Notice of Intent to Sole Source.doc

Food and Drug Administration (FDA)

Notice of Intent to Sole Source

Subject: Sole Source IDIQ Firm Fixed Price (FFP) Contract Type for the Procurement of Laboratory Services and Qiagen Molecular Biology and Sequencing Library Reagents, for a Base Year (12 Months), Plus Four (12 Months) Option Years, under Request for Quote FDA- Sol-75F40121R00005-Requisition- 2021-1237394.

Notice of Intent to Sole Source – QIAGEN LLC.

Pursuant to the authority of 41 USC 3304(a)(1), as implemented by Federal Acquisition Regulation (FAR) Subpart 6.302-1, (there is only one responsible source and no other supplies or services will satisfy agency requirements), the Food and Drug Administration (FDA) intends to award a Sole Source firm-fixed price purchase order to QIAGEN LLC., located at:

19300 Germantown Rd

Germantown, MD 20874

Phone: 800-426-8157

Email: customercare-us@qiagen.com https://www.qiagen.com/us/service-and-support/order-support/terms-and-conditions-usa/ FDA has a requirement to procure Laboratory Services and Qiagen Molecular Biology and Sequencing Library Reagents, for a Base Year, Plus Four (12 Months) Option Years, under FDA-Sol: 75F40121R00005.

FDA has been using Qiagen Molecular Biology and Sequencing Library Reagents for previous research and intends to sole source this acquisition to Qiagen LLC. Multiple molecular biology and sequencing projects in DARS require proprietary consumables and reagents from Qiagen. Because the frequency and scheduling of current and future molecular biology, omic research and clinical trial studies requiring sequencing and other molecular testing, FDA requires proprietary reagents for different analyses and research projects involving the isolation, purification and characterization of DNA, RNA and protein molecules or modifications. In addition, FDA requires laboratory services that will provide an independent source for technical replication of sequence data from FDA’s clinical trial samples that will replicate or complete miRNA sequencing and genomic DNA extraction in parallel to DARS using exactly the same SOP and proprietary reagents so data can be harmonized and/or merged. Qiagen LLC., is the only responsible source because they are the only manufacturer of the “Qiagen Molecular Biology and Sequencing Library Reagents”, which are being requested. Qiagen Molecular Biology and Sequencing Library Reagents are only provided by the manufacturer and the manufacturer does not authorize third party service providers.

Current protocols described above use Qiagen LLC reagents. DARS has previously compared the validity metrics of other vendor reagents against Qiagen prior to establishing the optimized SOPs. To use a different reagent would mean less sensitivity and accuracy and would require new protocols to be established. For replication and technical support for our clinical trial testing, Qiagen LLC also offers a parallel miRNA-seq service and DNA extraction method, which will provide additional support and throughput capacity for DARS as FDA moves delayed projects forward to completion. No other vendor can provide the services as the protocols and reagents are specific to Qiagen.

The NAICS code: 325413 - In-Vitro Diagnostic Substance Manufacturing.

This notice is not a request for competitive proposals. However, any party that believes that it is capable of meeting this requirement as stated herein may submit a written capability statement that clearly supports and demonstrates their ability to perform the requirement. Capability statements must be received by the response date and time of this notice. Submissions will be reviewed to determine if they can meet the requirement. A determination by the Government to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government.

It is anticipated that an award will be issued to Qiagen LLC., within approximately fifteen (15) days after the date of this notice unless the Government determines that any other organization has the capacity to meet this requirement.

Response Date: 12:00 p.m. EST 03/05/2021. Please email responses to Emmanuel Mbah at Emmanuel.mbah@fda.hhs.gov Template