Medical Devices for Pediatric Population Affected by Substance Use and Addiction (R41 - Clinical Trials Optional)

The National Institute on Drug Abuse (NIDA) invites applications for its Small Business Technology Transfer (STTR) Phase I program to develop innovative medical devices tailored for the pediatric population (ages 0–21) affected by substance use and addiction. This program focuses on early-stage, proof-of-concept projects and does not require preliminary data for application. A maximum budget of $400,000 is available for projects lasting up to one year. NIDA intends to fund two to three proposals in FY 2026, with $1 million allocated. This funding opportunity seeks novel therapeutic and diagnostic devices, particularly digital therapeutics and diagnostics, designed to address the unique needs of pediatric populations. Priority areas include solutions for behavioral health, substance use prevention and treatment, sleep disturbances associated with substance use, and wearable or artificial intelligence-enabled diagnostic tools. Proposals must address the technical and commercial feasibility of their ideas, outline clear milestones, and consider accessibility and affordability for diverse pediatric populations. Engagement with FDA regulatory pathways and payer programs is strongly encouraged, along with participation in NIH's entrepreneurial I-Corps program to explore commercialization strategies. Eligible applicants are U.S.-based small business concerns (SBCs), including partnerships with nonprofit research institutions. Applicants must perform at least 40% of the research effort themselves and allocate at least 30% to their nonprofit partner. Companies must adhere to the NIH’s guidelines for disclosure of foreign affiliations and other regulatory requirements. Applicants must complete registrations in SAM.gov, Grants.gov, eRA Commons, and SBA Company Registry. Applications will be evaluated on criteria including significance, innovation, feasibility, and the expertise of the team. Strong proposals will demonstrate a clear pathway to FDA approval, consider inclusivity in participant recruitment, and address the unique needs of diverse and underserved pediatric populations. Key review factors include the potential for commercialization, the scientific and business environment, and the technical merit of the proposed device. Submission opens on January 25, 2025, with applications due by February 26, 2025. Letters of intent, while optional, are recommended to assist NIDA in planning the review process. Proposals must follow the SBIR/STTR-specific guidelines in the NIH Application Guide. Non-compliance or incomplete applications will not be reviewed. Applicants are encouraged to contact NIDA’s program staff for guidance before submission.