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/ab300093b7bf444a88b8eaa22f9cad55/view
Timeline
    Description

    The Department of Health and Human Services, specifically the Centers for Disease Control and Prevention (CDC), is seeking proposals for the development and production of diagnostic tests aimed at enhancing emergency response capabilities for public health threats. The procurement involves the creation of Nucleic Acid Amplification Tests (NAATs) for selected pathogens, requiring contractors to collaborate with the CDC to establish validation plans, optimize test performance, and manage regulatory submissions for Emergency Use Authorization (EUA) or 510(k) approval. This initiative is critical for ensuring rapid scalability and readiness in the face of potential outbreaks, with a maximum contract value of $148 million and proposals due by December 13, 2024. Interested vendors can direct inquiries to Shayna Connery at xvj9@cdc.gov or Austin Pagliaccetti at zsm6@cdc.gov 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 Amendment 0001.pdf
    The document is an amendment to solicitation 75D301-25-R-73207, concerning Diagnostic Test Development and Production for Emergency Response from the Centers for Disease Control and Prevention (CDC). It specifies that offers must acknowledge receipt of the amendment by the designated deadline to avoid rejection. The amendment provides responses to vendor inquiries, extends the due date for offers to December 13, 2024, and revises other key dates. This is a new solicitation with no current incumbent vendor. Key changes include the adjustment of the period of performance from February 7, 2025, to February 6, 2026, for various services related to the development and validation of diagnostic tests. The document clarifies contract clauses and regulations regarding submission and acknowledgment of offers. Inquiries are now due by November 29, 2024, and must be submitted to designated contracting specialists. Overall, this amendment ensures prospective vendors have the latest information and timelines, facilitating a transparent and structured bidding process for critical public health services.
    75D301-25-R-73207 Amendment 0002.pdf
    The solicitation 75D301-25-R-73207 outlines the requirements for the development and production of diagnostic tests for emergency response conducted by the CDC. This contract is open to full competition, allowing manufacturers beyond testing laboratories to apply. A notable change includes the requirement for a subcontracting plan to be submitted prior to contract award, unless exempt for small businesses. Key themes include the specification for nucleic acid amplification tests (NAATs) using established high-throughput instruments, with a clear focus on rapid scalability—producing over 1 million tests weekly within a month of initiation. The document also details the FDA's role in regulatory submissions including Emergency Use Authorization (EUA) and 510(k) processes. Vendors must comply with their proposals throughout the contract duration and provide sufficient information on pricing and methodologies without needing to hold inventory. Communication within the project is emphasized, including collaboration between contractors and CDC, particularly on validation and specimen provisions. This RFP aims to enhance public health response capabilities by establishing a framework for the rapid development and deployment of diagnostic tests in the face of emerging pathogens, thereby ensuring better preparedness and response to public health emergencies.
    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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