Inactive

INTRODUCTION THIS IS A PRE-SOLICITATION NOTICE OF INTENT (NOI) TO AWARD A CONTRACT OR PURCHASE ORDER. The National Institutes of Health (NIH), Clinical Center (CC), Office of Purchasing and Contracts ... INTRODUCTION THIS IS A PRE-SOLICITATION NOTICE OF INTENT (NOI) TO AWARD A CONTRACT OR PURCHASE ORDER. The National Institutes of Health (NIH), Clinical Center (CC), Office of Purchasing and Contracts (OPC) on behalf of the Department of Laboratory Medicine (DLM), Clinical Center (CC) at the National Institutes of Health (NIH) intends to negotiate and award a contract without providing for full and open competition (including brand-name) to: OMIXON, Inc 1 Broadway Cambridge, MA, 02142-1100, UNITED STATES. NORTH AMERICAN INDUSTRY CLASSIFICATION SYSTEM (NAICS) CODE The intended procurement is classified under NAICS code 325413 with a Size Standard $20.5 million. REGULATORY AUTHORITY The resultant contract will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 2021-03 February 16, 2021. 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. 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. GENERAL INFORMATION 1. Title: Omixon/ Various reagents. 2. Background Information: The Department of Transfusion Medicine needs supplies from Omixon Holotype Next Generation Sequencing (NGS) typing kits. The Omixon Holotype NGS kits provide the highest level of resolution available for HLA tying. This enables our laboratory to provide the clinicians the most complete information when searching for donors for a hemapoetic stem cell transplant. The higher the resolution, the better the chance of success for the transplant. Implementation of next generation sequencing (NGS) was a lengthy process which required utilization of reagents which have been validated in other institutions. Omixon has worked exclusively with a colleague in the HLA field to optimize the technology utilized for NGS. In addition, over 5,000 typings have been performed utilizing these kits which are comparable to a predicate device, meaning that these kits provide results equivalent to the highest standard in the field and are utilized for comparison to original set of testing. These are the only kits which have been validated by the HLA Lab. Use of another vendor would require a lengthy validation process which would interfere with laboratory testing for transplant patients and donors. 3. Purpose or Objective: The Department of Transfusion Medicine (DTM) at National Institutes of Health (NIH) Clinical Center (CC), Bethesda, MD, intends to procure from Omixon at various quantities the line items and kits listed: 25x Holotype HLA 24/11 – Configuration A1 v2 25x Holotype HLA 24/11 – Configuration A2 v2 100x Promega GoTaq Long PCR Master Mix 1x HLA Twin Shipping and Handling 4. Period of Performance: 7/1/21 to 6/30/22. CONTRACTING WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION (INCLUDING BRAND-NAME) DETERMINATION This system is on site and has been validated for use on CC patients. It would be detrimental to the government to attempt to change systems and quite impossible as these instruments are proprietary and only distributed by Omixon, Inc. With the continuation of using the same system will also help reduces the risk of a disruption in patient care. 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. 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 a technical proposal, a cost-price proposal, and the period of performance, the Dun & Bradstreet Number (DUNS), 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 must be received by May 6th, 2021, 2:30 PM Eastern time and must reference solicitation number 21-006802. Responses may be submitted electronically to Mrs. Grace Wong-Darko, Contracting Specialist at Grace.Wong-Darko@nih.gov. Fax responses will not be accepted. "All responsible sources may submit a capability statement, proposal, or quotation, which shall be considered by the agency."