HEAL Initiative: Translational Devices to Treat Pain (UG3/UH3 Clinical Trial Optional)

Funding Agency:
National Institutes of Health

The purpose of this Funding Opportunity Announcement (FOA) is to encourage investigators to pursue translational activities and clinical trials to treat pain with innovative, targeted, and non-addictive diagnostic and/or therapeutic devices that improve patient outcomes and decrease or eliminate the need to prescribe opioids. Activities supported in this program include implementation of clinical prototype devices, non-clinical safety and efficacy testing, design verification and validation activities, obtaining an Investigational Device Exemption (IDE) for a Significant Risk (SR) study or Institutional Review Board (IRB) approval for a Non-Significant Risk (NSR) study, as well as a subsequent small clinical trial (e.g., Early Feasibility Study). The clinical trial is expected to provide information about the device function or final design that cannot be practically obtained through additional non-clinical assessments (e.g., bench top or animal studies) due to the novelty of the device or its intended use. This is a milestone-driven cooperative agreement program and will involve participation of NIH program staff in the development of the project plan and monitoring of research progress.

This FOA will leverage Public-Private Partnership Programs (PPP) initiated under the NIH BRAIN Initiative, the Office of Strategic Coordination – The Common Fund’s Stimulating Peripheral Activity to Relieve Conditions (SPARC) Program, and the HEAL Initiative. These programs include agreements (Memoranda of Understanding,  MOU) with a number of device manufacturers willing to make such devices available, including devices and capabilities not yet market approved but appropriate for clinical research.  In general, it is expected that the devices' existing safety and utility data will be sufficient to enable new IRB NSR or FDA IDE approval without the need for significant additional non-clinical data. 

For more information see https://braininitiative.nih.gov/resources/brain_ppp/index.htmhttps://commonfund.nih.gov/sparc/newmarkets, and https://www.nih.gov/research-training/medical-research-initiatives/heal-initiative/public-private-partnership. Individuals, institutions, or businesses developing their own devices or that already have established collaborations with device manufacturers are welcome to apply directly to this FOA or the companion opportunities.

 

Companion FOAs:

RFA-NS-19-017U44Small Business Innovation Research (SBIR) Cooperative Agreement

RFA-NS-19-018UH3 Exploratory Phased Award Cooperative Agreement

RFA-NS-18-041R61/R33Exploratory/Developmental Phased Award

RFA-NS-18-046, ?R61/R33Exploratory/Developmental Phased Award

RFA-NS-18-042R01Research Project Grant

RFA-NS-18-043R21Exploratory/Developmental Grant

RFA-RM-19-001U01 Research Project – Cooperative Agreements

RFA-EB-18-003U18 Research Demonstration – Cooperative Agreements

Deadlines:

  • Letter of Intent Due Date(s): 30 days prior to receipt date
  • Application Due Date(s): January 9, 2019, March 22, 2019, June 21, 2019, October 21, 2019, February 21, 2020, June 22, 2020, October 21, 2020, February 21, 2021 

RFA-NS-19-016 Expiration Date February 22, 2021
 

Agency Website

Amount Description

 

    Funding Type

    Grant

    Eligibility

    Faculty

    Category

    Engineering and Physical Sciences
    Medical
    Medical - Translational

    External Deadline

    October 21, 2019