ITAMAR MEDICAL INC.NOTICE OF INTENT.75N94024Q00108.pdf

RFQ# 75N94024Q00108

INTRODUCTION

THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A CONTRACT OR PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME).

The National Institutes of Health, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Office of Acquisitions (OA) on behalf of the on behalf of the National Institute of Digestive, Diabetes & Kidney Diseases intends to award a purchase order without providing for full and open competition (Including brand-name) to ITAMAR MEDICAL INC for the Acquisition of an EndoPATx Kit, Laptop EndoPAT2000, US DELL, and EndoPATx accessories.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS code 334516 with a Size Standard of 1,000.

PRIMARY PRODUCT/SERVICE CODE

6640 - LABORATORY EQUIPMENT AND SUPPLIES

REGULATORY AUTHORITY

The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular FAC 2024-04 Effective May 1, 2024.

This acquisition is conducted under the procedures as prescribed in FAR subpart 13—Simplified Acquisition Procedures at an amount not exceeding the simplified acquisition threshold ($250,000).

STATUTORY AUTHORITY

This acquisition is conducted under the authority of 41 U.S.C. 253(c) under provisions of the statutory authority of FAR Subpart 6.302- FAR 6.302-1—Only one responsible source and no other supplies or services will satisfy agency requirements 41 U.S.C. 253(c)(1).

PERIOD OF PERFORMANCE

Within 30 Days of Award

Place of Performance National Institutes of Health National Institute of Digestive, Diabetes & Kidney Diseases 10 Center Drive Bethesda, MD 20892

PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS

DESCRIPTION OF REQUIREMENT

The mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) is to conduct and support medical research and research training and to disseminate science-based information on diabetes and other endocrine and metabolic diseases; digestive diseases, nutritional disorders, and obesity; and kidney, urologic, and hematologic diseases, to improve people’s health and quality of life.

The NIDDK supports a wide range of medical research through grants to universities and other medical research institutions across the country. The Institute also supports government scientists who conduct basic, translational, and clinical research across a broad spectrum of research topics and serious, chronic diseases and conditions related to the Institute's mission. In addition, the NIDDK supports research training for students and scientists at various stages of their careers and a range of education and outreach programs to bring science-based information to patients and their families, health care professionals, and the public.

Endothelial dysfunction is an established indicator and independent risk factor of atherosclerotic heart disease, a major cause of morbidity and mortality in the world. The assessment of endothelial function is a validated marker for the development and progression of cardiovascular disease and is an important risk assessment tool. Moreover, endothelial dysfunction may be modifiable, especially in certain high-risk groups.

PURPOSE AND OBJECTIVES

The objective of this contract is to purchase the EndoPATX machine, and the associated supplies needed to study patients at the NIH on IRB-approved research protocols. This is needed for our new protocol 001746-DK (PI Dr. Stephanie Chung) and for protocols by PIs Dr. Rebecca Brown, and Dr. Amber Courville.

SALIENT / REQUIRED FEATURES AND SPECIFICATIONS

The EndoPATX is the only FDA-cleared device indicated for the diagnosis of endothelial dysfunction. It is an innovating, safe and non-invasive testing device that reflects the vascular health of small vessels. The procedure takes only 15 minutes and automatically scores and produces test results in an operator and interpreter independent fashion. This makes it a specialized tool for research in special populations, such as children and adolescents. Using this FDA-cleared device will minimize risk and maximize benefit to our research participants and provide high quality research data needed for NIH studies.

TASK AREAS:

Independently, and not as an agent of the Government, the contractor shall perform all the detailed Task Areas listed below:

Task Area 1 – Delivery/Installation – The Contractor shall Contractor shall ship equipment to: The National Institute of Diabetes, Digestive, Kidney Disease, 10 Center Drive, Building 10-CRC, Suite 6-5750, Room 6-5740, Bethesda, Maryland 20892.

Task Area 2 – Training – The Contractor shall provide training to be coordinated with team via virtual online platform or in-person training. No additional cost is to be associated with training.

CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME)

DETERMINATION

The determination by the Government to award a contract without providing for full and open competition is based upon the market research conducted as prescribed in FAR Part 10—Market Research. Only one source is available: Per FAR 13.106-1(b)(1) the Contracting Officer has determined ITAMAR MEDICAL INC to be the only reasonable available source to provide an EndoPATX Machine and Supplies.

This acquisition was pursued on a sole source basis centered on the following: Itamar Medical, Inc., is the sole entity that can supply the EndoPATX machine and the associated supplies and is the only FDA-cleared device for the diagnosis of endothelial dysfunction. No other contractor has the compatible components and FDA approved machine to meet the requirements. Itmar Medical Inc.’s EndoPATX machine provides innovating, safe and non-invasive testing device that reflects the vascular health of small vessels that is required for NIH research studies. Failure to use Itamar Medical, Inc. to provide the EndoPATX machine and its many existing compatibility components may result in voiding any manufacturer warranties on the equipment, resulting in additional time and cost(s) needed to study patients at the NIH on IRB-approved research protocols.

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. Responses to this notice shall contain sufficient information to establish the interested parties’ bona-fide capabilities for fulfilling the requirement and include: descriptive literature, delivery timeframe, warranties and/or other information that demonstrates that the offer meets all the foregoing requirements, the prompt payment discount terms, the F.O.B. Point (Destination or Origin), the Unique Entity Identifier (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.”

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. 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.

All responses to this notice shall be submitted electronically by 9:00 am Eastern Standard Time, on Wednesday, May 22, 2024 to the Contract Specialist, Amber Harris, at amber.harris@nih.gov .

Assessment of Capability Lowest Price Technically Acceptable http://www.sam.gov/ mailto:amber.harris@nih.gov