Inactive

NOTICE OF INTENT to Sole Source SOLICITATION NUMBER: NIMH-006139-NOI TITLE: NIMH MECTA ?igma ECT CLASSIFICATION CODE: 65 – Medical/dental/veterinary Equipment/supplies NAICS CODE: 334510 – Electromedi... NOTICE OF INTENT to Sole Source SOLICITATION NUMBER: NIMH-006139-NOI TITLE: NIMH MECTA ?igma ECT CLASSIFICATION CODE: 65 – Medical/dental/veterinary Equipment/supplies NAICS CODE: 334510 – Electromedical and Electrotherapeutic Apparatus Manufacturing RESPONSE DATE: 8/3/22 PRIMARY POINTS OF CONTACT: Kyle Miller Kyle.miller2@nih.gov Christine Frate Christine.frate@nih.gov DESCRIPTION: 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) Noninvasive Neuromodulation Unit intends to negotiate on a sole source basis with MECTA CORPORATION for the purchase of a MECTA ?igmaTM electroconvulsive therapy (ECT) device NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE and SET ASIDE STATUS The intended procurement is classified under NAICS code 334516 – Analytical Laboratory Instrument Manufacturing with a Size Standard of 1,250 employees. 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) 2022-06 dated April 26, 2022. DESCRIPTION OF REQUIREMENT The mission of the National Institute of Mental Health (NIMH) Noninvasive Neuromodulation Unit(NNU) is to promote the development and refinement of new and existing non-invasive neuromodulation technologies with the goal of furthering the understanding and treatment of mental illnesses using transcranial magnetic stimulation (TMS), electroconvulsive therapy (ECT), magnetic seizure therapy (MST), vagus nerve stimulation (VNS), deep brain stimulation (DBS), and other devices. The NNU is currently using the MECTA SpECTrum device for their study, Safety and Feasibility of Individualized Low Amplitude Seizure Therapy (iLAST). The MECTA spectrum device has been recently discontinued by MECTA and will no longer be supported for servicing and accessories. Therefore, it is critical to their mission of conducting ECT research and providing standard of care ECT here at the NIH Clinical Center to purchase the new generation of MECTA ECT device that can be supported by the manufacturer. Having the new device will enable the Non Invasive Neuromodulation Unit to continue their research and provide ECT at the NIH Clinical Center without disruption of their protocols. Delivery is expected 60 days after award. CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION During market research, it was found that the MECTA ?igmaTM device is the only device compatible with the study design of our protocol. It is the only device that enables the attachment of NNU’s novel Multichannel simulation interface (IDE G180192) that modulates current amplitude and is essential to their study. The only available alternative device cannot be used with the NNU’s novel interface. Furthermore, the MECTA ?igmaTM has a full spectrum dosing parameter set that enables the investigator to individually set each stimulus parameter--pulse width, frequency, duration and current—that determines the overall charge and energy delivered, by adjusting four dials on the front of the device. This dosing flexibility enables the most precise dosing of any FDA-cleared ECT device on the market. Therefore, with these facts in mind, it was found that MECTA is the only supplier that can provide the needed products. The intended source is: MECTA Corporation 19799 SW 95th Ave Tualatin, Oregon 97062 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, the delivery period after contract award, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Unique Entity Identifier ID (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. All responses must be received by the closing date and time of this announcement and must reference the solicitation number, NIMH-22-006139-NOI. Responses must be submitted electronically to Kyle Miller, Contract Specialist, at kyle.miller2@nih.gov and Christine Frate, Contracting Officer, at christine.frate@nih.gov. U.S. Mail and fax responses will not be accepted.