1239907 Notice of Intent to SS.pdf

FDA Notice of Intent to Award Sole Source #FDA_SS_1239907 - Pacific Biosciences of California, Sequel II Sequencing kit 2.0 Bundles and the SMRT Cell 8M Trays

Date Posted: May 18, 2021

Response Date: May 25, 2021 2:00 PM CST

Classification Code: 6640 – Laboratory Equipment and Supplies

NAICS Code: 334516 – Analytical Laboratory Instrument Manufacturing; with a Small

Business Size Standard of 1,000 employees

The U.S. Food and Drug Administration (FDA) National Center for Toxicological Research (NCTR), intends to award a firm fixed price purchase order to Pacific Biosciences of California, Inc., 1305 O’Brien Drive, Menlo, CA 94025-1445, under the authority of FAR 13.106-1(b)(1).

NCTR’s Division of Genetic and Molecular Toxicology (DGMT) requires Sequel II Sequencing kit 2.0 Bundles and Single Molecule Real-Time (SMRT) Cell 8M Trays, manufactured exclusively by Pacific Biosciences for use in a Sequel II sequencing instrument, also manufactured only by Pacific Biosciences. These sequencing consumables are necessary for a large long-read sequencing project.

The instrument itself is unique and incorporates a proprietary technology - Single Molecule Real- Time or (SMRT) – capable of generating high-throughput, efficient reads of very long lengths for a broad range of applications, including whole genome sequencing, RNA sequencing, epigenetics, and targeted gene sequencing.

The required kits and trays are also manufactured solely by Pacific Biosciences and designed to be used with the Sequel II instrument described above. Using the same SMRT technology, the kits provide highly accurate purification and sequencing of very large fragments of DNA. The sequencing kits and trays required herein must seamlessly integrate with a Sequel II instrument system identified as Pacific Biosciences Part Number 101-447-000.

This notice is being published in accordance with Federal Acquisition Regulation (FAR) Part 5.101(a)(2) requiring the dissemination of information on proposed contract actions. This is a notice of intent to award a sole source contract and is not a request for competitive proposals. The statutory authority for this sole-source procurement is FAR 13.106-1(b)(1).

This notice of intent is not a request for competitive proposals. Interested parties who believe they can meet the requirement may submit a capability statement to Tim Walbert at timothy.walbert@fda.hhs.gov before May 25, 2021 at 2:00 pm Central Time (CT). A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government. If no responsive statements are received before the closing date and time, an award will subsequently be made to Pacific Biosciences of California, Inc.

mailto:timothy.walbert@fda.hhs.gov