Opportunity Information: Apply for PAR 25 141
The NIAMS Clinical Trial Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required), funding opportunity number PAR-25-141, is a National Institutes of Health (NIH) discretionary grant program run by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). It uses a cooperative agreement mechanism, meaning NIAMS expects to have substantial involvement with awardees during the project, rather than simply providing funds with minimal agency interaction. The program is intended to support the implementation of clinical trials within NIAMS mission areas, and it specifically requires that the application propose a clinical trial. The listing is identified under CFDA number 93.846 and remains open with an application due date of March 4, 2027 (as shown by the original closing date).
This announcement is a re-issue of PAR-24-208, and the re-issue was driven by NIH-wide changes tied to the Simplifying Review of Research Project Grant Applications initiative. In practical terms, the only stated modifications in this re-issued version are in Section V, Application Review Information, where the simplified peer review framework is reflected. Everything else about the opportunity is described as unchanged. For applicants, the key takeaway is that the science and operational expectations of the program are the same as before, but the way reviewers are instructed to evaluate and score applications has been updated to match NIH's simplified review approach.
The award is structured as a phased UG3/UH3 mechanism. While the notice text provided does not go into the full details of the phases, in NIH practice a UG3/UH3 design generally supports a milestone-driven transition from an initial phase focused on finalizing readiness activities (often planning, start-up, and meeting pre-specified milestones) into a second phase that supports full clinical trial implementation and conduct once those milestones are met. Because this is a cooperative agreement, investigators should also expect closer coordination with NIAMS staff around trial governance, milestones, and progress monitoring.
Eligibility is broad and includes many types of domestic organizations and government entities. Eligible applicants listed include state, county, city or township, and 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; Native American tribal organizations that are not federally recognized tribal governments; public housing authorities/Indian housing authorities; nonprofits both with and without 501(c)(3) IRS status (as long as they are not institutions of higher education in those nonprofit categories); for-profit organizations (other than small businesses); and small businesses. The opportunity also explicitly calls out 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, and U.S. territories or possessions.
At the same time, there are clear restrictions related to foreign participation. Non-domestic (non-U.S.) entities (foreign organizations) are not eligible to apply, 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. In NIH terms, that usually means a U.S. applicant organization can include certain discrete elements of the project that take place outside the U.S. when well-justified and compliant, even though the primary applicant organization itself must be domestic.
The posting does not specify an award ceiling or the expected number of awards in the fields shown, suggesting those details may be provided in the full funding opportunity announcement or may vary by year and availability of funds. The creation date for this re-issued listing is December 9, 2024, and the overall purpose is to support NIAMS-relevant clinical trial implementation through a milestone-based, collaboratively managed NIH cooperative agreement structure, evaluated under NIH's updated simplified peer review criteria in the review section of the announcement.Apply for PAR 25 141
- The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIAMS Clinical Trial Implementation Cooperative Agreement (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): 93.846.
- This funding opportunity was created on 2024-12-09.
- Applicants must submit their applications by 2027-03-04.
- 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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FAQs: NIAMS Clinical Trial Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required) - PAR-25-141
What is the name of this funding opportunity?
The opportunity is the NIAMS Clinical Trial Implementation Cooperative Agreement (UG3/UH3 Clinical Trial Required).
What is the funding opportunity number (FOA)?
The funding opportunity number is PAR-25-141.
Which federal agency and NIH institute run this program?
This is an NIH discretionary grant program administered by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS).
What type of grant mechanism is being used?
The mechanism is a cooperative agreement. That means NIAMS expects substantial involvement with awardees during the project rather than providing funds with minimal agency interaction.
What is the purpose of this program?
The program is intended to support the implementation of clinical trials within NIAMS mission areas.
Is proposing a clinical trial required?
Yes. The opportunity specifically requires that the application propose a clinical trial.
What activity code or project structure does the award use?
The award uses a phased UG3/UH3 structure, which in NIH practice generally supports a milestone-driven transition from an initial phase focused on readiness activities into a second phase supporting full clinical trial implementation and conduct once milestones are met.
How should applicants think about the UG3 and UH3 phases?
While the provided notice text does not list full phase details, NIH practice for UG3/UH3 generally involves an initial phase for planning and start-up/readiness activities tied to pre-specified milestones, followed by a second phase for full trial implementation and conduct after milestone completion.
What does "milestone-driven transition" mean in this context?
It generally means continuation from the earlier phase to the later phase is expected to depend on meeting pre-specified milestones, with NIAMS coordinating closely around milestones and progress monitoring due to the cooperative agreement structure.
What does NIAMS "substantial involvement" typically imply for awardees?
Based on the cooperative agreement description provided, investigators should expect closer coordination with NIAMS staff around trial governance, milestones, and progress monitoring.
What is the CFDA (assistance listing) number for this program?
The listing is identified under CFDA number 93.846.
What is the application due date shown for this opportunity?
The listing indicates an application due date of March 4, 2027 (shown as the original closing date).
Is this funding opportunity currently open?
Yes. The listing is described as remaining open, with the due date shown as March 4, 2027.
When was this re-issued listing created?
The creation date for the re-issued listing is December 9, 2024.
Is PAR-25-141 a new announcement or a re-issue?
It is a re-issue of PAR-24-208.
Why was this announcement re-issued?
The re-issue was driven by NIH-wide changes tied to the Simplifying Review of Research Project Grant Applications initiative.
What changed in the re-issued version compared to the prior version?
The only stated modifications are in Section V, Application Review Information, where the simplified peer review framework is reflected. Everything else is described as unchanged.
Does the re-issue change the scientific or operational expectations of the program?
No. The key takeaway provided is that the science and operational expectations are the same as before, but reviewer instructions and scoring have been updated to align with NIH's simplified review approach.
Where in the FOA are the review-related changes located?
The stated changes are in Section V, Application Review Information.
Who is eligible to apply?
Eligibility is broad and includes many types of domestic organizations and government entities, including:
- State governments
- County governments
- 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
- Native American tribal organizations (other than federally recognized tribal governments)
- Public housing authorities/Indian housing authorities
- Nonprofits with 501(c)(3) IRS status (other than institutions of higher education in those nonprofit categories)
- Nonprofits without 501(c)(3) IRS status (other than institutions of higher education in those nonprofit categories)
- For-profit organizations (other than small businesses)
- Small businesses
Are any additional applicant categories explicitly called out as eligible?
Yes. The opportunity explicitly calls out additional eligible 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
- U.S. territories or possessions
Are foreign (non-U.S.) organizations eligible to apply as the applicant?
No. Non-domestic (non-U.S.) entities (foreign organizations) are not eligible to apply.
Are non-domestic components of U.S. organizations eligible to apply?
No. Non-domestic components of U.S. organizations are also not eligible to apply.
Are foreign components allowed in the project at all?
Yes. Foreign components are allowed, as defined in the NIH Grants Policy Statement. In NIH terms, that generally means a U.S. applicant organization may include discrete elements of the project that take place outside the U.S. when well-justified and compliant, even though the primary applicant organization must be domestic.
Does the posting list an award ceiling (maximum budget) or expected number of awards?
No. The posting does not specify an award ceiling or the expected number of awards in the fields shown, suggesting those details may be provided in the full funding opportunity announcement or may vary by year and availability of funds.
What is the main theme applicants should keep in mind about this opportunity?
The core theme described is NIAMS-relevant clinical trial implementation using a milestone-based UG3/UH3 cooperative agreement structure with substantial NIAMS involvement, and applications reviewed under NIH's updated simplified peer review criteria (reflected in Section V).
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