Limited Competition: Competing Revisions to Support Clinical Trials in Somatic Cell Genome Editing (U19 Clinical Trial Required) | RFA RM 24 008

Opportunity Information: Apply for RFA RM 24 008

The Limited Competition: Competing Revisions to Support Clinical Trials in Somatic Cell Genome Editing (U19 Clinical Trial Required) funding opportunity (RFA-RM-24-008) is a National Institutes of Health (NIH) Notice of Funding Opportunity designed to help existing NIH Somatic Cell Genome Editing (SCGE) program awardees move from advanced preclinical development into first-in-human testing. The mechanism is a cooperative agreement, which generally means NIH will have substantial scientific and programmatic involvement during the project, reflecting the complexity and high oversight expectations typical of early-stage genome editing clinical trials. In practical terms, this NOFO is not for brand-new, stand-alone projects; it is specifically for competitive revisions (formerly called competitive supplements) that expand the scope of an already funded project.

The core purpose is to solicit applications from investigators who currently hold active U19 awards that were originally funded under RFA-RM-22-015 within the NIH SCGE program. Those earlier U19 awards supported development and advancement of therapeutic genome editing candidates, but they explicitly did not allow clinical trials. This new NOFO changes that constraint: it requires a clinical trial and is intended to enable first-in-human genome editing studies using the therapeutic clinical candidates that were developed through the existing U19 projects. In other words, the opportunity is structured as a bridge from a preclinical, development-focused U19 to a version of that same project that is expanded to include the clinical trial phase, assuming the candidate is ready and the team can meet all clinical, regulatory, manufacturing, and oversight requirements.

Eligibility is limited in a way that reflects the "limited competition" label. The primary eligible applicants are awardees with active U19 awards funded under RFA-RM-22-015, since the application is for a competing revision to an existing award rather than a new award from scratch. The opportunity also lists categories of eligible applicants such as independent school districts, federally recognized Native American tribal governments, public housing authorities/Indian housing authorities, and other entities, but the operative limitation is that applicants must be tied to an eligible, active parent U19 award under the specified prior solicitation. The NOFO makes clear that non-domestic (non-U.S.) entities (foreign organizations) are not eligible to apply as applicants. However, non-domestic components of U.S. organizations are eligible to participate, and foreign components are allowed as defined by the NIH Grants Policy Statement, meaning parts of the work may be conducted internationally when justified and permitted under NIH policy, even though the prime applicant organization must be U.S.-based and otherwise eligible.

Administratively, the funding opportunity is issued by the NIH, falls under the Health funding activity category, and uses the cooperative agreement funding instrument. It is associated with CFDA number 93.310. The opportunity was created on 2024-11-21, and the original closing date is 2026-02-13. The summary information provided does not specify an award ceiling or the expected number of awards, which often means applicants need to consult the full NOFO text for budget limits, project period allowances, and any caps tied to the parent award or clinical trial scope.

Taken together, the opportunity is best understood as a targeted NIH pathway for SCGE teams who already built a therapeutic genome editing candidate under the earlier U19 program and are now positioned to take the next major step: launching a first-in-human clinical trial under a revised and expanded project scope. The clinical trial is not optional under this NOFO; it is a required element, reflecting NIHs intent to accelerate translation of somatic cell genome editing technologies into carefully overseen early clinical testing.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Limited Competition: Competing Revisions to Support Clinical Trials in Somatic Cell Genome Editing (U19 Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.310.
• This funding opportunity was created on 2024-11-21.
• Applicants must submit their applications by 2026-02-13. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: Independent school districts, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Others.

Apply for RFA RM 24 008

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