Opportunity Information: Apply for PAR 16 430
The Strategic Alliances for Medications Development to Treat Substance Use Disorders (R01) opportunity (PAR 16-430) is a National Institutes of Health (NIH) research grant designed to speed up the development of medications for substance use disorders by pushing promising compounds closer to Food and Drug Administration (FDA) approval. The core idea is to fund projects that move beyond early, open-ended research and instead achieve concrete progress along a defined drug development pathway. To do that, the announcement emphasizes partnerships that combine National Institute on Drug Abuse (NIDA) funding with the capabilities, assets, and practical development experience of outside organizations. These alliances are meant to reduce the typical bottlenecks in medications development by sharing expertise, infrastructure, manufacturing capacity, and regulatory know-how, ultimately increasing the pace at which SUD treatments can reach patients.
A major feature of this program is its strong preference for strategic collaborations involving multiple types of organizations, such as academic institutions, pharmaceutical or biotechnology companies, private or public foundations, nonprofits, and small businesses. At the same time, the FOA also allows applications from a single organization if that organization can demonstrate that it is bringing substantial in-kind or direct resource commitments to the project. Examples of meaningful commitment include covering salary support for key personnel, supplying specialized capabilities, or handling production and formulation of clinical trial materials. In other words, the program is not simply funding a lab to do isolated experiments; it is supporting well-resourced, development-ready efforts where partners can demonstrably contribute to the steps needed for FDA advancement.
The scope of supported work is broad across the medications development lifecycle, as long as it is clearly tied to advancing a candidate toward FDA approval. Projects may involve development of a new molecular entity or expanding the clinical indication(s) of an existing medication, which could include repurposing or pursuing additional uses for a compound already known to have some clinical profile. Regardless of the starting point, each application is expected to define a clear entry point and exit point in the development pathway, signaling that the project is structured around specific milestones and deliverables rather than exploratory research alone. The end goal is measurable forward movement in the FDA approval process, which can include steps that de-risk the candidate, support an Investigational New Drug (IND)-enabling package, or progress through clinical development in a way aligned with regulatory expectations.
The program structure, including project period and budget approach, is intentionally framed to accelerate timelines compared to traditional investigator-initiated R01 research. While standard R01 projects often prioritize hypothesis-driven discovery, this FOA is aimed at development-oriented outcomes and faster advancement through the drug pipeline. The listed award ceiling is up to $3,000,000, reflecting the reality that later-stage preclinical work, manufacturing, formulation, and clinical testing activities can be resource-intensive when the objective is regulatory progress rather than basic research insights.
Eligibility is broad and includes a wide range of domestic organizations commonly eligible for federal research funding, such as state, county, and local governments; special district governments; independent school districts; public and state-controlled universities; private institutions of higher education; federally recognized Native American tribal governments; public housing authorities/Indian housing authorities; tribal organizations not federally recognized; nonprofits with or without 501(c)(3) status; for-profit organizations (including those other than small businesses); and small businesses. The announcement also explicitly notes additional eligible applicants, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), 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, U.S. territories or possessions, and non-U.S. (foreign) entities. This breadth reflects an intent to pull in the strongest possible development teams and to encourage partnerships that can connect research, communities, clinical settings, and industry-grade development resources.
Administratively, this is a discretionary grant in the Education and Health activity category under CFDA 93.279, administered by NIH with programmatic emphasis from NIDA. The opportunity was created on 2016-09-08, with an original closing date listed as 2018-01-24. Overall, the FOA is best understood as a translational, milestone-oriented mechanism aimed at moving real medication candidates for substance use disorders toward FDA decision points, using structured alliances and tangible resource commitments to shorten the path from promising science to approved treatment options.Apply for PAR 16 430
- The National Institutes of Health in the education, health sector is offering a public funding opportunity titled "Strategic Alliances for Medications Development to Treat Substance Use Disorders (R01)" 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 $3,000,000.00 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 Strategic Alliances for Medications Development to Treat Substance Use Disorders (R01) opportunity?
It is an NIH research grant opportunity (PAR 16-430) intended to speed up the development of medications for substance use disorders (SUD) by moving promising compounds closer to FDA approval. The focus is on concrete progress along a defined drug development pathway rather than open-ended early research.
Which NIH institute is associated with the program emphasis?
The program is administered by NIH with programmatic emphasis from the National Institute on Drug Abuse (NIDA).
What is the main goal of this funding opportunity?
The goal is measurable forward movement in the FDA approval process for SUD medications. This can include work that de-risks a candidate, supports an IND-enabling package, or advances clinical development in ways aligned with regulatory expectations.
How is this opportunity different from a typical investigator-initiated R01?
While many R01 projects emphasize hypothesis-driven discovery, this FOA is development-oriented and milestone-focused. It is structured to accelerate timelines by requiring defined development entry and exit points and by emphasizing deliverables that advance a candidate toward FDA decision points.
What types of projects are supported?
The scope is broad across the medications development lifecycle as long as the work is clearly tied to advancing a candidate toward FDA approval. Projects can include development of a new molecular entity or expansion of the clinical indication(s) of an existing medication, including repurposing.
Does the program support repurposing or new indications for existing medications?
Yes. The FOA allows expanding the clinical indication(s) of an existing medication, including repurposing or pursuing additional uses for a compound with an existing clinical profile.
What does it mean to have a defined entry point and exit point in the development pathway?
Each application is expected to state where the project begins in the drug development process (entry point) and what specific development milestone or endpoint it will reach (exit point). This requirement reinforces that the project is organized around milestones and deliverables rather than exploratory research alone.
Why does the FOA emphasize partnerships and alliances?
The program aims to reduce typical bottlenecks in medications development by combining NIDA support with outside organizations that can contribute expertise, infrastructure, manufacturing capacity, and regulatory know-how, thereby increasing the pace at which SUD treatments can reach patients.
What types of partners are preferred in strategic collaborations?
The FOA expresses a strong preference for collaborations that may include academic institutions, pharmaceutical or biotechnology companies, private or public foundations, nonprofits, and small businesses.
Can a single organization apply without partners?
Yes. The FOA allows applications from a single organization if it can demonstrate substantial in-kind or direct resource commitments to the project.
What counts as a substantial in-kind or direct resource commitment?
Examples described include covering salary support for key personnel, supplying specialized capabilities, or handling production and formulation of clinical trial materials.
Is this funding meant for isolated lab experiments?
No. The FOA is described as supporting well-resourced, development-ready efforts where partners can demonstrably contribute to steps needed for FDA advancement, rather than funding isolated experiments.
What is the award ceiling mentioned for this opportunity?
The listed award ceiling is up to $3,000,000.
Why is the budget ceiling relatively high?
The FOA notes that later-stage preclinical work, manufacturing, formulation, and clinical testing can be resource-intensive when the objective is regulatory progress toward FDA advancement rather than basic research insights.
Who is eligible to apply?
Eligibility is broad and includes many domestic organizations typically eligible for federal research funding, including government entities (state, county, local), special district governments, independent school districts, public and state-controlled universities, private institutions of higher education, federally recognized Native American tribal governments, public housing authorities/Indian housing authorities, tribal organizations not federally recognized, nonprofits (with or without 501(c)(3) status), for-profit organizations (including those other than small businesses), and small businesses.
Are non-U.S. (foreign) entities eligible?
Yes. The announcement explicitly includes non-U.S. (foreign) entities among eligible applicants.
Are U.S. territories or possessions eligible?
Yes. The eligibility list explicitly includes U.S. territories or possessions.
Are specific institution types explicitly called out as eligible?
Yes. The announcement explicitly notes eligibility for Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), and faith-based or community-based organizations.
Are eligible federal agencies included?
Yes. Eligible federal agencies are explicitly listed as eligible applicants.
What is the assistance listing or CFDA number associated with this opportunity?
The opportunity is associated with CFDA 93.279.
What type of grant is this categorized as?
It is described as a discretionary grant in the Education and Health activity category.
When was this opportunity created and what is the original closing date listed?
The opportunity was created on 2016-09-08, with an original closing date listed as 2018-01-24.
What outcomes is the FOA trying to achieve at a high level?
At a high level, the FOA is intended to shorten the path from promising science to approved treatment options for substance use disorders by using structured alliances, tangible resource commitments, and a milestone-oriented development plan that pushes candidates toward FDA decision points.
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