Notice of Intent.pdf

Notice of Intent to Sole Source

Solicitation Number: 75N94025Q00096 Solicitation Type: Sole Source (Non-Competitive) Title: NIAAA: Supply: MeIplus Synthesizer 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 Institute of Child Health and Human Development (NICHD), Office of Acquisitions (OA), intends to negotiate and award a purchase order on a noncompetitive sole source basis to Synthra GMBH to provide a MeIplus Synthesizer.

Background Information

Given fentanyl's critical role both in medicine and in the overdose crisis, investigating its pharmacokinetics has been essential for optimizing its therapeutic use while also enhancing the lab’s understanding of overdose mechanisms, ultimately informing more effective management strategies.

Although fentanyl’s onset, duration, and toxicity depend on its pharmacokinetics and specific tissue distribution, most studies have focused primarily on plasma concentrations, leaving its distribution in critical tissues largely unexplored. This knowledge gap limits understanding of fentanyl’s clinical effects, tissue accumulation, and the factors influencing its efficacy and safety. Herein, the lab plans to develop radioactive fentanyl for PET imaging to measure fentanyl pharmacokinetics in humans. In addition, C-11 labeled fentanyl will be utilized to evaluate novel treatment options such fentanyl vaccine and monoclonal antibody.

The Laboratory of Neuroimaging in NIAAA requires a radiochemistry synthesis module to support ongoing radiochemistry work. This radiochemistry synthesizer will be used for automated C-11 synthon synthesis to limit radiation exposure to radiochemists when producing radiotracers used in ongoing projects including 11C-fentanyl project.

Purpose and Objectives

The purpose of this contract is to obtain a radiochemistry synthesis module to synthesize C-11 labeled fentanyl.

Delivery/Warranty:

Delivery will be within 5 months after award and the warranty is one year.

Contractor Requirements

The contractor needs to provide a MeIplus Research module with C02 trap, 2m version with the following features:

A heatable loop reactor

Gas phase synthesis of 11-C MeI, 11-C HCN and 11-C CO

Compatibility with CO2 AND methane targets

No cassettes required

Integrated quaternary HPLC and UV detector with a wavelength range from 190 to 900 nm

Conversion of MeI to triflate is possible

Product solvent evaporator to remove residual solvents

A CO2 trap with a 2m stainless steel capillary, ID 0.75mm

Six shielded radiation detectors

Self-Cleaning System

Eight small (1 – 3 mL) and two large (10 - 15 mL) volume glass vials for reagents

Two closed reaction vessel (-196 °C – 200 °C)

Open Software with customizable GUIs

One Year warranty after installation

Sole Source Justification

Synthra GmbH is the manufacturer and only authorized distributor of the Synthra MeIplus Research with CO2 trap, 2m version. The Laboratory of Neuroimaging in the NIAAA in the NIH requires the acquisition of a radiochemistry synthesis module to synthesize C-11 labeled fentanyl. Firstly, among a couple of commercially available C-11 radiotracer synthesizers, only this system has two reaction pots, which requires C-11 fentanyl synthesis (the most important factor). All others have one-pot for C-11 labeling process. Secondly, only this system has a cryogenic C-11 CO2 trap. Since preventing natural C-12 contamination is critical for C-11 fentanyl production for safety (high mass of fentanyl is dangerous) and the cryogenic trapping method can reduce C-12 contamination, this system can produce high quality of C-11 fentanyl. Thirdly, this system can generate C-11 carbon monoxide which could be a radioactive precursor for C-11 fentanyl. None of the other synthetic modules can generate C-11 carbon monoxide.

Otherwise, in order to have C-11 carbon monoxide, we must buy C-11 carbon monoxide synthesizer. The absence of this device would prevent the laboratory from generating radioactive fentanyl. Without the advent of a special new method, the research itself would need to be halted. This would render impossible to pursue pharmacokinetic PET study of fentanyl in animal and human. Since overdose death in the US is a pertinent and pressing issue, this research must be conducted timely.

Regulatory Authority

This acquisition is conducted under the authority of the Federal Acquisition Regulations (FAR) Subpart 13.106-1(b) Soliciting from a single source. (1) 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, or industrial mobilization).

FAR Clauses

The following clauses apply to this acquisition and are incorporated by reference:

FAR clause 52.212-1, Instructions to Offerors – Commercial Items

FAR clause 52.212-2, Evaluation – Commercial Items, 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 meet the specifications provided above.

FAR clause 52.212-3, Offeror Representations and Certifications – Commercial Products and Commercial Services (MAY 2024) (DEVIATION FEB 2025)

FAR clause 52.212-4, Contract Terms and Conditions – Commercial Products and Commercial Services

(NOV 2023)

FAR clause 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders

– Commercial Products and Commercial Services (JAN 2025) (DEVIATION FEB 2025)

FAR clause 52.247-34, F.o.b. Destination (JAN 1991)

Per FAR CLASS DEVIATION 2025-02 Amendment 1:

“System updates may lag policy updates. The System for Award Management (SAM) may continue to require entities to complete representations based on provisions that are not included in agency solicitations, including 52.223-22, Public Disclosure of Greenhouse Gas Emissions and Reduction Goals— Representation, and paragraph (t) of 52.212-3, Offeror Representations and Certifications—Commercial Products and Commercial Services. Agencies will not consider or use these representations. Entities are not required to, nor are they able to, update their entity registration to remove these representations in

SAM.”

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 FAR Part 13, Simplified Acquisition Procedures, 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 2025-04 effective January 17, 2025.

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 July 8, 2025 5:00 PM ET and must reference solicitation number 75N94025Q00096. Responses shall be submitted electronically to nicole.freid@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.