Opportunity Information: Apply for PAR 21 092
The NIDA Translational Avant-Garde Award for Development of Medication to Treat Substance Use Disorders (UG3/UH3 Clinical Trial Optional) is a National Institutes of Health (NIH) funding opportunity from the National Institute on Drug Abuse (NIDA) designed to push promising medication ideas further down the real-world drug development path. It is aimed at researchers who can take discoveries from basic science and/or clinical research and translate them into actual therapeutic candidates for substance use disorders (SUDs). The program is specifically focused on medications intended to treat SUDs related to tobacco, cannabis, cocaine, methamphetamine, heroin, or prescription opioid use, with an emphasis on moving molecules closer to eventual Food and Drug Administration (FDA) approval.
This opportunity uses a cooperative agreement mechanism, meaning awardees should expect substantial NIH/NIDA involvement compared with a standard research grant. The funding mechanism is structured as UG3/UH3, which generally reflects a phased approach: an initial stage supporting milestone-driven planning and early development activities (UG3), followed by a second stage intended to support more advanced development once specific milestones are met (UH3). The notice indicates that clinical trials are optional, which signals that projects may focus on preclinical development, translational studies, early clinical work, or a combination, so long as the proposed work credibly advances a medication candidate along the development continuum.
A central expectation is that applicants can demonstrate a credible capability to develop molecules with therapeutic potential and to advance those candidates through recognized steps of drug development. In practical terms, this typically means applicants should be able to show a compelling scientific rationale and target or mechanism, evidence supporting a lead compound or series, and a well-structured plan for activities such as lead optimization, pharmacology, safety-related studies, formulation, and other translational elements that make a candidate more viable for regulatory progression. The overall goal is not simply to generate academic knowledge, but to create a realistic path toward a medication that could ultimately meet regulatory requirements and be positioned for FDA review.
The program falls under the U.S. Department of Health and Human Services (HHS), NIH, and is listed under CFDA number 93.279. It is categorized as a discretionary grant opportunity and sits within the education and health activity area, reflecting NIH's broader mission to improve health through research while also supporting the training and development of translational research capabilities.
Eligibility is broad and includes many types of domestic organizations. Eligible applicants include 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 and Indian housing authorities; nonprofit organizations with or without 501(c)(3) status (excluding institutions of higher education when specified); for-profit organizations other than small businesses; small businesses; and other entities as described in the opportunity's additional eligibility information. This wide eligibility scope is consistent with the translational nature of the program, which often benefits from participation by academic groups, medical centers, nonprofits, and industry or industry-like development teams.
In terms of scale and competitiveness, the opportunity lists an award ceiling of $1,000,000 and anticipates making about two awards. That combination of a relatively high cap and a small expected number of awards signals a selective program intended for highly compelling, well-justified projects with strong teams and a clear development strategy. The opportunity was created on December 21, 2020, and lists an original closing date of July 25, 2023, under Funding Opportunity Number PAR-21-092.
Overall, the NIDA Translational Avant-Garde Award is best understood as a targeted translational pipeline accelerator for SUD medication development: it supports investigators who can bridge discovery and product-oriented development, emphasizes concrete advancement of therapeutic molecules, and aims to reduce the gap between promising research findings and viable, FDA-approvable medications for high-impact substance use disorders.Apply for PAR 21 092
- The Department of Health and Human Services, National Institutes of Health in the education, health sector is offering a public funding opportunity titled "NIDA Translational Avant-Garde Award for Development of Medication to Treat Substance Use Disorders (UG3/UH3 Clinical Trial Optional)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.279.
- This funding opportunity was created on Dec 21, 2020.
- Applicants must submit their applications by Jul 25, 2023. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $1,000,000.00 in funding.
- The number of recipients for this funding is limited to 2 candidate(s).
- 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 (see text field entitled Additional Information on Eligibility for clarification).
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