Intent to Sole Source Notice.doc

75F40126Q00172

Notice of Intent to Sole Source for Commercial Purchases Under SAT

1. Solicitation Number: 75F40126Q00172

2. Title: CARR® PowerFuge® Pilot Separation System

3. Classification Code: 6640

4. NAICS Code: 334516

5. Response Date: 06/22/2026 by 3:00 PM Eastern Time (ET). Capability Statements shall be submitted via email to the Contracting Officer identified in this notice. Interested parties believing they can satisfy the Government's requirement shall submit a Capability Statement demonstrating their ability to provide a product meeting all requirements identified in the attached Statement of Work. Capability Statements must be received by the response date identified in this notice.

6. Description: This action is for one (1) CARR® PowerFuge® Pilot Separation System, along with required accessories, as specified in the Statement of Work (SOW) dated March 3, 2026. Delivery Date: 90 days after contract award

7. Purpose:

NOTICE OF INTENT TO AWARD A SOLE SOURCE PURCHASE ORDER

The proposed contract action is for supplies or services for which the Government intends to solicit and negotiate with only one source under the authority of FAR 13.106-1(b)(1). The Government intends to award a firm fixed price purchase order to: CARR Biosystems, 14550 58th Street North, Clearwater, FL 33760-3743, USA.

This notice is not a request for competitive quotations, proposals, or bids. However, interested parties may submit capability statements demonstrating their ability to satisfy the Government’s requirements. Responses received by the closing date of this notice will be considered solely for the purpose of determining whether to conduct a competitive procurement. A determination by the Government not to compete this proposed action based upon responses received to this notice is solely within the discretion of the Government. The Government will not be responsible for any costs incurred by interested parties in responding to this notice.

8. Rationale: Market research identified the CARR PowerFuge Pilot as the only known source that meets the Government’s minimum technical requirements for a pilot-scale continuous-feed centrifuge, including an imperforate solid bowl design, operation at ≥20,000 × g, integrated cooling, removable autoclavable titanium bowl, and compatibility with existing validated CFPS workflows.

PART 2 – SUPPLIES OR SERVICES

The Food and Drug Administration intends to issue a Sole Source Firm-Fixed Price Purchase Order for the following:

PART 3 - DESCRIPTION OF REQUIREMENTS

See attached Statement of Work