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 Drug Evaluation and Research (CDER), in order to determine if there are existing small business sources capable of providing Liquid Nitrogen and Carbon Dioxide deliveries. Other than small business concerns, especially vendors who may be able to offer domestic products, are also encouraged to submit a capability statement that provides company information, as well as information demonstrating that it can meet all of the minimum requirements included below, to include the country of manufacture of products offered.

If your firm is considered a small business source under North American Industry Classification System (NAICS) Code 325120 - Industrial Gas Manufacturing; with a Small Business Size Standard of 1,200 employees and you believe that your firm would be able to provide the FDA with the supplies/services described below, please submit an email to Warren.Dutter@fda.hhs.gov.

Background The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), Division of Applied Regulatory Science (DARS) operates six laboratories that conduct mission-critical research in support of regulatory review, translational science, and emerging public health issues.

DARS performs a broad range of scientific studies related to drug application review, including work in immunology/toxicology, bioanalytics, proteomics/genomics, microphysiological systems, pharmacokinetics/pharmacodynamics, and electrophysiology.

Liquid nitrogen is required for the storage of valuable and irreplaceable biological samples in cryogenic dewars. Carbon dioxide is required to support the operation of essential laboratory equipment, including cell culture incubators.

Scope The Contractor shall provide all liquid nitrogen and carbon dioxide necessary to support DARS laboratory operations throughout the performance period.

Minimum Technical Requirements

1. Delivery Schedule

• Liquid nitrogen and carbon dioxide tanks shall be delivered on an as-needed basis, consistent with estimated usage levels.

2. Delivery Coordination mailto:Warren.Dutter@fda.hhs.gov

• Deliveries shall be coordinated by phone at least two (2) business days in advance and shall be performed Monday through Friday between 8:00 a.m. and 4:00 p.m.

Eastern Time, excluding Federal holidays.

• Coordination shall include confirmation of required items, delivery date, and a one-hour delivery window.

• No deliveries shall take place unless a request from the FDA has been received by the contractor.

3. Delivery and Installation

• The Contractor shall deliver tanks to the designated location and connect them to the appropriate dewars.

• All connections must be secured and verified to be leak-free.

4. Cylinder Retrieval

• The Contractor shall remove and retrieve all empty cylinders at the time of delivery.

5. Tank Requirements

All delivered tanks must meet the following criteria:

a. Equipped with a functional digital gauge (volume meter)

b. Filled to at least 90% capacity upon delivery

c. Free from damage or leaks and compliant with all applicable certification requirements

Inspection and Acceptance

• Deliveries may be refused and replacements requested if any requirements are not met.

• All products must be delivered in proper condition, undamaged, and suitable for use.

• Deliveries will be inspected upon arrival by the Technical Point of Contact (TPOC).

• Delivered items will be verified against the packing slip.

• Upon successful verification, the Project Officer or Delivery Contact will sign the packing slip and forward it to the Contracting Officer’s Representative (COR) for receipt and processing.

Delivery Schedule:

Item # Description Unit Estimated

Qty Delivery

Frequency

Estimated Annual

Deliveries

Liquid Nitrogen, 240 Liter Dewar, 22 PSIG, with Digital Gauge Ea 3 Every 2 weeks 26

2 Carbon Dioxide, Extra Dry, 50 lb Cylinder Ea 5 Every 3 months 4 3 Carbon Dioxide, Extra Dry, 20 lb Cylinder Ea 1 1-2 times yearly 2

Nitrogen Gas, 4.5 high purity grade, 99.995%, 255 cu ft Cylinder Ea 1 Twice yearly 2

Nitrogen Gas, Ultra High Purity (Carrier Grade) Grade 5.0, 99.999%, Size 300 Ea 1 Yearly 1

6 Delivery, Guaranteed Window (1-hour) Ea 1 Every 2 weeks 26

Place of Performance:

FOB Point Destination. All items shall include shipping, handling, installation, and inside delivery to the destination identified herein.

CDER/OTS/OCP/DARS

U.S. Food and Drug Administration Building WO-64, Second floor, service corridor 10903 New Hampshire Ave Silver Spring, MD 20993

Period of Performance:

Base year: 6/1/2026 – 5/30/2027 Option Year 1: 6/1/2027 – 5/30/2028 Option Year 2: 6/1/2028 – 5/30/2029 Option Year 3: 6/1/2029 – 5/30/2030 Option Year 4: 6/1/2030 – 5/30/2031

Responses to this Sources Sought shall unequivocally demonstrate that the respondent is regularly engaged in the sale of same or substantially similar product/service. 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:

• Business name and bio, unique entity identification (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.

• Past Performance information for the manufacturer and/or sale of same or substantially similar product and service or similar brand instruments to include date of sale, description, 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 the manufacturer (to include UEI number and size status) if not the respondent.

• Descriptive literature, brochures, marketing material, etc. detailing the nature of the product and service the responding firm is regularly engaged in manufacturing and/or selling.

7 Cylinder/Dewar Rental Fee Ea 1 Monthly 12 Quantities represented herein are estimates and should not be construed as maximum or minimum quantity.

• The offeror shall furnish sufficient technical information necessary for the Government to conclusively determine that the offered items/services meet the technical requirements identified above.

• 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.

• 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.

• Identification of AbilityOne Contracts available that can meet the requirement

• If a large business, provide whether subcontracting opportunities exist for small business concerns.

• Standard commercial warranty and payment terms.

• 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.

• Informational pricing is desired.

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

Interested Contractors must respond with capability statements which are due by email to the point of contact listed below on or before May 5, 2026, by 1:00 PM Central Time at the Food and Drug Administration, Field Operations Branch, FDA|OO|OFBA|OAGS|DAP, Attn: Warren Dutter, email warren.dutter@fda.hhs.gov. Reference: FDA-SSN- 133600.

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.

Responses with weblinks will not be opened or viewed.

Responses must demonstrate capability, not merely affirm the respondent's capability (i.e. the response must go beyond the statement that, "XYZ company can provide the instrument, technical support etc.").

mailto:warren.dutter@fda.hhs.gov

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 and Proprietary Information:

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.

Failure to provide information indicating that the listed specifications are too restrictive will be interpreted as confirmation that the specifications are adequate for a competitive environment.

This is a sources sought announcement, a market survey for written information only. This is not a solicitation announcement for proposals and no contract will be awarded from this announcement. No reimbursement will be made for any costs associated with providing information in response to this announcement or any follow-up information requests. No telephone calls will be accepted requesting an RFQ package or solicitation. There is no RFQ package or solicitation. In order to protect the procurement integrity of any future procurement, if any, that may arise from this announcement, information regarding the technical point of contact will not be given.