U-Rhythm Device

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

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.

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), in support of the work of the National Institute of Diabetes, Digestive, and Kidney Disease (NIDDK), intends to award a purchase order without providing for full and open competition to M Dialysis, Inc., 73 Princeton Street, Suite 302, North Chelmsford, MA 01863 to acquire Development of the U-Rhythm device for endocrine and metabolic investigation.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE - The intended procurement is classified under NAICS code 334516 with a Size Standard 1000.

REGULATORY AUTHORITY - The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Regulation (FAR) Circular (FAC) 2024-05 effective 05/22/2024.  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) and FAR Subpart 12- Acquisition of Commercial Items. 

STATUTORY AUTHORITY - This acquisition is conducted under the authority of the Federal Acquisition Regulation (FAR) Part 13—Simplified Acquisition Procedures, Subpart 13.106-1 (b) (1), Soliciting from a single source and is not expected to exceed the simplified acquisition threshold.  Contracts awarded using FAR Part 13—Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6—Competition Requirements.

Place of Performance - National Institutes of Health, 9000 Rockville Pike, Bethesda MD 20892, United States

DESCRIPTION OF REQUIREMENT - The National Institutes of Health (NIH), National Institutes of Diabetes and Digestive and Kidney Disease (NIDDK), needs to purchase U-RHYTHM microdialysis collection devices to carry out a protocol that requires collection of interstitial tissue fluid to measure hormone levels in the fluid.  The recently developed U-RHYTHM system is a novel way to interrogate tissue exposure of people to cortisol or other hormones/substances over a 24-hour period (or longer) in a real-world ambulatory setting.  A portable, battery-operated syringe pump that can be coupled to a subcutaneous microdialysis catheter with 20kD pores that can be attached to an automated, body-worn fraction collector.

REF #                                    Description                                                                                  

8010650                              66 Linear Microdialysis Catheter, 4/pkg                

8010191                              Syringes for 106/107, 20/pkg

P000034                              T1 Perfusion Fluid, sterile

P000127                              107 Microdialysis Pump

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 that M Dialysis, Inc the sole provider of the U-Rhythm device for endocrine and metabolic investigation.

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. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provided feedback to respondents with respect to any information submitted.  Responses to this notice shall contain sufficient information to establish the interested parties’ bona-fide capabilities for fulfilling the requirement, 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 Vendor/Contractor’s (UEI) the Unique Entity ID from SAM.gov is now the authoritative identifier for those doing business with the federal government. The DUNS Number is no longer valid for federal award identification, 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.”  Note to Contractor: The contractor shall provide a completed copy of FAR 52.204-24, "Representation Regarding Certain Telecommunications and Video Surveillance Services or Equipment" with their quote in response to this solicitation.

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 (75N94024Q00211) shall be submitted electronically by 11:00 AM Eastern Standard Time, on August 9, 2024.