Limited Competition: Regenerative Medicine Innovation Project (RMIP) Investigator-Initiated Studies (U01 Clinical Trial Not Allowed) | RFA AR 25 013

Opportunity Information: Apply for RFA AR 25 013

The Limited Competition: Regenerative Medicine Innovation Project (RMIP) Investigator-Initiated Studies funding opportunity (RFA-AR-25-013) is a National Institutes of Health (NIH) discretionary grant solicitation that supports investigator-initiated research in regenerative medicine through a cooperative agreement mechanism (U01). The cooperative agreement format means NIH program staff are expected to have substantial involvement in the project’s conduct compared with a standard research grant, typically through shared planning, coordination, milestones, and other forms of programmatic stewardship. The notice is explicitly labeled “Clinical Trial Not Allowed,” so proposed projects must be preclinical, translational, mechanistic, or otherwise non-clinical-trial human research under NIH definitions, and applicants should be careful not to include study designs that meet NIH’s definition of a clinical trial.

This opportunity sits within NIH’s health research mission and is associated with multiple CFDA numbers: 93.233, 93.837, 93.838, 93.839, 93.840, 93.846, and 93.867. While the brief source text does not spell out specific scientific topics, the title and program name indicate a focus on regenerative medicine innovation, meaning projects are typically expected to advance approaches that repair, replace, regenerate, or restore function to cells, tissues, or organs, and to do so in a way that is novel, enabling, or meaningfully accelerates the field. Because it is “limited competition,” eligibility to apply may be constrained beyond standard NIH rules (for example, by requiring a particular status or meeting program-specific requirements), so applicants generally need to confirm they meet any special eligibility conditions described in the full announcement.

The applicant eligibility scope is broad on the U.S. side. Eligible applicants include state, county, city/township, and special district governments; independent school districts; public and state-controlled institutions of higher education; private institutions of higher education; small businesses; for-profit organizations other than small businesses; and nonprofit organizations both with and without 501(c)(3) status (excluding higher education institutions when applying in those nonprofit categories). Federally recognized Native American tribal governments are eligible, and the announcement also explicitly notes that Indian/Native American tribal governments other than federally recognized entities may apply as well. The description further clarifies additional eligible applicant types, including eligible agencies of the federal government, faith-based or community-based organizations, regional organizations, and U.S. territories or possessions.

Foreign involvement is restricted in a specific way. Non-domestic (non-U.S.) entities (foreign organizations) are not eligible to apply as the applicant organization, and non-domestic components of U.S. organizations are also not eligible to apply as components. However, “foreign components” are allowed as defined in the NIH Grants Policy Statement, which generally means a U.S. applicant can include certain types of substantive foreign involvement (for example, a performance site or a significant element of the project carried out abroad) if it meets NIH’s definition and is appropriately justified and disclosed, even though a foreign institution cannot be the direct applicant.

The opportunity’s original closing date is October 21, 2025, and the opportunity was created on June 17, 2025. The provided source data does not list an award ceiling or the expected number of awards, so applicants would need to consult the full funding opportunity announcement for budget limits, project period, anticipated award counts, and any required milestones or cooperative agreement terms. Overall, this solicitation is best understood as NIH support for non-clinical-trial regenerative medicine studies under a U01 cooperative model, open to a wide range of U.S.-based organizational types, with foreign participation permitted only through NIH-defined foreign components rather than foreign applicant organizations.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Limited Competition: Regenerative Medicine Innovation Project (RMIP) Investigator-Initiated Studies (U01 Clinical Trial Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.233, 93.837, 93.838, 93.839, 93.840, 93.846, 93.867.
• This funding opportunity was created on 2025-06-17.
• Applicants must submit their applications by 2025-10-21. (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 RFA AR 25 013

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