2_JA 2067736.pdf

Brand Name, Limited Source Justification At or Below the Simplified Acquisition

Project Title: Measurement of Pylorus and Esophageal Impedance in OATFEED and EOS clinical trials

I. Identification of the agency and contracting activity

DHHS, NIH, NIAID, LPD, HES

Address of the requesting lab/office: 4 Memorial Drive,Bethesda, MD, USA 20892

II. Description of the project, and supplies or services required to meet the agency’s needs III. Period of performance, inclusive of options: delivery 30 days aro

IV. Project Background :

The Human Eosinophil Section (HES) conducts basic and translational research related to the role of the eosinophil and eosinophil activation in disease pathogenesis, with the ultimate goal of developing novel diagnostic tools and treatment approaches for hypereosinophilic syndromes and other conditions associated with marked eosinophilia, including helminth infection.

The HES has designed a clinical protocol to estimate the prevalence of gastric motility disorders in participants with Eosinophilic Gastritis (EG) that have symptoms suggestive of a gastric motility disorder, to assess the relationship between gastric function, disease activity, patient-reported symptoms and quality of life (QoL) in participants with EG, and to investigate the underlying pathophysiology of gastric dysfunction in participants with EG. The PilOt Assessment To Find Evidence of gastric motility abnormalities in Eosinophilic gastric Disorders (OAT-FEED) is currently pending IRB approval. In order to assess the number of patients with gastric or enteric obsgraction (pyloric stenosis, enteric strictures) detected by endoscopy, it essential to use an EndoFlip (Endolumenal Functional Lumen Imaging Probe).

Project Description: The EndoFlip impedance planimetry system measures the area across the inside of a gastrointestinal organ and determine the pressure inside that organ, which is essential to determine the extent of gastric or enteric obstruction obsgraction (pyloric stenosis, enteric strictures) in patients enrolled on the OAT-FEED clinical protocol.

Requirement List: (1 each) Endoflip 1 System #EF-100 Endoflip Localizatio Kit #LK-103 EF-100 Endoflip 1 Year Service Plan #80442 Endo Catheter 8cm Nasal Tip #EF-325N Shipping and Handling

III. Identification of the statutory authority permitting other than full and open competition (SELECT ONE)

☒ 41 USC 253(c)(1) a n d F A R P a r t 6 . 3 0 2 - 1 : Only one responsible source ☐ 41 USC 501 a n d F A R P a r t 8 . 4 0 5 - 6 : Federal Supply Schedule (FSS), limited competition Important Note: The statutory authorities listed below will rarely ever be used in NIH. Before selecting one of these authorities, please ensure that you have read and understood the citation and discussed it with the cognizant Contracting Officer.

☐ 41 USC 253(c)(2) a n d F A R P a r t 6 . 3 0 2 - 2 : Unusual & compelling urgency ☐ 41 USC 253(c)(3) a n d F A R P a r t 6 . 3 0 2 - 3 : Industrial mobilization; or engineering, developmental, or research capability; or expert services ☐ 41 USC 253(c)(4) a n d F A R P a r t 6 . 3 0 2 - 4 : International agreement ☐ 41 USC 253(c)(5) a n d F A R P a r t 6 . 3 0 2 - 5 : Authorized or required by statute ☐ 41 USC 253(c)(6) a n d F A R P a r t 6 . 3 0 2 - 6 : National security ☐ 41 USC 253(c)(7) a n d F A R P a r t 6 . 3 0 2 - 7 : Public interest

IV. Demonstration that the proposed contractor(s) unique qualifications or the nature of the acquisition requires use of the authority cited

A. Name and address of the proposed contractor(s):

Covidien Sales – Medtronic 3555 Koger Blvd, Ste 200 Duluth, GA 30096 770-662-0870

B. Describe why only the requested supply/service will meet the government’s needs Covidien Sales – Medtronic produces the EndoFlip system. Our research requries a product that provides the impedance planimetry measurement needed for our research exactly as the Medtronic Endoflip system does.