National Cooperative Drug Discovery and Development Groups (NCDDDG) for the Treatment of Mental Disorders, Drug or Alcohol Addiction (U01/U19) | Apply Online

Frequently Asked Questions (FAQs)

What is the National Cooperative Drug Discovery and Development Groups (NCDDDG) program?

The National Cooperative Drug Discovery and Development Groups (NCDDDG) program (PAR-08-238) is an NIH cooperative agreement funding opportunity designed to support coordinated, multidisciplinary teams working to discover, develop, and early-test new medications for mental disorders and for drug or alcohol addiction.

What is the main purpose of this funding opportunity?

The main purpose is to speed up translation from research ideas to potential medications by supporting organized partnerships that can move work from target identification and compound discovery through preclinical development and, when appropriate, into early human studies.

What kinds of problems or conditions does the program focus on?

The program focuses on therapeutics for mental illness and substance use disorders, including drug addiction and alcohol addiction.

Which NIH institutes participate in this opportunity?

Three NIH institutes are involved: the National Institute of Mental Health (NIMH), the National Institute on Drug Abuse (NIDA), and the National Institute on Alcohol Abuse and Alcoholism (NIAAA).

What stages of drug development can be supported under this program?

The opportunity is intended to support a range of connected activities, including discovery, preclinical development, and proof-of-concept testing. This can span target identification, compound discovery and optimization, preclinical testing, IND-enabling or IND-ready steps as described, and early-phase human clinical testing when appropriate.

Does this program support early human clinical studies?

Yes. The program supports early-phase human clinical testing intended to quickly assess safety signals and preliminary efficacy, including proof-of-concept studies. It also allows testing new therapeutic indications for drugs that are already IND-ready.

Is the program intended to fund isolated individual projects?

No. A central emphasis is on coordinated partnerships rather than isolated projects, with integrated expertise across the pipeline to move candidate therapeutics efficiently from discovery toward early testing.

What types of expertise are expected in a strong application team?

The announcement emphasizes multidisciplinary teams that may combine expertise such as medicinal chemistry, pharmacology, behavioral science, toxicology, biomarkers, and clinical research within a single organized effort.

Are academic-industry collaborations encouraged?

Yes. The program specifically encourages academic-industry collaborations as part of the coordinated partnership approach.

What are the key scientific objectives outlined by the program?

The program describes several connected objectives that strong applications are expected to address, including: (1) accelerating innovative drug discovery grounded in a clear biological rationale; (2) creating pharmacologic tools (such as novel ligands) for the broader research community; (3) developing and validating models to evaluate treatments (in vitro, animal, or translational paradigms); and (4) supporting early-phase human clinical testing for safety signals and preliminary efficacy.

Does the program fund pharmacologic tools and tool compounds?

Yes. The announcement highlights support for pharmacologic tools, including novel ligands and tool compounds, that can help characterize existing targets or validate new ones and enable downstream clinical progress.

Does the program fund model development and validation?

Yes. It prioritizes the development and validation of models used to evaluate potential treatments, which may include in vitro systems, animal models, or translational paradigms intended to help predict human response.

What funding mechanisms are used for this opportunity?

Funding is provided through NIH cooperative agreement mechanisms, specifically the U01 and the multi-project U19.

What is the difference between a U01 and a U19 under this program?

Based on the description provided, applicants may propose either: (1) a single-project cooperative agreement (U01), or (2) a multi-component, multi-project structure (U19) when the work is best organized as several integrated projects with shared cores or resources.

What does it mean that this is a cooperative agreement?

A cooperative agreement indicates that NIH expects substantial scientific involvement during the life of the award compared with a standard research project grant. The description notes this can involve coordination, milestone-based progress, and active programmatic collaboration.

Are there related opportunities for small businesses?

Yes. The announcement notes a parallel set of opportunities for small businesses through SBIR and STTR mechanisms (R43/R44 and R41/R42), which may be relevant for teams considering whether the cooperative agreement route or a small business commercialization pathway is the best fit.

How much funding is available per award?

The amount of funding is not fixed in advance. Award size can vary widely depending on scientific scope, development stage, timelines, and resource needs (for example, whether the work focuses on discovery chemistry, model validation, preclinical development steps, or an early clinical study).

How many awards will be made?

The number of awards is not fixed in advance. NIH indicates that the number of funded projects will depend on factors such as the mix of mechanisms requested, overall quality of submissions, proposed timelines, and budget justifications.

Can award duration differ between projects?

Yes. The description indicates that award size and duration can differ substantially depending on the proposed work, its stage of development, and associated resource needs.

Who is eligible to apply?

Eligibility is broad and includes for-profit organizations (including but not limited to small businesses), public and private institutions of higher education, and nonprofit organizations with or without 501(c)(3) status. Certain federal government agencies may also be eligible as described in the eligibility details.

Is cost sharing or matching required?

No. There is no cost sharing or matching requirement, meaning applicants are not required to contribute non-federal funds as a condition of the award.

Who is the sponsoring agency?

The sponsoring agency is the National Institutes of Health (NIH).

What are the relevant CFDA program areas associated with this opportunity?

The listing references CFDA program areas covering mental health research (93.242), alcohol research programs (93.273), and drug abuse and addiction research programs (93.279).

When was this opportunity posted, and what is its current status?

The opportunity was originally posted on December 3, 2008, and it was later archived in 2011.

Where can applicants find the source announcement?

The source announcement is available through the NIH grants guide page associated with PAR-08-238.

Who should be contacted for access or technical linking issues related to the announcement?

For access or technical linking issues, the notice provides a contact for the NIH Office of Extramural Research (OER) webmaster.