Opportunity Information: Apply for RFA TR 20 031
The National Institutes of Health (NIH) funding opportunity titled "Basket Clinical Trials of Drugs Targeting Shared Molecular Etiologies in Multiple Rare Diseases (UG3/UH3 Clinical Trial Required)" (Funding Opportunity Number RFA-TR-20-031; CFDA 93.350) is a discretionary, health-focused cooperative agreement designed to move promising therapeutics into clinical testing across multiple rare diseases that share the same underlying molecular cause. The central idea is to support "basket" clinical trials, meaning a single clinical trial framework can evaluate one drug (or drug approach) across more than one rare disease, as long as those diseases are linked by a common molecular etiology. This approach is intended to increase efficiency in rare disease drug development by leveraging shared biology, reducing duplication across separate trials, and generating broader evidence for a therapy that targets a specific molecular mechanism rather than a single diagnosis.
The award mechanism uses the UG3/UH3 phased cooperative agreement structure and explicitly requires a clinical trial. In practice, this structure typically supports a milestone-driven transition from an initial planning and start-up phase (UG3) to a later implementation and execution phase (UH3). Because it is a cooperative agreement, NIH is expected to have substantial programmatic involvement during the life of the project, which can include collaboration on study conduct expectations, milestone tracking, and other aspects of trial oversight consistent with NIH cooperative agreement policies.
Eligibility is broad and includes many standard domestic applicant types, such as state, county, and city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations other than federally recognized tribal governments; public housing authorities and Indian housing authorities; nonprofit organizations with and without 501(c)(3) status (as long as they are not institutions of higher education, which are separately listed); for-profit organizations other than small businesses; small businesses; and other organizations. The FOA also highlights additional eligible applicant categories, including 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 that are not federally recognized; and U.S. territories or possessions.
At the same time, the opportunity places clear limits on non-U.S. participation at the applicant level. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply, and non-domestic components of U.S. organizations are not eligible to apply. However, "foreign components" are allowed as defined in the NIH Grants Policy Statement, which generally means a U.S. applicant may include certain well-justified elements of the project that take place outside the United States if they meet NIH policy requirements and receive appropriate approvals.
Key administrative details included in the source information are that the sponsoring agency is NIH, the funding instrument is a cooperative agreement, and the original closing date for applications was November 12, 2020 (with a creation date of September 15, 2020). The provided summary data does not specify an award ceiling or the expected number of awards, indicating those fields were not populated in the excerpt. Overall, the FOA is aimed at accelerating therapeutics for rare diseases by supporting molecularly driven, multi-disease clinical trials under a structured, milestone-based UG3/UH3 model with active NIH involvement.Apply for RFA TR 20 031
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "Basket Clinical Trials of Drugs Targeting Shared Molecular Etiologies in Multiple Rare Diseases (UG3/UH3 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 2020-09-15.
- Applicants must submit their applications by 2020-11-12. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
- 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 title of this NIH funding opportunity?
The funding opportunity is titled "Basket Clinical Trials of Drugs Targeting Shared Molecular Etiologies in Multiple Rare Diseases (UG3/UH3 Clinical Trial Required)."
What is the Funding Opportunity Number (FOA number) for this program?
The Funding Opportunity Number is RFA-TR-20-031.
What CFDA number is associated with this opportunity?
The CFDA number listed is 93.350.
Which agency sponsors this grant opportunity?
The sponsoring agency is the National Institutes of Health (NIH).
What type of funding instrument is being used?
This opportunity uses a cooperative agreement as the funding instrument.
What does it mean that this is a cooperative agreement?
As a cooperative agreement, NIH is expected to have substantial programmatic involvement during the project. This can include collaboration on expectations for study conduct, milestone tracking, and other aspects of trial oversight consistent with NIH cooperative agreement policies.
What is the main purpose of this FOA?
The purpose is to move promising therapeutics into clinical testing across multiple rare diseases that share the same underlying molecular cause, using a basket clinical trial approach to increase efficiency and reduce duplication across separate trials.
What is a "basket" clinical trial in the context of this opportunity?
A basket clinical trial is a single clinical trial framework used to evaluate one drug (or drug approach) across more than one rare disease, as long as those diseases are linked by a common molecular etiology.
Why does the FOA focus on shared molecular etiologies rather than a single diagnosis?
The FOA is designed to generate broader evidence for a therapy that targets a specific molecular mechanism across multiple rare diseases, rather than limiting evaluation to a single diagnosis.
Does this opportunity require a clinical trial?
Yes. The FOA explicitly requires a clinical trial.
What award mechanism does this opportunity use?
The award mechanism is the UG3/UH3 phased cooperative agreement structure.
How does the UG3/UH3 phased structure generally work?
It is typically milestone-driven and supports a transition from an initial planning and start-up phase (UG3) to a later implementation and execution phase (UH3).
Who is eligible to apply?
Eligibility is broad and includes domestic applicant types such as state, county, and city or township governments; special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; federally recognized Native American tribal governments; tribal organizations other than federally recognized tribal governments; public housing authorities and Indian housing authorities; nonprofit organizations with and without 501(c)(3) status (as long as they are not institutions of higher education, which are separately listed); for-profit organizations other than small businesses; small businesses; and other organizations.
Are small businesses eligible to apply?
Yes. Small businesses are listed among eligible applicant types.
Are for-profit organizations eligible to apply?
Yes. For-profit organizations other than small businesses are eligible, and small businesses are also eligible.
Are nonprofit organizations eligible to apply?
Yes. Nonprofit organizations with and without 501(c)(3) status are eligible, provided they are not institutions of higher education (which are addressed as separate eligible categories).
Are colleges and universities eligible to apply?
Yes. Public and state-controlled institutions of higher education and private institutions of higher education are listed as eligible applicants.
Are tribal governments and tribal organizations eligible to apply?
Yes. Federally recognized Native American tribal governments are eligible, and tribal organizations other than federally recognized tribal governments are also listed as eligible. The FOA also highlights Indian/Native American tribal governments that are not federally recognized as an additional eligible category.
Are U.S. territories or possessions eligible to apply?
Yes. U.S. territories or possessions are specifically highlighted as eligible applicant categories.
Are faith-based or community-based organizations eligible to apply?
Yes. Faith-based or community-based organizations are highlighted as eligible applicant categories.
Are minority-serving institutions included as eligible applicants?
Yes. The FOA highlights several categories, including 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 others.
Are federal agencies eligible to apply?
Yes. Eligible federal agencies are listed among the highlighted eligible applicant categories.
Can non-U.S. (foreign) organizations apply as the applicant?
No. Non-domestic (non-U.S.) entities and foreign institutions are not eligible to apply.
Can a non-U.S. component of a U.S. organization apply?
No. Non-domestic components of U.S. organizations are not eligible to apply.
Are any foreign activities allowed under this FOA?
Yes. "Foreign components" are allowed as defined in the NIH Grants Policy Statement, meaning a U.S. applicant may include well-justified elements of the project that take place outside the United States if they meet NIH policy requirements and receive appropriate approvals.
What is the original application closing date listed for this opportunity?
The original closing date for applications was November 12, 2020.
What is the creation date listed for this opportunity?
The creation date listed is September 15, 2020.
Does the provided summary specify the award ceiling?
No. The summary data provided does not specify an award ceiling; that field was not populated in the excerpt.
Does the provided summary specify the expected number of awards?
No. The summary data provided does not specify the expected number of awards; that field was not populated in the excerpt.
What kinds of projects is NIH trying to accelerate through this FOA?
The FOA aims to accelerate therapeutics for rare diseases by supporting molecularly driven, multi-disease clinical trials using a structured, milestone-based UG3/UH3 model with active NIH involvement.
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