Opportunity Information: Apply for PAR 14 208
Apply for PAR 14 208
- 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 Exploratory 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 Extramural Research Programs in the Neurosciences and Neurological Disorders.
- This funding opportunity was created on May 7, 2014 and posted on May 7, 2014.
- Applicants must submit their applications by May 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 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 NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) for Exploratory Clinical Trials and Clinical Research (R44) opportunity (Funding Opportunity Number PAR-14-208) is a National Institutes of Health (NIH) grant program designed to help small businesses push previously funded NIH SBIR or STTR Phase II projects into the clinical stage needed for eventual commercialization. The central idea is to provide additional, follow-on SBIR support specifically for exploratory clinical trials and other clinical research activities that are often too expensive to complete with a standard Phase II budget, but are necessary to demonstrate clinical promise, reduce investor risk, and move a product toward market readiness. The focus must align with the mission and goals of the National Institute of Neurological Disorders and Stroke (NINDS), meaning the work should address neurological disorders, stroke, or related areas within NINDS scientific priorities.
This FOA is aimed at clinical testing and clinical research around a product or intervention that has already been advanced through an NIH Phase II award, rather than supporting early discovery. Projects can involve a wide range of product types as long as they fit NINDS interests, including therapeutics such as drugs and biologics, as well as medical devices and diagnostics. It can also support clinical evaluation of certain non-pharmacologic approaches, including surgical interventions, behavioral therapies, and rehabilitation strategies. In practice, the award is meant to help a small business generate the kind of human data that is often required for regulatory planning, validation of clinical endpoints, refinement of dosing or device parameters, feasibility testing, and other steps that typically precede larger pivotal trials or commercial partnerships.
A defining feature of this Phase IIB concept is its emphasis on commercialization and outside investment. NINDS is explicitly using this funding to encourage partnerships between NIH-funded small businesses and third-party investors or strategic partners, based on the reality that clinical trials are capital intensive and that external capital is usually needed to reach the market. Applicants are required to submit a Commercialization Plan (consistent with SF424 instructions for SBIR Phase II applications), and that plan needs to spell out the companys strategy for bringing the product to market, including concrete information about any independent third-party funding already secured or expected during the project period. The FOA sets a clear expectation that the amount of independent third-party investor or partner funding should be at least equal to, and ideally exceed, the amount of NINDS funding requested over the Phase IIB project period. In other words, the program is structured as a leverage mechanism: federal dollars are intended to catalyze, match, or de-risk substantial non-federal support to speed translation to commercialization.
Eligibility is limited to U.S. small business concerns (SBCs) applying under the SBIR mechanism, with typical SBIR size and ownership rules. The business must be for-profit, have a place of business in the United States, and operate primarily in the United States or make a significant contribution to the U.S. economy through taxes or the use of American products, materials, or labor. The organization can take many legal forms (for example, LLC, corporation, partnership, sole proprietorship, or certain joint ventures), and must have no more than 500 employees including affiliates. Ownership and control requirements follow SBIR rules, including pathways that allow majority ownership by U.S. individuals/permanent residents, or (for SBIR only) majority ownership by multiple venture capital operating companies, hedge funds, or private equity firms as long as no single one owns more than 50 percent. Joint ventures are allowed if they comply with the specified SBIR ownership conditions, including additional registration and proposal requirements in certain cases.
Administratively, this is a discretionary grant program in the health area under CFDA 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders), and it does not require cost sharing or matching as a formal condition of the award. That said, while there is no formal cost-sharing requirement, the programmatically important expectation is the substantial third-party investment described above, which is treated as an essential component of the commercialization strategy and a core rationale for making a Phase IIB award. The opportunity was posted May 7, 2014, with an original and final closing date of May 7, 2017, and an archive date of June 7, 2017, indicating the FOA is no longer active but remains useful as a reference for NINDS SBIR clinical-stage funding priorities and structure.
Overall, this FOA is best understood as a bridge between an earlier SBIR Phase II development effort and the clinical evidence needed for commercial launch or major partnering. It supports exploratory clinical trials and related clinical research for NINDS-relevant products while pushing applicants to demonstrate real-world commercial traction through credible commercialization planning and significant engagement from independent investors or strategic partners.
FAQs: NINDS Renewal Awards of SBIR Phase II Grants (Phase IIB) for Exploratory Clinical Trials and Clinical Research (R44) - PAR-14-208
What is the PAR-14-208 funding opportunity?
PAR-14-208 is an NIH funding opportunity from the National Institute of Neurological Disorders and Stroke (NINDS) that provides follow-on SBIR Phase II (Phase IIB) support for small businesses to advance previously funded NIH SBIR or STTR Phase II projects into exploratory clinical trials and other clinical research activities aimed at eventual commercialization.
What is the main purpose of the Phase IIB (R44) renewal award?
The purpose is to help small businesses generate human clinical data and complete clinical research steps that are often too costly for a standard SBIR Phase II budget, but are important for demonstrating clinical promise, reducing investor risk, supporting regulatory planning, and moving a product closer to market readiness.
Is this program intended for early discovery research?
No. The program is intended for clinical testing and clinical research around a product or intervention that has already been advanced through an NIH Phase II award, rather than for early-stage discovery work.
What types of activities does this FOA support?
It supports exploratory clinical trials and related clinical research activities, such as generating human data needed for regulatory planning, validating clinical endpoints, refining dosing or device parameters, feasibility testing, and other steps that typically occur before larger pivotal trials or commercial partnerships.
What product types are eligible to be supported under this FOA?
A wide range of product types may be supported as long as they align with NINDS interests, including therapeutics (such as drugs and biologics), medical devices, and diagnostics. It can also support clinical evaluation of certain non-pharmacologic approaches, including surgical interventions, behavioral therapies, and rehabilitation strategies.
What scientific areas must the project align with?
The project must align with the mission and goals of NINDS, meaning it should address neurological disorders, stroke, or related areas within NINDS scientific priorities.
What is the role of commercialization in this opportunity?
Commercialization is central to the Phase IIB concept. The FOA emphasizes moving products toward commercialization and encourages partnerships with third-party investors or strategic partners, recognizing that clinical trials are capital intensive and external funding is typically needed to reach the market.
Is a Commercialization Plan required?
Yes. Applicants are required to submit a Commercialization Plan consistent with the SF424 instructions for SBIR Phase II applications. The plan must describe the strategy for bringing the product to market and include concrete information about independent third-party funding already secured or expected during the project period.
What does the FOA say about third-party funding expectations?
The FOA sets a clear expectation that independent third-party investor or partner funding should be at least equal to, and ideally exceed, the amount of NINDS funding requested over the Phase IIB project period. Federal funding is intended to leverage substantial non-federal support.
Is formal cost sharing or matching required?
No. The FOA states that it does not require cost sharing or matching as a formal condition of the award. However, substantial third-party investment is treated as an essential programmatic expectation and a core rationale for making a Phase IIB award.
Who is eligible to apply?
Eligibility is limited to U.S. small business concerns (SBCs) applying under the SBIR mechanism, subject to standard SBIR size and ownership requirements.
What are the basic organizational requirements for the small business concern?
The business must be for-profit, have a place of business in the United States, and operate primarily in the United States or make a significant contribution to the U.S. economy through taxes or the use of American products, materials, or labor.
What legal entity types can qualify as the applicant organization?
The organization can take many legal forms, including an LLC, corporation, partnership, sole proprietorship, or certain joint ventures, as long as it meets SBIR eligibility rules.
Is there an employee size limit?
Yes. The small business concern must have no more than 500 employees, including affiliates.
What ownership and control structures are allowed under the SBIR rules described?
Ownership and control follow SBIR rules, including pathways that allow majority ownership by U.S. individuals or permanent residents, or (for SBIR only) majority ownership by multiple venture capital operating companies, hedge funds, or private equity firms, provided that no single such entity owns more than 50 percent.
Are joint ventures allowed to apply?
Yes. Joint ventures are allowed if they comply with the specified SBIR ownership conditions. The FOA notes that joint ventures may trigger additional registration and proposal requirements in certain cases.
What is the CFDA number associated with this program?
The FOA is identified as a discretionary health-area grant program under CFDA 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders).
When was this FOA posted and is it still active?
The FOA was posted on May 7, 2014. It had an original and final closing date of May 7, 2017, and an archive date of June 7, 2017. Based on those dates, the FOA is no longer active, but it may remain useful as a reference for NINDS SBIR clinical-stage funding priorities and structure.
What stage of development is this award designed to support?
This award is best understood as a bridge between an earlier SBIR Phase II development effort and the clinical evidence needed for commercial launch or major partnering, focusing on exploratory clinical trials and related clinical research.
Why does the FOA emphasize outside investment and partnerships?
The FOA emphasizes outside investment because clinical trials are expensive and external capital is usually needed to reach the market. The program is structured to use federal dollars to catalyze, match, or de-risk substantial non-federal support to speed translation toward commercialization.
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