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 National Heart, Lung, and Blood Institute (NHLBI) intends to publish a Funding Opportunity Announcement (FOA) to solicit applications for a Clinical Coordinating Center to generate an intergenerational precision medicine resource for the study of factor VIII immunogenicity in severe hemophilia A. The intended FOA will utilize the UG3/UH3 Exploratory/Developmental Phased Award Cooperative Agreement activity code to issue a single three-year milestone-driven UG3 award, followed by an up to four-year award if NHLBI-approved milestones are successfully met, for a total of up to seven years of support for this new initiative. • The Clinical Coordinating Center will be responsible for completing core milestones, which are scheduled events in the project timeline that signify 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. • 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. • The opportunity is open to various types of organizations, including public and state-controlled institutions of higher education, nonprofits, small businesses, and others.