National Cooperative Drug/Device Discovery/Development Groups (NCDDG) for the Treatment of Mental or Substance Use Disorders or Alcohol Disorder (U19 Clinical Trial Optional) | PAR 20 119

Opportunity Information: Apply for PAR 20 119

The National Cooperative Drug/Device Discovery/Development Groups (NCDDG) program for the Treatment of Mental or Substance Use Disorders or Alcohol Use Disorder is a National Institutes of Health (NIH) funding opportunity that uses a U19 cooperative agreement mechanism to push promising treatment ideas across the difficult gap between early discovery and initial human testing. The core aim is to speed up the creation and early validation of new therapeutics for mental disorders, substance use disorders (SUDs), and alcohol use disorder (AUD), including both traditional pharmacologic approaches (small molecules, biologics, novel ligands) and neuromodulatory or neurostimulation technologies (devices intended to engage circuits and change brain activity in a targeted way). Because it is a cooperative agreement, NIH is typically more actively involved than in a standard grant, with an emphasis on milestone-driven teamwork, shared problem-solving, and coordinated development plans.

This FOA is designed to support a pipeline of work that can include discovery, preclinical development, and proof-of-concept (PoC) evaluation, with a strong translational focus. On the discovery and tool-building side, it encourages the development of pharmacologic and neuromodulatory tools that can be used in both basic and clinical research. That includes creating and validating compounds or stimulation approaches that help researchers confirm whether a biological target or neural circuit is actually relevant to a disorder, and whether engaging it produces measurable, meaningful changes. In parallel, it supports work to develop and validate tools for experimental therapeutics, meaning the kinds of interventions and measurements needed to test innovative candidates in a way that clearly links mechanism (target engagement or circuit engagement) to functional outcomes.

A major emphasis is on readiness for early-stage human studies when appropriate. The FOA explicitly supports early clinical efforts that rapidly assess safety, tolerability, and pharmacodynamics, so that programs do not stall after preclinical success. It also highlights interest in studies involving IND-ready agents (Investigational New Drug-ready candidates) or IDE-ready devices (Investigational Device Exemption-ready devices), as well as new therapeutic indications for novel candidates that are already sufficiently developed to move toward initial human evaluation. The "Clinical Trial Optional" label indicates that applications may include clinical trials if they fit the project goals and readiness level, but a clinical trial is not mandatory for every application. The overall intent is to help teams make rigorous go/no-go decisions using objective data rather than letting projects linger without a clear development path.

The program strongly encourages partnerships between academia and industry, reflecting the reality that successful drug and device development often requires capabilities spread across sectors, such as medicinal chemistry, formulation, manufacturing considerations, regulatory strategy, device engineering, quality systems, and clinical operations. The NCDDG structure is meant to support collaborative, multi-component projects where different groups contribute specialized expertise toward a shared translational goal, such as advancing a candidate therapy to PoC testing or delivering a validated research tool that can accelerate target validation across the field.

Eligibility is broad and includes many types of U.S.-based organizations: 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; tribal organizations that are not federally recognized; 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 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 (AANAPISI), faith-based or community-based organizations, eligible federal agencies, regional organizations, tribal governments that are not federally recognized, and U.S. territories or possessions. At the same time, it makes a key restriction clear: non-U.S. (non-domestic) entities and foreign institutions are not eligible to apply as the applicant organization, and non-U.S. components of U.S. organizations are not eligible to apply. However, "foreign components" as defined by the NIH Grants Policy Statement are allowed, meaning a U.S. applicant may include certain well-justified international collaborations or performance sites as part of the project if they meet NIH policy requirements.

Administratively, the opportunity is listed as PAR-20-119, offered by NIH under CFDA numbers 93.242, 93.273, and 93.279, and categorized under education and health-related funding activities. The original posting date is February 25, 2020, and the listed original closing date is March 25, 2022. The award ceiling and expected number of awards are not specified in the provided listing, which is common for some NIH program announcements where budgets and award counts can vary based on appropriations, application quality, and program priorities. Overall, the opportunity is best viewed as a structured, milestone-oriented way to assemble a multidisciplinary team to move a therapy or enabling research tool forward with enough rigor to support later-stage development, while keeping the focus on mechanism-based innovation for mental health conditions, SUDs, and AUD.

• 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 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, 93.279.
• This funding opportunity was created on 2020-02-25.
• Applicants must submit their applications by 2022-03-25. (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.

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