National Cooperative Drug/Device Discovery/Development Groups (NCDDG) for the Treatment of Mental or Substance Use Disorders or Alcohol Addiction (U19 Clinical Trial Optional) | PAR 18 231

Opportunity Information: Apply for PAR 18 231

The National Cooperative Drug/Device Discovery/Development Groups (NCDDG) for the Treatment of Mental or Substance Use Disorders or Alcohol Addiction (U19 Clinical Trial Optional) is a National Institutes of Health (NIH) cooperative agreement program designed to speed up the pipeline from early discovery to early human testing for new therapeutics and research tools targeting mental disorders, substance use disorders (SUDs), and alcohol addiction. The overarching aim is to move beyond incremental progress by supporting coordinated, milestone-driven teams that can discover, refine, and test novel pharmacologic agents and neuromodulatory or neurostimulation devices. Because it uses a U19 cooperative agreement mechanism, the expectation is that awardees will work in close collaboration with NIH staff, typically with substantial programmatic involvement and an emphasis on well-managed multi-project efforts rather than a single independent research project.

A central focus of this opportunity is accelerating innovative drug and device discovery and development, including both treatment candidates and enabling tools that advance the science. On the drug side, this can include the identification and optimization of rationally designed candidate agents, development of new ligands, and other pharmacologic tools that help confirm targets and mechanisms in the brain and body. On the device side, the program supports neuromodulatory and neurostimulation approaches, including tools and devices aimed at circuit engagement, with the goal of better understanding and validating neural targets and translating that understanding into candidate interventions. In other words, the program is not only about producing a final therapy; it also invests in tools that help the field measure whether a target or circuit is truly engaged and whether that engagement produces the intended biological and behavioral effects.

The funding announcement explicitly encourages applications that take candidates through discovery, preclinical development, and proof-of-concept (PoC) testing, with an emphasis on projects that are grounded in a clear rationale. Preclinical activities can include development and validation work needed to make a candidate credible for translation, such as pharmacology, target validation, safety-related studies, and device feasibility steps that position an intervention for later regulatory pathways. For projects that are ready, the FOA also supports early stage human studies intended to rapidly assess safety, tolerability, and pharmacodynamics. These early clinical efforts are meant to provide quick, decision-relevant data on whether a promising candidate drug or device is behaving as expected in people, including potential new indications for agents that are already IND-ready (for drugs) or devices that are PMA-ready (for devices). The “Clinical Trial Optional” designation indicates that applicants may propose clinical trials when appropriate, but they are not required to include a trial if the work is at an earlier stage.

A distinguishing feature of this initiative is its emphasis on translational readiness and practical development outcomes, including progress toward regulatory-grade packages. For drugs, that often means positioning a compound for Investigational New Drug (IND) enabling steps or leveraging an IND-ready agent toward a new use in mental health or addiction. For devices, it means advancing candidates that could realistically move toward the FDA’s Pre-Market Approval (PMA) pathway or otherwise fit established regulatory routes, with the expectation that development plans, testing strategies, and endpoints are aligned with real-world translational needs. The initiative also highlights experimental therapeutics, meaning it values projects that can connect a therapeutic hypothesis to measurable target engagement and functional outcomes, rather than treating clinical testing as a purely empirical exercise.

Partnerships between academia and industry are strongly encouraged, reflecting the reality that successful drug and device development often requires blending academic innovation with industry development experience, manufacturing knowledge, regulatory strategy, and operational capacity. The program is structured to support collaborative groups that can integrate medicinal chemistry or device engineering, neurobiology, pharmacology, behavioral science, and clinical expertise into a single coordinated development plan. This cooperative, team-science model is meant to reduce the common handoff failures that occur when discovery and development are separated into disconnected efforts.

Eligibility is broad and includes many U.S.-based organization types: 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; Native American tribal organizations other than federally recognized tribal governments; public housing authorities/Indian housing authorities; nonprofits both with and without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses. The FOA also notes 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, and Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), along with faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions. At the same time, it places clear limits on foreign involvement: non-U.S. entities (foreign organizations and foreign institutions) are not eligible to apply as applicants, and non-U.S. components of U.S. organizations are not eligible to apply. However, “foreign components” may be allowed under NIH policy, meaning certain well-justified foreign collaborations or performance sites can be included if they meet NIH definitions and requirements.

From an administrative standpoint, this opportunity is listed as a discretionary funding program under NIH, using the cooperative agreement instrument (U19) and aligned with health-related program areas (CFDA numbers 93.242, 93.273, 93.279). The funding opportunity number is PAR-18-231, and the source information provided indicates an original closing date of February 24, 2020, with a creation date of November 21, 2017. While those dates matter for historical context, the program description is most useful as a template for understanding what NIH sought to fund: coordinated, translationally focused groups capable of producing credible therapeutic candidates or enabling tools for mental health and addiction research, with a clear path toward proof-of-concept and, where feasible, early human evaluation focused on safety, tolerability, and pharmacodynamic evidence of target or circuit engagement.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "National Cooperative Drug/Device Discovery/Development Groups (NCDDG) for the Treatment of Mental or Substance Use Disorders or Alcohol Addiction (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, 93.279.
• This funding opportunity was created on 2017-11-21.
• Applicants must submit their applications by 2020-02-24. (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 18 231

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