SPECIAL NOTICE
65 -- Cryopreserved Human iPSC Derived Neurons
- Notice Date
- 2/8/2022 7:50:52 AM
- Notice Type
- Special Notice
- NAICS
- 325414
— Biological Product (except Diagnostic) Manufacturing
- Contracting Office
- NATIONAL INSTITUTES OF HEALTH NIDA Bethesda MD 20892 USA
- ZIP Code
- 20892
- Solicitation Number
- NCATS-22-002098
- Response Due
- 2/21/2022 9:00:00 AM
- Point of Contact
- Sarah Adan, Phone: 3014805422, Valerie Whipple
- E-Mail Address
-
sarah.adan@nih.gov, valerie.whipple@nih.gov
(sarah.adan@nih.gov, valerie.whipple@nih.gov)
- 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 Institute of Mental Health (NIMH) intends to negotiate on a sole source basis with FUJIFILM Cellular Dynamics, Inc. for Cryopreserved Human iPSC Derived Neurons . 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) 2022-04 dated January 30, 2022. DESCRIPTION OF REQUIREMENT PURPOSE AND OBJECTIVES: The Therapeutic Development Branch (TBD) 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 determine neurotoxicity in a 3D culture, pilot studies using �designer� neuronal spheroids to mimic different brain regions were generated in house using FCDI iCell cryopreserved neurons derived from human induced pluripotent stem cells (iPSCs) (from non-fetal tissue source). High throughput calcium imaging assays were conducted to measure changes in neuronal activity following treatment with ASO for toxicity screening. For the next phase of this study, enough neurons to generate (10) 384-well plates will be required for calcium imaging assays for ASO toxicity screens. SPECIFIC REQUIREMENTS: ????? 1)�� �Trade name: iPSC Astrocyte Kit Brand name: iCell Astrocytes Kit Manufacture: FCDI Model: Kit, Donor 01434� Catalog: R1092 2)�� �Trade name: iPSC Glutamatergic neuron kit Brand name: iCell GlutaNeurons Kit Manufacture: FCDI Model: Kit, Donor 01279, 1 Vial: ? 6 x 106 cells/vial Catalog: R1034 3)�� �Trade name: IPSC Gabaergic neuron Kit Brand name: iCell GABANeurons Kit Manufacture: FCDI Model: Kit, Donor 01279, 1 Vial: ? 4 x 106 cells/vial Catalog: R1011 4)�� �Trade name: IPSC Gabaergic neurons Brand name: iCell GABANeuron vials Manufacture: FCDI Model: Donor 01279, 1 Vial: ? 4 x 106 cells/vial Catalog: C1008 5)�� �Trade name: IPSC Dopaminergic neuron kit Brand name: iCell DopaNeurons Kit Manufacture: FCDI Model: Kit, Donor 01279, 1 Vial: ? 5 x 106 cells/vial Catalog: R1032 6)�� �Trade name: IPSC Dopaminergic neurons Brand name: iCell DopaNeuron vials Manufacture: FCDI Model: Donor 01279, 1 Vial: ? 5 x 106 cells/vial Catalog: C1028 Quantity:� (10) iCell Astrocytes Kit, Cat# R1092 (5) iCell GlutaNeurons Kit, Cat# R1034 (5) iCell GABANeurons Kit, Cat# R1011 (5) iCell GABANeurons vials, Cat# C1008 (5) iCell DopaNeurons Kit, Cat# R1032 (5) iCell DopaNeuron vials, Cat# C1028� � Delivery Date: Within 30 working days of date of award 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, NCATS-22-002098. Responses must be submitted electronically to Sarah Adan, Contract Specialist, at sarah.adan@nih.gov and Valerie Whipple, Contracting Officer, at valerie.whipple@nih.gov.� U.S. Mail and fax responses will not be accepted.
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/bc5872349dad4e8a96fe73ecc98e1cb0/view)
- Place of Performance
- Address: Madison, WI 53711, USA
- Zip Code: 53711
- Country: USA
- Zip Code: 53711
- Record
- SN06235810-F 20220210/220209211714 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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