Research Opportunity Announcement (ROA): All of Us Biobank

Overview: The All of Us Research Program, within the Office of the Director (OD) at the National Institutes of Health (NIH), has issued a research opportunity announcement to solicit proposals. A ROA is a method of solicitation that announces the anticipated availability of Other Transactions (OT) awards, a special type of legal instrument other than contracts, grants, or cooperative agreements.

Purpose: The purpose of this announcement is to fund one award that will maintain the existing biobank specimens and expand the All of Us Biobank to support the biospecimen collections, processes, workflows, methods, services, long-term storage, access and distribution of high-quality diverse biospecimens leading to the generation and dissemination of data derived from these samples.

This Research Opportunity Announcement (ROA) processes include three phases for the submission, downstream review and evaluation, and selection of one proposal. These phases aim to identify a proposer that has, or can readily, transit, maintain and sustain the All of Us Biobank operations within 12 months of award, and is also capable of innovating and applying novel or emerging technologies, techniques, and processes to fulfill the scope described herein. The three phases include the following:

Phase I – Submission and Evaluation of Full Technical Proposal Phase II – Biospecimen Laboratory, Storage and Research & Development Capabilities Demonstration and Evaluation and Cost/Budget Proposal Submission (Invitation Only) Phase III – Negotiation and Other Transactions (OT) Award (Invitation Only) The NIH intends to down-select at each phase resulting in making one OT award in Phase III. Depending on program requirements, the NIH reserves the right to omit Phase II Biospecimen Laboratory, Storage and Research & Development Capabilities Demonstration and Evaluation, and/or to combine the Phase submissions, as needed.

Award Project Duration: Award periods are anticipated to be up to five (5) years but may be shortened or extended as needed.

Pre-Submission Webinar: A webinar will be conducted on 03 December 2024 at 1:00 pm EST. All attendees are required to register. Registration will remain open until the webinar end time.

Questions to be addressed during the webinar must be emailed to AllofUsDCDAwardRequirements@nih.gov by 25 November 2024, 10:00 a.m. EST. Letter of Intent NIH is requesting that proposers who intend to submit a proposal in response to this ROA complete the Intent to Submit Proposal Form (Appendix B) and submit it to AllofUsDCDAwardRequirements@nih.gov by 09 December 2024, 10:00 a.m. EST. Although a letter of intent is not binding and does not enter into the review of a subsequent proposal, the information that it contains allows the All of Us Research Program to estimate the potential review workload and plan the review.

Documents and Related Links: The full ROA package is attached in the 'Attachments/Links' section. Potential proposers are encouraged to carefully review the announcement before submitting questions and/or letters of intent. A link to the All of Us Research Program webpage has been provided for additional information about our program. AMENDMENT 2 - DECEMBER 18, 2024 - This announcement has been revised as follows:

1. 8.1.5 Proposal Review/Evaluation Process and Selection 2. Frequently Asked Question (FAQ) Document - an updated FAQ document with questions and answers has been uploaded under the ‘Attachments/Links’ section for the Biobank ROA. AMENDMENT 1 - DECEMBER 12, 2024 - This announcement has been revised as follows:

1. 8.1.2 Proposal Format – the ‘Appendix 1: Key Personnel NIH Biosketches and Resumes’ content has been revised.

2. 8.1.3 Proposal Content - the Key Personnel content has been updated.

3. Webinar Slides and Recording - the presentation slides and recording have been uploaded under the ‘Attachments/Links’ section.

4. Frequently Asked Questions (FAQ) Document - a FAQ document with questions and answers has been uploaded under the ‘Attachments/Links’ section for the Biobank ROA.