Diagnostic Test Development and Production for Emergency Response
ID: 75D301-25-R-73207Type: Combined Synopsis/Solicitation
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFCENTERS FOR DISEASE CONTROL AND PREVENTIONCDC OFFICE OF ACQUISITION SERVICESATLANTA, GA, 30333, USA

NAICS

Testing Laboratories and Services (541380)

PSC

SUPPORT- PROFESSIONAL: OTHER (R499)

Original Source

https://sam.gov/opp/8da29c2cec7e4532ac9f0f439b12375d/view
Timeline
    Description

    The Department of Health and Human Services, specifically the Centers for Disease Control and Prevention (CDC), is seeking contractors for the development and production of diagnostic tests aimed at enhancing emergency response capabilities for public health threats. The procurement involves a range of tasks, including the rapid development and validation of Nucleic Acid Amplification Tests for selected pathogens, regulatory submissions for Emergency Use Authorization (EUA) or 510(k) approval, and the manufacturing of tests to meet outbreak demands. This initiative is critical for bolstering the national laboratory system's readiness and efficiency in addressing public health emergencies. Proposals are due by December 2, 2024, with a maximum contract value of $148 million and a minimum order of $10,000. Interested parties can contact Shayna Connery at xvj9@cdc.gov or (404) 498-0715 for further information.

    Point(s) of Contact
    Shayna Connery
    (404) 498-0715
    xvj9@cdc.gov
    Austin Pagliaccetti
    (770) 488-5472
    zsm6@cdc.gov
    Files
    Title
    Posted
    75D301-25-R-73207 Combined Synopsis and Solicitation Final.pdf
    The document outlines a solicitation by the Centers for Disease Control and Prevention (CDC) for the development and production of diagnostic tests in response to public health emergencies. It is a Request for Proposal (RFP) identified as 75D301-25-R-73207, issued on November 7, 2024, with proposals due by December 2, 2024. The CDC plans to award multiple Indefinite Delivery Indefinite Quantity (IDIQ) contracts, emphasizing firm-fixed price and cost-reimbursable task orders for laboratory testing services, development of diagnostic methods, and regulatory submissions. The RFP specifically targets laboratory testing and test development services, aiming to enhance the national laboratory system's efficiency and readiness. Offerors are encouraged to submit proposals that include a completed Offeror Representations and Certifications and respond to all outlined contract clauses related to federal regulations. The maximum contract value is set at $148 million, with a minimum order of $10,000. The solicitation incorporates numerous Federal Acquisition Regulation clauses to ensure compliance and outlines the processes for submitting questions and proposals. The document underscores the government’s intent to bolster public health infrastructure through competitive procurement while ensuring adherence to required standards and practices.
    Pricing Table (Protected).xlsx
    The document outlines a pricing table for diagnostic testing initiatives associated with the development and validation of diagnostic tests for selected pathogens. It comprises various tasks, including the creation of a Diagnostic Development and Validation Plan, optimizing test sensitivity and specificity, and manufacturing tests. Notably, it mentions producing tests in response to outbreaks and the submission of a validation data package to the FDA for Emergency Use Authorization (EUA) or 510(k) approval. Costs for various tasks over multiple years are specified, indicating a structured approach to budget allocation. The table includes subtasks for test validation, differentiating between situations where pathogen samples are sourced in advance or during an outbreak. The aim of these efforts is to ensure readiness for public health challenges, hinting at cooperation with the CDC for resources and data. This document fits within federal RFPs and grant proposals, highlighting the government's proactive stance on public health emergencies through efficient funding and resource allocation for diagnostic testing capabilities.
    Lifecycle
    Title
    Type
    Diagnostic Test Development and Production for Emergency Response
    Currently viewing
    Combined Synopsis/Solicitation
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