The National Institutes of Health (NIH) is offering this U01 grant to solicit applications focused on the optimization and characterization of advanced technologies and assays. This funding opportunity specifically targets innovations with the potential for direct utilization and adoption in regulatory submissions concerning therapeutic genome editing. The primary purpose of this grant is to enhance the crucial tools and methodologies required for the development and approval of new genome editing therapeutics. This initiative aims to address the critical need for robust, standardized, and verifiable scientific methods to support IND (Investigational New Drug) applications. Projects should therefore concentrate on improving the foundational elements that underpin successful gene editing treatments, ultimately accelerating their journey from research to patient care and ensuring regulatory readiness.
Opportunity ID: 353126
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-RM-24-007 |
| Funding Opportunity Title: | Technologies and Assays for Therapeutic Genome Editing INDs (U01, Clinical Trial Not Allowed) |
| 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: | Mar 22, 2024 |
| Last Updated Date: | Mar 22, 2024 |
| Original Closing Date for Applications: | Jul 26, 2024 |
| Current Closing Date for Applications: | Jul 26, 2024 |
| Archive Date: | Aug 31, 2024 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education State governments Public and State controlled institutions of higher education City or township governments Public housing authorities/Indian housing authorities Small businesses Independent school districts Native American tribal governments (Federally recognized) Special district governments Native American tribal organizations (other than Federally recognized tribal governments) Others (see text field entitled “Additional Information on Eligibility” for clarification) County governments Private institutions of higher education Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education For profit organizations other than small businesses |
| Additional Information on Eligibility: | Other Eligible Applicants include the following: Alaska Native and Native Hawaiian Serving Institutions; Asian American Native American Pacific Islander Serving Institutions (AANAPISISs); Eligible Agencies of the Federal Government; Faith-based or Community-based Organizations; Hispanic-serving Institutions; Historically Black Colleges and Universities (HBCUs); Indian/Native American Tribal Governments (Other than Federally Recognized); Non-domestic (non-U.S.) Entities (Foreign Organizations); Regional Organizations; Tribally Controlled Colleges and Universities (TCCUs) ; U.S. Territory or Possession. |
Additional Information
| Agency Name: | National Institutes of Health |
| Description: | The purpose of this Notice Of Funding Opportunity (NOFO) is to solicit applications on the optimization and characterization of technologies and assays with the potential for utilization and adoption in regulatory submissions of genome editing therapeutics. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/rfa-files/RFA-RM-24-007.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-H | Use for due dates on or after January 25, 2023 | PKG00285507 | Jun 26, 2024 | Jul 26, 2024 | View |
Package 1
Mandatory forms
353126 RR_SF424_5_0-5.0.pdf
353126 PHS398_CoverPageSupplement_5_0-5.0.pdf
353126 RR_OtherProjectInfo_1_4-1.4.pdf
353126 PerformanceSite_4_0-4.0.pdf
353126 RR_KeyPersonExpanded_4_0-4.0.pdf
353126 PHS398_ResearchPlan_5_0-5.0.pdf
353126 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
353126 RR_Budget_3_0-3.0.pdf
353126 RR_SubawardBudget30_3_0-3.0.pdf
353126 PHS398_ModularBudget_1_2-1.2.pdf
353126 PHS_AssignmentRequestForm_3_0-3.0.pdf
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