Opportunity Information: Apply for RFA NS 18 021
This NIH BRAIN Initiative funding opportunity (RFA-NS-18-021) supports the development and early clinical testing of next-generation invasive devices that can record from and/or modulate activity in the human central nervous system. The goal is strongly translational: projects should advance devices that can both deepen scientific understanding of the human brain and move toward treating neurological or neuropsychiatric disorders. The FOA is built around taking a device from an advanced prototype stage through the key regulatory and clinical steps needed to demonstrate that it can function as intended in people, especially when critical questions cannot be answered well through additional benchtop work or animal studies because the device or use case is genuinely novel.
The mechanism is a UG3/UH3 cooperative agreement, meaning NIH is expected to have substantial involvement and the project is structured in phases. In the earlier phase, investigators are supported to do the work required to reach an appropriate regulatory and ethics “green light” for a first-in-human or similarly early clinical evaluation. That includes preparing and submitting an Investigational Device Exemption (IDE) application to FDA for a Significant Risk (SR) study, or alternatively obtaining Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study when an IDE is not required. Once those milestones are met, the later phase supports the execution of a single small clinical trial, often described as an Early Feasibility Study. The expectation is that this trial is not a large pivotal study; instead, it should generate targeted data that answers a small set of decisive questions about safety, usability, performance, and design choices that will shape the final device configuration.
The clinical trial component is central and required. NIH is looking for studies that will clarify the function or final design of the device and help position it for later-stage clinical trials and eventual market clearance or approval. In practical terms, the work may include implementing clinical prototype devices, completing non-clinical safety and efficacy testing that is still needed, and carrying out design verification and validation activities. The trial is expected to produce information that is difficult or impossible to obtain through nonclinical testing alone, such as human-specific performance characteristics, interface stability, stimulation/recording effects in the intended anatomical context, or workflow and surgical considerations that only become clear in clinical use.
A notable feature of this program is its connection to the BRAIN Initiative Public-Private Partnership Program (BRAIN PPP). Through memoranda of understanding with device manufacturers, the PPP is intended to make advanced devices available for clinical research, including capabilities that may not yet be market approved but are suitable for carefully controlled clinical investigation. The FOA suggests that, in many cases, existing safety and utility data from these partner devices may be sufficient to support new IRB NSR determinations or FDA IDE approval without requiring extensive additional nonclinical testing, which is meant to speed responsible translation into early human studies. Applicants are directed to the BRAIN PPP website for details on participating companies and available technologies.
Eligibility is broad and includes many U.S.-based organization types: state, local, and tribal governments; public and private institutions of higher education; nonprofits (with or without 501(c)(3) status); for-profit entities (including small businesses, but not limited to them); independent school districts; special district governments; and public housing authorities/Indian housing authorities. The FOA also explicitly highlights a wide range of institutional categories such as HBCUs, Hispanic-serving institutions, AANAPISI institutions, Alaska Native and Native Hawaiian-serving institutions, tribally controlled colleges and universities, faith-based or community-based organizations, and U.S. territories or possessions. Non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations are not eligible to apply, but foreign components are allowed as defined in the NIH Grants Policy Statement, meaning certain project activities may be conducted abroad under NIH rules even though the applicant organization must be domestic.
Administratively, the opportunity is run by the National Institutes of Health and uses the cooperative agreement funding instrument. It is listed under multiple CFDA numbers associated with NIH neuroscience and mental health programs (including 93.173, 93.213, 93.242, 93.273, 93.279, 93.286, 93.853, 93.865, 93.866, 93.867). The original posting dates to December 21, 2017, and the original closing date shown is February 22, 2021. Overall, the FOA is designed for teams that can integrate engineering, clinical neurology/neurosurgery, human subjects protections, and regulatory strategy to produce an actionable early clinical dataset that meaningfully de-risks a next-generation invasive neural interface or neuromodulation device.Apply for RFA NS 18 021
- 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 (UG3/UH3 - Clinical Trial Required)" 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 2017-12-21.
- Applicants must submit their applications by 2021-02-22. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.
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FAQs: NIH BRAIN Initiative UG3/UH3 Invasive Neural Device Development and Early Clinical Testing (RFA-NS-18-021)
What is this funding opportunity?
This NIH BRAIN Initiative funding opportunity (RFA-NS-18-021) supports the development and early clinical testing of next-generation invasive devices that can record from and/or modulate activity in the human central nervous system.
What kinds of devices does the FOA focus on?
The focus is on invasive neural interface or neuromodulation devices intended to record neural activity, modulate neural activity, or do both, in the human central nervous system.
What is the overall goal of the program?
The goal is strongly translational: to advance devices that both deepen scientific understanding of the human brain and move toward treating neurological or neuropsychiatric disorders.
Is this opportunity meant for basic research or translational work?
It is designed for translational work. Projects are expected to move an advanced prototype through key regulatory and clinical steps to demonstrate that it can function as intended in people, particularly when critical questions cannot be answered well through benchtop or animal studies due to genuine novelty in the device or use case.
What funding mechanism is used?
The mechanism is a UG3/UH3 cooperative agreement, meaning NIH is expected to have substantial involvement and the project is structured into phases.
What does "cooperative agreement" imply for how the project will run?
Because this is a cooperative agreement, NIH is expected to have substantial involvement. The award is organized in phases with milestone-driven progression from the initial stage to the clinical trial stage once key regulatory and ethics milestones are met.
How are the UG3 and UH3 phases different?
The earlier UG3 phase supports work needed to reach an appropriate regulatory and ethics "green light" for first-in-human or similarly early clinical evaluation. The later UH3 phase supports executing a single small clinical trial (often an Early Feasibility Study) after those milestones are achieved.
What is expected to happen during the UG3 phase?
The UG3 phase is intended to support preparation for early clinical testing, including completing the work required to obtain appropriate regulatory and ethics approval to proceed in people.
What regulatory milestone is expected for a Significant Risk (SR) study?
For a Significant Risk (SR) study, the UG3 phase includes preparing and submitting an Investigational Device Exemption (IDE) application to the FDA.
What regulatory/ethics milestone is expected when an IDE is not required?
When an IDE is not required, the UG3 phase includes obtaining Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study.
What happens once the IDE is approved or IRB NSR approval is obtained?
Once those milestones are met, the UH3 phase supports executing a single small clinical trial to generate targeted data about the device in people.
Is a clinical trial required under this FOA?
Yes. The clinical trial component is central and required.
What type of clinical trial is envisioned?
The FOA expects a single small clinical trial, often described as an Early Feasibility Study. It is not expected to be a large pivotal trial.
What is the purpose of the clinical trial in this program?
The trial is expected to answer a small set of decisive questions about safety, usability, performance, and design choices, and to clarify device function or final design to position the technology for later-stage clinical trials and eventual market clearance or approval.
What kinds of outcomes or data is the trial expected to produce?
The trial should generate targeted information that is difficult or impossible to obtain through nonclinical testing alone, such as human-specific performance characteristics, interface stability, stimulation/recording effects in the intended anatomical context, and workflow or surgical considerations that only become clear in clinical use.
Does the FOA allow or expect continued nonclinical testing?
Yes. The FOA notes that work may include completing non-clinical safety and efficacy testing that is still needed, along with design verification and validation activities, alongside implementing clinical prototype devices and conducting the early clinical trial.
What stage of device development is this opportunity aimed at?
It is aimed at taking a device from an advanced prototype stage into early clinical evaluation in people, particularly when additional benchtop or animal studies are not sufficient to answer key questions because the device or use case is novel.
How does this FOA relate to the BRAIN Initiative Public-Private Partnership Program (BRAIN PPP)?
A notable feature is its connection to the BRAIN PPP. Through memoranda of understanding with device manufacturers, the PPP is intended to make advanced devices available for clinical research, including capabilities that may not be market approved but are suitable for carefully controlled clinical investigation.
What is the potential benefit of using BRAIN PPP partner devices?
The FOA suggests that existing safety and utility data from partner devices may, in many cases, be sufficient to support new IRB NSR determinations or FDA IDE approval without requiring extensive additional nonclinical testing, which is intended to speed responsible translation into early human studies.
Where are applicants directed to learn about participating PPP companies and technologies?
Applicants are directed to the BRAIN PPP website for details on participating companies and available technologies.
Who is eligible to apply?
Eligibility is broad and includes U.S.-based organizations such as state, local, and tribal governments; public and private institutions of higher education; nonprofits (with or without 501(c)(3) status); for-profit entities (including small businesses, but not limited to them); independent school districts; special district governments; and public housing authorities/Indian housing authorities.
Does the FOA specifically encourage certain institution types?
Yes. It explicitly highlights a wide range of institutional categories, including HBCUs, Hispanic-serving institutions, AANAPISI institutions, Alaska Native and Native Hawaiian-serving institutions, tribally controlled colleges and universities, faith-based or community-based organizations, and U.S. territories or possessions.
Are non-U.S. (non-domestic) entities eligible to apply?
No. Non-domestic (non-U.S.) entities are not eligible to apply.
Are non-domestic components of U.S. organizations eligible?
No. Non-domestic components of U.S. organizations are not eligible to apply.
Are foreign components allowed at all?
Yes. Foreign components are allowed as defined in the NIH Grants Policy Statement, meaning certain project activities may be conducted abroad under NIH rules, even though the applicant organization must be domestic.
Which agency runs this opportunity?
The opportunity is run by the National Institutes of Health (NIH).
What is the official identifier for this FOA?
The FOA is identified as RFA-NS-18-021.
Which CFDA numbers are associated with this opportunity?
It is listed under multiple CFDA numbers, including 93.173, 93.213, 93.242, 93.273, 93.279, 93.286, 93.853, 93.865, 93.866, and 93.867.
What are the key posting and closing dates mentioned?
The original posting date is December 21, 2017, and the original closing date shown is February 22, 2021.
What kind of team or expertise is this FOA designed for?
It is designed for teams that can integrate engineering, clinical neurology/neurosurgery, human subjects protections, and regulatory strategy to produce an actionable early clinical dataset that meaningfully de-risks a next-generation invasive neural interface or neuromodulation device.
Does the program aim for market clearance or approval within this award?
The FOA frames the early clinical work as positioning the device for later-stage clinical trials and eventual market clearance or approval, rather than completing large pivotal trials within this award.
What is meant by "early clinical testing" in this context?
Early clinical testing here refers to first-in-human or similarly early evaluations, typically via a single small clinical trial designed to resolve targeted questions about how the device performs and can be used in people.
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| BRAIN Initiative: Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (U44 Clinical Trial Required) Apply for RFA NS 18 022 Funding Number: RFA NS 18 022 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| BRAIN Initiative: Clinical Studies to Advance Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (UH3 - Clinical Trial Required) Apply for RFA NS 18 023 Funding Number: RFA NS 18 023 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 of Disorders of the Nervous System (UG3/UH3) - Clinical Trial Optional Apply for PAR 18 546 Funding Number: PAR 18 546 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Innovation Research Grant Applications (Parent SBIR [R43/R44] Clinical Trial Required) Apply for PA 18 573 Funding Number: PA 18 573 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| PHS 2018-02 Omnibus Solicitation of the NIH, CDC, and FDA for Small Business Technology Transfer Grant Applications (Parent STTR [R41/R42] Clinical Trial Required) Apply for PA 18 576 Funding Number: PA 18 576 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| BRAIN Initiative: New Concepts and Early - Stage Research for Large - Scale Recording and Modulation in the Nervous System (R21) (Clinical Trial Not Allowed) Apply for RFA EY 18 001 Funding Number: RFA EY 18 001 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: $200,000 |
| BRAIN Initiative: New Technologies and Novel Approaches for Large-Scale Recording and Modulation in the Nervous System (R01 Clinical Trials Not Allowed) Apply for RFA NS 18 020 Funding Number: RFA NS 18 020 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| BRAIN Initiative: Optimization of Transformative Technologies for Large Scale Recording and Modulation in the Nervous System (U01-Clinical Trials Not Allowed) Apply for RFA NS 18 019 Funding Number: RFA NS 18 019 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Reducing Stigma to Improve HIV/AIDS Prevention, Treatment and Care in Low and Middle- Income Countries (R21 Clinical Trial Optional) Apply for PAR 18 732 Funding Number: PAR 18 732 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: $125,000 |
| Addressing the Challenges of the Opioid Epidemic in Minority Health and Health Disparities Research in the U.S. (R21 Clinical Trial Optional) Apply for PAR 18 745 Funding Number: PAR 18 745 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: $200,000 |
| Addressing the Challenges of the Opioid Epidemic in Minority Health and Health Disparities Research in the U.S. (R01 Clinical Trial Optional) Apply for PAR 18 747 Funding Number: PAR 18 747 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 Clinical Trial Not Allowed) Apply for RFA NS 18 030 Funding Number: RFA NS 18 030 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| BRAIN Initiative: Development and Validation of Novel Tools to Probe Cell-Specific and Circuit-Specific Processes in the Brain (R01 Clinical Trial Not Allowed) Apply for RFA MH 19 136 Funding Number: RFA MH 19 136 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| BRAIN Initiative Advanced Postdoctoral Career Transition Award to Promote Diversity (K99/R00 Independent Clinical Trial Not Allowed) Apply for PAR 18 814 Funding Number: PAR 18 814 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| BRAIN Initiative Advanced Postdoctoral Career Transition Award to Promote Diversity (K99/R00 Clinical Trial Required) Apply for PAR 18 813 Funding Number: PAR 18 813 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| The Role of Epitranscriptomics in Development and Disease (R01 - Clinical Trial Not Allowed) Apply for PAR 18 830 Funding Number: PAR 18 830 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: $499,999 |
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| BRAIN Initiative: Data Archives for the BRAIN Initiative (R24 Clinical Trial Optional) Apply for RFA MH 19 145 Funding Number: RFA MH 19 145 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| BRAIN Initiative: Integration and Analysis of BRAIN Initiative Data (R01 Clinical Trial Not Allowed) Apply for RFA MH 19 147 Funding Number: RFA MH 19 147 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| BRAIN Initiative: Development Optimization, and Validation of Novel Tools and Technologies for Neuroscience Research (SBIR) (R43/R44 - Clinical Trial Not Allowed) Apply for PA 18 871 Funding Number: PA 18 871 Agency: National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
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