Opportunity Information: Apply for PAR 18 910
The Limited Competition for NIH-Industry Program: Discovering New Therapeutic Uses for Existing Molecules (U01) (Clinical Trial Required) is a National Institutes of Health (NIH) funding opportunity designed to support clinical testing of new disease uses for existing experimental drugs or biologics, referred to as "Assets." Instead of developing a new compound from scratch, applicants are expected to take advantage of investigational molecules already developed by pharmaceutical company partners and propose a scientifically grounded new therapeutic indication. The program is meant to accelerate translation to the clinic by pairing promising academic or other research ideas with industry-held molecules, with the expectation that the proposed work includes a clinical trial.
This announcement is issued as a cooperative agreement (U01), which typically means NIH will have substantial involvement in the project beyond standard grant oversight. In practical terms, awardees should be prepared for an active partnership model where NIH may coordinate, advise, or collaborate on key elements of the study as it moves forward. The activity falls under the health category (CFDA 93.350), and it focuses on clinical evaluation, not just preclinical hypothesis generation. The emphasis is on testing new therapeutic uses across a broad range of human diseases and conditions, and it explicitly allows inclusion of both adult and pediatric populations, as appropriate for the proposed indication and trial design.
A competitive application is expected to make a strong scientific case that changing or modulating the Asset's biological target is likely to benefit the chosen disease or condition. That usually implies the proposal should be backed by convincing mechanistic rationale, prior evidence from human or animal biology, clinical observations, or other data that connect the target to disease pathways. The goal is not simply to run a trial because a molecule is available, but to pursue a well-justified repurposing concept where the underlying biology supports a reasonable chance of clinical impact.
Eligibility is broad and includes many common U.S.-based applicant types such as state, county, and local governments; public and private institutions of higher education; independent school districts; special district governments; small businesses and other for-profit entities (other than small businesses); and nonprofit organizations, including both 501(c)(3) and non-501(c)(3) nonprofits (excluding institutions of higher education when specified in those categories). It also includes federally recognized Native American tribal governments, public housing authorities/Indian housing authorities, and Native American tribal organizations that are not federally recognized tribal governments. The FOA also highlights additional eligible applicant categories such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, Indian/Native American Tribal Governments (other than federally recognized), and U.S. territories or possessions.
Foreign eligibility is restricted in a specific way. Non-domestic (non-U.S.) entities and non-domestic (non-U.S.) institutions are not eligible to apply as the primary applicant organization, and non-domestic components of U.S. organizations are also not eligible to apply. However, foreign components are allowed as defined in the NIH Grants Policy Statement, meaning a U.S. applicant may include certain foreign-based elements of the research (for example, a collaborating site or performance component) if it meets NIH definitions and policy requirements. This structure keeps the applicant organization U.S.-based while still allowing justified international collaboration components when permitted.
Key administrative details included in the source information are that the opportunity number is PAR 18 910, the FOA was created on 2018-08-31, and the original closing date listed is 2021-05-03. The award ceiling is shown as $3,000,000. The announcement does not specify the number of expected awards in the provided excerpt, but the ceiling indicates the program can support relatively large, trial-oriented projects where clinical operations, regulatory needs, and coordination costs are significant.
Overall, this FOA supports investigator-proposed clinical trials that aim to find new therapeutic uses for existing investigational industry molecules, with NIH operating in a cooperative partner role. The strongest proposals are expected to combine a clear and compelling biological rationale with a feasible clinical trial plan that can meaningfully test whether the Asset can improve outcomes in the proposed disease or condition.Apply for PAR 18 910
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Limited Competition for NIH-Industry Program: Discovering New Therapeutic Uses for Existing Molecules (U01) (Clinical Trial Required)" and is now available to receive applicants.
- Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.350.
- This funding opportunity was created on 2018-08-31.
- Applicants must submit their applications by 2021-05-03. (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: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), 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, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.
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Frequently Asked Questions (FAQs)
What is the main purpose of this funding opportunity?
This NIH opportunity supports clinical testing of new therapeutic uses for existing experimental drugs or biologics (called "Assets"). The intent is to speed translation to the clinic by pairing an investigator-proposed new disease indication with an industry-held investigational molecule, rather than developing a brand-new compound.
What does "Discovering New Therapeutic Uses for Existing Molecules" mean in practice?
It means proposing a new disease or condition to treat using an investigational molecule that already exists and has been developed by a pharmaceutical company partner. The application should focus on evaluating that molecule for a different therapeutic indication than it was originally developed for.
Is a clinical trial required under this FOA?
Yes. This opportunity is explicitly described as "Clinical Trial Required," and the emphasis is on clinical evaluation rather than only preclinical work or hypothesis generation.
What type of NIH award mechanism is used?
The FOA uses a cooperative agreement mechanism (U01). This typically involves substantial NIH involvement in the project beyond normal grant oversight.
What does NIH "substantial involvement" mean for applicants and awardees?
Because this is a U01 cooperative agreement, awardees should expect an active partnership model where NIH may coordinate, advise, or collaborate on key aspects of the study as it progresses, rather than operating solely as a traditional funder.
What kinds of molecules qualify as "Assets" in this program?
The Assets are existing experimental drugs or biologics that have already been developed by pharmaceutical company partners. The program is designed to use those investigational molecules for a new disease indication.
Does the FOA focus on developing new compounds from scratch?
No. The program is designed around repurposing or identifying new uses for existing investigational molecules, not inventing and developing brand-new compounds.
What is the scientific expectation for a competitive application?
A competitive application is expected to present a strong scientific case that modulating the Asset's biological target is likely to benefit the proposed disease or condition. The proposal should be biologically and mechanistically grounded and aimed at meaningful clinical impact.
What types of evidence can support the biological rationale?
The FOA indicates that a convincing rationale may be supported by mechanistic reasoning, prior evidence from human or animal biology, clinical observations, or other data that connect the target to the disease pathway(s).
Is it acceptable to propose a trial simply because a molecule is available?
No. The information provided stresses that the goal is not to run a trial just because an Asset exists; the application should pursue a well-justified repurposing concept where the underlying biology supports a reasonable chance of clinical impact.
What disease areas are eligible?
The FOA supports testing new therapeutic uses across a broad range of human diseases and conditions. The excerpt does not limit the program to specific disease categories.
Can the clinical trial include adult and/or pediatric populations?
Yes. The FOA explicitly allows inclusion of both adult and pediatric populations, as appropriate to the proposed indication and trial design.
What is the CFDA number and program category?
The activity falls under the health category with CFDA 93.350.
Who is eligible to apply (in general)?
Eligibility is broad and includes many U.S.-based applicant types, including state, county, and local governments; public and private institutions of higher education; independent school districts; special district governments; small businesses; other for-profit entities (other than small businesses); and nonprofit organizations (including 501(c)(3) and non-501(c)(3) nonprofits, with the exclusions noted in the excerpt).
Are tribal and Native organizations eligible?
Yes. The FOA includes federally recognized Native American tribal governments, public housing authorities/Indian housing authorities, and Native American tribal organizations that are not federally recognized tribal governments. It also highlights Indian/Native American Tribal Governments (other than federally recognized) as an eligible category.
Are minority-serving institutions and similar organizations eligible?
Yes. The FOA highlights eligibility for Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISIs); Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs); and other related categories mentioned in the excerpt.
Are faith-based or community-based organizations eligible to apply?
Yes. The FOA explicitly lists faith-based or community-based organizations among eligible applicant categories.
Are U.S. territories or possessions eligible?
Yes. U.S. territories or possessions are listed as eligible applicants in the excerpt.
Can foreign (non-U.S.) organizations apply as the primary applicant?
No. Non-domestic (non-U.S.) entities and non-domestic (non-U.S.) institutions are not eligible to apply as the primary applicant organization under this FOA.
Can a non-domestic component of a U.S. organization apply?
No. Non-domestic components of U.S. organizations are also not eligible to apply as the applicant organization.
Are any types of foreign involvement allowed at all?
Yes. Foreign components are allowed as defined in the NIH Grants Policy Statement. This means a U.S. applicant may be able to include certain foreign-based elements of the research (such as a collaborating site or other performance component) if it fits NIH definitions and policy requirements.
What is the opportunity number for this FOA?
The opportunity number provided is PAR 18 910.
When was this FOA created?
The FOA creation date listed is 2018-08-31.
What is the closing date shown in the provided information?
The original closing date listed in the excerpt is 2021-05-03.
What is the maximum award amount indicated?
The award ceiling shown is $3,000,000.
Does the excerpt specify how many awards NIH expects to make?
No. The provided excerpt does not specify the expected number of awards.
What kinds of projects does the award ceiling suggest NIH is aiming to support?
Based on the excerpt, the ceiling suggests the program can support relatively large, trial-oriented projects where clinical operations, regulatory needs, and coordination costs may be significant.
What is the overall "best fit" project for this FOA?
A best-fit project is an investigator-proposed clinical trial to test whether an existing industry investigational molecule can improve outcomes in a new disease or condition, supported by a clear and compelling biological rationale and a feasible clinical trial plan, with NIH involvement consistent with a U01 cooperative agreement.
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Applicants who have applied for this opportunity (PAR 18 910) also looked into and applied for these:
| Funding Opportunity |
|---|
| U.S. - India Collaborative Vision Research Program (R01 Clinical Trial Not Allowed) Apply for PAR 18 912 Funding Number: PAR 18 912 Agency: National Institutes of Health Category: Health Funding Amount: $250,000 |
| Supplements to Advance Research (STAR) from Projects to Programs (Admin Supp)- Clinical Trial Not Allowed Apply for PA 18 914 Funding Number: PA 18 914 Agency: National Institutes of Health Category: Health Funding Amount: $300,000 |
| Screening and Management of Unhealthy Alcohol Use in Primary Care: Dissemination and Implementation of PCOR Evidence (R18) Apply for RFA HS 18 002 Funding Number: RFA HS 18 002 Agency: Agency for Health Care Research and Quality Category: Health Funding Amount: Case Dependent |
| Novel Mechanism Research on Neuropsychiatric Symptoms (NPS) in Alzheimers Dementia (R01 Clinical Trial Optional) Apply for RFA MH 19 510 Funding Number: RFA MH 19 510 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Characterization of Mycobacterial Induced Immunity in HIV-infected and Uninfected Individuals (R21 Clinical Trial Not Allowed) Apply for PAR 18 923 Funding Number: PAR 18 923 Agency: National Institutes of Health Category: Health Funding Amount: $200,000 |
| Novel Mechanism Research on Neuropsychiatric Symptoms (NPS) in Alzheimers Dementia (R21 Clinical Trial Optional) Apply for RFA MH 19 511 Funding Number: RFA MH 19 511 Agency: National Institutes of Health Category: Health Funding Amount: $200,000 |
| Primary Caregiver Technical Assistance Supplements (PCTAS) (Clinical Trial Optional Admin Supp) Apply for PA 18 926 Funding Number: PA 18 926 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Innovative Technologies for HIV Behavioral and Social Science Research (R43/R44 Clinical Trial Optional) Apply for PA 18 928 Funding Number: PA 18 928 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Innovative Technologies for HIV Behavioral and Social Science Research (R41/R42 Clinical Trial Optional) Apply for PA 18 927 Funding Number: PA 18 927 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| NIDCR Award for Sustaining Outstanding Achievement in Research (SOAR) (R35 Clinical Trial Not Allowed) Apply for RFA DE 19 005 Funding Number: RFA DE 19 005 Agency: National Institutes of Health Category: Health Funding Amount: $650,000 |
| Research Centers in Minority Institutions (RCMI) (U54)- Clinical Trials Optional Apply for RFA MD 18 012 Funding Number: RFA MD 18 012 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| High-Priority Areas for Research Leveraging EHR and Large-Scale Data (R01 Clinical Trial Not Allowed) Apply for PAR 18 929 Funding Number: PAR 18 929 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Development and Optimization of Tasks and Measures for Functional Domains of Behavior (R01 Clinical Trial Not Allowed) Apply for PAR 18 930 Funding Number: PAR 18 930 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| NIH Administrative Supplements to Recover Losses Due to Hurricanes Harvey, Irma, and Maria Under the Bipartisan Budget Act of 2018 Non-Construction (Admin Supp Clinical Trial Optional) Apply for PA 18 936 Funding Number: PA 18 936 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Research on Chronic Overlapping Pain Conditions (R21 Clinical Trial Not Allowed) Apply for PA 18 939 Funding Number: PA 18 939 Agency: National Institutes of Health Category: Health Funding Amount: $200,000 |
| Research on Chronic Overlapping Pain Conditions (R01 Clinical Trial Optional) Apply for PA 18 937 Funding Number: PA 18 937 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Clinical and Translational Science Award (U54 Clinical Trial Optional) Apply for PAR 18 940 Funding Number: PAR 18 940 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Neuromodulation/Neurostimulation Device Development for Mental Health Applications (R21 Clinical Trial Optional) Apply for PAR 18 941 Funding Number: PAR 18 941 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Neuromodulation/Neurostimulation Device Development for Mental Health Applications (R01 Clinical Trial Optional) Apply for PAR 18 942 Funding Number: PAR 18 942 Agency: National Institutes of Health Category: Health Funding Amount: Case Dependent |
| Leadership Group for an Infectious Diseases Clinical Research Consortium (IDCRC) (UM1 Clinical Trial Required) Apply for RFA AI 18 047 Funding Number: RFA AI 18 047 Agency: National Institutes of Health Category: Health Funding Amount: $1,700,000 |
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