Inactive

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 Institutes o... 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 Institutes of Health, National Institute of Neurological Disorders and Stroke (NINDS) EEG Section and the NINDS Surgical Neurology Branch, intends to negotiate on a sole source basis with Natus Neurology for a Natus LTM Portable Model BOM EEG recording system, with Natus Quantum (Phase II) 256-channel amplifier. In addition to the above hardware, the purchase includes the Natus NeuroWorks review software, Natus server software, and installation and training. 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 1250 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) 2023-04 dated June 2, 2023. DESCRIPTION OF REQUIREMENT The NINDS EEG Section engages in collaborative research to better understand the pathophysiology of epilepsy, as well as to advance the evaluation and treatment of patients with medically refractory epilepsy. In close collaboration with the Clinical Epilepsy Section and the Surgical Neurology Branch, this section seeks to use neurophysiologic and neuroimaging techniques to improve the ability to localize epileptic foci in preparation for possible surgical resection. The Functional Neurosurgery Section is part of the NNDS Surgical Neurology Branch. The Functional Neurosurgery Section exploits the unique investigative opportunities provided by intracranial EEG recordings performed by the NINDS EEG Section. Using recordings captured from epilepsy patients implanted with subdural and depth electrodes, the Functional Neurosurgery Section investigates the activation of cortical networks during memory encoding and recall. The Natus 256-Channel EEG recording system is used to evaluate electrical signals of the brain for patients undergoing invasive (intracranial) monitoring for epilepsy surgery evaluation. The Natus system will integrate with the existing BlackRock hardware used by the NINDS Functional Neurosurgery Section to concurrently record data for ongoing research activity. This system meets all the requirements for an EEG system for the clinical and research recordings performed by the NINDS EEG Section and the NINDS Functional Neurosurgery Section. The EEG recording system is manufactured by Micromed, a company which will no longer provide clinical and technical support for the system. Micromed was recently acquired by Natus. To continue their collaborative clinical and research activities, the NINDS EEG Section and NINDS Functional Neurosurgery Section require another recording system which can integrate the existing BlackRock research hardware used for the Functional Neurosurgery Section’s research recordings, as well as record high-channel clinical EEG recordings, performed by the NINDS EEG Section. No other EEG equipment vendor has a system which meets our requirements for clinical and research EEG recordings; this will be a sole-source purchase. 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. The Natus EEG system a direct replacement for the Micromed EEG system. In this case, the end-of-life Micromed 256-channel EEG system will be replaced by the Natus 256-channel EEG system, to ensure continuity of neurodiagnostic clinical EEG recorded by the NINDS EEG Section, as well as the simultaneous research EEG recorded by the NINDS Functional Neurosurgery Section. This recording system is critical for ongoing NIH protocol activity, and for diagnostic pre-surgical evaluation of epilepsy patients being evaluated in the NIH Clinical Center. Only this suggested source can furnish the requirements, to the exclusion of other sources. The system described can only be furnished by Natus Neurology. The intended source is: Natus Neurology 68 Schooner Street, Coquitlam, BC, V3K 7A1 Canada, 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. One (1) copy of the response is required and must be in Microsoft Word or Adobe PDF format using 11point or 12 point font, 8-1 /2" x 11" paper size, with 1" top, bottom, left and right margins, and with single or double spacing. The response is limited to ten (10) page limit. The 10-page limit does not include the cover page, executive summary, or references, if requested. All responses must be received by the closing date and time of this announcement and must reference the solicitation number, NINDS-NOI-23-008129. Responses must be submitted electronically to Tiffany Stone, Contract Specialist, at tiffany.stone@nih.gov. U.S. Mail and fax responses will not be accepted.