Preventative Maintenance Agreement for 36 Heracell Vios 160i CO2 incubators
ID: NOI-CC-26-000054Type: Special Notice
Overview

Buyer

HEALTH AND HUMAN SERVICES, DEPARTMENT OFNATIONAL INSTITUTES OF HEALTHNATIONAL INSTITUTES OF HEALTH - CCBETHESDA, MD, 20892, USA

NAICS

Surgical and Medical Instrument Manufacturing (339112)

PSC

MAINT/REPAIR/REBUILD OF EQUIPMENT- INSTRUMENTS AND LABORATORY EQUIPMENT (J066)

Set Aside

No Set aside used (NONE)
Timeline
    Description

    The Department of Health and Human Services, through the National Institutes of Health (NIH), intends to award a firm-fixed-price contract to Thermo Fisher Scientific for a preventative maintenance agreement covering 36 HERA VIOS 160i CO2 incubators. This sole-source acquisition is essential for maintaining critical equipment used in the manufacturing of cell-based therapies, as mandated by the FDA's regulations on controlled maintenance of such equipment. The estimated cost for this project is $55,311.32, and it is crucial for ensuring the continuous, compliant operation of equipment vital for patient care. Interested parties may submit capability statements by email to valerie.gregorio@nih.gov by 11:00 AM EST on December 18, 2025, referencing the notice of intent (NOI-CC-26-000054).

    Point(s) of Contact
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    Files
    Title
    Posted
    The Department of Health and Human Services, National Institutes of Health, Clinical Center, intends to award a firm-fixed-priced contract to Thermo Fisher Scientific for a preventative maintenance agreement covering 36 HERA VIOS 160i CO2 incubators. This sole-source acquisition, justified under FAR 13.106-1(b)(1) for purchases not exceeding the simplified acquisition threshold, is essential for maintaining critical equipment used in manufacturing cell-based therapies. The FDA mandates controlled maintenance of such equipment (21 CFR 211.63, 21 CFR 211.67). Thermo Fisher Scientific is the original equipment manufacturer, uniquely qualified to perform required software and firmware updates and is the only vendor approved by the Center for Cellular Engineering Quality Assurance Team. Transitioning to a new vendor would cause significant delays to patient treatments due to lengthy qualification processes. The estimated cost for this project is $55,311.32, and it supports the continuous, compliant operation of equipment vital for patient care.
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