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TSE 700500-MFC-OUT-002 Electronic Mass Flow Controllers (MFCs)

Waiver type - Procurement: Nonavailability

Agency: FOOD AND DRUG ADMINISTRATION (7524) • Product Service Code (PSC) : 6640 | Last Modified: 08/06/2024

Procurement Summary

The Food and Drug Administration (FDA), National Center for Toxicological Research (NCTR), Division of Biochemical Toxicology/CTP requires a quantity of five (5) TSE 700500-MFC-OUT-002 Electronic Mass Flow Controllers (MFCs) to support Center for Tobacco Products (CTP) animal inhalation studies at the National Center for Toxicological Research (NCTR) in Jefferson AR. These mass flow controllers (MFCs) will be used for replacement parts for the existing TSE Daco Data Acquisition System (hardware and software) inhalation system. During the annual inhalation system Preventative Maintenance (PM) service, the TSE technician will install and test the newly purchased MFCs (the MFCs will be connected to the TSE Daco Data Acquisition System [hardware and software] in each inhalation system; one TSE computer with DACO software will send signals to control the MFC and collect signals from the MFC). Any MFCs that do not pass testing will be sent back to TSE for repair/replacement. As well, if any of the system MFCs do not pass the testing or are otherwise malfunctioning, a new MFC will replace a malfunctioning one. It is necessary to purchase the MFCs from TSE as TSE will not recalibrate/repair/replace MFCs that are not their own equipment and do not pass the aforementioned testing.

Waiver Rationale Summary

Based on the results of the market research conducted (including the SSN)and the results of the RFQ, it is determined that items which meet the Government’s need are not produced or manufactured in the United States in sufficient and/or reasonably available commercial quantities and of a satisfactory quality. A domestically manufactured item is not available to meet the FDA’s need.

Did / Will the solicitation include one of the standard BAA provisions announcing the agency’s intention to provide a price preference for domestic end products and construction material?

Yes

Was a sources sought or Request for Information issued?

Yes

OMB Determination

Consistent with Policy

Product

LABORATORY EQUIPMENT AND SUPPLIES

NAICS

334516 - Analytical Laboratory Instrument Manufacturing

Date Submitted

07/29/2024

Procurement Instrument Identifier (PIID)

75F40124P00297

Solicitation ID

75F40124Q123814-1

Procurement Stage

Post-solicitation

Expected Maximum Duration of the Proposed Waiver

Instant Delivery Only

Waiver Coverage

Individual Waiver

Funding Agency

FOOD AND DRUG ADMINISTRATION