Transcranial Magnetic Stimulation (TMS) Figure 8 Coils

INTRODUCTION 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 MagVenture, Inc for Transcranial Magnetic Stimulation (TMS) Figure 8 Coils. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE and SET ASIDE STATUS The intended procurement is classified under NAICS code 339112 – Surgical and Medical Instrument Manufacturing with a Size Standard of 1,000 employees. This acquisition is set aside for small businesses. 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) 2021-05 dated March 10, 2021. DESCRIPTION OF REQUIREMENT PURPOSE AND OBJECTIVES: The Non-Invasive Neuromodulation Unit (NNU) is within the Experimental Therapeutics & Pathophysiology Branch at the National Institute of Mental Health (NIMH). The NNU is studying the brain mechanisms underlying major depression and other mood disorders. The C-B60 Butterfly and the Cool-B65 coils are two transcranial magnetic stimulation (TMS) coils needed to support the ongoing studies entitled: “Concurrent fMRI-guided rTMS and cognitive therapy for the treatment of major depressive episode” (Protocol# 17M0147); “Neuropharmacologic Imaging and Biomarker Assessments of Response to Acute and Repeated-Dosed Ketamine Infusions in Major Depressive Disorder” (17M0060); and “Development of Non-Invasive Brain Stimulation Techniques” (18M0015). The C-B60 Butterfly coil is a small (6.5 x 3.35 x 0.75 inches), and light (1.5 lbs) TMS coil that can deliver single TMS pulses. The combination of its weight and dimension makes it perfect for motor hot spot search and motor threshold assessment, two crucial steps in TMS studies that allows defining the stimulation intensities for subsequent rTMS sessions. The Cool-B65 coil is designed with a cooling system which makes it ideal for high repetition rates and long pulse trains, as uncooled coils will heat up and break down in this situation. It therefore allows delivery of the high frequency TMS used in the NNU studies. Purchase Description: 1) C-B60 Butterfly Coil – with power control Product number: 9016E0482 2) Cool-B65 Coil- dynamic liquid cooled figure of eight coil Product number: 9016E0491 The salient product characteristics are as follows: Both are figure-of-eight coils. The C-B60 Butterfly Coil is equipped with a power control knob to adjust stimulation intensity. The Coil Cool-B65 has a liquid cooling system built in. Both coils are operational for a minimum of 5 years. 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. Specifically, MagVenture, Inc is the only vendor in the marketplace that can provide the products required by the Non-Invasive Neuromodulation Unit . The intended source is: MagVenture, Inc 2300 Lakeview Parkway, Suite 700 Alpharetta, GA 30009 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 purposes 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 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. All responses must be received by the closing date and time of this announcement and must reference the solicitation number, NIMH-21-004226. Responses must be submitted electronically to Sarah Adan, Contract Specialist, at [email protected] and Valerie Whipple, Contracting Officer, at [email protected]. U.S. Mail and fax responses will not be accepted.