National Cooperative Drug Discovery/Development Groups (NCDDG) for the Treatment of Mental Disorders, Drug or Alcohol Addiction (U19) | Apply Online

FAQs: National Cooperative Drug Discovery/Development Groups (NCDDG) for the Treatment of Mental Disorders, Drug or Alcohol Addiction (U19)

What is this funding opportunity?

This is an NIH funding opportunity called the National Cooperative Drug Discovery/Development Groups (NCDDG) for the Treatment of Mental Disorders, Drug or Alcohol Addiction, using the U19 cooperative agreement mechanism. It is designed to move promising neuroscience and addiction-treatment concepts further toward real therapies and practical research tools.

What is the main goal of the NCDDG program?

The main goal is to accelerate innovative drug discovery and preclinical development for mental disorders and for drug or alcohol addiction, with an emphasis on advancing candidates and tools that can realistically move from biological insight to translational outcomes (for example, optimized lead compounds, validated targets, and early clinical data when appropriate).

What kinds of work does NIH expect teams to do under this program?

The program expects coordinated, multidisciplinary work across key drug discovery and development functions such as target identification and validation, medicinal chemistry, pharmacology, biomarker development, toxicology, formulation, and early clinical testing. The overall expectation is a connected plan that links discovery and development steps with clear decision points.

Does the program focus only on discovery, or also on development?

It explicitly emphasizes both discovery and development. Teams are encouraged not just to identify promising ideas, but to move candidates through preclinical milestones, generate evidence to justify further investment, and develop/validate experimental therapeutics support tools (such as biomarkers or translational assays) that enable rational progression.

What does "rationally based candidate agents" mean in this context?

It means the candidate agents should be grounded in a clear biological rationale, mechanism of action, or therapeutic hypothesis, rather than relying on broad trial-and-error screening alone. The work is expected to connect the therapeutic concept to underlying biology and a coherent development strategy.

Are research tools and probes part of the expected outcomes?

Yes. A central aim is to generate high-quality pharmacologic probes and ligands that can serve as research tools. These may help the field understand and validate drug targets, including characterizing existing targets more precisely or validating new targets that could open up new treatment strategies.

Does this opportunity support human clinical studies?

Yes, it explicitly supports early phase human clinical testing when appropriate and feasible. The intent is to enable proof of concept studies and other early clinical assessments that can quickly determine whether a candidate appears safe enough and effective enough to justify larger trials.

Can projects include testing new indications for compounds that are already IND-ready?

Yes. The opportunity notes that evaluating new indications for agents that are already IND-ready can be an efficient path, since those compounds may have already cleared significant regulatory and development hurdles.

What makes this a "cooperative agreement" (U19) rather than a standard grant?

The U19 mechanism typically involves substantial programmatic involvement by NIH staff compared with standard investigator-initiated grants. Practically, applicants should expect emphasis on coordinated teamwork, milestone-driven progress, defined project management, and active collaboration across participating components.

Is team science required?

Yes. The program is built on the premise that modern drug development for mental health and substance use disorders is too complex for any single lab or discipline to handle alone. NIH is looking for coordinated teams with complementary expertise that can execute an integrated translational plan.

What expertise areas are specifically highlighted as relevant for a competitive team?

The description highlights expertise such as target identification/validation, medicinal chemistry, pharmacology, biomarker development, toxicology, formulation, and early clinical testing. It also points to the value of capabilities often associated with industry settings, such as high-throughput screening infrastructure, manufacturing and formulation expertise, regulatory strategy, and clinical development experience.

Are academic-industry partnerships encouraged?

Yes. The FOA strongly encourages partnerships between academia and industry, reflecting the specialized capabilities often needed for successful drug discovery and development.

What kinds of planning elements are implied to be important for applications?

Based on the description, strong applications would be expected to include a credible integrated plan connecting discovery to development, with clear milestones and go/no-go decision points, plus a structure that demonstrates the team can deliver tangible outputs (candidates, validated targets, tools, and possibly early clinical data).

What is the Funding Opportunity Number (FOA number)?

The Funding Opportunity Number provided is PAR-14-234.

Which agency is offering this opportunity?

This opportunity was issued by the National Institutes of Health (NIH).

Which CFDA numbers are associated with this opportunity?

The opportunity is associated with CFDA 93.242 (Mental Health Research Grants), 93.273 (Alcohol Research Programs), and 93.279 (Drug Abuse and Addiction Research Programs).

Is cost sharing or matching required?

No. The opportunity does not require cost sharing or matching.

Who is eligible to apply?

Eligible applicants include a broad range of organizations, including public and private institutions of higher education, nonprofit organizations with and without 501(c)(3) status, small businesses, and for-profit organizations other than small businesses, along with certain other categories specified by NIH.

Can foreign organizations apply as the main applicant?

No. Foreign organizations and foreign institutions are not eligible to apply directly under the eligibility language provided.

Are foreign components allowed?

Yes. Foreign components (as defined by NIH policy) are allowed, which can enable international collaboration when it meaningfully strengthens the science.

What are the key dates listed for this announcement?

The posted and creation date is May 20, 2014. The original and current closing date is February 23, 2017. The archive date is March 26, 2017.

Is this funding opportunity still open?

No. The dates indicate the announcement is archived (archive date March 26, 2017) and the closing date is listed as February 23, 2017, so it is not currently open for applications.

If it is archived, why might it still be useful?

It can still serve as a reference point for similar NIH programs and expectations, especially around team-science structure, milestone-driven management, translational focus, and the kinds of capabilities NIH views as important for moving therapies and tools toward early clinical testing.

What types of outputs does NIH appear to be looking for?

The description emphasizes tangible translational outputs such as optimized lead compounds, validated targets, translational tools (including ligands and probes), and evidence that supports go/no-go decisions and further investment. When appropriate, it also includes early phase clinical data from proof of concept or early assessments.

How does this program address the challenges in mental health and addiction drug development?

It is positioned to bridge discovery research and early clinical translation in areas where failure rates have been high and progress has been slow. The program does this by pushing coordinated multidisciplinary teams to pursue disciplined, milestone-driven development rooted in a clear biological rationale, and by supporting early clinical testing when feasible.