National Cooperative Drug/Device Discovery/Development Groups (NCDDG) for the Treatment of Mental Disorders or Alcohol Use Disorder (U19 Clinical Trial Optional) | PAR 22 144

Opportunity Information: Apply for PAR 22 144

The National Cooperative Drug/Device Discovery/Development Groups (NCDDG) for the Treatment of Mental Disorders or Alcohol Use Disorder (U19 Clinical Trial Optional) funding opportunity (PAR-22-144) is an NIH cooperative agreement designed to push promising treatment ideas further down the pipeline, from discovery through preclinical work and into early proof-of-concept testing. It is a reissue of PAR-20-119 and focuses on developing new, rationally designed therapeutic candidates and neurostimulation approaches for mental disorders, substance use disorders (SUDs), and alcohol use disorder (AUD). In practical terms, NIH is looking for teams that can move beyond basic observation and instead build a coherent, milestone-driven program that generates candidate drugs, biologics, or devices with a credible path toward demonstrating that they engage the intended target and produce meaningful signals of efficacy.

A central goal of this FOA is to support multi-project, integrated research programs rather than single, stand-alone studies. The U19 mechanism is meant for a broadly based and multidisciplinary effort organized around one major objective or program theme, often requiring long-term coordination across specialties. Typical programs under this structure might combine medicinal chemistry or biologics engineering, pharmacology and toxicology, biomarkers and target engagement assays, device engineering for neuromodulation, and early-stage human or translational testing. The FOA also explicitly supports the development of novel ligands and circuit-engagement devices as research tools, particularly when those tools help characterize existing therapeutic targets or validate new ones. That means applicants can propose tool-building work when it is clearly tied to sharpening target selection, confirming mechanism, or enabling better translation from preclinical models to human studies.

The opportunity places strong emphasis on collaboration, especially partnerships between academia and industry. NIH is signaling that it values programs that bring together the strengths of academic discovery and industry-style development discipline, such as scalable chemistry/manufacturing plans, regulatory-aware study design, robust safety and pharmacokinetic evaluation strategies, device quality considerations, and realistic go/no-go criteria. Because this is a cooperative agreement, the relationship with NIH is typically more hands-on than with a standard grant, with NIH staff expected to have substantial involvement in the stewardship of the program’s progress and coordination, consistent with cooperative agreement norms.

The FOA is labeled "Clinical Trial Optional," which generally indicates that a program may include clinical trial activities but is not required to do so. Applicants can propose preclinical-only packages aimed at readiness for first-in-human or proof-of-concept work, or they can include clinical proof-of-concept components where justified and feasible. The common thread is that the program should be development-oriented and directed toward deliverables that meaningfully advance a candidate intervention or enabling tool toward real-world testing and use.

This announcement also clarifies when applicants might consider a different mechanism. If a team is seeking support for a more discrete, circumscribed project that is primarily centered on the named investigator’s specific area of interest and can be executed without the broader, multi-project cooperative structure, NIH points them toward the companion U01 FOA. The U19, by contrast, is positioned for coordinated programs that need multiple interlocking projects and cores to achieve a shared, high-level goal.

Eligibility is broad across U.S.-based organizational types. Eligible applicants include state, county, and local governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; other Native American tribal organizations; public housing authorities/Indian housing authorities; nonprofits (with or without 501(c)(3) status); for-profit organizations (other than small businesses); and small businesses. The FOA also highlights additional eligible categories 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, and U.S. territories or possessions. At the same time, it draws clear boundaries around foreign participation: non-U.S. (non-domestic) entities and foreign institutions are not eligible to apply as the applicant organization, and non-domestic components of U.S. organizations are not eligible to apply. However, foreign components, as defined in the NIH Grants Policy Statement, are allowed, which typically means foreign collaborations may be included in a limited, well-justified way under NIH policy even though the applicant organization must be domestic.

From an administrative standpoint, the funding instrument is a cooperative agreement, the activity category is health, and the relevant CFDA numbers are 93.242 and 93.273. The sponsor is the National Institutes of Health. The original closing date listed for this opportunity is 2025-02-24. The public listing does not specify an award ceiling or expected number of awards in the provided text, so applicants would usually need to confirm budget guidance, project period expectations, and any program-specific caps or limits in the full FOA document and related NIH institute guidance.

Overall, PAR-22-144 is aimed at teams that want to do serious, translationally focused development work on new drugs, devices, and neurostimulation approaches for mental health conditions and AUD, including the creation of enabling ligands and circuit tools that make target validation and mechanism testing more rigorous. The NIH preference is for integrated, milestone-driven, multi-project programs with strong cross-sector partnerships and a clear plan to generate actionable proof-of-concept evidence rather than isolated exploratory studies.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "National Cooperative Drug/Device Discovery/Development Groups (NCDDG) for the Treatment of Mental Disorders or Alcohol Use Disorder (U19 Clinical Trial Optional)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.242, 93.273.
• This funding opportunity was created on 2022-05-06.
• Applicants must submit their applications by 2025-02-24. (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 22 144

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