Notice of Intent to Sole Source: FCDI iCell Neurons and supplements for neurotoxicity screening

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 National Institute on Drug Abuse (NIDA), Office of Acquisition (OA) the National Center for Advancing Translational Sciences (NCATS), intends to negotiate and award a purchase order without providing for full and open competition (including brand-name) to FujiFilm Cellular Dynamics Inc 525 Science Dr Madison WI 53711 for FCDI iCell Neurons and supplements for neurotoxicity screening.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE and SET ASIDE STATUS

The intended procurement is classified under NAICS 325414 Research and Development in Biotechnology with a Size Standard of 1,250.  

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) 2022-08 dated October 22, 2022.

DESCRIPTION OF REQUIREMENT

PURPOSE AND OBJECTIVES:

The purpose of this procurement is the acquisition of FCDI iCell neurons and supplements for neurotoxicity screening.

Purchase Description:

The Therapeutic Development Branch (TBD) within the National Center for Advancing Translational Sciences (NCATS) Division of Preclinical Innovation (DPI) is aimed at developing assays for predictive toxicity of antisense oligonucleotides (ASOs). 2D cultures using human induced pluripotent stem cell (hiPSC)-derived neurons (from non-fetal tissue source) have been adapted and extensively optimized by NCATS scientist to successfully predict neurotoxicity of ASOs.

2D hiPSC-derived spinal motor neurons co-cultured with astrocytes on 48-well microelectrode array (MEA) plates allows spontaneous electrical activity to be measured over the course of the culture. Changes in neuronal firing following ASO treatment can be quantified to determine acute neurotoxicity and is typically used as a secondary screen for hits detected with 3D cultures.

Previous optimization of both neuronal 2D (POTS: 24-002733) cultures have established the optimal number of neurons for both types of cultures to screen ASOs for neurotoxicity and have been used to successful complete early Milestone of the ongoing project ((N=1 General) (POTS: 24-002733). In order to complete the remaining milestones enough hiPSC neurons and supplements for 2D culture plates are needed and is a requirement to meet the goals of this project (N=1 General).

Trade name: iPSC Astrocyte Kit

Brand name: iCell Astrocytes Kit

Manufacture: FCDI

Model: Kit, Donor 01434, 1 Vial: ≥ 1 x 10^6 cells/vial

Catalog: R1092

Trade name: iPSC Motor Neuron Kit

Brand name: iCell Motor Neurons Kit

Manufacturer: FCDI

Model: Kit, Donor 01279, 1 Vial: ≥ 3 x 10^6 cells/vial

Catalog: R1049

Trade name: Growth factor supplement for neuronal cell types

Brand name: iCell Nervous System Supplement

Manufacturer: FCDI

Model: NA

Catalog: M1031

Trade name: Neuronal medium supplement, serum-free

Brand name: iCell Neural Supplement A

Manufacturer: FCDI

Model: NA

Catalog: M1032

iPSCs that are derived from the same patient as cells used in other assays reduces the impact of genetic diversity on assay variability.

(7) iCell Astrocytes Kit, Cat# R1092

(7) iCell Motor Neurons Kit, Cat# R1049

(20) iCell Nervous System Supplement, Cat# M1031

(15) iCell Neural Supplement A, Cat# M1032

ESTIMATED PERIOD OF PERFORMANCE:

30 Days ARO

CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION

The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted. Specifically, FujiFilm Cellular Dynamics Inc 525 Science Dr Madison WI 53711 is the only vendor in the marketplace that can provide the services required by NIDA .

The intended source is:

FujiFilm Cellular Dynamics Inc 525 Science Dr Madison WI 53711

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, 75N95024Q00531. Responses must be submitted electronically to Kaitlyn Landi, Contract Specialist, at kaitlyn.landi@nih.gov and KJ Shaikh, Contracting Officer, at kj.shaikh@nih.gov.  U.S. Mail and fax responses will not be accepted.