October 13, 2022
RFA-HG-22-008 - Multi-Omics for Health and Disease - Disease Study Sites (U01 Clinical Trial Optional)
RFA-HG-22-009 - Multi-Omics for Health and Disease - 'Omics Production Centers (U01 Clinical Trial Not Allowed)
RFA-HG-22-010 - Multi-Omics for Health and Disease - Data Analysis and Coordination Center (U01 Clinical Trial Not Allowed)
NOT-HG-23-007 - Notice of Change in the Number of Disease Study Sites (DSSs) in RFA-HG-22-009 “Multi-Omics for Health and Disease - 'Omics Production Centers (U01 Clinical Trial Not Allowed)”
NOT-HG-23-008 - Notice of Change in the Number of Disease Study Sites (DSSs) in RFA-HG-22-010 “Multi-Omics for Health and Disease - Data Analysis and Coordination Center (U01 Clinical Trial Not Allowed)”
National Human Genome Research Institute (NHGRI)
The “Multi-Omics for Health and Disease Consortium” is a consortium involving three related RFAs (RFA-HG-22-008, RFA-HG-22-009, and RFA-HG-22-010). The purpose of this Notice is to correct the number of DSSs in RFA-HG-22-008 “Multi-Omics for Health and Disease - Disease Study Sites (U01 Clinical Trial Optional)” that will be funded as part of the Multi-Omics for Health and Disease Consortium. Text within the following two sections -- 1) Part 2. Section I. Funding Opportunity Description and 2) Part 2. Section IV. Application and Submission information (in bold italics) -- has been edited. The number of DSSs in RFA-HG-22-009 and RFA-HG-22-010 will be corrected in separate Notices (NOT-HG-23-007 and NOT-HG-23-008, respectively).
Answers to questions discussed during the recently held pre-application webinar, as well as the webinar recording and slides, are available at:https://www.genome.gov/event-calendar/pre-applicant-webinar-for-multi-omics-for-health-and-disease-consortium. They will further clarify the number of DSSs and provide additional details about the Consortium, including questions around the budget and sample size.
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Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Background and Objectives (Paragraph #5)
This FOA solicits applications to establish 4 DSSs.RFA-HG-22-009 and RFA-HG-22-010 will establish the OPC(s) and the DACC, respectively.
Section IV. Application and Submission Information
PHS 398 Research Plan (Paragraph #9)
Applicants should provide power calculations and justification for the number of participants with and without disease (while estimating the comparator group pooled, where appropriate, which would be approximately 400 participants without disease across 4 DSS, the range of effect sizes, the extent of multiple testing, the models to be tested, and the significance levels for testing, allowing for a justifiable rate of loss to follow-up. If the study design requires separate analysis of subject groups (e.g., phenotypic classes or ancestry groups) power analyses for each category should be provided.
Modified to read
Part 2. Full Text of Announcement
Section I. Funding Opportunity Description
Background and Objectives (Paragraph #5)
This FOA solicits applications to establish up to 6 DSSs.RFA-HG-22-009 and RFA-HG-22-010 will establish the OPC(s) and the DACC, respectively.
Section IV. Application and Submission Information
PHS 398 Research Plan (Paragraph #9)
Applicants should provide power calculations and justification for the number of participants with and without disease (while estimating the comparator group pooled, where appropriate, which would be up to 600 participants without disease across up to 6 DSSs), the range of effect sizes, the extent of multiple testing, the models to be tested, and the significance levels for testing, allowing for a justifiable rate of loss to follow-up. If the study design requires separate analysis of subject groups (e.g., phenotypic classes or ancestry groups) power analyses for each category should be provided.
All other aspects of the FOA remain unchanged.
Please direct all inquiries to:
Joannella Morales, Ph.D.
National Human Genome Research Institute (NHGRI)
Email: joannella.morales@nih.gov
and Human Services (HHS)
