Opportunity Information: Apply for PAR 14 212
Apply for PAR 14 212
- The National Institutes of Health in the education health income security and social services sector is offering a public funding opportunity titled "Limited Competition for NIH Industry Program Discovering New Therapeutic Uses for Existing Molecules (UH2/UH3)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103 Food and Drug AdministrationResearch 93.121 Oral Diseases and Disorders Research 93.173 Research Related to Deafness and Communication Disorders 93.242 Mental Health Research Grants 93.273 Alcohol Research Programs 93.279 Drug Abuse and Addiction Research Programs 93.350 National Center for Advancing Translational Sciences 93.853 Extramural Research Programs in the Neurosciences and Neurological Disorders 93.865 Child Health and Human Development Extramural Research 93.866 Aging Research 93.867 Vision Research.
- This funding opportunity was created on May 12, 2014 and posted on May 12, 2014.
- Applicants must submit their applications by Jan 16, 2015. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: Independent school districts Small businesses Native American tribal governments (Federally recognized) Others (see text field entitled Additional Information on Eligibility for clarification) For profit organizations other than small businesses Public and State controlled institutions of higher education State governments Special district governments Private institutions of higher education Public housing authorities/Indian housing authorities 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 County governments Native American tribal organizations (other than Federally recognized tribal governments) City or township governments.
- 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) Regional Organizations Tribally Controlled Colleges and Universities (TCCUs) U.S. Territory or Possession Foreign components, as defined in the NIH Grants Policy Statement, are allowed.
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Opportunity Summary:
The Limited Competition for NIH Industry Program Discovering New Therapeutic Uses for Existing Molecules (UH2/UH3), PAR-14-212, is a National Institutes of Health opportunity led by the National Center for Advancing Translational Sciences (NCATS) that focuses on drug repurposing: finding new therapeutic uses for proprietary drug candidates that have already been developed by pharmaceutical companies. The core idea is to speed translation by pairing outside investigators with industry-held compounds (called "Agents") and supporting studies that test whether those existing molecules can address unmet needs in different diseases than originally intended. Because the molecules are proprietary and supplied through pharmaceutical partners, the competition is limited and the program is structured to make it feasible to move quickly from mechanistic justification into early clinical testing.
Applications are expected to be driven by a strong scientific rationale linking the Agent to the proposed disease or condition, specifically evidence that modulating the Agent's known target is likely to have a beneficial effect in the new indication. In other words, applicants are not simply proposing a screening exercise; they are expected to present convincing biology, translational data, and a credible path to demonstrating target engagement and clinical signal in humans. The program is designed to cover a broad range of human diseases, with companion opportunities that can route projects to different mechanisms depending on the situation, including pediatric indications.
A key feature is that this funding opportunity sits behind an initial pre-application step. PAR-14-213 encourages submission of an X02 pre-application, which functions as the first gate in the process for PAR-14-212 as well as its companion FOAs (PAR-14-210 and PAR-14-211). Those X02 submissions are reviewed by outside experts, and only the most meritorious pre-applications lead to an invitation to submit a full cooperative agreement application. Depending on the project and the companion announcement, invitees may be directed to submit either a two-stage UH2/UH3 application under PAR-14-212, a UH3-only application under PAR-14-211, or a UH2/UH3 under PAR-14-210 for pediatric-focused work. This staged approach is meant to reduce wasted effort for applicants and keep the full application pipeline focused on proposals with strong feasibility and impact.
The funding mechanism is a cooperative agreement, meaning NIH expects substantial programmatic involvement compared with a standard grant. The scientific plan is organized as a milestone-driven, two-stage award. Stage 1 is the UH2 phase, which can support targeted preclinical work to verify that the Agent engages its target in an appropriate disease model, and/or a Phase 1b clinical study using the Agent as-is (existing formulation and route of administration). The Phase 1b component is intended to establish dosing or exposure in the proposed patient population and to inform patient selection, rather than to serve as a large efficacy trial. UH2 support is relatively short, typically from six months up to one year, and continuation is not automatic.
Projects that successfully meet the predefined scientific milestones and feasibility requirements during UH2 can transition rapidly to Stage 2, the UH3 phase, after an NIH administrative review. The UH3 stage supports milestone-driven Phase 2a clinical trials. The purpose of the Phase 2a work is to show that, in the new disease population, the Agent both modulates the intended target (evidence of biological activity/target engagement) and shows potential to produce the desired clinical outcome, providing an early efficacy signal that can justify further development. The UH3 project period can be up to two years, reflecting the emphasis on generating actionable clinical evidence within a defined timeframe.
Administratively, the opportunity (as posted) lists no cost sharing or matching requirement and was originally posted May 12, 2014, with a closing date of January 16, 2015 (archived February 16, 2015). The CFDA program numbers span multiple NIH research areas, reflecting the cross-cutting nature of repurposing across disease domains. Eligibility is broad and includes a wide range of domestic organizations such as higher education institutions (public and private), nonprofits (with or without 501(c)(3) status), small businesses and other for-profit organizations, state and local governments, tribal governments and tribal organizations, public housing authorities/Indian housing authorities, independent school districts, and various mission-serving institutions (for example HBCUs, Hispanic-serving institutions, AANAPISIs, TCCUs). Foreign components are allowed as defined by the NIH Grants Policy Statement, which can enable international collaboration when justified.
In practical terms, this program is best suited for teams that can connect a specific industry-provided molecule to a well-argued disease hypothesis, and that can execute a tightly managed translational plan with clear go/no-go milestones. Successful applicants typically need to show they understand the Agent's mechanism, can measure target engagement, can design early-phase clinical studies that are realistic within the UH2 and UH3 time limits, and can define decision points that justify moving from initial validation into a Phase 2a signal-seeking trial. For full details, NIH pointed applicants to the official announcement page at grants.nih.gov under PAR-14-212.
FAQs: Limited Competition for NIH Industry Program - Discovering New Therapeutic Uses for Existing Molecules (UH2/UH3), PAR-14-212
What is PAR-14-212 trying to fund?
PAR-14-212 supports drug repurposing projects that test whether proprietary drug candidates (called "Agents") originally developed by pharmaceutical companies can be used to treat a different disease or condition than originally intended. The goal is to speed translation by pairing outside investigators with industry-held compounds and supporting studies that move from strong mechanistic justification into early clinical testing.
Who leads this NIH opportunity?
The opportunity is a National Institutes of Health (NIH) program led by the National Center for Advancing Translational Sciences (NCATS).
What does "limited competition" mean in this program?
The competition is limited because the molecules being studied are proprietary and are supplied through pharmaceutical partners. The structure is designed to make it feasible to move quickly using industry-held compounds rather than starting from scratch with new molecule discovery.
What is an "Agent" in this program?
An "Agent" is a proprietary drug candidate that has already been developed by a pharmaceutical company. Investigators propose new therapeutic uses for these industry-held compounds.
Does this program support general screening to find any potential use for a molecule?
No. Applications are expected to present a strong scientific rationale that links the Agent to the proposed disease or condition, including evidence that modulating the Agent's known target is likely to have a beneficial effect in the new indication. The program is not positioned as a broad screening exercise.
What kind of scientific rationale is expected in an application?
Projects are expected to include convincing biology and translational data, plus a credible plan to demonstrate target engagement and clinical signal in humans. The emphasis is on mechanistic justification and a realistic path to early clinical evidence in the new disease context.
What diseases or conditions are eligible?
The program is designed to cover a broad range of human diseases. The materials also describe companion opportunities that can route projects to different mechanisms depending on the situation, including pediatric indications.
Is there a required pre-application step?
Yes. This opportunity sits behind an initial pre-application step. PAR-14-213 encourages submission of an X02 pre-application that functions as the first gate in the process for PAR-14-212 and its companion FOAs.
What is the X02 pre-application and how is it used?
The X02 is a pre-application submitted under PAR-14-213. These submissions are reviewed by outside experts, and only the most meritorious pre-applications result in an invitation to submit a full cooperative agreement application.
Does submitting an X02 guarantee an invitation for a full application?
No. Only the most meritorious pre-applications lead to an invitation to submit a full application.
After the X02 step, what kind of full application might an invited team submit?
Depending on the project and the companion announcement, invitees may be directed to submit one of several options: a two-stage UH2/UH3 application under PAR-14-212, a UH3-only application under PAR-14-211, or a UH2/UH3 application under PAR-14-210 for pediatric-focused work.
Why does the program use a staged approach?
The staged approach is intended to reduce wasted effort for applicants and keep the full application pipeline focused on proposals with strong feasibility and impact.
What funding mechanism is used under PAR-14-212?
The mechanism is a cooperative agreement. NIH expects substantial programmatic involvement compared with a standard grant.
What are the two stages of the UH2/UH3 award?
The award is milestone-driven and organized into two stages: Stage 1 (UH2) and Stage 2 (UH3). UH2 supports targeted preclinical verification and/or a Phase 1b clinical study, and UH3 supports a milestone-driven Phase 2a clinical trial.
What activities can be supported in the UH2 stage?
UH2 can support targeted preclinical work to verify that the Agent engages its target in an appropriate disease model, and/or a Phase 1b clinical study using the Agent as-is (existing formulation and route of administration).
What is the purpose of the Phase 1b clinical component in UH2?
The Phase 1b component is intended to establish dosing or exposure in the proposed patient population and inform patient selection. It is not intended to be a large efficacy trial.
How long is the UH2 phase typically?
UH2 support is relatively short, typically from six months up to one year.
Is continuation from UH2 to UH3 automatic?
No. Continuation is not automatic. Projects must meet predefined scientific milestones and feasibility requirements during UH2 to be eligible to transition.
How does a project transition from UH2 to UH3?
If the UH2 milestones and feasibility requirements are successfully met, the project can transition rapidly to the UH3 phase after an NIH administrative review.
What does the UH3 stage support?
UH3 supports milestone-driven Phase 2a clinical trials designed to generate actionable clinical evidence in the new indication within a defined timeframe.
What is the goal of the Phase 2a work in UH3?
The Phase 2a work aims to show that, in the new disease population, the Agent modulates the intended target (evidence of biological activity or target engagement) and shows potential to produce the desired clinical outcome, providing an early efficacy signal to justify further development.
How long can the UH3 project period be?
The UH3 project period can be up to two years.
Does the FOA require cost sharing or matching funds?
No cost sharing or matching requirement is listed for this opportunity as posted.
When was PAR-14-212 posted and when did it close?
The opportunity was originally posted May 12, 2014, with a closing date of January 16, 2015, and it was archived February 16, 2015.
Who is eligible to apply?
Eligibility is broad and includes many domestic organization types, including higher education institutions (public and private), nonprofits (with or without 501(c)(3) status), small businesses and other for-profit organizations, state and local governments, tribal governments and tribal organizations, public housing authorities/Indian housing authorities, independent school districts, and various mission-serving institutions such as HBCUs, Hispanic-serving institutions, AANAPISIs, and TCCUs.
Are foreign components allowed?
Yes. Foreign components are allowed as defined by the NIH Grants Policy Statement, enabling international collaboration when justified.
What does it mean that CFDA program numbers span multiple NIH research areas?
It reflects the cross-cutting nature of repurposing across disease domains, since the same drug candidate framework can potentially be applied to many different areas of human disease research.
What kinds of teams are a good fit for this program?
The opportunity is best suited for teams that can connect a specific industry-provided molecule to a well-argued disease hypothesis and execute a tightly managed translational plan with clear go/no-go milestones. Strong applications typically demonstrate understanding of the Agent's mechanism, an ability to measure target engagement, and realistic early-phase clinical study designs that fit within UH2 and UH3 time limits.
What kind of clinical evidence is the program trying to produce?
The design emphasizes early, actionable human evidence: Phase 1b work to inform dosing/exposure and patient selection, followed by Phase 2a work to demonstrate target modulation and an early clinical signal in the new disease population.
Where were applicants directed for full official details?
Applicants were directed to the official announcement page at grants.nih.gov under PAR-14-212.
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Applicants who have applied for this opportunity (PAR 14 212) also looked into and applied for these:
| Funding Opportunity |
|---|
| Pre application for the NIH Industry Program Discovering New Therapeutic Uses for Existing Molecules (X02) Apply for PAR 14 213 Funding Number: PAR 14 213 Agency: National Institutes of Health Category: Education Health Income Security and Social Services Funding Amount: Case Dependent |
| Research on Chronic Overlapping Pain Conditions (R21) Apply for PA 14 243 Funding Number: PA 14 243 Agency: National Institutes of Health Category: Education Health Income Security and Social Services Funding Amount: $200,000 |
| Basic Research on HIV Persistence (R21) Apply for PAR 14 248 Funding Number: PAR 14 248 Agency: National Institutes of Health Category: Education Health Income Security and Social Services Funding Amount: $200,000 |
| Basic Research on HIV Persistence (R01) Apply for PAR 14 247 Funding Number: PAR 14 247 Agency: National Institutes of Health Category: Education Health Income Security and Social Services Funding Amount: Case Dependent |
| Discovery of in vivo Chemical Probes (R01) Apply for PAR 14 279 Funding Number: PAR 14 279 Agency: National Institutes of Health Category: Education Health Income Security and Social Services Funding Amount: Case Dependent |
| U.S. China Program for Research Toward a Cure for HIV/AIDS (R01) Apply for RFA AI 14 057 Funding Number: RFA AI 14 057 Agency: National Institutes of Health Category: Education Health Income Security and Social Services Funding Amount: $1,350,000 |
| High Throughput Screening (HTS) to Discover Chemical Probes (R21) Apply for PAR 14 283 Funding Number: PAR 14 283 Agency: National Institutes of Health Category: Education Health Income Security and Social Services Funding Amount: $200,000 |
| Blueprint Neurotherapeutics Network (BPN) Small Molecule Drug Discovery and Development for Disorders of the Nervous System (U44) Apply for PAR 14 292 Funding Number: PAR 14 292 Agency: National Institutes of Health Category: Education Health Income Security and Social Services Funding Amount: Case Dependent |
| Blueprint Neurotherapeutics Network (BPN) Small Molecule Drug Discovery and Development for Disorders of the Nervous System (UH2/UH3) Apply for PAR 14 293 Funding Number: PAR 14 293 Agency: National Institutes of Health Category: Education Health Income Security and Social Services Funding Amount: Case Dependent |
| Limited Competition Research Training for Career Development of Junior Faculty in Medical Education Partnership Initiative (MEPI) Institutions (D43) Apply for RFA TW 14 003 Funding Number: RFA TW 14 003 Agency: National Institutes of Health Category: Education Health Income Security and Social Services Funding Amount: $600,000 |
| Physical Sciences Oncology Network (PS ON) Physical Sciences Oncology Projects (PS OP) (U01) Apply for PAR 15 021 Funding Number: PAR 15 021 Agency: National Institutes of Health Category: Education Health Income Security and Social Services Funding Amount: $500,000 |
| Pediatric HIV/AIDS Cohort Study (PHACS) Data and Operations Center (DOC) (U01) Apply for RFA HD 15 029 Funding Number: RFA HD 15 029 Agency: National Institutes of Health Category: Education Health Income Security and Social Services Funding Amount: $17,975,000 |
| BRAIN Initiative New Technologies and Novel Approaches for Large Scale Recording and Modulation in the Nervous System (U01) Apply for RFA NS 15 003 Funding Number: RFA NS 15 003 Agency: National Institutes of Health Category: Education Health Income Security and Social Services Funding Amount: Case Dependent |
| BRAIN Initiative Optimization of Transformative Technologies for Large Scale Recording and Modulation in the Nervous System (U01) Apply for RFA NS 15 004 Funding Number: RFA NS 15 004 Agency: National Institutes of Health Category: Education Health Income Security and Social Services Funding Amount: Case Dependent |
| BRAIN Initiative Integrated Approaches to Understanding Circuit Function in the Nervous System (U01) Apply for RFA NS 15 005 Funding Number: RFA NS 15 005 Agency: National Institutes of Health Category: Education Health Income Security and Social Services Funding Amount: Case Dependent |
| BRAIN Initiative Planning for Next Generation Human Brain Imaging (R24) Apply for RFA MH 15 200 Funding Number: RFA MH 15 200 Agency: National Institutes of Health Category: Education Health Income Security and Social Services Funding Amount: $300,000 |
| BRAIN Initiative Development and Validation of Novel Tools to Analyze Cell Specific and Circuit Specific Processes in the Brain (U01) Apply for RFA MH 15 225 Funding Number: RFA MH 15 225 Agency: National Institutes of Health Category: Education Health Income Security and Social Services Funding Amount: Case Dependent |
| Empirical Research on Ethical Issues Related to Central IRBs and Consent for Research Using Clinical Records and Data (R01) Apply for RFA OD 15 002 Funding Number: RFA OD 15 002 Agency: National Institutes of Health Category: Education Health Income Security and Social Services Funding Amount: Case Dependent |
| BRAIN Initiative Short Courses in Computational Neuroscience (R25) Apply for RFA MH 15 215 Funding Number: RFA MH 15 215 Agency: National Institutes of Health Category: Education Health Income Security and Social Services Funding Amount: $200,000 |
| BRAIN Initiative Short Courses in Research Tools and Methods (R25) Apply for RFA MH 15 220 Funding Number: RFA MH 15 220 Agency: National Institutes of Health Category: Education Health Income Security and Social Services Funding Amount: $250,000 |
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