Notice of Intent to Publish a Funding Opportunity Announcement for SPARC Human Open Research Neural Engineering Technology (HORNET) Initiative (U41 Clinical Trial Optional)
Notice Number:
NOT-RM-21-023

Key Dates

Release Date:
May 26, 2021
Estimated Publication Date of Funding Opportunity Announcement:
August 06, 2021
First Estimated Application Due Date:
November 15, 2021
Earliest Estimated Award Date:
July 01, 2022
Earliest Estimated Start Date:
August 01, 2022
Related Announcements

None

Issued by

Office of Strategic Coordination (Common Fund)

Purpose

The Office of Strategic Coordination (Common Fund) intends to publish a Funding Opportunity Announcement (FOA) to solicit applications for a new initiative of the Stimulating Peripheral Activity to Relieve Conditions (SPARC) program. This initiative is intended to support Biotechnology Resource Centers to develop and disseminate open-source implantable neuromodulation modules and systems for use in human subjects research.

The FOA will utilize the cooperative agreement U41 activity code. The FOA is expected to be published in Summer 2021 with an expected application due date in Fall 2021 for FY22 funding.

This Notice is being provided for informational purposes to allow potential applicants additional time to develop responsive applications and meaningful collaborations. NIH reserves the right to modify the scope and objectives as described in this Notice. Final scope, objectives, and requirements will be set forth in the published FOA.

Additional information related to the planned FOA is provided below.

Research Initiative Details

The NIH Common Fund’s Stimulating Peripheral Activity to Relieve Conditions (SPARC) program seeks to accelerate development of therapeutic approaches that modulate electrical activity in peripheral nerves to improve organ function. SPARC is generating maps, tools, and models to identify and influence therapeutic targets that exist within the neural circuitry of a wide range of visceral organs and tissues.

Advancement of such therapeutic approaches from early-stage development to successful clinical translation requires the availability of clinical-grade neuromodulation platforms. Currently, such platforms are either costly to develop from the ground up or difficult to access for exploratory use from large medical device companies. These barriers to translation have hindered the research community from bringing innovative therapeutic approaches to the patients who need them most. As some modular components (e.g., hardware, signal processing, algorithms, software and firmware) may be common to most implantable neuromodulation approaches, SPARC seeks to develop neuromodulation technologies that can be applied to many biomedical applications. Thus, SPARC has the unique opportunity to advance the field of peripheral neuromodulation by supporting the development of individual open-source modules and creating templates for complete systems. Modules may include development of libraries for electrodes, leads, connectors, electronics, batteries, enclosures, hermetic technologies, and insulation layers. The SPARC team, in collaboration with BRAIN Initiative staff, will pilot an open-source neuromodulation platforms initiative, SPARC Human Open Research Neural Engineering Technologies (HORNET).

The U41 FOA will fund Biotechnology Research Centers to create interoperable modules that can be combined into custom modular profiles for new exploratory and clinical neuromodulation studies in the peripheral nervous system, and for potential application(s) in the central nervous system. Investigators will create interoperability specifications and compatible modules that can be sustainably supported using FAIR principles. The centers will disseminate the open-source biotechnology resources broadly.

Funding for HORNET will come from the NIH Common Fund, which supports cross-cutting programs expected to have exceptionally high impact. All Common Fund initiatives invite investigators to develop bold, innovative, and high-risk approaches to address problems that may seem intractable or to seize new opportunities that offer the potential for rapid progress.

Through this FOA, SPARC will support a network of HORNET Biotechnology Resource Centers through the U41 cooperative agreement mechanism. These Centers will create critical and unique technologies and methods at the forefront of their respective fields and apply them to a broad range of basic, translational, and clinical research. These Centers will be highly creative, productive, and constitute a significant element in SPARC’s technology-development portfolio. While the specific design and implementation plan for a Center may vary for each applicant team, a competitive application for this program should incorporate the following components:

  1. An Administrative Core to manage the overall program and priorities.
  2. Technology Projects for designing, developing, and testing open-source modular neuromodulation hardware, software, and firmware.

A Training and Dissemination Core that publicly communicates details of the Center’s open-source modules and templates, and coordinates with other HORNET Centers.

Funding Information
Estimated Total Funding

$30,000,000 over 3 years

Expected Number of Awards

5 Awards

Estimated Award Ceiling

$5,000,000 total cost per year

Primary Assistance Listing Number(s)

93.310

Anticipated Eligible Organizations
Eligible Agencies of the Federal Government
Private Institution of Higher Education
Public/State Controlled 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
Regional Organization
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)

Applications are not being solicited at this time. 

Inquiries

Please direct all inquiries to:

Eric Hudak, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
301-496-1779
[email protected]

Brooks Gross, Ph.D.
Program Director
National Institute of Neurological Disorders and Stroke (NINDS)
301-496-1779
[email protected]


Weekly TOC for this Announcement
NIH Funding Opportunities and Notices