Expanding the Human Genome Editing Repertoire (U01 Clinical Trial Not Allowed) | RFA RM 18 017

Opportunity Information: Apply for RFA RM 18 017

This government grant opportunity, titled "Expanding the Human Genome Editing Repertoire (U01 Clinical Trial Not Allowed)," is a National Institutes of Health (NIH) funding announcement designed to push genome editing technology beyond the current set of commonly used in vivo editing systems. The central goal is to support research that creates brand-new genome editing complexes or substantially improves alternatives to existing in vivo genome editing tools, with an emphasis on innovation and optimization rather than using today’s standard approaches as-is. Because it is labeled "Clinical Trial Not Allowed," the work is intended to stay in the preclinical or technology development space and should not involve clinical trial activities, even if the long-term vision of the technology is therapeutic.

The award uses the cooperative agreement mechanism (U01), which typically means NIH expects a more hands-on partnership than in a standard research project grant. Under a U01, recipients generally carry out the research program, but NIH program staff may have substantial involvement in project coordination, milestone tracking, or collaborative planning. The funding activity category is Health, and the listed CFDA number is 93.310, placing it within NIH’s broader biomedical research support portfolio. The opportunity is categorized as discretionary funding, meaning it is awarded competitively based on merit review and program priorities rather than by formula.

From a scientific scope standpoint, the FOA focuses on expanding the "repertoire" of genome editing by developing novel and optimized alternatives to existing in vivo genome editing complexes. In practical terms, this kind of solicitation usually targets next-generation editing systems that can overcome limitations of current platforms, such as constraints on targeting range, editing precision, off-target effects, delivery challenges, immune responses, or difficulties editing specific cell types or tissues in living organisms. While the announcement text provided is brief, the phrase "novel and optimized alternatives" signals that NIH was looking for more than incremental tweaks; it suggests support for new architectures, engineered variants, or fundamentally different approaches that could broaden what is feasible for in vivo genome editing.

Eligibility is broad and includes many types of applicants across government, academia, nonprofit, and industry. Eligible domestic applicants include state, county, and city or township 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; public housing authorities and Indian housing authorities; and Native American tribal organizations other than federally recognized tribal governments. Nonprofit organizations are eligible whether or not they have 501(c)(3) status, as long as they are not institutions of higher education (since those are covered separately). For-profit organizations other than small businesses and small businesses are also eligible, indicating NIH intended to encourage participation from biotechnology and related companies that may be actively developing genome editing platforms. The FOA also explicitly calls out additional eligible applicants, including Alaska Native and Native Hawaiian Serving Institutions, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, U.S. territories or possessions, and non-U.S. entities (foreign organizations). Including foreign organizations and U.S. territories widens the pool further and signals interest in the best technical approaches regardless of geography, provided all NIH policy requirements are met.

Key administrative details from the source data include the Funding Opportunity Number RFA RM 18 017, with an original closing date of April 3, 2018, and a creation date of January 24, 2018. The award ceiling and expected number of awards are not provided in the supplied data, which sometimes happens when budgets are dependent on application quality, availability of funds, or programmatic balance. Since this was an RFA (Request for Applications), it likely had defined program objectives and may have been associated with a specific NIH institute/center initiative or a multi-institute effort focused on advancing genome editing toolkits.

Overall, the opportunity can be summarized as an NIH-backed, cooperative agreement funding program meant to accelerate the development of next-generation in vivo genome editing systems by supporting the creation and optimization of alternatives to existing editing complexes, while keeping the work in the research and technology development domain rather than clinical trials.

• The National Institutes of Health in the health sector is offering a public funding opportunity titled "Expanding the Human Genome Editing Repertoire (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): 93.310.
• This funding opportunity was created on 2018-01-24.
• Applicants must submit their applications by 2018-04-03. (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 RM 18 017

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