Life Tech / Various reagents.

INTRODUCTIONTHIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME).The National Institutes of Health (NIH), Clinical Center (CC), Office of Purchasing and Contracts (OPC) on behalf of the Department of Transfusion Medicine (DTM), Clinical Center (CC) at the National Institutes of Health (NIH) intends to negotiate and award a contract without providing for full and open competition (including brand-name) to:Life Technologies Corporation3175 Staley RoadIsland, New York 14072 USANORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODEThe intended procurement is classified under NAICS code 325413 with a Size Standard 1,250.  PSC 6550REGULATORY AUTHORITYThe resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2020-08, July 14, 2020. This acquisition is conducted under the procedures as

prescribed in FAR subpart 13-Simplified Acquisition Procedures at an amount not exceeding the simplified acquisition threshold.STATUTORY AUTHORITYThis acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures, Subpart 13.106-1 (b) (1), Soliciting from a single source and is not expected to exceed the simplified acquisition threshold. Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements.GENERAL INFORMATION1. Title: Life Tech / Various reagents.2. Background Information:  The Center for Cellular Engineering (CCE), Department of Transfusion Medicine, NIH Clinical Center (CC) is an AABB accredited cellular therapy laboratory whose central mission is to provide services to the NIH Institutes to support their intramural clinical trials. These services include (1) performing research aimed at development, evaluation and validation of new manufacturing processes for cellular therapies (2) manufacture of cellular therapy products for approved clinical trials. The majority of these trials are early phase (I/II) 2 trials not intended to result in the development of a commercial product. CCE produces clinical therapies from cells collected from NIH CC patients and healthy donors. The product manufactured in this project by the laboratory is retinal pigment epithelium (RPE) generated from patient’s blood cells. This product (RPE) will be used to treat age-related macular degeneration. The above listed reagents are required in the manufacturing process of this product. RPE will be manufactured using US Food and Drug Administration (FDA) guidelines for good manufacturing practices (GMP). It will require review and approval for use as an investigational new drug (IND) by the FDA.3. Purpose or Objective: The reagents are required at different stages of manufacturing to be fed to the cells in culture.4. Deliver before 1/25/2021.CONTRACTOR REQUIREMENTS (SCOPE OF WORK)                            The reagents and disposables may include but not limited to those listed below:50x Essential 8 medium kit100x CTS Vitronectin Recombinant Human Protein20x DMEM NUTRIENT MIX F12 500ML10x TRYPLE TM SELECT CTS TM 100ML10x Sodium Pyruvate1x MEM NEAA, 100X1x EDTA BUFFER, PH 8, 0.5M 4 X 100ML2. The Contractor shall supply technical support for all reagents and supplies and their performance characteristics at no additional cost to the Government.Delivery ScheduleThese reagents and disposables will be shipped Monday through Thursday to:          NIH/CC/DTM/Center Cellular Engineering          10 Center Drive Bldg. Rm. 3C710          Bethesda, MD 20892-1288          Attention:  FANG HUAShipments will use government carrier at the expense of the government unless otherwise arranged.The contractor shall bear the cost of replacement for reagents found to be damaged or defective upon receipt by NIH or for incorrect or incomplete shipments.Government Responsibilities1.       The Center Cellular Engineering shall use the reagents in accordance with manufacturer’s package inserts and approved IND/IDE uses if applicable.2.       The NIH CC Center Cellular Engineering shall inspect shipments upon receipt and report any damage, defects or errors in shipment to the contractor. CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATIONThis system is on site and has been validated for use on CC patients.  It would be detrimental to the government to attempt to change systems and quite impossible as these instruments are proprietary and only distributed by Life Technologies.  With the continuation of using the same system will also help reduces the risk of a disruption in patient care. The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted as prescribed in FAR Part 10-Market Research.CLOSING STATEMENTThis 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 a technical proposal, a cost-price proposal, the period of performance, 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 January 15th, 2021, 2:00 PM Eastern time and must reference solicitation number 21-004018. Responses may be submitted electronically to Mrs. Grace Wong-Darko, Contracting Specialist at Grace.Wong-Darko@nih.gov. Fax responses will not be accepted."All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency."