FDA_17-233-1180178_Attachment_1.pdf

FDA_17-233-1180178

Attachment #1

Attachment #1 Statement of Work

Introduction

Various Divisions of the Food and Drug Administration (FDA) to include:

• CBER - Center for Biologics Evaluation and Research

• CDER - Center for Drugs Evaluation and Research (DPA) (DMA)

• CDRH - Center for Devices and Radiological Health

• CFSAN - Center for Food Safety and Applied Nutrition

• CTP - Center for Tobacco Products

• CVM - Center for Veterinary Medicine

• NCTR - National Center for Toxicological Research

• ORA - Office of Regulatory Affairs are engaging in research, studies, and projects such as:

• Genomics o Whole-Genome Sequencing o Exome Sequencing o De Novo Sequencing o Targeted Sequencing

• Transcriptomics o Total RNA and mRNA Sequencing o Targeted RNA Sequencing o Small RNA and Noncoding RNA Sequencing

• Epigenomics o Methylation Sequencing o ChiP Sequencing o Ribosome Profiling using a variety of Illumina Inc., MiniSeq, MiSeq, NextSeq, HiSeq, and NovaSeq series instruments. All of which require Reagent (Chemistry) Kits for data analysis as follows:

• Sequencing by Synthesis (SBS) Kits

• Cluster Density and Throughput Kits

• DNA Library Preparation Kits

• Sample Indexes Preparation Kit

• RNA- Sequencing Kits

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.

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

Alaska

Florida

Massachusetts

Ohio Anchorage

Dania Beach

Winchester

Cincinnati

Gainesville

Reynoldsburg Arizona

Tallahassee

Michigan

Flagstaff

Detroit

Pennsylvania Arkansas

Georgia

East Lansing

University Park

Jefferson

Atlanta

Minnesota

South Dakoda

California

Hawaii

St Paul

Brookings Alameda

Pearl City

Irvine

New Mexico

Texas Lakewood

Iowa

Las Cruces

Austin

Richmond

Coralville

New York

Virginia

Colorado

Maryland

Albany

Richmond Denver

Baltimore

Jamaica

College Park

Washington

Laurel

North Carolina

Bothell

Silver Spring

Raleigh

Shoreline

Statement of Need All-inclusive Reagent Kits for Illumina Inc., MiniSeq, MiSeq, NextSeq, HiSeq, and NovaSeq series instruments.

During the life of the contract, reagents shall be added or deleted at any time from the List of Reagents in Attachment #2 which accompanies the Contract to accommodate re-formulations, development of new reagents, or deletions/replacement of reagents at the request of either the Contractor or the Government.

Technical Requirements

• All Reagent Kits offered shall be proven with documentation they are compatible for use with Illumina Inc., MiniSeq, MiSeq, NextSeq, HiSeq, and NovaSeq series instruments and their use 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 be 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