Opportunity Information: Apply for RFA RM 18 023

The National Institutes of Health (NIH) funding opportunity titled "Innovative Technologies to Deliver Genome Editing Machinery to Disease-relevant Cells and Tissues (UG3/UH3 Clinical Trial Not Allowed)" supports research aimed at solving one of the biggest practical hurdles in therapeutic genome editing: getting the editing tools into the right somatic cells and tissues safely and efficiently. The overall goal is to speed progress toward genome editing-based treatments for human disease by advancing delivery technologies that can reliably transport genome editing machinery (such as nucleases and associated components) to disease-relevant targets in the body. A key boundary of the announcement is that it does not allow clinical trials, meaning the work is intended to stay in preclinical or technology-development stages rather than testing interventions in human participants.

This opportunity uses a cooperative agreement mechanism and specifically the UG3/UH3 phased award structure. In practical terms, that structure is typically designed to fund a milestone-driven project in two stages: an initial phase focused on feasibility, development, and early validation (UG3), followed by an expansion phase to further optimize, scale, and demonstrate performance if predefined milestones are met (UH3). Because it is a cooperative agreement, NIH involvement is generally more hands-on than with a standard grant, with program staff often collaborating on progress assessment, milestones, and coordination. The emphasis on "innovative approaches" signals that the program is looking for new or significantly improved delivery strategies, not just incremental refinements of well-established methods, with an expectation that the work will be evaluated rigorously in relevant models and settings.

The funding opportunity number is RFA-RM-18-023, and it falls under the health category with CFDA number 93.310. The instrument type is listed as a cooperative agreement, and the opportunity is categorized as discretionary funding. The original closing date for submissions was October 18, 2018, and the opportunity record shows a creation date of July 25, 2018. The listed award ceiling is $500,000. While the record includes a field for expected awards, no specific number is provided in the source data shared, so applicants would have needed to consult the full FOA or NIH postings at the time for any program-level projections about how many awards might be made.

Eligibility is broad and includes a wide range of organization types across the public, private, nonprofit, and academic sectors. Eligible applicants include state governments, county governments, city or township governments, special district governments, and independent school districts, as well as public and state-controlled institutions of higher education and private institutions of higher education. The eligibility list also includes Native American tribal governments (federally recognized), public housing authorities and Indian housing authorities, and Native American tribal organizations that are not federally recognized tribal governments. Nonprofit organizations are eligible whether they have 501(c)(3) status or not (as long as they are not institutions of higher education), and for-profit organizations other than small businesses may apply, along with small businesses. The announcement also explicitly calls out additional eligible applicant categories, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, and eligible agencies of the federal government. It also indicates that non-domestic (non-U.S.) entities (foreign organizations), regional organizations, tribal governments other than federally recognized tribes, and U.S. territories or possessions are eligible, reflecting an intent to include diverse institutional participants and potentially global expertise in delivery technologies.

In short, this NIH program was designed to push the field of genome editing forward by funding the development and evaluation of delivery systems that can bring genome editing machinery to the specific somatic cells and tissues implicated in disease, under a milestone-based UG3/UH3 cooperative agreement structure, with no clinical trials allowed and with broad eligibility spanning governmental, academic, nonprofit, and private-sector organizations, including many categories of minority-serving institutions and U.S. territories as well as foreign entities.

  • The National Institutes of Health in the health sector is offering a public funding opportunity titled "Innovative Technologies to Deliver Genome Editing Machinery to Disease-relevant Cells and Tissues (UG3/UH3 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 2018-07-25.
  • Applicants must submit their applications by 2018-10-18. (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 $500,000.00 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 RM 18 023

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Frequently Asked Questions (FAQs)

What is the title of this NIH funding opportunity?

The funding opportunity is titled "Innovative Technologies to Deliver Genome Editing Machinery to Disease-relevant Cells and Tissues (UG3/UH3 Clinical Trial Not Allowed)."

What is the main goal of this funding opportunity?

The goal is to accelerate progress toward genome editing-based treatments for human disease by advancing delivery technologies that can safely and efficiently transport genome editing machinery to disease-relevant somatic cells and tissues in the body.

What problem is NIH trying to solve through this program?

This program targets a major practical hurdle in therapeutic genome editing: getting genome editing tools into the right cells and tissues reliably, safely, and efficiently.

What types of technologies or approaches are in scope?

Projects should focus on delivery technologies capable of transporting genome editing machinery (such as nucleases and associated components) to disease-relevant targets. The emphasis is on innovative approaches rather than incremental improvements to well-established delivery methods.

What does "genome editing machinery" mean in this context?

In this opportunity, genome editing machinery refers to the tools used to perform genome editing, including nucleases and associated components that must be delivered to the relevant cells or tissues.

What does "disease-relevant cells and tissues" mean?

It refers to the somatic (non-reproductive) cells and tissues in the body that are implicated in a disease and therefore need to receive the genome editing machinery for a therapeutic approach to be feasible.

Are clinical trials allowed under this opportunity?

No. The funding opportunity is explicitly labeled "Clinical Trial Not Allowed," meaning supported activities are intended to remain in preclinical or technology-development stages rather than testing interventions in human participants.

If clinical trials are not allowed, what kind of work is expected?

Work is expected to focus on preclinical research, technology development, feasibility testing, early validation, optimization, and rigorous evaluation in relevant models and settings.

What grant mechanism is used for this opportunity?

This opportunity uses a cooperative agreement mechanism.

What does it mean that this is a cooperative agreement?

A cooperative agreement generally means NIH involvement is more hands-on than in a standard grant, with NIH program staff often collaborating on progress assessment, milestone development and evaluation, and coordination during the project.

What is the UG3/UH3 phased award structure?

The UG3/UH3 structure is a milestone-driven, two-stage phased award. It typically supports an initial phase (UG3) focused on feasibility, development, and early validation, followed by a second phase (UH3) that expands and advances the work if predefined milestones are achieved.

What typically happens during the UG3 phase?

The UG3 phase is typically used for feasibility, technology development, and early validation work to demonstrate that the approach can meet the program's milestones.

What typically happens during the UH3 phase?

If UG3 milestones are met, the UH3 phase generally supports expanded efforts to further optimize the delivery technology, scale it as appropriate, and demonstrate performance more broadly in relevant models and settings.

Is transition from UG3 to UH3 automatic?

No. The phased structure is milestone-based, so progression to the UH3 phase is typically contingent on meeting predefined milestones established for the UG3 phase.

What does NIH mean by "innovative approaches" here?

The opportunity signals interest in new or significantly improved delivery strategies, not just small refinements of well-established methods, with an expectation of rigorous evaluation in relevant contexts.

What is the funding opportunity number?

The funding opportunity number is RFA-RM-18-023.

What is the CFDA number and category?

The CFDA number listed is 93.310, and the opportunity is in the health category.

What type of funding is this considered?

The opportunity is categorized as discretionary funding.

What is the award ceiling?

The listed award ceiling is $500,000.

How many awards were expected?

The source information provided includes a field for expected awards but does not provide a specific number. Applicants would have needed to consult the full FOA or NIH postings at the time for projections about the number of awards.

What was the original submission closing date?

The original closing date for submissions was October 18, 2018.

When was the opportunity record created?

The opportunity record shows a creation date of July 25, 2018.

Who is eligible to apply?

Eligibility is broad and includes many organization types across public, private, nonprofit, and academic sectors, as well as certain federal, territorial, tribal, and foreign entities.

Are state and local governments eligible?

Yes. Eligible applicants include state governments, county governments, city or township governments, special district governments, and independent school districts.

Are colleges and universities eligible?

Yes. Eligible applicants include public and state-controlled institutions of higher education and private institutions of higher education.

Are tribal entities eligible?

Yes. The eligibility list includes Native American tribal governments (federally recognized) and also includes tribal governments other than federally recognized tribes, as well as Native American tribal organizations that are not federally recognized tribal governments.

Are nonprofits eligible?

Yes. Nonprofit organizations are eligible whether or not they have 501(c)(3) status, provided they are not institutions of higher education.

Are for-profit organizations eligible?

Yes. For-profit organizations other than small businesses may apply, and small businesses are also eligible.

Are public housing authorities eligible?

Yes. Public housing authorities and Indian housing authorities are listed as eligible.

Are U.S. territories or possessions eligible?

Yes. U.S. territories or possessions are indicated as eligible.

Are non-U.S. (foreign) organizations eligible?

Yes. The eligibility list indicates that non-domestic (non-U.S.) entities (foreign organizations) and regional organizations are eligible.

Are minority-serving institutions specifically included in eligibility?

Yes. The announcement explicitly calls out multiple categories, including Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), and Tribally Controlled Colleges and Universities (TCCUs).

Are faith-based or community-based organizations eligible?

Yes. Faith-based or community-based organizations are explicitly listed among eligible applicant categories.

Are federal agencies eligible?

Yes. Eligible agencies of the federal government are listed as eligible applicants.

What is the intended impact of this program in the genome editing field?

The program is intended to push the field forward by funding the development and evaluation of delivery systems that can bring genome editing machinery to the specific somatic cells and tissues implicated in disease, helping enable future genome editing-based treatments.

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