Notice of Intent to Sole Source.pdf
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- Solicitation number
- FDA-RFQ-CFSAN-2024-123879
About this file
This document is a Notice of Intent to Sole Source for the procurement of an Agilent 6475 Triple Quadrupole Mass Spectrometer for the FDA's Office of Applied Research and Safety Assessment (OARSA).
The FDA intends to award a sole source, fixed-price purchase order to Agilent Technologies as the sole manufacturer and supplier of this instrument, which is technically required to meet the agency's needs. The FDA currently has an older Agilent mass spectrometer that is nearing the end of its service life, and this purchase will allow the agency to trade in the older unit for a newer, more advanced model to ensure continued high performance at manageable cost. The associated NAICS code is 34516-Analytical Laboratory Instrument Manufacturing.
Offerors must have an active SAM.gov registration with completed representations and certifications by the response date of 12:00 p.m. EST on 05/27/2024. Any party that believes it can meet the requirement may submit a written capability statement demonstrating their ability to perform by the response date. The government will review submissions to determine if they can meet the requirement, and a decision to compete the contract will be at the government's discretion. The anticipated award to Agilent Technologies is within approximately 15 days after the notice date, unless another organization is determined capable of meeting the requirement.
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Notice of Intent to Sole Source
Subject: Fixed Price (FFP) Purchase Order Type for the procurement of: CFSAN-2024-123879 ss Purchase of Agilent 6475 Triple Quadrupole Mass Spectrometer for OARSA, Sole Source, under Solicitation: FDA-RFQ-CFSAN-2024-123879.
Notice of Intent to Sole Source to: Berthold Technologies USA, LLC.
Pursuant to the authority of 41 USC 3304(a)(1), as implemented by Federal Acquisition Regulation (FAR) Subpart 6.302-1, (there is only one responsible source, and no other supplies or services will satisfy agency requirements). The Food and Drug Administration (FDA) intends to award a Sole Source Fixed Price (FFP) Purchase Order Type to Agilent Technologies., located at:
Agilent Technologies ATTN: Jessica Andujo Greenwood Pl, Savage, MD 20763 Email: JESS.ANDUJO@AGILENT.COM Phone:1-800-227-9770 option 1 email: Lscainstrumentsales@agilent.com website:www.agilent.com/store.
FDA requires the CFSAN-2024-123879 ss Purchase of Agilent 6475 Triple Quadrupole Mass Spectrometer for OARSA, Sole Source, under Solicitation: FDA-RFQ-CFSAN-2024-123879, and the items/services are solely distributed/provided by the manufacturer/subsidiaries and official distributors, with no thirty party re-sellers.
This vendor is the sole manufacturer and supplier for this instrument, which is best technically acceptable for FDA’s needs. FDA currently has a mass spectrometer from Agilent Technologies that is nearing the end of its service life. In order to adhere to budget constraints, FDA’s strategy involves trading in this older unit for a newer, more advanced model from the same Vendor. This upgrade will ensure continued high performance while keeping costs manageable.
In a sole source letter provided to FDA the manufacturer notes:
“Agilent Technologies, Inc. is the sole equipment manufacturer for the items listed on Quote 4797878, specifically a high-performance LC/MS/MS with wide mass range (5 to 3,000 m/z), aortic gate valve, resistive glass ion transfer capillary, hyperbolic quadrupole rods, and advanced control software enabling dynamically calculated inter-MRMR delays for optimized duty cycle and particle swarm optimization-based autotune. Agilent is also the ISO 9001-certified source for factory-authorized service, including installation and familiarization, for all Agilent hardware and software, parts, training, technical support, and at-your-site service and support procedures. Only Agilent service representatives are certified through current and ongoing factory training and hold factory authorization to perform service on Agilent equipment. Agilent does not certify, authorize, or warrant any individuals, third parties, or other equipment manufacturers outside Agilent’s authorized service provider network to provide service or support for any Agilent product. Services performed by providers who are not Agilent factory-authorized could invalidate Agilent’s warranties, and/or lead to irreparable damage, and/or cause safety hazards. Please be advised of that authorization.”
The associated NAICS 34516-Analytical Laboratory Instrument Manufacturing. Offerors must have an active registration in www.SAM.gov, with completed representations and certifications, by the close date of the solicitation.
This notice is not a request for competitive proposals. However, any party that believes it is capable of meeting this requirement as stated herein may submit a written capability statement that clearly supports and demonstrates their ability to perform the requirement. Capability statements must be received by the response date and time of this notice. Submissions will be reviewed to determine if they can meet the requirement. A determination by the Government to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government.
It is anticipated that an award will be issued to Agilent Technologies Inc., within approximately fifteen (15) days after the date of this notice unless the Government determines that any other organization has the capacity to meet this requirement.
Response Date: 12:00 p.m. EST 05/27/2024. Please email responses to Emmanuel Mbah at Emmanuel.mbah@fda.hhs.gov mailto:Emmanuel.mbah@fda.hhs.gov
File details come from the government source that posted it. Updated .