The NIH Common Fund is offering this U19 grant to support team-based research aimed at accelerating the optimization and development of genome editing-based therapeutic leads. This grant is for advancing these leads towards IND-enabling studies and preparing an Investigational New Drug (IND) application for submission to the U.S. Food and Drug Administration (FDA). Eligible therapeutic leads must demonstrate strong biological rationale and robust in vitro and/or in vivo proof of concept data from relevant model systems. A key focus is on developing genome editing approaches that are potentially adaptable to target various pathogenic variants within the same cell or tissue types. Clinical trials are not permitted under this specific funding opportunity.
Opportunity ID: 339372
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-RM-22-015 |
| Funding Opportunity Title: | IND-enabling Studies of Somatic Genome Editing Therapeutic Leads (U19, 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: | Apr 11, 2022 |
| Last Updated Date: | Apr 11, 2022 |
| Original Closing Date for Applications: | Jul 19, 2022 |
| Current Closing Date for Applications: | Jul 19, 2022 |
| Archive Date: | Aug 24, 2022 |
| Estimated Total Program Funding: | – |
| Award Ceiling: | – |
| Award Floor: | – |
Eligibility
| Eligible Applicants: | Public housing authorities/Indian housing authorities Native American tribal organizations (other than Federally recognized tribal governments) Independent school districts Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Small businesses Others (see text field entitled “Additional Information on Eligibility” for clarification) Special district governments State governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education Private institutions of higher education City or township governments Public and State controlled institutions of higher education County governments Native American tribal governments (Federally recognized) 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 Institutions) 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: | This funding opportunity announcement (FOA) is part of a suite of FOAs of the NIH Common Fund Somatic Cell Genome Editing (SCGE) Phase II Program. The goal of this U19 FOA is to support team-based research Projects to accelerate further optimization and development of genome editing-based therapeutic leads towards IND-enabling studies and an IND (Investigational New Drug) application submission to the U.S. Food and Drug Administration (FDA). The proposed leads should demonstrate strong biological rationale and in vitro and/or in vivo proof of concept (POC) data generated in model system(s) each defined by the targeted cell or tissue type to establish a genome editing therapeutic approach that is potentially adaptable to target different pathogenic variants in the same cell or tissue types. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-22-015.html |
| Grantor Contact Information: | If you have difficulty accessing the full announcement electronically, please contact:
NIH OER Webmaster
OERWebmaster03@od.nih.gov Email:OERWebmaster03@od.nih.gov |
Version History
| Version | Modification Description | Updated Date |
|---|---|---|
Related Documents
There are no related documents on this grant.
Packages
| Agency Contact Information: | NIH OER Webmaster OERWebmaster03@od.nih.gov Email: OERWebmaster03@od.nih.gov |
| Who Can Apply: | Organization Applicants |
| Assistance Listing Number | Competition ID | Competition Title | Opportunity Package ID | Opening Date | Closing Date | Actions |
|---|---|---|---|---|---|---|
| FORMS-G | Use for due dates on or after January 25, 2022 | PKG00273238 | Jun 17, 2022 | Jul 19, 2022 | View |
Package 1
Mandatory forms
339372 RR_SF424_5_0-5.0.pdf
339372 PHS398_CoverPageSupplement_5_0-5.0.pdf
339372 RR_OtherProjectInfo_1_4-1.4.pdf
339372 PerformanceSite_4_0-4.0.pdf
339372 RR_KeyPersonExpanded_4_0-4.0.pdf
339372 PHS398_ResearchPlan_4_0-4.0.pdf
339372 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
339372 PHS_Additional_IndirectCosts_2_0-2.0.pdf
339372 PHS_AssignmentRequestForm_3_0-3.0.pdf
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