Intent to Sole Source (Steritest Pump)

Subject: Sole Source Fixed Price Contract for the procurement of Steritest Pump under Request for Quote FDA-RFQ-24Q-1277903.

Notice of Intent to Sole Source to:

EMD Millipore 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 contract to Cerulean located at: EMD Millipore 400 Summit Drive Burlington, MA.

01903 FDA has a requirement to procure Steritest Pump under Request for Quote FDA-RFQ-24-1277903 as a sole source acquisition. Use of a pump from a different manufacturer would not be compatible with the Steritest system. We currently already have a set up to run the Steritest system as well as over $14,000 in consumable supplies that would be obsolete. Additionally, we have secured funding for two Isolators which have a custom design; this design integrates the use of Steritest.

If we do not have the pumps to move forward with this design that is in place, we face having an obsolete isolator set up, each costing $460,000. The NAICS Code for this procurement is:

339113 – Surgical Appliance and Supplies Manufacturing 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 EMD Millipore within approximately fifteen (15) days after the closing date of this notice unless the Government determines that any other organization has the capacity to meet this requirement.

Response Date: 11:00 a.m. EST 9/4/2024. Please email responses to Warren Jackson at warren.jackson@fda.hhs.gov