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NOTICE OF INTENT to Sole Source SOLICITATION NUMBER: NIMH21002185 TITLE: MECTA Sigma Electroconvulsive Therapy Device CLASSIFICATION CODE: 66 -- Instruments & laboratory equipment NAICS CODE: 334510 –... NOTICE OF INTENT to Sole Source SOLICITATION NUMBER: NIMH21002185 TITLE: MECTA Sigma Electroconvulsive Therapy Device CLASSIFICATION CODE: 66 -- Instruments & laboratory equipment NAICS CODE: 334510 – Electromedical and Electrotherapeutic Apparatus Manufacturing RESPONSE DATE: March 19, 2021 at 5:00 PM EST PRIMARY POINT OF CONTACT: Michael Horn michael.horn@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) intends to negotiate on a sole source basis with the Mecta Corporation for a MECTA Sigma Electroconvulsive therapy device. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE and SET ASIDE STATUS The intended procurement is classified under NAICS code 334510 – Electromedical and Electrotherapeutic Apparatus 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) 2021-04 dated January 19, 2021. DESCRIPTION OF REQUIREMENT The overall objective of “A Feasibility Study of Transcranial Electric Stimulation Therapy (TEST) for treatment resistant depression (TRD)” is to assess whether a type of noninvasive brain stimulation that is like electroconvulsie therapy (ECT) but uses a lower dose of current so as not to cause a seizure can cause less side effects than ECT, while remaining as effective as ECT for TRD. ECT is the most effective treatment for TRD, but it is very underused due to its side effects, primarily its adverse effects on memory. The study could have a major effect on TRD therapy by determining whether a seizure is necessary for the antidepressant effect of ECT. If a seizure is not required, then approaches like TEST could eventually be used in clinical practice to reach a large group of individuals with TRD who have rejected ECT over concern over side effects. TEST can be administered with a standard, FDA-cleared ECT device with the dosing set at a very low level so as not to induce a seizure. The MECTA Sigma electroconvulsive therapy (ECT) device, modified by the manufacturer to have a lower, more extensive frequency range, is needed to administer an experimental brain stimulation therapy as part of a proposed Noninvasive Neuromodulation Unit (NNU) protocol, “A Feasibility Study of Transcranial Electric Stimulation Therapy (TEST) for treatment resistant depression (TRD)”. 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. During market research, it was determined that the Mecta Corporation is the only source that manufactures an electroconvulsive therapy device that enables a precisely age-based dosing. The MECTA Sigma has a full spectrum dosing parameter set that enables the NIH investigator to individually set each stimulus parameter--pulse width, frequency, duration and current—that determines the overall charge and energy delivered. The MECTA Sigma device will be modified by the manufacturer to decrease the lowest frequency setting from 20 to 10 Hz. This modification will enable the device to match/deliver stimuli at the lower, sub-seizure threshold doses that NIH used in its preliminary study. The intended source is: Mecta Corporation 19799 SW 95th Ave Tualatin, Oregon 97062 United States 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: service/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, NIMH21002185. Responses must be submitted electronically to Michael Horn, Contracting Officer, at michael.horn@nih.gov. U.S. Mail and fax responses will not bed accepted. Attachment 1 - NIMH21002185 A0001 SF30