NOTICE OF INTENT TO AWARD A CONTRACT WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION: Biocompatible Telemetry Transmitters

NOTICE OF INTENT to Sole Source SOLICITATION NUMBER: 75N95024Q00183 TITLE: NIMH Biocompatible Telemetry System CLASSIFICATION CODE: 66 -- Instruments & laboratory equipment NAICS CODE: 334516 - Analytical Laboratory Instrument Manufacturing RESPONSE DATE: March 14, 5:00 PM EST PRIMARY POINTS OF CONTACT: Joseph Kennedy joseph.kennedy@nih.gov 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) Intramural Research Program (IRP) intends to negotiate on a sole source basis with TSE Systems, Inc. for the purchase of biocompatible telemetry equipment to enable wireless monitoring and recording of physiological measures in socially housed rhesus monkeys. 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 1,000 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) 2024-03 dated February 23, 2024. DESCRIPTION OF REQUIREMENT The National Institute of Mental Health (NIMH) Intramural Research Program (IRP) conducts basic research on the neurophysiological substrates of many cognitive functions'including reward processing, decision making, and emotional regulation. As such, several research projects within the Laboratory of Neuropsychology (LN) necessitate wireless monitoring of heart rate and body temperature in awake, unrestrained rhesus monkeys. To accomplish this, NIH requires the use of surgically implanted telemetry transmitters that are MRI-compatible, well-tolerated in nonhuman primates, and have a battery that can last 180 days or longer (depending on sampling rate). Because rhesus monkeys are free to move around home cage environments that exceed the transmission range of typical telemetry receivers (i.e., ~5 meters), it is imperative to use memory-style telemetry implants that can record and store physiological data locally until the monkey comes within range of the telemetry receiver'at which point the locally stored data can be wirelessly transferred. It is also crucial that the telemetry transmitters are capable of interfacing with BIOPAC software that the LN currently uses to collect and analyze physiologic data. The Stellar Telemetry implants (model: BTA-XL) produced by TSE systems fit this description and are, therefore, well-suited for LN research projects. The purpose of this requirement is to acquire new biocompatible telemetry equipment (i.e., implantable transmitters) to expand ongoing research that requires wireless monitoring and recording of physiological measures (e.g., heart rate, body temperature) in socially housed rhesus monkeys. Salient characteristics Surgically implantable transmitters are less than 20 cc in volume, and compatible with large mammals (i.e., rhesus monkeys) weighing over 6 kg. Biopotential leads are sufficiently long (i.e., 60 cm) to safely record heart rate (i.e., ECG) Temperature sensor range (i.e., 0 - 45'C) is appropriate for use in rhesus monkeys. Accelerometer in the implanted transmitter detects and records the animal's movements. Fully enclosed in biocompatible casing and safe to place in MRI scanners. Memory-style implanted transmitter stores data locally to prevent data loss when subject(s) are out of range (i.e., >5 meters) from the wireless receiver. Transmitters can be put into a - low-power state to conserve battery life. Compatible with existing BIOPAC data acquisition software used by the LN. Delivery within sixteen weeks after contract award). CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION The essential characteristics of the biocompatible telemetry transmitters that limit the availability to a sole source are: (1) surgically implantable transmitters which are less than 20 cc in volume and compatible with large mammals weighing over 6 kg.; (2) biopotential leads are sufficiently long (i.e. 60 cm) to safely record heart rate; (3) accelerometer in the implanted transmitter detects and records the animal's movement; and (4) memory-style implanted transmitter stores data locally to prevent data loss when subjects are out of range from the wireless receiver. Only this suggested source can furnish the requirements, to the exclusion of other sources, because these TSE Systems telemetry transmitters are the only transmitters on the market that exceed the transmission range of typical telemetry receivers (i.e., approximately 5 meters). Additionally, the LN must continue these research projects by expanding data collection from additional subjects; as such, the requested surgically implantable telemetry transmitters are required to be compatible with the existing technology and methods used by the LN. This vendor's product is the only product in the market that uses memory-style telemetry implants that can record and store physiological data locally until the monkey comes within range of the telemetry receiver- at which point the locally stored data can be wirelessly transferred. Through market research, NIH has found that no competing product or vendor exists. The intended source is: TSE Systems, Inc. 4403 MERAMEC BOTTOM RD STE A SAINT LOUIS, MO 63129-2565 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. Responses must include the place of manufacturing (i.e. address if supply/equipment is a domestic end product and include country of manufacture). All responses must be received by the closing date and time of this announcement and must reference the solicitation number, 75N95024Q00183. Responses must be submitted electronically to Joseph Kennedy, Contract Specialist, at joseph.kennedy@nih.gov and Michael Horn, Contracting Officer, at michael.horn@nih.gov. U.S. Mail and fax responses will not be accepted.