Opportunity Information: Apply for RFA NS 15 008
Apply for RFA NS 15 008
- The National Institutes of Health in the education health income security and social services sector is offering a public funding opportunity titled "BRAIN Initiative Clinical Studies to Advance Next Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (UH3)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.173 Research Related to Deafness and Communication Disorders 93.213 Research and Training in Complementary and Integrative Health 93.242 Mental Health Research Grants 93.273 Alcohol Research Programs 93.279 Drug Abuse and Addiction Research Programs 93.286 Discovery and Applied Research for Technological Innovations to Improve Human Health 93.853 Extramural Research Programs in the Neurosciences and Neurological Disorders 93.865 Child Health and Human Development Extramural Research 93.866 Aging Research 93.867 Vision Research.
- This funding opportunity was created on Feb 3, 2015 and posted on Feb 3, 2015.
- Applicants must submit their applications by Apr 14, 2015. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $3,000,000.00 to eligible and selected applicants.
- Each selected applicant is eligible to receive up to $1,500,000.00 in funding.
- Eligible applicants include: For profit organizations other than small businesses Small businesses Special district governments Others (see text field entitled Additional Information on Eligibility for clarification) Public and State controlled institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Independent school districts Native American tribal organizations (other than Federally recognized tribal governments) State governments Public housing authorities/Indian housing authorities Native American tribal governments (Federally recognized) Private institutions of higher education County governments City or township governments Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Institutions) are not eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal:
Opportunity Summary:
This funding opportunity (RFA-NS-15-008) is an NIH BRAIN Initiative call that supports small, well-justified clinical studies aimed at moving next generation invasive neurotechnology closer to real-world use in people. The core goal is to generate the critical human data needed to advance devices that can record from and/or stimulate the human central nervous system, either to treat neurological or psychiatric disorders or to improve scientific understanding of how the human brain works. The emphasis is not on large efficacy trials, but on focused clinical investigations that answer high-impact questions about how a device performs in humans and what design changes are required before it can responsibly progress to larger clinical trials and, eventually, potential regulatory clearance or approval.
The FOA is specifically oriented toward early clinical work where animal models and benchtop testing are no longer enough, typically because the device is novel or the intended use is uniquely human. Studies may include acute or short-term procedures that an Institutional Review Board determines to be Non-Significant Risk (NSR), as well as Significant Risk (SR) studies. For SR studies, the project may involve longer-term or chronic implants and would generally require an Investigational Device Exemption (IDE) from the FDA. In all cases, the clinical study is expected to provide information that cannot be practically obtained through additional nonclinical testing. In other words, applicants need to make a clear case that human use is necessary to resolve key uncertainties, and that the proposed study is designed to answer those uncertainties directly.
A central feature of the program is that the clinical study must be tightly connected to device advancement. The work should produce data that informs device function, safety considerations, usability in a clinical environment, signal quality or stimulation performance, reliability over time, or other engineering and translational questions that determine the final design. The FOA points toward the idea of a "final device design" that, after incorporating findings from the study, may be ready for much of the remaining nonclinical testing expected on the pathway to more advanced trials and eventual market pathways. Practically, that means reviewers will be looking for a development plan where the clinical study is not an isolated experiment, but a decisive step that de-risks the technology and clarifies what the next version of the device should be.
The funding mechanism is a cooperative agreement (UH3), which usually signals that NIH will have substantial programmatic involvement during the project. These mechanisms are commonly used when the agency expects active coordination, milestone tracking, and frequent communication to keep complex translational projects on course. The opportunity is categorized as discretionary funding, with NIH as the sponsoring agency, and it spans multiple relevant CFDA program areas across neuroscience, mental health, addiction, aging, vision, child health, and technology innovation, reflecting how broadly invasive neural recording and modulation tools can apply across CNS conditions and research needs.
From a practical funding standpoint, the FOA listed an estimated total funding amount of $3,000,000 and an award ceiling of $1,500,000, with no cost sharing or matching requirement. The opportunity was posted February 3, 2015, with an original and current closing date of April 14, 2015, and an archive date of May 15, 2015, indicating this specific announcement is no longer accepting applications, but it remains a useful reference point for understanding NIH expectations for early feasibility clinical studies of invasive neural devices.
Eligibility is broad across many U.S.-based organization types, including public and private institutions of higher education, nonprofits (including those with and without 501(c)(3) status), for-profit organizations (including small businesses), and various state, local, tribal, and regional government entities, as well as independent school districts and certain housing authorities. The FOA explicitly includes eligibility for a wide range of institution types such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, and AANAPISIs, along with faith-based and community-based organizations and eligible federal agencies. At the same time, it clearly excludes non-U.S. entities: foreign institutions cannot apply, non-U.S. components of U.S. organizations are not eligible, and foreign components (as defined by NIH policy) are not allowed.
Overall, the opportunity is best understood as NIH support for the "last mile" of early human testing needed to refine invasive brain recording or stimulation devices into a credible, test-ready design. It prioritizes studies that are small but decisive, designed to answer concrete design and functional questions in humans, and structured in a way that supports a realistic pathway toward the next stage of clinical development and eventual broader deployment.
FAQs: NIH BRAIN Initiative RFA-NS-15-008 (Invasive Neurotechnology Early Clinical Studies, UH3)
What is RFA-NS-15-008?
RFA-NS-15-008 is an NIH BRAIN Initiative funding opportunity focused on supporting small, well-justified clinical studies in humans that help move next-generation invasive neurotechnology closer to real-world use.
What is the main goal of this funding opportunity?
The core goal is to generate critical human data needed to advance devices that can record from and/or stimulate the human central nervous system. The intent is to accelerate device translation by answering key questions about how the device performs in people and what design changes are needed before progressing to larger trials and eventual regulatory pathways.
What kinds of devices are in scope?
Devices in scope are invasive neurotechnologies designed to record neural activity and/or deliver stimulation in the human central nervous system. The FOA emphasizes next-generation tools intended to treat neurological or psychiatric disorders or to improve scientific understanding of how the human brain works.
Is this meant to fund large clinical efficacy trials?
No. The emphasis is not on large efficacy trials. The FOA prioritizes focused clinical investigations that answer high-impact questions about device performance in humans and inform concrete device design decisions.
What stage of development is this program aimed at?
This program targets early clinical work where animal models and benchtop testing are no longer enough, typically because the device is novel or because the intended use is uniquely human. The proposed human study is expected to produce information that cannot be practically obtained through additional nonclinical testing.
What makes a proposed clinical study a good fit for this FOA?
A strong fit is a small but decisive human study that directly resolves key uncertainties about the device, such as how it functions in humans, what safety considerations emerge in human use, whether signal quality or stimulation performance meets expectations, how usable it is in a clinical environment, and what engineering changes are required before moving forward.
What types of human studies are allowed (NSR vs SR)?
The FOA allows studies that an Institutional Review Board (IRB) determines to be Non-Significant Risk (NSR), including acute or short-term procedures. It also allows Significant Risk (SR) studies, which may involve longer-term or chronic implants.
When would an Investigational Device Exemption (IDE) be relevant?
For Significant Risk (SR) studies, the project would generally require an Investigational Device Exemption (IDE) from the FDA. This FOA explicitly anticipates SR studies where an IDE would typically be part of the pathway.
Does NIH expect applicants to justify why human testing is necessary?
Yes. Applicants are expected to make a clear case that human use is necessary to resolve key uncertainties and that the proposed study is designed to answer those uncertainties directly, in ways that cannot be practically achieved through additional nonclinical work.
How should the clinical study connect to device development?
The clinical study is expected to be tightly connected to device advancement rather than being an isolated experiment. The study should generate data that informs device function, safety, usability, performance, reliability over time, and other engineering or translational questions that drive the next device iteration.
What does the FOA mean by a "final device design"?
The FOA points toward the concept that, after incorporating findings from the clinical study, the device may reach a design state that is ready for much of the remaining nonclinical testing typically expected before more advanced trials and potential market pathways. In practice, reviewers are looking for a development plan where the study clarifies what the next version of the device should be.
What is the funding mechanism and why does it matter?
The mechanism is a cooperative agreement (UH3). Cooperative agreements generally indicate substantial NIH programmatic involvement, such as active coordination, milestone tracking, and frequent communication to keep complex translational projects aligned with program goals.
How much funding was available under this announcement?
The FOA listed an estimated total funding amount of $3,000,000, with an award ceiling of $1,500,000.
Is cost sharing or matching required?
No. The opportunity states there is no cost sharing or matching requirement.
What is the sponsoring agency and program context?
The sponsoring agency is NIH, and the opportunity is part of the NIH BRAIN Initiative. It spans multiple neuroscience- and health-related program areas, reflecting the broad applicability of invasive neural recording and modulation tools across CNS conditions and research needs.
What types of organizations were eligible to apply?
Eligibility was broad across many U.S.-based organization types, including public and private institutions of higher education, nonprofits (including those with and without 501(c)(3) status), for-profit organizations (including small businesses), and various state, local, tribal, and regional government entities. The FOA also explicitly includes many institution categories such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian serving institutions, and AANAPISIs, as well as faith-based and community-based organizations and eligible federal agencies.
Are foreign institutions or non-U.S. components eligible?
No. The FOA explicitly excludes non-U.S. entities: foreign institutions cannot apply, non-U.S. components of U.S. organizations are not eligible, and foreign components (as defined by NIH policy) are not allowed.
What were the key dates for this funding opportunity?
The opportunity was posted on February 3, 2015. The original and current closing date was April 14, 2015, and the archive date was May 15, 2015.
Is this FOA currently accepting applications?
No. Based on the provided dates and archive status, this specific announcement is no longer accepting applications, though it may still be useful as a reference for NIH expectations for early feasibility clinical studies of invasive neural devices.
What is the overall purpose or "best use" of this opportunity?
Overall, it is best understood as NIH support for the last stretch of early human testing needed to refine invasive brain recording or stimulation devices into a credible, test-ready design. It prioritizes small, high-impact studies that de-risk the technology and define what the next device version should be before moving toward larger clinical trials and potential regulatory clearance or approval.
Browse more opportunities from the same category: Education Health Income Security and Social Services
Next opportunity: Cooperative Agreements to Benefit Homeless Individuals for States (CABHI States)
Previous opportunity: Bureau of Democracy, Human Rights and Labor Request for Statements of Interest Iraq Programs
USGrants.org Applicant Portal:
Are you interested in learning about about how to apply for this government funding opportunity? You can create a free applicant account and receive instant access to our applicant portal that many business owners like you have benefited from.
Apply for RFA NS 15 008
[Watch] how do funding administrators access proposals?
Applicants also applied for:
Applicants who have applied for this opportunity (RFA NS 15 008) also looked into and applied for these:
| Funding Opportunity |
|---|
| Adolescent Brain Cognitive Development (ABCD) Study Research Project Sites (U01) Apply for RFA DA 15 015 Funding Number: RFA DA 15 015 Agency: National Institutes of Health Category: Education Health Income Security and Social Services Funding Amount: Case Dependent |
| Adolescent Brain Cognitive Development (ABCD) Study Coordinating Center (U24) Apply for RFA DA 15 014 Funding Number: RFA DA 15 014 Agency: National Institutes of Health Category: Education Health Income Security and Social Services Funding Amount: Case Dependent |
| Adolescent Brain Cognitive Development (ABCD) Study Data Analysis and Informatics Center (U24) Apply for RFA DA 15 016 Funding Number: RFA DA 15 016 Agency: National Institutes of Health Category: Education Health Income Security and Social Services Funding Amount: Case Dependent |
| Big Data to Knowledge (BD2K) Advancing Biomedical Science Using Crowdsourcing and Interactive Digital Media (UH2) Apply for RFA CA 15 006 Funding Number: RFA CA 15 006 Agency: National Institutes of Health Category: Education Health Income Security and Social Services Funding Amount: $200,000 |
| Advancing Translational and Clinical Probiotic/Prebiotic and Human Microbiome Research (R01) Apply for PA 15 127 Funding Number: PA 15 127 Agency: National Institutes of Health Category: Education Health Income Security and Social Services Funding Amount: Case Dependent |
| Jointly Sponsored Ruth L. Kirschstein National Research Service Award Institutional Predoctoral Training Program in the Neurosciences (T32) Apply for PAR 15 178 Funding Number: PAR 15 178 Agency: National Institutes of Health Category: Education Health Income Security and Social Services Funding Amount: Case Dependent |
| Limited Competition International epidemiology Databases to Evaluate AIDS (IeDEA) (U01) Apply for RFA AI 15 017 Funding Number: RFA AI 15 017 Agency: National Institutes of Health Category: Education Health Income Security and Social Services Funding Amount: Case Dependent |
| NIH PEPFAR Collaboration on Implementation Science for HIV Towards an AIDS free Generation (R01) Apply for RFA AI 15 020 Funding Number: RFA AI 15 020 Agency: National Institutes of Health Category: Education Health Income Security and Social Services Funding Amount: $500,000 |
| NIH PEPFAR Collaboration on Implementation Science for HIV Towards an AIDS free Generation (R21) Apply for RFA AI 15 021 Funding Number: RFA AI 15 021 Agency: National Institutes of Health Category: Education Health Income Security and Social Services Funding Amount: $200,000 |
| Developing the Therapeutic Potential of the Endocannabinoid System for Pain Treatment (R01) Apply for PA 15 188 Funding Number: PA 15 188 Agency: National Institutes of Health Category: Education Health Income Security and Social Services Funding Amount: Case Dependent |
| The Health of Sexual and Gender Minority (SGM) Populations (R21) Apply for PA 15 263 Funding Number: PA 15 263 Agency: National Institutes of Health Category: Education Health Income Security and Social Services Funding Amount: $200,000 |
| The Health of Sexual and Gender Minority (SGM) Populations (R03) Apply for PA 15 262 Funding Number: PA 15 262 Agency: National Institutes of Health Category: Education Health Income Security and Social Services Funding Amount: $50,000 |
| The Health of Sexual and Gender Minority (SGM) Populations (R15) Apply for PA 15 260 Funding Number: PA 15 260 Agency: National Institutes of Health Category: Education Health Income Security and Social Services Funding Amount: Case Dependent |
| The Health of Sexual and Gender Minority (SGM) Populations (R01) Apply for PA 15 261 Funding Number: PA 15 261 Agency: National Institutes of Health Category: Education Health Income Security and Social Services Funding Amount: Case Dependent |
| Pre application Opportunities for Collaborative Research at the NIH Clinical Center (X02) Apply for PAR 15 286 Funding Number: PAR 15 286 Agency: National Institutes of Health Category: Education Health Income Security and Social Services Funding Amount: Case Dependent |
| BRAIN Theories, Models and Methods for Analysis of Complex Data from the Brain (R01) Apply for RFA EB 15 006 Funding Number: RFA EB 15 006 Agency: National Institutes of Health Category: Education Health Income Security and Social Services Funding Amount: Case Dependent |
| End of Life and Palliative Needs of Adolescents and Young Adults (AYA) with Serious Illnesses (R01) Apply for PA 15 324 Funding Number: PA 15 324 Agency: National Institutes of Health Category: Education Health Income Security and Social Services Funding Amount: Case Dependent |
| End of Life and Palliative Needs of Adolescents and Young Adults (AYA) with Serious Illnesses (R21) Apply for PA 15 325 Funding Number: PA 15 325 Agency: National Institutes of Health Category: Education Health Income Security and Social Services Funding Amount: $200,000 |
| Administrative Supplements for Research on Sexual and Gender Minority (SGM) Populations (Admin Supp) Apply for PA 15 329 Funding Number: PA 15 329 Agency: National Institutes of Health Category: Education Health Income Security and Social Services Funding Amount: $100,000 |
| BRAIN Initiative Technology Sharing and Propagation (R03) Apply for RFA MH 16 725 Funding Number: RFA MH 16 725 Agency: National Institutes of Health Category: Education Health Income Security and Social Services Funding Amount: $100,000 |
Grant application guides and resources
It is always free to apply for government grants. However the process may be very complex depending on the funding opportunity you are applying for. Let us help you!
Apply for Grants
Premium leads for funding administrators, grant writers, and loan issuers
Thousands of people visit our website for their funding needs every day. When a user creates a grant proposal and files for submission, we pass the information on to funding administrators, grant writers, and government loan issuers.
If you manage government grant programs, provide grant writing services, or issue personal or government loans, we can help you reach your audience.
Subscribe to Leads
Request more information:
Would you like to learn more about this funding opportunity, similar opportunities to "RFA NS 15 008", eligibility, application service, and/or application tips? Submit an inquiry below:
Don't forget to subscribe to our grant alerts mailing list to receive weekly alerts on new and updated grant funding opportunities like this one in your email.