RRPV Solicitation Summary: Central Influenza and Emerging Infectious Diseases Vaccine Immunogenicity Laboratory Services
ID: RPP-24-07-CentralIEIDLabType: Special Notice
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFWashington, DC, 20201, US

NAICS

Research and Development in Biotechnology (except Nanobiotechnology) (541714)

PSC

HEALTH R&D SERVICES; HEALTH CARE - OTHER; APPLIED RESEARCH (AN42)

Original Source

https://sam.gov/opp/98e342e3d3c4446c98e1a4f60b8088bf/view
Timeline
    Description

    The Department of Health and Human Services, through the Biomedical Advanced Research and Development Authority (BARDA), is soliciting proposals for the establishment of Central Influenza and Emerging Infectious Diseases Vaccine Immunogenicity Laboratory Services under Solicitation Number RRPV 24-07-CentralIEIDLab. This initiative aims to enhance national health security by developing medical countermeasures against influenza pandemics and emerging infectious diseases, with a focus on conducting immunoassays to support vaccine research and clinical trials. The selected offeror will play a crucial role in bolstering biodefense infrastructure, ensuring readiness for public health emergencies through standardized laboratory practices. Proposals are due by May 30, 2025, with questions accepted until April 24, 2025; interested parties can contact Rebecca Harmon at rebecca.harmon@ati.org for further information.

    Point(s) of Contact
    Rebecca Harmon
    rebecca.harmon@ati.org
    Files
    Title
    Posted
    24-07-CentralIEIDLab_QandA_2025.05.05.xlsx
    The document outlines questions and responses related to a Request for Proposals (RFP) issued by BARDA, focusing on requirements for testing human clinical samples at Central Labs. Key inquiries include compliance standards (GCLP vs. GLP), the necessity for eCTD format submissions, audit frequencies, proficiency testing for assays, and the clarification of acronyms. It emphasizes that both governmental and commercial past performances will be considered for proposals, and it specifies requirements for certain influenza assays. The document clarifies that proposals must include costs for a 10-year period, details on personnel submissions, and various components of the Technical Proposal. Mandatory eligibility criteria and submission guidelines are underscored, including limitations on document attachments. The RFP mandates that cost-sharing is expected if assays developed with USG funding are used for commercial purposes. This comprehensive set of guidelines is critical for ensuring that potential offerors understand the expectations for proposal submissions, ultimately aiming to enhance public health preparedness against influenza through well-defined and regulated laboratory practices.
    RRPV-RPP-24-07-CentralIEIDLab_Amd02.docx
    The Biomedical Advanced Research and Development Authority (BARDA) seeks proposals under Solicitation Number RRPV 24-07-CentralIEIDLab for the establishment of a Central Influenza and Emerging Infectious Diseases Vaccine Immunoassay Laboratory. This initiative is geared towards enhancing national health security through the rapid development of vaccines in response to potential pandemics. The laboratory will conduct immunoassays to support vaccine research and clinical trials, ensuring readiness for high pathogenicity avian influenza and other infectious diseases. The RFP outlines the administrative and technical requirements for submission, including mandatory eligibility criteria and specific capabilities in assay development and testing. Offerors must demonstrate prior experience, provide validation reports, and outline partnerships necessary for fulfilling additional capability areas. Key dates include the proposal deadline on May 30, 2025, with prior questions due by April 24, 2025. Proposals are evaluated based on a Full Technical Proposal and Full Cost Proposal approach, emphasizing the importance of relevant experience and a comprehensive project management plan. Additionally, BARDA encourages small business participation. The successful applicant will play a vital role in bolstering biodefense infrastructure through the provision of efficient, standardized immunoassay laboratory services.
    RRPV-RPP-24-07-CentralIEIDLab_Amd03 posted.docx
    The Biomedical Advanced Research and Development Authority (BARDA) has issued a Request for Project Proposals (RPP) under solicitation number RRPV 24-07-CentralIEIDLab. This solicitation seeks proposals for Central Influenza and Emerging Infectious Diseases Vaccine Immunoassay Laboratory Services. The aim is to enhance national health security by developing medical countermeasures against influenza pandemics and emerging infectious diseases. Key activities involve partnering with laboratories to conduct immunoassays for vaccine trials, validating immune assays for various viral strains, and ensuring readiness for public health emergencies. Offerors must be RRPV Consortium members with experience in immunoassay testing and must meet specific eligibility criteria to submit proposals. The anticipated performance period spans up to ten years, and selected proposals will undergo evaluation based on government priorities. Proposal submissions must strictly adhere to specified formats and deadlines, with a focus on cost-sharing and leveraging resources. Key capabilities outlined in the RPP include developing, qualifying, and performing various immunoassays, conducting concordance studies, and technology transfer related to assay processes. Overall, this initiative seeks to optimize immune assay development and testing to support vaccine development and regulatory approvals, ultimately strengthening the U.S.'s readiness against contagious threats.
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