BioProfile FLEX2 Parts and Component
ID: 75F40125Q00195Type: Combined Synopsis/Solicitation
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFFOOD AND DRUG ADMINISTRATIONFDA OFFICE OF OPERATIONSSilver Spring, MD, 20993, USA

NAICS

Analytical Laboratory Instrument Manufacturing (334516)

PSC

LABORATORY EQUIPMENT AND SUPPLIES (6640)

Set Aside

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

Original Source

https://sam.gov/opp/9c6b714bde294b959c7acc84fd2a9662/view
Timeline
    Description

    The Department of Health and Human Services, specifically the Food and Drug Administration (FDA), is seeking proposals for the procurement of operational parts and consumables for three Nova BioProfile FLEX2 instruments utilized in their Center for Drug Evaluation and Research (CDER). This small business set-aside solicitation (75F40125Q00195) aims to acquire brand-name parts essential for maintaining the functionality of these instruments, which play a critical role in advanced biomanufacturing and analytical processes. Timely delivery of these parts is crucial due to potential expiration issues, and some items may require refrigeration or special handling to ensure their effectiveness. Interested vendors should contact Natapol Sirikhan at Natapol.Sirikhan@fda.hhs.gov or by phone at 240-402-8031 for further details, as proposals must comply with Federal Acquisition Regulations (FAR) and are due by the specified deadline.

    Point(s) of Contact
    Natapol Sirikhan
    (240) 402-8031
    Natapol.Sirikhan@fda.hhs.gov
    Files
    Title
    Posted
    RFQ 75F40125Q00195 - FY25 FLEX2 Parts and Components - FINAL 04-29-25.docx.pdf
    The document outlines a Request for Quote (RFQ) for operational parts and consumables for the FDA's three Nova BioProfile Flex 2 instruments, essential for Process Analytical Technology in bioreactor systems. This small business set-aside aims for firm-fixed pricing and requests detailed pricing schedules including shipping costs. Offerors need to demonstrate technical capability to meet specific requirements and submit an Accessibility Conformance Report (ACR) for compliance with 508 standards. Quantities and timelines for various parts—such as pH/Gas MicroSensor™ Cards, Reference Sensors, Calibrator Cartridges, and their delivery schedules—are listed. Additionally, the contractor must ensure timely delivery and conform to proper shipping conditions. The document includes stipulations regarding service records, government holidays, and points of contact for administrative matters, ensuring compliance with federal regulations like the Buy American Act and Executive Orders. Ultimately, the RFQ emphasizes the importance of compatibility with existing instruments, the need for accurate and timely supply management, and adherence to governmental standards, positioning it within the context of federal procurement processes.
    SAM - SOW 05-28-25.pdf
    The document outlines a combined synopsis/solicitation for operational parts and consumables for three Nova BioProfile Flex 2 instruments utilized by the Food and Drug Administration (FDA) in their Center for Drug Evaluation and Research (CDER). This small business set-aside solicitation (75F40125P00195) is intended for the procurement of brand-name parts essential for maintaining the instruments' functionality within their advanced biomanufacturing and analytical processes. The delivery of these parts requires adherence to specific timelines due to potential expiration issues, and some items may need refrigeration or special handling. Contractors are instructed to include all necessary representations, certifications, and compliance with the Federal Acquisition Regulations (FAR) terms relevant to commercial products and services. The document specifies that all proposals will be evaluated under FAR guidelines and emphasizes the role of key personnel, such as the Contract Specialist, Contracting Officer, and Contracting Officer's Representative, in overseeing the contract's execution and compliance. This RFP is significant as it reflects the government's ongoing commitment to supporting specialized analytical capabilities within FDA's laboratories, enhancing efficiency in bioprocessing and data collection.
    Lifecycle
    Title
    Type
    BioProfile FLEX2 Parts and Component
    Currently viewing
    Combined Synopsis/Solicitation
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