JA18152_Redacted.pdf

Control No. JA18152

Sole Source Justification (SSJ) in accordance with FAR subparts 13.106 or 13.5 using Simplified Acquisitions Procedures (SAP)

1. Contracting Activity:

The contracting activity for this action is the US Army Medical Research Acquisition Activity (USAMRAA), Fort Detrick, MD 21703.

2. Requiring Activity:

US Army Research Institute of Environmental Medicine (USARIEM), Natick, MA 01760.

3. Nature of Action

Commercial Item Non-Commercial Item New Requirement Follow-on Requirement Mod to Existing Purchase Order/Contract Number

Pricing: Firm-Fixed Price Time & Materials Cost

Funds: RDT&E Operations and Maintenance, Army (OMA) Other Funds: DARPA

Fiscal Year of Funds: 2018 for First Call Order. TBD for each additional Call Order.

Estimated Total Dollar Value over 5 Year Ordering Period:

4. Contractor Name:

Covidien Sales LLC dba Given Imaging 3555 Koger Boulevard Suite 200 Duluth, GA 30096 Phone: (770) 662-0870 Fax: (770) 662-0510 Email: gi-usacustomer@covidien.com

DUNS: 090073722

Cage Code: 1YH71

5. Description of Supplies/Services:

USARIEM has a need for a Blanket Purchase Agreement (BPA) for SmartPill supplies (Starter Kit, Motiligi Notebook kit, recorder kit, Capsule 5, Smart Bar 5, Docking kit, activation fixture, and service plan). The BPA will have a five year ordering period and a contract ceiling of These supplies will be used in a series of studies aiming 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.

Item Product Code Product Name 1 409990081 SmartPill starter Kit

2 30102401 SmartPill MotiliGi notebook kit 3 50100500 SmartPill recorder kit 4 FGS-0503 SmartPill Capsule 5 5 FGS-0505 SmartPill SmartBar 5 6 50100600 SmartPill docking kit 7 50100400 SmartPill activation fixture 8 50100600 SmartPill docking kit 9 50100500 SmartPill recorder kit 10 80356 SmartPill l 2 year Svc Plan

6. Authority Cited: 41 U.S.C. 1901 OR 41 U.S.C. 1903

(a) FAR 13.106-1(b)(1)(i): Only one source reasonable available (e.g., urgency, exclusive licensing agreement, brand name or industrial mobilization); OR

(b) FAR 13.106-1(b)(1)(ii): Only one source can provide a portion of the purchase that is a particular brand-name item; OR

(c) FAR 13.501(a)(1)(i): Only one source reasonably available (including brand name); OR

(d) FAR 13.501(a)(1)(ii): Only one source can provide a portion of the purchase that is a particular brand-name item.

7. Reason for Authority Cited:

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. The 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. As described below, only 1 vendor meets this requirement.

Market research and an RFI identified ten potential vendors that measure some aspect of the GI microbiome. All but one of the vendors did not meet the minimum essential characteristics for the following reasons: Nine vendors did not measure gastrointestinal pH, temperature and pressure in real time. Five of the Nine were home test kits were privacy concerns and accuracy are of great concern even if they could meet the requirements. Three of the Nine are capsules but only takes pictures and don’t address pH, temperature or pressure. One of the Nine is a simple paper test that does measure pH but it is only able to be performed on expelled fecal material and doesn’t address temperature or pressure in real time. Only one product, the SmartPill, manufactured by Given Imaging Ltd. possesses the technical parameters to fulfill our requirements.

8. Efforts to Obtain Competition: Market Research and a Sources Saught RFI have identified that no alternatives exist for Given Imaging Ltd. SmartPill device and software. No effective competition is anticipated. Notice of Intent to Sole Source will be posted to FBO for 15 days.

9. Actions to Increase Competition: N/A. Given Imaging Ltd. is the only current source available to provide the required equipment.

10. Market Survey: Internet searches and a Request for Information were conducted to determine if any other vendors were capable of meeting the requirement. Based on the results of the research Given Imaging Ltd. is the only vendor capable of meeting the requirement.

11. Interested Sources: There are no known other sources which can provide the equipment required.

12. Procurement History and any other facts:

Previous Contract or Purchase Order Number: N/A

Previously competed: N/A

13. Technical / Requirements Certification: I certify that the support data under my cognizance which are included in this SSJ are accurate and complete to the best of my knowledge and belief.

14. Contracting Officer Certification and Approval: I certify that this justification is accurate and complete to the best of my knowledge and belief. Based upon the facts described herein, I hereby determine that the anticipated price to the Government will be fair and reasonable, and a determination of price reasonableness will be documented and placed in the contract file.