Solicitation Description

To address a capability readiness gap that has been identified within BARDA’s product portfolio responding to a viral pandemic event, BARDA is seeking to partner with laboratories with existing capabilities to perform centralized immune assays using samples collected from nonclinical studies and from subjects enrolled in influenza, SARS-CoV, and emerging infectious disease vaccine clinical trials conducted under the U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) applications and to perform cross-reactive immune response testing of clinical samples for pandemic preparedness and response.

Data from these assays may be used in primary, secondary, and exploratory endpoint analyses for vaccine clinical trials, cross-reactivity testing for pandemic readiness and response purposes, or perform correlates of protection analyses. Data may be used to support a U.S. FDA Emergency Use Authorization (EUA) or a Biological License Application (BLA).

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.

Solicitation Details

Q&A Release:

Issued: 28 June 2024

Includes: Questions #1-24

Amendment 01 Release:

Issued: 28 June 2024

Due: 15 July 2024, by 1PM Eastern

Changes: Provides an update to Attachment 2: BARDA’s Document QC Guide.  A copy of this document will be provided after award and kick-off meeting. BARDA’s Regulatory Operations will share and train on “BARDA’s Document QC Guide”, which has direct impact on FDA submissions.

Original RPP Release:

Issued: 14 June 2024

Due: 15 July 2024, by 1PM Eastern

Original RPP Release