The National Institutes of Health (NIH) is offering this grant to support essential IND-enabling studies. This grant is for the development of a novel in vivo genome editing therapeutic platform, utilizing the same genome editor, route of administration, and delivery system, for two or more distinct disease indications. The primary purpose of this grant is to explore how using such a therapeutic platform can streamline the regulatory path for multiple diseases. Furthermore, NIH aims to disseminate the resulting regulatory information and supporting documentation to the scientific community. This initiative seeks to accelerate the translation of groundbreaking genome editing technologies into broad clinical applications.
Opportunity ID: 350822
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-RM-24-001 |
| Funding Opportunity Title: | IND-enabling Studies for Platform Clinical Trials of Genome Editing in Multiple Diseases (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: | Nov 01, 2023 |
| Last Updated Date: | Nov 01, 2023 |
| Original Closing Date for Applications: | Feb 22, 2024 |
| Current Closing Date for Applications: | Feb 22, 2024 |
| Archive Date: | Mar 29, 2024 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | $2,000,000 |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | 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) 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 Others (see text field entitled “Additional Information on Eligibility” for clarification) Independent school districts Public housing authorities/Indian housing authorities County governments Small businesses Special district governments Native American tribal organizations (other than Federally recognized tribal governments) City or township governments Private 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; Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not 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 NOFO is to provide support for applications for IND-enabling studies for the development of a novel in vivo genome editing therapeutic platform (genome editor plus delivery system) for two or more disease indications, using the same genome editor, route of administration, and delivery system. Through this initiative, NIH aims to explore the extent to which the use of a therapeutic genome editing platform can streamline the regulatory path for multiple disease indications and to disseminate this regulatory information (and supporting documentation) to the scientific community. |
| Link to Additional Information: | https://grants.nih.gov/grants/guide/rfa-files/RFA-RM-24-001.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
Folder 350822 Full Announcement-RFA-RM-24-001 -> RFA-RM-24-001-Full-Announcement.pdf
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 | PKG00283670 | Jan 22, 2024 | Feb 22, 2024 | View |
Package 1
Mandatory forms
350822 RR_SF424_5_0-5.0.pdf
350822 PHS398_CoverPageSupplement_5_0-5.0.pdf
350822 RR_OtherProjectInfo_1_4-1.4.pdf
350822 PerformanceSite_4_0-4.0.pdf
350822 RR_KeyPersonExpanded_4_0-4.0.pdf
350822 PHS398_ResearchPlan_5_0-5.0.pdf
350822 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
350822 RR_Budget_3_0-3.0.pdf
350822 RR_SubawardBudget30_3_0-3.0.pdf
350822 PHS398_ModularBudget_1_2-1.2.pdf
350822 PHS_AssignmentRequestForm_3_0-3.0.pdf
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