The U.S. Food and Drug Administration's (FDA Center for Food Safety and Applied Nutrition (CFSAN) has a requirement for Genome Sequencing and Genome Scaffolding workstation with Irys. This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested, and a separate written solicitation will not be issued.

This solicitation is a Request for Quote (RFQ) using FAR Parts 12 and 13 procedures. The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2005-86. The North American Industry Classification System (NAICS) code for the proposed acquisition is 334516, Analytical Laboratory Instrument Manufacturing. The associated small business standard is 500 employees. This requirement is for a small business set-aside.

Part 2 - Supplies or Services and Prices/Costs

Purchase Order Type: Firm-Fixed Price
Base Year
Manufacturer Product Code Description Quantity Price
BioNano Genomics IN-011-01 Irys automated single-molecule imaging instrument for use with IrysChip and IrysPrep consumables 1
Installation and onsite training
Shipping
One (1) year warranty on parts, labor, and travel
Total Firm-Fixed Price

Option Years
Option Year Description Price
1 Service Agreement
2 Service Agreement
3 Service Agreement
4 Service Agreement
Total Firm Fixed Price

The total price for the base and four option years is $____________.

Part 3 - Description/Specifications

3.1 Background
Current technologies of sequencing, both bacterial and larger genomes such as molds or plants, requires a combination of both fine scale and large scale technologies. An instrument that provides larger scale data and allows for small scale data sequencing and scaffolding is required.

3.2 Statement of Work/Salient Characteristics
The instrument shall possess the following:

• An error rate of less than 1% and label site positional accuracy of < 150bp (stdev)
• High throughput data generation (50-200Gb per run
• Instrument can be refurbished or a "demo" model

The instrument shall be able to complete the following tasks/steps:

1. DNA molecules, 100,000 to 1,000,000 base pairs are released from cells and impurities are removed, such as RNA and proteins;
2. Fluorescent labels are inserted into the long molecules at sequence specific sites;
3. Labeled molecules are carefully pumped through very small channels and the positions of the labels along the molecules are measured and accumulated for many long molecules; and
4. Specialized software assembles the data which consists of multiple overlapping reads of these very long molecules and whole genome maps are produced.
The instrument shall perform the following:
1. Delivery, Installation, Training and Warranty:
• Installation shall include of the installation of the system and all components, as well as calibration, quantification, and software installation
• Shall include a demonstration/training for lab personnel
• Shall include a warranty for at least one (1) year from date of installation which covers all labor, parts, and travel expenses required for repairs for equipment and software. Technical support and troubleshooting assistance shall be provided via phone, email, or live-chat interface.

3.3 Optional Service Agreement

The FDA shall have a unilateral right to exercise optional periods to continue the service agreement described below:

The offerors pricing for optional service agreement shall include coverage of labor, parts and travel expenses.

Parts- The service plan will use Original Equipment Manufacturer (OEM) certified parts.

Services On-Site- The contractor will initiate corrective maintenance/repairs within 48 hours from the service call. The repairs will be completed within 72 hours from the on-site arrival of the technician/service engineer. There will be no limit to the number of on-site repair service visits. The service shall be delivered by an authorized OEM service provider.

Services Off-Site- Technical support and troubleshooting assistance will be provided by the contractor via phone, email, or live-chat interface within 1 hour of initial contact.

Part 4 -Performance and Deliverables

4.1 Place of Performance and Work Hours

All applicable equipment is located at the location listed below. Normal workdays are Monday through Friday except US Federal Holidays. Work hours are typically from 8 am to 5 pm (et). Service visits shall be coordinated with TBD, see below.

Location and Point of Contact:
Food and Drug Administration
8401 Muirkirk Road
Laurel, MD 20708

ATTN: TBD

The system will be delivered to the address above for assembly, installation, and onsite training.
4.2 Period of Performance

The equipment shall be delivered by July 15, 2016. The warranty shall start when equipment is installed and accepted by FDA and be in effect for one year.

Optional Periods

Deliverable Period of Performance
Option Period 1 -Service Agreement To begin 1st year following receipt of equipment
Option Period 2 -Service Agreement To begin 2nd year following receipt of equipment
Option Period 3 -Service Agreement To begin 3rd year following receipt of equipment
Option Period 4 -Service Agreement To begin 4th year following receipt of equipment

Part 5 -Contract Administration

5.1 Representative's
The Contracting Officer's Representative (COR) will perform inspection and acceptance of materials and services to be provided.

For the purpose of this PART, (COR TBD) is the authorized representative of the Contracting Officer.

The COR is responsible for the following as required by this order: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the Statement of Work and any other technical performance requirements; (3) performing technical evaluations; (4) performing technical inspections and acceptances; and (5) assisting in the resolution of technical problems encountered during performance.

The Contracting Officer is the only person with authority to act as an agent of the Government under this order. Only the Contracting Officer has authority to: direct or negotiate any changes in the order, including modifying or extending the period of performance, changing the delivery schedule, authorizing reimbursement to the Contractor for any costs incurred during the performance of this order, or otherwise change any terms and conditions of this order.

The contact information for the Contracting Officer is the following:

Sean Wybenga
U.S. Food and Drug Administration
Office of Acquisitions and Grants Services
5630 Fishers Lane
Rockville, MD 20857
[email protected];
(240) 402-7629

The contact information for the Contract Specialist is the following:

Lisa Yaw
U.S. Food and Drug Administration
Office of Acquisitions and Grants Services
5630 Fishers Lane
Rockville, MD 20857
[email protected];
(240) 402-4018

The contact information for the Contractor is the following:
(TBD)