SOW_Final_OC-2026-132529.pdf

Attachment 1 - SOW

Statement of Work Purchase of One (1) Whole Genome Sequencing Instrument for IRVLMP

I. Background The Food and Drug Administration (FDA), Irvine Medical Products Laboratory (IRVLMP), performs microbiological testing on medical products to ensure compliance with USP and other regulatory requirements. A Whole Genome Sequencing instrument is required to support sequencing of microorganisms obtained from regulatory pharmaceutical samples.

II. Scope The Contractor shall provide one (1) Whole Genome Sequencing instrument for IRVLMP, Irvine, CA, that meets or exceeds the requirements below.

Salient Characteristics

• Uses sequencing-by-synthesis next-generation sequencing technology

• Supports single-read and paired-end libraries

• Output range up to 25 Gigabases

• Up to 50 million paired-end reads per run

• Maximum read length of at least 2 × 300 base pairs

• ≥85% of bases achieving Q30 at 2 × 300bp

• RFID or equivalent consumable tracking

• Reagents stored at room temperature

• Includes onboard data collection and sequence alignment software

• Includes monitor and control computer

• Benchtop system not exceeding 16” × 18” × 26” (W×D×H)

III. Warranty Requirement The Contractor shall provide a minimum one (1) year manufacturer’s warranty covering all parts, labor, and operational support. Warranty shall begin upon final Government acceptance.

IV. Records and Reports For any warranty-related service performed, the Contractor shall provide a service report including equipment identification, description of issue and corrective action, parts replaced, and technician information.

Attachment 1 - SOW

V. Training Requirements The Contractor shall provide operator training and system familiarization for up to (3) end-users. Training shall be conducted upon installation and prior to Government acceptance.

VI. Deliverables / Delivery Schedule Deliverable Quantity Due Date Whole Genome Sequencing System

1 Within 60 days after award

Manufacturer Warranty 1 Begins upon acceptance

VII. Delivery Location

FDA / IRVLMP

19701 Fairchild Irvine, CA 92612

VIII. Period of Performance Delivery shall occur within 60 days of award. Warranty begins upon acceptance.

IX. Hours of Operation/Site Access The Contractor shall perform all on-site work during normal Government business hours, Monday through Friday, excluding Federal holidays, unless otherwise approved by the Contracting Officer or Contracting Officer’s Representative.

X. Point of Contact Contracting Officer (CO):

Name: Iris Johnson Email:

Iris.Johnson1@fda.hhs.gov Phone: (301) 796-3353

Contracting Officer Representative (COR): Will be designated at the time of award.

mailto:Iris.Johnson1@fda.hhs.gov