NIAMS Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required) | PAR 21 036

Opportunity Information: Apply for PAR 21 036

The NIAMS Clinical Trial Implementation Cooperative Agreement (U01 Clinical Trial Required), funding opportunity number PAR-21-036, is a discretionary National Institutes of Health (NIH) grant mechanism designed specifically to support the implementation of clinical trials within the mission areas of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). It uses a cooperative agreement funding instrument (U01), which generally means NIAMS expects to have substantial scientific and/or programmatic involvement during the life of the award compared with a more traditional research project grant. The activity category is health, and it is associated with CFDA number 93.846, which corresponds to NIAMS-related NIH funding. The key point embedded in the title is that a clinical trial is required under this announcement, so applications are expected to propose an actual clinical trial that is ready for implementation rather than exploratory, pre-clinical, or purely observational work.

A wide range of applicant organizations are eligible, reflecting NIH’s broad approach to who can lead federally funded research when they have the expertise and infrastructure to do so. Eligible applicants include state, county, city/township, and special district governments; federally recognized Native American tribal governments; public housing authorities and Indian housing authorities; independent school districts; and both public and private institutions of higher education. The opportunity is also open to nonprofit organizations, including those with 501(c)(3) status and those without 501(c)(3) status (as long as they are not institutions of higher education under the particular category listed). For-profit organizations are eligible as well (other than small businesses), and small businesses are also listed as eligible. In addition, the announcement explicitly highlights several categories of “other eligible applicants,” including Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISI); Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Tribally Controlled Colleges and Universities (TCCUs); faith-based or community-based organizations; eligible agencies of the federal government; regional organizations; Indian/Native American tribal governments that are not federally recognized; and U.S. territories or possessions. The practical takeaway is that NIAMS is casting a wide net across academic, clinical, governmental, community, and tribal entities that can credibly carry out a NIAMS-relevant clinical trial.

At the same time, the eligibility rules draw a clear line around non-U.S. applicants and non-U.S. organizational components. Non-domestic (non-U.S.) entities (foreign organizations) and non-domestic (non-U.S.) entities (foreign institutions) are stated as not eligible to apply. Non-domestic components of U.S. organizations are also not eligible to apply. However, the announcement notes that “foreign components,” as defined in the NIH Grants Policy Statement, are allowed. In NIH language, that typically means a primarily U.S.-based applicant organization can include certain foreign elements (for example, specific performance sites, collaborations, or subawards) if they meet NIH policy definitions and are appropriately justified, but the prime applicant organization itself must be domestic and the arrangement must comply with NIH rules.

From an administrative standpoint, the opportunity was created on 2020-11-12 and lists an original closing date of 2023-11-03. The award ceiling and expected number of awards are not specified in the provided source data, which usually means applicants would need to consult the full funding opportunity announcement or NIH notices for budget expectations, typical award sizes, project period limits, and any institute-specific caps or constraints. The sponsoring agency is the National Institutes of Health, with NIAMS as the institute behind the program.

Overall, this funding opportunity is best understood as a mechanism for teams that are ready to run a NIAMS-relevant clinical trial and are prepared to do so in a cooperative agreement environment, where NIH staff may work closely with awardees on major aspects of the project. Organizations considering applying would typically need established clinical trial capacity (or a strong partnership structure), a well-developed trial protocol, and the operational readiness to implement and manage a trial under NIH and NIAMS expectations, including compliance and reporting obligations that commonly accompany NIH clinical trial awards.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "NIAMS Clinical Trial Implementation Cooperative Agreement (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): 93.846.
• This funding opportunity was created on 2020-11-12.
• Applicants must submit their applications by 2023-11-03. (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.

Apply for PAR 21 036

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