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

Frequently Asked Questions (FAQs)

What is the title and identification number of this funding opportunity?

The opportunity is titled "Device Based Treatments for Substance Use Disorders (UG3/UH3 Clinical Trial Optional)" and is identified as PAR-23-253.

Which agency is offering this opportunity?

This is a National Institutes of Health (NIH) funding opportunity.

What type of funding instrument is being used?

The funding instrument is a Cooperative Agreement, which typically means NIH will have substantial involvement in the project during the award period.

What is the main goal of this program?

The main goal is to speed the creation and advancement of medical devices that can treat substance use disorders (SUDs), with an emphasis on moving promising devices forward along the U.S. Food and Drug Administration (FDA) approval pathway toward eventual FDA-authorized, device-based SUD treatments.

What kinds of projects does this FOA prioritize?

This FOA prioritizes practical, development-focused projects that advance a device toward a regulatory decision point. It is less focused on general addiction research and more focused on tangible device development activities that support FDA-facing progress.

What device approaches are especially emphasized?

The FOA emphasizes device-based approaches, especially those using neuromodulation or neurophysiological methods, reflecting the potential of modern technologies to deliver safe, effective, and scalable interventions for addiction.

Is this opportunity only for early-stage discovery research?

No. The announcement is oriented toward helping promising devices move forward in a practical development pathway. The emphasis is on advancing beyond basic proof-of-concept toward activities that support regulatory progress.

What does the UG3/UH3 structure mean for applicants?

The UG3/UH3 structure typically supports a staged project design. The UG3 phase generally supports planning, refinement, and early milestones that reduce risk and establish feasibility. The UH3 phase supports the next level of execution after predefined milestones are met.

How does the transition from UG3 to UH3 typically work in this FOA?

The staged design is milestone-based. Progress and achievement of predefined milestones in the UG3 phase are generally expected to determine whether the project can move into the UH3 phase to carry out the next stage of work.

What does "Clinical Trial Optional" mean?

"Clinical Trial Optional" means applicants may propose projects that include a clinical trial, but a clinical trial is not required if the device development stage and next FDA-facing steps do not require one.

Does this FOA require projects to include a clinical trial?

No. A clinical trial may be included, but it is not mandatory under the "clinical trial optional" designation.

What does it mean that this is a cooperative agreement?

Because this is a cooperative agreement, awardees should expect substantial NIH involvement during the project period. This can include active programmatic collaboration, milestone-based oversight, and coordination to keep work aligned with translational and regulatory objectives.

What types of development activities are likely to fit the NIH objectives described here?

Projects are expected to focus on development needs recognizable within an FDA 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.

What is the long-term outcome NIH is aiming for?

The long-term goal is to produce new, FDA-approved device treatments that can make a measurable difference in substance use disorder care.

How should applicants frame their project to align with the translational emphasis?

Applicants should frame the project around a credible FDA-facing development plan with measurable milestones and a clear strategy to generate the safety, performance, and/or effectiveness evidence needed for the next regulatory step (for example, a submission, clearance, or approval-related decision point).

What does the FOA mean by focusing on the "next decision point"?

It means the project should be designed to move the device forward to its next regulatory milestone rather than stopping at results that are not yet positioned for real-world authorization and adoption.

Who is eligible to apply?

Eligibility is broad and includes many types of organizations and governments, including domestic organizations and additional categories explicitly noted in the FOA, including non-U.S. entities (foreign organizations).

Are state and local governments eligible to apply?

Yes. Eligible applicants include state, county, city, township, special district governments, and independent school districts.

Are colleges and universities eligible?

Yes. Eligible applicants include public and state-controlled institutions of higher education and private institutions of higher education.

Are small businesses eligible?

Yes. Small businesses are listed as eligible applicants.

Are for-profit organizations eligible?

Yes. For-profit organizations other than small businesses are listed as eligible applicants.

Are nonprofits eligible?

Yes. Nonprofits with or without 501(c)(3) status are eligible, excluding institutions of higher education within those nonprofit categories as stated in the provided eligibility list.

Are tribal entities eligible?

Yes. Eligible applicants include Native American tribal governments (federally recognized) and Native American tribal organizations (other than federally recognized tribal governments).

Are public housing authorities eligible?

Yes. Public housing authorities and Indian housing authorities are listed as eligible applicants.

Are U.S. territories or possessions eligible?

Yes. U.S. territories or possessions are explicitly called out as eligible.

Are foreign (non-U.S.) organizations eligible?

Yes. The FOA explicitly lists non-U.S. entities (foreign organizations) as eligible applicant types.

Does the FOA mention specific institution types such as HBCUs or HSIs?

Yes. The FOA explicitly calls out additional eligible applicant types, including Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), and other serving institutions such as Alaska Native and Native Hawaiian Serving Institutions and AANAPISISs.

Are faith-based or community-based organizations eligible?

Yes. Faith-based or community-based organizations are explicitly listed among additional eligible applicant types.

Are federal agencies eligible to apply?

Yes. Eligible federal agencies are explicitly mentioned as additional eligible applicant types.

What is the Assistance Listing (CFDA) number for this opportunity?

The Assistance Listing (CFDA) number provided is 93.279.

What is the activity category for this opportunity?

The activity category is listed as Health (and also listed as Education, Health).

When was this opportunity created?

The opportunity was created on 2023-08-18.

What is the closing date listed for this opportunity?

The listed closing date is 2026-08-13.

Does the provided information include an award ceiling or expected number of awards?

No. The provided information does not include an award ceiling or the expected number of awards.

What kinds of applicants are a strong fit for this program?

Teams developing neuromodulatory or neurophysiological devices (and potentially other device modalities aligned with SUD treatment) that are ready to transition into a more regulatory-facing stage are described as strong fits, especially when they can present a clear clinical need, a plausible therapeutic rationale, a realistic milestone-driven development plan, and a strategy to produce the data needed for the next FDA step.

What kinds of evidence does NIH appear to want applicants to generate?

The FOA emphasizes evidence that supports regulatory progress, such as safety and effectiveness validation, key performance data, device reliability improvements, usability improvements, and evidence needed for the next regulatory interaction.

How does NIH involvement relate to milestones and oversight?

The provided description indicates NIH involvement may include active programmatic collaboration, milestone-based oversight, and coordination intended to keep the project aligned with translational objectives and regulatory progress.

Is the program focused on treating substance use disorders specifically?

Yes. The opportunity is specifically focused on device-based treatments for substance use disorders (SUDs).

What is the overarching theme of the FOA in plain terms?

The theme is moving promising device technologies for SUD treatment from development into the kind of evidence-generating work that supports FDA-facing decisions, with the ultimate aim of producing FDA-approved device treatments.