Opportunity Information: Apply for RFA NS 17 007
The BRAIN Initiative: Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (U44) funding opportunity (RFA-NS-17-007) is an NIH cooperative agreement aimed at helping small business concerns move invasive neural recording and/or stimulation technologies from late-stage development into early human testing. The core goal is translational: generating the practical safety, performance, and regulatory evidence needed to advance novel implanted or otherwise invasive devices intended to treat disorders of the nervous system, while also enabling better measurement and understanding of human brain function. Unlike basic research programs, this FOA is structured to push device projects across the difficult boundary between preclinical development and a first small clinical study, especially when the device is too new or its intended use is too novel for bench testing or animal work to fully answer the key questions.
The award uses a U44 cooperative agreement mechanism, which typically means NIH staff are expected to be actively involved in the project through substantial programmatic oversight and collaboration compared with a standard grant. The supported work spans two tightly connected stages: (1) translational non-clinical studies needed to prepare for human use, and (2) execution of a single small clinical study, often described as an Early Feasibility Study. On the non-clinical side, the program is designed to cover the kinds of activities that directly support a regulatory submission pathway, specifically the work required either to submit an Investigational Device Exemption (IDE) to FDA for a Significant Risk (SR) clinical study or to obtain Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study. In practical terms, this is the package of verification, validation, and safety evidence that demonstrates the device can reasonably be tested in humans under appropriate controls.
The FOA emphasizes concrete development tasks that are typical bottlenecks for invasive neural devices. Supported activities include building and implementing a clinical prototype (meaning a device version appropriate for human use rather than a purely lab prototype), conducting non-clinical safety and efficacy testing, and performing design verification and validation work. It also supports the regulatory and operational steps needed to actually start and run the clinical study, not just plan it. The intention is that by the time the project reaches the clinical stage, the device design is sufficiently mature that the study can answer decisive questions about function, usability, and final design decisions, rather than serving as an exploratory experiment with an unfinished technology.
A key requirement is that the clinical component is limited to one small clinical study, and that this study must be justified as necessary because the information sought cannot be practically obtained through additional non-clinical testing such as benchtop experiments or animal models. In other words, the program is explicitly meant for situations where human data are essential to resolve critical uncertainties, such as how the device performs in the human central nervous system environment, how reliably it records or modulates neural activity in real clinical contexts, how implantation or interfacing approaches behave in practice, or how design choices affect safety, performance, and workflow. The expected outcome is data that directly informs the device's final design and de-risks the path toward larger clinical trials and eventual market authorization.
Eligibility is restricted to small business concerns, aligning with NIH small business programs and the goal of accelerating commercialization-ready neurotechnology. Non-domestic (non-U.S.) entities are not eligible to apply, and non-domestic components of U.S. organizations are also not eligible. However, foreign components may be allowed in limited circumstances as defined by the NIH Grants Policy Statement, which generally refers to discrete parts of the project performed outside the U.S. when they are clearly justified and permissible under NIH policy.
From the provided opportunity details, the sponsoring agency is the National Institutes of Health, the instrument type is a cooperative agreement, and the activity category falls under education, health, income security, and social services. The opportunity listed an expected number of awards of five, with an original closing date of October 18, 2017, and a creation date of September 28, 2016. Multiple CFDA numbers are associated with the program (including 93.173, 93.213, 93.242, 93.273, 93.279, 93.286, 93.853, 93.865, 93.866, and 93.867), reflecting the multi-institute nature of BRAIN-related funding and NIH’s cross-cutting support for neuroscience and neurotechnology development.
Overall, this FOA is best understood as a targeted translational bridge for small businesses developing next-generation invasive CNS devices: it funds the final preclinical steps required for IDE/IRB readiness, then supports one tightly focused early clinical study designed to answer essential device design and function questions that only human testing can address, setting the project up for subsequent larger trials and the longer regulatory pathway to broader clinical use.Apply for RFA NS 17 007
- The National Institutes of Health in the education, health, income security and social services sector is offering a public funding opportunity titled "BRAIN Initiative: 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 2017-10-18. (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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Frequently Asked Questions (FAQs)
1) What is this funding opportunity?
This opportunity is the NIH BRAIN Initiative funding announcement titled "Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (U44)" (RFA-NS-17-007). It is designed to help small business concerns move invasive neural recording and/or stimulation technologies from late-stage development into early human testing.
2) What is the main goal of the program?
The core goal is translational: to generate practical safety, performance, and regulatory evidence needed to advance novel implanted or otherwise invasive devices intended to treat disorders of the nervous system, while also enabling better measurement and understanding of human brain function.
3) How is this different from a basic research grant?
This FOA is structured to push device projects across the boundary between preclinical development and a first small clinical study. It focuses on concrete development and regulatory-enabling work rather than exploratory or purely basic research, especially for devices that are too new or have intended uses too novel for benchtop or animal testing to fully address key questions.
4) What award mechanism is used?
The program uses a U44 cooperative agreement mechanism.
5) What does a "cooperative agreement" mean for how the project is run?
A U44 cooperative agreement typically means NIH staff are expected to be actively involved through substantial programmatic oversight and collaboration, compared with a standard grant where the recipient usually has more independent control.
6) Who is eligible to apply?
Eligibility is restricted to small business concerns, aligning with NIH small business programs and the program goal of accelerating commercialization-ready neurotechnology.
7) Are non-U.S. (non-domestic) applicants eligible?
No. Non-domestic (non-U.S.) entities are not eligible to apply.
8) Can a U.S. organization include non-U.S. components?
Non-domestic components of U.S. organizations are not eligible. However, foreign components may be allowed in limited circumstances, as defined by the NIH Grants Policy Statement, when a discrete part of the project is performed outside the U.S. and is clearly justified and permissible under NIH policy.
9) What kinds of technologies does this FOA support?
It supports invasive neural recording and/or stimulation (modulation) technologies intended for use in the human central nervous system, including implanted or otherwise invasive devices.
10) What stages of work does the FOA support?
The supported work spans two tightly connected stages:
- Translational non-clinical studies needed to prepare for human use
- Execution of a single small clinical study (often described as an Early Feasibility Study)
11) What is meant by "translational non-clinical studies" in this FOA?
These are non-clinical activities aimed at preparing the device for human testing by generating verification, validation, and safety evidence that supports a regulatory submission pathway and demonstrates the device can reasonably be tested in humans under appropriate controls.
12) What regulatory milestones is the non-clinical work intended to support?
The program is designed to cover the work required either:
- to submit an Investigational Device Exemption (IDE) to the FDA for a Significant Risk (SR) clinical study, or
- to obtain Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study.
13) What types of development activities are specifically emphasized?
The FOA emphasizes concrete development tasks that are typical bottlenecks for invasive neural devices, including:
- Building and implementing a clinical prototype (appropriate for human use, not only a lab prototype)
- Conducting non-clinical safety and efficacy testing
- Performing design verification and validation work
- Completing regulatory and operational steps needed to start and run the clinical study
14) What is a "clinical prototype" in the context of this FOA?
A clinical prototype is a device version appropriate for human use rather than a purely laboratory prototype. The FOA expects the design to be sufficiently mature for early human testing.
15) Does the FOA fund only planning for a clinical study?
No. It supports the regulatory and operational steps needed to actually start and run the clinical study, not just plan it.
16) How many clinical studies can be supported under this award?
The clinical component is limited to one small clinical study.
17) What type of clinical study is expected?
The FOA anticipates a single small clinical study, often described as an Early Feasibility Study.
18) Why does the FOA require only one small clinical study?
The program is intended to generate essential human data that cannot practically be obtained through additional non-clinical testing, while keeping the clinical scope tightly focused on de-risking key uncertainties and informing final device design decisions.
19) When is a human study considered justified under this FOA?
The human study must be justified as necessary because the information sought cannot be practically obtained through benchtop experiments or animal models.
20) What kinds of questions is the early clinical study expected to answer?
The study is expected to answer decisive questions about device function, usability, and final design decisions. Examples mentioned or implied by the FOA include:
- How the device performs in the human central nervous system environment
- How reliably it records or modulates neural activity in real clinical contexts
- How implantation or interfacing approaches behave in practice
- How design choices affect safety, performance, and clinical workflow
21) What outcomes is NIH looking for by the end of the project?
The expected outcome is data that directly informs the device's final design and de-risks the path toward larger clinical trials and eventual market authorization.
22) What is the intended maturity level of the device by the clinical stage?
By the time the project reaches the clinical stage, the device design is expected to be sufficiently mature so the study can resolve key questions about function, usability, and design choices, rather than serving as an exploratory experiment with an unfinished technology.
23) Which agency sponsors this opportunity?
The sponsoring agency is the National Institutes of Health (NIH).
24) What is the instrument type and activity category listed for the opportunity?
The instrument type is a cooperative agreement. The activity category is listed under education, health, income security, and social services.
25) How many awards were expected?
The opportunity listed an expected number of awards of five.
26) What were the key dates listed for this opportunity?
The creation date was September 28, 2016, and the original closing date was October 18, 2017.
27) What CFDA numbers are associated with this program?
Multiple CFDA numbers are associated with the program: 93.173, 93.213, 93.242, 93.273, 93.279, 93.286, 93.853, 93.865, 93.866, and 93.867. This reflects the multi-institute nature of BRAIN-related funding and NIH's cross-cutting support for neuroscience and neurotechnology development.
28) What is the FOA trying to bridge?
It is best understood as a targeted translational bridge: it funds the final preclinical steps required for IDE/IRB readiness, then supports one tightly focused early clinical study to obtain the human evidence needed to move toward larger trials and the longer regulatory pathway to broader clinical use.
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| Funding Opportunity |
|---|
| BRAIN Initiative: Clinical Studies to Advance Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (UH3) Apply for RFA NS 17 006 Funding Number: RFA NS 17 006 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| BRAIN Initiative: Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (UG3/UH3) Apply for RFA NS 17 005 Funding Number: RFA NS 17 005 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| BRAIN Initiative: SBIR Direct to Phase II Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (U44) Apply for RFA NS 17 008 Funding Number: RFA NS 17 008 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| BRAIN Initiative: Research Career Enhancement Award for Investigators to Build Skills in a Cross-Disciplinary Area (K18) Apply for RFA DA 17 022 Funding Number: RFA DA 17 022 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| BRAIN Initiative Cell Census Network (BICCN) - Specialized Center on Human and Non-Human Primate Brain Cell Atlases (U01) Apply for RFA MH 17 210 Funding Number: RFA MH 17 210 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| BRAIN Initiative Cell Census Network (BICCN) - Specialized Center on Mouse Brain Cell Atlas (U01) Apply for RFA MH 17 230 Funding Number: RFA MH 17 230 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| BRAIN Initiative Cell Census Network (BICCN) Brain Cell Data Center (U24) Apply for RFA MH 17 215 Funding Number: RFA MH 17 215 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| BRAIN Initiative Cell Census Network (BICCN) Comprehensive Center on Mouse Brain Cell Atlas (U19) Apply for RFA MH 17 225 Funding Number: RFA MH 17 225 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| BRAIN Initiative: Proof of Concept Development of Early Stage Next Generation Human Brain Imaging (R01) Apply for RFA EB 17 001 Funding Number: RFA EB 17 001 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: $300,000 |
| BRAIN Initiative: Research on the Ethical Implications of Advancements in Neurotechnology and Brain Science (R01) Apply for RFA MH 17 260 Funding Number: RFA MH 17 260 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: $300,000 |
| BRAIN Initiative: Development of Next Generation Human Brain Imaging Tools and Technologies (U01) Apply for RFA EB 17 002 Funding Number: RFA EB 17 002 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| BRAIN Initiative: Research Opportunities Using Invasive Neural Recording and Stimulating Technologies in the Human Brain (U01) Apply for RFA NS 17 019 Funding Number: RFA NS 17 019 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| BRAIN Initiative: Team-Research BRAIN Circuit Programs - TeamBCP (U19) Apply for RFA NS 17 018 Funding Number: RFA NS 17 018 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| BRAIN Initiative: Targeted BRAIN Circuits Projects - TargetedBCP (R01) Apply for RFA NS 17 014 Funding Number: RFA NS 17 014 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Revision Applications for U.S-South Africa Program for Collaborative Biomedical Research (R01) Apply for RFA AI 16 082 Funding Number: RFA AI 16 082 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Revision Applications for U.S.-South Africa Program for Collaborative Biomedical Research (U01) Apply for RFA AI 16 083 Funding Number: RFA AI 16 083 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| NIH-DoD-VA Pain Management Collaboratory - Pragmatic Clinical Trials Demonstration Projects (UG3/UH3) Apply for RFA AT 17 001 Funding Number: RFA AT 17 001 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Research To Address Sleep Disorders in the Context of Medical Rehabilitation (R01) Apply for PAR 17 163 Funding Number: PAR 17 163 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: $499,999 |
| Blueprint Neurotherapeutics Network (BPN): Small Molecule Drug Discovery and Development for Disorders of the Nervous System (UG3/UH3) Apply for PAR 17 205 Funding Number: PAR 17 205 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Blueprint Neurotherapeutics Network (BPN): Small Molecule Drug Discovery and Development for Disorders of the Nervous System (U44) Apply for PAR 17 201 Funding Number: PAR 17 201 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
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