Inactive

INTRODUCTION THIS 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 Nat... INTRODUCTION THIS 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 Center for Cellular Engineering (CCE), 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: Global Life Sciences Solutions USA, LLC. 100 Results Way Marlborough, MA, 01752-3078 UNITED STATES. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 325413 with a Size Standard $20.5 million. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2021-05 March 10, 2021. 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 AUTHORITY This 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 INFORMATION 1. Title: Global Life Sciences(Cytiva)/ 100x FETAL BOVINE SERUM-CHAR, 500 ML, HEAT INACTIVATED Lot#AF29485596. 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) 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. Objective: To procure the FETAL BOVINE SERUM-CHAR, 500 ML, HEAT INACTIVATED reagents. 4. Delivery: 14 days A.R.O. 5. CONTRACTOR REQUIREMENTS (SCOPE OF WORK): (a) The reagents and disposables may include but not limited to those listed below: -100x Catalog # SH30071.03HI, FETAL BOVINE SERUM-CHAR, 500 ML, HEAT INACTIVATED, Lot #: AF29485596 (b) The Contractor shall supply technical support for all reagents and supplies and their performance characteristics at no additional cost to the Government. Delivery Schedule These reagents and disposables will be shipped Monday through Thursday to: NIH/CC/DTM/Center Cellular Engineering 10 Center Drive. Rm. 3C710 Bethesda, MD 20892-1288 Attention: FANG HUA CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION This 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 Global Life Sciences Solutions USA, LLC. 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 STATEMENT 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 a technical proposal, a cost-price proposal, and 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 June 3rd, 2021, 3:00 PM Eastern time and must reference solicitation number 21-010216. 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."