SAMDaily.us | PRESOL | 65 | Sefia S-2000 Cell Separation System with software.

SAMDAILY.US - ISSUE OF MARCH 14, 2020 SAM #6680
SOLICITATION NOTICE

65 -- Sefia S-2000 Cell Separation System with software.

Notice Date: 3/12/2020 7:18:25 AM
Notice Type: Presolicitation
NAICS: 334516 — Analytical Laboratory Instrument Manufacturing
Contracting Office: NATIONAL INSTITUTES OF HEALTH - CC BETHESDA MD 20892 USA
ZIP Code: 20892
Solicitation Number: 20-006612
Response Due: 3/24/2020 7:30:00 AM
Archive Date: 04/08/2020
Point of Contact: Grace Wong-Darko, Phone: 3014961199
E-Mail Address: Grace.Wong-Darko@nih.gov
(Grace.Wong-Darko@nih.gov)
Description: 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 Department of Transfusion Medicine (DTM), 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 334516 with a Size Standard 1000 employees. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2020-3, December 13, 2019. 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: Sefia S-2000 Cell Separation System with software. 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 and is no longer manufactured and will soon lose support in terms of disposable supplies from the manufacturer. This project is to replace this equipment prior to that date to allow continuity of operations across the phase out period. 3. Purpose or Objective: Purchase of Sefia Cell Processing System from Global Life Sciences Solutions USA LLC with installation and Operational Qualification package. 4. Delivery: 90 days A.R.O. CONTRACTOR REQUIREMENTS (SCOPE OF WORK) 1. Requirements The deliverables are the device, the two software packages and a completed IOQ binder documenting that the device meets the expectations listed on the installation and operational qualification tests.� 1x Sefia S-2000 �� 1x FlexCell Sefia Protocol Software�� 1x PremierCell Protocol Software�� 1x Commisioning and Qualification Performance �� 1 Binder IQOQ Sefia 2.� �� References These operations are regulated by the Current Good Manufacturing Practices (cGMPs) as mandated by the FDA in 21 CFR 210, 211, 600 and 1271. 3.� �� Tasks The contractor shall conduct the following tasks: List the tasks (no. and name) in sequential order by phase (if applicable).� Provide sufficient level of detail to enable the prospective contractor to plan personnel utilization and other requirements with maximum efficiency. Delivery of device Installation of FlexCell Protocol Installation of PremierCell Protocol Performance of Installation Qualification Performance of Operational Qualification Delivery of binder documenting acceptance of installation and operational qualification. Installation and operational qualification will occur in building 10 the Center for Cellular Engineering. Sign off on documentation by Center for Cellular Engineering Quality Assurance. 4. Progress/Compliance The Government requires the following from contractors in order to monitor progress and ensure compliance: �� Weekly Status Report�� Weekly Meetings �� Monthly Progress Report �� Project Management Team (PMT) Meetings �� Program Reviews �� Outlines and Drafts 5. Transmittal/Delivery/Accessibility The contractor shall provide [1] hard copies of each deliverable and one electronic version. CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION This clinical research trial is ongoing and utilizing Sefia S-2000 Cell Separation System �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 March 23, 2020, 10:30 AM Eastern time and must reference pre-solicitation number 20-006612. 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.""
Web Link: SAM.gov Permalink
(https://beta.sam.gov/opp/595e513a616d4e70af7cea84144ab504/view)
Place of Performance: Address: Bethesda, MD 20892, USA; Zip Code: 20892; Country: USA
Record: SN05587695-F 20200314/200312230147 (samdaily.us)
Source: SAM.gov Link to This Notice
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65 -- Sefia S-2000 Cell Separation System with software.