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:Clinical Coordinating Center

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 programSatisfactory 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.