iPSC derived human neurons and astrocytes for use in DPI-APP_Biology Antiviral Drug Development IDDA DPI (8051491)

NOTICE OF INTENT to Sole Source
COVID-19
1.    SOLICITATION NUMBER:
NCATS-22-005552
2.    TITLE:  Cryopreserved Human iPSC Derived Neurons 

3.    CLASSIFICATION CODE:
65 -- Medical, dental & veterinary equipment & supplies
NAICS CODE: 325414 – Biological Product (except Diagnostic) Manufacturing
RESPONSE DATE:
July 11, 2022 at 3:00 PM EST
4.    PRIMARY POINT OF CONTACT:
Michelle Cecilia
michelle.cecilia@nih.gov
Phone: 301.827.7199
5.    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) intends to negotiate on a sole source basis with FUJIFILM Cellular Dynamics, Inc. for iPSC derived human neurons and astrocytes for use in DPI-APP Biology  Antiviral Drug Development IDDA DPI (8051491).

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 1250 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 Antiviral Program for Pandemics is tasked with identifying and developing antivirals for a variety of viruses of outbreak and pandemic potential, including a number of neurotrophic viruses (e.g. encephalitic bunyavirales viruses, flaviviruses, alphaviruses). We have developed a robust HTS compatible neuronal spheroid model using iPSC derived neurons (glutamatergic, GABAergic, and dopaminergic) and iPSC derived astrocytes for robust cultures for investigating viral infection. We have developed this model specifically using FujiFilm/CDI iPSC derived neurons and astrocytes.

SPECIFIC REQUIREMENTS:
1)    Trade name: iCell Astrocytes Kit, 01434
Brand name: iCell Astrocytes Kit, 01434
Manufacture: FCDI
Catalog: R1092
Quantity: 20 vials

2)    Trade name: iCell DopaNeurons Kit, 01279
Brand name: iCell DopaNeurons Kit, 01279
Manufacture: FCDI
Catalog: R1088
Quantity: 20 vials

3)    Trade name: iCell DopaNeurons Kit, 01279
Brand name: iCell DopaNeurons Kit, 01279
Manufacture: FCDI
Catalog: R1032
Quantity: 10 vials

4)    Trade name: iCell GABANeurons Kit, 01279
Brand name: iCell GABANeurons Kit, 01279
Manufacture: FCDI
Catalog: R1013
Quantity: 15 vials

5)    Trade name: iCell GABANeurons Kit, 01279
Brand name: iCell GABANeurons Kit, 01279
Manufacture: FCDI
Catalog: R1013
Quantity: 15 vials

6)    Trade name: iCell GlutaNeurons Kit, 01279
Brand name: iCell GlutaNeurons Kit, 01279
Manufacture: FCDI
Catalog: R1061
Quantity: 20 vials

7)    Trade name: iCell GlutaNeurons Kit, 01279
Brand name: iCell GlutaNeurons Kit, 01279
Manufacture: FCDI
Catalog: R1034
Quantity: 10 vials

Delivery Date: Three Weeks 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, 75N95022Q00355. Responses must be submitted electronically to Michelle Cecilia, Contracting Officer, at michelle.cecilia@nih.gov.  U.S. Mail and fax responses will not be accepted.