Revision Applications for Regenerative Medicine Innovation Projects (RMIP) (U24) | RFA HL 17 028

Opportunity Information: Apply for RFA HL 17 028

Revision Applications for Regenerative Medicine Innovation Projects (RMIP) (U24) is a one-time NIH and FDA funding opportunity designed specifically for investigators who already hold an active U24 cooperative agreement and need additional support to expand the scope of their ongoing work. The mechanism is a competing revision, meaning it is not a brand-new standalone grant but a request for increased funds during the current budget period to add significant new components to an existing, NIH-approved project or clinical research protocol. The central goal is to accelerate progress in regenerative medicine that uses adult stem cells by backing practical, innovation-oriented studies that can remove well-known bottlenecks in the path from discovery to real-world therapy.

The program is strongly oriented toward translation and real-world readiness, especially the kinds of evidence and development practices that matter when a therapy is moving toward regulatory review. Applications are expected to propose solutions to widely recognized development challenges in creating regenerative medicine products that are safe, effective, and consistently manufactured. A major emphasis is on addressing critical issues in product development that are directly relevant to eventual regulatory submissions. In other words, the opportunity is less about basic exploratory biology and more about improving the tools and approaches that make regenerative medicine products understandable, testable, and reviewable in a rigorous way.

The FOA highlights several example focus areas, all tied to improving evaluation and confidence in regenerative medicine products. This includes developing or refining tools, methods, and standards, as well as applied science approaches that strengthen how the field assesses manufacturing and product quality, demonstrates safety, and supports claims of effectiveness. Projects could, for example, address how a cell-based product is produced and controlled (manufacturing robustness, batch-to-batch consistency), how quality attributes are measured (assays, reference materials, standardization), how risks are identified and mitigated (safety testing strategies, potency or tumorigenicity-related assessments where relevant), and how clinical or translational data can be made more interpretable for decision-making. The common thread is work that improves evaluation, comparability, and reliability in ways that help therapies move forward responsibly.

Administratively, this is a discretionary funding opportunity under the U.S. Department of Health and Human Services, National Institutes of Health, using the cooperative agreement instrument (U24). A cooperative agreement typically indicates substantial NIH involvement during performance, which often means closer coordination, shared oversight expectations, and a more collaborative relationship than a standard research project grant. The opportunity is identified as RFA-HL-17-028, created April 28, 2017, with an original closing date of June 26, 2017. The announcement anticipated up to 6 awards, with an award ceiling listed at $3,245,000.

Eligibility is broad on paper and includes many organization types, such as state, county, and city governments; special district governments; independent school districts; public and private institutions of higher education; federally recognized Native American tribal governments and other tribal organizations; public housing authorities/Indian housing authorities; nonprofits with and without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses. That said, the practical gating factor is built into the purpose of the FOA: applicants must be positioned to submit a competing revision tied to an active U24 award, since the funding is meant to expand an already-funded U24 project rather than initiate a new one. The listed CFDA numbers span multiple NIH programs, reflecting the cross-institute nature of the initiative and the participation of multiple NIH Institutes and Centers along with FDA.

Overall, this FOA is best understood as targeted, time-sensitive supplemental expansion funding for existing U24 teams to tackle high-impact, field-wide problems in adult stem cell-based regenerative medicine development. It prioritizes work that strengthens the evidence base, standardization, and applied development science needed to produce therapies that can be manufactured consistently and evaluated credibly for quality, safety, and effectiveness, particularly in contexts that align with regulatory expectations.

• The Department of Health and Human Services, National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Revision Applications for Regenerative Medicine Innovation Projects (RMIP) (U24)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.121, 93.173, 93.233, 93.242, 93.286, 93.350, 93.837, 93.838, 93.839, 93.840, 93.846, 93.847, 93.853, 93.855, 93.856, 93.866, 93.867.
• This funding opportunity was created on Apr 28, 2017.
• Applicants must submit their applications by Jun 26, 2017. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $3,245,000.00 in funding.
• The number of recipients for this funding is limited to 6 candidate(s).
• 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 (see text field entitled Additional Information on Eligibility for clarification).

Apply for RFA HL 17 028

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