Testing Centers for Evaluation of Somatic Cell Genome Editing Approaches for Translational Applications (U42 Clinical Trial Not Allowed)
🏛 National Institutes of Health (HHS-NIH11)
✓ Free, no account · Source: Grants.gov · Last verified Oct 20, 2026
Can you apply?
This grant is for NIH-supported testing centers that evaluate somatic cell genome editing technologies for translational research. Eligible applicants are academic institutions, research centers, and organizations with capacity to establish and operate research facilities with in vivo and in vitro models.
The centers must support NIH-funded investigators assessing genome editing efficacy, safety, and delivery. Work focuses on developing assays, standard operating procedures, and new approach methodologies (NAMs) to complement traditional animal models.
Testing centers will provide fee-for-service resources to the biomedical community on local, regional, and national levels. Clinical trials are not allowed under this mechanism.
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Key dates
- Oct 13, 2026 Applications open
- Jan 25, 2028 Application deadline in 461 days
- Jul 30, 2028 Award announced
- Aug 1, 2028 Project start
Program description
This Notice of Funding Opportunity (NOFO) invites applicants to support Testing Centers for Evaluation of Somatic Cell Genome Editing Approaches for Translational Applications. Each center will provide resources and testing services to the growing community, developing new genome editing technologies and conducting preclinical testing based on these technologies for therapeutics for human diseases. The testing centers will work with NIH-funded investigators to assess the efficacy and safety of genome editing and delivery technologies, determine genome editing thresholds for specific diseases associated with minimal off-target effects, and ascertain feasibility parameters in model systems. This NOFO is especially interested in the application of new approach methodologies (NAMs) to complement traditional in vivo models for the purposes described in this announcement.
Research Initiative Details
The Testing Centers will establish in vivo and in vitro research models applicable to human health and disease, including NAMs and human-biology-based models. The Testing Centers will develop assays and Standard Operating Procedures (SOPs) for evaluating new genome editing technologies. Data generated by the Centers will help determine whether a treatment strategy using a specific set of tools is effective, has an acceptable safety profile, or requires significant improvement in editing efficacy and specificity. Although each Testing Center will work on a limited number of focused projects, the program and pipeline(s) developed are expected to support multifaceted research activities, build core model systems that can be adapted to accommodate a broad spectrum of diseases, and provide fee-for-service resources to the wider biomedical community on a local, regional, and national basis.
The goal of projects supported by this NOFO is to provide research resources that facilitate optimization and enhance scientific rigor, transparency, and experimental reproducibility in biomedical research.
Who can apply
Eligible applicants
How to apply
Application links
Key dates & requirements
Required documents
- SF-424 (R&R) Form
- Project Narrative/Research Plan
- Budget and Budget Justification
- Biosketches of Key Personnel
- Institutional Support Letter
- Facilities and Resources Documentation
- Letters of Commitment from Partner Investigators
Program contact
- 👤 Division of Comparative Medicine
- 📧 ORIPDCM@mail.nih.gov
- 📞 301-435-0744
Funding track record
Recent awards under CFDA 93.351 from the last 3 years — real organizations that won funding through this same program.
Top 10 Largest Recent Awards
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$203,025,735
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$201,841,608
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$191,271,017
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$167,023,331
-
$150,172,413
-
$143,135,086
-
$129,717,894
-
$41,295,933
-
$37,946,246
-
$33,594,411
Top States by Funding
- OR 7 awards $291.7M
- CA 9 awards $272.7M
- TX 10 awards $235.4M
- WA 2 awards $234.1M
- LA 6 awards $201.4M
Source: USAspending.gov — federal spending transparency. Data covers last 3 years.
Funding history
Annual funding for this program — Federal obligations (CFDA 93.351). How funding has trended year over year.
| 2024 | $279,889,905 | |
| 2025 | $284,089,258 | |
| 2026 est. | $283,084,958 |
FAQ
Who can apply for this grant?
Research institutions with capacity to establish testing centers for genome editing evaluation. Applicants must support NIH-funded investigators and have resources for in vivo and in vitro research.
What activities are supported?
Development of research models, assays, and standard operating procedures for genome editing technologies. Fee-for-service testing and evaluation of efficacy and safety for therapeutic applications are core activities.
Are clinical trials allowed?
No. This mechanism explicitly prohibits clinical trials. Work must remain in preclinical testing and model system development.
What is the funding range?
Awards typically range from $580,000 to $900,000 annually. The exact amount depends on project scope and institutional capacity.
Can centers work on multiple disease areas?
Yes. While each center focuses on limited projects initially, core model systems should adapt to accommodate diverse diseases and provide broad community resources.
💡 Tips for applicants
- Emphasize your institution's capacity to establish robust in vivo and in vitro model systems and maintain high experimental standards.
- Demonstrate strong partnerships with NIH-funded investigators who will use your testing services and validate your approaches.
- Highlight plans for standardized operating procedures and new approach methodologies to improve scientific rigor and reproducibility.
- Plan a realistic fee-for-service business model that sustains operations and serves the broader biomedical research community.
- Show how your center will generate high-quality data to support genome editing technology optimization and safety assessment.
⚠️ Common mistakes
Proposing clinical trial activities or human subject research, which are explicitly excluded. Failing to demonstrate established partnerships with NIH-funded investigators who will actively use testing services. Underestimating operational costs for maintaining compliant research facilities and generating high-quality, reproducible data.
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