Notice of Intent to Sole Source.pdf

Notice of Intent to Sole Source

Subject: Fixed Price (FFP) Purchase Order Type for the procurement of a CDER-2023-117519-ss- Osmolality Module Upgrade for High THRU-Put Nutrient Analyzer, Sole Source, under Request for Quote FDA-RFQ-CDER-2023-117519-ss.

Notice of Intent to Sole Source to: PerkinElmer Health Sciences 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 Nova Biomedical Inc., located at:

ATTN: Richard Benson Nova Biomedical Inc.

200 Prospect Street Waltham, MA 02454 Email: +1 7034888616 Email rbenson@novabio.com

FDA requires a CDER-2023-117519-ss-Osmolality Module Upgrade for High THRU-Put Nutrient Analyzer, Sole Source, under Request for Quote FDA-RFQ-CDER-2023-117519-ss. This is a request for the procurement of a Osmolality Module Upgrade for High THRU-Put Nutrient Analyzer, plus One

(1) option year of Preventative Maintenance Agreement (PMA), and the instrument is solely distributed by the manufacturer/subsidiaries and official distributors, with no thirty party re-sellers. The proposed acquisition is to upgrade the hardware and software of existing equipment owned and operated by OBP.

More specifically, we are requesting a retrofit upgrade of the Nova Biomedical BioProfile FLEX2 system with an OSMO48 that can enable high-throughput osmolality data collection. Nova Biomedical is the sole manufacturer of the system, and no market equivalents exist. This upgrade requires parts and components strictly manufactured by Nova Biomedical and installation by OEM-trained service engineers and professionals. Furthermore, this upgrade requires updates and configuration to the ambr15’s software to ensure proper integration and communication between the ambr15 and our Nova Biomedical Flex2.

The Nova Biomedical Inc. Ambr15 is currently under maintenance contract until June of 2023, under contract # 75F40119P10302. FDA previously procured this instrument under contracts # HHSF223201400300G for purchase of the ambr15 48-way system and contract #75F40119P10454 for Flex2 maintenance contract and contract #75F40120P00236 for Flex2 consumables contract. The instrument is solely distributed by the manufacturer/subsidiaries and official distributors, with no thirty party re-sellers. Also, because this is an upgrade to an existing system, there are no competitors that manufacture or sell something that either competes with or replaces the items and services requested as part of this acquisition. There are no third-party or after-market items that are equivalent substitutions.

mailto:rbenson@novabio.com

In summary, only Nova Biomedical can fulfill this acquisition and ensure a successful upgrade. The instrument is solely distributed by the manufacturer/subsidiaries and official distributors, with no thirty party re-sellers.

The associated NAICS Code is: 334516-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 Nova Biomedical 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 04/15/2023. Please email responses to Emmanuel Mbah at Emmanuel.mbah@fda.hhs.gov mailto:Emmanuel.mbah@fda.hhs.gov