Opportunity Information: Apply for PAR 16 431
The Grand Opportunity in Medications Development for Substance-Use Disorders (U01) (Funding Opportunity Number PAR 16 431) is a National Institutes of Health (NIH) funding announcement designed to speed up the development of medications to treat substance-use disorders (SUDs). The central focus is on moving promising medication candidates forward through the kinds of studies that generate clear, decision-ready evidence, with the explicit aim of advancing treatments closer to eventual U.S. Food and Drug Administration (FDA) approval. Unlike smaller, longer-horizon investigator-initiated grants, this opportunity is set up to support projects that can produce high-impact results on an accelerated timeline and directly address critical gaps in the medications development pipeline.
The mechanism is a U01 cooperative agreement, which means awardees should expect substantial scientific involvement from the funding institute rather than a hands-off relationship. In this case, the National Institute on Drug Abuse (NIDA) plays an active role through close monitoring and significant participation in the scientific direction and oversight of the funded work. This structure is intended to keep projects tightly focused, milestone-driven, and aligned with regulatory and translational requirements, particularly when the work needs coordinated guidance to move efficiently from experimental findings toward clinical utility.
Projects may be preclinical, clinical, or include both, as long as they meaningfully contribute to medications development for SUDs. The FOA emphasizes studies that are likely to yield the kinds of results needed to justify and design later-stage development steps, including work that may be difficult to fund under a traditional R01 because it can be too expensive, too time-sensitive, or too operationally complex. In practice, the opportunity is meant to cover pivotal enabling studies that can quickly clarify whether a candidate medication is ready to advance, how it should be tested, or what key risks and uncertainties must be resolved first.
The awards are expected to be short-term and large. Funding can last up to 3 years, with an award ceiling of up to $5,000,000 per year, reflecting the expectation that these projects may involve significant coordination, specialized infrastructure, intensive data collection, or other resource-heavy components typical of advanced translational work. The goal is not incremental progress over many years, but rather concentrated investment to generate decisive outcomes that move a medication development program forward.
Eligibility is broad and includes many types of U.S. and non-U.S. organizations, reflecting an intent to draw from a wide range of scientific, clinical, and community-based expertise. Eligible applicants include state, county, and local governments; special districts; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; Native American tribal organizations (other than federally recognized 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 FOA also explicitly highlights additional eligible applicants such as 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), faith-based or community-based organizations, eligible federal agencies, regional organizations, non-domestic (foreign) entities, tribal governments that are not federally recognized, and U.S. territories or possessions.
Administratively, this is a discretionary funding opportunity in the education and health activity category, associated with CFDA number 93.279. The listing notes an original closing date of January 24, 2018, and a creation date of September 8, 2016. Overall, the opportunity is best understood as a high-dollar, high-intensity, milestone-oriented pathway for medications development in SUDs, deliberately structured to support projects that need strong institute partnership and resources to reach outcomes that can meaningfully accelerate progress toward FDA-regulated approval pathways.Apply for PAR 16 431
- The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Grand Opportunity in Medications Development for Substance-Use Disorders (U01)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.279.
- This funding opportunity was created on 2016-09-08.
- Applicants must submit their applications by 2018-01-24. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Each selected applicant is eligible to receive up to $5,000,000.00 in funding.
- 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 the "Grand Opportunity in Medications Development for Substance-Use Disorders (U01)"?
It is a National Institutes of Health (NIH) funding announcement designed to speed up the development of medications to treat substance-use disorders (SUDs). It focuses on moving promising medication candidates into studies that produce clear, decision-ready evidence needed to advance treatments toward eventual U.S. Food and Drug Administration (FDA) approval.
What is the funding opportunity number for this program?
The Funding Opportunity Number is PAR 16 431.
Which NIH institute is leading this opportunity?
The opportunity is associated with the National Institute on Drug Abuse (NIDA), which plays an active role in monitoring and participating in the scientific direction and oversight of funded projects.
What does it mean that this is a U01 cooperative agreement?
A U01 cooperative agreement means the awardee should expect substantial scientific involvement from the funding institute rather than a hands-off relationship. Under this structure, NIDA provides close monitoring and significant participation in scientific direction and oversight to help keep projects focused, milestone-driven, and aligned with translational and regulatory needs.
What is the main goal of projects funded under this FOA?
The main goal is to generate decisive outcomes that move a medication development program forward, particularly outcomes that support next development steps and help bring treatments closer to FDA-regulated approval pathways.
What types of projects are supported (preclinical, clinical, or both)?
Projects may be preclinical, clinical, or include both, as long as they meaningfully contribute to medications development for substance-use disorders.
How is this opportunity different from a traditional investigator-initiated grant (like an R01)?
This FOA is positioned for projects that can produce high-impact results on an accelerated timeline and directly address critical gaps in the medications development pipeline. It is intended to support studies that may be too expensive, too time-sensitive, or too operationally complex for a traditional R01, and it is structured for intensive institute involvement and milestone-driven progress.
What kind of studies does the FOA emphasize?
The FOA emphasizes studies likely to yield results needed to justify and design later-stage development steps. It is meant to fund pivotal enabling studies that clarify whether a medication candidate is ready to advance, how it should be tested, or what key risks and uncertainties must be resolved.
What does "milestone-driven" mean in the context of this program?
In this program, milestone-driven work refers to projects being kept tightly focused on defined, decision-ready outcomes, supported by close institute monitoring and oversight intended to keep progress aligned with translational and regulatory requirements.
How long can the funding last?
Funding can last up to 3 years.
What is the maximum funding amount available?
The award ceiling is up to $5,000,000 per year.
Why is the award described as "short-term and large"?
The FOA is designed for concentrated investment over a limited time period to generate decisive outcomes, rather than incremental progress over many years. The high ceiling reflects that projects may require significant coordination, specialized infrastructure, intensive data collection, or other resource-heavy components common in advanced translational work.
Who is eligible to apply?
Eligibility is broad and includes many types of U.S. and non-U.S. organizations. Eligible applicants include state, county, and local governments; special districts; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; Native American tribal organizations (other than federally recognized 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 non-U.S. (foreign) organizations eligible?
Yes. The FOA explicitly includes non-domestic (foreign) entities among the eligible applicants.
Are for-profit organizations eligible?
Yes. For-profit organizations (other than small businesses) are listed as eligible, and small businesses are also listed separately as eligible applicants.
Are nonprofits required to have 501(c)(3) status to apply?
No. The eligibility list includes nonprofits with or without 501(c)(3) status.
Are tribal entities eligible, including those that are not federally recognized?
Yes. The FOA includes federally recognized Native American tribal governments and also highlights tribal governments that are not federally recognized, as well as Native American tribal organizations (other than federally recognized governments).
Are U.S. territories or possessions eligible to apply?
Yes. The FOA explicitly highlights U.S. territories or possessions among additional eligible applicants.
Does the FOA highlight any specific institution types as eligible?
Yes. It explicitly highlights additional eligible applicants such as 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); and faith-based or community-based organizations, among others.
What is the CFDA number associated with this opportunity?
The opportunity is associated with CFDA number 93.279.
What activity category is this funding opportunity listed under?
It is listed as a discretionary funding opportunity in the education and health activity category.
What is the original closing date listed for this opportunity?
The listing notes an original closing date of January 24, 2018.
When was this opportunity created?
The listing notes a creation date of September 8, 2016.
What kind of institute involvement should applicants expect during the project?
Applicants should expect close monitoring and significant participation by NIDA in scientific direction and oversight. The cooperative agreement structure is intended to support coordinated guidance and keep the work aligned with milestone expectations and translational and regulatory requirements.
What is the broader purpose of NIDA's active partnership in this U01?
The active partnership is intended to help projects move efficiently from experimental findings toward clinical utility by keeping them tightly focused, milestone-driven, and aligned with regulatory and translational requirements.
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Applicants also applied for:
Applicants who have applied for this opportunity (PAR 16 431) also looked into and applied for these:
| Funding Opportunity |
|---|
| Strategic Alliances for Medications Development to Treat Substance Use Disorders (R01) Apply for PAR 16 430 Funding Number: PAR 16 430 Agency: National Institutes of Health Category: Education, Health Funding Amount: $3,000,000 |
| Health Promotion Among Racial and Ethnic Minority Males (R21) Apply for PA 16 432 Funding Number: PA 16 432 Agency: National Institutes of Health Category: Education, Health Funding Amount: $200,000 |
| Symptom Management in HIV-Infected Individuals with Comorbid Conditions (R01) Apply for PA 16 427 Funding Number: PA 16 427 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Symptom Management in HIV-Infected Individuals with Comorbid Conditions (R21) Apply for PA 16 429 Funding Number: PA 16 429 Agency: National Institutes of Health Category: Education, Health Funding Amount: $200,000 |
| Encouraging Appropriate Care Using Behavioral Economics through Electronic Health Records (R21/R33) Apply for RFA AG 17 013 Funding Number: RFA AG 17 013 Agency: National Institutes of Health Category: Education, Health Funding Amount: $200,000 |
| Drug Abuse Dissertation Research (R36) Apply for PA 16 443 Funding Number: PA 16 443 Agency: National Institutes of Health Category: Education, Health Funding Amount: $50,000 |
| Improving the HIV Pre-Exposure Prophylaxis (PrEP) Cascade (R34) Apply for RFA MH 17 361 Funding Number: RFA MH 17 361 Agency: National Institutes of Health Category: Education, Health Funding Amount: $225,000 |
| Improving the HIV Pre-Exposure Prophylaxis (PrEP) Cascade (R01) Apply for RFA MH 17 360 Funding Number: RFA MH 17 360 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Multi-Site Pilot and Feasibility Studies for System-Level Implementation of Substance Use Prevention and Treatment Services (R34) Apply for PAR 16 456 Funding Number: PAR 16 456 Agency: National Institutes of Health Category: Education, Health Funding Amount: $225,000 |
| Multi-Site Studies for System-Level Implementation of Substance Use Prevention and Treatment Services (R01) Apply for PAR 16 455 Funding Number: PAR 16 455 Agency: National Institutes of Health Category: Education, Health Funding Amount: $500,000 |
| Collaborative Consortia for the Study of HIV Associated Cancers: U.S. and Low-and Middle-Income Country Partnerships (U54) Apply for RFA CA 16 018 Funding Number: RFA CA 16 018 Agency: National Institutes of Health Category: Education, Health Funding Amount: $600,000 |
| National Cancer Institute Program Project Applications (P01) Apply for PAR 16 457 Funding Number: PAR 16 457 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| International Research Scientist Development Award (IRSDA) (K01) Apply for PAR 17 002 Funding Number: PAR 17 002 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Revision Applications for Validation of Biomarker Assays Developed Through NIH-Supported Research Grants (R01) Apply for PAR 17 003 Funding Number: PAR 17 003 Agency: National Institutes of Health Category: Education, Health Funding Amount: $150,000 |
| Hepatitis C Virus (HCV) Advanced Molecular Detection in Support of Systems for Prevention, Treatment and Control of HIV, HCV and Related Comorbidities in Rural Communities Affected by Opioid Injection Drug Epidemics in the United States (U24) Apply for RFA DA 17 023 Funding Number: RFA DA 17 023 Agency: National Institutes of Health Category: Education, Health Funding Amount: $370,000 |
| HIV, HCV and Related Comorbidities in Rural Communities Affected by Opioid Injection Drug Epidemics in the United States: Building Systems for Prevention, Treatment and Control (UG3/UH3) Apply for RFA DA 17 014 Funding Number: RFA DA 17 014 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Use of Technology to Enhance Patient Outcomes and Prevent Illness (R21) Apply for PA 17 009 Funding Number: PA 17 009 Agency: National Institutes of Health Category: Education, Health Funding Amount: $200,000 |
| Improving Individual and Family Outcomes through Continuity and Coordination of Care in Hospice (R21) Apply for PA 17 015 Funding Number: PA 17 015 Agency: National Institutes of Health Category: Education, Health Funding Amount: $200,000 |
| Self-Management Interventions and Technologies to Sustain Health and Optimize Functional Capabilities (R01) Apply for PA 17 012 Funding Number: PA 17 012 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
| Addressing Unmet Needs in Persons with Dementia to Decrease Behavioral Symptoms and Improve Quality of Life (R01) Apply for PA 17 014 Funding Number: PA 17 014 Agency: National Institutes of Health Category: Education, Health Funding Amount: Case Dependent |
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