Opportunity Information: Apply for RFA DA 26 020
This funding opportunity (RFA-DA-26-020) from the National Institutes of Health supports the creation of a dedicated Center that functions as a flexible, service-oriented drug development infrastructure for substance use disorder (SUD) therapeutics. The core purpose is to strengthen and expand the SUD medication pipeline by speeding up the evaluation, validation, and advancement of existing drugs that can be repurposed or repositioned for SUD treatment. Rather than funding a single therapeutic candidate or a single disease area, the program is designed to stand up an ongoing capability that can assist many investigators and many projects over time, with the expectation that this shared infrastructure will reduce duplication, shorten timelines, and raise the quality and readiness of repurposing efforts across the field.
The award mechanism is a U54 cooperative agreement, which typically means substantial scientific and/or programmatic involvement from NIH staff in coordination with the awardee. The NOFO explicitly states clinical trials are not allowed, so the Center is expected to focus on preclinical, translational, and enabling activities that prepare candidates for later-stage testing, or on other non-trial activities that de-risk and advance repurposing projects. The emphasis is on building a dynamic and adaptable platform: in practical terms, a Center that can take in a steady flow of new project ideas from the community, quickly triage and select the most promising ones, and then provide the specialized expertise and coordinated support needed to move those candidates forward through key development milestones.
A major feature of this opportunity is the provision of comprehensive drug development services delivered by a team of subject matter experts. The NOFO highlights specific support functions such as creating Target Product Profiles (TPPs), which help define the intended patient population, indication, dosing and delivery considerations, efficacy expectations, safety requirements, and differentiation goals that guide development decisions. It also calls out Freedom-to-Operate (FTO) analyses and intellectual property consultations, reflecting a practical focus on whether a repurposing concept can realistically be advanced and later commercialized or otherwise deployed without blocking patent barriers. In addition, the Center is expected to provide regulatory guidance and technical pipeline support, which can include planning for required studies, aligning evidence packages with likely regulatory pathways, and helping investigators understand what data are needed to justify progression to later phases even if the U54 itself does not fund clinical trials.
Another central expectation is robust outreach and community engagement. The Center is not meant to operate passively; it is expected to connect actively with academic researchers, biotech teams, and other potential contributors working on SUD indications, solicit project proposals, and maintain transparent processes for evaluating, selecting, and advancing projects. This implies the need for an organized intake system (for example, periodic calls for proposals), clear selection criteria, and an internal governance model that can make defensible, timely decisions about which projects receive support. Because SUD is a broad umbrella covering different substances and patterns of use, the NOFO anticipates a portfolio approach where the Center supports multiple projects across different SUD indications, thereby increasing the chance that at least some candidates will progress toward meaningful impact and reducing reliance on any single scientific bet.
In terms of who can apply, eligibility is broad and includes many types of U.S. organizations and governmental entities: state, county, city, township, and special district governments; independent school districts; public and state-controlled and private institutions of higher education; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status; for-profit organizations (other than small businesses) and small businesses. The NOFO also lists additional eligible applicants such as eligible federal agencies, faith-based or community-based organizations, tribal governments that are not federally recognized, non-U.S. (foreign) entities, regional organizations, and U.S. territories or possessions. This wide eligibility reflects the infrastructure nature of the award and the value of drawing expertise from many settings, including organizations with strong translational, regulatory, intellectual property, and community engagement capabilities.
Administratively, the opportunity is categorized as discretionary funding and sits within health-related activity (CFDA 93.279). The application due date listed is January 28, 2026, and the posting date provided is September 24, 2025. While the excerpt does not provide an award ceiling or expected number of awards, the structure and scope imply a sizable, multi-component Center effort with coordinated expert services and ongoing project support. Overall, the program is aimed at creating an enabling engine for the field: a well-organized Center that helps researchers move repurposed or repositioned medication ideas from concept toward development readiness for SUDs, while building a repeatable process for outreach, selection, and advancement that can serve the broader research community over time.Apply for RFA DA 26 020
- The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Dynamic and Adaptable Infrastructure for Drug Development and Outreach to Aid the Research Community in Advancing Medication Repurposing and Repositioning Efforts for Substance Use Disorders (SUDs) (U54 - Clinical Trials Not Allowed)" 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 2025-09-24.
- Applicants must submit their applications by 2026-01-28. (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.
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Frequently Asked Questions (FAQs): RFA-DA-26-020 (NIH) U54 Center for SUD Therapeutics Repurposing Infrastructure
What is the main purpose of this funding opportunity?
This opportunity (RFA-DA-26-020) supports creation of a dedicated Center that serves as a flexible, service-oriented drug development infrastructure focused on substance use disorder (SUD) therapeutics. The goal is to strengthen and expand the SUD medication pipeline by speeding up evaluation, validation, and advancement of existing drugs that can be repurposed or repositioned for SUD treatment.
Is the program funding a single drug candidate or a single disease area?
No. The program is designed to establish an ongoing capability (a Center) that can assist many investigators and many projects over time. It is intended to reduce duplication, shorten timelines, and improve the quality and readiness of repurposing efforts across the field rather than funding one therapeutic candidate or one disease area.
What award mechanism is being used?
The award mechanism is a U54 cooperative agreement.
What does it mean that this is a U54 cooperative agreement?
A U54 cooperative agreement typically involves substantial scientific and/or programmatic involvement from NIH staff working in coordination with the awardee. In practice, this generally implies ongoing interaction with NIH as the Center operates and carries out its activities.
Are clinical trials allowed under this NOFO?
No. The NOFO explicitly states that clinical trials are not allowed. The Center is expected to focus on preclinical, translational, and enabling activities that prepare candidates for later-stage testing, or other non-trial activities that de-risk and advance repurposing projects.
If clinical trials are not allowed, what kinds of activities is the Center expected to support?
The Center is expected to support preclinical, translational, and other enabling activities that move repurposed or repositioned candidates toward development readiness. The opportunity emphasizes services and coordinated technical support that help investigators progress through key development milestones without conducting clinical trials within this award.
What is meant by a "flexible, service-oriented" drug development infrastructure?
The Center is expected to function as a dynamic and adaptable platform that can take in a steady flow of project ideas from the community, triage and select promising projects, and provide specialized expertise and coordinated support to move candidates forward through development milestones.
How is the Center expected to handle multiple projects over time?
The NOFO anticipates a portfolio approach. The Center is expected to support multiple projects across different SUD indications, increasing the likelihood that some candidates progress toward impact and reducing dependence on any single scientific bet.
What types of drug development services are specifically highlighted?
The NOFO highlights comprehensive drug development services delivered by a team of subject matter experts. Examples called out include Target Product Profile (TPP) development, Freedom-to-Operate (FTO) analyses, intellectual property consultations, regulatory guidance, and technical pipeline support.
What is a Target Product Profile (TPP), and why is it important here?
A TPP is used to define the intended patient population, indication, dosing and delivery considerations, efficacy expectations, safety requirements, and differentiation goals. In this program, TPPs are emphasized as a tool to guide development decisions for repurposed or repositioned SUD therapeutics and to align projects with clear development objectives.
What is a Freedom-to-Operate (FTO) analysis in the context of this Center?
An FTO analysis evaluates whether a repurposing concept can realistically be advanced and later commercialized or otherwise deployed without being blocked by existing patents or other intellectual property barriers. The NOFO emphasizes FTO analyses and intellectual property consultations as practical components of advancing repurposing projects.
Will the Center provide intellectual property (IP) support?
Yes. The NOFO explicitly mentions intellectual property consultations alongside Freedom-to-Operate analyses, reflecting a focus on practical feasibility for advancing repurposed candidates.
What kind of regulatory support is expected from the Center?
The Center is expected to provide regulatory guidance and technical pipeline support. This can include planning for required studies, aligning evidence packages with likely regulatory pathways, and helping investigators understand what data are needed to justify progression to later phases (even though the U54 itself does not fund clinical trials).
Is outreach and community engagement required?
Yes. Robust outreach and community engagement are central expectations. The Center is expected to actively connect with academic researchers, biotech teams, and other contributors working on SUD indications, solicit project proposals, and maintain transparent processes for evaluating, selecting, and advancing projects.
How will new projects be identified and brought into the Center?
The NOFO implies an organized intake system, such as periodic calls for proposals, where the Center solicits project ideas from the broader community and then triages and selects the most promising ones for support.
Does the NOFO describe how projects should be selected?
It emphasizes the need for clear selection criteria, transparent evaluation processes, and an internal governance model capable of making timely, defensible decisions about which projects receive support.
Why does the NOFO emphasize reducing duplication and shortening timelines?
Because the program is building shared infrastructure intended to serve many investigators and projects, the expectation is that centralized, coordinated services will reduce duplicated effort across separate teams, speed up repurposing evaluations, and raise overall readiness and quality across the field.
What substances or conditions are included under "SUD" for this program?
The excerpt describes SUD as a broad umbrella covering different substances and patterns of use. The Center is expected to be able to support a range of SUD indications through a portfolio approach.
Who is eligible to apply for this funding opportunity?
Eligibility is broad. The NOFO lists many types of eligible applicants, including U.S. state, county, city, township, and special district governments; independent school districts; public and state-controlled and private institutions of higher education; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status; for-profit organizations (other than small businesses) and small businesses.
Are non-U.S. (foreign) entities eligible to apply?
Yes. The NOFO includes non-U.S. (foreign) entities among additional eligible applicants.
Are U.S. territories or possessions eligible?
Yes. The NOFO lists U.S. territories or possessions among additional eligible applicants.
Are tribal governments that are not federally recognized eligible?
Yes. The NOFO includes tribal governments that are not federally recognized among additional eligible applicants.
Are faith-based or community-based organizations eligible?
Yes. The NOFO includes faith-based or community-based organizations among additional eligible applicants.
Are for-profit organizations eligible?
Yes. The NOFO lists for-profit organizations (other than small businesses) and small businesses as eligible.
Are federal agencies eligible to apply?
Yes. The NOFO lists eligible federal agencies among additional eligible applicants.
What is the application due date?
The application due date listed is January 28, 2026.
What is the posting date for this opportunity?
The posting date provided is September 24, 2025.
How is this opportunity categorized administratively?
The opportunity is categorized as discretionary funding and is within health-related activity under CFDA 93.279.
Does the provided information include the award ceiling or the expected number of awards?
No. The excerpt states that it does not provide an award ceiling or expected number of awards. It does note that the structure and scope imply a sizable, multi-component Center effort.
What is the overall expected impact of creating this Center?
The program aims to create an enabling engine for the field by helping researchers move repurposed or repositioned medication ideas from concept toward development readiness for SUDs, while building a repeatable process for outreach, selection, and advancement that can serve the broader research community over time.
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