Opportunity Information: Apply for PAR 12 076
Apply for PAR 12 076
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NINDS Competing Renewal Awards of STTR Phase II (Phase IIB) Grants (STTR R42)" 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 Jan 11, 2012 and posted on Jan 11, 2012.
- Applicants must submit their applications by Sep 7, 2013. (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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Opportunity Summary:
The NINDS Competing Renewal Awards of STTR Phase II (Phase IIB) Grants (STTR R42) opportunity (Funding Opportunity Number PAR-12-076) is a discretionary NIH grant program run under the National Institute of Neurological Disorders and Stroke (NINDS). It is designed specifically for small business concerns that have already completed an STTR Phase II project and now need additional, targeted support to move the technology into its next development stage, particularly when the product or technology will require approval from a federal regulatory agency. In practical terms, this FOA is meant to help a project cross the high-cost, high-risk gap between a successful Phase II outcome and a commercially viable product that is ready for regulatory submission, clearance, or approval and eventual market entry in the neuroscience and neurological disorders space.
A central purpose of the program is to push promising, previously funded STTR Phase II efforts closer to commercialization by strengthening the business case and encouraging real market participation. NINDS signals that it wants awardees to engage with third party investors and/or strategic partners, such as venture investors, corporate partners, or other non-federal entities that can validate the technology and help finance and execute late-stage development. The FOA is therefore not only a scientific or engineering development mechanism; it is also a commercialization-focused bridge that rewards applicants who can demonstrate that there is credible external interest and a viable path to market.
A key requirement highlighted in the announcement is the Commercialization Plan, which is mandatory for STTR Phase II applications under SF424 instructions and is emphasized here because Phase IIB is explicitly about transition to commercialization. The commercialization plan is expected to go beyond general statements of intent and instead provide concrete details about the product strategy, competitive positioning, target customers or end users, intellectual property status, development milestones, regulatory pathway, manufacturing and scale-up considerations (as relevant), and a realistic financing and partnering strategy. Critically, the plan should document any independent third party investor funding already secured or expected during the project period. The FOA makes a strong expectation that this independent third party support will be equal to or greater than the amount of NINDS funding requested across the Phase IIB project period, reinforcing that NIH funds are intended to leverage substantial outside capital rather than replace it.
From an eligibility and administrative standpoint, the eligible applicants are small businesses, consistent with the STTR program structure that requires collaboration between the small business and a research institution partner. The funding instrument is a grant, and the activity category is health, with CFDA number 93.853 (Extramural Research Programs in the Neurosciences and Neurological Disorders). There is no cost sharing or matching requirement listed as a formal condition of award; however, the program’s commercialization emphasis effectively functions as a leverage expectation through the strong preference for significant third party investment participation.
Timing and status information provided in the source indicates the FOA was posted on January 11, 2012, with an original and final closing date of September 7, 2013, and it was archived on October 8, 2013. While those dates indicate this specific announcement is no longer open, the summary captures how NINDS framed Phase IIB competing renewals at the time: as an extension of Phase II for the subset of projects that are ready for regulatory-oriented development and that can attract serious external validation and funding. Additional details and the full text were hosted through the NIH Grants Guide at the link provided in the announcement. For access issues, the NIH Office of Extramural Research webmaster contact information is included in the listing.
FAQs: NINDS Competing Renewal Awards of STTR Phase II (Phase IIB) Grants (STTR R42) - PAR-12-076
What is this grant opportunity?
This opportunity is the NINDS Competing Renewal Awards of STTR Phase II (Phase IIB) Grants (STTR R42), Funding Opportunity Number PAR-12-076. It is a discretionary NIH grant program administered by the National Institute of Neurological Disorders and Stroke (NINDS).
What is the main purpose of the STTR Phase IIB (R42) competing renewal?
The program is designed to provide additional, targeted support to small businesses that have already completed an STTR Phase II project and need help advancing the technology into the next development stage. A major focus is bridging the high-cost, high-risk gap between a successful Phase II outcome and a commercially viable product that is ready for regulatory submission, clearance, or approval and eventual market entry.
Who is this program intended for?
The eligible applicants are small business concerns under the STTR program structure. STTR also requires collaboration between the small business and a research institution partner.
What kinds of projects is NINDS trying to support through this FOA?
This FOA targets projects in the neuroscience and neurological disorders space that have already been supported through STTR Phase II and are ready for late-stage, commercialization-oriented development. It is particularly relevant when the product or technology will require approval from a federal regulatory agency.
How is Phase IIB different from a typical research-focused grant?
Based on the description provided, this FOA is not only a scientific or engineering development mechanism. It is explicitly a commercialization-focused bridge intended to move technologies closer to market readiness, including preparation for regulatory processes.
What is the role of commercialization in this FOA?
Commercialization is central to the program. NINDS frames Phase IIB as a transition-to-commercialization effort meant to strengthen the business case, encourage real market participation, and push previously funded STTR Phase II technologies toward commercial viability.
Does the FOA encourage outside investors or partners?
Yes. NINDS signals a desire for awardees to engage with third party investors and/or strategic partners (for example, venture investors, corporate partners, or other non-federal entities). This external participation is presented as a way to validate the technology and help finance and execute late-stage development.
Is a Commercialization Plan required?
Yes. A Commercialization Plan is mandatory for STTR Phase II applications under the SF424 instructions, and the FOA emphasizes it because Phase IIB is explicitly about transition to commercialization.
What should the Commercialization Plan cover, according to the description?
The plan is expected to go beyond general statements and include concrete details such as product strategy, competitive positioning, target customers or end users, intellectual property status, development milestones, regulatory pathway, and manufacturing/scale-up considerations (as relevant). It should also present a realistic financing and partnering strategy.
What does the FOA say about third party investor funding?
The Commercialization Plan should document any independent third party investor funding already secured or expected during the project period. The FOA strongly expects that this independent third party support will be equal to or greater than the amount of NINDS funding requested across the Phase IIB project period.
Is cost sharing or matching required?
No formal cost sharing or matching requirement is listed as a condition of award. However, the FOA describes a strong expectation of significant independent third party investment, functioning as a leverage expectation rather than a formal match requirement.
What is the funding mechanism and activity category?
The funding instrument is a grant. The activity category is health.
What is the CFDA number associated with this program?
The CFDA number provided is 93.853, titled Extramural Research Programs in the Neurosciences and Neurological Disorders.
Is this funding opportunity currently open?
No. The FOA was posted on January 11, 2012, had an original and final closing date of September 7, 2013, and was archived on October 8, 2013.
Where was the full announcement hosted?
Additional details and the full text were hosted through the NIH Grants Guide at the link provided in the announcement.
Who should be contacted for access issues related to the posting?
The listing includes NIH Office of Extramural Research webmaster contact information for access issues.
What stage of development is this FOA meant to support?
It is meant to support the stage between a successful Phase II outcome and a commercially viable product, especially when preparing for regulatory submission, clearance, or approval and eventual market entry.
What does NINDS appear to value in applications for this FOA?
Based on the summary provided, NINDS values credible external interest and a viable path to market, including demonstrated or expected participation from third party investors or strategic partners and a detailed, realistic commercialization plan.
Does this FOA apply to projects that have not completed STTR Phase II?
The program is described as being designed specifically for small businesses that have already completed an STTR Phase II project and are seeking a Phase IIB competing renewal to move into the next development stage.
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Previous opportunity: NINDS Competing Renewal Awards of SBIR Phase II (Phase IIB) Grants (SBIR R44)
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