Notice of Intent_final.pdf

Title: MRI-compatible TMS Neuronavigation System

PRE-SOLICITATION NON-COMPETITIVE - NOTICE OF INTENT

Date: September 2, 2020 Solicitation # 75N95020Q00294

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 MagVenture, Inc. located at 2300 Lakeview Parkway, Suite 700, Alpharetta, GA 30009 to provide a MRI-compatible TMS Neuronavigation System.

II. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 334516 - Analytical Laboratory Instrument Manufacturing with a business size standard classification of 1000 employees.

III. REGULATORY AUTHORITY

The resultant purchase order will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2020-07 effective date 08-31-2020.

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 The Neuroimaging Research Branch of the National Institute on Drug Abuse (NIDA) Intramural Research Program (IRP) is currently investigating the effects of transcranial magnetic stimulation (TMS) in the brain, using an existing MagPro® X100 (with the MagOption) stimulator outside and inside the scanner. This acquisition will allow NIDA IRP to utilize a novel technique of applying TMS stimulation during MRI acquisition and capture real-time data on the effects of TMS.

In the concurrent TMS and fMRI platform, which is being used to understand the TMS treatment effects on drug addiction, localization cannot be done onsite due to incompatibility to MRI of the current navigator. The addition of the navigator will significantly improve the accuracy of brain localization. Such an improvement will substantially enhance the capability of performing research on the platform. Additionally, the improved localization provided by this system will allow for further scientific endeavors into using this platform on non-human primates.

TMS stimulation is sensitive to coil location, orientation and angle. In conventional TMS suite, the neuronavigation system provides an effective way in positioning the coil for accurate and replicable stimulation of the site. The MRI compatible TMS system currently in use is a valuable tool for us to monitor and explore the instant/acute stimulation effect combining TMS and fMRI, which can greatly help to understand the brain mechanisms of TMS stimulation systematically. However, the current arrangement of MRI compatible TMS system lacks the neuronavigation system as would be found in the conventional TMS suite. While providing precision in time domain, this compromises the necessary spatial accuracy.

Purpose and Objectives The purpose of this acquisition is to acquire an MRI compatible neuro-navigation system for use with existing MRI compatible transcranial magnetic stimulation (TMS) device for accurate coil positioning during stimulation with the aim of experimental application to treat substance abuse (e.g., cocaine dependence). The simultaneous multimodality of TMS and MRI will improve our understanding regarding the underlying mechanism of magnetic stimulation in both the healthy and addicted brain. This will aid in the development of treatment protocols utilizing TMS for those who suffer from addiction.

Purchase Description & Quantity:

MRI-compatible TMS Neuronavigation System – quantity: 1

Delivery Date & Address :

Seven (7) weeks from the date of award.

Biomedical Research Center 251 Bayview Boulevard, Room 07A711 Baltimore, MD 21224

Installation:

The Contractor shall install the instrument at the above address. Installation shall occur within 30 days after delivery. Installation shall include, at a minimum, uncrating/unpacking of all equipment, set-up and hook-up of all equipment, start-up, demonstration of specifications, and removal of all trash.

Training The Contractor shall provide one day of on-site, in-service training, at the above address. Training must be conducted by a professional sales representative and completed within 30 days after delivery and installation. The training shall include, at a minimum, all equipment functions, equipment operation, troubleshooting, and routine maintenance procedures.

Packaging, Packing, and Shipping Instructions:

The Contractor shall ensure that all items are preserved, packaged, packed and marked in accordance with best commercial practices to meet the packing requirements of the carrier and to ensure safe and timely delivery at the intended destination. All data and correspondence submitted shall reference:

1) The Contract Number

2) The government end user agency

3) The name of the recipient

4) Name of contractor

5) Description of items contained therein

6) Consignee(s) name and address

Inspection and Acceptance Criteria:

The Government will review, for completeness, preliminary or draft products that the Contractor submits, and may return them to the Contractor for correction. Final approval and acceptance of products required herein shall be by written approval and acceptance by the Government. The Contractor shall not construe any letter of acknowledgment of receipt of products as a waiver of review, or as an acknowledgment that a product is in conformance with this purchase description.

Any approval given during preparation of a product, or approval for shipment shall not guarantee the final acceptance of the completed product.

Warranty:

The Contractor shall provide, at a minimum, a one-year warranty for the equipment. The warranty shall cover all parts, labor and travel costs. The warranty shall commence upon successful completion of delivery, installation and training.

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 required MRI compatible neuronavigation system must be compatible with the government owned MRI compatible transcranial stimulation device for the experimental application to treat substance abuse (e.g., cocaine dependence). After performing significant market research and contacting industry experts, it was found that the requested MRI compatible system, manufactured by Localite, is the only commercially available solution on the market that can provide the unique capabilities that the program requires. In particular, the Localite TMS Navigator is the sole system that can perform inside/in-bore navigation (both online and offline) and is compatible with the government owned MRI compatible TMS system.

The required device is among the first newly developed MRI compatible neuronavigation systems and has been reviewed for compatibility with our existing MRI compatible TMS system. With the inclusion of this MRI compatible neuronavigation system, more accurate TMS coil positioning inside the MRI chamber can be achieved and more reliable and reproducible data can be obtained.

VII. 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. 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.”

http://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 8, 2020 by 2:00 pm EST. Responses must be submitted electronically to Erin Dwyer, Contract Specialist at erin.dwyer@nih.gov.

mailto:erin.dwyer@nih.gov