Notice of Intent 1245086.pdf

The Food and Drug Administration (FDA) intends to negotiate on a sole-source basis with

Pacific Biosciences of California, Inc. for a Versatile Sequencing System under the authority of 41 U.S.C. 1901.

Background Information and Basis for Sole Source

The FDA’s Center for Food Safety and Applied Nutrition (CFSAN) Division of Microbiology in the Office of Regulatory Science is currently working on microbial genomics and metagenomics for use in epidemiology of foodborne illness associated with agricultural commodities, growing conditions, agricultural and processing practices and all environments where it is possible for contamination to take place on the path of fresh fruits and vegetables as they travel from the farm to the consumers table.

To fulfill its mission, CFSAN requires a sequencing system in order to produce high resolution characterization of all biological risks associated with various growing and production pipelines.

This information will guide the development of improved management practices for safe agricultural production and safe processing of fresh produce for American consumption. Draft and closed genomes will be uploaded to the GenomeTrakr database to support outbreak investigations and source tracking of foodborne pathogens.

To maintain uniformity and consistency with pre-existing Next-Generation Sequencing (NGS) systems, it is critical that Pacific Biosciences of California, Inc. provides a system which produces reads extending to 8,000 to >20,000 bases with the ability to run at a minimum of 8 multiplexed samples and a cell confinement structure capacity of 100,000 - 150,000 zero-mode waveguide (ZMW) holes; and provide data analysis software to determine the quality of sequencing results.

General

The North American Classification System (NAICS) code for this acquisition is 334516 –

Analytical Laboratory Instrument Manufacturing. The small business size standard is 1,000 employees.

No solicitation package will be issued. This notice of intent is not a request for competitive quotations; however, responses received by 12:00 p.m. Eastern Time on August 9, 2021 will be considered by the Government.

A determination by the Government not to compete the proposed acquisition based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement.

Interested parties that believe they could satisfy the requirements listed above for FDA may clearly and unambiguously identify their capability in writing on or before the response date for this notice. This notice of intent is not a solicitation. Any questions regarding this notice must be submitted in writing via email to Janae Hughes at janae.hughes@fda.hhs.gov. All responses to this notice of intent must be submitted so that they are received at janae.hughes@gmail.com no later than the aforementioned due date.