Isothermal LN2 Freezer

This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with FAR RFO part 12. This announcement constitutes the only solicitation. Offers are being requested and a separate written solicitation will not be issued. The solicitation number is 75F40126Q135849. This solicitation is issued as a Request for Quote (RFQ) for an isothermal liquid nitrogen freezer. This acquisition is not set-aside for small business concerns. This solicitation incorporates provisions and clauses by reference. The full text of provisions and clauses may be accessed electronically at https://www.acquisition.gov/far-overhaul. The associated North American Industry Classification System (NAICS) Code is- 333415 - Air Conditioning and Warm Air Heating Equipment and Commercial and Industrial Refrigeration Equipment Manufacturing; the applicable Small Business Size Standard is 1,250 employees. This requirement is solicited as unrestricted full and open competition, any sized business may submit a quote. Schedule of Items (all shipping and handling shall be included in the price) Item Description QTY Unit of Measure Unit Price Extended Price 1 Isothermal liquid nitrogen freezer with tank switcher as specified herein 1 Ea $___________ $___________ Statement of Work Background The Food and Drug Administration (FDA), National Center for Toxicological Research (NCTR), Division of Genetic and Molecular Toxicology (DGMT), requires the purchase of one (1) isothermal liquid nitrogen freezer and an accompanying automatic tank switcher to ensure the secure, long-term storage of critical biological research materials. This equipment is essential for maintaining the viability and integrity of irreplaceable cryopreserved primary human and monkey hepatocytes, HepaRG cells, TK6 cells, and other cell lines that support multiple ongoing and future research projects. Failure to provide reliable cryogenic storage could result in the irreversible loss of valuable biological specimens, significant delays in research, increased costs associated with replacing specialized materials, and disruption of mission-critical studies. These research projects directly support the FDA Predictive Toxicology Roadmap by advancing the development and application of New Approach Methodologies (NAMs) for nonclinical toxicological risk assessments. The work also provides critical scientific support to other FDA product centers, including the Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), Center for Veterinary Medicine (CVM), and the Human Foods Program (HFP). The acquisition of this liquid nitrogen freezer and tank switcher is therefore essential to ensuring research continuity, protecting valuable government-funded biological resources, and maintaining the integrity of studies that directly support FDA's public health mission. The outcomes of these projects will strengthen the Agency's oversight of FDA-regulated products, 75F40126Q135849 1 of 14 -- 1 of 14 -- improve the scientific basis for regulatory decisions, reduce potential human health risks, including cancer risks, and ultimately enhance the protection of public health. Objectives The objective for this acquisition is to purchase a quantity of one; CBS V-1500AB/ST isothermal liquid nitrogen freezer, or equivalent, with warranty, with tank switcher controller, installation kit to be used to cryopreserve invaluable cells in the DGMT. Product Description The DGMT requires the purchase of one (1) CBS V-1500AB/ST isothermal liquid nitrogen freeze, or equivalent. Brand name part numbers include: 55156V-ST isothermal ln2 freezer including cryotouch controller, gas bypass & 6 ft. transfer hose, 2001S-C100S system-(7) 1201plr-o (14r9-0001), (91) 2" cardboard boxes, (91) d100s, 51013 ts-1b tank switcher controller, 51016 tsic4-1b tank switcher interface controller, and 51013-1 installation kit for ts- 1b. Salient Characteristics At a minimum, the one (1) freezer shall contain/provide:  Uniform temperature, with storage temperature variation of less than 10ºC from the top to the bottom of the chamber  Samples shall be stored in a dry-vapor chamber physically isolated from direct contact with, immersion in, or splashing by liquid nitrogen during normal operation and sample retrieval.  Minium contact with or splashing of liquid nitrogen  The freezer shall provide minimum storage capacity of six (6) vertical storage racks, each approximately 28½ × 5⅝ × 5½ inches (724 × 143 × 140 mm) and capable of holding thirteen (13) 2-inch cryogenic storage boxes.  The freezer design shall reduce the potential for cross-contamination by physically isolating stored samples from the liquid nitrogen reservoir.  The freezer shall provide 24/7 remote monitoring of freezer temperature and operating status. Deliverables Delivery Deliverable Quantity Delivery Date Freezer and tank switcher including accessories identified in the salient characteristics section above and delivery 1 Within 60 calendar days after award Warranty 1 One calendar year after date of acceptance 75F40126Q135849 2 of 14 -- 2 of 14 -- The contractor must deliver the entirety of the one (1) isothermal liquid nitrogen freezer, tank switcher controller, installation kit within 60 calendar days of date of award. Ship to: The items will be FOB destination to 3900 NCTR Road, Jefferson, AR 72079, building 14, room 1002. Additional System Requirements: 1. The components and equipment shall be newly manufactured, not used or refurbished, or previously used for demonstration. 2. Offered systems shall be a turn-key solution i.e., the Contractor shall be responsible for providing all hardware, components, instruments, software, and that otherwise required to meet these specifications and the FDA’s stated need. 3. Systems/equipment shall be warranted for not less than one (1) year from FDA acceptance of the system(s). Warranty shall be included with the equ…