Notice of Intent - VISHNU ENAMINE NIAAA 08396.docx

Hospital and Laboratory Support Division Office of Logistics and Operations (OLAO) Office of Acquisition and Logistics Management (OALM)

Title: Assay Service for assessing ADME properties and in vivo PK properties with the selected vendor.

Presolicitation

Synopsis No. 75N98026Q01083

SYNOPSIS: 75N98026Q01083

General Information

Contracting Office Address

National Institutes of Health (NIH), Office of the Director (OD) Office of Logistics and Operations (OLAO) Office of Acquisition and Logistics Management (OALM) Hospital and Laboratory Support Division 6701 Rockledge Drive Bethesda, MD 20817

Description

INTRODUCTION

THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME).

The National Institutes of Health (NIH) intends to negotiate and award a contract without providing for full and open competition (Including brand-name) to:

ENAMINE US INC.

1 Distribution WAY Monmouth Junction, New Jersey 08852-3001 United States

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 424690 with a Size Standard $34M.

REGULATORY AUTHORITY

The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2005-99-1, July 16, 2018. This acquisition is conducted under the procedures as prescribed in FAR subpart 13-Simplified Acquisition Procedures at an amount not exceeding the simplified acquisition threshold ($350,000).

STATUTORY AUTHORITY

This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13-Simplified Acquisition Procedures, Subpart 13.106-1 (b) (1), Soliciting from a single source and is not expected to exceed the simplified acquisition threshold. Contracts awarded using FAR Part 13-Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6-Competition Requirements.

GENERAL INFORMATION

1. Title: Assay Service for assessing ADME properties and in vivo PK properties with the selected vendor.

2. Background Information: The Section on Medicinal Chemistry (SMC) develops new molecular entities with implications in improving health and treatment for various metabolic and alcohol associated diseases. To assess the translational potential of novel molecular entities, which would allow us to make decisions to proceed with the compounds for further development we utilize multiple derisking assays. These assays comprise of both cell-based (in vitro) testing and then eventually in mice to assess pharmacokinetic parameters to see if the drug is orally available.

Request to procure Chemical Reagent (Assay) Development & Laboratory Testing Service SMC to produce grouped ADME assays and perform a Pharmacokinetic study in C57BL6 mice. By including the Caco-2 Permeability Assay in our ADME evaluation it'll accurately predict the oral absorption potential of our compounds. This well-established in vitro model closely mimics the human intestinal epithelium, providing critical insights into a compound’s passive diffusion, active transport, and efflux processes, such as those mediated by P-glycoprotein (P-gp). The data generated from this assay are vital for informing structure-activity relationship (SAR) optimization, improving compound permeability, and reducing transporter-related liabilities that could hinder bioavailability. CACO and MDCKR assays allow to know the brain penetrance of the compounds. hERG assays allow to know if the compounds will show cardiac toxicity. The plasma stability and binding show how the compounds behave in bodily fluids. Finally, the best compounds then undergo testing in mice to know if they can be given orally and thus have translational potential in human testing. These assays are integral to the work of section on medicinal chemistry at NIAAA as these enable to progress compounds for further development as therapeutics in metabolic and alcohol use disorders.

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. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include a technical proposal, a cost-price proposal, the period of performance, 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.

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. 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.

All responses must be received by February 26, 2026 at 9:00 AM Eastern time and must reference solicitation number 75N94026Q00049. Responses may be submitted electronically to Mr. Vishnuvajjala Hanumanth Rao, Lead Purchasing Agent at, vishnuh@mail.nih.gov Fax responses will not be accepted.

"All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency.”

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