Notice of Intent to Sole Source-133701.docx
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- Solicitation number
- FDA-133701
About this file
This is a Notice of Intent to Award a Sole Source Contract from the Food and Drug Administration (FDA). The FDA intends to award a firm-fixed price commercial Purchase Order to Hitachi under solicitation number FDA-133701 for a high voltage pump replacement part for the existing Hitachi SU6600 Field Emission Scanning Electron Microscope (FE-SEM). The pump serves as a direct replacement component and is critical to maintaining operational reliability of this analytical instrument, which is used to analyze criminal and public health samples. The acquisition is being conducted under simplified acquisition procedures in accordance with FAR Part 12 for commercial products. NAICS Code 334516 applies to this analytical laboratory instrument manufacturing action.
Market research confirmed that Hitachi is the only manufacturer capable of producing a compatible high voltage pump for this specific FE-SEM model. As the original equipment manufacturer, Hitachi possesses the proprietary technical specifications and manufacturing processes necessary to ensure seamless integration and compatibility. Installation of third-party components would risk incompatibility, equipment malfunction, and data integrity concerns. The justification for sole source procurement is based on FAR 6.302-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. Any firms interested in demonstrating capability to meet the requirements must submit a capability statement to Janice Heard at janice.heard@fda.hhs.gov no later than June 19, 2026. The Government reserves the right to determine whether to compete this requirement based on any submitted responses.
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Notice of Intent to Award a Sole Source Contract
Notice of Intent to Award a Sole Source Contract to Hitachi (FDA-133701) The Food and Drug Administration (FDA) intends to award a Sole Source firm-fixed price commercial Purchase Order (PO) to Hitachi in accordance with the authority under FAR RFO Part 6.302-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. The NAICS Code for this action is 334516–Analytical Laboratory Instrument Manufacturing industry. This acquisition is being conducted using simplified acquisition procedures in accordance with FAR RFO Part 12 for the acquisition of commercial products and commercial services.
Hitachi is the only manufacturer of the high voltage pump that serves as a direct replacement part for the existing Hitachi SU6600 Field Emission Scanning Electron Microscope (FE-SEM). The FE-SEM is a critical analytical instrument used to analyze criminal and public health samples, making system reliability essential to mission-critical operations. Only Hitachi, as the original equipment manufacturer, possesses the technical specifications and manufacturing processes necessary to produce components that meet the exact specifications and integrate seamlessly with the SU6600 system. Market research confirmed that no other manufacturer produces high voltage pumps compatible with this specific FE-SEM model, and installation of third-party components would risk incompatibility and potentially cause equipment malfunction or data integrity concerns.
This notice is not a request for competitive quotes. Any other firms desiring consideration must fully identify their interest and capability of meeting the requirements by submitting a capability statement to Janice Heard at janice.heard@fda.hhs.gov no later than June 19, 2026. Any response shall undergo review to determine if it can meet the requirements. A determination by the Government not to compete this proposed requirement based upon a response to this notice is solely within the discretion of the Government.
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