Opportunity Information: Apply for RFA NS 17 008
The BRAIN Initiative SBIR Direct to Phase II FOA, titled "Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (U44)" (RFA-NS-17-008), is a National Institutes of Health funding opportunity aimed at helping small business concerns move advanced neurotechnology into a small, targeted human clinical study. It is structured as a Direct to Phase II Small Business Innovation Research award using a cooperative agreement mechanism (U44), which typically means NIH program staff will have substantial involvement during the project period compared with a standard grant. The overall goal is to accelerate the development of invasive devices that can record from and/or stimulate the human central nervous system, with an emphasis on generating practical, decision-making data that supports device refinement and future clinical development for central nervous system disorders, while also contributing to a better understanding of the human brain.
The core activity supported under this opportunity is a small clinical study, often described as an early feasibility study, designed to answer key questions about device function, usability, safety, performance, or final design requirements. The intent is not to fund large pivotal trials, but rather to support the kind of focused human testing that helps a company determine whether the device works as intended in real clinical conditions and what modifications are needed before moving toward larger trials and eventual regulatory clearance or approval. A major theme of the FOA is that the clinical study should produce information that cannot realistically be obtained through additional non-clinical work, such as benchtop testing or animal studies, because the device or its intended use is novel and human data are required to resolve the most important uncertainties. In other words, the funding is meant to bridge the point where traditional preclinical testing is no longer sufficient, but where early human experience can significantly de-risk the development path.
The FOA explicitly allows for different risk categories of studies, reflecting the realities of invasive neurotechnology development. It may support acute or short-term procedures that an Institutional Review Board determines to be Non-Significant Risk (NSR), as well as Significant Risk (SR) clinical studies that require an Investigational Device Exemption from the U.S. Food and Drug Administration, including studies involving chronic implants. This flexibility matters because some next-generation recording and stimulation systems are intended for brief intraoperative use, while others are designed for longer-term implantation, and the regulatory and oversight requirements differ accordingly. Regardless of whether the study is NSR or SR, the expectation is that the work will be tightly linked to a clear set of engineering and clinical questions that directly inform the final device design.
From a development standpoint, the FOA positions the supported study as a late-stage step toward more advanced clinical trials and market pathways. It highlights that the "final device design" evaluated or informed by the study may require most, if not all, of the non-clinical testing needed on the path to later clinical trials and eventual marketing authorization. That framing signals that applicants should already have made substantial technical progress and should be prepared to justify why they are ready for a human study now, what specific design decisions the study will support, and how the results will be used to advance the product toward broader clinical validation and commercialization. The emphasis is on practical translation: producing high-value evidence that meaningfully advances the device, not simply generating exploratory academic insights.
Eligibility is limited to small businesses, consistent with the SBIR program. Foreign institutions are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible to apply. However, foreign components, as defined by NIH Grants Policy, may be allowable in some cases, which typically implies that limited, well-justified foreign involvement could be permissible if it is essential to the project and consistent with NIH policy, but the applicant organization itself must be U.S.-based and meet SBIR small business requirements. The opportunity is categorized as discretionary funding, and it lists multiple CFDA numbers associated with NIH neuroscience and related institute programs (including 93.173, 93.213, 93.242, 93.273, 93.279, 93.286, 93.853, 93.865, 93.866, 93.867), reflecting the cross-institute nature of BRAIN Initiative activities.
In terms of basic administrative details, the FOA was created on September 28, 2016, with an original closing date of May 24, 2017, and it anticipated making around five awards. While the specific award ceiling is not stated in the provided text, the combination of "Direct to Phase II" and "small clinical study" signals that NIH expected applicants to propose a well-developed, comparatively mature project plan appropriate for human testing, including regulatory strategy (IRB determinations and, where applicable, IDE planning), clinical site readiness, and a clear pathway for using study outcomes to finalize the device and move to the next regulatory and clinical milestones.
Overall, this grant opportunity is best understood as targeted support for a small business that has a next-generation invasive CNS recording and/or modulation technology that is far enough along to justify early human evaluation, and that needs that human study specifically to answer concrete questions about device function and final design. The BRAIN Initiative context underscores the dual-purpose value: enabling better treatments for neurological or psychiatric disorders through improved neurotechnology, and enabling new capabilities for understanding human brain function through advanced recording and stimulation tools.Apply for RFA NS 17 008
- The National Institutes of Health in the education, health, income security and social services sector is offering a public funding opportunity titled "BRAIN Initiative: SBIR Direct to Phase II Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (U44)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.173, 93.213, 93.242, 93.273, 93.279, 93.286, 93.853, 93.865, 93.866, 93.867.
- This funding opportunity was created on 2016-09-28.
- Applicants must submit their applications by 2017-05-24. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The number of recipients for this funding is limited to 5 candidate(s).
- Eligible applicants include: Small businesses.
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FAQs: BRAIN Initiative SBIR Direct to Phase II - Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (U44)
1. What is the official title and mechanism of this funding opportunity?
The funding opportunity is titled "Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (U44)" under the BRAIN Initiative SBIR Direct to Phase II FOA (RFA-NS-17-008). It uses a cooperative agreement mechanism (U44), meaning NIH program staff typically have substantial involvement during the project period compared with a standard grant.
2. What is the main goal of this FOA?
The goal is to accelerate development of next-generation invasive devices that can record from and/or stimulate the human central nervous system by supporting a small, targeted human clinical study that generates practical, decision-making data for device refinement and future clinical development for CNS disorders, while also contributing to understanding of the human brain.
3. What kind of work does the FOA primarily support?
The core activity supported is a small human clinical study, often described as an early feasibility study, designed to answer key questions about device function, usability, safety, performance, or final design requirements.
4. Is this FOA intended to fund large pivotal clinical trials?
No. The intent is not to fund large pivotal trials. It is meant to support focused early human testing that helps determine whether a device works as intended in real clinical conditions and what modifications may be needed before moving toward larger trials and eventual regulatory clearance or approval.
5. Why does the FOA emphasize human clinical data rather than more benchtop or animal testing?
A major theme is that the clinical study should produce information that cannot realistically be obtained through additional non-clinical work (such as benchtop testing or animal studies) because the device or intended use is novel and human data are required to resolve the most important uncertainties.
6. What types of invasive neurotechnology devices are in scope?
Devices in scope are invasive devices intended to record from and/or modulate (stimulate) the human central nervous system. The FOA highlights next-generation recording and stimulation systems and emphasizes generating evidence that informs device refinement and final design decisions.
7. What study risk categories are allowed (NSR vs SR)?
The FOA explicitly allows different risk categories of studies. It may support acute or short-term procedures that an Institutional Review Board (IRB) determines to be Non-Significant Risk (NSR), as well as Significant Risk (SR) clinical studies that require an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA), including studies involving chronic implants.
8. Can this FOA support chronic implant studies?
Yes. The FOA indicates it may support Significant Risk (SR) clinical studies requiring an FDA IDE, including studies involving chronic implants.
9. Can this FOA support acute or short-term intraoperative use cases?
Yes. It may support acute or short-term procedures that an IRB determines to be Non-Significant Risk (NSR), which aligns with devices intended for brief intraoperative use.
10. What is NIH expecting the clinical study to accomplish?
The expectation is that the human study is tightly linked to a clear set of engineering and clinical questions that directly inform the final device design. The purpose is to generate practical evidence that supports refinement and helps de-risk the path toward later clinical trials and marketing pathways.
11. How mature should a project be to fit this Direct to Phase II opportunity?
The FOA is positioned for comparatively mature projects that are ready for human testing. It signals applicants should have made substantial technical progress and be prepared to justify readiness for a human study now, identify which design decisions the study will support, and explain how results will advance the product toward the next regulatory and clinical milestones.
12. What does "final device design" mean in the context of this FOA?
The FOA highlights that the "final device design" evaluated or informed by the study may require most, if not all, of the non-clinical testing needed on the path to later clinical trials and eventual marketing authorization. In practice, that means the study is meant to inform or validate late-stage design decisions rather than early exploratory concepts.
13. What kinds of outcomes does NIH want from the supported study?
NIH emphasizes high-value, decision-making outcomes such as information on device function, usability, safety, performance, and design requirements that meaningfully advances the device toward broader clinical validation and commercialization, not just exploratory academic insights.
14. Who is eligible to apply?
Eligibility is limited to small business concerns, consistent with the SBIR program.
15. Are foreign institutions eligible to apply?
No. Foreign institutions are not eligible to apply.
16. Are non-U.S. components of U.S. organizations eligible to apply?
No. Non-U.S. components of U.S. organizations are not eligible to apply.
17. Are any foreign components allowed at all?
Foreign components (as defined by NIH Grants Policy) may be allowable in some cases. The applicant organization must be U.S.-based and meet SBIR small business requirements, but limited, well-justified foreign involvement may be permissible if it is essential to the project and consistent with NIH policy.
18. What regulatory planning is implied for applicants?
The description indicates applicants should plan for regulatory strategy appropriate to their study type, including IRB determinations (NSR vs SR) and, where applicable, IDE planning for FDA oversight, along with clinical site readiness.
19. What does the cooperative agreement (U44) imply for project oversight?
Because it is a cooperative agreement, NIH program staff typically have substantial involvement during the project period compared with a standard grant. This generally means applicants should be prepared for active NIH engagement during execution of the project.
20. How many awards were anticipated?
The FOA anticipated making around five awards.
21. When was the FOA created and when did it close?
The FOA was created on September 28, 2016, with an original closing date of May 24, 2017.
22. Is the award ceiling listed in the provided information?
No. The specific award ceiling is not stated in the provided text.
23. What funding type is this opportunity categorized as?
The opportunity is categorized as discretionary funding.
24. What CFDA numbers are associated with this opportunity?
The opportunity lists multiple CFDA numbers associated with NIH neuroscience and related institute programs: 93.173, 93.213, 93.242, 93.273, 93.279, 93.286, 93.853, 93.865, 93.866, and 93.867.
25. How does the BRAIN Initiative context shape the purpose of this FOA?
The BRAIN Initiative context underscores a dual-purpose value: enabling better treatments for neurological or psychiatric disorders through improved neurotechnology, and enabling new capabilities for understanding human brain function through advanced recording and stimulation tools.
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