SOLICITATION NOTICE
66 -- Acquisition of a Therakos CELLEX UVAR XTS Extracorporeal Photopheresis (ECP) cell processing system
- Notice Date
- 8/22/2017
- Notice Type
- Presolicitation
- NAICS
- 334516
— Analytical Laboratory Instrument Manufacturing
- Contracting Office
- Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E128, Rockville, Maryland, 20852, United States
- ZIP Code
- 20852
- Solicitation Number
- N02RC72663-76
- Archive Date
- 9/2/2017
- Point of Contact
- Catherine Muir, Phone: (240) 276-5434
- E-Mail Address
-
muirca@mail.nih.gov
(muirca@mail.nih.gov)
- Small Business Set-Aside
- N/A
- Description
- Contracting Office Address: Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E144, Bethesda, MD 20892, USA. Description: National Cancer Institute (NCI), Center for Cancer Research (CCR), Experimental Transplantation and Immunology Branch (ETIB, plans to procure on a sole source basis a Therakos CELLEX UVAR XTS Extracorporeal Photopheresis (ECP) cell processing system that is manufactured by Therakos - Mallinckrodt Pharmaceuticals; 10 North High Street; West Chester, PA 19380 USA. The response close date of this notice for this requirement is in accordance with FAR 5.203(a)(1). This acquisition will be processed under FAR Part 12 - Acquisition for Commercial Items and in accordance with simplified acquisition procedures as stated in FAR Part 13.106-1(b)(1), and is exempt from the requirements of FAR Part 6. The North American Industry Classification System code is 334516 and the business size standard is 1,000 employees. Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type contract. Delivery, installation, and training will be within 60 days of receipt of the order. It has been determined there are no opportunities to acquire green products or services for this procurement. The Experimental Transplantation and Immunology Branch is dedicated to coordinated efforts in basic, preclinical and clinical investigations in the areas of immunotherapy, immune reconstitution, T cell biology, hematopoiesis, and hematopoietic stem cell transplantation. The goal is to generate information from basic and preclinical investigations to develop new, curative hematopoietic stem cell transplant-based therapies for cancer. Information from new treatment protocols (including novel endpoints generated in the course of basic/preclinical research) is used to generate new questions and studies in the basic and preclinical research efforts. The branch emphasizes excellence in these endeavors and acts to maximize strengths present in the community at large by vigorous intramural and extramural interactions and collaborations. This acquisition is in support of ETIB clinical programs, patient care and clinical trials. Extracorporeal Photopheresis (ECP) is a standard-of-care therapy for chronic graft-versus-host disease (cGVHD) post stem cell transplantation, particularly with steroid-refractory patients. For patients with cGVHD, there is a 75% failure rate for steroid therapy, and an estimated probability of death ranging from 5-50% depending on prognostic factors. ECP is a procedure which removes, treats, and infuses back to the patient their white blood cells that contribute to causing cGVHD. The white blood cells are exposed to UVA irradiation following pretreatment with medication (8-methoxypsoralen), which has been shown to result in cell death to the majority of these cells within 48 hours. ECP is also a potential therapy for acute GVHD that does not respond to steroid treatment. By American Society for Bone Marrow Transplantation criteria, steroid-refractory acute GVHD patients have an estimated probability of death of 75%. In these patients ECP is delivered at a strategic time point in the course of therapy with a goal is to transition from severe aGVHD and inpatient therapy to non-life threatening acute GVHD and outpatient maintenance therapy. Therefore, ECP equipment is urgently required to provide standard care to all patients with steroid resistant cGVHD, and a treatment option for patients with severe steroid refractory aGVHD in order to save lives. The Contractor shall provide the following physical, functional, and performance characteristics, inclusive of hardware and/or software specifications, that are deemed essential to the needs of the Government: • Integration of all critical processes in a single, stand-alone compact, FDA approved, unit including cell collection, separation and extraction by centrifugation, UV illumination, past-irradiation cell collection and reinfusion • Unit provides short-wavelength UVA irradiation of cells from patients previously treated with the photolytic drug 8-methoxypsoralen. • Single-harvest centrifuge design with continuous separation • customized fluid management and single- or double-needle mode treatment options • Single use, sterile procedural kit • Automated safety features to include air emboli detector, audible alarms and message display for specific alarm status, and line occlusion of all fluid lines DELIVERY / INSTALLATION Delivery address: Experimental Transplantation and Immunology Branch Center for Cancer Research National Cancer Institute Building 10, Room 3E (contact Technical Point of Contact for exact room number) Bethesda, MD 20892-1203 TRAINING The Contractor will provide the necessary training in-site for up to four (4) individuals. The standard warranty and service agreement will be honored. PAYMENT Payment shall be made in arrears after delivery, installation, inspection and acceptance, and successful completion of the required training stated above. Payment authorization requires submission and approval of invoices to the NCI Technical Point of Contact and the NIH Office of Financial Management (OFM), in accordance with the payment provisions in the order. The following clause is applicable to all Purchase Orders, Task or Delivery Orders, and Blanket Purchase Agreement (BPA) Calls: PROMPT PAYMENT (JUL 2013) FAR 52.232-25. This equipment is manufactured by Therakos - Mallinckrodt Pharmaceuticals. The Therakos system is currently the only FDA approved extracorporeal photophoresis system that manages cell removal, treatment and reinfusion with UVA irradiation of cells following 8-methoxypsoralen patient treatment. The system manages the entire treatment process in a single unit, including cell removal, separation, UVA treatment and reinfusion. No other commercially available system can meet this need in an FDA approved device. The ETIB has extensive experience in the operation of the Therakos system, and it has been and it currently is, a critical component of cGVHD therapy in the Branch. It is important that continuity be maintained between the older and newer systems. Furthermore, the Therakos system is the agency approved ECP device in a single integrated package, making it the only option for this treatment modality. It is therefore critical to the continuity of ETIB patient care and on-going clinical trials that the proposed equipment be acquired. The proposed equipment is essential to the Government's requirement, and market research indicates there are no other companies with a similar product to meet the Government's needs. This notice is not a request for competitive quotation. However, if any interested party, especially small businesses, believes it can meet the above requirement, it may submit a capability statement, proposal, or quotation, which shall be considered by the agency. The statement of capabilities and any other information furnished must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform the requirement. Responses must be received in the contracting office by 2:00PM EDT, on Sept. 1, 2017. All responses and questions must be in writing and faxed (240) 276-5401 or emailed to Catherine Muir, Contracting Officer via electronic mail at muirca@mail.nih.gov. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for determining whether to conduct a competitive procurement. No collect calls will be accepted. In order to receive an award, Contractors must be registered and have valid, current Entity Record, including current Representations and Certifications, in the System for Award Management (SAM) through SAM.gov. Reference: N02RC72663-76 on all correspondence.
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- SN04640896-W 20170824/170822232450-e233d2faa1668b03afb905bfa7889595 (fbodaily.com)
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