National Cooperative Drug/Device Discovery/Development Groups (U01) | PAR 17 185

Opportunity Information: Apply for PAR 17 185

The National Cooperative Drug/Device Discovery/Development Groups (U01) opportunity (Funding Opportunity Number PAR-17-185) is a National Institutes of Health (NIH) cooperative agreement designed to speed up the discovery and early development of new drugs and medical devices aimed at mental health conditions, substance use disorders (SUDs), and alcohol addiction. The program is built around moving promising ideas efficiently from early discovery through preclinical development and into early proof-of-concept (PoC) and initial human testing when appropriate. Because it is a U01 cooperative agreement, awardees should expect substantial NIH scientific involvement compared with a standard research grant, with a focus on milestone-driven progress and coordination to keep projects advancing toward clear translational endpoints.

The core purpose of the initiative is to accelerate innovative drug and device discovery while also strengthening the research toolbox available to the field. On the drug side, this includes discovering and developing rationally designed candidate agents and creating novel pharmacologic tools, such as ligands, that can help scientists better study biological targets and mechanisms relevant to psychiatric disorders and addiction. On the device side, the initiative emphasizes neuromodulatory and neurostimulation approaches, including developing and validating circuit-engagement devices that can be used both as experimental tools and as potential therapeutic candidates. A major theme throughout the opportunity is practical translational progress: generating evidence that a candidate agent or device engages its intended target, produces meaningful biological or functional effects, and has a plausible path toward clinical testing and eventual patient benefit.

Another key element is support for early-stage human studies intended to rapidly evaluate fundamentals such as safety, tolerability, and pharmacodynamics. The announcement specifically highlights interest in projects that can bring forward Investigational New Drug (IND)-ready agents or new indications for novel IND-ready agents, as well as Pre-Market Approval (PMA)-ready devices or PMA-ready device concepts. In other words, the NIH is looking for proposals that are not just exploratory, but that can reasonably progress toward regulatory-relevant packages and early clinical evaluation, helping the field make go/no-go decisions efficiently.

The FOA also encourages projects that develop and validate tools to support experimental therapeutic studies of innovative candidates. This can include pharmacologic probes, biomarkers, and device-based methods that improve the ability to test whether a target or neural circuit is engaged and whether that engagement is linked to measurable clinical or translational outcomes. By supporting both therapeutic candidates and enabling tools, the program aims to reduce bottlenecks that often slow psychiatric and addiction treatment development, such as limited target validation, weak translational measures, and uncertainty about mechanisms of action.

Partnerships between academia and industry are strongly encouraged, reflecting the reality that successful drug and device development often requires capabilities spread across sectors, such as medicinal chemistry, manufacturing, regulatory strategy, device engineering, and clinical operations. Collaborative arrangements can help applicants assemble the expertise needed to move beyond basic research and into development-grade workflows, including preparing for IND-enabling studies, device verification and validation, and early clinical trial execution.

Eligibility is broad across U.S.-based organizations and includes 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 and without 501(c)(3) status (other than institutions of higher education); for-profit organizations (other than small businesses); and small businesses. The announcement 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 (AANAPISIs), 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, and U.S. territories or possessions. At the same time, non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations are not eligible to apply. However, foreign components may be allowed as defined under the NIH Grants Policy Statement, meaning certain project elements can be conducted abroad under specific NIH rules even though a foreign institution cannot serve as the applicant organization.

Administratively, the opportunity is categorized as discretionary funding and uses the cooperative agreement funding instrument (U01). The activity category is listed under education and health, and associated CFDA numbers include 93.242, 93.273, and 93.279. The NIH posted the opportunity with a creation date of March 1, 2017, and the original closing date listed is January 24, 2018. The listing does not specify an award ceiling or the expected number of awards in the provided source data, so applicants typically would need to consult the full FOA text and NIH institute guidance for budget expectations, project periods, and any program-specific funding targets.

Overall, this grant opportunity is aimed at teams that can credibly advance new pharmacologic or neuromodulatory candidates for mental disorders and addiction from concept toward tangible development milestones, while also producing validated tools that strengthen the field’s ability to test targets, measure circuit engagement, and run informative early experimental therapeutics studies. The emphasis on IND- and PMA-readiness, early human safety and pharmacodynamic evaluation, and academia-industry collaboration signals a program that prioritizes translational momentum and real-world development pathways rather than purely exploratory research.

• The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "National Cooperative Drug/Device Discovery/Development Groups (U01)" 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 17 185

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