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HEAL Initiative: Translational Devices to Treat Pain (U44 Clinical Trial Optional)
The purpose of this Funding Opportunity Announcement (FOA) is to encourage small business concerns (SBCs) 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 nonclinical 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 NIH 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.htm, https://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 any of the companion opportunities.
- 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-19-017 Expiration Date February 22, 2021
Only United States small business concerns (SBCs) are eligible to submit applications for this opportunity.
Applications should rarely exceed $1,000,000 in total cost per year during the SBIR Phase I and $1,500,000 in total costs per year during the SBIR Phase II.