NOTICE OF INTENT to Sole Source

1. SOLICITATION NUMBER: 75N95024Q00058
2. TITLE: Recombinant Human NT-3 Protein
3. CLASSIFICATION CODE: 6505– DRUGS AND BIOLOGICALS
4. NAICS CODE: 325414 -Biological Product (except Diagnostic) Manufacturing
5. RESPONSE DATE: December 15, 2023 at 4:00 PM EST
6. PRIMARY POINT OF CONTACT:

Maggie Brant

Maggie.brant@nih.gov

Phone: 301.827.1771

1. 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 Research and Diagnostic Systems, Inc. for Recombinant Human NT-3 Protein.

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.

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) Number 2023-06, with effective date 12/4/23.

DESCRIPTION OF REQUIREMENT

PURPOSE AND OBJECTIVES:

Ongoing research projects in the Stem Cell Translation Laboratory (SCTL) within the National Center for Advancing Translational Sciences (NCATS) Division of Preclinical Innovation (DPI) focus on understanding molecular mechanisms regulating stem cell pluripotency and their multi-lineage differentiation capabilities with a focus on defining optimum culture conditions for maintaining pluripotent stem cells and their conversion to homogeneous and mature population of differentiated cells. To achieve these aims, SCTL performed rigorous internal tests of a variety of stem cell culture systems and small molecules from several vendors and concluded that small molecules and proteins from R&D Systems meets our specific requirement, including supporting stem cell pluripotency maintenance, multi-lineage differentiation and 3-D culture. Numerous batches of cells have been grown using R&D small molecules and the result was consistent and predictable growth resulting in successful assays performed at NIH NCATS.

SPECIFIC REQUIREMENTS:

Small molecules are formulated for best stability and are lyophilized from a sterile filtered solution. They are available without or with a carrier protein, usually bovine serum albumin (BSA) at 50 mg/mg of protein.

Quantity: (37) Thirty-seven each Recombinant Human NT-3 Protein

Delivery Date: We require that the vendor provide these items to be delivered as soon as possible upon initial receipt of the order by the vendor. Within 30 days of receipt of order.

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, Research and Diagnostic Systems, Inc. is the only vendor in the marketplace that can provide the service required by NCATS.

The intended source is:

Research and Diagnostic Systems, Inc.

614 McKinley Pl NE

Minneapolis, MN 55413-2610

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, 75N95024Q00058. 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.

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