Notice of Special Interest (NOSI): BRAIN Initiative: Translation of Groundbreaking Technologies from Early-stage Development through Early Clinical Study via Blueprint MedTech
Notice Number:
NOT-NS-22-052

Key Dates

Release Date:

January 6, 2022

First Available Due Date:
February 18, 2022
Expiration Date:
June 21, 2024

Related Announcements

PAR-21-315, UG3/ UH3 Blueprint MedTech Translator (UG3/UH3 - Clinical Trial Optional)

PAR-21-282, U44 Blueprint Medtech: Small Business Translator (U44 - Clinical Trial Optional)

Issued by

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)

Purpose

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.

Background

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.

Objectives

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:

  • Projects developing novel invasive neurostimulation devices for the human central nervous system (CNS).
  • Projects developing novel invasive brain recording devices for the human CNS.
  • Projects developing novel non-invasive brain stimulation devices for the human CNS. These devices should aim to achieve brain stimulation resolution of sub-millimeter at the cortical surface and depth. These approaches may incorporate electromagnetic, mechanical, or combination biological and device means (e.g., optogenetics).

Supported research and development will include non-clinical development and early-stage clinical testing of novel, groundbreaking neurotechnologies. Technologies should meet the following criteria:

  • Projects focused on technologies for the human CNS.
  • Novel medical device technologies that will advance upon current neurotechnology.
  • First-of-its-kind technologies, unique and novel intended use, new safety questions, and/or new regulatory questions, or pivot and refine existing technologies toward new intended use and use in novel settings.

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.

  • PAR-21-315 - Blueprint MedTech Translator (UG3/UH3 - Clinical Trial Optional)
  • PAR-21-282 - Blueprint MedTech: Small Business Translator (U44 - Clinical Trial Optional)

All instructions in the SF424 (R&R) Application Guide and the funding opportunity announcement used for submission must be followed, with the following additions:

  • For funding consideration, applicants must include “NOT-NS-22-052” (without quotation marks) in the Agency Routing Identifier field (box 4B) of the SF424 R&R form. Applications without this information in box 4B will not be considered for this initiative.

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:

  • All applications, regardless of the amount of direct costs requested for any one year, must include a Data Sharing Plan.
  • Applicants should anticipate that, if awarded, their project will join a consortium work group, coordinated by the NIH, to identify consensus standards of practice as well as supplemental opportunities to collect and provide data for ancillary studies, and to aggregate and standardize data for dissemination among the wider scientific community. Accordingly, the Data Sharing Plan should include a statement of agreement to join and cooperate with a future collaborative consortium of awardees to maximize data sharing opportunities (including collection, curation, analysis, and sharing) for this unique population of human subjects. The Data Sharing Plan should include accommodations for research-community input, including requests for collecting and disseminating data that will be valuable to the wider research community beyond the primary outcomes.
  • For PAR-21-282 - Blueprint MedTech: Small Business Translator (U44 - Clinical Trial Optional), the following also apply:
    • Investigators are expected to include a brief one-paragraph description of how the final research data will be shared or why data-sharing is not possible. If patent protection is being sought, investigators should explain how data will be shared after patent protection is secured.
  • For PAR-21-315 - Blueprint MedTech Translator (UG3/UH3 - Clinical Trial Optional), the following also apply:
    • Investigators must follow the guidelines outlined in NOT-MH-19-010 (https://grants.nih.gov/grants/guide/notice-files/NOT-MH-19-010.html) when creating the data sharing plan.
    • If patent protection is being sought, investigators should explain how data will be shared after filing for patent protection to allow for both further research and the development of commercial products to advance forward, consistent with achieving the goals of the program.
    • The plan should include information on IRB compliance for sharing de-identified data to maximize dissemination.

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.

Inquiries

Please direct all inquiries to the contacts in Section VII of the listed funding opportunity announcements with the following additions/substitutions:

Scientific/Research Contact(s)

Nick Langhals, PhD
National Institute of Neurological Disorders and Stroke (NINDS)
Telephone: 301-496-1779
E-mail: NINDS-Devices@nih.gov

David McMullen, M.D.
National Institute of Mental Health (NIMH)
Telephone: 301-451-0180
Email: david.mcmullen@nih.gov