NOTICE OF INTENT TO SOLE SOURCE.pdf

NOTICE OF INTENT TO SOLE SOURCE

Notice of Intent: 75N95022Q00464

INTRODUCTION

PURSUANT TO FAR Subpart 5.2—Synopses of Proposed Contract Actions, THIS IS A NON-COMPETITIVE NOTICE OF INTENT TO AWARD A CONTRACT OR

PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION

(INCLUDING BRAND-NAME).

The National Institute on Drug Abuse (NIDA), Office of Acquisitions, Contracts Management Branch Red on behalf of the National Institute on Mental Health intends to negotiate and award a contract for ABCD protocol compatible 32-channel MRI head coil for GE MR-750 3T MRI Scanner with Nova Medical Inc.

NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE

The intended procurement is classified under NAICS Code 334510 - Electromedical and Electrotherapeutic Apparatus Manufacturing.

REGULATORY AUTHORITY

The resultant contract will include all applicable provisions and clauses of the Federal acquisition Requlation (FAR) in effect through the Federal Acquisition Circular 2022-06, dated 26 April 2022.

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.

DESCRIPTION OF REQUIREMENT

Purchase Description One (1) 32-channel MRI head coil for General Electric MR-750 3T MRI Scanner.

Product Requirements Item must:

• Be hardware and software compatible with General Electric’s MR-750 3T MRI scanner hardware and software, including, but not limited to FMRI, ARC, ASSET, HyperBand, CUBE, and PROMO applications.

• Have full 510k clearance from the US Food and Drug Administration (FDA).

• Have at least 32 channels from which signal can be received from the subject or object being imaged.

• Be able to acquire data with slice-accelerated (multi-band, a.k.a. simultaneous multi-slice, a.k.a. SMS, a.k.a. HyperBand) factors greater than 2 along the head-to-foot (superior-to-inferior) axis of a human subject.

• Provide compatibility with data acquisition for the ABCD protocol, allowing Functional MRI (FMRI) data to be acquired with a SMS factor of 6, and Diffusion Tensor Imaging (DTI) data to be acquired with a SMS factor of 3, along the head-to-foot (superior-to-inferior) axis of a human subject.

• Provide flexible patient mirror mounting options to allow visual stimulus delivery via either front- or rear- -mounted screens.

Sole Source Justification:

The material or service must be compatible in all aspects (form, fit, and function) with existing systems presently installed. The current equipment is a GE MR-750 MRI 3T scanner, and the new item/service must coordinate, connect, or interface with the existing system by plugging into FMRIF’s MR-750 RF coil plugs, and demonstrating mechanical, electrical, and functional compatibility with GE MRI scanner hardware and software. The coil must also be FDA-approved. Nova Medical is the only known source that has already obtained FDA approval for its coil. In addition, Nova Medical’s head coil’s performance has also already been demonstrated with the ABCD MRI protocol. No other vendor is known to have satisfied all of these requirements.

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.

The respondents must submit clear and convincing evidence that their product is equivalent or superior to the product specified in this notice. Responses to this notice shall contain sufficient information to establish the interested parties' bona-fide capabilities for fulfilling the requirement and include: 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 Unique Entity ID Number (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. FAR clauses 52.212-4, Contract Terms and Conditions – Commercial Items and 52.212-5 Contract Terms and Conditions Required to Implement Statutes or Executive Orders – Commercial Items apply to this acquisition. The response must also indicate the country of manufacturer.

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 must be received by 3 August 2022 at 12 PM Eastern Time and must reference number 75N95022Q00464.

Responses must be submitted electronically to Polina Klimenkova, Contract Specialist, at polina.klimenkova@nih.gov, and must reference the solicitation number 75N95022Q00464, on your electronic request.

“All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency.”