The NIH Somatic Cell Genome Editing program is offering this grant to support competing revision applications for existing U19 awardees. This grant is for the purpose of expanding the scope of active U19 awards, initially funded under RFA-RM-22-015, to facilitate first-in-human genome editing clinical trials. While the original U19 program did not permit clinical trials, this current Notice of Funding Opportunity (RFA-RM-24-008) specifically requires them. The objective is to enable the progression of therapeutic clinical candidates, which have been developed through the existing U19 awards, into human trials. This represents a crucial advancement towards the clinical application and validation of somatic cell genome editing technologies.
Opportunity ID: 357306
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-RM-24-008 |
| Funding Opportunity Title: | Limited Competition: Competing Revisions to Support Clinical Trials in Somatic Cell Genome Editing (U19 Clinical Trial Required) |
| Opportunity Category: | Discretionary |
| Opportunity Category Explanation: | – |
| Funding Instrument Type: | Cooperative Agreement |
| Category of Funding Activity: | Health |
| Category Explanation: | – |
| Expected Number of Awards: | – |
| Assistance Listings: | 93.310 — Trans-NIH Research Support |
| Cost Sharing or Matching Requirement: | No |
| Version: | Synopsis 1 |
| Posted Date: | Nov 21, 2024 |
| Last Updated Date: | Nov 21, 2024 |
| Original Closing Date for Applications: | Feb 13, 2026 |
| Current Closing Date for Applications: | Feb 13, 2026 |
| Archive Date: | Mar 21, 2026 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Others (see text field entitled “Additional Information on Eligibility” for clarification) Independent school districts Native American tribal governments (Federally recognized) Public housing authorities/Indian housing authorities |
| Additional Information on Eligibility: | Other Eligible Applicants include the following: Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; U.S. Territory or Possession; Non-domestic (non-U.S.) Entities (Foreign Organization) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply. Foreign components, as defined in the NIH Grants Policy Statement, are allowed. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | The purpose of this Notice of Funding Opportunity (NOFO) is to solicit competitive revision (formerly known as competitive supplement) applications from awardees with active U19 awards funded under RFA-RM-22-015 as part ofthe NIH Somatic Cell Genome Editing program, in order to expand the scope of the original award to allow first in human genome editing clinical trials using the therapeutic clinical candidates developed through the U19 award. RFA-RM-22-015 did not allow a clinical trial, whereas the present NOFO (RFA-RM-24-008) requires a clinical trial. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/rfa-files/RFA-RM-24-008.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH Grants Information
grantsinfo@nih.gov Email:grantsinfo@nih.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
There are no related documents on this grant.
Packages
| Agency Contact Information: | NIH Grants Information grantsinfo@nih.gov Email: grantsinfo@nih.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-I | Use for due dates on or after January 25, 2025 | PKG00288884 | Jan 14, 2025 | Feb 13, 2026 | View |
Package 1
Mandatory forms
357306 RR_SF424_5_0-5.0.pdf
357306 PHS398_CoverPageSupplement_5_0-5.0.pdf
357306 RR_OtherProjectInfo_1_4-1.4.pdf
357306 PerformanceSite_4_0-4.0.pdf
357306 RR_KeyPersonExpanded_4_0-4.0.pdf
357306 PHS398_ResearchPlan_5_0-5.0.pdf
357306 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
357306 PHS_Additional_IndirectCosts_2_0-2.0.pdf
357306 PHS_AssignmentRequestForm_4_0-4.0.pdf
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