Opportunity Information: Apply for PAR 14 210
Apply for PAR 14 210
- 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 Pediatric 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.
- 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: Others (see text field entitled Additional Information on Eligibility for clarification) Public housing authorities/Indian housing authorities Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education State governments Native American tribal organizations (other than Federally recognized tribal governments) Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments County governments Small businesses City or township governments Public and State controlled institutions of higher education Native American tribal governments (Federally recognized) For profit organizations other than small businesses Private institutions of higher education 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) 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 Pediatric New Therapeutic Uses for Existing Molecules (UH2/UH3), PAR 14-210, is an NIH cooperative agreement opportunity led by the National Center for Advancing Translational Sciences (NCATS). Its core purpose is to speed up pediatric therapeutics development by finding new disease uses for existing proprietary drug candidates and compounds (called "Agents") that are owned by pharmaceutical company partners. Instead of starting from scratch with a brand-new molecule, the program is built around repurposing or repositioning candidates that already have some level of prior development and data. Applicants are expected to make a clear, evidence-based case that the Agent's biological target is relevant to the pediatric disease or condition they want to treat, and that changing activity at that target is likely to produce a meaningful benefit.
A key feature of this initiative is that it is "limited competition" and sits within a larger, coordinated set of NIH "New Therapeutic Uses" announcements. Investigators do not begin by submitting the full UH2/UH3 application. They first submit an X02 pre-application under a companion announcement (PAR 14-213). Those X02 pre-applications are reviewed by outside experts, and only the most meritorious submissions are invited to move forward with a full application. Depending on the project and fit, invitees may be directed to submit either a UH2/UH3 under this pediatric-focused FOA (PAR 14-210) or PAR 14-212, or potentially a UH3-only application under PAR 14-211. The structure is meant to screen ideas early, align projects with the right pathway, and ensure that full applications are built around realistic development plans and strong scientific rationale.
The award mechanism is a two-stage, milestone-driven cooperative agreement (UH2/UH3), which means NIH will have substantial programmatic involvement and the project must meet defined go/no-go criteria to advance. Stage 1 is the UH2 phase, designed to support the early translational steps needed to de-risk a pediatric indication and prepare for later-stage testing. For this FOA, UH2 work can include milestone-based preclinical studies such as juvenile toxicity testing and experiments to verify target engagement in an appropriate disease model, as well as early clinical development work including Phase 1a and 1b trials. The UH2 period can vary from one to two years, reflecting the fact that some Agents may already have more supporting data than others. If the project meets its scientific milestones and feasibility requirements, it can transition rapidly to Stage 2 after an NIH administrative review rather than going through a completely new competitive review cycle.
Stage 2 is the UH3 phase and focuses on generating clinical proof of concept in the intended pediatric population. Specifically, UH3 supports milestone-driven Phase 2a clinical trials aimed at showing that the pharmaceutical partner-provided Agent actually modulates its intended target in humans and has credible potential to produce the desired clinical outcome for the proposed pediatric disease or condition. The UH3 project period is up to two years. The overall design emphasizes objective progress measures, because the program is fundamentally about advancing the most promising repurposing opportunities toward real-world clinical impact rather than funding open-ended exploratory research.
From an administrative standpoint, the opportunity is listed as discretionary funding and uses the Cooperative Agreement funding instrument, reflecting the hands-on, milestone-managed nature of the program. It was posted May 12, 2014, with a closing date of January 16, 2015, and an archive date of February 16, 2015. There is no cost sharing or matching requirement. The program is associated with multiple CFDA numbers spanning a range of biomedical areas, including NCATS (93.350) as well as programs touching neurology, mental health, substance use, child health and development, aging, oral health, communication disorders, and FDA-related research, underscoring that proposed pediatric indications can come from many disease domains as long as there is a strong mechanistic and translational basis.
Eligibility is broad and includes many standard NIH-eligible applicant types: public and private institutions of higher education, nonprofits with and without 501(c)(3) status, for-profit organizations (including small businesses and other for-profits), state and local governments, tribal governments and tribal organizations, special district governments, and certain regional organizations. The announcement also explicitly recognizes a wide set of institution types and communities, such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian-serving institutions, and Asian American and Native American Pacific Islander-serving institutions. Foreign components are allowed as defined in NIH policy, which can be important for pediatric rare disease cohorts, global trial networks, or specialized preclinical resources located outside the United States.
In practical terms, a competitive project under this FOA is one that starts with a clear repurposing hypothesis for a specific pediatric condition, ties that hypothesis to a well-justified target biology argument, and then lays out a disciplined plan with measurable milestones that move from preclinical validation and safety considerations specific to children (including juvenile toxicity where appropriate) into early clinical testing and, if successful, a Phase 2a signal-seeking trial. The program also depends on access to the proprietary Agent through the industry partnership model, so applications are positioned around using those partner-supplied molecules to quickly test whether a plausible mechanistic idea can become an actionable pediatric therapeutic path.
The full announcement link provided in the source is: http://grants.nih.gov/grants/guide/pa-files/PAR-14-210.html . For access or technical issues, the NIH Office of Extramural Research (OER) webmaster contact is listed as FBOWebmaster@OD.NIH.GOV.
Frequently Asked Questions (FAQs)
What is the NIH opportunity PAR-14-210 about?
PAR-14-210 is a limited-competition NIH cooperative agreement opportunity called "Discovering Pediatric New Therapeutic Uses for Existing Molecules (UH2/UH3)." It is led by the National Center for Advancing Translational Sciences (NCATS) and is designed to speed pediatric therapeutics development by identifying new pediatric disease uses for existing, proprietary drug candidates and compounds provided by pharmaceutical company partners.
What is the main goal of this program?
The core purpose is to advance pediatric therapeutic development by repurposing or repositioning existing molecules (called "Agents") that already have some prior development history and supporting data, rather than starting with a brand-new molecule.
What is meant by "existing molecules" or "Agents" in this program?
"Agents" are proprietary drug candidates and compounds owned by participating pharmaceutical company partners. The program is built around using these partner-provided molecules to test new pediatric indications.
What kind of scientific rationale is expected for a proposed pediatric indication?
Applicants are expected to present a clear, evidence-based case that the Agent's biological target is relevant to the pediatric disease or condition being proposed, and that altering activity at that target is likely to produce a meaningful benefit.
Why is this described as a "limited competition" opportunity?
This funding opportunity is part of a coordinated NIH "New Therapeutic Uses" effort and uses a pre-screening approach. Investigators do not begin with a full UH2/UH3 application; only selected applicants are invited to submit a full application after submitting an initial X02 pre-application under a companion announcement.
Do applicants submit the full UH2/UH3 application first?
No. Investigators first submit an X02 pre-application under the companion announcement PAR-14-213. Those pre-applications are reviewed by outside experts, and only the most meritorious submissions are invited to submit a full application.
What is the pre-application mechanism used before a full application?
The program uses an X02 pre-application step submitted under PAR-14-213, which serves as an initial screening stage before an invited full application is allowed.
What happens after the X02 pre-applications are reviewed?
Selected invitees may be directed to submit a full application to this pediatric-focused UH2/UH3 FOA (PAR-14-210) or to PAR-14-212, or potentially to submit a UH3-only application under PAR-14-211, depending on project fit and pathway alignment.
What funding mechanism is used in PAR-14-210?
The award uses a two-stage, milestone-driven cooperative agreement mechanism (UH2/UH3). Because it is a cooperative agreement, NIH has substantial programmatic involvement and the project is managed against defined milestones and go/no-go criteria.
What does it mean that this is a cooperative agreement?
A cooperative agreement indicates substantial NIH involvement in the project. The work is milestone-managed, and continuation from the first stage to the second stage depends on meeting defined criteria.
How is the project structured across stages?
The project is structured in two stages: Stage 1 (UH2) supports early translational and early clinical steps to de-risk the pediatric indication, and Stage 2 (UH3) supports clinical proof of concept in the intended pediatric population through Phase 2a testing.
What is the focus of the UH2 stage?
The UH2 phase supports early translational work needed to prepare for later-stage testing. For this FOA, UH2 activities can include milestone-based preclinical studies such as juvenile toxicity testing and verifying target engagement in an appropriate disease model, as well as early clinical development activities including Phase 1a and 1b trials.
How long can the UH2 phase last?
The UH2 period can vary from one to two years, reflecting differences in how much prior data and development history already exist for a given Agent.
What is required to move from UH2 to UH3?
Transition from UH2 to UH3 depends on meeting scientific milestones and feasibility requirements, using defined go/no-go criteria. If milestones are met, the project can transition rapidly to Stage 2 following an NIH administrative review rather than a completely new competitive review cycle.
What is the focus of the UH3 stage?
The UH3 phase is focused on generating clinical proof of concept in the intended pediatric population. It supports milestone-driven Phase 2a clinical trials aimed at showing that the Agent modulates its intended target in humans and has credible potential to produce the desired clinical outcome for the proposed pediatric disease or condition.
How long can the UH3 phase last?
The UH3 project period is up to two years.
What types of clinical trials are included across the UH2/UH3 structure?
Under this FOA, UH2 can include early clinical development work such as Phase 1a and 1b trials, while UH3 supports Phase 2a clinical trials designed to generate proof-of-concept evidence in the pediatric population.
Is the program intended for open-ended exploratory research?
No. The overall design emphasizes objective, milestone-based progress measures and is oriented toward advancing the most promising repurposing opportunities toward real clinical impact.
Is cost sharing or matching required?
No. The opportunity states there is no cost sharing or matching requirement.
What is the posting date, closing date, and archive date for PAR-14-210?
The opportunity was posted on May 12, 2014. The closing date is January 16, 2015. The archive date is February 16, 2015.
What is the funding type listed for this opportunity?
It is listed as discretionary funding and uses a Cooperative Agreement funding instrument.
Who is eligible to apply?
Eligibility is broad and includes public and private institutions of higher education; nonprofits with and without 501(c)(3) status; for-profit organizations (including small businesses and other for-profits); state and local governments; tribal governments and tribal organizations; special district governments; and certain regional organizations.
Are specific institution types and underserved communities explicitly included?
Yes. The announcement explicitly recognizes institution types and communities such as HBCUs, Hispanic-serving institutions, tribally controlled colleges and universities, Alaska Native and Native Hawaiian-serving institutions, and Asian American and Native American Pacific Islander-serving institutions.
Are foreign components allowed?
Yes. Foreign components are allowed as defined in NIH policy, which may support access to pediatric rare disease cohorts, global trial networks, or specialized preclinical resources located outside the United States.
What kinds of pediatric disease areas can be proposed?
The program is associated with multiple CFDA numbers spanning many biomedical areas (including NCATS and areas touching neurology, mental health, substance use, child health and development, aging, oral health, communication disorders, and FDA-related research). This indicates pediatric indications may come from many disease domains, provided there is a strong mechanistic and translational basis.
What makes a project competitive under this FOA?
A competitive project typically includes a clear repurposing hypothesis for a specific pediatric condition, a well-justified argument linking target biology to that pediatric disease, and a disciplined, milestone-driven plan that moves from preclinical validation and pediatric safety considerations (including juvenile toxicity where appropriate) into early clinical testing and, if successful, a Phase 2a signal-seeking trial.
Does this program depend on industry partnership access to the Agent?
Yes. The model is built around using proprietary Agents owned by pharmaceutical company partners, so projects are positioned around accessing and using those partner-supplied molecules.
Where can applicants find the full announcement?
The full announcement link provided is http://grants.nih.gov/grants/guide/pa-files/PAR-14-210.html .
Who should be contacted for access or technical issues related to the announcement?
For access or technical issues, the NIH Office of Extramural Research (OER) webmaster contact listed is FBOWebmaster@OD.NIH.GOV.
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