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    Notice of Intent to Publish a Funding Opportunity Announcement for Generate A Precision Medicine Intergenerational Resource for the Study of Factor VIII Immunogenicity in Severe Hemophilia A:

    NOT-HL-19-726

    Iman K. Martin, PhD, MPH, MS

    Opening date 4 Dec 2019, 12:00AM

    Closing date N/A

    Funding Opportunity Number: NOT-HL-19-726

    Opportunity Category: Discretionary

    Expected Number of Awards: 1

    CFDA Number(s): 93.839 -- Blood Diseases and Resources Research

    Cost Sharing or Matching Requirement: No

    Posted Date: Dec 04, 2019 12:00:00 AM EST

    Closing Date: N/A

    Estimated Total Program Funding: 2060000

    Award Ceiling: $1338000

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

    Description: The Division of Blood Diseases and Resources within the National Heart, Lung, and Blood Institute (NHLBI) intends to promote a new initiative by publishing a Funding Opportunity Announcement (FOA) to solicit applications for the following: Generate an Intergenerational Precision Medicine Resource for the Study of Factor VIII Immunogenicity in Severe Hemophilia A: Clinical Coordinating Center ( UG3/UH3 Exploratory/Developmental Phased Award Cooperative Agreement ( Clinical Trial Not Allowed)). This Notice of Intent to Publish (NOITP) is being provided to allow potential eligible applicants sufficient time to develop competitive and responsive milestone-driven scientific projects and thus prepare the applicant for the timely submission of an application. The intended FOA will utilize the UG3/UH3 Exploratory/Developmental Phased Award Cooperative Agreement (Clinical Trial Not Allowed) activity code to issue a single three-year milestone-driven UG3 award, followed by an up to 4 year award if NHLBI-approved milestones are successfully met, for a total of up to seven year support for this new initiative. A companion award for a Biospecimen and Data Resource Center is anticipated to be made in parallel to the Clinical Coordinating Center to provide data management, laboratory support and expertise for the new initiative. (see NOT-HL-19-727) A key characteristic of the Clinical Coordinating Center application will be completion of core milestones. A core milestone is defined as a scheduled event in the project timeline that signifies the completion of a major project stage or activity. Milestones must be performance-based to achieve completion of the Intergenerational Severe Hemophilia A Precision Medicine Resource on time and on budget. Milestones must be established for both the first three years (the UG3 phase) and subsequent (up to) four years (the UH3 phase) of the program Satisfactory completion of the milestones for the first three years will be assessed administratively by NHLBI to determine eligibility to continue the award. Due to the collaborative and parallel nature of these FOAs, NHLBI will enter into negotiation with the Clinical Coordinating Center to achieve early phase-out of the award if Clinical Coordinating Center and/ or Biospecimen and Data Resource Center progress is deemed inadequate upon NHLBI administrative review. Details of the planned FOA are provided below.

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