Exploratory Clinical Trial Grants in Arthritis and Musculoskeletal and Skin Diseases (R61 Clinical Trial Required) | PAR 24 035

Opportunity Information: Apply for PAR 24 035

The Exploratory Clinical Trial Grants in Arthritis and Musculoskeletal and Skin Diseases (R61 Clinical Trial Required) funding opportunity (PAR-24-035) is a National Institutes of Health (NIH) discretionary grant program intended to support exploratory, early-stage clinical trials focused on arthritis and related musculoskeletal and skin diseases. As indicated by the activity code and the wording "Clinical Trial Required," the program is specifically geared toward projects that will actually conduct a clinical trial rather than only planning, developing tools, or running preclinical studies. In practical terms, applicants should expect to propose a clearly defined clinical study in humans that tests an intervention, approach, or strategy relevant to these disease areas, with an emphasis on generating early evidence about feasibility, safety, dosing, biological activity, or signals of efficacy that can justify larger, later-phase trials.

This opportunity uses the NIH grant funding instrument and falls under the Health funding activity category, with CFDA number 93.846. While the notice text provided here does not list an award ceiling or the expected number of awards, it does provide key administrative details: the opportunity was created on November 6, 2023, and the original closing date is November 2, 2026. That long application window suggests a standing or recurring solicitation where NIH may accept applications on standard NIH receipt dates up to the listed close date, though applicants should always confirm specific receipt dates and submission cycles in the full FOA on NIH/Grants.gov.

Eligibility is broad and includes many common U.S. applicant types across government, academia, nonprofits, and industry. Eligible applicants include state, county, city or township, and special district governments; independent school districts; and public housing authorities/Indian housing authorities. Higher education institutions are eligible in both public/state-controlled and private categories. Tribal entities are eligible, including federally recognized Native American tribal governments and Native American tribal organizations other than federally recognized tribal governments. The program is also open to nonprofits with or without 501(c)(3) status (so long as they are not institutions of higher education under that line item), for-profit organizations other than small businesses, and small businesses. Beyond those standard categories, the opportunity explicitly highlights additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions; Asian American, Native American, and 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 agencies of the federal government; regional organizations; U.S. territories or possessions; and Indian/Native American tribal governments other than federally recognized. Taken together, this indicates an intent to encourage applications from a wide range of institutions, including those serving historically underrepresented communities and organizations positioned to recruit, engage, and retain diverse clinical trial participants.

There are important restrictions related to foreign involvement. Non-domestic (non-U.S.) entities (foreign institutions) are not eligible to apply as the applicant organization, and non-domestic components of U.S. organizations are also not eligible to apply. At the same time, the notice states that foreign components, as defined in the NIH Grants Policy Statement, are allowed. In NIH terms, this typically means a U.S.-based applicant may include certain well-justified foreign elements (for example, specific performance sites, collaborations, or resources located outside the U.S.) when they are necessary for the science, but the primary applicant organization must be domestic and the structure must follow NIH rules for foreign components.

Because the mechanism is an R61 and the title emphasizes "exploratory clinical trial," the overall aim is usually to support earlier, higher-uncertainty clinical testing that can quickly inform whether an intervention or clinical strategy is worth advancing. Applicants should be prepared to describe a sound clinical trial design, define the intervention and comparator (as applicable), outline eligibility criteria and recruitment plans, specify endpoints and analysis plans appropriate for an exploratory trial, and address participant protections and oversight that NIH expects for human subjects research. Even in early-stage trials, NIH typically expects a realistic operational plan (study team, sites, timeline, enrollment projections, data management, and safety monitoring) and a clear rationale for how the trial’s results will guide next steps in development or clinical practice.

In short, PAR-24-035 is an NIH grant opportunity supporting the conduct of exploratory clinical trials in arthritis and musculoskeletal and skin diseases, open to a wide range of U.S. organizations across sectors, with explicit encouragement for diverse institution types, clear limits on foreign applicants, and allowance for properly justified foreign components under NIH policy, with an application closing date listed as November 2, 2026.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Exploratory Clinical Trial Grants in Arthritis and Musculoskeletal and Skin Diseases (R61 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 2023-11-06.
• Applicants must submit their applications by 2026-11-02. (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 24 035

[Watch] Creating a grant proposal using the step-by-step wizard inside the applicant portal: