SPECIAL NOTICE
65 -- Propionic acidemia, mutation in the propionyl-CoA carboxylase A (PCCA) Patient iPSC cells
- Notice Date
- 7/31/2023 9:17:03 AM
- Notice Type
- Special Notice
- Contracting Office
- NATIONAL INSTITUTES OF HEALTH NIDA Bethesda MD 20892 USA
- ZIP Code
- 20892
- Solicitation Number
- 75N95023Q00575
- Response Due
- 8/10/2023 9:00:00 AM
- Archive Date
- 08/25/2023
- Point of Contact
- Maggie Brant, Phone: 3018271771, KJ Shaikh, Phone: 3014351777
- E-Mail Address
-
maggie.brant@nih.gov, kj.shaikh@nih.gov
(maggie.brant@nih.gov, kj.shaikh@nih.gov)
- Description
- NOTICE OF INTENT to Sole Source SOLICITATION NUMBER: 75N95023Q00575 TITLE: �Propionic acidemia, mutation in the propionyl-CoA carboxylase A (PCCA) Patient iPSC cells CLASSIFICATION CODE: 6505� DRUGS AND BIOLOGICALS NAICS CODE: 325414 -Biological Product (except Diagnostic) Manufacturing RESPONSE DATE: August 10, 2023 at 12:00 PM EST PRIMARY POINT OF CONTACT: Maggie Brant Maggie.brant@nih.gov Phone: 301.827.1771 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 the University of Pittsburgh for propionic acidemia, mutation in the propionyl-CoA carboxylase A (PCCA) Patient iPSC cells. 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) 2023-04 dated June 2, 2023. DESCRIPTION OF REQUIREMENT PURPOSE AND OBJECTIVES: The National Center for Advancing Translational Sciences (NCATS) Platform Vector Gene Therapy (PaVe-GT) pilot project is in need of iPSCs produced from patients with Propionic acidemia, mutation in the propionyl-CoA carboxylase A (PCCA) disease, CRISPR-edited (corrected) iPSC-PCCA lines, and liver cells iPSCs (hepatocytes, endothelial and stellate cells) differentiated from the PCCA patient iPSC.� These PCCA patient-derived iPSC-differentiated liver cells will used to develop an engineered 3D liver tissue model as a physiologically relevant assay platform to test the in vitro efficacy and toxicity of AAV gene vectors being developed by the NCATS PaVe-GT program for the treatment of PCCA patients. SPECIFIC REQUIREMENTS: Generation of patient-iPSCs (Propionic acidemia, mutation in the�propionyl-CoA carboxylase A (PCCA) gene). Patient 1: Female 2 yo, Liver Transplantation 9/20/2020, Patient 2: Male 1 yo, Liver Transplantation 1/6/2021.� iPSCs validation data At least 3 clones per patient. CRISPR-edited (MUT gene) isogenic iPSC-PCCA for correction (control for the PCCA mutant) iPSC validation data. Hepatocyte-directed differentiation and liver non-parenchymal cells (stellate and endothelial cells) of patient PCCA-iPSCs and gene-edited (corrected) isogeneic PCCA-iPSC-lines. Hepatocyte differentiation validation data Stellate and Endothelial differentiation data Define optimal cell densities, media conditions, and length of co-culture time using cell type-specific markers for liver cells derived from PCCA mutant and corrected control lines and basic characterization of co-culture model functionality. This is a custom product that requires access to PCCA patients and expertise to produce IPSC cells and differentiation protocols to produce different liver cells from iPSC. Period of Performance: 6 months 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, the University of Pittsburgh is the only vendor in the marketplace that can provide the products required by NCATS. The intended source is: UNIVERSITY OF PITTSBURGH 4200 FIFTH AVENUE PITTSBURGH, PA 15260-0001 CLOSING STATEMENT THIS SYNOPSIS IS NOT A REQUEST FOR COMPETITIVE PROPOSALS. However, interested parties may identify their interest to receive a Request for Quotation (RFQ) 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 Identifier (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, 75N95023Q00575. Responses must be submitted electronically to Maggie Brant, Contract Specialist, at maggie.brant@nih.gov.� U.S. Mail and fax responses will not be accepted.
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/44a3d2d4a26d436a98aa390d0493734d/view)
- Place of Performance
- Address: PA 15260, USA
- Zip Code: 15260
- Country: USA
- Record
- SN06769572-F 20230802/230731230044 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
| FSG Index | This Issue's Index | Today's SAM Daily Index Page |