Soon to be Issued Funding Announcement for All of Us Genome Centers (OT2)

Notice Number: NOT-PM-18-002

Key Dates

Release Date: March 16, 2018
Estimated Publication Date of Funding Announcement: May 2018
First Estimated Application Due Date: July 2018
Earliest Estimated Award Date: August 2018
Earliest Estimated Start Date: September 2018

Related Announcements
NOT-PM-18-003

Issued by
National Institutes of Health (NIH)

Purpose

The National Institutes of Health intends to issue a funding announcement (FA) to solicit applications for large-scale Genome Centers to generate genomic data as part of the All of UsResearch Program. The All of Us Research Program seeks to create one of the world’s largest and most comprehensive precision medicine research platforms with a data resource containing multi-layered data on 1 million or more participants. The All of Us Genome Centers will be funded to generate both genotyping and whole genome sequencing data from biospecimens from this cohort. These Centers also will operate an analysis workflow resulting in high-confidence calling of all variant types (single nucleotide variants, small insertions/deletions, larger structural variants) and establish a robust pipeline to securely transmit data to the All of Us Data and Research Center.

The All of Us Research Program currently is in an enrollment beta phase in preparation for launching nationwide in the spring of 2018. It is anticipated that 100,000 persons will consent to participate and provide DNA for analysis by the end of this year, with 1 million or more participants within the next 5 years. Primary goals for the All of Us genomics platform, anchored by the large-scale Genome Centers, are to 1) develop the capacity and rigor necessary to achieve unprecedented scale of genomic data generation, up to 200,000 genome-wide assays per year, 2) generate high quality genotyping and genome sequence data, with state-of-the-science variant calling, as a crucial data element for the All of Us research resource, 3) provide comprehensive variant data to fuel analysis workflows for return of information to the participants in the program, 4) contribute to the advancement of technologies and approaches for population-scale genome analysis, 5) establish strong collaborative relationships among all investigators in the All of Us genomics platform, and 6) contribute to strategic direction of the program as members of All of Us consortium governance.

All of Us Genome Center Awards are anticipated for FY18 and the timeline for FA publication, application preparation, NIH review, and establishment of awards is abbreviated. This Notice is being provided to allow potential applicants sufficient time to develop meaningful collaborations and responsive applications.

The FA will use the OT mechanism and is subject to changes in timing and appropriation of funds.

Research Initiative Details

This Notice encourages organizations with substantial large-scale genomic data generation capabilities to begin to consider applying for this new FA. Applicants will be required to demonstrate prior experience in large-scale genotyping, genomic sequencing, and genome analysis. Furthermore, a viable strategy to achieve the scale required by the All of Us Research Program must be provided. Throughput requirements described below represent 50% of anticipated capacity of the program in its entirety. Throughput requirements for individual Genome Centers will be dependent on the total number of awards. All of Us Genome Center requirements are expected to include:
  • Annual throughput of 50,000 high-density genotyping arrays immediately following award,
  • Description of approach to ramp up to at least 100,000 genotyping assays annually,
  • Annual throughput of 10,000 whole genome sequencing assays immediately following award,
  • Description of approach to ramp up whole genome sequencing assays to as many as 100,000 per year,
  • Genome analysis and variant calling resources to process >100,000 genome-wide assays per year,
  • A laboratory certified and fully compliant with Clinical Laboratory Improvement Amendment (CLIA), with sufficient resources within this CLIA environment to achieve required throughput,
  • Description of analysis approaches and resources to interpret variant pathogenicity and clinical significance,
  • Sufficient computer storage and infrastructure to securely manage and transmit >100,000 genome-wide data sets annually.
The All of Us genomics platform will include a clinical validation laboratory to verify certain clinically-actionable variants using CLIA/CAP certified assays and including generation of a clinical report. Capabilities to operate the clinical validation laboratory will be an optional project element in applications for Genome Centers.

Awardees will be expected to participate in the existing All of Us governance structure and to work with NIH staff to understand stakeholder relationships, activities, opportunities and needs, including approaches for the responsible return of genomic results to All of Us participants.

The link to this OT FA may be accessed through the Current Opportunities Funding page at http://allofus.nih.gov .

Anticipated Eligible Organizations

The opportunity is open only to organizations with facilities within the U.S.A. or its territories. Consortia are eligible and encouraged.

APPLICATIONS ARE NOT BEING SOLICITED AT THIS TIME.

Inquiries

Please direct all inquiries to:

All of Us Genomics Team
Email: PMICPFOAInquiries@mail.nih.gov