Device Based Treatments for Substance Use Disorders (UG3/UH3 Clinical Trial Optional) | PAR 23 253

Opportunity Information: Apply for PAR 23 253

This funding opportunity, titled "Device Based Treatments for Substance Use Disorders (UG3/UH3 Clinical Trial Optional)" (PAR-23-253), is a National Institutes of Health (NIH) cooperative agreement aimed at speeding up the creation and advancement of medical devices that can treat substance use disorders (SUDs). The core focus is on device-based approaches, especially those that use neuromodulation or neurophysiological methods, reflecting the growing potential of modern technologies to deliver safe, effective, and scalable interventions for people affected by addiction. Rather than supporting only early discovery work, the announcement is oriented toward helping promising devices move forward in a practical, development-focused way so they can take the next step within the U.S. Food and Drug Administration (FDA) approval pathway. The long-term goal is clear: produce new, FDA-approved device treatments that can make a measurable difference in SUD care.

The FOA uses the UG3/UH3 structure, which typically supports a staged project design. In this kind of model, the UG3 phase is generally intended for planning, refinement, and early milestones that reduce risk and prove feasibility, while the UH3 phase supports the next level of execution once predefined milestones are met. The "clinical trial optional" language signals flexibility: applicants may propose projects that include a clinical trial, but they are not required to do so if their development stage and next FDA-facing steps do not demand it. Because the mechanism is a cooperative agreement, awardees should expect substantial NIH involvement during the project period, often including active programmatic collaboration, milestone-based oversight, and coordination to keep the work aligned with the translational objective of regulatory progress.

In terms of what the NIH is trying to accomplish, this opportunity is less about general addiction research and more about accelerating tangible device development that is ready to be pushed toward regulatory submission, clearance, or approval. Projects are therefore expected to be framed around development needs that the FDA would recognize as part of a credible pathway, such as generating key performance data, validating safety and effectiveness, improving device reliability and usability, or producing evidence needed for the next regulatory interaction. The overall emphasis is on moving a device forward to its next decision point, rather than stopping at proof-of-concept results that are not yet positioned for real-world authorization and adoption.

Eligibility is broad, spanning many types of domestic organizations and several categories beyond typical academic applicants. Eligible applicants include state, county, city, township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; Native American tribal governments (federally recognized); Native American tribal organizations (other than federally recognized tribal governments); public housing authorities and Indian housing authorities; nonprofits with or without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories); for-profit organizations other than small businesses; and small businesses. The FOA also explicitly calls out additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Hispanic-serving institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and even non-U.S. entities (foreign organizations). That wide eligibility signals an intent to pull in innovators wherever they are located, including groups that may be well positioned to develop, test, deploy, or support device solutions in diverse communities.

From an administrative standpoint, this is a discretionary grant opportunity under the NIH, with a Cooperative Agreement funding instrument, and it falls under the Health (and also listed as Education, Health) activity category. The CFDA (Assistance Listing) number provided is 93.279. The opportunity was created on 2023-08-18, and the listed closing date is 2026-08-13. While the source information does not provide an award ceiling or expected number of awards, the intent is clearly centered on advancing devices with a strong translational rationale and a credible plan to generate the evidence needed for the next step in FDA review.

Overall, the opportunity is designed for teams developing neuromodulatory or neurophysiological devices (and potentially other device modalities aligned with SUD treatment) who are ready to transition from promising development into a more regulatory-facing stage. Strong applications will typically be those that can show a clear SUD clinical need, a plausible mechanism of action or therapeutic rationale for the device, a realistic development plan with measurable milestones, and a well-defined strategy for producing the safety and performance data required to move along the FDA pathway toward an eventual approved device-based treatment for substance use disorders.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Device Based Treatments for Substance Use Disorders (UG3/UH3 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.279.
• This funding opportunity was created on 2023-08-18.
• Applicants must submit their applications by 2026-08-13. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

Apply for PAR 23 253

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