ICell Motor Neurons Kit

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 Center for Advancing Translational Sciences (NCATS) intends to negotiate on a sole source basis with FUJIFILM Cellular Dynamics, Inc. for a quantity of fifty (5) iCell Motor Neurons Kits.

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

The intended procurement is classified under NAICS code 325414 – Biological Product (except Diagnostic) Manufacturing with a Size Standard of 1,250 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) 2022-06 dated May 26, 2022.

DESCRIPTION OF REQUIREMENT

PURPOSE AND OBJECTIVES:

The Therapeutic Development Branch (TDB) requires iCell motor neuron kits on a brand-name only basis for generating electrically active cultures that will be used in microelectrode array assays for toxicity screening for the N=1 Ionis ASO collaborative project.

The Therapeutic Development Branch (TDB) within the National Center for Advancing Translational Sciences (NCATS) Division of Preclinical Innovation (DPI) collaborative project with Ionis is aimed at developing assays for predictive toxicity of antisense oligonucleotides (ASOs). To predict neurotoxicity in 2D culture, pilot studies using human induced pluripotent stem cell (IPSC)-derived (from non-fetal tissue source) spinal motor neurons suggest neuronal activity in microelectrode array (MEA) assays is impacted by treatment with neurotoxic ASOs.

These recently completed pilot studies using iPSC neurons from FCDI (POTS# 22-001605, 22-003110) established the optimal culture conditions for measuring activity, such as cell density and timing of ASO exposure. The optimal number of kits (includes nutrients required for cell culture) to generate a 48-well plate was also determined. For the next phase of this study, enough neurons to generate 25 48-well plates will be required for MEA assays for ASO toxicity screens.

SPECIFIC REQUIREMENTS:

1. Trade name: iPSC Motor Neuron Kit

Brand Name: iCell Motor Neurons Kit

Manufacturer: Fujifilm Cellular Dynamics Inc.

Model: Kit, Donor 01279

Catalog Number: R1049

Quantity:

Fifty (50)

Delivery Date:

Within 30 days after receipt of order (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. is the only vendor in the marketplace that can provide the products required by NCATS.

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 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.

All responses must be received by the closing date and time of this announcement and must reference the solicitation number, 75N95022Q00345 Responses must be submitted electronically to Chandani Hangilipola, Contract Specialist, at chandani.hangilipola@nih.gov. U.S. Mail and fax responses will not be accepted.