Opportunity Information: Apply for RFA TR 12 004
Apply for RFA TR 12 004
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Limited Competition for NIH Industry Pilot 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): 93.350 National Center for Advancing Translational Sciences.
- This funding opportunity was created on Jun 12, 2012 and posted on Jun 12, 2012.
- Applicants must submit their applications by Dec 17, 2012. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- The funding agency has allocated a total of $20,000,000.00 to eligible and selected applicants.
- Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification).
- Other Eligible Applicants include the following This FOA is a limited competition for those applicants who submitted a pre application in response to PAR 12 203 X02 and have been notified of the opportunity to submit a UH2/UH3 application.
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Opportunity Summary:
The funding opportunity titled "Limited Competition for NIH Industry Pilot Program Discovering New Therapeutic Uses for Existing Molecules (UH2/UH3)" (Funding Opportunity Number RFA-TR-12-004) is a National Institutes of Health initiative run through the National Center for Advancing Translational Sciences (NCATS). It was designed as a therapeutics discovery pilot program focused on finding new medical uses for existing proprietary drug candidates, referred to as "Agents." Instead of starting drug discovery from scratch, the program aims to take compounds that have already been developed by pharmaceutical companies (often with prior data on manufacturing, dosing, safety, or early clinical experience) and pair them with strong, scientifically grounded ideas from the broader biomedical research community about how those molecules might be repurposed to treat different diseases.
At the core of the program is a matchmaking model. Pharmaceutical company partners provide a set of proprietary Agents along with associated background data, and researchers propose novel therapeutic indications that could be tested using those Agents. NCATS is essentially trying to bridge two common gaps in translational science: first, that many promising compounds stall or are shelved for business or strategic reasons even if they might work in another disease area; and second, that academic and clinical researchers often have compelling hypotheses about disease biology but lack access to high-quality, industry-grade molecules and the supporting development data needed to move quickly toward clinical relevance. By combining industry assets with external innovation, the program is intended to accelerate the identification of new treatments across a wide range of human diseases.
This opportunity uses the NIH cooperative agreement mechanism, meaning it is not a typical grant where the recipient operates largely independently. Under a cooperative agreement, NIH expects to have substantial involvement in the project, which often includes active programmatic coordination, milestone-based oversight, and collaboration to ensure the effort stays aligned with the program goals. The funding mechanism is UH2/UH3, which is commonly structured as a phased, milestone-driven award. In general terms, the UH2 phase supports an initial stage of work to establish feasibility and generate key proof-of-concept data, while the UH3 phase supports a later stage that builds on successful UH2 results to advance the project further toward translational or clinical readiness. This structure is especially well-suited to repurposing efforts, where early experimental validation can quickly determine whether a new indication is realistic before larger investments are made.
The opportunity was categorized as discretionary funding, with an activity area aligned to health, and it falls under CFDA 93.350 for NCATS. The estimated total funding for the program was listed as $20,000,000, and there was no cost sharing or matching requirement, which means applicants were not required to provide additional non-federal funds as a condition of the award. The announcement was originally posted on June 12, 2012, with an application closing date of December 17, 2012, and it was later archived on January 17, 2013, indicating it was tied to a specific time-limited pilot effort rather than an open-ended recurring solicitation.
Eligibility was intentionally narrow because this was a limited competition. Only applicants who had previously submitted a pre-application in response to PAR-12-203 (X02) and were specifically notified that they were invited to submit a full UH2/UH3 application were allowed to apply. This kind of two-step process suggests NCATS wanted to screen and shape the pool of projects early, likely to ensure proposals were well matched to the available industry Agents and to manage the coordination complexity that comes with multi-party partnerships involving proprietary compounds.
Operationally, this program can be understood as an early attempt to formalize and scale drug repurposing partnerships between NIH, academia, and industry. The expectation is that selected projects would leverage industry-provided molecules and datasets, apply rigorous translational research strategies to test new disease applications, and generate evidence strong enough to justify further development steps. While the public-facing summary does not list specific research topics or disease priorities, it explicitly frames the scope as broad across human diseases, implying that the key selection factor would be the quality of the scientific rationale for a new therapeutic use and the feasibility of demonstrating that use with the available Agent and supporting data.
For applicants or readers trying to locate the original full announcement, the listing included an additional information link hosted on the NIH grants site. The contact information provided was directed to the NIH Office of Extramural Research (OER) webmaster addresses for technical issues accessing or linking to the announcement, rather than to a scientific program officer, which is typical for archived listings that primarily serve as a record of the opportunity.
Frequently Asked Questions (FAQs)
What is the official title of this funding opportunity?
The opportunity is titled "Limited Competition for NIH Industry Pilot Program Discovering New Therapeutic Uses for Existing Molecules (UH2/UH3)."
What is the funding opportunity number (FON)?
The Funding Opportunity Number is RFA-TR-12-004.
Which NIH organization runs this program?
This initiative is run through the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH).
What is the main goal of this program?
The program is a therapeutics discovery pilot focused on identifying new medical uses (new therapeutic indications) for existing proprietary drug candidates, referred to as "Agents." Rather than starting drug discovery from scratch, it aims to repurpose molecules that already exist and often have prior development information.
What does "existing molecules" mean in this context?
It refers to proprietary drug candidates supplied by pharmaceutical company partners. These molecules may already have background data such as information related to manufacturing, dosing, safety, or early clinical experience.
What are "Agents"?
"Agents" are the proprietary drug candidates contributed by pharmaceutical company partners for researchers to evaluate for new therapeutic uses.
Is this a drug repurposing program?
Yes. The program is explicitly designed around repurposing: pairing industry-provided compounds with new, scientifically grounded ideas for treating different diseases than originally intended.
How does the "matchmaking model" work?
Pharmaceutical company partners provide a set of proprietary Agents along with associated background data. Researchers then propose novel therapeutic indications to test using those Agents. The intent is to match external scientific innovation with industry assets.
What translational science gaps is NCATS trying to address with this program?
The program is intended to bridge two common gaps: (1) potentially useful compounds may be shelved or stalled for business or strategic reasons even though they could work in another disease area, and (2) academic and clinical researchers may have strong disease biology hypotheses but lack access to industry-grade molecules and supporting development data.
What type of NIH funding mechanism is used?
This opportunity uses a cooperative agreement mechanism, specifically the UH2/UH3 activity code structure.
What does it mean that this is a cooperative agreement?
A cooperative agreement is not a typical grant where the recipient operates largely independently. NIH expects to have substantial involvement, which can include active programmatic coordination, milestone-based oversight, and collaboration to keep projects aligned with program goals.
What is the UH2/UH3 structure?
UH2/UH3 is a phased, milestone-driven award. The UH2 phase supports an initial stage to establish feasibility and generate key proof-of-concept data. The UH3 phase supports a later stage that builds on successful UH2 results to advance the project toward translational or clinical readiness.
Why is a phased UH2/UH3 model a fit for repurposing efforts?
Repurposing projects can often be evaluated quickly with early experimental validation. The phased structure supports early feasibility work first, then allows further advancement only if UH2 milestones demonstrate that the new indication is realistic.
What is the estimated total funding amount for the program?
The estimated total funding listed for the program is $20,000,000.
Is cost sharing or matching required?
No. The announcement stated there was no cost sharing or matching requirement, meaning applicants were not required to provide additional non-federal funds as a condition of the award.
What is the CFDA number associated with this opportunity?
The opportunity falls under CFDA 93.350 for NCATS.
How was the opportunity categorized?
It was categorized as discretionary funding, with an activity area aligned to health.
Was this an open competition?
No. This was a limited competition with intentionally narrow eligibility.
Who was eligible to apply?
Only applicants who had previously submitted a pre-application in response to PAR-12-203 (X02) and were specifically notified that they were invited to submit a full UH2/UH3 application were eligible.
What does the two-step pre-application and invitation process indicate?
Based on the description, it suggests NCATS wanted to screen and shape the pool of projects early, likely to ensure proposals aligned with available industry Agents and to manage the coordination complexity associated with partnerships involving proprietary compounds.
What kinds of diseases or research areas were targeted?
The public summary did not list specific research topics or disease priorities. It framed the scope as broad across human diseases, indicating that selection would likely emphasize the strength of the scientific rationale for a new therapeutic use and the feasibility of demonstrating that use using an available Agent and its supporting data.
When was the announcement posted and when did it close?
The announcement was posted on June 12, 2012, and the application closing date was December 17, 2012.
Is this funding opportunity still active?
No. It was archived on January 17, 2013, which indicates it was tied to a specific time-limited pilot effort rather than an ongoing, recurring solicitation.
Where could applicants find the original full announcement?
The listing referenced an additional information link hosted on the NIH grants site.
What contact information was provided in the listing?
The contact information provided was directed to NIH Office of Extramural Research (OER) webmaster addresses for technical issues accessing or linking to the announcement, rather than a scientific program officer. This is typical for archived listings that serve primarily as a record.
What kinds of partners are involved in this pilot model?
The model involves NIH/NCATS, pharmaceutical company partners that provide proprietary Agents and background data, and researchers from the broader biomedical research community who propose and test new therapeutic indications.
What is the basic expectation for projects supported under this program?
Selected projects were expected to leverage industry-provided molecules and datasets, apply rigorous translational research strategies to test new disease applications, and generate evidence strong enough to justify further development steps.
Browse more opportunities from the same category: Health
Next opportunity: Limited Competition for NIH Industry Pilot Program Discovering New Therapeutic Uses for Existing Molecules (UH3)
Previous opportunity: A Pre application for the NIH Industry Pilot Program Discovering New Therapeutic Uses for Existing Molecules (X02)
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