Opportunity Information: Apply for PAR 13 086

  • The National Institutes of Health in the education health sector is offering a public funding opportunity titled "National Cooperative Drug Discovery/Development Groups (NCDDG) for the Treatment of Mental Disorders, Drug or Alcohol Addiction (U19)" and is now available to receive applicants.
  • Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.242 Mental Health Research Grants 93.273 Alcohol Research Programs 93.279 Drug Abuse and Addiction Research Programs.
  • This funding opportunity was created on May 20, 2014 and posted on Jan 11, 2013.
  • Applicants must submit their applications by May 20, 2014. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • Eligible applicants include: Small businesses Others (see text field entitled Additional Information on Eligibility for clarification) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Public and State controlled institutions of higher education For profit organizations other than small businesses Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education.
  • Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Tribally Controlled Colleges and Universities (TCCUs) Non domestic (non U.S.) Entities (Foreign Institutions) are not eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are not eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:

The National Cooperative Drug Discovery/Development Groups (NCDDG) for the Treatment of Mental Disorders, Drug or Alcohol Addiction (U19) is an NIH cooperative agreement program designed to build tightly integrated, multidisciplinary research teams focused on finding and advancing new pharmacological treatments for mental disorders and for drug or alcohol addiction. The central idea is to move beyond isolated, single-lab efforts by creating coordinated partnerships that can take a therapeutic concept from target and compound discovery through preclinical development and into early human testing when appropriate. The program is sponsored across three NIH institutes with aligned but distinct missions: the National Institute of Mental Health (NIMH), the National Institute on Drug Abuse (NIDA), and the National Institute on Alcohol Abuse and Alcoholism (NIAAA). Collectively, they are seeking projects that can deliver rationally designed candidate agents and also generate high-value research tools that clarify disease biology and drug target validity.

The opportunity emphasizes acceleration and translation. Applicants are expected to propose research that speeds innovative drug discovery, including identification and optimization of promising compounds or biologics, development of novel ligands that can serve as probes or tool compounds, and generation of pharmacologic agents that both treat disease and help study underlying mechanisms. A major theme is the creation and validation of models and experimental systems that can reliably evaluate new therapeutics for mental disorders or addiction, which can include in vitro assays, animal models, translational biomarkers, and other platforms that improve confidence that a candidate will perform in humans. Another key component is support for early phase clinical testing, particularly proof of concept studies intended to quickly assess safety, tolerability, and preliminary efficacy. The announcement also explicitly notes interest in testing new indications for agents that are already IND-ready, meaning compounds that are sufficiently developed for investigational use in humans and can be repurposed or redirected toward mental health or alcohol addiction treatment questions.

Because this is a U19 cooperative agreement, the structure implies both multi-project, team-based science and substantial involvement from NIH scientific staff compared to a standard investigator-initiated grant. In practical terms, awardees should anticipate active coordination with NIH program leadership, milestone-oriented management, and an expectation that the group operates as a cohesive development effort rather than a collection of loosely related studies. The program strongly encourages academia-industry partnerships, reflecting the reality that medicinal chemistry, formulation, toxicology, manufacturing considerations, regulatory strategy, and early clinical operations often benefit from industry experience and infrastructure. Collaborations can help shorten the path between discovery and clinical testing, while also improving the chances that successful candidates can be further developed and eventually translated into real-world therapies.

Administratively, this funding opportunity is identified as PAR-13-086 and is listed under NIH discretionary funding as a cooperative agreement in the health and education activity category. It is associated with CFDA numbers 93.242 (Mental Health Research Grants), 93.273 (Alcohol Research Programs), and 93.279 (Drug Abuse and Addiction Research Programs). There is no cost sharing or matching requirement. Eligible applicants include a broad range of U.S.-based organizations such as public and private institutions of higher education, nonprofit organizations (including those with and without 501(c)(3) status), for-profit organizations (including small businesses), and a set of designated institution types such as HBCUs, Hispanic-serving institutions, Tribal colleges and universities, Alaska Native and Native Hawaiian-serving institutions, and AANAPISI institutions. Non-U.S. (foreign) institutions and non-U.S. components of U.S. organizations are not eligible to apply, although foreign components as defined by NIH policy are allowed, which can permit certain international collaborations when they are part of an eligible U.S. applicant organization.

The announcement was posted on January 11, 2013, with an archive date of June 20, 2014. The record shows an original closing date of October 22, 2015, and also includes dates indicating the listing was created on May 20, 2014 and shows a closing date of May 20, 2014 in the provided source data, reflecting the archival/record timing for the opportunity listing. The administering agency is the National Institutes of Health, and the full announcement is available through the NIH Grants Guide. For technical access issues, the contact listed is the NIH Office of Extramural Research webmaster (FBOWebmaster@OD.NIH.GOV).

Frequently Asked Questions (FAQs): National Cooperative Drug Discovery/Development Groups (NCDDG) for the Treatment of Mental Disorders, Drug or Alcohol Addiction (U19) (PAR-13-086)

What is this funding opportunity?

This opportunity supports the National Cooperative Drug Discovery/Development Groups (NCDDG) program for the treatment of mental disorders and for drug or alcohol addiction. It is offered by NIH as a U19 cooperative agreement and is designed to fund tightly integrated, multidisciplinary research teams working on new pharmacological treatments and related research tools.

What is the main goal of the NCDDG U19 program?

The central goal is to accelerate and translate drug discovery and development by moving beyond isolated, single-lab efforts. The program aims to support coordinated partnerships that can advance a therapeutic concept from target and compound discovery through preclinical development and, when appropriate, into early human testing.

Which NIH institutes sponsor or participate in this program?

The program is sponsored across three NIH institutes with aligned but distinct missions: 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 types of research are expected under this opportunity?

Applicants are expected to propose research that speeds innovative drug discovery and development, including identifying and optimizing promising compounds or biologics, developing novel ligands that can serve as probes or tool compounds, and generating pharmacologic agents that both treat disease and help study underlying mechanisms.

Does the program support creating research tools as well as therapies?

Yes. In addition to advancing candidate agents, the opportunity explicitly emphasizes generating high-value research tools that clarify disease biology and drug target validity, such as novel ligands, probes, or tool compounds.

What role do models, assays, and biomarkers play in the proposed work?

A major theme is the creation and validation of models and experimental systems that can reliably evaluate new therapeutics. Examples described include in vitro assays, animal models, translational biomarkers, and other platforms intended to improve confidence that a candidate will perform in humans.

Is early phase clinical testing allowed or encouraged?

Yes. The opportunity includes support for early phase clinical testing, particularly proof of concept studies intended to quickly assess safety, tolerability, and preliminary efficacy.

Can applicants propose new indications for compounds that are already ready for human studies?

Yes. The announcement notes interest in testing new indications for agents that are already IND-ready (sufficiently developed for investigational use in humans), including repurposing or redirecting them toward mental health or alcohol addiction treatment questions.

What does it mean that this is a U19 cooperative agreement?

A U19 cooperative agreement implies a multi-project, team-based structure and substantial involvement from NIH scientific staff compared to a standard investigator-initiated grant. Awardees should anticipate active coordination with NIH program leadership, milestone-oriented management, and an expectation that the group operates as a cohesive development effort rather than loosely related studies.

Is NIH involvement expected to be more hands-on than in typical grants?

Yes. The description indicates substantial involvement from NIH scientific staff, along with active coordination, milestone-oriented management, and a cooperative, development-focused operating model.

Are academia-industry partnerships encouraged?

Yes. The program strongly encourages academia-industry partnerships, reflecting that medicinal chemistry, formulation, toxicology, manufacturing considerations, regulatory strategy, and early clinical operations can benefit from industry experience and infrastructure.

Why does the opportunity emphasize acceleration and translation?

The opportunity is oriented toward shortening the path between discovery and clinical testing while improving the likelihood that successful candidates can be further developed and translated into real-world therapies.

What is the funding opportunity number (FOA) for this program?

The funding opportunity is identified as PAR-13-086.

What is the administering agency?

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

Which CFDA numbers are associated with this opportunity?

The opportunity is associated with CFDA numbers 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 listing states there is no cost sharing or matching requirement.

Who is eligible to apply?

Eligible applicants include a broad range of U.S.-based organizations, including public and private institutions of higher education, nonprofit organizations (with or without 501(c)(3) status), for-profit organizations (including small businesses), and designated institution types such as HBCUs, Hispanic-serving institutions, Tribal colleges and universities, Alaska Native and Native Hawaiian-serving institutions, and AANAPISI institutions.

Are non-U.S. (foreign) institutions eligible to apply directly?

No. Non-U.S. (foreign) institutions and non-U.S. components of U.S. organizations are not eligible to apply.

Are any international collaborations allowed?

Yes, in a limited way. While non-U.S. institutions cannot apply directly, foreign components as defined by NIH policy are allowed. This can permit certain international collaborations when they are part of an eligible U.S. applicant organization.

What activity category is this opportunity listed under?

The opportunity is listed under NIH discretionary funding in the health and education activity category, using a cooperative agreement mechanism.

When was the announcement posted, and what are the archive and closing dates shown?

The announcement was posted on January 11, 2013, with an archive date of June 20, 2014. The record shows an original closing date of October 22, 2015, and also includes dates indicating the listing was created on May 20, 2014 and shows a closing date of May 20, 2014 in the provided source data, reflecting archival/record timing for the opportunity listing.

Where can applicants find the full announcement?

The full announcement is available through the NIH Grants Guide.

Who is the contact for technical access issues?

For technical access issues, the listed contact is the NIH Office of Extramural Research webmaster at FBOWebmaster@OD.NIH.GOV.

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