Opportunity Information: Apply for RFA NS 16 018
Apply for RFA NS 16 018
- The HHS-NIH11 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): 93.213, 93.273, 93.279, 93.286, 93.853, 93.865, 93.866,.
- This funding opportunity was created on Dec 18, 2015 and posted on Dec 18, 2015.
- Applicants must submit their applications by Apr 26, 2016. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $1,500,000.00 in funding.
- The number of recipients for this funding is limited to 5 candidate(s).
- Eligible applicants include: Small businesses.
[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal:
Opportunity Summary:
The BRAIN Initiative SBIR Direct to Phase II opportunity, titled "Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (U44)," is a National Institutes of Health (NIH) funding program designed to help small businesses move promising invasive neurotechnology into an initial, tightly focused human clinical study. The goal is to generate the kind of practical, decision-making evidence that is hard or impossible to get from additional bench testing or animal work, especially when a device is novel or its intended use pushes beyond what non-clinical studies can realistically predict. In plain terms, the program is meant to bridge the gap between advanced prototype development and the information needed to lock down a final device design that can later support more extensive clinical trials and, eventually, regulatory clearance or approval.
This FOA specifically targets devices that can record from and/or modulate the human central nervous system. That includes invasive technologies intended to interface with the brain or spinal cord to better understand brain function and to develop or improve treatments for central nervous system disorders. The emphasis is not on large pivotal trials; instead, it is on a small clinical study that answers key questions about how the device performs in humans and what design changes may be required before moving forward. The expected study type aligns with early feasibility work, where the main deliverable is actionable knowledge: for example, whether the recording signal quality is sufficient in the intended environment, whether stimulation parameters achieve the intended physiological effect, whether the implant approach is workable, or whether the device design needs specific refinements to improve safety, usability, or performance.
The clinical studies supported can fall into different regulatory risk categories. On the lower-risk end, the FOA allows acute or short-term procedures that an Institutional Review Board (IRB) deems Non-Significant Risk (NSR). On the higher-risk end, it also supports Significant Risk (SR) studies, including chronic implants, which typically require an Investigational Device Exemption (IDE) from the U.S. Food and Drug Administration (FDA). That means the program is structured to accommodate both short-duration human evaluations and more complex implant scenarios, so long as the study remains limited in scope and clearly justified as the most direct way to resolve specific, high-value design or function questions.
A central expectation is that the results of the proposed study will directly inform the final configuration of the device. The FOA frames this as generating data that guides function and final design decisions, and it notes that the final device design may already require most, if not all, of the non-clinical testing typically needed on the path toward later-stage clinical research and eventual market authorization. In other words, applicants are expected to be far enough along that a small human study is the logical next step, and that the study will meaningfully de-risk the program by confirming performance and usability in real clinical conditions or by clarifying what design changes are necessary before scaling up.
From an administrative and funding standpoint, this is an SBIR cooperative agreement (U44) offered by HHS/NIH, limited to eligible small business concerns. Being a cooperative agreement generally signals that NIH expects substantial programmatic involvement during the project compared to a standard grant, which often translates into closer coordination, milestone-based oversight, and more structured progress expectations. The opportunity number is RFA-NS-16-018. The award ceiling listed is $1,500,000, with an anticipated number of about five awards. The FOA was posted on December 18, 2015, created the same day, and had an application closing date of April 26, 2016 (as originally and currently stated in the source). The Catalog of Federal Domestic Assistance (CFDA) numbers associated with the announcement include 93.213, 93.273, 93.279, 93.286, 93.853, 93.865, and 93.866, reflecting the NIH program areas that can support BRAIN-related neurotechnology work.
Overall, the opportunity is best understood as targeted "direct-to-human" support for small businesses developing invasive neural recording and stimulation technologies, where the next major bottleneck is not another lab experiment but a carefully designed early clinical study. The core purpose is to help companies generate definitive human data that will either validate the device approach or drive necessary design changes, setting up the device for more advanced clinical testing and a credible regulatory path forward.
Frequently Asked Questions (FAQs)
What is the BRAIN Initiative SBIR Direct to Phase II opportunity (U44)?
It is an NIH funding opportunity under the BRAIN Initiative that uses an SBIR cooperative agreement mechanism (U44) to help eligible small businesses move a promising invasive neurotechnology into an initial, tightly focused human clinical study. The intent is to generate practical, decision-making evidence in humans that is difficult or impossible to obtain through additional bench testing or animal studies.
What is the official title of this funding opportunity?
The title is "Next-Generation Invasive Devices for Recording and Modulation in the Human Central Nervous System (U44)."
What is the opportunity number (FOA number)?
The opportunity number is RFA-NS-16-018.
Who is this program intended to support?
This program is intended for eligible small business concerns, since it is an SBIR funding opportunity. The goal is to help small businesses that are far enough along in development that a small human clinical study is the most direct next step.
What kinds of devices does the FOA target?
The FOA specifically targets invasive devices that can record from and/or modulate the human central nervous system, including technologies intended to interface with the brain or spinal cord.
What does "recording and/or modulation" mean in this context?
"Recording" refers to capturing signals from the human central nervous system (for example, neural activity), and "modulation" refers to influencing neural activity (for example, through stimulation) to achieve an intended physiological effect or therapeutic outcome.
What is the main goal of the funded clinical study?
The main goal is to obtain actionable human data that directly informs final device configuration decisions. The study should answer key questions about how the device performs in humans and what design changes may be required before moving forward to more extensive clinical trials and, eventually, regulatory clearance or approval.
Is this funding meant for large or pivotal clinical trials?
No. The emphasis is not on large pivotal trials. It supports a small clinical study aligned with early feasibility work, focused on resolving specific high-value questions about performance, usability, feasibility of the implant approach, stimulation parameters, recording quality, and/or safety-related design refinements.
Why does this FOA emphasize human clinical evidence instead of more animal or bench testing?
The FOA is designed for situations where additional bench testing or animal work cannot realistically predict performance in humans, particularly when a device is novel or its intended use pushes beyond what non-clinical studies can predict. The program is meant to bridge the gap between advanced prototype development and the information needed to lock down a final device design.
What types of human studies are allowed under this FOA?
The FOA supports early, limited-scope human clinical studies that can range from acute or short-term procedures to more complex chronic implant scenarios, as long as the study is tightly focused and justified as the most direct way to resolve key design or function questions.
Does the FOA support both Non-Significant Risk (NSR) and Significant Risk (SR) studies?
Yes. On the lower-risk end, it allows acute or short-term procedures that an Institutional Review Board (IRB) deems Non-Significant Risk (NSR). On the higher-risk end, it also supports Significant Risk (SR) studies, including chronic implants.
What is the role of the IRB in the study types mentioned?
The IRB determines whether certain acute or short-term procedures qualify as Non-Significant Risk (NSR). The FOA explicitly notes IRB involvement in determining NSR status for those lower-risk studies.
When might an Investigational Device Exemption (IDE) be required?
The FOA indicates that Significant Risk (SR) studies, including chronic implants, typically require an IDE from the U.S. Food and Drug Administration (FDA).
What kinds of outcomes or questions should the early feasibility study address?
The FOA highlights outcomes that produce actionable knowledge, such as whether recording signal quality is sufficient in the intended environment, whether stimulation parameters achieve the intended physiological effect, whether the implant approach is workable, and whether specific refinements are needed to improve safety, usability, or performance.
How should the study results be used according to the FOA?
The FOA expects that study results will directly guide function and final design decisions. In practical terms, the human data should either validate the device approach in real clinical conditions or clearly indicate what design changes are necessary before scaling up.
How mature should a device be before applying?
Applicants are expected to be far enough along that a small human clinical study is the logical next step. The FOA notes that the final device design may already require most, if not all, of the non-clinical testing typically needed on the path toward later-stage clinical research and eventual market authorization.
What does it mean that this award uses a cooperative agreement mechanism (U44)?
A cooperative agreement generally indicates that NIH expects substantial programmatic involvement during the project compared to a standard grant. The description suggests closer coordination, milestone-based oversight, and more structured progress expectations during the project period.
Which federal agency is offering this opportunity?
This opportunity is offered by the U.S. Department of Health and Human Services (HHS) through the National Institutes of Health (NIH).
What is the maximum award amount (award ceiling) listed?
The listed award ceiling is $1,500,000.
How many awards were anticipated?
The announcement indicates an anticipated number of about five awards.
When was the FOA posted and created?
It was posted on December 18, 2015, and created on December 18, 2015.
What was the application closing date stated in the source?
The stated application closing date is April 26, 2016.
Which CFDA numbers are associated with this announcement?
The CFDA numbers listed are 93.213, 93.273, 93.279, 93.286, 93.853, 93.865, 93.866, reflecting NIH program areas that can support BRAIN-related neurotechnology work.
What is the program trying to "bridge" for small businesses?
It is intended to bridge the gap between advanced prototype development and the specific human evidence needed to finalize device design and support later-stage clinical trials and a credible regulatory path.
Is the focus limited to the brain, or does it include the spinal cord?
It includes the human central nervous system and explicitly mentions devices intended to interface with the brain or spinal cord.
What is the overall purpose of this opportunity in plain terms?
It provides targeted direct-to-human support so that small businesses developing invasive neural recording and stimulation technologies can run a carefully designed early clinical study and generate definitive human data that validates the approach or drives necessary design changes.
Browse more opportunities from the same category: Education, Health, Income Security and Social Services
Next opportunity: MCH Research Network on Promoting Healthy Weight among Children with Autism Spectrum Disorder and other Developmental Disabilities
Previous opportunity: 2016-2020 YRBWEP Technical Support
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 16 018
[Watch] how do funding administrators access proposals?
Applicants also applied for:
Applicants who have applied for this opportunity (RFA NS 16 018) also looked into and applied for these:
| Funding Opportunity |
|---|
| Education and Health: New Frontiers (R01) Apply for PAR 16 080 Funding Number: PAR 16 080 Agency: HHS-NIH11 Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Education and Health: New Frontiers (R03) Apply for PAR 16 079 Funding Number: PAR 16 079 Agency: HHS-NIH11 Category: Education, Health, Income Security and Social Services Funding Amount: $50,000 |
| Education and Health: New Frontiers (R21) Apply for PAR 16 078 Funding Number: PAR 16 078 Agency: HHS-NIH11 Category: Education, Health, Income Security and Social Services Funding Amount: $200,000 |
| Basic Biopsychosocial Mechanisms and Processes in the Management of Chronic Conditions (R21) Apply for PAR 16 095 Funding Number: PAR 16 095 Agency: HHS-NIH11 Category: Education, Health, Income Security and Social Services Funding Amount: $200,000 |
| Obesity Policy Evaluation Research (R01) Apply for PA 16 165 Funding Number: PA 16 165 Agency: HHS-NIH11 Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| Administrative Supplements for Research on Sleep Disturbances and Impact on Chronic Pain (Admin Supp) Apply for PA 16 164 Funding Number: PA 16 164 Agency: HHS-NIH11 Category: Education, Health, Income Security and Social Services Funding Amount: $100,000 |
| Mentored Research Scientist Development Award (Parent K01) Apply for PA 16 190 Funding Number: PA 16 190 Agency: HHS-NIH11 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 16 040 Funding Number: RFA AI 16 040 Agency: HHS-NIH11 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 16 039 Funding Number: RFA AI 16 039 Agency: HHS-NIH11 Category: Education, Health, Income Security and Social Services Funding Amount: $200,000 |
| Building Interdisciplinary Research Careers in Women's Health (K12) Apply for RFA OD 16 013 Funding Number: RFA OD 16 013 Agency: Department of Health and Human Services, National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: $500,000 |
| BRAIN Initiative: Foundations of Non-Invasive Functional Human Brain Imaging and Recording - Bridging Scales and Modalities (R01) Apply for RFA MH 17 235 Funding Number: RFA MH 17 235 Agency: Department of Health and Human Services, National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: $700,000 |
| BRAIN Initiative: New Concepts and Early-Stage Research for Large-Scale Recording and Modulation in the Nervous System (R21) Apply for RFA EY 17 001 Funding Number: RFA EY 17 001 Agency: Department of Health and Human Services, National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: $200,000 |
| BRAIN Initiative: Exploratory Targeted BRAIN Circuits Projects - eTargetedBCP (R21) Apply for RFA NS 17 015 Funding Number: RFA NS 17 015 Agency: Department of Health and Human Services, 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 17 098 Funding Number: PA 17 098 Agency: Department of Health and Human Services, National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: $100,000 |
| BRAIN Initiative: Exploratory Team-Research BRAIN Circuit Programs - eTeamBCP (U01) Apply for RFA NS 18 008 Funding Number: RFA NS 18 008 Agency: Department of Health and Human Services, National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| BRAIN Initiative: Exploratory Research Opportunities Using Invasive Neural Recording and Stimulating Technologies in the Human Brain (U01) Apply for RFA NS 18 010 Funding Number: RFA NS 18 010 Agency: Department of Health and Human Services, National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| BRAIN Initiative: Exploratory Team-Research BRAIN Circuit Programs - eTeamBCP (U01 Clinical Trial Not Allowed) Apply for RFA NS 18 029 Funding Number: RFA NS 18 029 Agency: Department of Health and Human Services, 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 Clinical Trial Required) Apply for RFA NS 19 002 Funding Number: RFA NS 19 002 Agency: Department of Health and Human Services, 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 Clinical Trial Not Allowed) Apply for RFA NS 19 003 Funding Number: RFA NS 19 003 Agency: Department of Health and Human Services, National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: Case Dependent |
| HEAL Initiative: Back Pain Consortium (BACPAC) Research Program: Phase 2 Clinical Trials (UG3/UH3 Clinical Trial Required) Apply for RFA AR 19 029 Funding Number: RFA AR 19 029 Agency: Department of Health and Human Services, National Institutes of Health Category: Education, Health, Income Security and Social Services Funding Amount: $200,000 |
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 16 018", 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.