Opportunity Information: Apply for PAR 14 265
Apply for PAR 14 265
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NINDS Direct Phase II SBIR Grants to Support Exploratory Clinical Trials" 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 20, 2014 and posted on Jun 20, 2014.
- Applicants must submit their applications by Jan 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 percent 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 percent 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 percent 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 percent 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.
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Opportunity Summary:
The NINDS Direct Phase II SBIR Grants to Support Exploratory Clinical Trials opportunity (Funding Opportunity Number PAR-14-265) was a National Institutes of Health (NIH) discretionary grant program designed to move promising neuroscience and neurological disorder technologies into early clinical testing without requiring a prior, separate SBIR Phase I award. In other words, it used the "Direct to Phase II" SBIR pathway to let qualified small businesses skip the traditional two-step sequence, provided they could already show convincing evidence that the core Phase I-type work (feasibility, early prototype, and foundational proof-of-concept) had effectively been done. The overall intent was to speed up development timelines and strengthen commercialization prospects for products aligned with the mission of the National Institute of Neurological Disorders and Stroke (NINDS).
The program specifically encouraged applications for exploratory clinical trials. That focus means it was aimed at early-stage clinical studies intended to gather initial human data on safety, feasibility, dosing, performance, or signals of clinical activity, rather than large, definitive pivotal trials. NINDS made clear that the types of interventions and technologies could be broad as long as they fit the institute's neurological scope. Eligible product categories included drugs and biologics, medical devices, and diagnostics, and it also allowed evaluation of surgical approaches as well as behavioral or rehabilitation therapies. The unifying theme was that the work needed to advance a biomedical technology with commercial potential and a credible path toward real-world use in neurology or stroke-related areas.
A central eligibility and readiness expectation was that applicants had already demonstrated scientific and technical merit and the feasibility of the prototype stage. The FOA described this as having completed research and development characteristic of a Phase I (R43) SBIR project. Practically, this implies that an applicant needed to bring strong preliminary data, a working prototype or mature candidate, and a well-supported rationale for entering human testing. The Direct to Phase II structure is meant for teams that are past the earliest risk-reduction stage and are prepared to use Phase II-level resources to generate clinically meaningful evidence, refine the product, and set up subsequent commercialization steps such as regulatory strategy and market adoption planning.
Only United States small business concerns (SBCs) were eligible to apply, and the FOA laid out the standard SBIR small business requirements in detail. The business had to be for-profit, have a place of business in the United States, and operate primarily in the United States or otherwise make a significant contribution to the U.S. economy (for example through taxes or the use of American labor and materials). It also had to fit an acceptable legal structure (such as an LLC, corporation, partnership, sole proprietorship, and similar forms), with additional limits for joint ventures, including restrictions on foreign participation. Ownership and control rules followed SBIR policy, including eligibility for firms majority-owned by U.S. citizens or permanent residents, and also allowing certain venture capital, hedge fund, or private equity ownership structures so long as no single such entity owned more than 50 percent of the company. The company, including affiliates, could not exceed 500 employees.
Administratively, this was an NIH grant in the health funding category, associated with CFDA number 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders). There was no cost sharing or matching requirement. The opportunity was posted June 20, 2014, with an original and final closing date listed as January 7, 2017, and it was archived February 7, 2017, meaning it is no longer an active open solicitation. The FOA emphasized that its purpose was not only to support specific exploratory trials, but also to "enhance the pace of technology development and commercialization" by expanding SBIR R&D opportunities and reducing delays between promising preclinical development and first clinical evaluations.
In practical terms, a strong application under this FOA would have been expected to describe a neurological product candidate ready for an exploratory clinical trial, justify why the team was qualified to enter Direct to Phase II (including evidence that Phase I-type feasibility work was already successfully completed), and present a credible clinical development plan tailored to early human testing. Because the mechanism was explicitly commercialization-oriented, applicants would also be expected to connect the clinical trial to a broader product development strategy, including how the results would de-risk the technology, support regulatory interactions, and position the product for partnerships, follow-on investment, or later-stage clinical trials.
Frequently Asked Questions (FAQs)
What is the NINDS Direct Phase II SBIR Grants to Support Exploratory Clinical Trials opportunity (PAR-14-265)?
PAR-14-265 was a National Institutes of Health (NIH) discretionary grant funding opportunity from the National Institute of Neurological Disorders and Stroke (NINDS). It used the SBIR "Direct to Phase II" pathway to support small businesses that were ready to move promising neuroscience and neurological disorder technologies into early clinical testing, without requiring a separate prior SBIR Phase I award.
What was the main goal of this funding opportunity?
The central goal was to speed development timelines and improve commercialization prospects for technologies aligned with the NINDS mission. The program aimed to reduce delays between promising preclinical development and first clinical evaluations by allowing qualified small businesses to skip the traditional Phase I step when Phase I-type feasibility work had effectively already been completed.
What does "Direct to Phase II" mean in this FOA?
"Direct to Phase II" meant applicants did not need to have a prior, separate SBIR Phase I (R43) award to apply. Instead, applicants had to demonstrate that the core Phase I-type work (feasibility, early prototype development, and foundational proof-of-concept) had already been done convincingly, supporting readiness for Phase II-level clinical activity.
Did applicants need prior SBIR Phase I funding to apply?
No. This FOA was specifically designed to support applicants who could show convincing evidence that Phase I-characteristic research and development had already been completed, even if it was not funded through an SBIR Phase I award.
What kinds of clinical studies did this program focus on?
The FOA encouraged "exploratory clinical trials," meaning early-stage human studies intended to gather initial data such as safety, feasibility, dosing, performance, or early signals of clinical activity. It was not aimed at large, definitive pivotal trials.
What outcomes were exploratory clinical trials expected to generate?
Based on the FOA description, exploratory trials were expected to produce early human data to help de-risk the technology and guide next steps in development, such as refining the product, supporting regulatory planning, and strengthening the path toward commercialization and later-stage clinical evaluation.
What types of technologies or interventions were eligible under this opportunity?
The FOA allowed a broad range of interventions as long as they fit within NINDS neurological scope. Eligible categories included drugs and biologics, medical devices, and diagnostics. It also allowed evaluation of surgical approaches and behavioral or rehabilitation therapies.
What disease or mission area did the applications need to align with?
Projects needed to align with the mission of NINDS, meaning they had to be relevant to neuroscience, neurological disorders, and stroke-related areas within NINDS scope.
What was the expected readiness level for a project entering this program?
Applicants were expected to be beyond the earliest risk-reduction stage and ready for early human testing. The FOA described readiness as having completed research and development characteristic of a Phase I (R43) SBIR project, including demonstrated scientific and technical merit and feasibility at the prototype stage.
What kinds of evidence were applicants expected to provide to justify Direct to Phase II readiness?
The FOA indicated applicants should provide strong preliminary data, a working prototype or mature candidate, and a well-supported rationale for entering human testing. In practical terms, applicants needed to show that Phase I-type feasibility and proof-of-concept work had effectively already been accomplished.
Who was eligible to apply?
Only United States small business concerns (SBCs) were eligible. The FOA followed standard SBIR small business eligibility requirements, including business location, operational presence, ownership/control rules, and employee count limits.
What are the basic SBIR small business requirements described in the FOA?
The business had to be for-profit, have a place of business in the United States, and operate primarily in the United States or otherwise make a significant contribution to the U.S. economy (such as through taxes or using American labor and materials). The company also needed an acceptable legal structure (for example, LLC, corporation, partnership, or sole proprietorship).
Was there an employee size limit for applicant companies?
Yes. The company, including affiliates, could not exceed 500 employees.
Did the FOA allow venture-backed or investment-owned small businesses to apply?
Yes. The FOA described SBIR ownership/control rules that can allow certain venture capital, hedge fund, or private equity ownership structures, as long as no single such entity owned more than 50 percent of the company.
Were there any restrictions mentioned for joint ventures or foreign participation?
Yes. The FOA noted additional limits for joint ventures, including restrictions on foreign participation. It also emphasized the requirement to operate primarily in the United States or contribute significantly to the U.S. economy.
What funding category and federal program identifier were associated with this opportunity?
This was an NIH grant in the health funding category and was associated with CFDA number 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders).
Was cost sharing or matching required?
No. The FOA stated there was no cost sharing or matching requirement.
When was this opportunity posted, and what were the closing dates?
The opportunity was posted on June 20, 2014. The original and final closing date listed was January 7, 2017.
Is PAR-14-265 still open for applications?
No. The opportunity was archived on February 7, 2017, which means it is no longer an active open solicitation.
What would a strong application have been expected to include?
A strong application would have been expected to: (1) describe a neurological product candidate ready for an exploratory clinical trial; (2) justify eligibility for the Direct to Phase II approach with evidence that Phase I-type feasibility work was already successfully completed; and (3) present a credible clinical development plan tailored to early human testing.
How important was commercialization in this FOA?
Commercialization was a central theme. The FOA emphasized enhancing the pace of technology development and commercialization by expanding SBIR R&D opportunities and reducing delays from preclinical development to initial clinical evaluation.
How were applicants expected to connect the exploratory clinical trial to commercialization?
Applicants were expected to link the clinical trial to a broader product development strategy, including how results would de-risk the technology, support regulatory interactions, and position the product for partnerships, follow-on investment, later-stage clinical trials, and eventual real-world use.
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