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).

08.21.2025 JOFOC Hera Vios 160i CO2  ISR0229383 - T259691.docx

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.

Quote ISR0229383.pdf

This is a Notice of Intent, not a request for proposal.  The National Institute of Health, Clinical Center (NIH-CC) intends to negotiate on an other than full and open competition basis with the following vendor: Thermo Fisher Scientific Asheville LLC.

Acquisition Description:

The National Institutes of Health, Office of Purchasing and Contracts on behalf of Center for Cellular Engineering (CCE) department intends to award a firm-fixed priced contract to **Thermo Fisher Scientific**, for a preventative maintenance agreement for the following incubators 36 models equipment: HERA VIOS 160i CO2 with a list of serial numbers.

This acquisition is to purchase a Thermo Scientific instrument service preventative maintenance agreement for the following equipment, 36 models: HERA VIOS 160i CO2. The manufacturing operations of the Center for Cellular Engineering are regulated by the Current Good Manufacturing Practices (cGMPs) as mandated by the FDA in 21 CFR 210, 211, 600 and 1271. The FDA mandates that critical equipment used in the manufacturing, processing, and testing of drug product must be maintained in a controlled manner (21 CFR 211.63, 21 CFR 211.67).

The Department of Transfusion Medicine, Center for Cellular Engineering Services requires a preventative maintenance agreement for 36 Heracell Vios 160i CO2 incubators.  The Department of Transfusion Medicine, Center for Cellular Engineering Service manufactures cell-based therapies for patients enrolled on clinical trials. The activities of the Department of Transfusion Medicine, Center for Cellular Engineering Service are regulated by the Food and Drug Administration that mandates critical equipment used in the manufacturing, processing, and testing of drug product be maintained in a controlled manner (21 CFR 211.63, 21 CFR 211.67).  Thermo Fisher Scientific has been performing these services and is the original equipment manufacturer capable of performing these services and perform software updates.  The Food and Drug Administration mandates that all firmware and software used to control devices are kept up to date to prevent security vulnerabilities from being exploited during manufacturing, potentially placing patients at risk.  Only the original equipment manufacturer can perform the software and firmware updates.  Thermo Fisher has been qualified and validated and the only vendor approved by the Center for Cellular Engineering Quality Assurance Team.

The statutory authority for this sole source requirement is 41 U.S.C. 1901 (a) (1) as implemented by FAR 13.106-1 only one responsible source and no other supply of service will satisfy agency requirements. THIS IS NOT A REQUEST FOR PROPOSAL.  All responsible sources that could provide the required may submit a capability statement that will be considered by email (subject line to reference NOI-CC-26-000054) by 11:00 AM eastern standard time on 12/18/2025 to: valerie.gregorio@nih.gov.

All responses received by the closing date of this synopsis will be considered by the Government.  A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government.

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