Sources Sought Notice of Intent_CDER-2024-123858.pdf

Sources Sought Notice/Intent to Sole Source Laboratory Gas Supply/Bulk Gas Delivery

CDER-2024-123858

PURPOSE

THIS IS A SOURCES SOUGHT NOTICE WITH INTENT TO SOLE SOURCE

ANNOUNCEMENT, A MARKET SURVEY FOR WRITTEN INFORMATION ONLY. THIS

NOTICE DOES NOT IN ANY WAY CONSTITUTE A REQUEST FOR QUOTATION (RFQ)

AND AS SUCH, SHALL NOT BE CONSTRUED AS A COMMITMENT BY THE

GOVERNMENT (IMPLIED OR OTHERWISE) TO ISSUE A SOLICITATION OR

ULTIMATELY AWARD A PURCHASE ORDER.

The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grant Services (OAGS) issues this Source Sought Notice/Intent to Sole Source Announcement on behalf of the Center for Drug Evaluation and Research providing a Laboratory Gas Supply/Bulk Gas Delivery. This action is for the acquisition of supplies for which the Government intends to solicit and negotiate with only one source under the authority of Federal Acquisition Regulation (FAR) Subpart 13.106-1(b)(1). The period of performance is for a base period (twelve months) and two (2) option periods (12 months). The Government is intent to sole source this requirement to CEE-KEY Supply, Inc, 5835 Manchester Ave, St. Louis, MO 63110.

The North American Industry Classification System (NAICS) 325120 – Industrial Gas Manufacturing; with a Small Business Size Standard of 1,200 employees, and a firm is capable of providing the equipment and service described in the DRAFT SOW, please submit a complete response to Iris.Johnson1@fda.hhs.gov.

**Substantial duplication of cost to the Government that is not expected to be recovered through competition; **

** The 1500-gallon liquid nitrogen tank and 450-liter argon tank are currently rented under a GSA lease agreement with a sole source provider. Helium, nitrogen, and argon cylinders are also rented for the duration of this lease. Changing tanks or cylinders before the lease ends will incur additional costs to the Government. ** The Gases shall be provided by the sole source provider of the GSA lease agreement of the Cylinders and Bulk Tanks for the duration of the Lease.**

DRAFT STATEMENT OF WORK

SCOPE OF WORK

To purchase laboratory gas supply services for laboratory research and testing work carried out at the Office of Pharmaceutical Quality Research (OPQR), Saint Louis site (OPQR-STL). These services will support OPQR-STL continual efforts and will contribute effectively to the FDA’s overarching objectives.

Background:

The laboratory research and testing work carried out at the Office of Pharmaceutical Quality Research (OPQR), Saint Louis site (OPQR-STL) in CDER/OPQR plays a critical role in mailto:Iris.Johnson1@fda.hhs.gov

CDER-2024-123858

supporting the FDA’s mission of regulating and assessing pharmaceutical products. Central to OPQR-STL’s operations are a variety of analytical instruments which are used for identifying, characterizing, and testing various pharmaceutical products. Many of these instruments rely on laboratory gases for their operation and function. As such, OPQR-STL necessitates continuous access to laboratory gas supply services to support its efforts and contribute effectively to the FDA’s overarching objectives.

Objective:

To obtain gas supplies and services to ensure the operation of OPQR’s laboratory in Saint Louis, MO

Requirements:

1. Vendor shall provide technology and be accountable for monitoring the usage of bulk liquid nitrogen (1500 Gallon tank) and bulk argon (450 Liter tank) at the site of performance

(OPQR-STL).

2. Vendor shall maintain the bulk nitrogen and bulk argon tanks at the site of performance to ensure their functionality and safety.

3. Vendor shall deliver bulk nitrogen or bulk argon to the site of performance and conduct refilling to ensure uninterrupted supply for OPQR-STL’s operation.

4. Vendor shall deliver bulk nitrogen or bulk argon to the site of performance and perform refilling only when the level of bulk nitrogen or bulk argon reaches or falls below 30% of capacity.

5. Vendor shall promptly alert OPQR-STL of any unusual increases in bulk nitrogen or bulk argon usage during a billing period.

6. Vendor shall deliver helium gas cylinders or other gas supplies and services within two (2) business days upon request.

7. Vendor shall provide same-day delivery of requested gas supply and services when an urgent need (period of unforeseen heavy use that consumes a high quantity of one or more gases) arises.

8. Invoice shall be billed on a monthly basis.

9. Gases and Liquids:

OPQR-STL requires the following laboratory gases/liquids. The vendor shall ensure availability of these supplies:

a) Bulk liquid nitrogen

b) Bulk argon

c) Helium, UHP grade 5.0 300 CF

d) Nitrogen, UHP Grade 5.0 size 300 CF

e) Carbon Dioxide

CDER-2024-123858

f) Oxygen

The below represents the estimated annual need at the site of performance:

Site of performance:

FDA Saint Louis Site 645 Newstead Ave St. Louis, MO 63110

Schedule:

Vendor shall deliver nitrogen (bulk), argon (bulk) as described in “Requirement’ and deliver helium gas cylinders or other gas supply and services within 2 business days of request. In case of urgent need, the vendor shall provide same-day delivery.

Inspection and Acceptance Criteria:

Delivered gas supplies will be confirmed against requested gas supplies at the time of delivery.

Period of Performance:

The period of performance will be a base period (12 months) with the addition of 2 Option Periods (12 months)

DISCLAIMER

The Government is not responsible for locating or securing any information not identified in your response, thus please ensure completeness prior to submission.

The Government will not reimburse respondents for any costs associated with information submitted in response to this Sources Sought. Responders are solely responsible for all expenses associated with responding to the notice.

Responses to this Notice are not offers and cannot be accepted by the Government for the basis of forming a binding contract. This Notice is being issued solely for the purpose of gathering information for planning purposes. This Notice does not commit the Government to a contract

GAS TYPE; PURITY; SIZE Unit QTY

Argon, refrigerated liquid (bulk) CF 67000

Liquid Nitrogen (bulk) CF 4100000

Helium UHP grade 5.0, 300 CF cylinder 60

Nitrogen UHP grade 5.0, 300 CF cylinder 4

Argon, compressed, UHP grade 5.0, 300 CF cylinder 4

CDER-2024-123858

for any supply or service. Furthermore, the Government is not at this time seeking quotes and will not accept unsolicited quotes.

Respondents to this Notice/Intent to Sole Source may be requested to provide additional information/details based on their initial submittals. The Government reserves the right to select one (1), some, or none of the submissions for further information. Vendors who submit information in response to this Notice do so with the understanding that U.S. Government personnel may review their materials and or data.

RESPONSE DEADLINE

Responses must be submitted in writing by e-mail to Iris Johnson, at Iris.Johnson1@fda.hhs.gov no later than Wednesday July 17, 2024. Questions regarding this Sources Sought Notice must be submitted via email as telephone inquiries will NOT be addressed and shall NOT contain proprietary or classified information.