Opportunity Information: Apply for PAR 20 279
The grant opportunity titled "Device-Based Treatments for Substance Use Disorders (UG3/UH3, Clinical Trial Optional)" (Funding Opportunity Number PAR 20 279) is a National Institutes of Health (NIH) cooperative agreement designed to speed up the development of medical devices intended to treat substance use disorders (SUDs). Its central focus is on taking advantage of modern technological advances, especially in neuromodulation and neurophysiology, to create device-based interventions that are both safe and effective for people struggling with SUDs. The overarching aim is practical and translational rather than purely exploratory: to push promising device candidates forward to the next milestone in the U.S. Food and Drug Administration (FDA) approval pathway, with the long-term goal of producing new, FDA-approved device treatments for SUDs.
A key feature of this opportunity is its UG3/UH3 structure, which generally supports a phased approach to development under a single program. In practice, this kind of mechanism is commonly used to fund an early, milestone-driven stage (UG3) that de-risks the project by completing defined development activities, followed by a later stage (UH3) that continues or expands the work once the project has demonstrated it can meet those milestones. Because the FOA is a cooperative agreement, NIH is expected to have substantial involvement during the project, meaning applicants should anticipate more active scientific and programmatic coordination than they might see in a standard research grant. The notice also states "Clinical Trial Optional," indicating that applicants may propose projects that include clinical testing, but a clinical trial is not required; both preclinical development and clinical evaluation pathways can potentially fit, as long as the work is clearly oriented toward advancing a device toward FDA-related next steps.
The program is open to a broad set of applicants across government, academia, nonprofit, and industry. Eligible applicants explicitly include state, county, city or 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); tribal organizations that are not federally recognized tribal governments; public housing authorities and Indian housing authorities; nonprofits with and without 501(c)(3) status (excluding institutions of higher education in those nonprofit categories); for-profit organizations other than small businesses; small businesses; and other unspecified eligible entities. The FOA also highlights additional eligible applicant types, emphasizing inclusion of organizations such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), 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. (foreign) entities. Taken together, that eligibility language signals NIH interest in drawing proposals from a wide range of research and implementation environments, including those serving populations disproportionately affected by SUDs.
From an administrative standpoint, the opportunity is categorized as discretionary funding and uses the cooperative agreement funding instrument. The activity areas are listed under education and health, and the associated CFDA (assistance listing) numbers are 93.273 and 93.279. The source data lists an award ceiling of $500,000, and it notes an original closing date of 2023-08-10. The FOA was created on 2020-07-27. While the listing does not provide details such as project period length, review criteria, or specific milestones, its stated purpose makes clear that proposals should be strongly development-oriented, anchored in a credible regulatory and translational plan, and aimed at producing evidence and technical progress that materially advances a device toward FDA clearance or approval for treating substance use disorders.Apply for PAR 20 279
- 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): 93.273, 93.279.
- This funding opportunity was created on 2020-07-27.
- Applicants must submit their applications by 2023-08-10. (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.
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FAQs: Device-Based Treatments for Substance Use Disorders (UG3/UH3, Clinical Trial Optional) - PAR 20 279
What is the purpose of this grant opportunity?
This NIH cooperative agreement is intended to speed up the development of medical devices designed to treat substance use disorders (SUDs). The emphasis is on practical, translational work that advances promising device candidates to the next milestone in the FDA approval pathway, with the long-term goal of producing new, FDA-approved device treatments for SUDs.
What is the official title and funding opportunity number?
The opportunity is titled "Device-Based Treatments for Substance Use Disorders (UG3/UH3, Clinical Trial Optional)" and the Funding Opportunity Number is PAR 20 279.
What kind of projects is NIH trying to support?
The program supports development-oriented device projects that leverage modern technological advances, especially in neuromodulation and neurophysiology, to create interventions that are safe and effective for people with substance use disorders. The work is expected to be oriented toward FDA-related next steps rather than purely exploratory research.
Does this opportunity require a clinical trial?
No. The FOA is labeled "Clinical Trial Optional," meaning a clinical trial may be proposed but is not required. Both preclinical development and clinical evaluation approaches may be appropriate, as long as the work is clearly aimed at moving a device forward toward FDA clearance or approval milestones for treating SUDs.
What does UG3/UH3 mean in this funding announcement?
The UG3/UH3 structure typically supports a phased approach within a single program. The UG3 phase is generally an early, milestone-driven stage intended to de-risk the project by completing defined development activities. The UH3 phase generally supports later-stage work that continues or expands development after successful completion of UG3 milestones.
What is a cooperative agreement, and how does it affect the project?
This opportunity uses a cooperative agreement funding instrument, which means NIH is expected to have substantial involvement during the project. Applicants should anticipate more active scientific and programmatic coordination than in a standard research grant.
What is the main technical focus mentioned in the opportunity description?
The central focus is on using modern technological advances, especially in neuromodulation and neurophysiology, to develop device-based interventions for substance use disorders.
What is the long-term goal of the program?
The long-term goal is to produce new, FDA-approved device treatments for substance use disorders by advancing device candidates along the FDA approval or clearance pathway.
What kinds of applicants are eligible to apply?
The opportunity is open to a broad range of applicants across government, academia, nonprofit, and industry. Eligible applicants explicitly include many types of entities, including state and local governments, institutions of higher education, tribal governments and tribal organizations, public housing authorities, nonprofits (with and without 501(c)(3) status, excluding institutions of higher education in those nonprofit categories), for-profit organizations, small businesses, and other eligible entities.
Are U.S. territories and non-U.S. organizations eligible?
Yes. The eligibility language explicitly includes U.S. territories or possessions and also includes non-U.S. (foreign) entities among eligible applicant types.
Does the FOA encourage proposals from organizations serving disproportionately affected populations?
Yes. The eligibility language emphasizes inclusion of organizations such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISIs, Hispanic-serving Institutions, HBCUs, TCCUs, and faith-based or community-based organizations, signaling interest in proposals from diverse environments, including those serving populations disproportionately affected by SUDs.
Is this opportunity considered discretionary funding?
Yes. The opportunity is categorized as discretionary funding.
What are the listed activity areas for this opportunity?
The activity areas are listed under education and health.
What are the associated assistance listing (CFDA) numbers?
The associated CFDA (assistance listing) numbers are 93.273 and 93.279.
What is the maximum award amount listed?
The source data lists an award ceiling of $500,000.
When was the funding opportunity created?
The FOA was created on 2020-07-27.
What is the closing date shown for this opportunity?
The source data notes an original closing date of 2023-08-10.
Does the listing provide details like project period length, review criteria, or specific milestones?
No. The provided listing does not include details such as project period length, review criteria, or specific milestones. However, it does state that proposals should be development-oriented, include a credible regulatory and translational plan, and produce evidence and technical progress that advances the device toward FDA-related next steps.
What kind of plan should applicants be prepared to describe?
Based on the stated purpose, proposals should be anchored in a credible regulatory and translational plan and should focus on generating evidence and technical progress that materially advances a device toward FDA clearance or approval for treating substance use disorders.
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