Notice of Intent to Sole Source: non-GMP scale up synthesis of (4-(1-(3-Fluorobenzyl)-1H-benzo[d]imidazol-2-yl)piperidin-1-yl)(4-((3-fluorobenzyl)oxy)-3-methoxyphenyl)methanone

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 on Drug Abuse (NIDA), Office of Acquisition (OA) the National Center for Advancing Translational Sciences (NCATS), intends to negotiate and award a purchase order without providing for full and open competition (including brand-name) to A1 BioChem Labs LLC 5598 Marvin K. Moss Lane, Wilmington, NC 28409 USA for non-GMP scale up synthesis of (4-(1-(3-Fluorobenzyl)-1H-benzo[d]imidazol-2-yl)piperidin-1-yl)(4-((3-fluorobenzyl)oxy)-3-methoxyphenyl)methanone

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE and SET ASIDE STATUS

The intended procurement is classified under NAICS code 541380 Testing Laboratories and Services with a Size Standard of $16.50.

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) 2022-08 dated October 22, 2022.

DESCRIPTION OF REQUIREMENT

PURPOSE AND OBJECTIVES:

This requisition is for the non-GMP scale-up synthesis of (4-(1-(3-Fluorobenzyl)-1H-benzo[d]imidazol-2-yl)piperidin-1-yl)(4-((3-fluorobenzyl)oxy)-3-methoxyphenyl)methanone in a 250 g quantity with >99% purity, as characterized by LCMS, NMR, and other analytical techniques. The amount of material is crucial for performing toxicity and efficacy studies in different animal models to further facilitate in developing as a non-opioid pain medication.

Provide all the data generated including raw data and reports. The test materials are not transferable or shall not be used for any other purposes

The contractor will provide the 250 g material in >99 % purity, data analysis and report for the contents of this statement of work either electronically or as a written report.

ESTIMATED PERIOD OF PERFORMANCE:

4 weeks 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, Cellecta, Inc. of Mountain View, CA is the only vendor in the marketplace that can provide the services required by NIDA .

The intended source is:

A1 BioChem Labs LLC

5598 Marvin K. Moss Lane

Wilmington, NC 28409 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, 75N95024Q00492. Responses must be submitted electronically to Kaitlyn Landi, Contract Specialist, at kaitlyn.landi@nih.gov and KJ Shaikh, Contracting Officer, at kj.shaikh@nih.gov. U.S. Mail and fax responses will not be accepted.