Amendment 1 - Synthesis of ‘961 for National Center for Advancing Translational Sciences (NCATS), Early Translation Branch (ETB)

NOTICE OF INTENT to Sole Source- Amendment 1 Answering questions and providing Statement of Work.

SOLICITATION NUMBER:

75N95024Q00502 TITLE: Synthesis of ‘961 for National Center for Advancing Translational Sciences (NCATS), Early Translation Branch (ETB)

CLASSIFICATION CODE:

6505- DRUGS AND BIOLOGICALS NAICS CODE:

325413 - IN-VITRO DIAGNOSTIC SUBSTANCE MANUFACTURING RESPONSE DATE: August 14 2024, at 4:00 PM ET PRIMARY POINT OF CONTACT:

Nick Niefeld Nick.niefeld@nih.gov Phone:

301.827.2094 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) is a part of the National Institutes of Health (NIH), whose mission it is to catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions.

The Early Translation Branch aims to uncover new small-molecule probes for disease targets and advance the process of therapeutic development through a collaborative research model. Its teams have expertise in assay biology, high-throughput screening, medicinal chemistry, cheminformatics and data science to complement the disease-area expertise of external collaborators.

The lead inhibitor ‘960 from the NNMT program is being evaluated in multiple efficacy, pharmaceutics and toxicity studies with a constant need for more materials. This contract will help synthesize 100 g of ‘961, the less active enantiomer of ‘960, for use as a control in all studies.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE and SET ASIDE STATUS The intended procurement is classified under NAICS code 811210 - Electronic and Precision Equipment Repair and Maintenance Dollars or Number of Employees: $34 million. 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) 2024-05 dated May 22, 2024. DESCRIPTION OF REQUIREMENT PURPOSE AND OBJECTIVES: The National Center for Advancing Translational Sciences (NCATS) is a part of the National Institutes of Health (NIH), whose mission it is to catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions.

The Early Translation Branch aims to uncover new small-molecule probes for disease targets and advance the process of therapeutic development through a collaborative research model. Its teams have expertise in assay biology, high-throughput screening, medicinal chemistry, cheminformatics and data science to complement the disease-area expertise of external collaborators.

The lead inhibitor ‘960 from the NNMT program is being evaluated in multiple efficacy, pharmaceutics and toxicity studies with a constant need for more materials. This contract will help synthesize 100 g of ‘961, the less active enantiomer of ‘960, for use as a control in all studies.

ESTIMATED PERIOD OF PERFORMANCE: Deliver within 12 months 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, Cell Mosaic is the only vendor that can provide this synthesize with the interest in continuity of science in consideration. The intended source is:

Cell Mosaic 10A Roessler Road, Woburn, MA 01801, 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, 75N95024Q00502. Responses must be submitted electronically to Nick Niefeld, Contract Specialist, at nick.niefeld@nih.gov. U.S. Mail and fax responses will not be accepted.