National Cooperative Drug/Device Discovery/Development Groups (NCDDG) for the Treatment of Mental Disorders or Alcohol Use Disorder (U01 Clinical Trial Optional) | PAR 22 143

Opportunity Information: Apply for PAR 22 143

The National Cooperative Drug/Device Discovery/Development Groups (NCDDG) for the Treatment of Mental Disorders or Alcohol Use Disorder (U01 Clinical Trial Optional) funding opportunity (PAR-22-143) is an NIH cooperative agreement designed to push promising treatment ideas further down the pipeline, from discovery through early-stage testing. It is a reissue of PAR-20-118 and focuses on building and advancing rational, evidence-based therapeutic candidates and neurostimulation approaches aimed at mental disorders, substance use disorders (including alcohol use disorder), and related conditions. The intent is not just basic exploration, but work that moves toward tangible, testable interventions and the tools needed to validate and understand the biological targets those interventions are meant to affect.

A central emphasis of this FOA is translational progress. Projects are expected to advance the discovery and preclinical development of candidate agents (such as small molecules, biologics, or other therapeutic modalities) and/or neurostimulation strategies, with a strong interest in reaching proof-of-concept (PoC) milestones. In practice, that means applicants should be proposing a structured plan that can generate decisive evidence that a candidate treatment or device engages a relevant target or circuit and shows potential for meaningful effects. The opportunity also supports development of novel ligands and circuit-engagement devices, not only as potential therapeutic components but also as research tools that help characterize existing targets or validate new ones. This tool-development aspect matters because it can clarify whether a target is truly relevant to a disorder and whether it can be modulated in a measurable, reproducible way.

The award uses the U01 mechanism, which supports a discrete, well-defined, and circumscribed project led by named investigator(s), aligned with their expertise and capabilities. Because this is a cooperative agreement rather than a standard grant, NIH is expected to have substantial programmatic involvement during the project period, typically meaning closer coordination, milestone-driven management, and ongoing interaction between awardees and the NIH program team. Applicants who want support for a broader, multi-project research program organized around a major objective and requiring a long-term, multidisciplinary structure are directed to consider the companion U19 FOA instead. In other words, U01 is positioned for a single cohesive project with clear deliverables, while U19 is meant for a larger center-like effort with multiple integrated projects.

A notable feature of the announcement is its encouragement of academia-industry partnerships. The FOA explicitly signals that collaborations between academic investigators and industry groups are strongly encouraged, reflecting the reality that successful drug and device development often requires complementary capabilities. Academic teams may contribute mechanistic insights, innovative models, and early validation, while industry partners can bring medicinal chemistry, formulation, manufacturing, device engineering, regulatory experience, and late-stage development planning. The FOA is structured to support the kind of coordinated work where discovery, target validation, and early development decisions are aligned with eventual clinical and regulatory realities, even if the supported work is still at an early stage.

From an eligibility standpoint, the FOA is broadly open to many types of domestic applicants. Eligible applicant organizations 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; federally recognized Native American tribal governments; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); and small businesses. The FOA also calls out additional eligible applicant categories such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions. At the same time, it makes clear that non-U.S. (non-domestic) entities are not eligible to apply as applicant organizations, and non-U.S. 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 a U.S.-based applicant may include certain well-justified foreign collaborations or activities as part of the project, consistent with NIH policy.

Administratively, the opportunity is listed as a discretionary funding opportunity under NIH, with a cooperative agreement funding instrument and a health-related funding activity category. The CFDA numbers associated with it are 93.242 and 93.273. The posting indicates an original closing date of 2025-02-24. The award ceiling and expected number of awards are not specified in the provided source data, which often means applicants need to rely on the FOA text itself, NIH institute guidance, or communication with program officials to understand typical budgets, project periods, and the likely scale of awards for specific institutes participating in the announcement.

Overall, PAR-22-143 is aimed at teams that can propose a focused development plan that makes measurable progress toward new treatments or enabling tools for mental disorders and alcohol use disorder (and, as described, SUDs more broadly). It is best suited for projects that can articulate a rational target or circuit hypothesis, define a clear development path, and commit to the kind of milestone-based execution that NIH typically expects under a cooperative agreement, ideally leveraging partnerships that strengthen the route from discovery to proof of concept.

• 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 (U01 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 22 143

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: