National Cooperative Drug/Device Discovery/Development Groups (NCDDG) for the Treatment of Mental or Substance Use Disorders or Alcohol Disorder (U01 Clinical Trial Optional) | PAR 20 118

Frequently Asked Questions (FAQs)

What is this funding opportunity?

This opportunity is the National Cooperative Drug/Device Discovery/Development Groups (NCDDG) for the Treatment of Mental or Substance Use Disorders or Alcohol Disorder (U01 Clinical Trial Optional), PAR-20-118. It is an NIH cooperative agreement intended to move promising drug and device ideas beyond discovery and into the practical development work needed to support early-stage testing in people.

What is the main goal of PAR-20-118?

The central goal is translation: advancing innovative therapeutic concepts for mental health disorders, substance use disorders (SUDs), and alcohol use disorder through development steps that enable first-in-human or other early clinical studies.

What does “U01 cooperative agreement” mean for applicants?

A U01 is a cooperative agreement, which typically involves an active partnership with NIH staff compared with a standard research project grant. The mechanism commonly includes collaboration with NIH and milestone-driven progress expectations.

Is a clinical trial required?

No. The FOA is labeled “Clinical Trial Optional,” meaning applicants may propose clinical trials when appropriate, but a clinical trial is not required for every application.

If a clinical trial is optional, what kinds of non-clinical projects can still fit?

Projects can focus on the preclinical-to-IND/IDE enabling pathway as long as the work clearly advances translation toward early human testing. Examples described include optimizing and characterizing candidates, establishing proof-of-concept in relevant models, developing device prototypes or stimulation parameters, and generating data packages that justify human evaluation.

What types of therapeutic approaches does this FOA support?

The FOA supports both pharmacologic and device-based approaches. This includes pharmacologic tools such as compounds or biologics with clear mechanisms, as well as neuromodulatory or neurostimulation tools such as device-based approaches.

What does the FOA mean by “pharmacologic tools”?

Based on the description provided, pharmacologic tools include candidates like compounds or biologics that have clear mechanisms and can be built and validated for use in basic and clinical research.

What does the FOA mean by “neuromodulatory or neurostimulation tools”?

These are device-based approaches intended to modulate or stimulate neural activity. The FOA indicates support for development work such as establishing stimulation parameters or developing device prototypes that can be used in research and potentially advanced toward early human evaluation.

What is meant by “experimental therapeutics” in this opportunity?

The FOA emphasizes development that enables experimental therapeutics, described as studies that do not only test whether something works, but also clarify how it works through measurable pharmacodynamic or target engagement signals.

What kinds of outcomes or signals are emphasized?

The description highlights measurable pharmacodynamic signals and/or target engagement signals, consistent with an approach focused on understanding mechanism and informing decision-making about advancement.

What stage of development is this FOA trying to support?

The FOA is designed to push promising drug and device ideas out of discovery and toward early-stage testing in people. It also supports the development work needed to justify and enable first-in-human or other early clinical studies.

Does the FOA prioritize early human studies?

Yes. A major focus described is supporting early-stage human studies that can quickly inform whether a candidate is worth advancing, including rapid assessment of safety, tolerability, and pharmacodynamics for promising drugs or devices.

Are new indications for existing candidates allowed?

The FOA description specifically mentions exploring new indications for agents that are already IND-ready and devices that are IDE-ready.

What does “IND-ready” mean in this context?

“IND-ready” is described as Investigational New Drug-ready, referring to a stage where an agent is prepared for IND-related steps and can be positioned for early-stage clinical evaluation.

What does “IDE-ready” mean in this context?

“IDE-ready” is described as Investigational Device Exemption-ready, referring to a stage where a device is prepared for IDE-related steps and can be positioned for early-stage clinical evaluation.

Which disorders or conditions are within scope?

The FOA targets therapeutic development for mental health disorders, substance use disorders (SUDs), and alcohol use disorder.

Who is eligible to apply?

Eligibility is broad for U.S.-based organizations and governmental entities. Eligible applicants listed include various levels of government (state, county, city, township, special district), independent school districts, public and state-controlled institutions of higher education, private institutions of higher education, nonprofit organizations (with or without 501(c)(3) status, other than institutions of higher education), for-profit organizations (other than small businesses), small businesses, public housing authorities/Indian housing authorities, and Native American tribal governments (federally recognized) as well as tribal organizations that are not federally recognized tribal governments.

Are specific institution types explicitly called out as eligible?

Yes. The FOA explicitly calls out additional eligible types including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), 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, Indian/Native American tribal governments other than federally recognized, and U.S. territories or possessions.

Can a foreign (non-U.S.) organization apply as the applicant?

No. Non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations are not eligible to apply as the applicant organization.

Are foreign collaborations allowed at all?

Yes. Foreign components are allowed as defined by the NIH Grants Policy Statement. In general terms, this means a U.S. applicant organization may include a foreign collaboration component when it is well justified and consistent with NIH policy, even though a foreign institution cannot be the direct applicant.

What funding instrument is used?

This opportunity uses the cooperative agreement funding instrument (U01), supporting coordinated translational development work with NIH involvement typical of cooperative agreements.

What are the CFDA numbers associated with this opportunity?

The listing includes CFDA numbers 93.242, 93.273, and 93.279.

When was this FOA created, and what closing date is listed?

The FOA was created on February 25, 2020, and the original closing date listed is March 25, 2022.

Does the provided listing include an award ceiling or number of expected awards?

No. The provided source data does not specify an award ceiling or the expected number of awards.

Where should applicants look for budget expectations, milestones, and institute-specific priorities?

Based on the information provided, prospective applicants typically need to consult the full FOA and NIH institute guidance for budget expectations, milestone structure, and any institute-specific priorities tied to mental health, SUD, or alcohol use disorder therapeutics development.

What kinds of development activities are described as responsive?

Examples in the description include optimizing and characterizing candidate drugs, establishing proof-of-concept in relevant models, developing stimulation parameters or device prototypes, and generating data packages needed to justify moving into human evaluation.

What kinds of assessments are highlighted for early human work?

The FOA highlights rapid assessment of safety, tolerability, and pharmacodynamics for promising drugs or devices as a way to quickly determine whether a candidate is worth advancing.