The National Institutes of Health (NIH) is offering this grant to establish a Translational Coordination and Dissemination Center (TCDC) for its Somatic Cell Genome Editing (SCGE) Consortium. This grant is for accelerating the development of genome-editing therapeutic agents. In its second phase (FY2023-2027), the SCGE program will advance therapies by facilitating IND-enabling studies, establishing regulatory pathways, and disseminating strategies for first-in-human trials. The TCDC will lead consortium-wide collaborations, support broad dissemination for regulatory submissions, and create a public online platform for SCGE data collection and preservation.
Opportunity ID: 339373
General Information
| Document Type: | Grants Notice |
| Funding Opportunity Number: | RFA-RM-22-017 |
| Funding Opportunity Title: | Somatic Cell Genome Editing Program Translational Coordination and Dissemination Center (TCDC) (U24 – 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 and State controlled institutions of higher education Public housing authorities/Indian housing authorities City or township governments Native American tribal organizations (other than Federally recognized tribal governments) Native American tribal governments (Federally recognized) State governments Independent school districts Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education Special district governments Nonprofits that do not have a 501(c)(3) status with the IRS, other than institutions of higher education County governments Others (see text field entitled “Additional Information on Eligibility” for clarification) Small businesses For profit organizations other than small businesses Private institutions of higher education |
| 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: | The purpose of this FOA is to support the establishment of a Translational Coordination and Dissemination Center (TCDC) for the NIH Somatic Cell Genome Editing (SCGE) Consortium. In its second phase (FY2023-2027), the SCGE program will accelerate the development of genome-editing therapeutic agents by: facilitating IND-enabling studies; establishing pathways to regulatory approval; and disseminating successful strategies for initiating first in human clinical trials. In addition to this TCDC, the Consortium will include three components (development of technology/assays that support IND-submissions, optimize genome editing-based therapeutic leads for safety and efficacy and conduct platform clinical trials using genome editing technologies in 1 disease) which together will accelerate the optimization of promising clinical candidates toward IND filings and future first in human clinical trials. The TCDC is expected to lead consortium-wide activities that facilitate intra-consortium collaborations and that support broad dissemination strategies for regulatory submission. The TCDC will develop a publicly available online platform for data collection and dissemination of consortium-wide activities including stewardship and preservation of data generated by SCGE in Phase I. |
| Link to Additional Information: | http://grants.nih.gov/grants/guide/rfa-files/RFA-RM-22-017.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 | PKG00273241 | Jun 17, 2022 | Jul 19, 2022 | View |
Package 1
Mandatory forms
339373 RR_SF424_5_0-5.0.pdf
339373 PHS398_CoverPageSupplement_5_0-5.0.pdf
339373 RR_OtherProjectInfo_1_4-1.4.pdf
339373 PerformanceSite_4_0-4.0.pdf
339373 RR_KeyPersonExpanded_4_0-4.0.pdf
339373 RR_Budget_3_0-3.0.pdf
339373 PHS398_ResearchPlan_4_0-4.0.pdf
339373 PHSHumanSubjectsAndClinicalTrialsInfo_3_0-3.0.pdf
Optional forms
339373 RR_SubawardBudget30_3_0-3.0.pdf
339373 PHS_AssignmentRequestForm_3_0-3.0.pdf
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