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: Miltenyi Biotec, Inc. 2303 Lindberg St. Auburn, CA, 95602-9562 NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 334516 with a Size Standard 1000. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2021-02, November 23, 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/ 2x CliniMACS Plus instruments and and 2x CliniMACS PLUS IQ/OQ. 2. Background Information: The Center for Cellular Engineering is an AABB accredited cellular therapy laboratory whose central mission is to provide services to the NIH Institutes in support of more than 50 intramural clinical trials. These services include (1) development, evaluation, and validation of cellular therapies for INDs and (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 by the NIH. To provide these services, CCE operates a core facility for the manufacture, storage, and distribution of cellular therapy products. CCE manufactures cellular therapy products from more than 800 collections from patients and healthy donors per year. The products manufactured by the laboratory are used to treat NIH CC patients with cancer, hematological malignancies, marrow failure, genetic immune disorders and autoimmune diseases. All products are manufactured using current good manufacturing practices (cGMP). The NIH protocols are institutional review board (IRB) approved and in the case of INDs, approval by the US Food and Drug Administration (FDA) for treatment of human subjects. The Center of Cellular Engineering needs to replace equipment that is becoming obsolete with spare parts no longer being manufactured, as a consequence, CCE will soon lose manufacturer support for these older devices.. The Center for Cellular Engineering manufactures cell based therapies for patients who have 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. This contract is to purchase two CliniMACS plus devices with IQ/OQ packages. 3. Purpose or Objective: Purchase of two replacement CliniMACS plus instruments with IQ/OQ package. 4. DELIVERY: 90 DAYS A.R.O. 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. Tasks Delivery of two (2) CliniMACS plus devices IQ/OQ of the two (2) CliniMACS plus devices Sign off on documentation by Center for Cellular Engineering Quality Assurance. The contractor shall conduct the following tasks: Delivery of two (2) CliniMACS plus devices IQ/OQ of the two (2) CliniMACS plus devices Sign off on documentation by Center for Cellular Engineering Quality Assurance The vendor will provide a installation report for review by the Center for Cellular Engineering Quality Assurance team. 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 The manufacturer of the device, Miltenyi Biotec is the sole entity able to perform this maintenance as the software and parts for this device are proprietary. 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 Biotec, Inc. 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), Unique Entity ID, 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 10th, 2022, 4:00 PM Eastern time and must reference solicitation number 22-007717. Responses may be submitted electronically to Ms. 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."