Notice of Intent to Publish a Funding Opportunity Announcement for Generate an Intergenerational Precision Medicine Resource for the Study of Factor VIII Immunogenicity in Severe Hemophilia A: Biospecimen and Data Resource Center (U24)

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Opportunity ID: 322899
Opportunity Number: NOT-HL-19-727
Opportunity Title: Notice of Intent to Publish a Funding Opportunity Announcement for Generate an Intergenerational Precision Medicine Resource for the Study of Factor VIII Immunogenicity in Severe Hemophilia A: Biospecimen and Data Resource Center (U24)
Opportunity Category: Discretionary
Opportunity Category Explanation:
Funding Instrument Type: Cooperative Agreement
Category of Funding Activity: Health
Category Explanation:
CFDA Number(s): 93.839
Eligible Applicants: State governments
County governments
Independent school districts
Public and State controlled institutions of higher education
Native American tribal governments (Federally recognized)
Public housing authorities/Indian housing authorities
Native American tribal organizations (other than Federally recognized tribal governments)
Nonprofits having a 501(c)(3) status with the IRS, other than institutions of higher education
Private institutions of higher education
For profit organizations other than small businesses
Small businesses
Others (see text field entitled “Additional Information on Eligibility” for clarification)
Additional Information on Eligibility:
Agency Code: HHS-NIH11
Agency Name: Department of Health and Human Services
National Institutes of Health
Posted Date: Dec 04, 2019
Last Updated Date: Dec 04, 2019
Estimated Synopsis Post Date: Mar 02, 2020
Fiscal Year: 2021
Award Ceiling: $872,000
Award Floor:
Estimated Total Program Funding: $1,343,000
Expected Number of Awards: 1
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: Biospecimen and Data Resource Center , U24 Resource-Related Research Projects – Cooperative Agreement ). 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 applicants for the timely submission of an application. The anticipated FOA will utilize the U24 Resource-Related Research Projects – Cooperative Agreement activity code to issue a single award for up to seven years for the Biospecimen and Data Resource Center that will provide data management, laboratory, and biospecimen support necessary to establish the anticipated FOA, “An Intergenerational Precision Medicine Resource for the Study of Factor VIII Immunogenicity in Severe Hemophilia A”. The role of the Biospecimen and Data Resource Center is to provide overall project coordination, administration, data and biospecimen management, biostatistics/data analytics support, as well as laboratory (including multi-omics) and biorepository expertise for development of this unique resource. The companion award for the Clinical Coordinating Center (UG3/UH3) (see NOT-19-HL-726) is anticipated to be made in parallel to the Biospecimen and Data Resource Center to allow for the establishment of this unique biospecimen resource. The Clinical Coordinating Center FOA will provide investigators with the opportunity to propose the design of a unique Intergenerational Precision Medicine Resource, derived from a de novo antenatal/ neonatal /pediatric cohort with severe hemophilia A and annotated with robust intergenerational clinical and demographic data, for the purpose of enabling future mechanistic and translational studies of factor VIII immunogenicity and tolerance. A key characteristic of the Biospecimen and Data Resource 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 Precision Medicine Resource on time and on budget and must be established to align with the bi-phasic mechanism of the Clinical Coordinating Center award. Milestones must be established for both the first three years (coinciding with the UG3 phase of the Clinical Coordinating Center award) and subsequent four years (coinciding with the UH3 phase of the Clinical Coordinating Center award) of the project. 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 Biospecimen and Data Resource 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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