Solicitation - BARDA Accelerator Network 2.0

The Office of Biomedical Advanced Research and Development Authority (BARDA), within the Administration for Strategic Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS) seeks to establish partnerships to build the next iteration of the BARDA Accelerator Network (BAN 2.0) using BARDA’s Other Transaction Authority to foster the health security innovation ecosystem with commercialization and wrap-around support and to enable rapid development, evaluation, validation, and commercialization of medical countermeasures.

With BAN 2.0, BARDA aims to further enhance the global health security innovation ecosystem, optimize startup acceleration and wrap-around services, and ultimately develop the Accelerator Network as a scalable infrastructure for commercialization including active product development support, and validation capabilities during regular operations as well as rapid response during public health emergencies.

BARDA envisions that BAN 2.0 will support BARDA’s mission by addressing the following objectives/tasks: Support health security innovators, startups, and existing BARDA partners already receiving BARDA funding (“BARDA funded partners”) by providing wraparound accelerator services including entrepreneurship education and access to technical and business/commercialization expertise and resources.

Provide BARDA with capabilities to source, review, fund, and accelerate startups and perform product development, evaluation, and validation of MCMs based on BARDA’s strategic priorities. Build a rapid emergency response infrastructure to fund and accelerate product development and validation of MCMs that can be developed and deployed as quickly as possible in the event of a public health emergency.

BARDA intends to enter into other transaction agreements with five or more Accelerator Hub organizations with each Accelerator Hub providing resources and support focused on one of the following Technology Areas: Therapeutics/Vaccines Diagnostics/Medical Devices Digital Health Enabling Technologies (e.g., Biomanufacturing/Drug Development/Clinical Support) Special Populations (e.g., Pediatrics, low resource settings) Submissions are due at 12:00PM ET on the due dates listed below for each technology area.

BARDA may adjust the closing date for submissions under any of the following technology areas through amendment of this notice. Diagnostics/Medical Devices on September 15, 2023, with the intent to make an award within 90-120 days of the proposal due date. Therapeutics/Vaccines on October 2, 2023, with the intent to make an award within 90-120 days of the proposal due date. Enabling Technologies on October 2, 2023, with the intent to make an award within 90-120 days of the proposal due date.

Digital Health on January 12, 2024, with the intent to make an award within 90-120 days of the proposal due date. Special Populations (e.g., Pediatrics, Immunocompromised, Low Resource Settings) on January 12, 2024, with the intent to make an award within 90-120 days of the proposal due date. Additional information is available in the attached solicitation documents. Additionally, please visit https://drive.hhs.gov/.

Amendment 01: BARDA DRIVe will be hosting a Proposer's Day on August 30, 2023 from 1:30p-3:00p ET. The purpose of this event is to provide an overview of the solicitation requirements and allow interested parties to ask questions. Questions are to be submitted in advance of the event and will be addressed live. Please submit questions using the 'Questions & Comments' box within the zoom registration form. Advance registration via the following link is required to attend: https://aspr.zoomgov.com/webinar/register/WN_ltzQQdMITTSxvpRZjWjdHw.

Amendment 02: The purpose of this amendment is to do the following:

1) Provide the presentation slide deck from the Proposers' Day webinar event 2.) Update Attachment 2 - FAQ for BAN 2.0 Solicitation as Revision 1. 3.) Update the BARDA Accelerator Network 2.0 - Solicitation Removed reference to the Rapid Response Capability Activation Plan (Line 217 of the original solicitation published July 26, 2023) No additional updates to the solicitation.

Amendment 03: The purpose of this amendment is to do the following:

Extend the due date for Diagnostics/Medical Devices technology area. Proposals for Diagnostics/Medical Devices are now due September 18, 2023 at 9:00AM ET.

Amendment 04: The purpose of this amendment is to provide an updated Attachment 2 - FAQ for BAN 2.0 Solicitation as Revision 2.

Amendment 5: The purpose of this amendment is to revise the solicitation close date to February 29, 2024. The submission due date of 12:00pm ET, January 12, 2024 for the Special Population and Digital Health hub is unchanged under this amendment.

Amendment 6: The purpose of this amendment is to re-open the submission period for the Enabling Technologies focus area. Please reference the attached document 'Attachment 3_Enabling Technologies_Reopening of Submissions' for updated information on the efforts BARDA is seeking in the Enabling Technologies focus area for Wraparound Accelerator Services, DEV Services, and Rapid Response Capability. Please submit proposals by 12:00PM ET March 25, 2024.

Amendment 07: The purpose of this amendment is to provide an updated Attachment 2 - FAQ for BAN 2.0 Solicitation as Revision 3.