BRAIN Initiative: Clinical Studies to Advance Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (UH3) | RFA NS 17 006

Frequently Asked Questions (FAQs)

What is this funding opportunity?

This is an NIH BRAIN Initiative funding opportunity (RFA-NS-17-006) that supports small, focused clinical studies intended to advance next-generation invasive devices that can record from and/or stimulate the human central nervous system.

What is the main goal of the program?

The main goal is to generate critical human data needed to answer key questions about device performance and to inform the final device design. The intent is to help the technology progress toward larger clinical trials and, ultimately, regulatory clearance or approval.

What kinds of devices are in scope?

The opportunity focuses on invasive devices designed to record from and/or stimulate the human central nervous system, with an emphasis on next-generation neurotechnology under the NIH BRAIN Initiative.

What type of clinical studies does the FOA support?

The FOA supports early-stage, tightly scoped clinical work similar in spirit to an Early Feasibility Study, designed to answer specific, decision-driving questions about the device in humans.

Is this meant to be a large clinical trial or an efficacy study?

No. The clinical study is not intended to be a broad efficacy trial. It is intended to produce targeted evidence about device function, safety, usability, performance, or design features that directly informs next development steps.

Why does the FOA emphasize human data instead of more bench or animal testing?

The FOA is aimed at situations where additional bench testing or animal work cannot realistically provide the needed answers because the device is novel, the intended use is new, or the most important uncertainties only appear in humans.

What kinds of endpoints or questions should the study be built around?

The study is expected to be structured around specific, decision-driving questions tied to device function, safety, usability, performance, and/or design features, with concrete endpoints that inform whether the device works as intended in humans and what needs to change before moving forward.

Can studies include acute or short-term procedures?

Yes. The FOA envisions early-stage clinical work that may include acute or short-term procedures, including those an Institutional Review Board (IRB) determines are Non-Significant Risk (NSR).

Can studies include chronic implants?

Yes. Significant Risk (SR) studies are also contemplated, including studies with chronic implants, when appropriate.

How does IRB risk determination relate to this FOA?

The FOA acknowledges that some projects may be Non-Significant Risk (NSR) as determined by an IRB, while others may be Significant Risk (SR). In either case, the clinical study should be focused and structured around specific device-related questions.

When is an FDA Investigational Device Exemption (IDE) relevant?

An IDE is relevant for Significant Risk (SR) studies that require FDA authorization to conduct the investigation, including certain studies with chronic implants.

Does the FOA require a particular risk category (NSR vs SR)?

No. The FOA allows for both NSR and SR studies, with the expectation that the work remains early-stage, tightly scoped, and designed to answer targeted questions that inform device development decisions.

What does the FOA mean by "device translation"?

The FOA emphasizes moving the technology forward along a practical development pathway. It highlights that the final device design emerging from this stage may still require extensive non-clinical testing for advanced trials and eventual market authorization, and that the supported clinical study should fill human-specific unknowns that cannot be addressed non-clinically.

How should applicants justify the need for a human study?

Applicants are expected to justify why the information being sought cannot be obtained practically through additional non-clinical assessments, and why a small human clinical study is the right next step for de-risking the technology and making key design decisions.

What funding mechanism is used for this opportunity?

The funding mechanism is a cooperative agreement (UH3).

What does a cooperative agreement (UH3) imply about NIH involvement?

A UH3 cooperative agreement typically means NIH staff will have substantial involvement during the project period compared with a standard grant.

Does the provided summary include award size or the number of awards?

No. The summary text provided does not list award sizes or the number of awards, but it frames the scope around a small clinical study with concrete endpoints tied to device design and function.

Which organizations are eligible to apply?

Eligibility is broad across U.S.-based organizations and government entities, including state, county, and city/township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized tribal governments; tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses.

Are there additional eligible applicant categories called out?

Yes. The FOA highlights additional eligible categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions.

Can non-U.S. organizations apply directly?

No. Non-domestic (non-U.S.) entities and non-U.S. institutions are not eligible to apply.

Can a U.S. organization apply if it has a non-U.S. component doing part of the work?

Non-domestic components of U.S. organizations are not eligible to apply. However, foreign components (as defined in the NIH Grants Policy Statement) are allowed, meaning a U.S. applicant may include certain foreign collaborations or elements if they meet NIH definitions and requirements.

What CFDA numbers are associated with this opportunity?

The opportunity is associated with multiple CFDA numbers: 93.173, 93.213, 93.242, 93.273, 93.279, 93.286, 93.853, 93.865, 93.866, and 93.867.

What does the presence of multiple CFDA numbers suggest?

It reflects the multi-institute nature of BRAIN-related and neuroscience device work within NIH.

What key dates are provided?

The source information includes a creation date of 2016-09-28 and an original closing date of 2017-10-18.

How is this opportunity categorized?

The opportunity is categorized as discretionary funding.

What activity areas are listed for this opportunity?

The activity area is listed under education, health, income security, and social services, consistent with NIH biomedical research and clinical translation priorities.