NOTICE OF INTENT to Sole Source_cardiomyocytes_v2.docx

NOTICE OF INTENT to Sole Source

1. SOLICITATION NUMBER:

75N95020Q00266

2. TITLE: Cardiomyocytes for Cardiac Toxicity Evaluation

3. CLASSIFICATION CODE:

6640 (Laboratory Equipment and Supplies)

4. NAICS CODE:

541714

5. RESPONSE DATE:

9/21/2020 12:00 pm Eastern Time

6. PRIMARY POINT OF CONTACT:

Scott Duernberger scott.duernberger@nih.gov Phone: 301-594-0670

7. 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 National Center for Advancing Translational Sciences (NCATS), Office Therapeutic Development Brand, intends to award a sole source contract under the authority of Federal Acquisition Regulation (FAR) 6.302-1, Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements. This contract will be awarded to FUJIFILM Cellular Dynamics, Inc, 525 Science Dr. Madison, WI 53711], for award on or around September 20, 2020. The purpose of this acquisition is to procure twenty-five (25) iCell® Cardiomyocytes2 kits for cardiac toxicity evaluation in NCATS TDB bio program.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE and SET ASIDE STATUS The intended procurement is classified under NAICS code 541714 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) 2020-01 dated November 12, 2019.

DESCRIPTION OF REQUIREMENT PURPOSE AND OBJECTIVES:

The purpose of this acquisition is to procure twenty-five (25) iCell® Cardiomyocytes2 kits for cardiac toxicity evaluation in NCATS TDB bio program. The iCell cardiomyocyte is the commonly used widely accepted human iPS-derived cardiac model and is used to evaluate the cardiac toxicity of a set of compounds in combination with the impedance technology. This project will assess the compound effects on cardio cells from both electrophysiological and contractile aspects.

PROJECT REQUIREMENTS:

The Contractor shall provide twenty-five (25) iCell® Cardiomyocytes2 kits for cardiac toxicity evaluation. Requirements include:

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 supplies required by NCATS.

In accordance with FAR part 10, extensive market research was conducted to reach this determination. Specifically, contacts with knowledgeable individuals both in industry and Government, as well as reviews of available product literature, revealed no other sources. Finally a review of responses and of previous government acquisitions returned no results that meet all of the requirements. Therefore, only FUJIFILM Cellular Dynamics, Inc. is capable of meeting the needs of this requirement.

The intended source is:

FUJIFILM Cellular 525 Science Dr.

Madison, WI 53711 United States of America

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, 75N95020Q00266. Responses must be submitted electronically to Scott Duernberger, Contract Specialist, at scott.duernberger@nih.gov. U.S. Mail and Fax responses will not be accepted.