Notice of Intent to Sole Source.pdf

NOTICE OF INTENT to Sole Source

1. SOLICITATION NUMBER:

75N95025Q00237

2. TITLE: Toxicity evaluation of YC1 in hSULT1A1 and mSULT1A1 mice

3. CLASSIFICATION CODE:

B504 – Special Studies/Analysis-Chemical/Biological

NAICS CODE: 541380 – Testing Laboratories and Services

4. RESPONSE DATE:

August 18, 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 GemPharmatech LLC for evaluating YC1’s selective toxicity in mice with hSULT1A1 (human SULAT1A1) vs mice with mSULT1A1 (mouse

SULT1A1).

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 seeks to determine if YC1 which works with a unique mechanism of cytotoxicity towards cancer cells that express SULT1A1. In doing so, NCATS shall establish the therapeutic window for YC1. To that end NCATS requires head-to-head comparison on YC1 in mice that have humanized SULT1A1 (custom mice available at GemPharmaTech) and with mouse SULT1A1 (wild type).

Period of Performance:

Delivery shall be made 6 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:

hSULT1A1 and mSULT1A1 mice (8-9 weeks old), male, 24 mice will be divided into 4 groups of 3M and 3F each and treated with ascending doses of 25, 50, 100, 200 (4-5 days every dose) mpk YC1 with monitoring of visible signs of toxicity. Once doses are established a 14d tox study will be initiated which will end with monitoring blood chemistry and histopathology. GemPharmatech has produced mice with humanized SULT1A1 protein via a prior order PO# 75N95023P00824. They are the only source for this mice; these specialized mice are not available with any other vendor.

The intended source is:

GemPharmatech LLC 11175 Flintkote Ave. Ste. B San Diego, CA 92121, 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 75N95025Q00237. 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.