FOA 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)
Grant Type: 
NOT-HL-19-727
Primary IC: 
NHLBI
Release Date: 
Nov 19 2019
Expiration Date: 
N/A
AC Source: 
N/A
Purpose: 
Notice Intent Publish Funding Opportunity Announcement Generate Intergenerational Precision Medicine Resource the Study Factor VIII Immunogenicity Severe Hemophilia A: Biospecimen Data Resource Center U24) Notice Number: NOT-HL-19-727 Key Dates Release Date: November 19, 2019 Estimated Publication Date Funding Opportunity Announcement: March 02, 2020 First Estimated Application Due Date: June 25, 2020 Earliest Estimated Award Date: January 05, 2021 Earliest Estimated Start Date: January 05, 2021 Related Announcements NOT-HL-19-726 Issued National Heart, Lung, Blood Institute NHLBI) Purpose Division Blood Diseases Resources within National Heart, Lung, Blood Institute NHLBI) intends promote new initiative publishing Funding Opportunity Announcement FOA) solicit applications the following: Generate Intergenerational Precision Medicine Resource the Study Factor VIII Immunogenicity Severe Hemophilia A: Biospecimen Data Resource Center, (U24 Resource-Related Research Projects - Cooperative Agreement). Notice Intent Publish NOITP) being provided allow potential eligible applicants sufficient time develop competitive responsive milestone-driven scientific projects thus prepare applicants the timely submission an application. anticipated FOA utilize the U24 Resource-Related Research Projects - Cooperative Agreement activity code issue single award up seven years the Biospecimen Data Resource Center will provide data management, laboratory, biospecimen support necessary establish anticipated FOA, Intergenerational Precision Medicine Resource the Study Factor VIII Immunogenicity Severe Hemophilia A”. role the Biospecimen Data Resource Center to provide overall project coordination, administration, data biospecimen management, biostatistics/data analytics support, well laboratory including multi-omics) biorepository expertise development this unique resource. companion award the Clinical Coordinating Center UG3/UH3)(see NOT-19-HL-726) anticipated be in parallel the Biospecimen Data Resource Center to allow the establishment this unique biospecimen resource. Clinical Coordinating Center FOA provide investigators the opportunity propose design a unique Intergenerational Precision Medicine Resource, derived a de novo antenatal/ neonatal pediatric cohort severe hemophilia and annotated robust intergenerational clinical demographic data, the purpose enabling future mechanistic translational studies factor VIII immunogenicity tolerance. key characteristic the Biospecimen Data Resource Center application be completion core milestones. core milestone defined a scheduled event the project timeline signifies completion a major project stage activity. Milestones must performance-based achieve completion the Intergenerational Precision Medicine Resource on time on budget must established align the bi-phasic mechanism the Clinical Coordinating Center award. Milestones must established both first three years coinciding the UG3 phase the Clinical Coordinating Center award) subsequent four years coinciding the UH3 phase the Clinical Coordinating Center award) the project. Satisfactory completion the milestones the first three years be assessed administratively NHLBI determine eligibility continue award. Due the collaborative parallel nature these FOAs, NHLBI enter negotiation the Biospecimen Data Resource Center achieve early phase-out the award Clinical Coordinating Center and/or Biospecimen Data Resource Center progress deemed inadequate upon NHLBI administrative review. Details the planned FOA provided below. Research Initiative Details planned Funding Opportunity Announcement FOA) support applications a Biospecimen Data Resource Center will support development an Intergenerational Precision Medicine Resource the study factor VIII immunogenicity hemophilia by providing expertise relevant laboratory including multi-omics) methodology, biorepository science, data science, bioinformatics, complex statistical including trans-omics) analysis, project management, administrative support. Biospecimen Data Resource Center applications be expected demonstrate required scientific laboratory expertise response capability lead coordinate rapid collection, quality control QC), well implementation scientifically-prioritized tissue blood biospecimen acquisition protocols storage distribution procedures. Responsive applications emphasize on-site and/or collaborative scientific laboratory expertise multi-omics, immunology, microbiology coagulation science; expertise biorepository science collection, processing, shipping, storage all types liquid tissue biospecimens); expertise the management microtechnological assay small volume specimens derived neonates children; the capability dispatch oversee expert specimen collection well timely processing the field. Biospecimen Data Resource Center also provide centralized, facilitated approaches complex data management integration, QC procedures, data integrity security, the necessary statistical support ensure conduct well-designed precision medicine studies timely large data including trans-omics) analysis. data collection overseen the Biospecimen Data Resource Center be expected adhere FAIR Findable, Accessible, Interoperable, Reusable) principles ensure transparency, reproducibility, reusability Wilkinson MD, et al., Scientific Data 2016), use standard protocols supported through NIH PhenX toolkit https://www.phenxtoolkit.org), to incorporate appropriate well-validated patient-reported outcome PRO) measures supported through, comparable those supported through NIH Toolbox http://www.healthmeasures.net/explore-measurement-systems/nih-toolbox). Responsive applications must therefore demonstrate requisite data science, bioinformatics, analytic including integrative omics analytics) epidemiological expertise, well experience coordinating conduct multiple multicenter studies maternal/fetal, neonatal and/or pediatric populations. Responsive applications must also demonstrate relevant biostatistical expertise experience the design intergenerational studies, experience the integrative analyses large datasets include multi-omics data; project management expertise coordinating managing large multicenter studies the target populations; laboratory biorepository science expertise; requisite expertise support complex big data biospecimen tracking management; the capacity development maintenance a study coordination web site. Biospecimen Data Resource Center be supported parallel a companion Clinical Coordinating Center see NOT-19-HL-726 for specific goals be achieved through establishment this Intergenerational Precision Medicine Resource). Applicants be expected propose milestone-driven activities support, collaboration the Clinical Coordinating Center: initial three-year phase the project including, not limited to: scientific operational Intergenerational Severe Hemophilia Precision Medicine Resource protocol development; development implementation the Resource’s Operating Procedures, data biospecimen management tracking systems, a study coordination web site; conduct laboratory pilot studies; development manual procedures didactic preparation sites implement feasible scientific operational procedures data collection quality control; development manuals procedures didactic preparation materials implement feasible scientific operational procedures biospecimen collection, processing, testing, shipping, storage; Development implementation procedures provide data, laboratory, biospecimen management support clinical sites will enrolling following participants during three-year phase. second four-year phase the project include, not limited to: Full implementation all procedures provide data, laboratory biospecimen management support clinical sites will enrolling following participants; Complete collection the protocol data biospecimens the final build a sharable fully annotated biorepository; Data analysis dissemination findings; Submission the public-use data biospecimens the NIH repository resources. Funding Information Estimated Total Funding 1,343,000 total costs Expected Number Awards 1 Estimated Award Ceiling 872,000 direct costs Primary CFDA Numbers 93.839 Anticipated Eligible Organizations Public/State Controlled Institution Higher Education Private Institution Higher Education Nonprofit 501(c)(3) IRS Status than Institution Higher Education) Small Business For-Profit Organization than Small Business) State Government Indian/Native American Tribal Government Federally Recognized) County governments Independent school districts Public housing authorities/Indian housing authorities Indian/Native American Tribally Designated Organization Native American tribal organizations than Federally recognized tribal governments) U.S. Territory Possession Indian/Native American Tribal Government than Federally Recognized) Regional Organization Applications not being solicited this time.  Inquiries Please direct inquiries to: Iman K. Martin, PhD, MPH, MSNational Heart, Lung, Blood Institute NHLBI)301-435-0065FactorVIII@DBDR.NIH.NHLBI.gov