January 6, 2022
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)
All applications to this funding opportunity announcement should fall within the mission of the Institutes/Centers. The following NIH Offices may co-fund applications assigned to those Institutes/Centers.
Office of Behavioral and Social Sciences Research (OBSSR)
This Notice of Special Interest (NOSI) encourages the translation of the novel neurotechnologies, funded through the Brain Research through Advancing Innovative Neurotechnologies® (BRAIN) Initiative and overseen by the NIH Blueprint MedTech program. Academic and Small Business Concerns (SBCs) are encouraged to submit grant applications that propose non-clinical validation for subsequent clinical feasibility studies. Applications supporting the development and translation of groundbreaking neurotechnologies that fit within the mission of the BRAIN Initiative are encouraged.
The BRAIN Initiative is aimed at revolutionizing our understanding of the human brain. By accelerating the development and application of innovative technologies, researchers will be able to produce a new dynamic picture of the brain that, for the first time, shows how individual cells and complex neural circuits interact in both time and space. It is expected that the application of these new tools and technologies will ultimately lead to new ways to identify, treat, cure, and even prevent brain disorders.
The NIH and the BRAIN Initiative have invested a significant amount of funds in the development of new neurotechnologies. This investment has produced novel, groundbreaking technologies. However, non-commercial developers often lack the resources and product development training to translate these devices from bench to bedside. Consequently, the devices may struggle to progress beyond a small number of niche labs. The BRAIN Initiative 2.0: From Cells to Circuits, Towards Cures report highlights the need to further support innovative neuroscience technologies' dissemination.
The NIH Blueprint MedTech incubator program aims to accelerate access to groundbreaking, safe, and effective medical devices. Blueprint MedTech offers an opportunity to address these gaps by providing support to sufficiently develop and de-risk technologies to the point where additional investments are warranted from industry partners, investors, and government.
The Blueprint MedTech Program aims to accelerate the development of cutting-edge medical devices to diagnose and/or treat nervous system disorders. The program's mission is to catalyze the translation of novel neurotechnologies from early-stage development to first-in-human clinical studies. The program provides: (a) non-dilutive funds to support medical device development activities led by investigators and (b) additional resources and support services.
This NOSI is intended to alert applicants that there is a need to help transition BRAIN Initiative-relevant technologies from early device development to first-in-human studies. Projects that fit the following categories can be submitted through the Blueprint MedTech Program.
BRAIN will support the following efforts coming into the BP MedTech UG3/UH3 and U44 funding opportunities:
Supported research and development will include non-clinical development and early-stage clinical testing of novel, groundbreaking neurotechnologies. Technologies should meet the following criteria:
Proposed medical devices and their indications will likely follow De Novo or Premarket Approval (PMA) regulatory pathways. Medical devices with indications that may fit within an existing 510(k) pathway may also be accepted, as long as the application can demonstrate a clear clinical and technological innovation beyond the state of the art of existing FDA-cleared predicates.
Applicants are strongly encouraged to consult Program Staff regarding the appropriateness of the planned application to the BRAIN Initiative's mission, scientific areas of interest, and programmatic priorities.
Awardees will be expected to participate in the Blueprint MedTech Program, which provides consultants, industry experts, and resources to support the device's technological, regulatory, clinical, and commercial advancement.
Application and Submission Information
This notice applies to due dates on or after February 18, 2022, and subsequent receipt dates through June 20, 2024.
Submit applications for this initiative using one of the following funding opportunity announcements (FOAs) or any reissues of these announcement through the expiration date of this notice. Applicants must select the IC and associated FOA to use for submission of an application in response to the NOSI. The selection must align with the IC requirements listed in order to be considered responsive to that FOA. Non-responsive applications will be withdrawn from consideration for this initiative.
All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:
To meet BRAIN Initiative data sharing requirements, individuals are required to comply with the instructions for the Resource Sharing Plans as provided in the SF424 (R&R) Application Guide for PAR-21-315, or the SF424 (R&R) SBIR/STTR Application Guide for PAR-21-282, with the following modifications:
Although NIDCD is not listed as a Participating Organization in all the FOAs listed above, applications for this initiative will be accepted.
Applications nonresponsive to terms of this NOSI will be withdrawn from consideration for this initiative.