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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). This is... 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). This is not a request for a quotation. A solicitation document will not be issued and quotations will not be requested. 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: ProteinSimple 3001 Orchard PKWY San Jose, CA 95134-2017 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) 2021-07, July 30, 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: ProteinSimple/ Ella Automated Immunoassay System. 2. Background Information: The Center for Cellular Engineering (CCE) is responsible for the manufacture of human cells and tissue-based products utilized in phase I/II clinical protocols for transplantation, adoptive immunotherapy and gene therapy conducted in the Clinical Center at the NIH. Cell processing procedures are tailored to each of the 30 or more different patient-care clinical research protocols supported. Also, regarding Institute research support it: 1)Develops biologics collection and manufacturing processes to support clinical trials, 2) Collects, manufactures and distribute blood components for in vitro research use, 3) Collaboration in the design, planning, execution and data analysis of clinical studies, 4) Collects and manufactures specialized cellular products to support clinical trials and, 5) Develops and evaluate assays for clinical application and biologics safety testing and cellular characterization. The Ella Automated Immunoassay System will be used for Dr. Panch’s research project by performing automated immunoassay and with build-in standard curve, to monitor and track treatment efficiency of immunue thearapy during the manufacturing of CAR-T cells and other engineered cells products. 3. Purpose or Objective: We are seeking to purchase Ella Automated Immunoassay System including installation and training. 4. Delivery: 30 day A.R.O. CONTRACTOR REQUIREMENTS (SCOPE OF WORK) The subject contract shall cover preventive maintenance, support and emergency servicing for the Advia2120i located on 3rd floor, CCE of building 10. The preventive maintenance is required to compliance with manufacturer and FDA 21 CFR 211.67. The Advia2120i Complete Blood Count (CBC) Instrument to test over 15,000 samples per year. The instrument is used to perform blood count on patient serum for both licensed blood products and cellular therapy products. The CBC is strongly regulated by the FDA, without accurate blood counts, patients cannot be treated; no blood products can be licensed. 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 211.67. Performance The Contractor shall install the system to include, at a minimum, un-packaging of all equipment, set-up and hook-up of all equipment, start-up, and demonstration of all required specifications 30-60 days after receipt of goods. The Contractor shall provide qualified personnel to perform the installation and perform all activities necessary to ensure the System is 100% functional and meets original manufactures specifications. The Contractor’s installation personnel shall also perform all diagnostic tests after installation in the presence of the government. All costs associated with the installation to include labor, travel, and other expenses necessary to install the equipment will be borne solely by the contractor at no additional cost to the U.S. Government. The following is the list of items for the system: 1. Ella Automated Immunoassay System. Cat.# 600-100. 2. Ella System Training. Includes a Simple Plex Demo kit (PN: 600-102). Cat.#600-101. 3. Simple Plex System Software with 21 CFR Part 11 compliance tools. Cat.# 600-151. 4. Ella IQ/OQ Validation Service. Cat.#600-104. 5. Freight. Warranty: The contractor shall warrant the entire system for a period of at least [1 year]. The warranty shall include unlimited telephone/e-mail support of the contractor’s obligation to repair or replace the defective item(s). All costs including parts, labor, travel, and other expenses necessary to repair or replace the Ella Automated Immunoassay System shall be borne solely by the contractor at no additional cost to the U.S. Government. 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 ProteinSimple. 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 September 1st, 2021, 1:00 PM Eastern time and must reference solicitation number 21-010807. 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."