Research Opportunity Announcement (ROA): NIH All of Us Engagement, Communications, and Enrollment Partnerships

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Research Opportunity Announcement (ROA) Title: All of Us Engagement, Communications, and Enrollment Partnerships

ROA Number: OTA-22-006

ROA Open Period: May 26, 2022 to May 23, 2025 (Note: open period includes multiple white paper deadlines)

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 white papers supporting various Areas of Interest (AOIs). 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 All of Us Research Program is a historic effort to gather data from at least 1 million people, with the goal of accelerating health research and medical breakthroughs, and enabling individualized prevention, treatment, and care. The program is creating a national research resource to inform thousands of studies, covering a wide variety of health conditions. Researchers will use data from the program to learn more about how individual differences in lifestyle, environment, and biological makeup can influence health and disease.

The purpose of this announcement is to fund organizations who can help All of Us build its cohort of volunteers who reflect the rich diversity of the United States and are actively engaged as partners. These funded organizations will help design and implement strategies to raise awareness of the program through community and health care provider organizations, drive increased enrollment of participants, foster regular communication with participants, and engage the research community to use the data being gathered.

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

White Paper Deadlines: This ROA will remain open for three (3) years from its issue date, unless otherwise updated via an amendment, and includes multiple white paper (WP) submission deadlines. All WP deadline times are 3:00 PM Eastern Time:

Calendar Year 2024 WP Deadlines

August 30, 2024

Calendar Year 2025 WP Deadlines

February 28, 2025

May 23, 2025

Documents and Related Links: The full ROA package is attached in the 'Attachments/Links' section. Potential offerors are encouraged to carefully review the most recent updates to the announcement and attachments before submitting questions and/or preparing a white paper submission. A link to the All of Us Research Program webpage has been provided for additional information about our program.

AMENDMENT 9- January 17, 2025-The updates for Amendment 9 are detailed

in Section 11 - SUMMARY OF CHANGES to the Amendment 8 ROA Attachment. An updated Questions and Answers Template has also been added.

PLEASE NOTE: Please review all of the requirements to ensure Technical Assessment Papers (formerly known as White Papers) comply with all of the ROA Requirements.

AMENDMENT 8 - January 8, 2025-The updates for Amendment 8 are detailed in Section 11 - SUMMARY OF CHANGES to the Amendment 8 ROA Attachment. An updated Questions and Answers Template has also been added.

PLEASE NOTE: Please review all of the requirements to ensure Technical Assessment Papers (formerly known as White Papers) comply with all of the ROA Requirements.

AMENDMENT 7- June 13, 2024-The updates for Amendment 7 are detailed in Section 11 - SUMMARY OF CHANGES to the Amendment 7 ROA Attachment. Revised Appendix A Sample Terms and Conditions has been added to the attachments section and Attachment 2, Questions and Answers Template has also been added.

PLEASE NOTE: For the August 30, 2024 submission date, Technical Assessment Papers (formerly known as White Papers) will only be accepted for submissions proposed against Area of Interest 3: Engagement with Tribal Nations, American Indian and Alaska Native populations, and Indigenous Communities.

AMENDMENT 6- December 19, 2023- The updates for Amendment 6 are detailed in Section 11 - SUMMARY OF CHANGES to the amendment 6 ROA Attachment. Revised Appendix A Sample Terms and Conditions has been added to the attachments section and Attachment 2, Questions and Answers Template has been added.

AMENDMENT 5 - MAY 18, 2023- The updates for Amendment 5 are detailed in Section 11 - SUMMARY OF CHANGES to the amended ROA.

AMENDMENT 4 - FEBRUARY 3, 2023 - The updates for Amendment 4 are detailed in Section 11 - SUMMARY OF CHANGES to the amended ROA.

AMENDMENT 3 - OCTOBER 4, 2022 - The updates below are included in Amendment 3. Please review Section 11-SUMMARY OF CHANGES of the amended ROA for complete details.

AMENDMENT 2 - JULY 29, 2022 - The updates below are included in Amendment 2. Please review Section 11-SUMMARY OF CHANGES of the amended ROA for complete details.

The second paragraph of Section 2.2-Questions been revised to provide additional instructions for question submission.

The first paragraph of Section 2.3-Amendments has been revised to include general information on how to receive automated notifications from SAM.gov when updates are made to this ROA.

Section 3.2.1-Anticipated Funding has been amended to clarify the funding amounts that may be available per award, per year.

The fifth bullet in Section 5.1.3-Technical Approach, Task 2, under Area of Interest 1, has been revised to remove "in Observational Medical Outcomes Partnership (OMOP) format."

A PDF of the June 27, 2022 webinar slide deck has been added to the ‘Attachments/Links’ section of the SAM.gov announcement; the document is labeled “Amendment2_OTA22006_Attach1_Webinar Slides 06.27.2022”

Answers to questions received from potential offerors via the All of Us ROA Inquiries email, between May 26, 2022 and July 6, 2022, and during the June 27, 2022 webinar, are included in this amendment. A PDF of the Q&A list has been added to the ‘Attachments/Links’ section of the SAM.gov announcement; it is labeled “Amendment2_OTA22006_Attach2_QAs 05.26.2022-07.06.2022”

Section 8.1 Pre-Submission Webinar - now includes the links to the June 27, 2022 pre-submission webinar briefing slides and videos.

Section 8.3.1 Full Proposal Format - the page limit has been updated from 27 pages to 31 pages to accommodate the addition of the new Abstract and Specific Aims requirements.

Section 8.3.2 Full Proposal Content - language has been added to accommodate the addition of the new Abstract and Specific Aims requirements.

The Offers Due Date has been updated: FROM: August 31, 2022; TO: November 30, 2022

Links to the video of the June 27, 2022, webinar has been added to the ‘Attachments/Links’ section of the SAM.gov announcement.

Answers to questions received from potential offerors via the All of Us ROA Inquiries email, between May 26, 2022 and August 17, 2022, are included in this amendment. A PDF of the Q&A list has been added to the ‘Attachments/Links’ section of the SAM.gov announcement; it is labeled “ROA OTA-22-006_AMENDMENT 3_ATTACHMENT 2_QAs”

A revised ‘Appendix A’ (Terms and Conditions Template) is now accessible in the ‘Attachments/Links’ section of the SAM.gov posting as a separate PDF document

AMENDMENT 1 - JUNE 2, 2022 - This announcement has been revised as follows:

Section 8.1 of the ROA document now includes the time of the June 27, 2022 pre-submission webinar and the registration link.

The ROA document and its 'Appendix A' (Terms and Conditions Template) have been separated; they are now accessible in the 'Attachments/Links' section of this announcement as separate PDF documents.

The registration link to the June 27, 2022 pre-submission webinar has been added to the 'Attachments/Links' section of this announcement.

Attachments/Links