Multi-Antigen Diagnostic Tests
ID: 75A50424R00006Type: Combined Synopsis/Solicitation
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFOFFICE OF ASSISTANT SECRETARY FOR PREPAREDNESS AND RESPONSEINDUSTRIAL BASED MANUFACTURING AND SUPPLY CHAIN (IBMSC)Washington, DC, 20024, USA

NAICS

In-Vitro Diagnostic Substance Manufacturing (325413)

PSC

IN VITRO DIAGNOSTIC SUBSTANCES, REAGENTS, TEST KITS AND SETS (6550)

Set Aside

Total Small Business Set-Aside (FAR 19.5) (SBA)

Original Source

https://sam.gov/opp/2c34513acbc94614bbc24e6d048c1217/view
Timeline
    Description

    The U.S. Department of Health and Human Services (HHS) is seeking proposals for the procurement of one million FDA-approved multi-antigen diagnostic test kits capable of detecting SARS-CoV-2 and Influenza A/B, under solicitation number 75A50424R00006. This initiative is a 100% Small Business Set-Aside, aimed at replenishing the diagnostics stockpile in response to public health demands, with all tests required to originate from the original equipment manufacturer (OEM) and meet specific FDA standards. The selected contractor will deliver the kits to designated government warehouses, with delivery commencing 15 days post-award and a total performance period of 12 months. Proposals must be submitted electronically by 4:00 PM ET on September 17, 2024, to IBMSCC-Submissions@hhs.gov, with inquiries directed to Christopher Newell at christopher.newell@hhs.gov.

    Point(s) of Contact
    Chris Newell
    christopher.newell@hhs.gov
    IBMSCC
    IBMSCC-Submissions@hhs.gov
    Files
    Title
    Posted
    75A50424R00006 AMD 0001 - Multi-antigen Diagnostic Test Kits - FE.pdf
    This document pertains to Amendment 0001 of Solicitation Number 75A50424R00006, issued by the U.S. Department of Health and Human Services for Multi-Antigen Diagnostic Tests, specifically targeting SARS-CoV-2 and Influenza A/B. The amendment corrects a typo in the solicitation and responds to vendor inquiries surrounding manufacturing requirements, shelf life, product approvals, and small business classifications. Notably, there are no strict domestic manufacturing requirements due to the applicability of trade agreements which allow for products from designated countries, including Korea. The amendment indicates that a total of one million tests are requested, clarifies that these can be delivered over a 12-month period, and specifies that submissions must come directly from the original equipment manufacturer (OEM). Furthermore, the responses outline that the evaluation will be based on the lowest priced acceptable offer, without preferences for domestic content, and reaffirm the focus on antigen tests instead of molecular testing. Overall, the document serves to clarify specifications and requirements for potential suppliers interested in participating in this federal procurement process.
    75A50424R00006 Multi-Antigen Diagnostic Tests RFP 9-10-24.pdf
    The U.S. Department of Health and Human Services (HHS) issued a Request for Proposal (RFP) 75A50424R00006 for the procurement of one million FDA-approved multi-antigen diagnostic test kits that can detect SARS-CoV-2 and Influenza A/B. This procurement is federally mandated as a 100% Small Business Set-Aside under NAICS code 325413, aimed at replenishing the diagnostics stockpile in response to public health demands. Offerors must submit their proposals electronically by September 17, 2024. The selected contractor will deliver kits to designated government warehouses, with delivery starting 15 days post-award and a total performance period of 12 months. The contract type is Firm Fixed Price (FFP), and evaluations will rely on the lowest price technically acceptable offeror (LPTA). All tests must originate from the original equipment manufacturer (OEM) and meet specific FDA requirements. The contractor must comply with a detailed set of specifications, including appropriate packaging, shipping, documentation, and delivery protocols. The RFP outlines submission requirements, evaluation criteria, and compliance with various federal regulations, including provisions for electronic invoicing and payment processes. This initiative underscores the government's effort to enhance public health preparedness amidst ongoing health emergencies.
    Attachment 1 - Vendor Proposed Delivery Schedule.docx
    The document outlines the proposed delivery schedule for a federal procurement, indicating that delivery will commence approximately 15 days post-award and continue over a 12-month performance period, maintaining stockpile levels from September 2024 to potentially September 2025. Detailed quantities for each warehouse location across multiple states will be provided to the selected contractor shortly before shipping. The contractor must submit a proposed delivery schedule for approval by the Contracting Officer Representative. It lists several government warehouse facilities located in Memphis, TN; Salt Lake City, UT; Columbus, OH; Bethlehem, PA; Dallas/Garland, TX; and Longview, TX. The delivery schedule includes a weekly layout to support proper tracking and management of shipments. This document emphasizes the organization and timely execution of the procurement process within the framework of government RFPs, ensuring readiness and compliance with federal guidelines.
    Lifecycle
    Title
    Type
    Multi-Antigen Diagnostic Tests
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    Combined Synopsis/Solicitation
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