Sponsor Deadline
Posted: 3/20/2024

Developing Regulated Therapeutic and Diagnostic Solutions for Patients Affected by Opioid and/or Stimulants use Disorders (OUD/StUD) (R43/R44 - Clinical Trial Optional)

This Funding Opportunity Announcement (FOA) encourages Small Business Innovation Research (SBIR) grant applications from small business concerns (SBCs) proposing research projects, directed towards commercialization, for the development of novel, evidence-based, FDA-regulated medical products addressing the needs of patients suffering from opioid use disorders (OUD) and/or stimulant use disorders (StUD). Applications received under this FOA may fall within two scientific areas, namely: (1) pharmacotherapeutics (small molecules and biologics) and (2) medical therapeutic and diagnostic devices, including software as a medical device. This FOA strives to contribute to the effort against the national opioid and psychostimulant emergency and offer new medical products for individuals, families, and communities affected by this devastating crisis. Small business companies that developed currently marketed technologies or are developing technologies for different indications and are interested in demonstrating that their FDA-regulated product has a potential application in the OUD/StUD space are encouraged to apply.


  • Letter of Intent Due Date(s): 30 days prior to receipt date

  • Application Due Dates: Aug. 15, 2022; Feb 14, 2023; Aug 15, 2023; Feb 14, 2024; Aug 13, 2024; Feb 14, 2025

RFA-DA-23-021 Expiration Date February 15, 2025

Eligibility Requirements

Only United States small business concerns (SBCs) are eligible to submit applications for this opportunity.

Amount Description

Total funding support (direct costs, indirect costs, fee) may not exceed $320,000 for Phase I awards and $2,500,000 for Phase II awards.