INTRODUCTION THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION. The National Heart, Lung, and Blood Institute (NHLBI), Office of Acquisitions (OA), intends to negotiate and award a purchase order on a noncompetitive sole source basis to Fenwal, Inc., 3 Corporate Drive Suite 300, Lake Zurich, IL, 60047-8930, to provide an Amicus apheresis machine to the National Heart, Lung, and Blood Institute's (NHLBI) Hematology Branch (HB). BACKGROUND Hematopoiesis, the development and differentiation of stem cells into multiple types of blood cells, occurs throughout life and its dysfunction is associated with low blood counts or leukemia. The lab's research focuses on understanding the process of hematopoiesis in vivo, as well as on optimizing and improving the safety of gene transfer into primary hematopoietic cells for therapeutic purposes. The lab's goals are synergistic: insight into the control of hematopoiesis is required to successfully manipulate and genetically modify hematopoietic cells; conversely, genetic marking of hematopoietic stem and progenitor cells has provided novel insights into lineage relationships, stem cell dynamics, and stem cell numbers in vivo that are applicable to gene therapy, stem cell transplantation, and other clinical interventions. For over twenty years, the laboratory has had the privilege of utilizing a rhesus macaque transplantation model. The facility is one of only a handful worldwide able to successfully support non-human primates through stem cell transplantation. This model provides unique and highly relevant insights into hematopoiesis and has resulted in successful optimization of gene and cell therapy approaches later translated successfully into human clinical trials. The proposed acquisition will give the lab enhanced ability to perform small volume apheresis procedures that are high risk and require careful balance between hemodynamic fluid and anti-coagulation monitoring. PURPOSE The purpose of this acquisition is to procure an Amicus apheresis machine that will allow the lab to continue performing research for protocol H-0136R3 (Gene transfer into non-human primate hematopoietic cells). In order to release primitive CD34+ hematopoietic cells from the bone marrow into peripheral blood an apheresis must be performed. PROCUREMENT The contractor shall provide the following equipment: - Amicus Device for MNC and TPE - Amicus Mononuclear Cell Kit (MNC) (x6) JUSTIFICATION Through the market research performed, we have determined that Fenwal, Inc. is the only vendor currently offering an apheresis machine that meets all of the capability requirements of the Hematology Branch. Moreover, the branch up until now has used a Fenwal, Inc. apheresis machine to perform procedures under a clinical protocol. It is imperative that the lab purchase a similar machine in order to maintain continuity and the integrity of their data. REGULATORY AUTHORITY This acquisition is conducted under the authority of the Federal Acquisition Regulations (FAR) Subpart 13.106-1(b), soliciting from a single source (for purchases not exceeding the simplified acquisition threshold) and only one responsible source and no other supplies or services will satisfy agency requirements. ADDITIONAL INFORMATION Industry Classification (NAICS) Code is 339113, Surgical Appliance and Supplies Manufacturing, and the Small Business Size Standard is 750 employees. The acquisition is being conducted under FAR Part 13, Simplified Acquisition Procedures, therefore the requirements of FAR Part 6, Competitive Requirements, are not applicable (FAR Part 6.001). The resultant award will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 05-88 (June 15th, 2016). This synopsis is not a request for competitive proposals. However, interested parties may identify their interest and capability to respond to this notice. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Dun & Bradstreet Number (DUNS), the Taxpayer Identification Number (TIN), and the certification of business size. All offerors must have an active registration in the System for Award Management (SAM) www.sam.gov. A determination by the Government not to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government. The information received will normally be considered solely for the purposes of determining whether to proceed on a non-competitive basis or to conduct a competitive procurement. All responses must be received by July 11, 2016 at 9:00AM EST and must reference synopsis number NHLBI-CSB-(HL)-2016-198-KMA. Responses shall be submitted to the National Heart, Lung, and Blood Institute, Office of Acquisitions, COAC Services Branch, 6701 Rockledge Drive, Room 6127, Bethesda, Maryland 20892-7902, Attention: Kevin Alvarez. Responses may be submitted electronically to
contact@example.gov. Faxes will not be accepted. Responses will only be accepted if dated and signed by an authorized company representative. "All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency."
