Theta-Burst Stimulation as a Treatment for Reducing Cocaine Use

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). THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION WILL NOT BE ISSUED AND PROPOSALS WILL NOT BE REQUESTED. The National Institute on Drug Abuse (NIDA), Consolidated Station Support and Simplified Acquisitions (CSS/SA) Branch intends to negotiate and award a purchase order to Magventure, Inc for a Human TMS system without providing for full and open competition (including brand-name). NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 423490 with a Size Standard of 150 Employees. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2005-89 dated July 15, 2016. This acquisition is for a commercial item or service and is conducted under the procedures as prescribed in FAR subpart 13-Simplified Acquisition Procedures. This acquisition is NOT expected to exceed the simplified acquisition threshold STATUTORY AUTHORITY This acquisition is conducted under the authority of the authority of FAR Subpart 13.106.1.b-1 DESCRIPTION OF REQUIREMENT The NIDA-IRP requires (1) a transcranial magnetic stimulation (TMS) device for the experimental application to treat substance abuse (e.g., cocaine dependence). A recent study from Dr. Antonello Bonci's lab (NIDA/IRP Scientific Director) showed that optogenetic stimulation of the prelimbic cortex can remove compulsive cocaine seeking behavior in rats trained to self-administer cocaine in the face of a punishment. To translate the findings from the animal model to human clinical studies and to better understand the underlying neurobiological mechanisms, development of non-invasive brain stimulation coupled with fMRI measurements is necessary. We plan to use the TMS device to a) understand acute brain circuit alterations in the presence of TMS using neuroimaging in both control and cocaine using participants, b) understand long-term brain circuit alterations related to chronic application of TMS using neuroimaging in cocaine using participants, and 3) investigate the efficacy of the TMS intervention in reducing cocaine use in cocaine using participants. Specifically, the NIDA-IRP, Office of the Scientific Director requires a MagVenture X100 with MagOption Magnetic Stimulator, 230V or its equal. For reference, the MagVenture X100 with MagOption Magnetic Stimulator, 230V, supporting equipment, and TMS coils meet the needs of this requirement includes the following Part Numbers (1each): 9016E0731, 9016D0031, 9016E0482, 9016E0501, and 9016B0151. The brand name human TMS stimulation system and coil must meet the following requirements: 1. It must be equipped with a strong power supply and a transcranial magnetic stimulation (TMS) coil that is cooled and specific for stimulating the human brain. 2. The TMS system and coil should be able to continuously administer theta-burst stimulation (TBS) at 100% duty cycle without overheating and with clinical accuracy. 3. The power supply and related hardware and software must be able to provide repetitive TBS stimuli that, at a minimum, meets the following requirements: a stimulation intensity that represents 110% of the average resting motor threshold of clinical participants, must be able to administer at least 4 minutes of intermittent TBS delivered once per hour for up to 8 hours a day, and the coil must be actively cooled. 4. The equipment must have capabilities to elicit motor evoked potentials, deliver paired pulse stimulation, and communicate with a device to display and record the motor evoked potentials and activation elicited during paired pulse stimulation. 5. Delivery must include installation and onsite user training. Delivery time 90 days from receipt of order 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, NIDA-IRP, Neuroimaging Research Branch requires a MagVenture X100 with MagOption Magnetic Stimulator, 230V or its equal. For reference, the MagVenture X100 with MagOption Magnetic Stimulator, 230V, supporting equipment, and TMS coils meet the needs of this requirement includes the following Part Numbers (1each): 9016E0731, 9016D0031, 9016E0482, 9016E0501, and 9016B0151. The unique aspect of this TMS machine is that it provides continuous theta burst stimulation (i.e. 100% duty cycle). This continuous theta burst stimulation is required for the proposed research protocol. MagVenture is the sole manufacturer and supplier of a TMS machine that meets this required specification. The intended source is: Magventure, Inc 2300 Lakeview Parkway, Ste 700 Alpharetta, GA 30009-9066 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. 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. 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 the closing date and time of this announcement and must reference the solicitation number. Responses may be submitted electronically to Farrin Stanton, Contract Specialist, at Farrin.Stanton@nih.gov. US Mail and Fax responses will not be accepted.