Notice of Intent_final.docx

Title: Thermal Stimulator with MRI Compatible Thermodes

PRE-SOLICITATION NON-COMPETITIVE - NOTICE OF INTENT

Date: August 31, 2021 Solicitation #75N95021Q00397

I. 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 Institute on Drug Abuse (NIDA), NIDA Section, Contracts Management Branch Red on behalf of the National Institute on Drug Abuse (NIDA), Intramural Research Program (IRP) intends to negotiate and award a purchase order without providing for full and open competition (Including brand-name) to Medoc Advanced Medical Systems, Inc. located at 1502 West N.C. Highway 54, Suite 404, Durham, North Carolina 27707.

II. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 811219 – Other Electronic and Precision Equipment Repair and Maintenance with a business size standard classification of 1250 employees.

III. REGULATORY AUTHORITY

The resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2021-06 effective date 07-12-2021.

This acquisition is conducted under the procedures as prescribed in FAR subpart 13—Simplified Acquisition Procedures at an amount not exceeding the SAT.

IV. 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.

V. DESCRIPTION OF REQUIREMENT

Background Pain is an important component of substance use disorders on several levels. First, many people start using opioids, often by prescription, to alleviate pain. They then transition to illicit opioids both for the continued alleviation of pain and, critically, due to the compulsions of a use disorder. A second important component of use disorders is stigma. The emotional pain from this stigma is thought to negatively affect the use disorder and its treatment. Importantly, the potential common neural pathways of these two types of pain is understudied, especially in the context of use disorders. In order to study this, the NIDA-IRP needs a way to induce temporary, transient, physical pain during a functional MRI scan. The way that physical pain is typically studied is with a thermal stimulator. We thus need to purchase an MRI compatible thermal stimulator to perform these critical experiments. Without this device, these experiments will be impossible.

Purpose and Objectives The translational addiction medicine branch and neuroimaging research branch of the NIDA intramural research program (NIDA-IRP) needs to purchase an MRI compatible thermal stimulator for protocols studying pain.

Purchase Description:

Independently and not as an agent of the Government, the Contractor shall furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government as needed to perform the Purchase Description below:

Medoc advanced medical systems model TSA2 fMRI thermosensory stimulator. Part number MO00015-f. The purchase should include a second MRI compatible thermode (part number AS00178), and standard thermode (part number AAS00176) and a calibration kit (part number AS00184).

Salient characteristics; the device must:

· be a thermal stimulator designed for pain research.

· be FDA approved.

· include the capability of MRI-compatible thermodes with any/all associated extra hardware.

· include or be compatible with non-MRI thermodes for use in purely behavioral experiments.

· be two channels so that we can perform pain discrimination experiments.

· Be fully controllable remotely through MATLAB.

· have a temperature range of at least 0C-50C, with a minimum thermal slew rate of 10C/sec. It must be accurate to at least +/- 0.5C and be controllable to at least 0.1C.

· be able to be calibrated locally by NIDA personal.

· have a TTL compatible output that we can integrate with our existing physiology recording systems.

· Includes at least an eighteen-month manufacturer’s warranty for parts and labor

Delivery Date & Address :

Sixty (60) days from receipt of purchase order.

Biomedical Research Center 251 Bayview Boulevard, Room 07A719 Baltimore, MD 21224

VI. CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (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 as prescribed in FAR Part 10—Market Research.

The sole source determination is based on the fact that the MRI compatible thermal stimulator is available from only one source, and competition is precluded for reasons specified below. The acquisition is restricted to Medoc Advanced Medical Systems, US model TSA2 Fmri thermosensory stimulator. Part number MO00015-f. The purchase should include a second MRI compatible thermode (part number AS00178), and standard thermode (part number AAS00176) and calibration kit (part number AS00184).

Brand-name or Items peculiar to one manufacturer:

The essential characteristics of the MRI compatible thermal stimulator that limit the availability to a sole source are that it is MRI compatible, FDA approved for research in pain, compatible with non-MRI thermodes for use in purely behavioral experiments, and two channels, so that we can perform pain discrimination experiments. Only this suggested source can furnish the requirements, to the exclusion of other sources, because of the salient characteristics needed for compatibility.

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 Dun & Bradstreet Number (DUNS), 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. 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.

All responses must be received by September 3, 2021 by 12:00 pm EST. Responses must be submitted electronically to Andrew Varley, Contract Specialist at Andrew.Varley@nih.gov .