Notice of Intent to Publish a Funding Opportunity Announcement for Development of Translational Devices to Treat Pain (U18 Clinical Trial Not Allowed)

Notice Number: NOT-EB-18-030

Key Dates

Release Date: October 22, 2018
Estimated Publication Date of Funding Opportunity Announcement: December 15, 2018
First Estimated Application Due Date: February 15, 2019
Earliest Estimated Award Date: September 15, 2019
Earliest Estimated Start Date: October 15, 2019

Related Announcements
None

Issued by
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Neurological Disorders and Stroke (NINDS)
National Center for Complementary and Integrative Health (NCCIH)

Purpose

The National Institute of Biomedical Imaging and Bioengineering (NIBIB) 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 through the U18 activity code

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 up to the stage of readiness for first in human (FIH) clinical trials by overcoming key challenges identified during preliminary proof-of-concept studies. The scope of the program includes technology development and optimization, and studies to prepare for approvals for human use.

This Notice is being provided to allow potential applicants sufficient time to develop responsive projects using systems engineering principles and practices and to form meaningful collaborations with potential technology transition and manufacturing partners. Applicants may contact members of the public private partnerships from the BRAIN Initiative and theSPARC Initiative. Potential applicants are strongly encouraged to discuss their proposed project with NIBIB program staff.

This FOA is expected to be published in December 2018 with an expected application due date in February 2019.

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, and scientifically sound assays to test the system. 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. Early stage technologies may be considered, as long as there is a sufficiently credible research plan and supporting data.

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.

Clinical research, basic research, and studies of disease mechanism or mechanism of action are not the focus of this FOA, and may be supported through other FOAs within the HEAL Initiative.

Funding Information

Estimated Total Funding TBD
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)
Regional Organization
Eligible Agencies of the Federal Government, including the NIH Intramural Program

Applications are not being solicited at this time.

Inquiries

Please direct all inquiries to:

Michael Wolfson
National Institute of Biomedical Imaging and Bioengineering (NIBIB)
301-451-4778
Michael.Wolfson@NIH.gov