National Cooperative Drug/Device Discovery/Development Groups (NCDDG) for the Treatment of Mental or Substance Use Disorders or Alcohol Addiction (U19) | PAR 17 186

Opportunity Information: Apply for PAR 17 186

The National Cooperative Drug/Device Discovery/Development Groups (NCDDG) for the Treatment of Mental or Substance Use Disorders or Alcohol Addiction (U19) funding opportunity (PAR-17-186) is a National Institutes of Health (NIH) cooperative agreement designed to speed up the creation and early testing of new drugs and neurostimulation devices aimed at treating mental disorders, substance use disorders (SUDs), and alcohol addiction. The core idea is to move promising, scientifically grounded treatment concepts more efficiently from discovery through preclinical development and into early human studies, while also generating research tools that help the field understand and validate biological targets and brain circuits relevant to these conditions. Because it uses the U19 cooperative agreement mechanism, projects are generally expected to involve substantial scientific interaction with NIH staff compared with a standard grant, reflecting the program’s emphasis on coordinated, milestone-driven development work.

The initiative emphasizes several connected goals across the development pipeline. First, it seeks to accelerate innovative discovery and development of pharmacologic candidates (such as small molecules or other therapeutic agents) and neuromodulatory approaches (such as neurostimulation strategies) that can ultimately become treatments. Second, it supports the development of pharmacologic and neuromodulatory tools that can be used in both basic and clinical research, meaning the program is not limited to therapy candidates alone; it also values tools that help researchers probe mechanisms, measure target engagement, and understand how interventions affect neural circuits and behavior. Third, it aims to develop and validate tools, whether drug-based or device-based, specifically to support experimental therapeutic studies of new candidates. This includes generating the kind of evidence needed to justify moving into proof-of-concept testing, and building confidence that a target or circuit is worth pursuing.

A major focus is advancing projects to key translational endpoints. The announcement explicitly encourages work that progresses from discovery through preclinical development and into proof-of-concept (PoC) testing, including early stage human studies. Those early human studies are framed around rapidly assessing safety, tolerability, and pharmacodynamics, in other words, whether the candidate is safe enough at relevant doses, how well people tolerate it, and whether it produces measurable biological effects consistent with the proposed mechanism (for example, evidence of target engagement or circuit modulation). The program also signals readiness expectations for later-stage translation by referencing IND-ready agents (Investigational New Drug-ready drug candidates) and PMA-ready devices (Pre-Market Approval-ready device candidates), as well as exploring new indications for novel candidates that are already at or near these regulatory readiness points. In practical terms, applicants are being invited to propose plans that generate the data packages needed to make regulatory and clinical development decisions sooner rather than later.

Beyond therapies themselves, the FOA highlights the importance of enabling technologies and validation tools, such as novel ligands and circuit-engagement devices. These are positioned as tools to better characterize existing targets or to validate new ones, which is particularly important in mental health and addiction where translating basic neuroscience into effective clinical interventions often hinges on having reliable measures of whether an intervention is engaging the intended biology in humans. By supporting ligands and circuit-engagement devices, the program is signaling that it values biomarkers, imaging agents, stimulation paradigms, and other translational tools that can de-risk development by clarifying mechanism and providing objective readouts during experimental medicine studies.

Collaboration is a central theme. The FOA strongly encourages partnerships between academia and industry, reflecting the reality that successful drug and device development typically requires capabilities that are distributed across sectors, such as medicinal chemistry and screening platforms, manufacturing and scale-up, device engineering, regulatory strategy, and clinical trial execution. The NCDDG structure is intended to support multi-component, team-based efforts that can integrate discovery science with development expertise, rather than isolated projects that stop short of actionable translational deliverables.

Eligibility is broad and includes many U.S.-based organizational types: state, county, and local governments; special district governments; independent school districts; public and state-controlled and private institutions of higher education; federally recognized Native American tribal governments; tribal organizations other than federally recognized governments; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses); small businesses; and other eligible entities. The FOA also calls out additional eligible applicant categories, including 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, regional organizations, eligible agencies of the federal government, and U.S. territories or possessions. At the same time, it draws a clear boundary around foreign participation: 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 in the NIH Grants Policy Statement, meaning a U.S. applicant may include certain foreign elements in the project when well-justified and compliant with NIH policy.

Administratively, the opportunity is listed as a discretionary funding program under NIH, with activity tied to education and health and associated CFDA numbers 93.242, 93.273, and 93.279. The opportunity was created on 2017-03-01, and the original closing date listed is 2018-01-24. While the provided excerpt does not specify an award ceiling or the expected number of awards, the overall scope and cooperative agreement structure suggest that NIH intended to support substantial, coordinated development programs capable of delivering concrete translational milestones, such as validated targets, optimized candidates, IND- or PMA-enabling data elements, and early human evidence of safety and biological activity for interventions aimed at mental illness, SUDs, and alcohol addiction.

• 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)" 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 2017-03-01.
• Applicants must submit their applications by 2018-01-24. (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 17 186

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