Notice of Intent to Sole Source - Smart Pill Motility Testing System

THIS IS A NOTICE OF INTENT TO AWARD A SOLE-SOURCE CONTRACT AND IS NOT A REQUEST FOR COMPETITIVE PROPOSALS.

The United Stated Army Medical Research Acquisition Activity (USAMRAA)
intends to negotiate on a sole source basis, IAW FAR 13.501, with Covidian Sales LLC (dba Given Imaging), 3555 Koger Boulevard Suite 200, Duluth, GA 30096, as the only responsible source that can provide SmartPill non-invasive telemetry based supplies for GI transit time and pH as defined by the Minimum Essential Characteristics of this requirement. This acquisition is being conducted under FAR Part 12 Acquisition of Commercial Items. Provisions and clauses in effect through Federal Acquisition Circular 2005-83 are incorporated.

United States Army Research Institute of Environmental Medicine (USARIEM) intends to procure firm-fixed-price Blanket Purchase Agreement with a Five (5) Year Ordering Period for SmartPill products used in a series of studies with the intent to determine how military-relevant stress and dietary supplementation impact gastrointestinal transit time and pH, and to what extent changes in those parameters are associated with changes in the composition and activity of intestinal microorganisms and changes in appetite physiology.

Items being included in this acquisition are:
409990081 SmartPill starter Kit
30102401 SmartPill MotiliGi notebook kit
50100400 SmartPill docking station kit
50100500 SmartPill recorder kit
FGS-0503 SmartPill Capsule 5 pack
FGS-0505 SmartPill SmartBar 5 pack
50100600 SmartPill activation fixture
FGS-0658 SmartPill software v3.1
80356 SmartPill l 2 year Svc Plan

USARIEM has a requirement for a non-invasive telemetry based device that is approved for human use and capable of measuring gastrointestinal (GI) transit time and GI pH. Given Imaging's SmartPill motility system utilizes a pill that measures the GI Transit time and transmits data via telemetry. The single-use ingestible capsule is a self-contained system that will measure GI tract pressure, temperature and pH, its 2.54 cm long and 1.27 cm wide with a working life of 120+ hours (exceeding average transit time of 12-36 hours). This will allow us to measure whole gut transit time along with the gastric emptying of the small bowel, large bowel and colon. GI transit time is a key outcome relevant to two separate USARIEM research areas: the gut microbiota and appetite regulation. Both military-relevant stressors (e.g., environmental extremes, psychological stress, physical activity) and diet are known to modulate GI transit time, which can in turn influence the composition and activity of the gut microbiota and appetite regulation. However, these relationships are not well understood, in part, because of the difficulty in measuring GI transit time accurately, especially in free-living (i.e., non-hospital) environments. An improved understanding of how these interactions occur is necessary to design strategies for leveraging the gut microbiota to enhance performance, and to promote eating during operations where undereating has historically predominated. GI pH is a critical parameter of GI health and gut microbiota activity, and influences the types of microbes that can survive in the GI tract. Current methods of measuring GI pH rely on fecal samples which only represent pH at the distal GI tract which is largely uninformative because pH varies dramatically throughout the GI tract including throughout the colon where the majority of gut microbes reside. The capability to accurately measure in vivo GI transit time and pH in free-living Soldiers will enhance the technical capacity within two separate USARIEM research areas, and these outcomes are integral to several planned studies.

Minimum Essential Characteristics:
• Shall be FDA approved for human use and minimal risk for healthy adults.
• Shall include an ingestible capsule capable of measuring gastrointestinal (GI) pH, pressure, transit time and temperature within normal physiologic range.
• Capsule shall communicate wirelessly with a data receiver.
• Battery life of capsule shall be >72hr.
• Data receivers shall be rechargeable.
• Program software shall run on Windows 10, 64 bit.
• Software shall be provided on a CD so that the buyer can install it on their own computer.
• System shall allow data on data receiver to be downloaded to computer running system software.
• Software shall allow export of data in .txt or .xlsx format.

The intended procurement will be classified under North American Industry Classification System (NAICS) 339113 with a Small Business Size Standard of 750 employees. This notice of intent is not a request for competitive proposals and no solicitation document will be posted for this requirement. However, parties interested in responding to this notice shall submit technical data, including cost, sufficient to determine capability in providing the same product. All capability statements received by closing of this notification of this synopsis will be considered by the Government. A determination by the Government not to compete based on responses to this notice is solely within the discretion of the Government. Information received will be
considered solely for the purpose of determining whether to conduct a competitive procurement.

Based on the above information, the only technically acceptable non-invasive telemetry based supplies for GI transit time and pH is SmartPill provided by Covidian Sales LLC (dba Given Imaging), 3555 Koger Boulevard Suite 200, Duluth, GA 30096. Submit email capabilities statements (using PDF, MS Word, Excel attachments) to Jeffrey Sprecher at jeffrey.b.sprecher.civ@mail.mil. Statements are due no later than 1:00 P.M. EST on 22 June 2018. No phone calls accepted.