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SOLICITATION NUMBER: 75N9502300243 TITLE: CENTREPOINT Insight Watch CLASSIFICATION CODE: 7E21 - IT and Telecom—Mobile Device Products (Hardware and Perpetual License Software) NAICS CODE: 541512 Compu... SOLICITATION NUMBER: 75N9502300243 TITLE: CENTREPOINT Insight Watch CLASSIFICATION CODE: 7E21 - IT and Telecom—Mobile Device Products (Hardware and Perpetual License Software) NAICS CODE: 541512 Computer Systems Design Services RESPONSE DATE: 5/3/2023 PRIMARY POINT OF CONTACT: Shivani Patel, Contracts Specialist NINDS Contracts Management Branch, NIDA Shivani.patel@nih.gov DESCRIPTION: THIS IS A PRE-SOLICITATION NOTICE OF INTENT TO AWARD ON A SOLE SOURCE BASIS. THIS IS NOT A REQUEST FOR QUOTE/PROPOSALS. The National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Metabolic Clinical Research Unit (MCRU) requires purchase of the CENTREPOINT Insight Watch in order to Measure human movements in physiological studies of metabolism, dietary, exercise, and environmental interventions in body weight regulations. These wearable monitors are to study bipolar disorders, Gulf War Illness, immune disorders, Parkinson’s disease, and recovery from COVID-19 - which is all critical to the labs mission. This requirement includes 12 months of access to the CENTREPOINT software platform and 2 option years to maintain continued platform access. NIH intends to award this requirement on a sole-source basis to ActiGraph, LLC. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE and SET ASIDE STATUS The intended procurement is classified under NAICS code 541512 with a Size Standard of $34M. This acquisition is NOT set aside for small businesses. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses of the Federal acquisition Regulation (FAR) in effect through the Federal Acquisition Circular (FAC) 2023-02, dated 2/22/2023. BACKGROUND, PURPOSE AND OBJECTIVES OF REQUIREMENT Objective and continuous physical activity monitoring has been used for epidemiological research to assess population physical activity levels and sedentary behavior patterns. Recently, these monitors have been applied in clinical trials to evaluate the potential effects of treatments on physical functions such as movement and sleep in the free-living. The MCRU has been involved in the development and evaluation of many types of research-based wearable technology and are providing support to increasing number of clinical trials that are requesting such approaches. One of the most validated devices in the scientific literature is ActiGraph (by ActiGraph Inc., Pensacola FL), which uses triaxial accelerometry technology to measure movements of the body with high time- and amplitude-resolutions. With its’ software (Actilife), raw acceleration data and time-integrated activity counts can be ascertained to extract features and patterns of health-related outcomes, either comparing to healthy normal populations (such as NHANES studies which also used the ActiGraph monitors) or to compare with individuals themselves in pre- vs. post-treatment conditions. CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION The leading research-grade wearable manufacturer is ActiGraph, LLC. ActiGraph devices have been thoroughly validated and are the most frequently cited research-grade device in the literature. The vast majority of ongoing and upcoming clinical protocols at the MCRU incorporating a wearable-based measure of physical behavior are using ActiGraph devices. The MCRU also requires continuity within and between studies the Core supports. This includes backwards compatibility with devices used to collect the data so the data remain comparable within and between studies. MCRU started using the ActiGraph CentrePoint cloud-based study management system in 2020 and have continued to ramp up use ever since by adding more protocols to the platform as demand continues to grow for inclusion of wearable device-based measures in clinical research. ActiGraph is ISO:13485:2016 certified and manufactures FDA approved (Class II 510(k) cleared) devices and the CentrePoint platform meets all of the regulatory requirements for security and privacy including being HIPPA compliant and exceeding requirements for NIST and FedRAMP minimum standards. Based on the MCRU’s requirements, ActiGraph is the sole source capable of supplying it with the devices and software it needs. Vendor Address: ActiGraph 70 N Baylen Street, Suite 400 Pensacola, FL 32502 Contract Type: A firm-fixed price type contract with option periods is planned for this acquisition, consistent with commercial practices. CLOSING STATEMENT THIS NOTICE OF INTENT TO AWARD ON A SOLE-SOURCE BASIS 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. All responses must provide evidence that they can provide equipment that meets all of the requirements in this announcement. All responses must be received by 5/3/2023 by 5:00 PM EST and must reference the solicitation number, 75N9502300243. Responses must be submitted electronically to Shivani Patel, Contracts Specialist, Contracts Management Branch – Red, NINDS Section, NIDA, at Shivani.patel@nih.gov. U.S. Mail and Fax responses will not be accepted.