Notice of Intent to Sole Source.pdf

Notice of Intent to Sole Source

Subject: Fixed Price (FFP) Purchase Order Type for the procurement of: CFSAN-2024-124127 Purchase of Anoxomat III Anaerobic and Custom Gassing Environment System (Advanced Instruments, LLC), Sole Source, under Solicitation: FDA-RFQ- CFSAN-2024-124127.

Notice of Intent to Sole Source to: Advanced Instruments Inc.

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 Advanced Instruments Inc., located at:

Advanced Instruments Inc., Norwood, MA 02062, USA.

FDA requires the CFSAN-2024-124127 Purchase of Anoxomat III Anaerobic and Custom Gassing Environment System (Advanced Instruments, LLC), Sole Source, under Solicitation: FDA-RFQ- CFSAN-2024-124127, 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. Market analysis suggested that i) Anoxomat® III (Advanced Instruments Inc) is the only equipment currently available in the market to create anaerobic environments for culturing, isolating, storing and maintaining toxin producing anaerobic microorganisms, meeting the technical specification with unique features to fulfill our project and research needs.

In a sole source letter provided to FDA the manufacturer notes:

“Advanced Instruments, Two Technology Way, Norwood, MA 02062, USA, is the sole manufacturer and supplier of the Anoxomat® Anaerobic Jar System in North America. Unique features and benefits include but are not limited to:

i. Anaerobic, microaerophilic, and custom gas environment creation.

ii. Three gas ports in the equipment to connect to different gas cylinders to create custom environments, rather than switching out different gas cylinders to a single gas port.

iii. Provision to mix N2, CO2 and H2 gas cylinders to create anaerobic gas mixture at different percentage concentrations as needed for different research protocols.

iv. Workflow efficiency and testing capacity due to the use of multiple jars being processed simultaneously to create the desired environment.

v. Testing capacity to incubate up to 36 dishes/jar to facilitate large sample analysis as needed for research use and FDA investigations.

vi. Quality control through a series of tests through environment generation crucial for testing, which includes a gas connection, jar connection, seal/leak, and catalyst testing.

vii. Lower operating costs with gas cylinders since custom environments can be readily generated using up to 3 separate gas connections, precluding the need to make premixed gas mixtures.

viii. Lower safety and storage concerns in the lab and facilities since versatile generating of desired environments can be achieved using 2 or 3 gas cylinders due to not needing to premix gases compared to other systems.

ix. A variety of ergonomic jar designs are available which are stackable to save incubator space and refrigerators.

x. Extra filtration can be added to the jar connectors for biocontainment.”

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 Advanced Instruments 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 06/12/2024. Please email responses to Emmanuel Mbah at Emmanuel.mbah@fda.hhs.gov mailto:Emmanuel.mbah@fda.hhs.gov