Notice of Intent-75N98026Q01010.pdf

Notice of Intent to Sole Source

Solicitation Number: 75N98026Q01010 Solicitation Type: Sole Source (Non-Competitive) Title: LightCycler® 480 Block Kit 384 Silver NAICS / Size Standard: 334516/ 1,000 Employees

Introduction

THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO

AWARD A PURCHASE ORDER WITHOUT PROVIDING FOR FULL AND OPEN

COMPETITION. The National Heart, Lung, and Blood Institute (NHLBI), Office of Acquisitions (OA), intends to negotiate and award a purchase order on a noncompetitive sole source basis to Roche

Diagnostics, Corp. to provide LightCycler® 480 Block Kit 384 Silver to the Division of Intramural

Research in accordance with the following information.

Background Information

The NHLBI currently utilizes the LightCycler® 480 system, which provides high-precision nucleic acid quantification and genotyping in regulated clinical diagnostics, translational research, and industrial quality control environments.

Purpose and Objectives

The purpose of this acquisition is to acquire a LightCycler® 480 Block Kit 384 Silver to support laboratory research operations requiring high-throughput real-time PCR analysis.

Contractor Requirements

The Contractor shall provide one LightCycler® 480 Block Kit 384 Silver.

Sole Source Justification

The National Heart, Lung, and Blood Institute (NHLBI) requires one LightCycler® 480 Block Kit 384

Silver. This item is required to support the operation of an existing LightCycler® 480 real-time PCR instrument and to enable the use of the 384-well block format for high-throughput nucleic acid amplification and detection workflows. The required block kit must be fully compatible with the instrument’s hardware, software, calibration, thermal cycling, and detection functions to ensure accurate data generation, seamless system integration, and uninterrupted analytical performance. The use of non-compatible components will result in instrument malfunction, invalid data, failed assays, additional validation requirements, or the inability to perform the required 384-well real-time PCR workflows.

Compatibility with the existing instrument is necessary to maintain continuity of ongoing laboratory operations and avoid delays in research activities.

Regulatory Authority

This acquisition is conducted under the authority of the Federal Acquisition Regulations (FAR) Subpart

12.102 (a), restricting competition. 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.

FAR Clauses

The provision at FAR clause 52.212-1, Instructions to Offerors – Commercial Products and Commercial

Services, applies to this acquisition.

The provision at FAR clause 52.212-2, Evaluation – Commercial Products and Commercial Services, is applicable. The Government will award a contract resulting from this notice to the offeror listed above. The following factors shall be used to evaluate the offer: The contractor shall demonstrate its ability to provide the services listed that meets the specifications provided above.

FAR clause 52.212-3, Offeror Representations and Certifications – Commercial Items, is applicable. An offeror shall complete only paragraphs (b) of this provision if the offeror has completed the annual representations and certificates electronically via http://www.acquisition.gov. If an offeror has not completed the annual representations and certifications electronically at the System for Award Management

(SAM) website, the offeror shall complete only paragraphs (c) through (p) of this provision.

FAR clause at 52.212-4, Contract Terms and Conditions – Commercial Items, applies to this acquisition.

FAR clause at 52.204-13 System for Award Management Maintenance, applies to this acquisition.

The provisions at FAR clause 52.203-17, Contractor Employee Whistleblower Rights, applies to this acquisition.

The provision at FAR clause 52.225-25, Prohibition on Contracting With Entities Engaging in Certain Activities or Transactions Relating to Iran—Representation and Certifications, applies to this acquisition.

FAR clause FAR 52.232-33, Payment by Electronic Funds Transfer—System for Award Management, applies to this acquisition.

HHSAR clause 352.239-78, Information and Communication Technology Accessibility Notice

HHSAR clause 352.239-79, Information and Communication Technology Accessibility

HHSAR clause 352.232-71, Electronic Submission of Payment Requests

Additional Information

The North American Industry Classification System (NAICS) Code is 334516 and the Small Business Size

Standard is 1,000 employees. This acquisition is being conducted under RFO FAR Part 12, Acquisition of

Commercial Products and Commercial Services, therefore the requirements of FAR Part 6, Competitive

Requirements, are not applicable and the resultant award will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2026-01 effective March 13, 2026.

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 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 Identifier

(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 September 08, 2026, at 12:00PM ED and must reference synopsis number 75N98026Q01010. Responses shall be submitted electronically to noelle.decenzo@nih.gov.

Responses will only be accepted if dated and signed by an authorized company representative. All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency.

http://www.sam.gov/ mailto:noelle.decenzo@nih.gov