Safety and Feasbility of Individualized Low Amplitude Seizure Therapy (iLAST)

This is a combined synopsis/solicitation for commercial items, prepared in accordance with format in FAR 12.6 as supplemented with additional information included in this notice. This announcement constitutes the only solicitation and a separate written solicitation will not be issued. This solicitation: No. NIMH-19-005381 includes all applicable provisions and clauses in effect through FAR Federal Acquisition Circular (FAC) 2019-3 (effective July 12, 2019)simplified procedures for commercial items. This acquisition will be conducted under the procedures for acquiring commercial items authorized in FAR Part 12 and under the authority to use simplified procedures for commercial requirements as provided in FAR 13.501. This requirement is assigned North American Industry Classification System (NAICS) code 334510 with a size standard of 1,250 Employees is being considered. Only one award will be made because of this solicitation. This will be awarded as a firm fixed price type contract. BACKGROUND The U.S. Department of Health and Human Services, National Institute of Mental Health (NIMH), plans to procure: (1) Brain Vision actiCHamp Plus 64 System with Brain Vision Recorder acquisition software, power supply, connection cables: BV-BP-100-2510, (1) 40-50pin Adapter Kit, to use passive BrainCaps with the actiCHamp Plus: BV-9999, (1) Bipolar Adapter Kit - BIP2AUX (E220X): BV-BPMCS-01_01, (1)Trigger Box Kit for ActiCHamp, V-Amp/FirstAmp: BV-BP-110-9000. The Non-Invasive Neuromodulation Unit within the National Institutes of Mental Health requires another EEG Cap amplifier system for a new clinical research study which was recently IRB approved, titled the Safety and Feasibility of Individualized Low Amplitude Seizure Therapy (iLAST). Specifically, the EEG Cap amplifier system and relevant accessories described in the quote are compatible with the EEG Caps which will be used for the iLAST study, and allow for high-density recordings, easy synchronization for multiple recording modalities, a powerful lithium-ion battery pack, clock synchronization outputs for easy integrations with external devices such as TMS with EMG, and compatibility with EEGLAB, MATLAB, LSL, and OpenViBE for data analysis. The Experimental Therapeutics and Pathophysiology Branch (ETPB) conducts clinical research on mood disorders with the goal of creating better ways to prevent, diagnose, and treat mental illness. The Non-invasive Neuromodulation Unit (NNU) within the ETPB uses transcranial magnetic stimulation combined with electroencephalography (EEG) recordings to investigate cortical excitability and methods to optimize the efficacy of psychiatric disorder treatments. The NNU's iLAST clinical trial, which was recently IRB approved, is a feasibility study aims to explore new techniques for optimizing the use of electroconvulsive therapy (ECT) to treat depression. In conjunction with ECT treatments, several neuroimaging techniques including EEG will be used to collect data on the cortical changes associated with the iLAST treatment. The NNU lab has previously ordered custom EEG caps from Brain Vision LLC for use during the iLAST clinical trial. The new acquisition described is an amplifier which is compatible with the NNU lab's current EEG caps and would allow for the collection of high-quality EEG data for analysis. The amplifier system comes with associated accessories required for use, as described in the quote attached, and the adaptors are required to connect the amplifier to our passive EEG caps. The salient characteristics that apply to this acquisition are as follows: - Compatible with the NNU's current passive EEG caps - Maximum sampling rate: 100,000 Hz - Maximum number of channels: 160 EEG + 8 AUX - Maximum bandwidth of the EEG channels: DC up to 7500 Hz - Digitization: 24-bit, one converter/channel - Input noise: 2 microVpp: (DC - 35Hz) - Input Voltage Range: +/- 400 mV (EEG), +/- 4.8 V (AUX) - Common mode rejection (CMR): 100 dB - Trigger input and output: 8 bit - Compatible with passive EEG electrodes - Impedance measurement capability - Compatible with Brain Vision recorder software - 8 AUX channels - Synchronization output: 3.5 mm stereo jack, TTL signal, always ON Clock signal of A/D converter, based on the three basic sampling rates of the amplifier (10 kHz, 50 kHz, 100 kHz). - Dimensions: Approx. 68 mm x 160 mm x 187 mm - Weight: Approx. 1.1 kg The EEG amplifier system with associated adaptors and accessories must satisfy the aforementioned physical and functional requirements. Quantity: 1 Delivery Date: 60 days after order placement. PAYMENT Payment shall be made upon the delivery and acceptance of all required items in accord with the Prompt Payment Act. DELIVERY / INSTALLATION The Contractor shall deliver the required item(s) within 60 days of purchase order award to the following location: National Institute of Health 10 Center Drive Bethesda, MD 20892 CONTRACT CLAUSES/PROVISIONS The following Federal Acquisition Regulation and Health & Human Services Acquisition Regulation Provisions/Clauses apply to this acquisition: FAR 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998) This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es): http://www.acquisition.gov/far/ and/or http://www.hhs.gov/policies/hhsar/. Clause No. Title FAR 52.212-1 INSTRUCTIONS TO OFFERORS-COMMERCIAL ITEMS (OCT 2018 FAR 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS-COMMERCIAL ITEMS (OCT 2018) FAR 52.212-4 CONTRACT TERMS AND CONDITIONS-COMMERCIAL ITEMS (OCT 2018) FAR 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS-COMMERCIAL ITEMS (JAN 2019). The following FAR clauses cited in paragraph (b) of the clause at FAR 52.212-5 are also applicable to this acquisition: FAR Clause 52.204-10 Reporting Executive Compensation and First Tier Subcontract Awards FAR Clause 52.209-6 Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment FAR Clause 52.209-9 Updates of Publicly Available Information Regarding Responsibility FAR Clause 52.219-28 Post Award Small Business Program Representation FAR Clause 52.222-3 Convict Labor FAR Clause 52.222-19 Child Labor-Cooperation with Authorities and Remedies FAR Clause 52.222-21 Prohibition of Segregated Facilities FAR Clause 52.222-26 Equal Opportunity FAR Clause 52.222-36 Affirmative Action for Workers with Disabilities FAR Clause 52.222-40 Notification of Employee Rights Concerning Payment of Union Dues or Fees FAR Clause 52.223-18 Encouraging Contractor Policies to Ban Text Messaging while Driving FAR Clause 52.225-3 Buy American Act -Free Trade Agreements - Israeli Trade Act FAR Clause 52.225-13 Restrictions on Certain Foreign Purchases Far Clause 52.232-33 Payment by Electronic Funds Transfer-System for Award Management FAR 52.211-6 BRAND NAME OR EQUAL (AUG 1999) (a) If an item in this solicitation is identified as "brand name or equal," the purchase description reflects the characteristics and level of quality that will satisfy the Government's needs. The salient physical, functional, or performance characteristics that "equal" products must meet are specified in the solicitation. (b) To be considered for award, offers of "equal" products, including "equal" products of the brand name manufacturer, must (1) Meet the salient physical, functional, or performance characteristic specified in this solicitation; (2) Clearly identify the item by- (i) Brand name, if any; and (ii) Make or model number; (3) Include descriptive literature such as illustrations, drawings, or a clear reference to previously furnished descriptive data or information available to the Contracting Officer; and (4) Clearly describe any modification the offeror plans to make in a product to make it conform to the solicitation requirements. Mark any descriptive material to clearly show the modification. (c) The Contracting Officer will evaluate "equal" products based on information furnished by the offeror or identified in the offer and reasonably available to the Contracting Officer. The Contracting Officer is not responsible for locating or obtaining any information not identified in the offer. (d) Unless the offeror clearly indicates in its offer that the product being offered is an "equal" product, the offeror shall provide the brand name product referenced in the solicitation. SUBMISSION INFORMATION Proposals must be submitted on an SF-1449 with a completed 52.212-3 Offeror Representations and Certifications-Commercial Items-with DUNS Number Addendum, signed by an authorized representative of the offeror OR provide a copy of valid certification in the System for Award Management (SAM) at www.sam.gov. All responses must be received by 2:00 P.M., Eastern Standard Time, on July 29, 2019, and reference number NIMH-19-005381. Responses must be submitted electronically via electronic mail at contact@example.gov and contact@example.gov . Fax responses will not be accepted. EVALUATION The award decision will be based on a Lowest Price Technically Acceptable (LPTA) determination. In order to be acceptable, the product must meet all the salient characteristics listed above and the product MUST be compatible with the Brain Vision Recorder Software. OFFERS THAT ARE NOT COMPATIBLE WITH THE HIGH BRAIN VISION RECORDER SOFTWARE WILL NOT BE CONSIDERED. Award will be made on all or none basis. If you are providing an "equal" product, you must submit additional documentation that highlights and describes how your offering is equal in accordance with FAR Clause 52.211-6. PRICE PROPOSAL The Offeror shall prepare a price proposal that contains all information necessary to allow for a comprehensive evaluation of the prices quoted. Specifically, your quote must include the following: Federal Tax Identification Number (TIN); Data Universal Numbering System (DUNS) Number; and Business Size (e.g., small or large). Contracting Office Address: 6001 Executive Boulevard Room 4211, MSC 9559 Rockville, Maryland 20852-9559 United States Primary Point of Contact.: Michelle Cecilia contact@example.gov Phone: +1 (555) 000-0000 Secondary Point of Contact: Valerie Whipple, Contracting Officer contact@example.gov Phone: +1 (555) 000-0000