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: Becton, Dickinson and Company 2350 Qume Dr. San Jose, CA, 95131-1812 UNITED STATES NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 811219 with a Size Standard $22.0 million. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2021-03, February 16, 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: BD /5-years Services Contract for 3 sets of BD FACS Cytometers and 3 sets of BD FACS Lyse Wash Assistants (LWA). 2. Background Information: The Center for Cellular Engineering manufactures cell based therapies for patients who either have 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 FDA mandates that flow cytometry system used in lot release assay before product collection and distributing, processing and testing of drug product must be flow cytometry assay for all cellular products manufactured at CCE. This service contract is required for all the flow cytometry system used for clinical testing. BD is the vendor which provides the service in a manner that complies with FDA mandates and cGMP rules and in a timely fashion. They provide the service as following. Periodically Preventive Maintenance Inspections once or twice/year, including Kits. Emergency on-site service visits on instrument issues raised. Unlimited phone support for instruments, reagents and applications. 4. Delivery: 90 Days A.R.O. CONTRACTOR REQUIREMENTS (SCOPE OF WORK) Work to be performed Independently, and not as an agent of the government, the contractor shall provide necessary personnel, supplies, and services to perform the work required by this contract as set forth in the sections. The contractor shall perform the following: 1. Svc Cont. for FACS flow cytometers and lasers Coverage includes the BD FACSMelody, FACSCanto and FACSCanto II with one Computer Workstation and three lasers for labor, travel expenses and parts (excluding consumable items), for the following: • 2 Preventive Maintenance Inspections during a year, including 2 PM Kits. • 24-hour guaranteed response to a request for emergency on-site service. • Latest software update during the Agreement term. • Unlimited service visits, Monday-Friday, excluding BD Biosciences holidays. • Unlimited telephone support for instruments, reagents and applications will be provided at no additional charge. 2. Svc Cont. for FACSLoader This plan covers the FACSLoader for labor, travel expenses and parts (excluding consumables), for the following: • Unlimited service visits, Monday-Friday, excluding BD Biosciences holidays. • Unlimited telephone support for instruments, reagents and applications will be provided at no additional charge. 3. Svc Cont. LWA System This plan covers the BD FACS Lyse/Wash Assistant (LWA), for travel expenses and parts (excluding consumables), for the following: • 1 Preventive Maintenance Inspections to be performed during a year. • Unlimited service visits, Monday-Friday, excluding holidays. • Unlimited telephone support for instruments, reagents and applications. • Latest software update. • Emergency on-site service response within 24 hours. Parts/Supplies The contractor shall supply all parts and supplies needed for service and maintenance. Labor and Travel The contractor shall provide all labor and travel at no additional cost for the duration of the contract. IT Security Concerns 1. Will the vendor install and/or maintain the equipment/software/hardware on site at NIH? Yes 2. How long will the vendor need to be on site? Depends on the complexity of the problem, the minimum time is 48 hrs. 3. Will the vendor have remote access to any system on site at NIH (e.g. patch management/trouble shooting, etc.)? If so, what remote access technology will the vendor use? No 4. Will the vendor have access (even inadvertently) to PII/PHI data on any NIH systems? No 5. Will the vendor develop a system or hold NIH data off site (at vendor facility)? No Period of Performance: BASE YEAR: 09/18/2021 - 09/17/2022 OPTION YEAR 1: 09/18/2022 - 09/17/2023 OPTION YEAR 2: 09/18/2023 - 09/17/2024 OPTION YEAR 3: 09/18/2024 - 09/17/2025 OPTION YEAR 4: 09/18/2025 - 09/17/2026 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 Becton Dickinson and Company. 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, 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 May 31, 2021, 3:00 PM Eastern time and must reference pre-solicitation number 21-006193. 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."