This is a combined synopsis/solicitation for commercial items prepared in accordance with the Federal Acquisition Regulation (FAR) format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested and a written solicitation will not be issued.  The solicitation is being issued in conjunction with FAR Part 13 - Simplified Acquisition Procedures. The solicitation number is FDA-NCTR-2023-121391. This solicitation is issued as a Request for Quote (RFQ).

The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2023-03, March 16, 2023.

The associated North American Industry Classification System (NAICS) Code is- 541990 – All Other Professional, Scientific and Technical Services; with a Small Business Size standards in $17 million. This requirement is being competed unrestricted and made available to Full and Open competition, meaning any qualified vendor regardless of size status may submit a quote.

Respondents are responsible for submitting proposal/quote and any supporting documents before 1:00 PM Central Time - Local Prevailing Time in Jefferson, Arkansas on January 25, 2023, by e-Mail to [email protected].

For information regarding this solicitation, please contact Warren Jackson by e-Mail at [email protected].

Statement of Need

The U.S. Food and Drug Administration (FDA), National Center for Toxicological Research (NCTR), Division of Systems Biology (DSB) requires a highly specific and sensitive miRNA Whole Transcriptome Assay (WTA). Since early 2020, more than 6.8 million of people including children in the world have died of Covid 19. To better understand the susceptibility of SARS-Cov 2 infection, plasma samples from Covid 19 patients are used to evaluate the risk factors associated with age, gender and other underline health conditions such as obesity, high blood pressure, and cancer etc. The information from this study could potentially be incorporated into treatment strategies in clinic setting. To fulfill this need, 120 plasma samples from adult covid 19 patients will be sequenced using highly sensitive high throughput sequencing technology. miRNA profiles in these plasma samples will aid in discovery of novel circulating miRNAs released in plasma in response to SARS-virus 2 infection. These miRNAs can serve as predictive biomarkers for patients whose is susceptible to SARS virus 2 infection. Due to the limited quantity of plasma samples in this study, we need a high throughput sequencing technology not only generate the highest quality of sequencing data, but also use smaller amount plasma samples. Therefore, a highly specific and sensitive miRNA Whole Transcriptome Assay (WTA) is required to accomplish our goal.

Minimum Performance/Technical Requirements:

• miRNA WTA shall utilize robust, automated HTG EdgeSeq system coupled with the sensitivity and dynamic range of next-generation sequencing (NGS)-based detection.
• miRNA WTA shall utilize HTG EdgeSeq technology that is a combination of nuclease protection assay and NGS for targeted sequencing to provide accurate and sensitive measurement of the expression.
• miRNA WTA shall utilize HTG EdgeSeq system to eliminate biases associated with DNA/RNA extraction, size selection, cDNA synthesis, and adapter ligation for eproducible results.
• miRNA WTA shall be capable of extraction-free sample preparation (without the need for RNA extraction) in plasma.
• miRNA WTA shall be capable of simultaneous, quantitative detection of ~2000 miRNA transcripts in a small volume of plasma (15 μl) in a single reaction.
• miRNA WTA shall be capable of running up to 100 - 200 plasma or RNA samples simultaneously in a 96-well plate and must provide fast, reliable, reproducible, and quantitative analysis of ~2000 targeted miRNAs in a single assay.
• miRNA WTA shall use sophisticated HTG EdgeSeq informatics package to significantly simplify data analysis and simplified data output in Excel format.
• All data shall be provided to NCTR in a Microsoft Excel spreadsheet via email or an internet site for downloading. The service company does not own the data (i.e., intellectual property). NCTR/FDA is the owner of the data.

Mandatory Requirement:

• Due to National Security concerns for this type of service, prior to any issuance of any Contract / Purchase Order Vendors will be review by the FDA Division of Counterintelligence and Insider Threat for potential security risk.
• In addition, the attached Contractor’s Commitment To Protect Non-Public Information (NPI) the attached FDA FORM 3398 shall be signed and returned with quote submission.

Item #1

miRNA Whole Transcriptome Assay (WTA) Service in Human Plasma Samples

To meet the above Minimum Performance/Technical Requirements

• All samples shall be provided to vendor no later than September 30, 2024.
• No samples shall be submitted to the vendor after that date.

Quantity: 120 Samples

Unit Price: _____________________

Extended Price: __________________________

GSA Contract Number: ______________________ (If Applicable)

PRICE QUOTES SHALL BE FOB DESTINATION INCLUSIVE OF ALL ANALYSIS, SHIPPING, HANDLING, & DELIVERY CHARGES

Analysis Delivery shall occur 30 - 60 working days after receipt of Government samples.

FOB Destination:

   U.S. Food and Drug Administration

   National Center for Toxicological Research (NCTR)

   3900 NCTR Road

   Jefferson, AR 72079

Contract Type-

Commercial Item - Firm fixed price.

See Attached Solicitation