Solicitation Description

The DxR2 program will solicit new point of care/remote-use products with domestic manufacturing capabilities which address test development for Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) biothreats to include glanders, botulism, tularemia, typhus, smallpox, and plague.

The overall goals of this program are to build a biothreat diagnostic portfolio, maintain domestic test manufacturing facilities, and to enable just-in-time manufacturing practices to be able to rapidly produce biothreat tests and needed supplies at scale, and to achieve aggressive test delivery schedules. The first phase of the DxR2 program will focus on the development and regulatory clearance of biothreat tests, and design transfer to manufacturing activities, such as limited production runs for validation, quality checks, stability studies, early adopter training, and manufacturing capacity studies. Additional phases may be added dependent upon program progress and available funding.

Submission Information

All RRPV submissions must be submitted to the BARDA Digital Resources (BDR) RRPV Portal. Offerors may submit, or re-submit, in advance of the deadline. Neither the Government nor the RRPV CMF will make allowances/exceptions for submission problems encountered by the Offeror using system-to-system interfaces. If the Offeror fails to submit the full submission prior to the deadline, the submission may not be accepted. It is the Offeror’s responsibility to ensure a timely and complete submission. Failure to propose your submission on time for any reason may result in the submission not being considered for award.

The account request process is simple but may take several days for approval and access. To request a BDR RRPV Portal account (first-time user), please contact the RRPV (RRPV@ati.org) and provide a set of basic information (first and last name, email address, and phone number, member organization). Once access to the BDR RRPV Portal account has been confirmed, the Offeror will log in to the Portal (www.rrpv.hhs.gov) using the prescribed two-factor authentication method. Once login is complete, the Offeror will be prompted to verify their user information and basic organization-related data. To request changes to your contact information, please contact RRPV (RRPV@ati.org). The Offeror will then be able to start a new submission and will be prompted to input the submission with other project-specific information. Offerors will be provided an automated confirmation of successful submission of a Proposal.

Documentation and reference materials for the BDR RRPV Portal are available to RRPV Member Organizations from the RRPV Members Only Site (for new users, request access here), and upon request from RRPV@ati.org.

Proposers Conference

A Proposers Conference was held on June 5, 2025 to discuss the Biothreat Diagnostic Rapid Response RPP.

Solicitation Details

Original RPP Release:

Phase 2 Issued: 29 May 2025

Due: 14 July 2025 by 1pm EST

Q&A Due: 12 June 2025