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    Notice of Intent to Publish a Funding Opportunity Announcement for Somatic Cell Genome Editing Translational Coordination and Dissemination Center (U24, Clinical Trial Not Allowed)

    NOT-RM-22-006

    Marrah Lachowicz-Scroggins, Ph.D.

    Opening date 24 Mar 2022, 12:00AM

    Closing date N/A

    Funding Opportunity Number: NOT-RM-22-006

    Opportunity Category: Discretionary

    Expected Number of Awards: 1

    Cost Sharing or Matching Requirement: No

    Posted Date: Mar 24, 2022 12:00:00 AM EDT

    Closing Date: N/A

    Estimated Total Program Funding: 2000000

    Eligible Applicants: Public housing authorities/Indian housing authorities,Independent school districts,Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education,County governments,Public and State controlled institutions of higher education,Native American tribal governments (Federally recognized),State governments,Native American tribal organizations (other than Federally recognized tribal governments),Private institutions of higher education,Small businesses,For profit organizations other than small businesses,Others (see text field entitled "Additional Information on Eligibility" for clarification)

    Description: The Somatic Cell Genome Editing (SCGE) program from the NIH Common Fund intends to issue Funding Opportunity Announcements (FOAs) for the second phase (FY2023-2027) of the program. In Phase 2 the SCGE program will accelerate the development of genome editing therapeutic agents by: facilitating Investigational New Drug (IND) application enabling studies; establishing pathways to regulatory approval; and disseminating successful strategies for initiating first in human clinical trials. SCGE Phase 2 will include four FOAs; 1) an initiative for the development of technology/assays that support IND-submissions, 2) another for optimizing genome editing-based therapeutic leads for safety and efficacy, 3) a platform clinical trials initiative using genome editing therapeutics for more than one disease, 4) and a Translational Coordination and Dissemination Center (TCDC). Together these initiatives will comprise a consortium that will accelerate the optimization of promising clinical candidates toward IND filings and first in human clinical trials. This Notice is being provided to allow potential TCDC applicants sufficient time to develop responsive projects. The FOA is expected to be published in Spring 2022 with expected application due dates in Summer 2022. Details are provided below.

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