Establishing a Center for the Advancement of Substance Use Disorder (SUD) Pharmacotherapeutics through Training and Preclinical Support (U54 Clinical Trial Not Allowed) | RFA DA 27 015

Frequently Asked Questions (FAQs)

What is RFA-DA-27-015?

RFA-DA-27-015 is a National Institutes of Health (NIH) funding opportunity that uses a cooperative agreement mechanism (U54) to establish a single Center focused on accelerating the development of new pharmacotherapies for substance use disorders (SUD).

What is the main goal of this funding opportunity?

The main goal is to create a national hub that helps close a common gap in the SUD medication development pipeline by (1) training researchers in formal, real-world product development and (2) providing hands-on preclinical support and early-stage resources to advance the most promising therapeutic concepts through initial experimental validation.

How many awards does NIH expect to make?

NIH expects to make one award, meaning this opportunity is intended to support a single, centralized Center rather than multiple independent awards.

What does it mean that this is a cooperative agreement (U54)?

A cooperative agreement indicates substantial programmatic involvement from NIH compared with a standard research grant. In practice, this often includes closer coordination with NIH staff, active governance expectations, milestone-based management, regular reporting, and a more structured approach to selecting projects and allocating Center resources.

Are clinical trials allowed under this opportunity?

No. The funding opportunity is explicitly designated as "Clinical Trial Not Allowed." The Center is not funded to run clinical trials under this announcement. The emphasis is on training and preclinical-stage advancement rather than human efficacy testing.

What kinds of activities is the Center expected to perform?

The Center is expected to perform two tightly linked functions: (1) structured training in formal product development for SUD medications, and (2) practical, hands-on preclinical support (including technical expertise and financial support) to move selected therapeutic concepts into initial experimental validation.

What does "structured training in formal product development" likely include?

Based on the description, training is expected to help researchers adopt a product development mindset and understand development milestones such as target product profiles, lead optimization strategy, pharmacology data packages, safety and toxicology considerations, formulation issues, regulatory expectations, and go/no-go decision making.

What does "hands-on preclinical support" mean in this context?

It implies more than general mentoring. The Center is expected to have practical capability to run or coordinate preclinical studies that can de-risk projects, strengthen translational readiness, and produce credible early data packages suitable for the next stage of development or subsequent funding.

What problem in the SUD medication pipeline is this Center meant to address?

The opportunity targets a common bottleneck where promising therapeutic concepts stall because investigators may lack formal product development training, practical development infrastructure, or early-stage resources needed to generate the data that would justify further investment.

What types of projects or ideas would the Center support?

The Center is intended to identify and select the most compelling SUD pharmacotherapy concepts and advance them through initial experimental validation using Center expertise and resources. The emphasis is on preclinical-stage advancement and de-risking, not clinical efficacy testing.

Does the listing specify required Center cores or components?

No. The provided text does not list required cores or specific components. However, the intent points toward an organized, multi-component structure commonly seen in Center models, often including leadership/administration, training and workforce development activities, and a preclinical support function.

Who is eligible to apply?

Eligibility is broad and includes state, county, and city governments; special districts; independent school districts; public and state-controlled universities; private universities; federally recognized tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofit organizations with or without 501(c)(3) status; for-profit organizations (other than small businesses) as well as small businesses; and an "other" category.

Are foreign organizations allowed to apply?

Yes. The opportunity explicitly allows non-U.S. entities to apply, allows non-U.S. components of U.S. organizations to participate, and permits foreign components under NIH policy.

Why might foreign participation matter for this opportunity?

The description notes that SUD pharmacotherapeutics development and preclinical capabilities can be globally distributed. Allowing foreign participation enables inclusion of international expertise or infrastructure when it strengthens the Center program.

What is the Assistance Listing (CFDA) number for this opportunity?

The Assistance Listing (CFDA) number is 93.279.

What is the funding category and program area?

The opportunity is categorized as discretionary funding in the health area and is administered by NIH.

When was the NOFO created?

The NOFO was created on May 21, 2026.

What is the application closing date?

The original closing date listed is September 30, 2026.

Is the maximum award amount (ceiling) provided in the listing?

No. The award ceiling is not specified in the provided listing. Applicants would need to consult the full NOFO for budget limits, project period, allowable costs, and any required cost structure across Center components.

What kinds of outputs is NIH trying to achieve through this Center?

The intended outputs include a stronger, more reliable pipeline of preclinically supported SUD pharmacotherapeutic candidates and a community of investigators trained to understand the product development path well enough to carry candidates forward to later-stage funding and, ultimately, clinical evaluation under other mechanisms.

If clinical trials are not allowed, how would supported concepts move toward clinical evaluation?

The Center is intended to mature concepts through preclinical work and generate credible data packages that position projects for subsequent funding and later-stage development steps, with clinical evaluation occurring under other funding mechanisms rather than this announcement.

What does a "milestone-driven process" imply for project selection and advancement?

It implies that the Center would likely use a competitive, managed approach to choose projects and advance them based on predefined development milestones and go/no-go decision points, supported by regular oversight and reporting consistent with a cooperative agreement model.

Is this opportunity focused on discovery science or development?

The emphasis is on development-oriented work: training researchers to think beyond discovery and supporting preclinical experiments that improve translational readiness and reduce risk in early development.

What is the overall structure NIH appears to be aiming for?

NIH appears to be aiming for a single, centralized, development-oriented Center that combines workforce training in formal product development with operational preclinical support to advance high-potential SUD medication concepts through early validation.