NOTICE OF INTENT to Sole Source.pdf

NOTICE OF INTENT to Sole Source

1. SOLICITATION NUMBER: NIMH25004458

2. TITLE: Purchase of Automated Batch Nucleic Acid Extractor, Promega Maxwell®

RSC

3. CLASSIFICATION CODE:R499 – SCIENTIFIC CONSULTING SERVICES

4. NAICS CODE: 334516 – Analytical Laboratory Instrument Manufacturing

5. RESPONSE DATE: September 9, 2025, at 12:00 PM EST

6. PRIMARY POINT OF CONTACT:

Joe Kennedy Joseph.kennedy@nih.gov Phone: 262-391-7630

7. DESCRIPTION:

INTRODUCTION

This is a notice of intent, not a request for a quotation.

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 of Mental Health (NIMH) intends to negotiate on a sole source basis with Promega Corporation, for one year.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

and SET ASIDE STATUS The intended procurement is classified under NAICS code 334516 – Analytical Laboratory Instrument Manufacturing with a Size Standard of $1000 employees.

This intended procurement will be a small business set-aside requirement.

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) Number 2025-04, dated May 12, 2025.

DESCRIPTION OF REQUIREMENT

Purchase Description

The Biospecimen Core Repository Lab receives clinical research samples from patients being treated and investigated at the NIH by world-class teams of physicians and researchers. One of the objectives of the laboratory is to provide the most state-of-the-art handling, breakdown of samples in component samples, freezing and storage for these investigators to be able to perform high-quality and transformative research. One aspect of current research focus is the state and essence of nucleic acids present in all types of cells and tissues – and the ability to extract, recover, store and utilize these molecular components of patient derived biological samples is a main priority of the biorepository. The purchase of the Promega Maxwell® RSC system for nucleic acid extraction will allow the lab the flexibility to offer NIH investigators additional options for the use of their samples for research. The system will allow the lab to extract nucleic acids from many different tissue types efficiently and without creating additional work burden on the repository personnel since the machine will extract up to 16 different samples at once over a 40min time-period, with no additional effort other than loading the samples into the system.

Specific Requirements

Automated Nucleic Extraction System capable of extracting DNA and/or RNA from a variety of biological samples, efficiently and in a reasonable timeframe for high-throughput laboratories.

Salient Characteristics:

1. There are currently 29 different nucleic acid extraction options available for different sample types.

2. Automated processing of 1 to 16 samples per purification run.

3. The Maxwell® purification method uses sample lysis and binding to paramagnetic particles as the primary separation principle

4. Utilization of a low elution volume format for sample processing allowing for maximum nucleic acid concentration, and heated elution to improve yields.

5. Pre-filled reagent cartridges

6. Pre-loaded extraction protocols associated for each Maxwell® Kit

7. Promega Portal software for seamless passing of sample tracking data from one

Promega Instrument module to the next

Delivery Date

N/A

Period of Performance

The proposed period of performance shall be one year.

Base: 9/30/2025 – 9/29/2026

Level of Effort

Government Responsibilities

None, other than the purchase of the equipment.

Reporting Requirements

OTHER CONSIDERARTIONS:

Data Rights

The government has the sole right regarding the use, production, and disclosure of the data generated.

Section 508—Electronic and Information Technology Standards

Confidentiality of Information:

(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, Promega Corporation, is the only vendor in the marketplace that can provide the services required by the National Institute of Mental Health.

The intended source is:

Promega Corporation 2800 Woods Hollow Rd.

Fitchburg, WI 53711

The Promega Maxwell® RSC is the only automated batch nucleic acid extraction system that fully meets the physical and personnel, as well as biological, demands of the core Biospecimen repository lab.

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 purpose 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.

Responses must include the place of manufacturing (i.e. address if supply/equipment is a domestic end product and include country of manufacture). 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, NIMH25004458.

Responses must be submitted electronically to Joe Kennedy, Contract Specialist, at joseph.kennedy@nih.gov

U.S. Mail and fax responses will not be accepted.

mailto:joseph.kennedy@nih.gov