FDA-SSN-118814.pdf

28.8 cu. ft Ultra-low temperature (-80C) Freezers Sources Sought Notice

FDA-SSN-118814

MARKET RESEARCH PURPOSES ONLY

NOT A REQUEST FOR PROPOSAL OR SOLICITATION

The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) is issuing this source sought announcement on behalf of the Center for Biologics Evaluation and Research (CBER) in order to determine if there are existing small business sources capable of providing 28.8 cu. ft Ultra-low temperature (-80C) freezers with on-site qualification. Other than small business concerns are also encouraged to submit capability statements. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for this effort.

The appropriate NAICS code for the acquisition is 333415 – Air Conditioning and Warm Air Heating Equipment and Commercial and Industrial Refrigeration Equipment Manufacturing;

Small Business Size standards – 1,250 employees.

Background:

The U. S. Food and Drug Administration (FDA), Center for Biologics Evaluation and Research (CBER) Division of Biological Standards and Quality Control (DBSQC), serves as a Standards Preparation and Testing laboratory of CBER. DBSQC is also an ISO 17025 accredited testing laboratory and ISO 17034 accredited Standards preparation facility. Vaccines and other biologics submitted to CBER by the Sponsors are to be tested in support of the mission of CBER. Ultra-low (-80C) freezers are used in support of standards preparation and/or testing for licensing, lot release, and other regulatory decisions of CBER.

The purchase of a -80C freezer including onsite qualification (IQ/OQ/PQ - Installation Qualification/Operation Qualification/Performance Qualification) is required to store regents and samples for the Laboratory of Blood products.

This requirement is as Brand Name or Equal configuration:

1. Thermo Scientific, TDE Series Ultra-Low Temperature Freezers, part # 01257933 @ 2 -

Each

2. Thermo Scientific, Ultra-Low Temperature Freezers - Unity Lab Services, part #

IOPQKE03484 @ 2 - Each

Minimum Technical Requirements:

A. Ultra-low temperature (-80C) freezer-

1. Upright

2. Outer Dimensions (D x W x H) 38.5 x 39.6 x 78 in. (97.7 x 100.6 x 198.1 cm), due to the limited lab space.

3. Inner Dimensions (D x W x H) 28.3 x 34.4 x 51.2 in. (71.9 x 87.3 x 130.1 cm), due to the limited lab space.

4. Storage Capacity: 28.8 cu. ft. 816L, due to the limited lab space.

5. Temperature Range: -50C to -86 C

6. Door Style: 1 outer and 4 inner doors

7. Defrost: Manual

8. Voltage: 208 – 230V, 60 Hz

9. Amperage: 6.2/15 A

10. Display: HID with capacitive touch buttons

11. Compliance: Energy star

12. Refrigerant: R290 (stage 1) and R170 + R290 mix (Stage 2)

13. Temperature Chart recorder not required

14. Warranty minimum 1 year including parts and labor

B. Qualification (IQ/OQ/PQ):

1. Provide qualification protocol for FDA review and address any comments / suggestions

2. Execute qualification based on FDA approved protocol

3. Use calibrators with current NIST traceable calibration

4. Confirm manufacturer’s specifications

5. Temperature mapping for 24 hours - empty chamber

6. Open door testing

7. Loss of power testing

8. And other testing as appropriate

9. Prepare qualification report with data and any deviations

10. Provide qualification report for FDA review and address any comments / suggestions

11. Qualification should be performed within 60 days after the delivery of the refrigerator.

Anticipated Delivery/Performance:

FOB Destination: Shipping, handling, in-side delivery, and validation shall be not later than 30 calendar days after receipt of contract award. The period of performance for the post warranty maintenance option periods in any resultant award will be estimated based on the date of award, required delivery, installation, and offered warranty period of the systems.

Place of Delivery/Performance:

U. S. FDA – Center for Biologics Evaluation and Research TPOC: To be provided upon award 10903 New Hampshire Ave.

Building 52/72, Ground Floor Silver Spring, MD 20993

Responses to this source sought shall unequivocally demonstrate the respondent is regularly providing 28.8 cu. ft Ultra-low temperature (-80C) Freezers and validation services. Though the target audience is small business vendors or small businesses capable of supplying a U.S. service of a small business vendor or producer, all interested parties may respond. At a minimum, responses shall include the following:

1. Business name and bio, SAM UEI number, business address, business website, business size status (i.e., SB, VOSB, SDVOSB, HUBZone SB, SDB, WOSB, LB), point of contact name, mailing address (if different from business address), phone number and email address. Provide this same information again if responding to provide a service offered by another firm.

2. The offeror shall furnish capability statements with sufficient technical information necessary for the Government to conclusively determine experience and qualifications of the firm for the minimum technical/performance requirements identified above, to include descriptive material, literature, brochures and other information .

3. Past Performance information within the last three years for the manufacture and/or sale in which the offeror has provided same or substantially similar instrument solutions and used for same or near-same applications as set forth herein. For each past performance reference include the date of service, description of service provided and the manufacturer name and model of the equipment serviced, dollar value, client name, client address, client contact name, client point of contact mailing address (if different from that provided for client), client point of contact phone number, client point of contact email address, and name of company (to include the firm’s SAM Unique Entity Identifier (UEI) number and size status) if not the respondent.

4. If applicable, identification of the firm's GSA Schedule contract(s) by Schedule number and SINs that are applicable to this potential requirement are also requested.

5. If applicable, identification of Best in Class (BIC) contract information or other Government Wide or HHS Wide Contracts that the equipment/service is available on.

6. If a large business, provide if subcontracting opportunities exist for small business concerns.

7. Standard commercial warranty.

8. Provide place of product manufacture or service performance and any other applicable information to enable review and analysis pertaining to the Buy American statute and requirements relating to Made in America in the event a nonavailability waiver request through the MIAO Digital Waiver Portal is needed.

9. Though this is not a request for quote, informational pricing is requested.

The Government is not responsible for locating or securing any information, not identified in the response.

Interested Parties shall respond with capability statements which are due by email to the point of contact listed below on or before July 17, 2023, by 12:00 PM (Central Time in Jefferson, Arkansas) to jennifer.johnson3@fda.hhs.gov, and reference: FDA‐SSN‐118814.

Notice of Intent:

Responses to this source sought announcement will assist the Government in determining whether any future requirement similar to this one should be set aside for small business, made available to full and open competition or procure through sole‐source acquisition procedures.

Disclaimer and Important Notes:

This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work.

Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, a pre‐solicitation synopsis and solicitation may be published in SAM.gov. However, responses to this notice will not be considered adequate responses to a solicitation.

Confidentiality:

No proprietary, classified, confidential, or sensitive information should be included in your response. The Government reserves the right to use any non‐proprietary technical information in any resultant solicitation(s).

Additional Notes:

If the stated requirements appear restrictive, please submit comments detailing the concern.

mailto:jennifer.johnson3@fda.hhs.gov