FOA Number: RFA-DA-22-001
“This Funding Opportunity Announcement (FOA), issued by the National Institute on Drug Abuse (NIDA), invites eligible United States small business concerns (SBCs) to submit Small Business Innovation Research (SBIR) grant applications to develop mobile health technologies, including wearables and other digital health enabled technologies, to address existing digital inequalities affecting underserved and vulnerable populations suffering from Substance Use Disorders (SUD).”
“Proposed Mobile Health Solutions are expected to fall under one of three different areas:
- FDA regulated devices, including Digital Therapeutics (i.e. with a medical purpose intended to diagnose, treat, cure, mitigate, prevent);
- low-risk general wellness that encourages use of healthy lifestyle and behaviors to reduce the impact of SUD or live well with SUD as described in the FDA’s general wellness guidance (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-wellness-policy-low-risk-devices), and
- solutions that help a patient self-manage their disease (without changing treatments/medications unless prescribed by a qualified medical professional) or better communicate with their healthcare professionals as described in the FDA’s policy for Device Software Functions and Mobile Medical Applications.”
“The SBIR/STTR program is a phased program.”
“The main objective in SBIR/STTR Phase I is to establish the technical merit and feasibility of the proposed research and development efforts, whereas in SBIR/STTR Phase II it is to continue the R&D efforts to advance the technology toward ultimate commercialization…”
