Notice of Intent to Sole Source.pdf

NOTICE OF INTENT to Sole Source

1. SOLICITATION NUMBER:

75N95025Q00236

2. TITLE: Synthesis and bioanalytical analysis of small molecules for the NCATS Early Translational Branch Chemistry Program

3. CLASSIFICATION CODE:

B504 – Special Studies/Analysis-Chemical/Biological

NAICS CODE: 541380 – Testing Laboratories and Services

4. RESPONSE DATE:

August 19, 2025 at 12:00 pm EST

5. PRIMARY POINT OF CONTACT:

Andrew Varley Andrew.Varley@nih.gov Phone: 301.827.5851

6. 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).

National Center for Advancing Translational Sciences (NCATS) intends to negotiate on a sole source basis with ChemoGenics BioPharma for the synthesis and bioanalytical analysis of small molecules for the NCATS Early Translational Branch chemistry program.

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 $19 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) 2025-04 dated June 11, 2025.

DESCRIPTION OF REQUIREMENT

PURPOSE AND OBJECTIVES:

NCATS is in need of custom synthesis and bioanalytical services in internal projects focused on developing small molecule inhibitors of physiological small molecule methyltransferases. NACTS is pursuing small molecules in two projects where methyltransferases are implicated in disease. NCATS requires key intermediates that will allow for the lab to scale up lead compounds or make analogs. NCATS also requires exposure data in various tissues of interest to gauge compound concentrations to select compounds for POC.

100g of N-(pyridin-3-yl)-2,3,4,5-tetrahydro-1H-pyrido[4,3-e][1,4]diazepin-8-amine 100g of (tert-butyl (R)-3-(5-oxo-4,5-dihydro-1H-1,2,4-triazol-3- yl)piperidine-1-carboxylate.

Mouse PK on at least 10 compounds with routes and tissues determined.

The final purity has to be >95% with optical purity >98%. Spectroscopic characterization and analytical data will be required and verified.

Period of Performance:

Delivery shall be made 9 months ARO.

CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION

(INCLUDING BRAND-NAME) DETERMINATION

The essential characteristics of the item or service that limit the availability to a sole source are:

This acquisition requires previous experience in the making of methyltransferase inhibitors. The service provided by this contractor will allow for continuity of research, consistency of data/results which is imperative in this project. Previous similar work was completed under Purchase Order No. 75N95024P00604.

The intended source is:

ChemoGenics BioPharma 3325 Durham Chapel Hill Blvd, Suite 250 Durham, NC 27707

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 75N95025Q00236. Responses must be submitted electronically to Andrew Varley, Contract Specialist at Andrew.Varley@nih.gov. U.S. Mail and fax responses will not be accepted.