Opportunity Information: Apply for PAR 13 334
Apply for PAR 13 334
- 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 Drug Abuse and Addiction Research Programs.
- This funding opportunity was created on Aug 11, 2014 and posted on Aug 19, 2013.
- Applicants must submit their applications by Sep 7, 2016. (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: Small businesses For profit organizations other than small businesses Private institutions of higher education Public and State controlled institutions of higher education City or township governments County governments State governments Native American tribal governments (Federally recognized) 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 Public housing authorities/Indian housing authorities Special district governments Others (see text field entitled Additional Information on Eligibility for clarification) Native American tribal organizations (other than Federally recognized tribal governments) Independent school districts.
- Other Eligible Applicants include the following Alaska Native and Native Hawaiian Serving Institutions Asian American Native American Pacific Islander Serving Institutions (AANAPISISs) Eligible Agencies of the Federal Government Faith based or Community based Organizations Hispanic serving Institutions Historically Black Colleges and Universities (HBCUs) Indian/Native American Tribal Governments (Other than Federally Recognized) Non domestic (non U.S.) Entities (Foreign Organizations) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Non domestic (non U.S.) Entities (Foreign Institutions) are eligible to apply. Non domestic (non U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:
The Strategic Alliances for Medications Development to Treat Substance Use Disorders (R01) opportunity (Funding Opportunity Number PAR-13-334) is an NIH initiative from the National Institute on Drug Abuse (NIDA) designed to speed up the development of medications for substance use disorders (SUDs) by pushing promising compounds further along the FDA approval pathway. The core problem it addresses is practical and common in SUD medication development: many academic or single-lab research efforts have strong scientific ideas but lack the full mix of drug development expertise, operational capacity, and sustained funding needed to move a candidate from one stage to the next. Drug development is inherently long, multidisciplinary, and expensive, so projects often stall when investigators hit requirements like manufacturing, formulation, toxicology, regulatory planning, or clinical trial execution.
To solve that bottleneck, the FOA emphasizes building "strategic alliances" that combine NIDA support with substantial external resources and real-world development experience. These alliances can include collaborations among academic institutions, pharmaceutical and biotechnology companies, private or public foundations, small businesses, and other for-profit or nonprofit partners. While the program encourages multi-organization partnerships, it also allows applications from a single organization if that organization can demonstrate a meaningful commitment of resources that materially accelerates development. Examples of that kind of commitment include providing salary support for key development personnel, contributing specialized capabilities (like GMP manufacturing), or covering production and formulation of clinical trial material. The overall intent is that pairing NIDA funds with partner contributions will move candidates through the pipeline faster than a traditional stand-alone research grant.
The scientific scope is broad but clearly anchored to translational outcomes. Proposed projects may focus on developing a new molecular entity or on expanding the clinical indication(s) of an existing medication, as long as the work is explicitly structured to advance the candidate toward FDA approval. A key requirement is that each project must define a clear "entry point" and "exit point" within the medication development pathway. In other words, applicants need to state where the project begins in development terms (for example, late preclinical development, IND-enabling studies, early clinical testing, or building evidence for a new indication) and what concrete milestone will mark successful completion (for example, readiness to file an IND, completion of a Phase 1 or Phase 2 study, or another step that directly advances the regulatory trajectory). This milestone-driven framing is meant to keep projects focused on movement through the FDA development process rather than open-ended basic research.
The award structure reflects the program's emphasis on acceleration. The project period can be up to three years, and the budget is designed to support intensive development work, with up to $2,000,000 per year in direct costs noted in the description (and an overall award ceiling listed as $3,000,000 in the source data). There is no cost sharing or matching requirement, but the program is explicitly built around leveraging NIDA funds with partner resources, so the practical competitiveness of an application depends heavily on demonstrating credible, concrete commitments from alliance partners or from the applying organization itself.
Eligibility is intentionally expansive to attract the kinds of partners needed for medication development. Eligible applicants include small businesses and other for-profit organizations, nonprofit organizations (including those with or without 501(c)(3) status), public and private institutions of higher education, and a wide range of government entities (state, county, city/township, special district, independent school districts, public housing authorities). Tribal governments and tribal organizations are eligible, along with U.S. territories and possessions. The FOA also allows foreign organizations and foreign components of U.S. organizations, consistent with NIH policies, and it explicitly includes mission-driven institutional categories such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian-serving institutions, and AANAPISIs, as well as faith-based or community-based organizations and eligible federal agencies.
Administratively, this is a discretionary grant under the NIH umbrella, categorized in the source data under education/health and associated with CFDA 93.279 (Drug Abuse and Addiction Research Programs). The posting date was August 19, 2013, with an original and final closing date of September 7, 2016, and an archive date of October 8, 2016, meaning the specific announcement is historical rather than currently open. The underlying concept, however, is clear: NIDA wanted to fund milestone-driven, partner-backed medication development efforts that can realistically bridge the gap between promising SUD treatment candidates and the regulatory steps required to bring them closer to clinical use.
FAQs: Strategic Alliances for Medications Development to Treat Substance Use Disorders (R01) (PAR-13-334)
What is PAR-13-334?
PAR-13-334 is an NIH Funding Opportunity Announcement (FOA) from the National Institute on Drug Abuse (NIDA) titled "Strategic Alliances for Medications Development to Treat Substance Use Disorders (R01)." It was designed to speed up the development of medications for substance use disorders (SUDs) by moving promising compounds further along the FDA approval pathway.
What problem is this FOA trying to solve?
The FOA targets a common bottleneck in SUD medication development: many academic or single-lab projects have strong science but do not have the full drug development expertise, operational capacity, or sustained funding needed to complete requirements such as manufacturing, formulation, toxicology, regulatory planning, or clinical trial execution. Because medication development is long, multidisciplinary, and expensive, projects often stall when they reach these practical development steps.
What does "strategic alliances" mean in this program?
"Strategic alliances" refers to collaborations that combine NIDA support with substantial external resources and real-world drug development experience. Alliances may include academic institutions, pharmaceutical and biotechnology companies, private or public foundations, small businesses, and other for-profit or nonprofit partners. The intent is that partner contributions plus NIDA funds accelerate progress more than a stand-alone research grant could.
Do you have to apply as a multi-organization partnership?
No. While multi-organization collaborations are encouraged, a single organization may apply if it can demonstrate a meaningful commitment of resources that materially accelerates development. Examples described include salary support for key development personnel, specialized capabilities such as GMP manufacturing, or covering production and formulation of clinical trial material.
What kinds of projects fit the scientific scope?
The scope is broad but clearly translational. Projects may focus on developing a new molecular entity or on expanding the clinical indication(s) of an existing medication, as long as the work is explicitly structured to advance the candidate toward FDA approval.
Is basic research the main focus?
No. The program is framed around advancing a candidate through the FDA development process. Projects are expected to be milestone-driven and tied to concrete regulatory progress rather than open-ended basic research.
What is meant by defining an "entry point" and "exit point" in development?
Each project must state where it begins in the medication development pathway (the "entry point") and what concrete milestone will mark successful completion (the "exit point"). Entry points could include late preclinical development, IND-enabling studies, early clinical testing, or building evidence for a new indication. Exit points could include readiness to file an IND, completion of a Phase 1 or Phase 2 study, or another step that directly advances the regulatory trajectory.
What kinds of milestones count as acceptable "exit points"?
The FOA describes exit points as concrete milestones that move the candidate forward toward FDA approval, such as readiness to file an IND or completion of a Phase 1 or Phase 2 study, or another definable step that directly advances the regulatory pathway.
How long can the project period be?
The project period can be up to three years.
What funding level is described for this opportunity?
The description notes a budget designed for intensive development work, with up to $2,000,000 per year in direct costs. The source data also lists an overall award ceiling of $3,000,000.
Is cost sharing or matching required?
No cost sharing or matching requirement is stated. However, the FOA is explicitly built around leveraging NIDA funds with partner resources, so applications are expected to demonstrate credible, concrete commitments from alliance partners (or from the applicant organization) that would accelerate development.
Why do partner commitments matter if matching is not required?
Because the program concept depends on combining NIDA funding with outside resources and practical development capabilities. Competitiveness is described as depending heavily on showing real commitments that materially speed development (for example, staffing support, manufacturing capabilities, or clinical material production and formulation).
Who is eligible to apply?
Eligibility is expansive and includes small businesses and other for-profit organizations; nonprofit organizations (with or without 501(c)(3) status); public and private institutions of higher education; and many government entities (state, county, city/township, special district, independent school districts, and public housing authorities). Tribal governments and tribal organizations are eligible, as are U.S. territories and possessions.
Are foreign organizations allowed to participate?
Yes. The FOA allows foreign organizations and foreign components of U.S. organizations, consistent with NIH policies.
Does the FOA specifically include certain institution types?
Yes. It explicitly includes categories such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian-serving institutions, and AANAPISIs. It also includes faith-based or community-based organizations and eligible federal agencies.
What NIH institute is running this program?
The opportunity is an NIH initiative from the National Institute on Drug Abuse (NIDA).
What is the CFDA number associated with this opportunity?
The opportunity is associated with CFDA 93.279 (Drug Abuse and Addiction Research Programs).
What type of grant is this?
It is described as a discretionary grant under the NIH umbrella, and the FOA mechanism is R01.
Is this funding opportunity currently open?
No. The posting date was August 19, 2013, with an original and final closing date of September 7, 2016, and an archive date of October 8, 2016. That means the specific announcement is historical rather than currently open.
What is the main goal of the program in plain terms?
The goal is to fund milestone-driven, partner-backed medication development projects that can realistically bridge the gap between promising SUD treatment candidates and the regulatory steps needed to bring them closer to clinical use.
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| Neuroscience Research on Drug Abuse (R21) Apply for PA 13 337 Funding Number: PA 13 337 Agency: National Institutes of Health Category: Education Health Funding Amount: $200,000 |
| Neuroscience Research on Drug Abuse (R03) Apply for PA 13 336 Funding Number: PA 13 336 Agency: National Institutes of Health Category: Education Health Funding Amount: $100,000 |
| Neuroscience Research on Drug Abuse (R01) Apply for PA 13 338 Funding Number: PA 13 338 Agency: National Institutes of Health Category: Education Health Funding Amount: Case Dependent |
| Mechanisms of Alcohol and Stimulant Co Addiction (R01) Apply for PA 13 339 Funding Number: PA 13 339 Agency: National Institutes of Health Category: Education Health Funding Amount: Case Dependent |
| Mechanisms of Alcohol and Stimulant Co Addiction (R21) Apply for PA 13 340 Funding Number: PA 13 340 Agency: National Institutes of Health Category: Education Health Funding Amount: $200,000 |
| Early Career Award in Chemistry of Drug Abuse and Addiction (ECHEM) (R21/R33) Apply for PAR 13 350 Funding Number: PAR 13 350 Agency: National Institutes of Health Category: Education Health Funding Amount: $250,000 |
| National Institute on Drug Abuse National Early Warning System (NEWS) Coordinating Center (U01) Apply for RFA DA 14 015 Funding Number: RFA DA 14 015 Agency: National Institutes of Health Category: Education Health Funding Amount: $900,000 |
| Research Answers to NCIs Provocative Questions Group A (R01) Apply for RFA CA 13 016 Funding Number: RFA CA 13 016 Agency: National Institutes of Health Category: Education Health Funding Amount: Case Dependent |
| Research Answers to NCIs Provocative Questions Group A (R21) Apply for RFA CA 13 017 Funding Number: RFA CA 13 017 Agency: National Institutes of Health Category: Education Health Funding Amount: $200,000 |
| Research Answers to NCIs Provocative Questions Group B (R01) Apply for RFA CA 13 018 Funding Number: RFA CA 13 018 Agency: National Institutes of Health Category: Education Health Funding Amount: Case Dependent |
| Research Answers to NCIs Provocative Questions Group C (R01) Apply for RFA CA 13 020 Funding Number: RFA CA 13 020 Agency: National Institutes of Health Category: Education Health Funding Amount: Case Dependent |
| Research Answers to NCIs Provocative Questions Group D (R01) Apply for RFA CA 13 022 Funding Number: RFA CA 13 022 Agency: National Institutes of Health Category: Education Health Funding Amount: Case Dependent |
| Research Answers to NCIs Provocative Questions Group D (R21) Apply for RFA CA 13 023 Funding Number: RFA CA 13 023 Agency: National Institutes of Health Category: Education Health Funding Amount: $200,000 |
| Research Answers to NCIs Provocative Questions Group B (R21) Apply for RFA CA 13 019 Funding Number: RFA CA 13 019 Agency: National Institutes of Health Category: Education Health Funding Amount: $200,000 |
| Research Answers to NCIs Provocative Questions Group C (R21) Apply for RFA CA 13 021 Funding Number: RFA CA 13 021 Agency: National Institutes of Health Category: Education Health Funding Amount: $200,000 |
| Research Answers to NCIs Provocative Questions Group E (R01) Apply for RFA CA 13 024 Funding Number: RFA CA 13 024 Agency: National Institutes of Health Category: Education Health Funding Amount: Case Dependent |
| Research Answers to NCIs Provocative Questions Group E (R21) Apply for RFA CA 13 025 Funding Number: RFA CA 13 025 Agency: National Institutes of Health Category: Education Health Funding Amount: $200,000 |
| Interpreting Variation in Human Non Coding Genomic Regions Using Computational Approaches and Experimental Assessment (R01) Apply for RFA HG 13 013 Funding Number: RFA HG 13 013 Agency: National Institutes of Health Category: Education Health Funding Amount: $500,000 |
| Planning for a National Center for Particle Beam Radiation Therapy Research (P20) Apply for PAR 13 371 Funding Number: PAR 13 371 Agency: National Institutes of Health Category: Education Health Funding Amount: $500,000 |
| Research on Malignancies in the Context of HIV/AIDS (R21) Apply for PA 13 378 Funding Number: PA 13 378 Agency: National Institutes of Health Category: Education Health Funding Amount: $200,000 |
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