Opportunity Information: Apply for PAR 14 213
Apply for PAR 14 213
- The National Institutes of Health in the education health income security and social services sector is offering a public funding opportunity titled "Pre application for the NIH Industry Program Discovering New Therapeutic Uses for Existing Molecules (X02)" 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 Jul 15, 2014. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- Eligible applicants include: City or township governments Special district governments County governments For profit organizations other than small businesses Independent school districts Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Native American tribal governments (Federally recognized) Native American tribal organizations (other than Federally recognized tribal governments) Public housing authorities/Indian housing authorities Others (see text field entitled Additional Information on Eligibility for clarification) State governments Public and State controlled 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.
- 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 NIH opportunity PAR-14-213 is an X02 pre-application mechanism connected to the NIH-Industry Program called "Discovering New Therapeutic Uses for Existing Molecules." It is run through the National Center for Advancing Translational Sciences (NCATS) and is designed to expand a therapeutics discovery effort first piloted in 2012. The central idea is drug repurposing: researchers propose new disease indications for proprietary drug candidates (called Agents) that are owned by pharmaceutical company partners. Instead of starting from scratch with a brand-new compound, the program aims to accelerate translation by leveraging existing molecules that already have substantial development history, such as prior preclinical packages or early clinical data, and then exploring whether those same molecules could be effective in different human diseases than originally intended.
A competitive pre-application is expected to make a clear, evidence-based case that the Agent is biologically plausible for the proposed disease area. In practical terms, the strongest proposals are built around convincing scientific rationale that modulating the drug target will positively affect the disease or condition being proposed. That means applicants are expected to connect what is known about the target biology, pathway involvement, genetics, disease mechanisms, and any prior experimental or clinical observations to the new indication. The program is broad in scope and is not limited to a single disease category, which is reflected in the wide range of CFDA areas listed (including mental health, substance use, neuroscience, aging, child health and development, vision research, and NCATS translational science). The emphasis is on generating credible translational hypotheses that can be tested efficiently using these industry-sourced compounds.
This X02 submission is explicitly described as the first step in a larger, staged application pathway. PAR-14-213 does not stand alone as the main award for full development; rather, it is a gateway used to screen and select the most promising concepts before applicants are invited to submit full cooperative agreement applications under companion announcements. Applicants are directed to read all the companion FOAs because the downstream funding routes depend on the type of project and target population. Based on the summary provided, meritorious X02 pre-applications may lead to an invitation to submit a UH2/UH3 application under PAR-14-212, a UH3 application under PAR-14-211, or, for pediatric indications, a UH2/UH3 application under PAR-14-210. In other words, the X02 functions as an initial concept and feasibility filter, after which selected teams can pursue more resource-intensive milestone-driven work through the UH2/UH3 phased structure or a UH3-only approach, depending on the companion FOA.
The review of X02 pre-applications is handled by outside experts, indicating that NIH uses external scientific assessment to rank proposals and determine which are most meritorious for invitation to the next stage. The program structure implies a strong focus on translational readiness, scientific rigor, and the practical feasibility of testing a new indication with an existing proprietary molecule. Because the Agents come from pharmaceutical partners, applicants should expect that access to compounds, certain development constraints, data sharing expectations, and project coordination requirements may be part of the broader NIH-industry framework described in the companion FOAs.
Eligibility for this opportunity is broad and includes many types of domestic organizations and governments, such as public and private institutions of higher education, nonprofits (with or without 501(c)(3) status), small businesses, for-profit organizations (other than small businesses), and various local, state, tribal, and regional governmental entities. The listing also explicitly includes several categories of minority-serving institutions (for example HBCUs, HSIs, AANAPISIs, and TCCUs), as well as faith-based and community-based organizations and eligible federal agencies. Foreign components are allowed as defined in NIH Grants Policy, which means certain parts of a project may be conducted outside the United States when consistent with NIH policy and justified scientifically. The opportunity states there is no cost sharing or matching requirement.
Key administrative details from the notice include the funding opportunity number PAR-14-213, posting and creation date of May 12, 2014, and an original and current closing date of July 15, 2014, with an archive date of August 15, 2014. The sponsoring agency is the National Institutes of Health, with NCATS as the center leading the effort. The full announcement was posted through the NIH Grants Guide (link provided in the source), and NIH Office of Extramural Research (OER) web support contacts were listed for access and technical issues.
FAQs: NIH PAR-14-213 (X02) - Discovering New Therapeutic Uses for Existing Molecules
What is PAR-14-213?
PAR-14-213 is an NIH funding opportunity that uses an X02 pre-application mechanism tied to the NIH-Industry Program called "Discovering New Therapeutic Uses for Existing Molecules." It is led through the National Center for Advancing Translational Sciences (NCATS).
What is the main goal of this opportunity?
The goal is to support drug repurposing concepts by encouraging researchers to propose new disease indications for existing proprietary drug candidates ("Agents") owned by pharmaceutical company partners, leveraging prior development work such as preclinical packages or early clinical data.
What does "drug repurposing" mean in the context of this program?
Drug repurposing here means taking a drug candidate that already exists (and has some development history) and evaluating whether it may be effective in a different human disease than the one it was originally developed to treat.
What is an "Agent" in this program?
An Agent is a proprietary drug candidate owned by a pharmaceutical company partner that can be proposed for a new therapeutic use (a new disease indication) under this NIH-industry effort.
Who runs and sponsors this opportunity?
The sponsoring agency is the National Institutes of Health (NIH), and the program is led by the National Center for Advancing Translational Sciences (NCATS).
How does this X02 pre-application fit into the broader funding pathway?
This X02 submission is described as the first step in a staged application pathway. It functions as a screening and selection step. It is not the main award for full development; instead, meritorious pre-applications may be invited to submit full cooperative agreement applications under companion announcements.
Is PAR-14-213 the main funding mechanism for full development work?
No. PAR-14-213 is a gateway pre-application intended to identify the most promising concepts before applicants are invited to submit more resource-intensive, milestone-driven applications under companion FOAs.
Which companion FOAs may applicants be invited to apply to after a successful X02?
Based on the information provided, meritorious X02 pre-applications may lead to an invitation to submit one of the following:
- UH2/UH3 application under PAR-14-212
- UH3 application under PAR-14-211
- For pediatric indications, UH2/UH3 application under PAR-14-210
Why are applicants directed to read the companion FOAs?
The downstream funding route depends on the type of project and the target population (including whether the proposed indication is pediatric). The companion FOAs describe the later-stage application requirements and program framework.
What makes an X02 pre-application competitive under PAR-14-213?
A competitive pre-application is expected to present a clear, evidence-based rationale that the Agent is biologically plausible for the proposed disease area. Strong proposals connect target biology, pathway involvement, genetics, disease mechanisms, and relevant prior experimental or clinical observations to the proposed new indication.
What kind of scientific rationale is NIH looking for in this pre-application?
The program emphasizes a convincing translational hypothesis that modulating the drug target will positively affect the proposed disease or condition, supported by credible connections to known biology and any prior observations.
Is this opportunity limited to a specific disease area?
No. The program is described as broad in scope and not limited to a single disease category, which is reflected by the wide range of CFDA areas mentioned (including mental health, substance use, neuroscience, aging, child health and development, vision research, and NCATS translational science).
What is the advantage of using existing molecules instead of developing a brand-new compound?
The program aims to accelerate translation by leveraging molecules that already have substantial development history, such as prior preclinical packages or early clinical data, rather than starting from scratch with a new compound.
How are X02 pre-applications reviewed?
The review is handled by outside experts, indicating that NIH uses external scientific assessment to rank proposals and determine which are most meritorious for invitation to the next stage.
What does the review and program structure suggest NIH will prioritize?
The structure implies a strong focus on translational readiness, scientific rigor, and the practical feasibility of testing a new indication using an existing proprietary molecule.
Are there special considerations because the Agents come from pharmaceutical company partners?
Yes. Because the compounds are proprietary and sourced from pharmaceutical partners, applicants should expect access-to-compound considerations, potential development constraints, data sharing expectations, and project coordination requirements as part of the broader NIH-industry framework described in the companion FOAs.
Who is eligible to apply?
Eligibility is broad and includes many types of domestic organizations and governments, including public and private institutions of higher education, nonprofits (with or without 501(c)(3) status), small businesses, for-profit organizations (other than small businesses), and various local, state, tribal, and regional governmental entities.
Are minority-serving institutions included in the eligibility list?
Yes. The eligibility listing explicitly includes several categories of minority-serving institutions, including HBCUs, HSIs, AANAPISIs, and TCCUs.
Are faith-based and community-based organizations eligible?
Yes. Faith-based and community-based organizations are explicitly included as eligible.
Are federal agencies eligible to apply?
Yes. The eligibility listing includes eligible federal agencies.
Are foreign components allowed under this opportunity?
Yes. Foreign components are allowed as defined in NIH Grants Policy, meaning parts of a project may be conducted outside the United States when consistent with NIH policy and justified scientifically.
Is cost sharing or matching required?
No. The opportunity states there is no cost sharing or matching requirement.
What is the funding opportunity number and key dates?
The funding opportunity number is PAR-14-213. The posting and creation date is May 12, 2014. The original and current closing date is July 15, 2014. The archive date is August 15, 2014.
Where was the full announcement posted?
The full announcement was posted through the NIH Grants Guide (as referenced in the provided source information).
Who should be contacted for access or technical issues?
NIH Office of Extramural Research (OER) web support contacts were listed for access and technical issues, as noted in the opportunity summary.
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