Inactive

INTRODUCTION THIS IS A PRE-SOLICITATION COMPETITION TO AWARD A CONTRACT OR PURCHASE ORDER. The National Institutes of Health (NIH), Clinical Center (CC), Office of Purchasing and Contracts (OPC) on be... INTRODUCTION THIS IS A PRE-SOLICITATION COMPETITION TO AWARD A CONTRACT OR PURCHASE ORDER. 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: NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 811219 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) 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 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: Miltenyi/ MACSQUANT Tyto cell sorter instrument Maintenance Agreement 2. Background Information: The Center for Cellular Engineering manufactures cell based therapies for patients who either no, or have exhausted all other standard treatment options. The manufacturing operations are regulated by the Current Good Manufacturing Practices (cGMPs) as mandated by the FDA in 21 CFR 210, 211, 600 and 1271. The manufacturing operations are regulated by the Current Good Manufacturing Practices (cGMPs) as mandated by the FDA in 21 CFR 210, 211, 600 and 1271. The FDA mandates that critical equipment used in the manufacturing, processing and testing of drug product must be maintained in a controlled manner (21 CFR 211.63, 21 CFR 211.67). 3. Purpose or Objective: Preventative maintenance services for a MACSQUANT Tyto cell sorter (10076) located in the Center for Cellular Engineering Production Facility where it is used to manufacture cell based therapies for patients. 4. Period of Performance: 12/1/20 to 11/30/23. CONTRACTOR REQUIREMENTS (SCOPE OF WORK) The FDA mandates that critical equipment used in the manufacturing, processing and testing of drug product must be maintained in a controlled manner 21 CFR 211.63, 21 CFR 211.67. Performance Requirements/Work Areas The vendor will provide a maintenance report for review by the Center for Cellular Engineering Quality Assurance team. The Vendor will ensure the devices are appropriately calibrated and operating within the design specifications and therefore will produce the desired outcomes in the center for cellular engineering manufacturing protocols. The contractor shall conduct the following tasks: The vendor will preventative maintenance on the MACSQUANT Tyto closed system cell sorter (10076)). The vendor will provide a preventative maintenance report for review by the Center for Cellular Engineering Quality Assurance team. The vendor will provide full preventative maintenance report for this device. The Vendor will ensure the devices are appropriately calibrated and operating within the design specifications and therefore will produce the desired outcomes in the center for cellular engineering manufacturing protocols. 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 Miltenyi. 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 October 30th, 2020, 9:45 AM Eastern time and must reference solicitation number 21-000133. 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."