Notice of Intent to Sole Source Invetech GMP Korus SUS Kits

Notice of Intent to Sole Source Invetech GMP Korus SUS Kits NAICS Code: 325413-In Vitro Diagnostic Substance Manufacturing (1250 Average Number of Employees| Product Service Code: 6550-In Vitro Diagnostic Substances, Reagents, Test Kits and Sets Place of Performance:

Bethesda, MD 200892 POTS:

25-001317 Description: This is a notice of intent, not a request for a quotation. A solicitation document will not be issued and quotations will not be requested. The National Institutes of Health, Clinical Center, Office of Purchasing and Contracts on behalf of the Department of Transfusion Medicine, Center Cellular Engineering intends to award a fixed price purchase order to Invetech Inc. located at 9980 Huennekens Street, Suite 140, in San Diego, CA 92121-2968 on a firm fixed price sole source award to supply GMP SUS Kits.

Product Description:

Line Item 0001 Product Number: Description Unit of Measure Quantity A005913-02-A GMP Korus SUS Kits Each 80 The Department of Transfusion Medicine, Center Cellular Engineering is responsible for the manufacture of human cells and tissue-based products utilized in phase I and phase II clinical protocols for transplantation, adoptive immunotherapy and gene therapy. The cell processing procedures are tailored to each of the 50 or more different patient-care clinical research protocols.

The Department of Transfusion Medicine, Center Cellular Engineering has a need for GMP Korus SUS Kits in support of patient care. Invetech Inc. is the only known source capable of supplying the GMP Korus SUS Kits that are compatible with the Invetech Korus™ Counterflow Elutriation System. The GMP SUS Kits are not interchangeable with other manufacture’s instruments and the only kits that are compatible with the Invetech Korus™ Counterflow Elutriation System.

Intech Inc. Is the only known source that can provide the proprietary GMPS SUS Kits. This acquisition is being conducted using policies unique to the Federal Acquisition Regulation (FAR) Part 13 – Simplified Acquisition Procedures, Subpart 13.106-1(b)(1). For purchases not exceeding the simplified acquisition threshold (SAT), contracting officers may solicit from one source if the contracting officer determines that the circumstance of the contract action deem only one source reasonably available.

Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements. Interested Parties Interested parties capable of providing the same or similar products or services described in this notice may submit a capability statement outlining their capability to perform the described work. Capability Statements must be received within the time set forth in this synopsis to be considered by the Government.

The determination to compete this proposed contract based on responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement.

Comments to this announcement, referencing this posting number on the email subject line, may be submitted to the NIH, Clinical Center, Office of Purchasing and Contracts, prior to the closing date specified in this announcement, to the attention of Sheri Eiri Contract Specialist via email to sheri.eiri@nih.gov by the due date November 14, 2024 by Noon 12:00 pm EST and time marked in this notice.