MIoBS ELISA Test Kits
ID: 75F401-24-Q-1279662Type: Combined Synopsis/Solicitation
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFFOOD AND DRUG ADMINISTRATIONFDA OFFICE OF ACQ GRANT SVCSBeltsville, MD, 20705, USA

NAICS

Analytical Laboratory Instrument Manufacturing (334516)

PSC

LABORATORY EQUIPMENT AND SUPPLIES (6640)

Original Source

https://sam.gov/opp/a37f479852774dd2be7f88404b0ff729/view
Timeline
    Description

    The Department of Health and Human Services, through the Food and Drug Administration (FDA), is seeking proposals for the procurement of MIoBS ELISA Test Kits, which are critical for detecting undeclared food allergens and gluten. The contract requires the vendor to supply up to seven test kits quarterly, ensuring that the kits are sourced from multiple lots to maintain maximum shelf life and minimize variability. These test kits are essential for the FDA's efforts to uphold food safety standards as mandated by the Food Allergen Consumer Protection Act of 2004 and the Gluten-Free Regulation of 2013. Interested vendors must submit their quotes by 4:30 PM EDT on September 6, 2024, to Joshua Reid at joshua.reid@fda.hhs.gov, with the performance period commencing on September 15, 2024.

    Point(s) of Contact
    Joshua Reid
    (954) 271-9362
    joshua.reid@fda.hhs.gov
    Files
    Title
    Posted
    Requirements Document.pdf
    The Food and Drug Administration (FDA), through its Center for Food Safety and Applied Nutrition (CFSAN), is seeking procurement of ELISA test kits essential for the detection of undeclared food allergens and gluten as mandated by the Food Allergen Consumer Protection Act of 2004 and the Gluten-Free Regulation of 2013. The contract aims to enable the acquisition of MIoBS (Morinaga Institutes of Biological Sciences, Inc.) ELISA test kits, known for their sensitivity and reliability in detecting major allergens like egg, milk, peanut, and gluten at low detection limits. The requirements stipulate quarterly provision of up to seven test kits, selected based on FDA's needs, and demand that test kits are sourced from multiple lots to ensure shelf-life and reduce variability. The vendor is responsible for delivering these kits, with an anticipated delivery time of up to eight weeks post-order. The performance period for this contract is set for one year, starting on September 15, 2024, with no options for renewal. LCDR Chung Y. Cho from the FDA serves as the project officer for this initiative, underscoring the importance of maintaining food safety standards.
    Lifecycle
    Title
    Type
    MIoBS ELISA Test Kits
    Currently viewing
    Combined Synopsis/Solicitation
    Similar Opportunities
    Contractor-Hosted Fully Integrated Records Facility (FIRF) IDIQ
    Active
    Health And Human Services, Department Of
    The U.S. Department of Health and Human Services, specifically the Food and Drug Administration (FDA), is conducting market research for a Contractor-Hosted Fully Integrated Records Facility (FIRF) services under an Indefinite Delivery-Indefinite Quantity (IDIQ) contract. The objective is to identify potential small business sources capable of providing comprehensive services such as document processing, data entry, and record tracking, aimed at enhancing the management of records related to public health. This initiative is crucial for improving operational efficiency and ensuring compliance with federal regulations, ultimately supporting the FDA's mission to safeguard public health. Interested vendors must submit their responses, including a completed Vendor Feedback Form and comments on the draft Statement of Work, via email to Contract Specialist Noah Wills by 12:00 PM (Eastern) on November 19, 2024, with the anticipated contract period running from September 15, 2025, to September 14, 2030.
    BIOFIRE Defense, LLC Test Kits and Reagents
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), intends to award a fixed-price contract to BioFire Defense, LLC for the provision of BIOFIRE® Reagent Kits and associated test kits. The procurement aims to secure proprietary test kits and reagents essential for the NIH Clinical Center's Department of Laboratory Medicine, which supports patient care and research by detecting pathogens in various patient specimens, including blood and respiratory samples. The BioFire test kits are critical for rapid diagnostics, allowing clinicians to initiate timely treatment for infections, and BioFire Defense, LLC is the sole source for these products due to compatibility requirements with government-owned analyzers. Interested parties capable of providing similar products may submit capability statements by November 17, 2024, at 12:00 PM EST to Sheri Eiri at sheri.eiri@nih.gov.
    The Navy Medical Readiness Logistics Command Detachment Fort Detrick has a requirement for the Drug Demand Reduction Program, for the initial (screen) immunoassay for the detection of 6-Acetylmorphine Immunoassay Reagent Kits in urine > 10 ng/mL.
    Active
    Dept Of Defense
    The Department of Defense, specifically the Navy Medical Readiness Logistics Command Detachment Fort Detrick, is seeking proposals for the procurement of FDA-approved Immunoassay Reagent Kits designed for the detection of 6-acetylmorphine (6AM) in urine samples. The contract requires vendors to provide reagent kits compatible with Beckman Coulter AU5800 series analyzers, capable of conducting up to 500,000 tests per month over a five-year period, while adhering to stringent FDA and quality management documentation standards. This procurement is critical for the Drug Demand Reduction Program, ensuring accurate and reliable drug testing within the Department of Defense. Interested vendors must submit technical documentation by October 25, 2024, with final quotes due by November 22, 2024. For further inquiries, contact James Berghaier at 215-697-2022 or via email at james.berghaier@navy.mil.
    Qiagen LLC QIAsymphony DSP DNA Midi Kits, filter tips and supplies
    Active
    Health And Human Services, Department Of
    The National Institutes of Health (NIH) intends to issue a sole source firm fixed-price purchase order to Qiagen LLC for QIAsymphony DSP DNA Midi Kits, filter tips, and related supplies, essential for the Microbiology Service section of the Department of Laboratory Medicine. This procurement aims to acquire reagents and supplies necessary for the efficient extraction of nucleic acids from clinical samples, which is critical for timely detection of infectious agents and supporting ongoing clinical testing. The items will be utilized with existing QIAsymphony SP and QIAgility instruments, which are vital for the laboratory's operations and the development of novel tests. Interested parties may submit their capability statements to Shasheshe Goolsby at shasheshe.goolsby@nih.gov by November 14, 2024, at 2:30 PM EST, as this is not a request for proposals.
    Business Data Enrichment Services
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the Food and Drug Administration (FDA), is seeking information on Business Data Enrichment Services to support the establishment of an enterprise master data management program. The primary objective is to enhance the accuracy and completeness of business data across operational and analytical systems, which is crucial for regulatory compliance and public health initiatives. This Request for Information (RFI) is part of the FDA's efforts to gather insights from the marketplace regarding potential solutions and capabilities, particularly in light of legislative requirements such as the Drug Supply Chain and Security Act. Interested stakeholders must submit their responses by November 15, 2024, and can direct inquiries to Noah Padilla at Noah.Padilla@fda.hhs.gov or Peter Lee at peter.lee@fda.hhs.gov.
    PRIMO Software Licensing
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the Food and Drug Administration (FDA), is seeking qualified small businesses to provide PRIMO Software Licensing and Maintenance Support Services. The procurement involves supplying 21 PRIMO software licenses for a base year, with two additional option years, to ensure the continuous operation of the FDA's CFSAN CAEMS system. This software is crucial for pharmacovigilance and regulatory compliance, enhancing the FDA's capabilities in monitoring food safety. Interested parties must submit their quotes by August 26, 2024, and are encouraged to contact Roosevelt Walker at roosevelt.walker@fda.hhs.gov for further details. The contract will be awarded as a firm-fixed-price purchase order, emphasizing compliance with federal acquisition regulations and accessibility standards.
    Diagnostic Test Development and Production for Emergency Response
    Active
    Health And Human Services, Department Of
    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.
    Revio reagent kit, 24pack All reagents for sequenc
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, specifically the National Institutes of Health (NIH), is seeking to procure the Revio reagent kit, which includes a 24-pack of all reagents necessary for sequencing 24 Revio SMRT Cells. This solicitation aims to acquire essential laboratory supplies that are critical for advanced genomic sequencing applications. The Revio reagent kit plays a vital role in supporting research and development in the field of genomics and personalized medicine. Interested vendors can reach out to Dorothy L. Maxwell at dorothy.maxwell@nih.gov or call 301-827-7729 for further details regarding the procurement process.
    Preventive Maintenance and Repair Services for a PacBio Sequel II next generation sequencer
    Active
    Health And Human Services, Department Of
    The U.S. Food and Drug Administration (FDA) is seeking qualified vendors to provide Preventive Maintenance and Repair Services for a PacBio Sequel II next generation sequencer, Serial Number: SQ64096, on behalf of the National Center for Toxicological Research (NCTR). The procurement includes a base year of service and three option years, with requirements for scheduled preventive maintenance visits, unlimited corrective maintenance, and technical support, all performed by OEM-certified engineers using OEM-certified parts. This equipment is crucial for the NCTR's research activities, and responses to this sources sought announcement must be submitted by November 8, 2024, to Warren Dutter at warren.dutter@fda.hhs.gov, with no contract awarded from this announcement.
    FY25 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science
    Active
    Health And Human Services, Department Of
    The Department of Health and Human Services, through the Food and Drug Administration (FDA), is soliciting proposals for the FY25 Broad Agency Announcement (BAA) aimed at advancing research and development in regulatory science. This initiative seeks to acquire innovative research proposals that enhance the FDA's mission to protect public health by modernizing the evaluation of FDA-regulated products and improving post-market surveillance. Eligible applicants, including private organizations and academic institutions, are encouraged to submit proposals that address critical knowledge gaps and align with FDA priorities, with a submission deadline for full proposals set for February 24, 2025. Interested parties can contact Ian Weiss at Ian.Weiss@fda.hhs.gov or by phone at 301-796-5728 for further information.