an emphasis on projects that were ready for exploratory or confirmatory clinical trials. In addition to intervention trials, the announcement also invited biomarker and outcome-measure validation studies, as long as those studies were immediately preparatory to clinical trials, meaning they directly supported near-term trial readiness rather than being open-ended discovery work.
A central feature of this opportunity was its use of a cooperative agreement mechanism (U44), which typically means NIH staff have substantial scientific and programmatic involvement compared with a standard grant. The FOA highlighted milestone-driven projects, signaling that awardees would be expected to define clear, measurable go/no-go points and to manage the work in a way that supports efficient decision-making. In practical terms, the intent was to fund studies that are operationally realistic, clinically meaningful, and structured to generate interpretable results that can support the next step in development, including progression to larger definitive trials when warranted.
The program was closely tied to NIH StrokeNet, a national clinical trials network supported by the National Institute of Neurological Disorders and Stroke (NINDS). Applicants with meritorious applications could be given access to this infrastructure, but access was not automatic. After peer review, NINDS indicated it would prioritize which of the highest-scoring trials would actually receive StrokeNet support. For projects that were selected, StrokeNet was positioned to reduce common barriers that slow down multicenter stroke studies, especially around startup, recruitment, standardized protocol implementation, and high-quality data handling.
StrokeNet support was described in a fairly concrete, operational way. The StrokeNet National Coordinating Center (NCC) would work with successful applicants to implement the study efficiently, which typically includes study startup coordination, site activation support, and overall trial operations. The National Data Management Center (NDMC) would provide statistical and data management support, covering the kinds of centralized services that many small companies struggle to stand up on their own, such as database development, data cleaning workflows, and statistical input aligned to the protocol and analysis plan. Recruitment and site-level execution would be supported through the Regional Coordinating Centers (RCCs) and their affiliated clinical sites, which would assist with enrollment/retention and on-site delivery of the clinical protocol, an especially important benefit in stroke trials where time windows, acute workflows, and standardized outcome assessments can be difficult to manage across disparate hospitals.
The announcement also emphasized that StrokeNet could uniquely collaborate with the NINDS Neurological Emergencies Treatment Trials Network (NETT) and potentially other U.S. and international consortia. This matters because many stroke interventions ultimately require larger, more definitive trials, sometimes across different emergency care environments and healthcare systems. By pointing to these collaborations, the FOA was signaling a pathway from smaller, well-controlled SBIR-supported studies into broader networks capable of running pivotal trials when early results justify that scale-up.
From an eligibility standpoint, the opportunity was limited to U.S. small business concerns (SBCs) meeting SBIR size and ownership requirements at the time of award for Phase I and Phase II. The business had to be for-profit, have a U.S. place of business, and generally operate primarily in the United States or make a significant contribution to the U.S. economy. The eligible legal forms covered common business structures (for example, LLCs and corporations) and allowed joint ventures with restrictions on foreign participation. Ownership rules included the standard SBIR categories (majority owned/controlled by U.S. citizens or permanent residents) and also allowed certain majority venture-backed ownership structures consistent with SBIR policy, with limits such as no single venture capital operating company, hedge fund, or private equity firm owning more than 50 percent. The size standard was not more than 500 employees including affiliates. The FOA explicitly indicated there was no cost sharing or matching requirement.
Administratively, this was a discretionary health funding opportunity under NIH, associated with CFDA 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders). The posting and creation date were June 6, 2014, and the final closing date listed was September 7, 2017, with an archive date of October 8, 2017, indicating it is no longer active. The announcement provided an NIH grants guide link for full details and listed NIH Office of Extramural Research (OER) webmaster contacts for technical access issues.
FAQs: NIH StrokeNet Small Business Innovation Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention (U44) - PAR 14-252
What is this funding opportunity?
This was an NIH Small Business Innovation Research (SBIR) cooperative agreement (U44) called "NIH StrokeNet Small Business Innovation Clinical Trials and Biomarker Studies for Stroke Treatment, Recovery, and Prevention" (PAR 14-252). It was designed to help U.S. small businesses move promising stroke-related innovations into human testing.
Which NIH organization and program were associated with this FOA?
The opportunity was tied to NIH StrokeNet, a national clinical trials network supported by the National Institute of Neurological Disorders and Stroke (NINDS).
What types of projects were the main focus?
The focus was on clinical research intended to meaningfully improve stroke prevention, acute treatment, or recovery, with an emphasis on projects that were ready for exploratory or confirmatory clinical trials.
Did the FOA support only intervention trials?
No. In addition to intervention trials, the FOA also invited biomarker and outcome-measure validation studies, as long as they were immediately preparatory to clinical trials.
What does "immediately preparatory to clinical trials" mean in this context?
It means biomarker and outcome-measure validation studies needed to directly support near-term trial readiness, rather than being open-ended discovery work.
What mechanism was used and why does it matter?
The FOA used a cooperative agreement mechanism (U44). In general, this indicates NIH staff have substantial scientific and programmatic involvement compared with a standard grant.
Were projects expected to be milestone-driven?
Yes. The FOA highlighted milestone-driven projects and indicated awardees would be expected to define clear, measurable go/no-go points to support efficient decision-making.
What kinds of outcomes was the program trying to produce?
The intent was to fund studies that are operationally realistic, clinically meaningful, and structured to generate interpretable results that can support the next step in development, including progression to larger definitive trials when warranted.
Was access to NIH StrokeNet automatic for awardees?
No. While applicants with meritorious applications could be given access to StrokeNet infrastructure, access was not automatic.
How was StrokeNet support decided?
After peer review, NINDS indicated it would prioritize which of the highest-scoring trials would actually receive StrokeNet support.
What problem was StrokeNet meant to help solve for small businesses?
StrokeNet support was positioned to reduce common barriers that slow down multicenter stroke studies, especially around startup, recruitment, standardized protocol implementation, and high-quality data handling.
What operational support could the StrokeNet National Coordinating Center (NCC) provide?
The NCC would work with successful applicants to implement the study efficiently, which typically includes study startup coordination, site activation support, and overall trial operations.
What support could the National Data Management Center (NDMC) provide?
The NDMC would provide statistical and data management support, including centralized services such as database development, data cleaning workflows, and statistical input aligned to the protocol and analysis plan.
How could Regional Coordinating Centers (RCCs) and affiliated clinical sites support a project?
RCCs and their affiliated clinical sites would support recruitment and site-level execution, assisting with enrollment and retention and on-site delivery of the clinical protocol.
Why might StrokeNet be especially helpful for stroke trials?
The FOA noted that stroke trials can be difficult to manage across hospitals due to time windows, acute workflows, and the need for standardized outcome assessments, making network-based recruitment and standardized execution valuable.
Did the FOA describe collaborations beyond StrokeNet?
Yes. The FOA emphasized that StrokeNet could uniquely collaborate with the NINDS Neurological Emergencies Treatment Trials Network (NETT) and potentially other U.S. and international consortia.
Why were these collaborations highlighted?
They were presented as relevant because many stroke interventions ultimately require larger, more definitive trials, sometimes across different emergency care environments and healthcare systems. The FOA signaled a pathway from smaller SBIR-supported studies into broader networks capable of running pivotal trials when early results justify scale-up.
Who was eligible to apply?
Eligibility was limited to U.S. small business concerns (SBCs) meeting SBIR size and ownership requirements at the time of award for Phase I and Phase II.
What basic business characteristics were required?
The business had to be for-profit, have a U.S. place of business, and generally operate primarily in the United States or make a significant contribution to the U.S. economy.
What kinds of legal entities were eligible?
The eligible legal forms covered common business structures (for example, LLCs and corporations) and allowed joint ventures with restrictions on foreign participation.
What were the SBIR ownership rules described in the FOA?
Ownership rules included standard SBIR categories (majority owned/controlled by U.S. citizens or permanent residents). The FOA also allowed certain majority venture-backed ownership structures consistent with SBIR policy, with limits such as no single venture capital operating company, hedge fund, or private equity firm owning more than 50 percent.
What was the size standard for an eligible small business?
The size standard was not more than 500 employees, including affiliates.
Was cost sharing or matching required?
No. The FOA explicitly indicated there was no cost sharing or matching requirement.
What is the CFDA number associated with this opportunity?
The FOA was associated with CFDA 93.853, "Extramural Research Programs in the Neurosciences and Neurological Disorders."
When was this funding opportunity posted, and is it still active?
The posting and creation date were June 6, 2014. The final closing date listed was September 7, 2017, with an archive date of October 8, 2017, indicating the opportunity is no longer active.
Where were applicants directed to find full details?
The announcement provided an NIH grants guide link for full details.
Who was listed for technical access issues?
NIH Office of Extramural Research (OER) webmaster contacts were listed for technical access issues.
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