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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Frequently Asked Questions (FAQ)
What is the NIDA Translational Avant-Garde Award for Development of Medication to Treat Substance Use Disorders (UG3/UH3 Clinical Trial Optional)?
This is an NIH funding opportunity from the National Institute on Drug Abuse (NIDA) intended to accelerate promising medication concepts toward real-world drug development. The focus is on translating discoveries from basic science and/or clinical research into therapeutic candidates for substance use disorders (SUDs), with the longer-term aim of positioning candidates for eventual Food and Drug Administration (FDA) review.
Which federal agency and institute run this opportunity?
The opportunity is under the U.S. Department of Health and Human Services (HHS) and the National Institutes of Health (NIH), specifically the National Institute on Drug Abuse (NIDA).
What is the main goal of the program?
The central goal is to move molecules closer to eventual FDA approval by supporting milestone-driven, product-oriented development work. It is meant to reduce the gap between promising research findings and viable, FDA-approvable medications for high-impact substance use disorders.
Which substance use disorders are specifically targeted?
The program is specifically focused on medications intended to treat SUDs related to tobacco, cannabis, cocaine, methamphetamine, heroin, or prescription opioid use.
Is the program limited to academic research, or is it intended to support product development?
The program is explicitly translational and development-focused. It is not aimed solely at generating academic knowledge; it is designed to support a realistic path toward a medication candidate that could ultimately meet regulatory requirements and be positioned for FDA review.
What does it mean that this is a cooperative agreement?
This opportunity uses a cooperative agreement mechanism, which means awardees should expect substantial NIH/NIDA involvement compared with a standard research grant.
What is the UG3/UH3 structure?
The award uses a phased UG3/UH3 structure. The UG3 phase generally supports milestone-driven planning and early development activities. The UH3 phase is intended to support more advanced development work after specific milestones are achieved.
Are clinical trials required?
No. The notice indicates that clinical trials are optional, meaning projects may focus on preclinical development, translational studies, early clinical work, or a combination, as long as the proposed work credibly advances a medication candidate along the development continuum.
What kinds of activities does NIDA expect to be included in a strong development plan?
Based on the description, applicants are expected to present a credible development strategy that may include elements such as lead optimization, pharmacology, safety-related studies, formulation, and other translational steps that make a therapeutic candidate more viable for regulatory progression.
What evidence or capabilities are applicants expected to demonstrate?
Applicants are expected to demonstrate credible capability to develop molecules with therapeutic potential and advance them through recognized steps of drug development. In practical terms, this includes a compelling scientific rationale and target or mechanism, evidence supporting a lead compound or series, and a well-structured plan to move the candidate forward.
What is the CFDA number for this opportunity?
The program is listed under CFDA number 93.279.
How is this opportunity categorized?
It is categorized as a discretionary grant opportunity and is associated with the education and health activity area.
Who is eligible to apply?
Eligibility is broad and includes many types of domestic organizations, including: 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.
How much funding is available per award?
The opportunity lists an award ceiling of $1,000,000.
How many awards does NIDA expect to make?
The opportunity anticipates making about two awards.
What does the combination of a $1,000,000 ceiling and about two awards suggest about competitiveness?
It suggests a selective program aimed at highly compelling, well-justified projects with strong teams and a clear development strategy.
What is the Funding Opportunity Number (FON)?
The Funding Opportunity Number provided is PAR-21-092.
When was this opportunity created and what closing date is listed?
The opportunity was created on December 21, 2020, and lists an original closing date of July 25, 2023.
What types of research inputs can be translated under this program?
The opportunity 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.
What is meant by "moving molecules closer to eventual FDA approval" in this context?
In this program description, it means advancing a medication candidate through recognized development steps (for example, optimization and translational work like pharmacology, safety-related studies, and formulation) so the candidate is more viable for regulatory progression and could be positioned for eventual FDA review.
Why is this described as a translational pipeline accelerator?
Because it is designed to support investigators who can bridge discovery and product-oriented development, emphasizing concrete advancement of therapeutic molecules rather than purely exploratory research.
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