The National Institute on Drug Abuse (NIDA) has announced a funding opportunity for Phase I Small Business Innovation Research (SBIR) grants, focusing on developing medical devices for pediatric populations affected by substance use and addiction. The initiative seeks innovative therapeutic and diagnostic devices tailored to children and adolescents (ages 0–21) to address significant gaps in treatment for substance use disorders (SUD) in this demographic. Target technologies include digital therapeutics, wearable sensors, and artificial intelligence-driven diagnostic tools, particularly those addressing health consequences such as sleep disturbances, behavioral health challenges, and stimulant use disorders.

NIDA emphasizes addressing unmet needs in pediatric addiction care, highlighting the critical shortage of FDA-approved devices and treatments for this group. Applicants are encouraged to propose projects that address technical, regulatory, and commercial challenges. Proposals should include plans for engaging the FDA and other regulatory resources, considering the unique needs of pediatric patients, and strategies for ensuring accessibility and affordability. The use of health equity principles, including recruitment of diverse populations and underserved groups, is also strongly recommended.

Eligible applicants are U.S.-based small business concerns (SBCs) meeting specific ownership and operational criteria. The program funds projects that demonstrate technical feasibility and proof of concept for innovative medical devices. Applicants do not need preliminary data but must outline clear, measurable milestones for assessing progress. Applications proposing products not regulated by the FDA or intended solely for adults or alcohol-related indications will be deemed non-responsive.

This Phase I program supports up to $400,000 in total funding per award for a project period not exceeding one year. Applications are due by February 26, 2025, with letters of intent encouraged but not required by January 25, 2025. NIDA plans to commit $2 million in FY 2026 to fund approximately 4-5 awards. Successful projects will address technical and commercial feasibility and demonstrate potential for FDA approval and market adoption.

The review process will evaluate scientific merit, commercial potential, and the applicant’s plans for regulatory engagement, including participation in FDA programs like the Q-submission program and the Breakthrough Devices Program. Reviewers will also assess the innovation, approach, and environment described in applications. High-priority proposals will include comprehensive commercialization plans and strategies for addressing barriers such as regulatory approval and market entry.

Applicants must meet NIH and SBIR-specific registration requirements, including registrations with SAM, Grants.gov, and the Small Business Administration (SBA). Proposals must be submitted through the NIH ASSIST system or other authorized platforms. For additional guidance, applicants are encouraged to contact NIDA representatives listed in the announcement.