-80 Degree Celsius Freezer of Various Dimensions

********************************************************************************

Solicitation No. 75F40123Q00226_A00001

Revised Date: May 31, 2023

The reason for the amendment is the following:

1.   On page 2 the statement “Models should be the listed Thermo Scientific TDE series Ultra Low Temperature Freezers or Equivalent” was deleted.

2.  On page 4, the Thermo Scientific Models numbers was deleted.

3.  Added Specifications under 2 A, B, and C.

4.  The terms and conditions remain unchanged.

********************************************************************************

Solicitation No. 75F40123Q00226

Date: May 22, 2023

.

This is a combined synopsis/solicitation for commercial services prepared in accordance with the

format in FAR 12.6 as supplemented with FAR 13 and additional information included in this notice. The incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2023-02.

THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION AND A SEPARATE SOLICITATION WILL NOT BE ISSUED. The solicitation number for this acquisition is 75F40123Q00226 and is being issued as a Request for Quote (RFQ). The NAICS Code for this solicitation is 334516- Analytical Laboratory Instrument Manufacturing. The small business size standard for NAICS 334516 is 1000 employees. The requirement will be awarded as Firm-Fixed Price and Small Business Set-Aside. Prospective Offeror’s are responsible for downloading the solicitation and any amendments from Sam.Gov. The Government reserves the right to award this order without discussions if the Contracting Officer determines that the initial offer is providing the Best Value Lowest Price Technically Acceptable to the Government and discussions are not necessary.

The Government intends to issue a Purchase Order.

The U. S. Food and Drug Administration (FDA), has a need to procure 8 -80 Degree Celsius Freezer of various dimensions.

**************************BRAND NAME OR EQUAL ***************************

Description: Statement of Work

1. Background:

The Office of Biotechnology Products currently owns and operates a variety of cold storage units to support the lab research program. We seek to procure eight (8) Ultra Low Temperature (-80C) freezers and side access freezer racks that will be housed in the WO campus freezer farm to expand lab storage capacity supporting the research program mission of the FDA of drug safety and efficacy and overall public health. New freezer units will be housed in shared space with other FDA Center equipment and will be connected with existing alarm system for monitoring and maintenance thus must be compliant with space and system requirements. We are looking for a single vendor that can supply the brand name items listed or equivalent items.

1. Scope of Work

Eight freezers are required. All freezers must be upright, with 5 shelves, inner doors to minimize temperature disruption during sample retrieval, and an upright configuration. Chest-style freezers will not be considered.

1. One (1) freezer will have a capacity of 19.4 cubic feet and a capacity of 400 standard 2-inch freezer boxes and require 208-230 volts. Ultra-Low Upright Freezers, 400-Box Capacity, Voltage:208-230V, 60Hz, Upright, Capacity 19.4 cubic feet, Temperature Range -50°C to -86°C, Door style: 1 outer, 4 inner, Insulation: Vacuum Insulation Panels (VIP) + Water-Blown Polyurethane Foam (SNAP-compliant), Interior: Stainless Steel, Shelves:3, Rack Capacity 3, Holds 2 in boxes (400), Certification/ Compliance cULus, Display: HIC 5.6 in. 7-segment display with capacitive touch buttons, Defrost: Manual, Dimensions: 38.5 x 28.3 x 78 in. (97.7 x 71.9 x 198.1 cm), Monitoring: Alarm, Recorder, Smart Vue Compatible, Amperage, 5.9/15A, Plug size, NEMA 6-15, Frequency: 60 Hz,  Energy Efficient, Vial Capacity: 40,000 x 2ml, Compressor: H-Drive Compressor, Refrigerant: R290 (1st stage), R170 + R290 mix (2nd stage), 

1. Three (3) freezers will have a capacity of 24.1 cubic feet, a capacity of 500 standard 2-inch cryoboxes, and require 120 volts.

Ultra-Low Upright Freezers, 500-Box Capacity, 115V, 60Hz, Capacity: 24.1 cu. ft., Temperature Range: -50°C to -86°C, Door Style: 1 outer, 1 inner,  Insulation: Vacuum Insulation Panels (VIP) + Water-Blown Polyurethane Foam (SNAP-compliant), Interior: Stainless Steel, Shelves: 3, Capacity Shelf: 205lbs., Rack Capacity 10, Holds: 2 in boxes (500), Certification/Compliance: cULus, Display: HIC 5.6 in. 7-segment display with capacitive touch buttons, Dimensions: 38.5 x 34.0 x 78 in. (97.7 x 86.4 x 198.1 cm), Defrost: Manual, Monitoring Options: Alarm, Recorder, Setpoint Security; Yes, Connectivity:  External  Monitoring/Cloud Compatible, 4-20mA, RS485, Dry Contacts, Amperage: Smart Vue Compatible, Amperage: 12.5/20A, Vial Capacity: 50,000 x 2mL, Compressor H-Drive Compressor, Refrigerant: R290 (1st stage), R170 + R290 mix (2nd stage), Energy Efficient, Frequency: 60 Hz, Plug Type: NEMA 5-20.

1. Four (4) freezers will have a capacity of 24.1 cubic feet, a capacity of 500 2-inch cryoboxes, and require 208-230 volts.

Ultra-Low Temperature Upright Freezers, 500 box capacity, 208-230V, 60Hz, Door Style: 1 Outer, 4 Inner, Insulation: Vacuum Insulation Panels (VIP) + Water-Blown Polyurethane Foam (SNAP-compliant), Interior: Stainless Steel, Shelves 3, Capacity Shelves 205lb., Rack Capacity: 10, Hold: 2 in Boxes (500), Certification/Compliance: cULus,  Dimensions: 38.5 x 34.0 x 78 in. (97.7 x 86.4 x 198.1 cm), Display, HIC 5.6 IN 7 segment Displace with tough buttons, Monitoring Options: Alarm, Recorder, Setpoint Security: Yes,  Connectivity: External Monitoring/Cloud Compatible; 4-20mA, RS485, Dry Contacts, Amperage: 5.0/15A, Energy Efficient, Refrigerant: R290 (1st stage), R170 + R290 mix (2nd stage).  Vial Capacity: 50,000 x 2ml, Compressor: H-Drive Compressor, Plug Type: NEMA 6-15, Smart Vue Compatible.

Freezers must have a setpoint of at least -80C, have a digital display to show current internal temperature, and have an alarm if temperature rises above a threshold. Freezers must be energy efficient and have fast open-door recovery time.

** Important **

**The Vendor shall indicate if the minimum salient characteristics have been met to be considered responsive for this requirement. 

**The Vendor shall explain why and how their system meets or exceeds each detailed technical requirement and include supportive data and descriptions.

1. Scope Requirements and Deliverables:

Technical Requirements

The instrumentation shall meet the following minimum salient characteristics.

The contractor/s must be able to deliver the following items listed in the description. Example manufacturers and part numbers are provided that fit the requirement:

1. The vendor will be responsible for all costs associated with shipping and handling and delivery of the freezers and racks to the FDA location. The TPOC will be responsible for determining the acceptability and completion of this initial work.
2. The equipment will be covered by a 1-year warranty plan.
3. The vendor will also provide side-access freezer racks for each freezer capable of accepting standard 2-inch freezer boxes.
4. The vendor/s shall provide shipping, handling, and delivery to the location in section 5.
5. All representatives of the Contractor/s must comply with mandatory FDA security procedures while onsite and voluntarily provide required proof of identity prior to building or laboratory access.
6. All representative of the Contractor/s must comply with the FDA’s laboratory safety guidelines while working and/or servicing equipment located within the laboratory space
7. Delivery and Installation

The Contractor shall deliver all line items to the FDA St. White Oak Campus, unless otherwise instructed via contract modification.

Location of installation and Place of Performance:

TBD

FDA White Oak Campus

Bldg. 71 Rm 2205

10903 New Hampshire Ave

Silver Spring, MD 20993

The FDA’s Technical Point of Contact (TPOC) will approve all tasks and deliverables. The TPOC will be responsible for determining the acceptance of the work that is completed. The delivery or services must be during regular business hours (Monday-Friday) during the times of 9:00 AM – 4:00 PM Eastern Time (ET), excluding holidays.

1. Acceptance Criteria

FOB: Destination  Inspection/Acceptance: Destination

Partial acceptance is made upon delivery of all the parts. Full acceptance is made after completion of Installation and Operational Qualification (IQ/OQ) by the contractor that the system meets all the specifications and requirements.

1. Reporting Requirements and Deliverables

The contractor shall provide 30-day notice prior to shipping.  All reports for installation and qualification shall be provided (electronic format preferred). Acceptance will be made by the government within 30 days following completion of instrument installation and qualification

1. Delivery/Period of Performance

Delivery of Instrument: within 60 days of Purchase order awarded.

The work cannot be done remotely; work shall be done at the Government site where the equipment is to be located.

Security: Supervision of install engineer upon arrival at FDA White Oak will be required. All software required must be approved on FDA’s Product Catalog and comply with OIMT requirements. Software not already on the FDA Product Catalog may be considered but must be approved on FDA Product Catalog prior to award.

See attachment Combined Synopsis/Solicitation Amendment 1