SAMDaily.us | PRESOL | 65 | One Lambda/ Various and reagents.

SAMDAILY.US - ISSUE OF MAY 19, 2022 SAM #7475
SOLICITATION NOTICE

65 -- One Lambda/ Various and reagents.

Notice Date: 5/17/2022 7:54:22 AM
Notice Type: Presolicitation
NAICS: 325413 — In-Vitro Diagnostic Substance Manufacturing
Contracting Office: NATIONAL INSTITUTES OF HEALTH - CC BETHESDA MD 20892 USA
ZIP Code: 20892
Solicitation Number: 22-008569
Response Due: 5/31/2022 8:00:00 AM
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 not a request for a quotation. A solicitation document will not be issued and quotations will not be requested. 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: One Lambda, Inc. 22801 Roscoe BLVD West Hills, California 91304-3200, United States NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 325413 with a Size Standard 1,250. � REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2022-04 January 30, 2022. 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: One Lambda/ Various and reagents. 2. Background Information:� The Center for Cell Engineering (CCE), a part of Clinical Center 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. We will perform cell metabolic analysis of CAR-T cell and other type of engineered cell products which manufactured at CCE to create standard parameters and monitor cell viability and metabolic environment to ensure the cell growth in health condition and cell product pass QC for clinical sample of lot release. The LABType SSO Class I and Class II kits are for genotyping on clinical samples which manufactured at CCE. 3. Purpose or Objective: The purpose of acquiring LABType SSO Class I and Class II genotyping reagent and kit is to perform genotyping analysis of CAR-T cell and other type of engineered cell products which manufactured at CCE to investigate how the genotype of cells affect efficiency of engineered cell products. 4. Delivery: ��90 days A.R.O. 5. CONTRACTOR REQUIREMENTS SCOPE: 1.�� The contractor will supply sufficient reagents and kits to process numerous assay samples per year. 2.�� The reagents and kits may include listed below: Cat#�� Total QTY. ��Description� �� RSSO1A ��5 �� LABType� SSO Class I A Locus Typing Test RSSO1B ��5 �� LABType� SSO Class I B Locus Typing Test RSSO1C ��5 �� LABType� SSO Class I C Locus Typing Test RSSO2B1�� 5�� LABType� SSO Class II DRB1 Typing Test RSSO2345�� 5�� LABType� SSO Class II DRB3,4,5 Typing Test RSSO2Q�� 5�� LABType� SSO Class II DQA1/DQB1 Typing Test LT-SAPE�� 2�� PE - Conjugated Streptavidin 3. �The Contractor shall supply technical support for all reagents and their performance characteristics at no additional cost to the Government. 6. Inspections and Acceptance Requirements Nu Cha from the CC DTM will �� Receive reagents and kits under the appropriate conditions �� That the packaging integrity is not compromised �� That all ordered materials have arrived �� That serial numbers match the documentation �� Any discrepancies are reported to One Lambda Logistical Requirements �� All materials will be delivered to the �DTM NIH/CC �10 Center Drive � Bldg. 10/ Rm. 1C744 � Bethesda, MD 20892-1288 � Attention: Nu Cha Deliveries are 9 AM to 5:30 PM and must be signed for. �� All packaging must be intact and a packing slip with serial numbers and certificates of analysis. Government Responsibilities The Center for Cellular Engineering (CCE) shall use the reagents and disposables in accordance with manufacturer�s package inserts and approved IND/IDE uses if applicable. The NIH CC Center for Cellular Engineering (CCE) shall inspect shipments upon receipt and report any damage, defects or errors in shipment to the contractor.� 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 One Lambda, Inc.� With the continuation of using the same supplies 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 May 31st, 2022, 11:00 AM Eastern time and must reference solicitation number 22-008569. 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://sam.gov/opp/7e2cbbfe156946a7b4b935efc6e70c74/view)
Place of Performance: Address: West Hills, CA 91304, USA; Zip Code: 91304; Country: USA
Record: SN06329808-F 20220519/220517230105 (samdaily.us)
Source: SAM.gov Link to This Notice
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65 -- One Lambda/ Various and reagents.