Sources Sought Synopsis

Notice to Small Businesses

The purpose of this notice is to obtain information regarding the availability and capability of qualified small business concerns; 8(a), Woman-Owned Small Businesses (WOSB), Historically Underutilized Business Zone (HUBZone), Small Businesses, and Service-Disabled Veteran-owned Small Businesses (SDVOSB). The Food and Drug Administration intends to provide maximum practicable opportunities in its acquisitions to small businesses.

FDA welcomes responses from all interested parties. FDA does not intend to make a selection decision or award a contract on the basis of responses nor otherwise pay for the preparation of any information submitted or FDA's use of such information. Acknowledgment of receipt of responses will not be made, nor will respondents be notified of the outcome of the FDA's review of the information received. Additionally, the FDA does not intend to hold discussions concerning this sources sought with any interested parties. However, FDA reserves the right to contact vendors if additional information is required.

The Food and Drug Administration (FDA) is conducting a market survey to assess the availability of small business firms as defined by NAICS code 334516 to provide an ion torrent system genome sequencer. This notification is for market research purposes and does not constitute a commitment, implied or otherwise, that a procurement will be accomplished.

Background

The Southeast Regional Laboratory is in need of an Ion Torrent System Genome Sequencer. This equipment is needed to support the analytical demands requiring complete genome sequencing. The equipment is critical in order to accommodate high through put analyses needed in the event of food pathogen contamination outbreaks, current assignment requirements, and to provide a reliable back up for aging equipment. The equipment is being used to provide confirmation identification and trend analysis during foodborne Outbreak, consumer complaints and general work planning evaluations. The Ion Torrent Systems will directly support in performing the complete genome sequencing of various microorganisms of public health importance that include various regulatory and research samples belonging to foodborne and waterborne isolates of human-pathogenic bacteria, virus, and fungi from foodborne outbreak, routine surveillance, environmental samples and sporadic cases.

Requirement

The potential requirement is to procure an ion torrent system genome sequencer that adheres to the following minimum salient characteristics:

Product Configuration

Server Specifications:

Processor: Dual 6-core 2.66 GHzCPU
Memory: 48 GB RAM
GPU Processor: 1x NVIDIA ®Tesla ® GPUs
Storage: 16 TB
Operating System: Ubuntu ® 10.04
Dimensions (APPROX): Width 8.5 in/21.6 cm
Depth 22.3 in/56.6 cm
Height 22.3 in/56.6 cm
Weight: 100 lb./45 kg
Power Voltage: 100V (min) to 240 V (max)
Current: 6.7 A (max)
Frequency: 50/60 Hz
Power Draw: 1,100W

Sequencer Specifications:

Working environment:

• Temperature: 68-77°F (20-25°C)
• Humidity: 40-60%, noncondensing
• Altitude: <6,500 ft. (2,000 m)
• Clearances: 12 in (30.5 cm) in rear
 4 in (10 cm) on left side
 4 in (10 cm) on right side
 4 in (10 cm) from front edge of bench to sequencer bezel
 36 in (90 cm) aisle in front of bench for operator access
 8 in (20 cm) from front edge of bench to the conical tubes
• Gas supply Connection: 0.25 in push-to-connect fitting
• Pressure: 35-45 psi Composition: nitrogen (grade 4.5, 99.995% or better)
• Other connections Ethernet: 1 GigE USB: 2x USB 2.0
• Power Voltage: 100 V (min) to 240 V (max)
• Current: 9 A (max)
• Frequency: 50/60 Hz
• Power draw: 200-300 W
• Dimensions Width: 24 in/61 cm Depth: 20 in/51 cm Height: 21 in/53 cm
• Weight Crated for shipment: 85 lb./39 kg Free-standing: 65 lb./30 kg

Minifuge 120 VSer

• The personal-sized Ion Chip^TM MiniFuge is designed and calibrated specifically for centrifugation of chips, enabling effective and efficient sample loading. The MiniFuge features a compact design with a small footprint.

• The cylindrical shape of the Ion Chip^TM Minifuge allows it to accommodate both size chips. The unit quickly accelerates to maximum speed and stops quickly.

Water Purification System, with purification Pack

• Produces 18.2 MΩ-cm, Type I ultrapure water

• Removes biologically active molecules (such as nucleases)

• TOC of less than 5 ppb (typically <1 ppb)

• Achieves purity through constant monitoring of inorganic quality and TOC

• Arrives ready-to-go with all required filtration components

• Simple to use, with easy to replace purification packs

• Tested and approved for performance with the Ion PGM^TM system

Additional Requirements

• Uses simple Ion semiconductor sequencing that requires no complex optics and employs natural nucleotides to enable highly accurate variant detection, extremely uniform coverage, and sensitivity to detect low-frequency variants.

• Counts post-light sequencer that counts protons, not photons using a semiconductor ship.

• Supports combination of fluidics, micromachining, and semiconductor technology which permits the direct translation of genetic information (DNA) to digital information (DAN sequence) and rapidly generate large amount of high-quality data.

• Offers the fastest run times ranging from 30 minutes to 7.3 hours*-as part of a single-day workflow from input DNA to variant calls.

• Uses a vast parallel array of semiconductors to perform direct real-time measurements of hydrogen ions produced during natural DNA replication.

- Generates highly accurate 200 - base and 400 base reads, with per-base raw read accuracy > 99% enabling a broad range of DNA and RNA sequencing applications.

- Supports semiconductor chips with a range of prices and outputs for flexible and scalable DNA and RNA sequencing projects

- Includes a complete end-to-end solution from base calls to variants.

- Provides simple and integrated tools for tertiary data analysis.

• Delivers the highest number of complete sequencing runs per week, via a simple and automated workflow.

• A small bench top footprint that fits within a 5 square foot area (instrument dimensions: 24 in x 20 in x 21 in).

• Offers a range of fast and simple library solutions and kits with low sample input requirements for a range of research applications including microbial genome sequencing.

• Incorporates high-density array of wells on the Ion Semiconductor Chip which provides millions of individual reactors, while integrated fluidics allow to flow over the sensory array.

- Automated template preparation and chip loading

- Cartridge-based reagent system

- Sample and reagent-tracking capability

- Intuitive user interface

- On-board diagnostics

Delivery Location

Food and Drug Administration
60 8th St. NE
Atlanta, GA 30309

General Instructions

Contractors that believe they possess the ability to provide the required equipment must submit documentation of their ability to meet each of the project requirements to the Contracting Officer (i.e. brochure, information on equipment that meets specifications, etc.). The capability statement should also include the organization name, type of business, DUNS number, point of contact name/telephone number/email address, and applicable NAICS code.

Capability statements that do not provide sufficient information for assessment will be considered non-responsive. When submitting the information, please reference the solicitation number FDA-14-1130889-SS.

Responses should be submitted via email to Tania Gates at [email protected] by 12:00 noon on April 2, 2014.