National Cooperative Drug/Device Discovery/Development Groups (NCDDG) for the Treatment of Mental or Substance Use Disorders or Alcohol Disorder (U01 Clinical Trial Optional) | PAR 20 118

Opportunity Information: Apply for PAR 20 118

The National Cooperative Drug/Device Discovery/Development Groups (NCDDG) for the Treatment of Mental or Substance Use Disorders or Alcohol Disorder (U01 Clinical Trial Optional), PAR-20-118, is an NIH cooperative agreement designed to push promising drug and device ideas out of the discovery phase and toward early-stage testing in people. The central goal is translation: taking innovative therapeutic concepts for mental health disorders, substance use disorders (SUDs), and alcohol use disorder and moving them through the practical development steps needed to support first-in-human or other early clinical studies. Because this is a U01 cooperative agreement, awardees should expect an active partnership with NIH staff compared with a standard research project grant, with collaboration and milestone-driven progress being typical of this mechanism.

This opportunity supports projects that build and validate pharmacologic tools (for example, compounds or biologics with clear mechanisms) and neuromodulatory or neurostimulation tools (for example, device-based approaches) that can be used for both basic and clinical research. The FOA emphasizes development work that enables experimental therapeutics, meaning studies that not only test whether something works, but also clarify how it works through measurable pharmacodynamic or target engagement signals. In practice, responsive applications may include efforts to optimize and characterize candidate drugs, establish proof-of-concept in relevant models, develop stimulation parameters or device prototypes, and generate the data packages needed to justify moving into human evaluation.

A major focus is supporting early-stage human studies that can quickly inform whether a candidate is worth advancing. The FOA highlights rapid assessment of safety, tolerability, and pharmacodynamics for promising drugs or devices, including exploration of new indications for agents that are already IND-ready (Investigational New Drug-ready) or devices that are IDE-ready (Investigational Device Exemption-ready). The "Clinical Trial Optional" designation signals that applicants may propose clinical trials when appropriate, but a clinical trial is not required for every application; projects can also center on the preclinical-to-IND/IDE enabling pathway as long as the work clearly advances translation toward early human testing.

Eligibility is broad and includes many types of U.S.-based organizations and governmental entities. Eligible applicants 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; nonprofit organizations with or without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); small businesses; public housing authorities/Indian housing authorities; and Native American tribal governments (federally recognized) as well as tribal organizations that are not federally recognized tribal governments. The FOA also explicitly calls out additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), eligible federal agencies, faith-based or community-based organizations, regional organizations, Indian/Native American tribal governments other than federally recognized, and U.S. territories or possessions.

Foreign eligibility is limited in a way that often matters for team composition. Non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations are not eligible to apply. However, foreign components are allowed as defined by the NIH Grants Policy Statement, which generally means a U.S. applicant organization can include a foreign collaboration component when it is well justified and consistent with NIH policy, even though a foreign institution cannot be the direct applicant.

The opportunity sits within NIH health-related program areas (CFDA numbers listed include 93.242, 93.273, and 93.279) and uses the cooperative agreement funding instrument to support coordinated, translational development work. The FOA was created on February 25, 2020, and the original closing date listed is March 25, 2022. The listing does not specify an award ceiling or expected number of awards in the provided source data, so prospective applicants typically need to consult the full FOA and NIH institute guidance for budget expectations, milestone structure, and any institute-specific priorities tied to mental health, SUD, or alcohol use disorder therapeutics development.

• 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 (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, 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.

Apply for PAR 20 118

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