Inactive

NOTICE OF INTENT to Sole Source SOLICITATION NUMBER: 75N95023Q00488 TITLE: Generation of iPSC clones for small molecule screening CLASSIFICATION CODE: 6505 – Drugs and Biologicals NAICS CODE: 541714 –... NOTICE OF INTENT to Sole Source SOLICITATION NUMBER: 75N95023Q00488 TITLE: Generation of iPSC clones for small molecule screening CLASSIFICATION CODE: 6505 – Drugs and Biologicals NAICS CODE: 541714 – Research and Development in Biotechnology (except Nanobiotechnology) RESPONSE DATE: July 25, 2023, 1 pm EST PRIMARY POINT OF CONTACT: Giuliana C. Faller Giuliana.faller@nih.gov Phone: 301-480-9789 DESCRIPTION: INTRODUCTION THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME). The NCATS Early Translation Branch (ETB) collaborates with investigators at NIH and in the academic, biopharmaceutical and nonprofit sectors to generate probes for studying a diverse cross-section of human biology, focusing specifically on new targets and untreatable diseases. The project team is collaboratively developing high-throughput screening assays to identify small molecules that improve function of macrophages. This requisition is to procure a a set of edited iPSC cell lines, with subsequent isolation and expansion from a single cell (clonal population) that can be used to differentiate into macrophages. The experimental procedure has been optimized for use with the 802-30F cell line, which is provided and can be engineered by Synthego. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE and SET ASIDE STATUS The intended procurement is classified under NAICS code 514741 – Research and Development in Biotechnology (except Nanobiotechnology) with a Size Standard of 1,000 Employees. REGULATORY AUTHORITY This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures. Contracts awarded using FAR Part 13—Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6—Competition Requirements. FAR Subpart 13.106-1 (b) Soliciting from a single source provides that: For purchases not exceeding the simplified acquisition threshold, Contracting Officers may solicit from one source IF the contracting officer determines that the circumstances of the contract action deem only one source reasonably available (e.g., urgency, exclusive licensing agreements, brand-name OR industrial mobilization). The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2023-04 dated June 2, 2023. DESCRIPTION OF REQUIREMENT PURPOSE AND OBJECTIVES: The purpose of this project is to generate clonal iPSC lines that can be differentiated into relevant cell types for high-throughput small molecule discovery work from Synthego Corp CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION The NCATS Early Translation Branch (ETB) collaborates with investigators at NIH and in the academic, biopharmaceutical and nonprofit sectors to generate probes for studying a diverse cross-section of human biology, focusing specifically on new targets and untreatable diseases. The project team is collaboratively developing high-throughput screening assays to identify small molecules that improve function of macrophages. This requisition is to procure a a set of edited iPSC cell lines, with subsequent isolation and expansion from a single cell (clonal population) that can be used to differentiate into macrophages. The experimental procedure has been optimized for use with the 802-30F cell line, which is provided and can be engineered by Synthego. Additionally, several edits to the genome have already been made by Synthego, and NCATS requires taking the mixed population of cells to clones. Purchasing an alternate would require re-engineering of the cell line and re-optimization of the experimental procedure, both of which would require substantial cost of effort and time. The essential characteristics the edited human cell lines that limit the availability to a sole source are 1) 802-30F iPSC cell model provided by vendor 2) capacity to perform edits (single nucleotide substitutions and small insertions) in 802-30F cells in complex genomic regions including GBA1 and 3) derivation of clonal cell populations from cell line that was previously edited by Synthego. Substituting an alternative product would require significant experimental reoptimization and cost (time and reagents). The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted. Specifically, Synthego Corp., is the only vendor in the marketplace that can provide the services required by NCATS in the interest of continuity of science The intended source is: Synthego Corp 3696 Haven Ave, Suite A - Redwood City, CA 94063 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. 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. All responsible sources may submit a capability statement, proposal, or quotation which shall be considered by the agency. 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. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: unit price, list price, shipping and handling costs, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Unique Entity ID (UEI), 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. All responses must be received by the closing date and time of this announcement and must reference the solicitation number 75N95023Q00488. Responses must be submitted electronically to Giuliana Faller, Contract Specialist, at giuliana.faller@nih.gov. U.S. Mail and fax responses will not be accepted.