Notice of Intent to Publish a Funding Opportunity Announcement for Translational Devices to Treat Pain (UG3/UH3 Clinical Trial Optional)

Notice Number: NOT-NS-19-009

Key Dates

Release Date:October 23, 2018
Estimated Publication Date of Funding Opportunity Announcement: November 15, 2018
First Estimated Application Due Date: December 15, 2018
Earliest Estimated Award Date: May 15, 2018
Earliest Estimated Start Date: July 01, 2019

Related Announcements
None

Issued by
National Institute of Neurological Disorders and Stroke (NINDS)

Purpose

The National Institute of Neurological Disorders and Stroke (NINDS) with other NIH Institutes and Centers participating in the HEAL (Helping to End Addiction Long-term) Initiative, intends to publish a Funding Opportunity Announcement (FOA) to support the development of therapeutic, diagnostic, and rehabilitative technologies for pain.

The focus of this FOA will be to support preclinical development and demonstration of safe, effective, and non-addictive device-based technologies and approaches to treat pain. The goal of the program will be to demonstrate treatment using credible neural targets for device-based interventions and/or diagnostics for pain, building upon the latest mechanistic knowledge about the anatomy and physiology of central, spinal, and peripheral pathways involved in pain. The FOA will facilitate the translation of new devices by overcoming key challenges identified during preliminary proof-of-concept studies. The scope of the program includes technology optimization, regulatory activities to enable IDE/IRB approvals, and a subsequent clinical study.

This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive projects.

The FOA is expected to be published in 2018 with an expected application due date in 2018.

This FOA will utilize the UG3/UH3 activity code. Details of the planned FOA are provided below.

Research Initiative Details

Translational research to develop new medical devices is the focus of this FOA. Applications to this FOA should not be hypothesis-driven, but should propose design-directed technology development.

Applications will be expected to have a rigorous mechanistic biological rationale, scientifically sound assays to test the system, and a near final device design. It is also expected that applications include supporting data that the mechanism of therapy, rehabilitation, or diagnosis has been demonstrated in humans or bench top, ex vivoin silicoin vitro, and/or in vivo models representative of the intended patient population and indication.

It is anticipated that there will be no restrictions on invasiveness (i.e., the devices may be non-invasive, minimally invasive, or invasive). Devices may utilize any viable modality to focally interact with the nervous system, such as optical, electrical, magnetic, acoustic, chemical/pharmaceutical, microfluidic, or combinations thereof. This FOA will not be specific to any one pain condition or patient population.

Funding Information

Estimated Total Funding Issuing IC and partner components intend to issue 5-7 awards in 2019. Awards issued under this FOA are part of funds set aside to support the HEAL (Helping to End Addiction Long-term) initiative.
Expected Number of Awards TBD
Estimated Award Ceiling TBD
Primary CFDA Numbers TBD

Anticipated Eligible Organizations

Public/State Controlled Institution of Higher Education
Private Institution of Higher Education
Nonprofit with 501(c)(3) IRS Status (Other than Institution of Higher Education)
Nonprofit without 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
City or township governments
Special district 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

 

Applications are not being solicited at this time. 

 

Inquiries

Please direct all inquiries to:

Nick Langhals, Ph.D.
National Institute of Neurological Disorders and Stroke (NINDS)
301-496-1447
Nick.Langhals@nih.gov