Opportunity Information: Apply for PAR 18 230
The National Cooperative Drug/Device Discovery/Development Groups (U01 Clinical Trial Optional) funding opportunity (PAR-18-230) is an NIH cooperative agreement designed to push promising new treatments and research tools for mental health conditions, substance use disorders (SUDs), and alcohol addiction through the critical early stages of development. The core idea is to speed up the pipeline from scientifically grounded concepts to practical, testable drug or device candidates by supporting discovery, preclinical development, and early proof-of-concept work. Unlike a traditional grant where the applicant largely drives the project independently, the U01 cooperative agreement structure typically means substantial NIH involvement, with closer collaboration and milestone-driven progress to keep projects moving efficiently.
A major emphasis of the program is on advancing both pharmacologic and neuromodulatory approaches. On the drug side, that can include discovering and optimizing new candidate compounds, developing novel ligands, and building the evidence needed to justify next-step testing. On the device side, the focus includes neurostimulation or circuit-engagement technologies that can either become therapeutic candidates themselves or serve as tools to probe brain circuits and validate targets. The opportunity is not limited to creating entirely new therapies; it also supports new indications for agents that are already IND-ready, and devices that are PMA-ready, meaning the work can include repurposing or extending advanced candidates toward mental disorders, SUDs, or alcohol addiction when there is a strong scientific rationale.
Another key goal is to support experimental therapeutic studies and early-stage human research that can quickly answer practical questions about a candidate's safety, tolerability, and pharmacodynamics. In other words, the program is meant to help investigators move beyond interesting biology into studies that show whether a drug or device engages its target, affects relevant mechanisms, and looks feasible to advance. While the FOA is described as “Clinical Trial Optional,” it explicitly welcomes projects that include early human testing when it is appropriate and can accelerate decision-making about whether to proceed to larger trials.
The FOA strongly encourages partnerships between academia and industry, reflecting the reality that successful translation often requires combined strengths: academic innovation and mechanistic insight alongside industry experience in development, manufacturing, regulatory strategy, and scaling. Projects that bring together these capabilities are well aligned with the program’s intent to produce candidates and tools that are genuinely positioned for the next stages of development rather than remaining purely exploratory.
Eligibility is broad and includes many U.S.-based entities such as state, county, and local governments; public and private institutions of higher education; federally recognized tribal governments; tribal organizations; independent school districts; special district governments; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses. The announcement also highlights additional eligible applicant types such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, certain tribal governments that are not federally recognized, regional organizations, eligible federal agencies, and U.S. territories or possessions. Foreign institutions and non-U.S. entities are not eligible to apply, and non-domestic components of U.S. organizations are not eligible; however, “foreign components” as defined by the NIH Grants Policy Statement may be included, which typically allows specific, justified elements of the work to occur abroad under a U.S. applicant organization.
Administrative details from the source listing include the opportunity category as discretionary, the funding instrument as a cooperative agreement (U01), and activity areas spanning education and health, with CFDA numbers 93.242, 93.273, and 93.279. The listing shows an original closing date of 2020-02-24 and a creation date of 2017-11-21. The award ceiling and expected number of awards are not specified in the provided data, which often means applicants need to consult the full FOA text for budget expectations, project period limits, milestones, and any institute-specific priorities tied to the announcement.
Taken together, this opportunity is aimed at teams that have a compelling, rationally based therapeutic or tool concept and can lay out a credible development path from discovery through preclinical work and, when appropriate, into early human testing. The most competitive projects are likely to be those that clearly define target or circuit engagement, specify measurable development milestones, and show how the proposed drug or device candidate will be de-risked efficiently for eventual clinical application in mental health, SUDs, or alcohol addiction.Apply for PAR 18 230
- The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "National Cooperative Drug/Device Discovery/Development Groups (U01 Clinical Trial Optional)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.242, 93.273, 93.279.
- This funding opportunity was created on 2017-11-21.
- Applicants must submit their applications by 2020-02-24. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.
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Frequently Asked Questions (FAQs)
What is PAR-18-230?
PAR-18-230 is the NIH funding opportunity titled "National Cooperative Drug/Device Discovery/Development Groups (U01 Clinical Trial Optional)." It uses a cooperative agreement mechanism (U01) to support research that moves promising drug or device concepts for mental health conditions, substance use disorders (SUDs), and alcohol addiction through early development stages.
What is the main purpose of this program?
The program is designed to speed the pipeline from scientifically grounded ideas to practical, testable drug or device candidates. It supports discovery, preclinical development, and early proof-of-concept work so teams can make faster, better-informed decisions about whether a candidate is ready for the next stage of development.
What types of conditions does this funding opportunity target?
The opportunity focuses on mental health conditions, substance use disorders (SUDs), and alcohol addiction.
What kinds of projects are supported (drugs, devices, or both)?
Both. A major emphasis is placed on advancing pharmacologic approaches (drugs) and neuromodulatory approaches (devices), including neurostimulation or circuit-engagement technologies.
What drug-related activities does the program support?
Examples described include discovering and optimizing new candidate compounds, developing novel ligands, and generating the evidence needed to justify next-step testing.
What device-related activities does the program support?
The program supports neuromodulatory and related device approaches, including neurostimulation or circuit-engagement technologies. Devices may be advanced as therapeutic candidates themselves or used as research tools to probe brain circuits and validate targets.
Does the program only support entirely new therapies?
No. It can also support new indications for advanced candidates, including agents that are already IND-ready and devices that are PMA-ready, when there is a strong scientific rationale for extending or repurposing them toward mental disorders, SUDs, or alcohol addiction.
What does "Clinical Trial Optional" mean in this FOA?
The FOA is described as "Clinical Trial Optional," meaning projects are not required to include a clinical trial. However, it explicitly welcomes early human testing when appropriate and when it can accelerate decision-making about whether to proceed to larger trials.
Are early-stage human studies allowed under this opportunity?
Yes. The opportunity welcomes experimental therapeutic studies and early-stage human research when appropriate, particularly to answer practical questions about safety, tolerability, pharmacodynamics, and whether a candidate engages its target or affects relevant mechanisms.
What kinds of questions should supported early human research help answer?
As described, early human work is intended to quickly assess practical issues such as safety, tolerability, pharmacodynamics, target engagement, mechanism engagement, and overall feasibility for advancing toward larger clinical trials.
How is a U01 cooperative agreement different from a traditional research grant?
In a U01 cooperative agreement, NIH typically has substantial involvement. The structure tends to be more collaborative and milestone-driven than a traditional grant, with closer NIH engagement intended to keep projects moving efficiently through development stages.
Is NIH involvement expected to be significant?
Yes. The provided description emphasizes that, unlike traditional grants where the applicant largely drives the work independently, the U01 structure typically includes substantial NIH involvement and closer collaboration with milestone-driven progress.
Are partnerships between academia and industry encouraged?
Yes. The FOA strongly encourages academia-industry partnerships, reflecting the combined strengths often needed for translation (academic innovation and mechanistic insight alongside industry capabilities in development, manufacturing, regulatory strategy, and scaling).
What kinds of teams are considered a strong fit for this opportunity?
Teams with a compelling, rationally based therapeutic or tool concept and a credible development plan from discovery through preclinical work and, when appropriate, early human testing. The description suggests competitive projects will clearly define target or circuit engagement and include measurable development milestones that efficiently de-risk the candidate for eventual clinical application.
What does "milestone-driven progress" imply for applicants?
Based on the description, applicants should expect to propose measurable development milestones and to use those milestones to demonstrate progress and guide efficient advancement of the drug or device candidate through early development.
Who is eligible to apply?
Eligibility is broad and includes many U.S.-based entities such as state, county, and local governments; public and private institutions of higher education; federally recognized tribal governments; tribal organizations; independent school districts; special district governments; public housing authorities/Indian housing authorities; nonprofits (with or without 501(c)(3) status); for-profit organizations (other than small businesses); and small businesses.
Are minority-serving institutions and community-based organizations eligible?
Yes. The listing highlights eligibility for entities such as HBCUs, Hispanic-serving institutions, Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Tribally Controlled Colleges and Universities (TCCUs), and faith-based or community-based organizations.
Are U.S. territories eligible to apply?
Yes. U.S. territories or possessions are listed among eligible applicants.
Can foreign institutions or non-U.S. entities apply?
No. Foreign institutions and non-U.S. entities are not eligible to apply based on the information provided.
Can a U.S. organization include work outside the United States?
Non-domestic components of U.S. organizations are not eligible. However, "foreign components" (as defined by the NIH Grants Policy Statement) may be included when justified, meaning specific elements of the work may occur abroad under a U.S. applicant organization.
What is the opportunity category and funding instrument?
The opportunity category is listed as discretionary, and the funding instrument is a cooperative agreement (U01).
What activity areas does this opportunity cover?
The listing describes activity areas spanning education and health.
What CFDA numbers are associated with this opportunity?
The CFDA numbers listed are 93.242, 93.273, and 93.279.
What are the key dates provided for this opportunity?
The source listing shows a creation date of 2017-11-21 and an original closing date of 2020-02-24.
Is the award ceiling stated in the provided information?
No. The award ceiling is not specified in the provided data.
Is the expected number of awards stated in the provided information?
No. The expected number of awards is not specified in the provided data.
Where should applicants look for budget expectations, project period limits, and institute-specific priorities?
The provided description indicates that when items like award ceiling, number of awards, budget expectations, project period limits, milestones, or institute-specific priorities are not shown in the listing, applicants typically need to consult the full FOA text for those details.
Does this opportunity support research tools as well as therapies?
Yes. In addition to therapeutic candidates, the program supports research tools, including device-based circuit-engagement technologies that can probe brain circuits and validate targets.
What does "de-risking" a candidate mean in the context provided?
In this context, de-risking refers to efficiently generating evidence (such as target engagement, mechanism effects, safety/tolerability, and feasibility signals) that helps determine whether a drug or device candidate is suitable to advance to later-stage clinical testing and development.
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Applicants also applied for:
Applicants who have applied for this opportunity (PAR 18 230) also looked into and applied for these:
| Funding Opportunity |
|---|
| NCI Transition Career Development Award to Promote Diversity (K22 Clinical Trial Required) Apply for PAR 18 367 Funding Number: PAR 18 367 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Strategic Alliances for Medications Development to Treat Substance Use Disorders (R01 Clinical Trial Optional) Apply for PAR 18 218 Funding Number: PAR 18 218 Agency: National Institutes of Health Category: Education, Health Funding Amount: $3,000,000 |
| Grand Opportunity in Medications Development for Substance-Use Disorders (U01 Clinical Trial Optional) Apply for PAR 18 219 Funding Number: PAR 18 219 Agency: National Institutes of Health Category: Education, Health Funding Amount: $5,000,000 |
| Independent Scientist Award (Parent K02 - Independent Clinical Trial Required) Apply for PA 18 370 Funding Number: PA 18 370 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| National Cooperative Drug/Device Discovery/Development Groups (NCDDG) for the Treatment of Mental or Substance Use Disorders or Alcohol Addiction (U19 Clinical Trial Optional) Apply for PAR 18 231 Funding Number: PAR 18 231 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| A Family-Centered Self-Management of Chronic Conditions (R01 Clinical Trial Optional) Apply for PA 18 383 Funding Number: PA 18 383 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Population Health Interventions: Integrating Individual and Group Level Evidence (R21)- Clinical Trials Not Allowed Apply for PA 18 406 Funding Number: PA 18 406 Agency: National Institutes of Health Category: Education, Health Funding Amount: $200,000 |
| Methodology and Measurement in the Behavioral and Social Sciences (R21) Clinical Trials Optional Apply for PAR 18 378 Funding Number: PAR 18 378 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| mHealth Tools for Individuals with Chronic Conditions to Promote Effective Patient-Provider Communication, Adherence to Treatment and Self-Management (R21 Clinical Trial Optional) Apply for PA 18 389 Funding Number: PA 18 389 Agency: National Institutes of Health Category: Education, Health Funding Amount: $200,000 |
| mHealth Tools for Individuals with Chronic Conditions to Promote Effective Patient-Provider Communication, Adherence to Treatment and Self-Management (R01 Clinical Trial Optional) Apply for PA 18 386 Funding Number: PA 18 386 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Population Health Interventions: Integrating Individual and Group Level Evidence (R01) - Clinical Trial Optional Apply for PA 18 385 Funding Number: PA 18 385 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Population Health Interventions: Integrating Individual and Group Level Evidence (R01) Clinical Trials Not Allowed Apply for PA 18 356 Funding Number: PA 18 356 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Methodology and Measurement in the Behavioral and Social Sciences (R01) Clinical Trials Optional Apply for PAR 18 352 Funding Number: PAR 18 352 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Family-Centered Self-Management of Chronic Conditions (R21 Clinical Trial Optional) Apply for PA 18 380 Funding Number: PA 18 380 Agency: National Institutes of Health Category: Education, Health Funding Amount: $200,000 |
| Midcareer Investigator Award in Patient-Oriented Research (Parent K24 - Clinical Trial Required) Apply for PA 18 393 Funding Number: PA 18 393 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Population Health Interventions: Integrating Individual and Group Level Evidence (R21) - Clinical Trials Optional Apply for PA 18 407 Funding Number: PA 18 407 Agency: National Institutes of Health Category: Education, Health Funding Amount: $200,000 |
| Healthy Habits: Timing for Developing Sustainable Healthy Behaviors in Children and Adolescents (R21 Clinical Trial Optional) Apply for PA 18 354 Funding Number: PA 18 354 Agency: National Institutes of Health Category: Education, Health Funding Amount: $200,000 |
| Healthy Habits: Timing for Developing Sustainable Healthy Behaviors in Children and Adolescents (R01 Clinical Trial Optional) Apply for PA 18 355 Funding Number: PA 18 355 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Tobacco Use and HIV in Low and Middle Income Countries (R01 Clinical Trial Optional) Apply for PAR 18 023 Funding Number: PAR 18 023 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Tobacco Use and HIV in Low and Middle Income Countries (R21 Clinical Trial Optional) Apply for PAR 18 022 Funding Number: PAR 18 022 Agency: National Institutes of Health Category: Education, Health Funding Amount: $200,000 |
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