Testing Centers for Evaluation of Somatic Cell Genome Editing Approaches for Translational Applications (U42 Clinical Trial Not Allowed)

Source-based overview

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. The official record contains the controlling eligibility, budget, attachment and submission requirements for opportunity PAR-28-084.

Eligibility

Eligible applicant types listed by the agency: City or township governments; Others (see text field entitled "Additional Information on Eligibility" for clarification); Public and State controlled institutions of higher education; County governments; Small businesses; Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education; Native American tribal governments (Federally recognized); Independent school districts; Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education; State governments; Native American tribal organizations (other than Federally recognized tribal governments); For profit organizations other than small businesses; Private institutions of higher education; Public housing authorities/Indian housing authorities; Special district governments. Applicants must also satisfy every programme-specific condition in the official notice.

Funding and benefits

Award ceiling: USD 900,000

Expected number of awards: 3

Themes and supported activities

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.

Opportunity number: PAR-28-084

Deadline and timeline

Forecast notice: deadline to be announced: Forecast notice: deadline to be announced.

Applicants should confirm the exact deadline time, time zone, required documents, portal steps and any institutional approvals on the official call page before submitting.

How to apply

Open the official Grants.gov record, review the full notice and attachments, and use the application package or agency route stated there.

Before applying, check eligibility rules, budgets, attachments, page limits, partner requirements, cost-share conditions and whether the opportunity uses an expression of interest, full proposal, registration or nomination stage.