SOLICITATION NOTICE
65 -- THERAKOS� CELLEX� Photopheresis SYSTEM Procedural Kits for Transfusion Medicine
- Notice Date
- 11/20/2020 12:22:29 PM
- Notice Type
- Presolicitation
- NAICS
- 325413
— In-Vitro Diagnostic Substance Manufacturing
- Contracting Office
- NATIONAL INSTITUTES OF HEALTH - CC BETHESDA MD 20892 USA
- ZIP Code
- 20892
- Solicitation Number
- 21-000513
- Response Due
- 11/30/2020 6:00:00 AM
- Archive Date
- 12/15/2020
- Point of Contact
- Malinda Dehner, Phone: 7876718868, Barbara Taylor, Phone: 3015945915
- E-Mail Address
-
DehnerM@cc.nih.gov, taylorb@cc.nih.gov
(DehnerM@cc.nih.gov, taylorb@cc.nih.gov)
- 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 Institute of Health (NIH), Clinical Center (CC) intends to award a one year fixed price purchase order to Therakos at Mallinckrodt, Hampton,�NJ 08827�on a sole source basis to procure THERAKOS� CELLEX� Photopheresis SYSTEM Procedural Kits, CLXUSA for extracorporeal photopheresis therapy to patients post stem-cell transplantation on the existing government owned THERAKOS� CELLEX� Photopheresis System Instrument. This purchase is required for the analysis of patients with confirmed acute graft-versus-host disease per protocol 15-C-0039. Extracorporeal Photopheresis (ECP) is a recognized therapy for graft-versus-host disease (GVHD) post stem cell transplantation, particularly the steroid-refractory patient population. Under protocol 15-C-0039, ECP is delivered at a strategic time-point in patients� therapy. Typically this therapy is in conjunction with other acute GVHD modalities. The goal of this treatment is to contribute to the patient�s transition from an acute inpatient therapy to outpatient maintenance therapy. Only one known vendor has been identified for the purchase of�7 cases of the THERAKOS� CELLEX�Procedural Kits-CLXUSA . Therokos Inc. is the sole registered trademark holder and manufacturer of the required product. If this specific product is not received, patients could be potentially harmed, causing an increased risk for post-stem-cell transplant complications, infection and death. This acquisition is being conducted under the authority of the FAR Subpart 13.106-1(b). Interested concerns capable of providing the same or similar products or services as described in this notice may submit a capability statement outlining their capabilities. Capability Statements must be received within the time set forth in this synopsis to be considered by the Government. A 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. Each response should include the following Business Information: a. DUNS. b. Company Name, address, POC, Phone and Email address c. Current GSA Schedules or NAICS codes appropriate to this Award. d. Type of Company (i.e., small business, 8(a), woman owned, hubZone, veteran owned, etc.) as validated in System For Award Management (SAM). All offerors must register on the SAM located at http://www.sam.gov/portal/SAM/#1 e. Capability Statement Comments to this announcement may be submitted to the Clinical Center, Office of Purchasing and Contracts, prior to the closing date specified in this announcement, electronically to the attention of Malinda Dehner, Contract Specialist, dehnerm@cc.nih.gov by the due date and time marked in this notice.
- Web Link
-
SAM.gov Permalink
(https://beta.sam.gov/opp/5daca6cce9844ffd852174e68763710e/view)
- Place of Performance
- Address: Bethesda, MD 20892, USA
- Zip Code: 20892
- Country: USA
- Zip Code: 20892
- Record
- SN05858232-F 20201122/201120230144 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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