Device-Based Treatments for Substance Use Disorders (UG3/UH3) (Clinical Trial Optional) | PAR 18 494

Opportunity Information: Apply for PAR 18 494

This National Institutes of Health (NIH) funding opportunity, titled "Device-Based Treatments for Substance Use Disorders (UG3/UH3) (Clinical Trial Optional)" (Funding Opportunity Number PAR 18 494), is a discretionary program that uses a cooperative agreement mechanism to speed up the development of medical devices aimed at treating substance use disorders (SUDs). The core idea is to take advantage of fast-moving advances in technology, especially in neuromodulatory and neurophysiological approaches, to push promising device concepts further along the pathway toward becoming safe, effective, and ultimately FDA-approved treatments for SUDs. In practical terms, the FOA is focused on helping teams move a device to its next step in the FDA approval process, rather than stopping at early proof-of-concept work, with the long-range goal of producing new, clinically useful, FDA-cleared or FDA-approved device-based interventions for people struggling with addiction.

A key feature of this opportunity is the UG3/UH3 phased structure. While the notice text provided does not spell out the full milestones, the UG3/UH3 format is generally designed as a staged program in which an initial phase supports planning, finalizing device development steps, and hitting defined feasibility or readiness benchmarks, followed by a second phase that supports the next level of implementation once those milestones are met. The "Clinical Trial Optional" label signals that applicants may propose projects that include a clinical trial, but they are not required to do so; applicants can also propose non-trial work that still meaningfully advances a device toward regulatory readiness. Because this is a cooperative agreement, NIH typically has substantial involvement during the project period compared with a standard grant, which can include collaborative oversight, milestone-based progression, and coordinated problem-solving intended to keep device development on a translational track.

The program sits within NIH health-related funding activity categories (CFDA numbers listed as 93.213, 93.273, and 93.279), reinforcing that its emphasis is biomedical and translational, with an explicit regulatory endpoint in mind. Although the listing frames the activity category broadly as education and health, the described purpose is clearly about accelerating device development for SUD treatment and aligning that work with the expectations of FDA advancement. The award information provided lists an award ceiling of $500,000, indicating that applications should be scoped to fit within that upper budget boundary as presented in the source data.

Eligibility for this FOA is intentionally broad, which is consistent with the interdisciplinary nature of device development. Eligible applicants include a wide range of governmental entities (state, county, city/township, and special district governments), public and state-controlled institutions of higher education, private institutions of higher education, independent school districts, and public housing authorities/Indian housing authorities. It also includes Native American tribal governments (federally recognized), as well as tribal organizations and tribal governments that are not federally recognized. On the nonprofit side, both 501(c)(3) organizations and nonprofits without 501(c)(3) status may apply (in both cases, other than institutions of higher education). The FOA also allows applications from for-profit organizations (other than small businesses) and from small businesses, reflecting the reality that many device concepts and prototypes originate in industry settings or academic-industry partnerships. In addition, the opportunity explicitly calls out a number of "other eligible applicants" categories, including 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-domestic (non-U.S.) entities (foreign organizations). Taken together, this wide eligibility net is meant to encourage participation from many types of institutions and communities, including those that serve populations disproportionately affected by substance use disorders.

Administratively, the source data lists NIH as the sponsoring agency, a creation date of 2017-12-15, and an original closing date of 2020-07-24. While the expected number of awards is not specified in the provided record, the structure and cooperative agreement format suggest NIH intended to support a set of projects that are sufficiently mature to be pushed toward the next regulatory stage, rather than a large volume of small exploratory studies. Overall, the opportunity is best understood as a translational push: it is aimed at converting advances in neuromodulation and neurophysiology into device-based SUD treatments that can realistically progress through FDA requirements and, eventually, expand the treatment toolbox available to clinicians and patients.

• 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): 93.213, 93.273, 93.279.
• This funding opportunity was created on 2017-12-15.
• Applicants must submit their applications by 2020-07-24. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $500,000.00 in funding.
• 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 18 494

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