Opportunity Information: Apply for RFA DA 19 018
The Laboratories for Early Clinical Evaluation of Pharmacotherapies for Substance Use Disorders (UG1 Clinical Trial Required) opportunity (RFA-DA-19-018) is a National Institutes of Health (NIH) cooperative agreement designed to build and support specialized clinical research "Laboratories" that can move potential medications for substance use disorders (SUDs) through early human testing. The central idea is to create a set of well-prepared, well-resourced clinical teams that can run early-stage trials quickly and rigorously, so promising compounds do not get stuck in the slow transition between preclinical work and larger confirmatory studies. The FOA focuses on accelerating medication development for SUD treatment by funding groups that already have, or can assemble, the clinical infrastructure and operational expertise needed to conduct FDA-defined Phase 1 and/or Phase 2 clinical trials of new or repurposed pharmacotherapies.
From a programmatic standpoint, the goal is efficiency and readiness: these Laboratories are expected to be capable of carrying out early clinical evaluation work in a timely manner, which typically implies strong capabilities in clinical pharmacology, participant safety monitoring, protocol implementation, regulatory compliance, and data quality. The scope specifically emphasizes Phase 1 and Phase 2 studies, meaning work such as first-in-human or early safety/tolerability evaluations, pharmacokinetics/pharmacodynamics efforts, dose-finding, proof-of-concept trials, and other early efficacy signals in relevant SUD populations. The FOA is explicitly a "Clinical Trial Required" mechanism, so the funded activities are not merely planning or observational studies; they are intended to include actual interventional trials that test pharmacotherapies.
The funding instrument is a cooperative agreement (UG1), which matters because it typically indicates substantial NIH scientific or programmatic involvement compared with a standard research project grant. In practice, that generally means awardees should expect close coordination with NIH staff on priorities, study selection, trial execution expectations, and performance milestones, consistent with how cooperative agreements are usually managed. The activity category is listed under education and health, and the CFDA number associated with this program is 93.279.
Eligibility is broad across U.S.-based organizations and includes many types of public and private entities. Eligible applicants include state, county, city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations other than federally recognized tribal governments; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (as long as they are not institutions of higher education under that specific category); for-profit organizations other than small businesses; small businesses; and other organizations that meet NIH eligibility rules. The FOA also highlights additional eligible applicant categories 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, tribal governments other than federally recognized tribes, and U.S. territories or possessions. At the same time, there are clear restrictions on foreign involvement: non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply, non-domestic components of U.S. organizations are not eligible, and foreign components (as NIH defines them in the NIH Grants Policy Statement) are not allowed.
Key administrative details in the provided source data include an original closing date of March 15, 2019, and a creation date of December 21, 2018. The listed award ceiling is $500,000, and the opportunity category is discretionary. The expected number of awards is not specified in the provided extract.
Overall, this FOA is best understood as NIH support for creating a small set of highly capable early-phase clinical trial "engines" focused specifically on pharmacotherapies for substance use disorders. Rather than funding a single isolated study, the intent is to strengthen and organize clinical trial capacity so that multiple candidate medications, including repurposed drugs, can be evaluated faster and more efficiently in Phase 1 and Phase 2 trials, helping promising treatments progress toward later-stage testing and eventual clinical use.Apply for RFA DA 19 018
- The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Laboratories for Early Clinical Evaluation of Pharmacotherapies for Substance Use Disorders (UG1 Clinical Trial Required)" 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 2018-12-21.
- Applicants must submit their applications by 2019-03-15. (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 $500,000.00 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 this grant opportunity?
This opportunity is called Laboratories for Early Clinical Evaluation of Pharmacotherapies for Substance Use Disorders (UG1 Clinical Trial Required) under RFA-DA-19-018. It is a National Institutes of Health (NIH) cooperative agreement intended to build and support specialized clinical research "Laboratories" that can move potential medications for substance use disorders (SUDs) through early human testing.
What is the main purpose of the program?
The main purpose is to accelerate medication development for substance use disorder treatment by funding clinical teams that are ready to run early-stage trials quickly and rigorously. The program aims to reduce delays between preclinical work and larger confirmatory studies by supporting well-prepared, well-resourced clinical trial teams.
What does the program mean by "Laboratories"?
"Laboratories" refers to specialized clinical research teams and infrastructure organized to conduct early-stage clinical trials efficiently. These are not laboratory bench science facilities; they are clinical trial-capable units designed to evaluate pharmacotherapies in humans in Phase 1 and/or Phase 2 settings.
What types of studies are supported (Phase 1 vs. Phase 2)?
The FOA emphasizes FDA-defined Phase 1 and/or Phase 2 clinical trials. The scope includes early human testing activities such as:
- First-in-human or early safety and tolerability evaluations
- Pharmacokinetics (PK) and pharmacodynamics (PD) efforts
- Dose-finding studies
- Proof-of-concept trials
- Other early efficacy signals in relevant SUD populations
Are clinical trials actually required?
Yes. The mechanism is explicitly labeled "Clinical Trial Required", meaning the funded activities are intended to include interventional trials that test pharmacotherapies, not just planning work or observational research.
What kinds of interventions are being tested?
The focus is on pharmacotherapies for substance use disorders, including new or repurposed medications that can be advanced through early clinical evaluation.
Is the goal to fund one study or build ongoing capacity?
Based on the description, the intent is to strengthen and organize clinical trial capacity so multiple candidate medications can be evaluated faster and more efficiently in early phases, rather than supporting a single isolated study in a one-off manner.
What does "UG1 cooperative agreement" mean for applicants?
The funding instrument is a cooperative agreement (UG1), which typically indicates substantial NIH scientific or programmatic involvement compared with a standard research project grant. Awardees should generally expect close coordination with NIH staff on priorities, study selection, execution expectations, and performance milestones, consistent with how cooperative agreements are managed.
What capabilities are expected of the funded Laboratories?
The FOA emphasizes efficiency and readiness. Laboratories are expected to be able to conduct early clinical evaluation work in a timely manner, which typically implies strong capabilities in:
- Clinical pharmacology
- Participant safety monitoring
- Protocol implementation
- Regulatory compliance
- Data quality
Who is eligible to apply?
Eligibility is broad across U.S.-based organizations and includes many types of public and private entities that meet NIH eligibility rules. Eligible applicants include:
- State, county, city, or township governments
- Special district governments
- Independent school districts
- Public and state-controlled institutions of higher education
- Private institutions of higher education
- Federally recognized Native American tribal governments
- Tribal organizations other than federally recognized tribal governments
- Public housing authorities/Indian housing authorities
- Nonprofits with or without 501(c)(3) status (as long as they fit the stated category and are not treated as institutions of higher education under that specific category)
- For-profit organizations other than small businesses
- Small businesses
- Other organizations that meet NIH eligibility rules
Are there specific institution types explicitly highlighted as eligible?
Yes. The FOA highlights additional eligible applicant categories 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
- Tribal governments other than federally recognized tribes
- U.S. territories or possessions
Are foreign organizations allowed to apply?
No. The FOA includes clear restrictions on foreign involvement. Based on the provided details:
- Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply.
- Non-domestic components of U.S. organizations are not eligible.
- Foreign components (as NIH defines them in the NIH Grants Policy Statement) are not allowed.
What is the award ceiling?
The listed award ceiling is $500,000.
How many awards will be made?
The expected number of awards is not specified in the provided extract.
What is the opportunity category?
The opportunity category is listed as discretionary.
What is the CFDA number for this program?
The CFDA number associated with this program is 93.279.
What general field or activity category does this fall under?
The activity category is listed under education and health.
What are the key dates mentioned?
The provided source data lists:
- Creation date: December 21, 2018
- Original closing date: March 15, 2019
What problem is this FOA trying to solve?
The FOA is designed to address the slow transition where promising compounds can get stuck between preclinical research and larger confirmatory studies. By building ready-to-run early-phase clinical trial capacity, the program aims to move candidates forward more efficiently.
What makes this FOA different from a standard research grant focused on a single project?
Based on the description, the emphasis is on creating a set of highly capable early-phase clinical trial engines that can evaluate multiple candidate medications over time, supported through a cooperative agreement structure with close NIH involvement, rather than funding only one standalone trial.
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