Opportunity Information: Apply for PAR 11 207

  • 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 Jun 10, 2011 and posted on Apr 22, 2011.
  • Applicants must submit their applications by Feb 22, 2013. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
  • Eligible applicants include: Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses For profit organizations other than small businesses Private institutions of higher education Public and State controlled institutions of higher education Others (see text field entitled Additional Information on Eligibility for clarification).
  • Other Eligible Applicants include the following Eligible Agencies of the Federal Government Non domestic (non U.S.) Entities (Foreign Organizations) are not permitted. Foreign (non U.S.) components of U.S. organizations are allowed.
Apply for PAR 11 207

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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 a National Institutes of Health (NIH) cooperative agreement program designed to push promising medication ideas further and faster by organizing them under coordinated, multidisciplinary research teams. The central purpose is to create integrated partnerships that can discover and develop pharmacological agents to both treat and better understand mental illness as well as drug and alcohol addiction. Rather than supporting isolated projects, this opportunity is built around the idea that modern therapeutics development moves best when basic scientists, translational researchers, clinical investigators, and (when possible) industry development experts work together under a shared plan with clear milestones and a strong emphasis on moving candidates toward real-world testing.

The scientific scope of the program spans the full early pipeline of therapeutics development. It prioritizes accelerating innovative drug discovery, meaning applicants are expected to propose rational, target-driven strategies that can produce new candidate medications or reposition existing ones in a scientifically justified way. A major objective is also the development of pharmacologic tools, such as novel ligands, that can be used in basic and clinical research to characterize existing targets more precisely or validate new targets. In practical terms, this can include compounds, probes, or other chemical/biological tools that help clarify how a target behaves in relevant systems, how strongly and selectively a candidate engages that target, and whether that engagement produces changes that matter for symptoms or disease mechanisms.

Another key emphasis is on building and validating models for evaluating novel therapeutics. That includes preclinical models that better predict clinical response and translational assays that bridge animal and human research. The program is explicitly interested in strengthening the evidence chain that connects a mechanistic hypothesis (target, pathway, circuit, or receptor system) to a measurable pharmacologic effect and then to clinically meaningful outcomes. Applicants are therefore encouraged to include plans for rigorous validation, reproducibility, and decision-making criteria that help determine whether a candidate should advance, be modified, or be stopped.

The opportunity also supports early phase human clinical testing, especially proof-of-concept work that can rapidly assess safety and potential efficacy. This aspect is aimed at shortening the time between preclinical promise and clinical reality by enabling well-designed early studies that test whether a drug candidate (or a new indication for an IND-ready drug) shows signs of benefit in relevant patient populations. The emphasis on "IND-ready" new indications highlights a practical development route: compounds that already have sufficient manufacturing, toxicology, and regulatory groundwork can be evaluated more efficiently for mental disorders or alcohol addiction, potentially speeding translation to patients.

Three NIH Institutes jointly sponsor and encourage applications under this announcement: 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 invite proposals that advance discovery, preclinical development, and proof-of-concept testing for rationally based candidate medications addressing mental disorders and substance use conditions, including alcohol addiction. The program also welcomes efforts to create novel ligands and other tools that sharpen the field's ability to interrogate targets and mechanisms, which can be just as important as advancing a single drug candidate because it improves the overall success rate of therapeutic development.

Because this is a cooperative agreement (U19), the structure implies a more collaborative relationship with NIH than a typical grant mechanism. Cooperative agreements generally involve substantial programmatic involvement from the funding agency, often including coordination, milestone-driven oversight, and active engagement to support progress and alignment with program goals. In plain terms, the expectation is not only strong science but also strong project management across multiple components, clear integration among participating investigators, and a translational plan that can withstand go/no-go decisions as data emerge.

Partnerships between academia and industry are strongly encouraged. That reflects the realities of drug development, where industry contributions can be decisive for medicinal chemistry optimization, formulation, manufacturing, regulatory planning, and the operational aspects of early clinical studies. At the same time, academic groups often bring deep disease expertise, novel target biology, cutting-edge models, and access to specialized clinical populations. Competitive applications would typically show how these complementary strengths are integrated into a single program with shared responsibilities rather than parallel, disconnected efforts.

Administratively, this opportunity was posted April 22, 2011, with an original and current closing date of February 22, 2013, and an archive date of March 25, 2013, under Funding Opportunity Number PAR-11-207. It falls under discretionary funding and uses the cooperative agreement instrument, with activity in the education and health category areas as listed. No cost sharing or matching is required. Eligible applicants include a wide range of U.S.-based organizations: public and state-controlled institutions of higher education, private institutions of higher education, nonprofits (with or without 501(c)(3) status, other than institutions of higher education), small businesses, and for-profit organizations other than small businesses. Eligible federal agencies may also apply. Foreign organizations are not permitted as applicant organizations, although foreign components of U.S. organizations are allowed, which can matter for projects that rely on specialized overseas resources while maintaining a U.S. institutional lead.

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), reflecting the cross-institute nature of the program. The full announcement was provided through the NIH grants guide (link in the source text), and NIH Office of Extramural Research (OER) webmaster contacts were listed for access or technical linking issues.

FAQs: National Cooperative Drug Discovery/Development Groups (NCDDG) for the Treatment of Mental Disorders, Drug or Alcohol Addiction (U19) - PAR-11-207

What is this funding opportunity?

This opportunity is the National Cooperative Drug Discovery/Development Groups (NCDDG) for the Treatment of Mental Disorders, Drug or Alcohol Addiction (U19), a National Institutes of Health (NIH) cooperative agreement program (Funding Opportunity Number PAR-11-207) focused on advancing medication discovery and development for mental disorders and substance use conditions, including drug and alcohol addiction.

What is the main goal of the NCDDG U19 program?

The central goal is to push promising medication ideas further and faster by organizing them under coordinated, multidisciplinary research teams. The program is designed to create integrated partnerships that discover and develop pharmacological agents to both treat and better understand mental illness and drug/alcohol addiction, with clear milestones and an emphasis on advancing candidates toward real-world testing.

What does "cooperative agreement (U19)" mean in this context?

Because this is a cooperative agreement, NIH is expected to have substantial programmatic involvement compared with a typical grant. The structure generally includes coordination, milestone-driven oversight, and active engagement to support progress and alignment with program goals, along with strong integration and project management across multiple components.

What kinds of research teams or partnerships does the program emphasize?

The program prioritizes coordinated, multidisciplinary teams rather than isolated projects. It is built around integrated partnerships that can include basic scientists, translational researchers, clinical investigators, and, when possible, industry development experts working together under a shared plan.

Which NIH Institutes sponsor this opportunity?

Three NIH Institutes jointly sponsor and encourage applications: 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 scientific areas and conditions does the opportunity target?

The focus is on rationally based candidate medications for mental disorders and substance use conditions, including alcohol addiction, as well as efforts that improve the ability to understand targets and mechanisms relevant to these conditions.

What stages of therapeutics development are supported?

The scientific scope spans the full early pipeline of therapeutics development, including innovative drug discovery, preclinical development, model development and validation, translational assays, and early phase human clinical testing (including proof-of-concept studies).

What does the program mean by "innovative drug discovery"?

Applicants are expected to propose rational, target-driven strategies intended to produce new candidate medications or reposition existing ones in a scientifically justified way.

Does the opportunity support repurposing or new indications for existing drugs?

Yes. The program highlights evaluating new indications for "IND-ready" drugs as a practical development route, since compounds with sufficient manufacturing, toxicology, and regulatory groundwork can potentially be tested more efficiently for mental disorders or alcohol addiction.

What are "pharmacologic tools" and are they supported?

Yes. A major objective includes development of pharmacologic tools such as novel ligands. These tools can be used in basic and clinical research to characterize targets more precisely or validate new targets, including compounds, probes, or other chemical/biological tools that clarify target behavior, engagement, selectivity, and meaningful downstream effects.

What does the program expect regarding models and assays?

A key emphasis is building and validating models for evaluating novel therapeutics, including improved preclinical models that better predict clinical response and translational assays that bridge animal and human research.

How important are rigor, reproducibility, and decision criteria in proposed projects?

They are explicitly emphasized. Applicants are encouraged to include plans for rigorous validation, reproducibility, and clear decision-making criteria to determine whether a candidate should advance, be modified, or be stopped based on emerging data.

Does the funding support human clinical studies?

Yes. The opportunity supports early phase human clinical testing, especially proof-of-concept work that can rapidly assess safety and potential efficacy in relevant patient populations.

What is the program trying to achieve with early phase proof-of-concept studies?

The intent is to shorten the time between preclinical promise and clinical reality by enabling well-designed early studies that quickly test whether a candidate (or a new indication for an IND-ready drug) shows signs of benefit.

Are academia-industry partnerships allowed or encouraged?

They are strongly encouraged. The opportunity notes that industry contributions can be important for medicinal chemistry optimization, formulation, manufacturing, regulatory planning, and operational aspects of early clinical studies, while academic groups often provide deep disease expertise, novel target biology, advanced models, and access to specialized clinical populations.

What does NIH look for in an academia-industry partnership under this program?

Competitive applications would typically demonstrate complementary strengths integrated into a single program with shared responsibilities, rather than parallel or disconnected efforts.

When was this opportunity posted and what are the key dates?

The opportunity was posted on April 22, 2011. The original and current closing date was February 22, 2013, and the archive date was March 25, 2013.

What is the Funding Opportunity Number?

The Funding Opportunity Number (FOA) is PAR-11-207.

What type of funding is it and is cost sharing required?

It is discretionary funding using the cooperative agreement instrument (U19). No cost sharing or matching is required.

Who is eligible to apply?

Eligible applicants include U.S.-based organizations such as public and state-controlled institutions of higher education, private institutions of higher education, nonprofits (with or without 501(c)(3) status, other than institutions of higher education), small businesses, and for-profit organizations other than small businesses. Eligible federal agencies may also apply.

Are foreign organizations eligible to apply?

No. Foreign organizations are not permitted as applicant organizations.

Are foreign components allowed if the applicant is a U.S. organization?

Yes. Foreign components of U.S. organizations are allowed, which may matter for projects using specialized overseas resources while maintaining a U.S. institutional lead.

What 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).

Where was the full announcement published?

The full announcement was provided through the NIH grants guide (as referenced in the source text).

Who was listed for help with access or technical link issues?

The NIH Office of Extramural Research (OER) webmaster contacts were listed for access or technical linking issues.

What broad category areas are listed for this opportunity?

The opportunity lists activity in the education and health category areas, as provided in the source information.

How does this program differ from funding isolated research projects?

Rather than supporting disconnected projects, the program is built around coordinated, integrated group efforts with shared milestones and a translational plan, bringing together multiple disciplines to move candidates toward testing and practical development decisions.

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