Therakos Cellex Photopheresis System Procedural Kits for the Department of Transfusion Medicine
Closed Pre-Solicitation Posted
- Solicitation number
- 25-002473
- Agency
-
NIH Clinical Center
National Institutes of Health, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 325413 In-Vitro Diagnostic Substance Manufacturing
- Place of performance
- Bethesda, Maryland 20892, United States
- Points of contact
Notice details come from SAM.gov. Updated .
About this opportunity
The National Institutes of Health Clinical Center, through its Office of Purchasing and Contracts, intends to award a firm-fixed price contract for five cases of Therakos Cellex Photopheresis System Procedural Kits for the Department of Transfusion Medicine. These specialized medical kits are critical for Extracorporeal Photopheresis (ECP) procedures, with Therakos Inc. identified as the sole registered trademark holder and manufacturer. The procurement is being conducted under FAR Part 13 Simplified Acquisition Procedures, which allows for single-source procurement when only one source is reasonably available. Interested parties capable of providing similar products can submit capability statements by December 16, 2024, at noon EST to Tasha Lowe, the designated Contract Specialist, at lowet2@mail.nih.gov. The government retains sole discretion in determining whether to competitively procure the contract based on received capability statements.
The pre-solicitation notice indicates no specific set-aside for this contract, and the procurement is classified under NAICS Code 325413 for In-Vitro Diagnostic Substance Manufacturing, with a small business size standard of 1,250 average employees. The place of performance is the NIH Clinical Center located at 10 Center Drive in Bethesda, Maryland. The procurement is specifically for five cases of Cellex USA Kits, which are deemed essential for patient care, with potential risks of post-stem-cell transplant complications and infections if not procured. The contract aims to ensure uninterrupted access to these critical medical procedural kits, with the government emphasizing that no other procedural kits are compatible with the Therakos Cellex Photopheresis System Instrument. The contract will be a firm-fixed price arrangement, though specific monetary values were not detailed in the pre-solicitation notice.
Notice text
Therakos Cellex Photopheresis System Procedural Kits for the Department of Transfusion Medicine
- Product Service Code: 6550- In Vitro Diagnostic Substances, Reagents, Test Kits and Sets
- NAICS Code: 325413- In-Vitro Diagnostic Substance Manufacturing. (Small Business Size Standards – 1,250 average number of employees)
- Place of Performance:
National Institutes of Health
Clinical Center
10 Center Drive
Bethesda, MD 20892
POTS: 25-002473
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, Office of Purchasing and Contracts on behalf of the Department of Transfusion Medicine intends to award a firm-fixed price contract to Therakos for a quantity five (5) cases of Cellex USA Kits needed for emergent Extracorporeal Photopheresis kits used for patient care.
Cellex USA Kits are required for emergent Extracorporeal Photopheresis (ECP) procedures for Clinical Center patients. Only one known vendor has been identified for the purchase of 5 cases of the THERAKOS® CELLEX®Procedural Kits-CLXUSA. Therokos Inc. is the sole registered trademark holder and manufacturer of the required product. If the THERAKOS® CELLEX®Procedural Kits are not procured, it would negatively impact patient care. Patients would be at an increased risk for post-stem-cell transplant complications, and infection. There are no other procedural kits compatible with the THERAKOS® CELLEX® Photopheresis System Instrument.
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:
Comments to this announcement, referencing this posting number on the email subject line, may be submitted to the CC, Office of Purchasing and Contracts, prior to the closing date specified in this announcement, electronically to the attention of Tasha Lowe Contract Specialist, lowet2@mail.nih.gov by the due date December 16, 2024, (Noon 12:00 pm EST) and time marked in this notice.
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