Research Opportunity Announcement (ROA): All of Us Biobank
ID: OTA-25-002Type: Solicitation
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFNATIONAL INSTITUTES OF HEALTHNIH OFFICE OF THE DIRECTORBethesda, MD, 20892, USA

NAICS

Research and Development in the Social Sciences and Humanities (541720)

PSC

COMMUNITY & REGIONAL DEVELOPMENT R&D SVCS; AREA & REGIONAL DEVELOPMENT; EXPERIMENTAL DEVELOPMENT (AB23)

Original Source

https://sam.gov/opp/4eac2ee5bbd14675a4a977ea917cbe0d/view
Timeline
    Description

    The National Institutes of Health (NIH) is soliciting proposals through a Research Opportunity Announcement (ROA) for the All of Us Biobank, aimed at enhancing the collection, processing, and distribution of high-quality biospecimens from a diverse participant pool to support biomedical research. The initiative seeks to fund one award that will maintain existing biobank specimens and expand operations to support the collection and dissemination of diverse biospecimens, with a focus on innovative technologies and methods. This program is critical for advancing health research and improving health equity by collecting data from historically underrepresented groups, with anticipated funding ranging from $13 million to $50 million over a potential five-year period. Interested proposers must submit a Letter of Intent by December 9, 2024, and can direct inquiries to AllofUsDCDAwardRequirements@nih.gov.

    Point(s) of Contact
    All of Us DCD Award Requirements
    allofusdcdawardrequirements@nih.gov
    Files
    Title
    Posted
    All of Us Biobank - Amendment 1.pdf
    The National Institutes of Health (NIH) announced an amendment to the Research Opportunity Announcement (ROA) for the "All of Us Biobank" program, identified as OTA-25-002, issued on December 13, 2024. Key changes include revisions to the proposal format and key personnel requirements. The updated format allows for expanded NIH biosketches for key personnel, with a four-page limit for the Principal Investigator or Program Manager, and a two-page resume for other key personnel, which do not count toward the overall page limit. Changes to the key personnel section clarify that at least one Principal Investigator or Program Director, along with one Program Manager, are mandatory. Proposed levels of effort for key roles must also be included. Additionally, resources such as webinar slides and an FAQ document have been made available under the “Attachments/Links” section of the ROA. All other existing requirements of the ROA remain unchanged. This amendment is vital for guiding proposals related to the Biobank, fostering a robust research environment consistent with current standards and expectations.
    All of Us Biobank - Amendment 2 December 18 2024.pdf
    All of Us Biobank - FAQs.pdf
    The National Institutes of Health (NIH) has released a Frequently Asked Questions (FAQ) document regarding the Biobank Research Opportunity Announcement (ROA) as part of the All of Us Research Program. This document addresses inquiries from potential proposers concerning the requirements and submission guidelines for the ROA. Key points include that proposers can include newly hired directors in their Phase I submission, are permitted to submit Letters of Support (limited to three pages), and must compile all required documents in a single proposal via eRA ASSIST. Additionally, the document outlines current and future automation standards for biospecimen collection, emphasizing the importance of automation for processing high-volume samples, enhancing accuracy and efficiency, and the anticipated role of artificial intelligence in optimizing biobank operations. This FAQ serves as a vital resource for applicants navigating the grant process, demonstrating the NIH's commitment to transparency and support within federally funded research initiatives.
    All of Us Biobank - FAQs - 2 December 18 2024.pdf
    All of Us Biobank - ROA Webinar_Slides.pdf
    The "All of Us Research Program Research Opportunity Announcement (ROA) No. OTA-25-002" outlines a new initiative to enhance the All of Us Biobank, aimed at collecting and distributing high-quality biospecimens from a diverse participant pool to accelerate health research. The program seeks to enroll over 1 million participants reflecting U.S. diversity and aims to process and manage extensive biospecimen collections, focusing on blood, saliva, and urine. The ROA provides a comprehensive overview, including the program's mission, strategic goals, and success metrics, emphasizing participant engagement, data security, and quality management. The proposed program structure comprises teams for laboratory operations, biospecimen research development, logistics, and training. Phases guide competitors through proposal submission, evaluation, and potential endorsement. Additional details cover logistical planning for specimen collection, adherence to regulatory compliance, and sustainable practices for biobanking operations. With a budget scope ranging from $13 to $50 million, the initiative encourages innovation and infrastructure expansion, prioritizing diverse and sustainable research collaborations. This ROA serves to stimulate valuable partnerships and improve public health outcomes based on cutting-edge research practices.
    All of Us Biobank Appendix A- Terms and Conditions.pdf
    The document outlines an Other Transactions Agreement between the National Institutes of Health (NIH) and a recipient institution, focusing on support for the All of Us Research Program. This program aims to collect health data from over a million diverse individuals to advance research and healthcare customization. The document specifies the agreement's scope, defining the roles of the NIH and the recipient in both administration and management of the project. It establishes guidelines on funding, reporting requirements, data ownership, and rights to inventions and technologies developed under the agreement. Key components include obligations and payments, data rights, and procedures for managing disagreements or disputes. The NIH retains significant rights over the data collected and any inventions arising from the research, ensuring they can be utilized for governmental purposes without restrictions. The document emphasizes compliance with federal regulations throughout its provisions, including stipulations on human and animal subjects research. The agreement highlights NIH's commitment to enhancing health equity and improving understanding of health disparities through a collaborative, well-structured approach to ongoing research. This framework is vital for ensuring accountability and proper utilization of federal resources in advancing public health goals.
    All of Us Biobank Appendix B - Letter of Intent.pdf
    The document outlines the Intent to Submit Proposal Form for the All of Us Biobank initiative, referenced as ROA No.: OTA-25-002. Interested entities intending to submit proposals must provide specific information, including institutional name, address, contact details, and proposed staff details such as names and titles of Program Directors/Principal Investigators. Furthermore, it requires details of collaborating institutions and investigators, listing names, titles, and institutional affiliations of subrecipients or consultants involved in the project. The submission deadline for this letter of intent is set for December 9, 2024, at 10:00 AM Eastern Time. While the letter is non-binding and does not influence subsequent proposal evaluations, it assists the All of Us Research Program in determining potential review workloads for planning purposes. Interested applicants must send their completed forms via email to the specified address, ensuring the subject line includes the relevant ROA reference. This document serves as a crucial step in the government RFP process, facilitating the organization and assessment of proposals related to the All of Us Biobank research program, which aims to enhance health data collection and biomedical research.
    All of Us Biobank ROA.pdf
    The National Institutes of Health (NIH) has issued a Research Opportunity Announcement (ROA) for the All of Us Biobank under the All of Us Research Program, aiming to enhance the collection, processing, and distribution of high-quality biospecimens from a diverse cohort for biomedical research. The program seeks to enroll over 1 million participants, focusing on groups historically underrepresented in research. The ROA entails a competitive selection process in three phases: submission and evaluation of a technical proposal, demonstration of capabilities (invitation only), and negotiation for an Other Transactions (OT) award (invitation only). The anticipated funding for the initial award period could range between $13 million to $50 million, covering a year with options for four yearly renewals. Key responsibilities outlined include developing innovative biospecimen collection methods, maintaining robust logistics for biospecimen shipment, and ensuring comprehensive participant training. The Biobank will also expand its scope to support pediatric participants, implement reassessment processes for adult specimens, and enhance collaborations for ancillary studies. Overall, the program is designed to advance health research while upholding principles of diversity, transparency, and accessibility in research methodologies.
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    Research Opportunity Announcement (ROA): All of Us Biobank
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