Loren Data's SAM Daily™

SAMDAILY.US - ISSUE OF OCTOBER 28, 2023 SAM #8005
SPECIAL NOTICE

65 -- Building disease model on TDP43 mediated ALS/FTD human cortical organoids using floating method.

Notice Date

10/26/2023 2:09:34 PM
 

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
 

Response Due

11/2/2023 1:30:00 PM
 

Archive Date

11/17/2023
 

Point of Contact

GIULIANA CAZETTA FALLER, Phone: 3014809789
 

E-Mail Address

giuliana.faller@nih.gov
(giuliana.faller@nih.gov)
 

Description

1. SOLICITATION NUMBER: 75N95024Q00015 2. TITLE: Building disease model on TDP43 mediated ALS/FTD human cortical organoids using floating method. 3. CLASSIFICATION CODE: 6505 � Drugs and Biologicals NAICS CODE: 325414 � Biological Product (Except Diagnostic) Manufacturing 4. RESPONSE DATE: November 2, 2023, 4:30 pm EST 5. PRIMARY POINT OF CONTACT: Giuliana C. Faller Giuliana.faller@nih.gov Phone: 301-480-9789 6. 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). ALS, FTD, and PD are neurodegenerative diseases affecting millions of people worldwide. 500,000 Americans, alone, are diagnosed with PD (NINDS). Currently, there are no effective treatments that can halt disease progression. Understanding the underlying mechanisms that cause these diseases will be instrumental to developing novel therapeutics to treat and to prevent neurodegeneration. However, studies of these diseases have been hindered by the lack of access to relevant samples. Existing animal models do not faithfully recapitulate the disease pathology. Therefore, a new strategy is greatly needed to combat these diseases. This project proposes to use TDP43 patient disease mutants iPSC lines to model ALS/FTD. We hypothesize that iPSC-derived brain organoids will generate consistent disease-specific phenotypes that can be used as a platform to screen for novel compounds to treat these devastating neurodegenerative diseases. 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 1,000 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) 2023-04 dated June 2, 2023. DESCRIPTION OF REQUIREMENT PURPOSE AND OBJECTIVES: This project proposes to use TDP43 patient disease mutants iPSC lines to model ALS/FTD. We hypothesize that iPSC-derived brain organoids will generate consistent disease-specific phenotypes that can be used as a platform to screen for novel compounds to treat these devastating neurodegenerative diseases. Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the�Statement of Work below: Contractor will expand these lines and optimize them for differentiation into 3D brain organoids. Contractor will differentiate these iPSCs into multiple region-specific brain organoids: cortical organoids. We may differentiate these iPSCs into other brain regions (frontal lobe, temporal lobe, etc.) at the request of NCATS. Contractor will characterize these 3D brain organoids at different stages of differentiation to make sure they have the correct identity. Contractor will perform slicing, immunostaining, and imaging to look for specific neuronal makers. Together with NCATS, Contractor will screen for phenotypic differences between disease vs. control brain organoid using multi-omics approaches. CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION In accordance with FAR part 10, the market research was conducted to reach this determination. Specifically, reviewed the results of recent (within the past 18-months) market research undertaken to meet similar or identical requirements. Finally, a review of the GSA Advantage, and previous government acquisitions returned no results that meet all of the requirements. Therefore, only Codex Biosolutions is capable of meeting the needs of this requirement. The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted. Specifically, Codex Solutions., is the only vendor in the marketplace that can provide the services required by NCATS in the interest of continuity of science. The intended source is: Codex Biosolutions, Inc. � 12358 Parklawn Drive, Suite 250A, Rockville, MD 20852, USA 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 Unique Entity ID (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 75N95024Q00015. Responses must be submitted electronically to Giuliana Faller, Contract Specialist, at �giuliana.faller@nih.gov.U.S. Mail and fax responses will not be accepted.
 

Web Link

SAM.gov Permalink
(https://sam.gov/opp/ed242bd2c1a74c31a34f7d6e60fe617b/view)
 

Place of Performance

Address: Rockville, MD 20850, USA

Zip Code: 20850

Country: USA
 

Record

SN06868791-F 20231028/231026230050 (samdaily.us)
 

Source

SAM.gov Link to This Notice
(may not be valid after Archive Date)

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