SOW Reagent Kits-1250278 3-30.docx

Scope of Work Reagent Chemistry Kits

Background

The Food and Drug Administration (FDA) has a requirement to establish an IDIQ for All-inclusive Reagent Kits for Illumina Inc., MiniSeq, MiSeq, NextSeq, HiSeq, and NovaSeq series instruments to support various divisions of the FDA.

In addition to the FDA wide requirements, The Office of Regulatory Science (ORA), Division of Microbiology supports a microbial genomics network known as the GenomeTrackr Network for tracking Salmonella that may be involved in future produce related outbreaks. Under the GenomeTrackr Network Federal and State Public Health and Food Safety Field Laboratories collected enteric bacterial isolates from various produce sources from disparate parts of the country. Each GenomeTrackr Network Laboratory have been supplied with an Illumina Inc., MiSeq Next-Generation Sequencing (NGS) Systems for providing draft genomes on related bacterial isolates and are required to report their findings to the FDA.

Miseq kits meet the ORS acquisition strategy by ensuring that the FDA is able to prevent distribution of products found to be in violation of the Food, Drug, and Cosmetic Act (FD&C). The success of FDA activities to protect the public health often depends on the ability of the agency's laboratories to quickly and accurately analyze samples.

GenomeTrackr Network Laboratories are located throughout the United States as indicated below with new locations being added as laboratory agreements are created.

Scope

The Contractor shall provide all resources necessary to accomplish the tasks and deliverables described in this Statement of Work (SOW). The Contractor shall provide All-inclusive Reagent Kits for Illumina Inc., MiniSeq, MiSeq, NextSeq, HiSeq, NovaSeq and all other compatible series instruments.

Requirements

Minimum Technical Requirements:

All Reagent Kits offered shall be proven with documentation they are compatible for use with Illumina Inc., MiniSeq, MiSeq, NextSeq, HiSeq, NovaSeq and all other compatible series instruments. The use of the kits will not void instrument warranty, maintenance and/or service agreements.

· Reagents for Next Generation Sequencing (NGS) methods shall accommodate a range of throughput and whole-genome sequencing, targeted DNA sequencing, whole-transcriptome sequencing, and targeted RNA sequencing,

· Reagent components shall have RFID-encoded and interact intelligently with the Illumina Instruments to validate compatibility with user-defined applications

· Library Preparation Solutions shall support a variety of sample types, from cell lines to fresh tissue, formalin-fixed paraffin-embedded (FFPE) samples, blood, and various sample types

· Reagent Sequencing Kits shall use sequencing-by-synthesis variants on the “cyclic array” strategy

· Reagent Sequencing Kits high accuracy and paired-end sequencing capability

· Reagent Sequencing Kits shall have options for both sequencing output and read length

· All Kits shall be ready-to-use

The work and data remain inside the U.S. in transfer of data must be approved by FDA.

Inspection and Acceptance

Supplies delivered hereunder shall be inspected and accepted at destination by the Contracting Officers Representative (COR) or Technical Point of Contact (TPC) as specified on each Delivery Order. If the supplies or are acceptable, the COR or TPC shall promptly forward a report of inspection and acceptance to the paying office. If the supplies are not acceptable, the COR or TPC shall document the nonconforming items and immediately notify the Contracting Officer.

Period of Performance

The period of performance begins the date of contract award execution.

The anticipated Period of Performance is as follows:

Period of Performance: September 15, 2022 – September 14, 2027

FDA Wide Reagent Kits

Pricing Year September 15, 2022 – September 14, 2023

Pricing Year #1 September 15, 2023 – September 14, 2024

Pricing Year #2 Ordering Period September 15, 2024 – September 14, 2025

Pricing Year #3 Ordering Period September 15, 2025– September 14, 2026

Pricing Year #4 Ordering Period September 15, 2026 – September 14, 2027

Deliverables

When Reagent (Chemistry) Kits are required under this contract the Government will issue a written fixed-price Delivery Order identifying required reagent kits, quantities, delivery date(s), and delivery location(s). The Contracting Officer or his/her designee is/are the only person(s) authorized to place these orders.

Deliveries will be made via task orders to the following locations:

Northeast Feed and Food Laboratory (NFFL) 158-15 Liberty Avenue Jamaica, NY 11433-1034

Pacific Northwest Laboratory (PNL) 22201 23rd DR SE Bothell, WA 98021

Denver Laboratory (DENL)

1 DENVER FEDERAL CENTER

BUILDING 20, ENTRANCE W10

Denver, CO 80225

Arkansas Lab (ARKL) 3900 NCTR Road Jefferson, Arkansas, 72079

Kansas City Laboratory (KCL) 10901 W 84th Terrace, Shawnee, KS 66214

Pacific Southwest Food and Feed Laboratory (PSFFL) 19701 Fairchild Irvine, CA 92612

San Francisco Laboratory (SANFL) 1201 Harbor Bay Parkway, Alameda, CA

Southeast Food and Feed Laboratory (SFFL) 60 8th St NE, Atlanta, GA 30309

Center for Food Safety and Applied Nutrition (CSFAN) 5001 Campus Dr, College Park, MD 20740

Pacific Southwest Medical Products Laboratory (PSMPL) 19701 Fairchild. Irvine, CA 92612

Forensic Chemistry Center (FCC) 6751 Steger Dr.

Cincinnati, OH 45237

Delivery shall not be scheduled during Federal Holidays or Federal Closures as determined by Executive Orders or WWW.OPM.GOV. Federal holidays are as follows:

New Year’s Day Martin Luther King, Jr.

Washington’s Birthday Memorial Day Juneteenth Day Independence Day Labor Day Columbus Day Veteran’s Day Thanksgiving Day Christmas Day

The Contractor shall provide the FDA Contracting Officer’s Representative (COR), and FDA Delivery Location Point of Contact with at least one (1) week’s written notice prior to delivery.