Regenerative Medicine Innovation Projects (RMIP) Clinical Trial Planning Grant (R34 - Clinical Trials Not Allowed) | RFA HL 23 020

Opportunity Information: Apply for RFA HL 23 020

The Regenerative Medicine Innovation Projects (RMIP) Clinical Trial Planning Grant (R34 - Clinical Trials Not Allowed), funding opportunity number RFA-HL-23-020, is an NIH grant program run by participating NIH Institutes and Centers in coordination with the U.S. Food and Drug Administration (FDA). Its purpose is to help teams get fully prepared to launch a future clinical trial focused on regenerative medicine approaches that use adult stem cells (explicitly not embryonic or fetal in origin). The emphasis is on enabling the development of regenerative medicine interventions that can be evaluated for safety and/or efficacy once a trial is ready to begin, but this particular award is limited to planning and startup preparation work rather than conducting the clinical trial itself.

A central deliverable supported by this planning grant is the creation of a detailed Manual of Procedures (MOP). NIH highlights that, before any clinical trial begins, the trial rationale, design, statistical and analytic approaches, and the operational protocols and procedures need to be clearly defined and documented. The MOP is meant to capture, in a practical and implementable way, how the study will actually run day to day, including consistent methods for recruitment, intervention administration, data collection, safety monitoring, outcome assessment, and quality control across sites and staff. In addition to the MOP, the program recognizes that launching a regenerative medicine clinical trial often requires substantial time and expense for other preparatory steps, and the grant is designed to cover those steps so that a subsequent trial application is realistic and executable.

Beyond writing the MOP, RMIP planning funds can be used for key pre-trial activities such as pursuing needed regulatory authorizations or approvals and putting essential partnerships and agreements in place. Examples include setting up arrangements with cell manufacturing and production facilities, assay or cell analysis centers, and data coordinating centers. The opportunity also acknowledges that planning can require limited preliminary data collection aimed at feasibility, for instance to confirm that recruitment processes are workable, procedures can be performed consistently, samples can be collected and processed reliably, or candidate endpoints and assays can be implemented as intended. The overall goal is to reduce avoidable delays and failures later by ensuring that the clinical trial is operationally and scientifically ready before it is proposed for execution.

The announcement flags that the requirements for this program can be complex, including expectations around matching funds (noted as an 11 matching funds requirement in the description) and resource sharing. Because of that complexity, applicants are strongly encouraged to contact the appropriate NIH Scientific/Research Contact in advance and review the program FAQs before submitting. The intent is to help applicants confirm that their project fits the program scope and that they understand how to meet the administrative and policy expectations that come with RMIP support.

Eligibility is broad across U.S.-based organizations and government entities. Eligible applicants include state, county, and local 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; tribal organizations that are not federally recognized; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (outside of higher education); for-profit organizations (other than small businesses) as well as small businesses; and other types of domestic entities. The opportunity also explicitly highlights additional eligible groups such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving Institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), faith-based or community-based organizations, eligible federal agencies, regional organizations, tribal governments that are not federally recognized, and U.S. territories or possessions. At the same time, foreign participation is restricted: non-U.S. entities (foreign organizations/institutions) are not eligible to apply, non-domestic components of U.S. organizations are not eligible, and foreign components as defined by NIH policy are not allowed.

From the provided listing details, the opportunity is categorized as a discretionary grant in the health area, administered by NIH, and associated with multiple CFDA numbers (93.121, 93.233, 93.350, 93.837, 93.838, 93.839, 93.840, 93.846, 93.847, 93.853, 93.855, 93.866, 93.867). The award ceiling shown is $150,000, and the original closing date listed is October 6, 2022. Overall, this FOA is best understood as a structured bridge between preclinical or early translational work and a later clinical trial application, giving teams targeted resources to finalize protocols, operational systems, regulatory readiness, and partner infrastructure so the eventual trial can start on solid footing.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Regenerative Medicine Innovation Projects (RMIP) Clinical Trial Planning Grant (R34 - Clinical Trials Not Allowed)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.121, 93.233, 93.350, 93.837, 93.838, 93.839, 93.840, 93.846, 93.847, 93.853, 93.855, 93.866, 93.867.
• This funding opportunity was created on 2022-07-07.
• Applicants must submit their applications by 2022-10-06. (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 $150,000.00 in funding.
• 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 HL 23 020

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