Inactive

NOTICE OF INTENT to Sole Source SOLICITATION NUMBER: NIMH-23-004914-NOI TITLE: NIMH Lease of Nine Empatica EmbracePlus Smart Watches CLASSIFICATION CODE: D -- Information technology services, includin... NOTICE OF INTENT to Sole Source SOLICITATION NUMBER: NIMH-23-004914-NOI TITLE: NIMH Lease of Nine Empatica EmbracePlus Smart Watches CLASSIFICATION CODE: D -- Information technology services, including telecommunications services NAICS CODE: 541990 - All Other Professional, Scientific and Technical Services RESPONSE DATE: 7/1/23 PRIMARY POINTS OF CONTACT: Kyle Miller Kyle.Miller2@nih.gov Christine Frate Christine.Frate@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 Empatica S.R.L. for the purchase of Empatica EmbracePlus wearable devices for the measurement of electrodermal activity (EDA), heart rate/heart rate variability, and temperature, during cognitive behavioral therapy. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE and SET ASIDE STATUS The intended procurement is classified under NAICS code 541990 - All Other Professional, Scientific and Technical Services with a Size Standard of $16.5M 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 02, 2022. DESCRIPTION OF REQUIREMENT Preliminary evidence from our lab (Naim et al., In Press) shows efficacy of exposure to anger-inducing cues (as part of exposure-based cognitive behavioral therapy, CBT) as a treatment for irritability with clinical improvement up to six months. However, findings are based solely on clinician ratings and parent/child subjective reports; the specific pathophysiologically informed exposure-related mechanisms leading to improvement remain unknown. Psychophysiological signals—including heart rate (HR), heart rate variability (HRV), and electrodermal activity (EDA)—are measurable indicators of autonomic nervous system functioning that have been broadly implicated in psychiatric disease (Maples-Keller et al., 2022). Psychophysiological signals like HR, HRV, and EDA have a place in assessment of psychology across cognitive, social, and functional domains that by nature overcome issues contributing to biased self-reports and over/under reporting of subjective symptoms (Harvey et al., 2022). When measured during psychotherapeutic sessions that model the context in which individuals manifest their symptoms/experience their most severe symptoms through exposures, validity is also enhanced. Therefore, the aim of this study is to assess in vivo psychophysiology—HRV, HR, and SCL—within and across exposure-based CBT for youth with clinically impairing irritability [including youth diagnosed with disruptive mood dysregulation disorder (DMDD), anxiety disorders, and attention deficit hyperactivity disorder (ADHD)], with the goal of identifying potential putative psychological mechanisms of treatment efficacy. We consider three psychophysiological signals, as they are differentially regulated and represent variant psychological symptoms (Maples?Keller et al., 2017). Pilot data from our lab using the Empatica E4 wearable device have indicated reductions in HR and improvements in HRV over the course of exposure-based CBT for youth with clinically impairing irritability. To continue to test these hypotheses, we are requesting new devices—the Empatica EmbracePlus wearables. This is because Empatica is phasing out the E4 watches and will no longer support data collection/extraction from the watch, interfering with our study aims. Additionally, the EmbracePlus offers the most advanced and highest-quality PPG, EDA, gyroscope, and accelometer for collection of target data. Included with the purchase of the EmbracePlus is the Care App—the link between the EmbracePlus and the Empatica Cloud. The data collected by the EmbracePlus is transferred to the Care App via Bluetooth, and the Care App then transmits this data to the Empatica Cloud, where users can directly access raw data. Together these comprise the Empatica Health Monitoring Platform, which is HIPAA compliant. Delivery is expected within 30 days after receipt of order. CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION During market research, it was found that this is the only commercial product in the market that is a research-grade product which can provide raw data and measurement of all psychophysiological data of interest. Additionally, as past data was collected by the Empatica E4 wearable devices would cause irreparable harm to ongoing experiments and research as it could corrupt data comparisons due to variability and possible different ways of data collection. Therefore, with these facts in mind, it was found that Empatica S.R.L. is the only vendor that can provide the needed products. The intended source is: Empatica S.R.L. Via Enrico Stendhal 36 Milano, 20144 ITA 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. All responses must be received by the closing date and time of this announcement and must reference the solicitation number, NIMH-23-004914-NOI. Responses must be submitted electronically to Kyle Miller, Contract Specialist, at kyle.miller2@nih.gov and Christine Frate, Contracting Officer, at Christine.Frate@nih.gov. U.S. Mail and fax responses will not be accepted.