Key Dates
None
National Institute of Neurological Disorders and Stroke (NINDS)
National Eye Institute (NEI)
National Institute on Aging (NIA)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute on Deafness and Other Communication Disorders (NIDCD)
National Institute on Drug Abuse (NIDA)
National Institute of Mental Health (NIMH)
National Center for Complementary and Integrative Health (NCCIH)
This Notice of Intent to Publish is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects for the following Notice of Funding Opportunity (NOFO), which is expected to be published in January 2024, with an anticipated application receipt date in May 2024.
The Brain Research through Advancing Innovative Neurotechnologies®(BRAIN) Initiative intends to promote a new initiative by publishing a NOFO to solicit applications that would support development and preclinical testing, beginning with proof of concept, of next-generation recording and/or modulation devices for human use to further our understanding of the human central nervous system and treat nervous system disorders.
This NOFO will utilize the R18 activity code. Details of the planned NOFO are provided below.
(Since 2014, the Brain Research through Advancing Innovative Neurotechnologies® (BRAIN) Initiative has aimed to accelerate the development and application of innovative neurotechnologies, enabling researchers to produce a new dynamic picture of the brain that reveals how individual cells and complex neural circuits interact in both time and space. It is expected that these advances will ultimately lead to new ways to treat and prevent brain disorders.
As one of several federal agencies involved in the BRAIN Initiative, NIH's contributions to the BRAIN initiative were initially guided by "BRAIN 2025: A Scientific Vision," a strategic plan that detailed seven high-priority research areas. This plan was updated and enhanced in 2019 by: "The BRAIN Initiative 2.0: From Cells to Circuits, Toward Cures" and "The BRAIN Initiative and Neuroethics: Enabling and Enhancing Neuroscience Advances for Society." This and other BRAIN Initiative Notices of Funding Opportunity (NOFOs) are based on this vision and issued with input from Advisory Councils of the 10 NIH Institutes and Centers supporting the BRAIN Initiative, as assisted by the NIH BRAIN Multi-Council Working Group and Neuroethics Working Group.
The NIH BRAIN Initiative recognizes that diverse teams working together and capitalizing on innovative ideas and distinct perspectives outperform homogeneous teams. There are many benefits that flow from a diverse scientific workforce, including: fostering scientific innovation, enhancing global competitiveness, contributing to robust learning environments, improving the quality of the research, advancing the likelihood that underserved populations participate in, and benefit from research, and enhancing public trust.
To support the best science, the NIH BRAIN Initiative encourages inclusivity in research. Examples of structures that promote diverse perspectives include but are not limited to:
- Transdisciplinary research projects and collaborations among neuroscientists and researchers from fields such as computational biology, physics, engineering, mathematics, computer and data sciences, as well as bioethics.
- Engagement from different types of institutions and organizations (e.g., research-intensive, undergraduate-focused, minority-serving, community-based).
- Individual applications and partnerships that enhance geographic and regional heterogeneity.
- Investigators and teams composed of researchers at different career stages.
- Participation of individuals from diverse backgrounds, including groups historically underrepresented in the biomedical, behavioral, and clinical research workforce (see NOT-OD-20-031), such as underrepresented racial and ethnic groups, those with disabilities, those from disadvantaged backgrounds, and women.
- Project-based opportunities to enhance the research environment to benefit early- and mid-career investigators.
The NIH also encourages businesses to participate in the BRAIN Initiative. It is possible for companies to submit applications directly to BRAIN Initiative program announcements or to collaborate with academic researchers in joint submissions. Small businesses should consider applying to one of the BRAIN Initiative small business NOFOs.
Plan for Enhancing Diverse Perspectives (PEDP)
This NOFO will require a Plan for Enhancing Diverse Perspectives (PEDP) as described in NOT-MH-21-310 (link: https://grants.nih.gov/grants/guide/notice-files/NOT-MH-21-310.html), submitted as Other Project Information as an attachment. Applicants are strongly encouraged to read the NOFO instructions carefully and view the available PEDP guidance material (link: https://braininitiative.nih.gov/about/plan-enhancing-diverse-perspectives-pedp).
Scope
The scope of this program, beginning with establishing proof of concept, may include efforts for technology development, optimization and pre-clinical testing that will advance next-generation recording and/or modulation devices along the translational path toward human use for disease treatment/treatments within the mission of BRAIN. Proof of concept is the initial exploration phase where the feasibility and viability of an innovative medical device concept are evaluated. It involves creating a prototype to demonstrate the basic functionality and potential of the idea, often without the full range of features. Devices may be non-invasive, minimally-invasive, invasive, or a combination thereof. Technologies may incorporate any signal modalitysuch as electrical, optical, magnetic, acoustic, or any combination thereof. Applications should propose design-directed development of a new technology and not be hypothesis-driven. Basic research and studies of disease mechanism or mechanism of action studies of the intended device would be considered outside the scope of this funding opportunity. Projects that seek to treat novel targets in specific patient populations (e.g., women and children) would be considered responsive.
Awarded activities would facilitate the translation of new devices beginning with proof of concept and up to the stage of readiness for first in human (FIH) clinical studies. Devices that are capable of synchronizing with other technologies are encouraged. These data must be synchronized in real time, but analysis may be done in an online or offline manner. Imaging technologies that are already approved for human use and activities involving imaging technologies that do not relate to translational efforts are considered out of scope.
General Entry Criteria
Examples of activities that are within the scope of this funding opportunity would include, but are not limited to:
- Demonstrate the basic functionality and potential of the idea (i.e., generate proof of concept data).
- Scaling device features for future human use.
- Activities that work towards preparing for future GLP testing or clinical studies for regulatory approvals.
- Activities to bring the development process under Design Control and Quality Systems processes.
- Device, software, and firmware design verification and validation activities.
- Development of packaging, connectors, surgical tools, and other accessories.
- Regulatory activities (e.g., pre-submission meetings with FDA).
Funding Information
TBD
TBD
Direct costs rarely to exceed $750,000 per year
TBD
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Small Business
For-Profit Organization (Other than Small Business)
State Government
Indian/Native American Tribal Government (Federally Recognized)
County governments
Independent school districts
Public housing authorities/Indian housing authorities
Indian/Native American Tribally Designated Organization (Native American tribal organizations (other than Federally recognized tribal governments)
U.S. Territory or Possession
Indian/Native American Tribal Government (Other than Federally Recognized)
Non-domestic (non-U.S.) Entity (Foreign Organization)
Regional Organization
Eligible Agencies of the Federal Government
Applications are not being solicited at this time.
Inquiries
Please direct all inquiries to:
Brooks Gross, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
301-496-1447
NINDS-Devices@nih.gov
and Human Services (HHS)
