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

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Opportunity ID:310181
Opportunity Number:NOT-EB-18-030
Opportunity Title:Notice of Intent to Publish a Funding Opportunity Announcement for Development of Translational Devices to Treat Pain (U18 Clinical Trial Not Allowed)
Opportunity Category:Discretionary
Opportunity Category Explanation:
Funding Instrument Type:Cooperative Agreement
Category of Funding Activity:Health
Category Explanation:
CFDA Number(s):
Eligible Applicants:State governments
County governments
City or township governments
Special district governments
Independent school districts
Public and State controlled institutions of higher education
Native American tribal governments (Federally recognized)
Public housing authorities/Indian housing authorities
Native American tribal organizations (other than Federally recognized tribal governments)
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education
Private institutions of higher education
For profit organizations other than small businesses
Small businesses
Others (see text field entitled “Additional Information on Eligibility” for clarification)
Additional Information on Eligibility:
Agency Code:HHS-NIH11
Agency Name:Department of Health and Human Services
National Institutes of Health
Posted Date:Nov 05, 2018
Last Updated Date:Nov 05, 2018
Estimated Synopsis Post Date:Dec 15, 2018
Fiscal Year:2019
Award Ceiling:
Award Floor:
Estimated Total Program Funding:
Expected Number of Awards:
Description: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 the SPARC 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 vivo, in silico, in 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.
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