INTRODUCTION THIS IS A PRE-SOLICITATION NON-COMPETITIVE (NOTICE OF INTENT) SYNOPSIS TO AWARD A PURCHASE ORDER WITHOUT PROVIDING FOR FULL OR OPEN COMPETITION. The National Heart, Lung, and Blood Institute (NHLBI), Office of Acquisitions (OA), intends to negotiate and award a purchase order on a noncompetitive sole source basis to Bio-Rad Laboratories, Inc., 2000 Alfred Nobel Dr, Hercules, CA, 94547-1804, to procure reagents and consumables for the Bio-Rad QX200 Droplet Digital PCR System used by NHLBI's Sickle Cell Branch. BACKGROUND This project, conducted by NHLBI's Sickle Cell Branch, is an investigation of the role of endothelial alpha globin as a regulator of blood pressure in humans. As part of this project, the lab needs to measure the number of alpha globin gene copies found in human subjects participating in certain clinical studies. Because the number of genes can vary from 0 to 5 copies, it is imperative that the lab has accurate data on copy number variants (CNVs). Digital PCR is the standard method for doing this, and is essential when dealing with more than 2 copies of a gene. Furthermore, the project will require quantification of gene expression in small tissue biopsies, where RNA levels will be very low. In these situations digital PCR vastly outperforms conventional QPCR and is therefore essential to the lab's research. PURPOSE The purpose of the acquisition is to procure reagents and consumables for the laboratory's Bio-Rad QX200 Droplet Digital PCR System. The lab will be performing a CLIA level assay, so it requires that all of the reagents and supplies are from the same lot. This will provide the laboratory with the capacity to quantitatively measure gene expression levels in blood and tissues, as well as gene copy number in samples of genomic DNA. Specifically, the lab will use the ddPCR system to measure gene copy number in mice and humans. PROCUREMENT The contractor shall provide the following: - PrimePCR ddPCR Expression Probe Assay: HBA2, Human (2,500 x 20ul reactions). Qt. 5. - PrimePCR ddPCR Copy Number Assay: RPP30, Human (2,500 x 20ul reactions). Qt. 5. - DG32 Automated Droplet Generator Cartridges (pkg. of 60). Qt. 8. - Automated Droplet Generation Oil for Probes (140ml). Qt. 8. - Pipet Tips for the AutoDG System (pkg. of 40, boxes of 96 each). Qt. 8. - Pipet Tip Waste Bins for the AutoDG System 9 (pkg. of 10). Qt. 10. - ddPCR Supermix for Probes (No dUTP) (25ml (5x5 ml) (2x supermix). Qt. 6. - PCR Plate Heat Seal, foil, pieceable (pkg. of 100 foil seals). Qt. 2. - ddPCR Droplet Reader Oil (2L (2x1 L)). Qt. 8. - ddPCR Plates 96-Well,Semi-Skirted (25/box). Qt. 12. JUSTIFICATION The sole-source justification is based on the fact that this procurement is in support of an ongoing study. It is imperative that the reagents to be procured are consistent with previously utilized reagents, as any changes to the protocol (including reagents, instruments, testing conditions, etc.) would damage the integrity of the data. Consistency is critical to data validity, and the lab must ensure that experimental protocols are maintained and unchanged for all studies. After research of many manufacturers' reagents, these specific reagents obtained from Bio-Rad Laboratories must be used. No other source can provide these specific reagents without substantial duplication of costs and unacceptable delays in fulfilling the agency's requirements. REGULATORY AUTHORITY This acquisition is conducted under the authority of the Federal Acquisition Regulations (FAR) Subpart 13.106-1(b), soliciting from a single source (for purchases not exceeding the simplified acquisition threshold) and only one responsible source and no other supplies or services will satisfy agency requirements. ADDITIONAL INFORMATION Industry Classification (NAICS) Code is 339113, Surgical Appliance and Supplies Manufacturing, and the Small Business Size Standard is 750 employees. The acquisition is being conducted under FAR Part 13, Simplified Acquisition Procedures, therefore the requirements of FAR Part 6, Competitive Requirements, are not applicable (FAR Part 6.001). The resultant award will include all applicable provisions and clauses in effect through the Federal Acquisition Circular (FAC) 05-89 (August 15th, 2016). 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: 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 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 September 8, 2016 at 9:00AM EST and must reference synopsis number NHLBI-CSB-HL-2016-295-KMA. Responses shall be submitted to the National Heart, Lung, and Blood Institute, Office of Acquisitions, COAC Services Branch, 6701 Rockledge Drive, Room 6127, Bethesda, Maryland 20892-7902, Attention: Kevin Alvarez. Responses may be submitted electronically to
contact@example.gov. Faxes will not be accepted. Responses will only be accepted if dated and signed by an authorized company representative. "All responsible sources may submit a bid, proposal, or quotation which shall be considered by the agency."
