Intent to Sole Source FDA-118342.pdf

Purchase of six (6) Aerosol Diluters, TSI Model 3302a Intent to Sole Source

FDA – 118342

Date Posted: June 20, 2023

Response Date: June 27, 2023 09:00 AM CST

Classification Code: 6640 – Laboratory Equipment and Supplies

NAICS Code: 334516 – Analytical Laboratory Instrument Manufacturing; with a Small Business Size Standard of 1,000 employees

The U.S. Food and Drug Administration (FDA)/National Center for Toxicological Research (NCTR) intends to award a brand name, firm fixed price purchase order to TSI Incorporated, 500 Cardigan Rd, Shoreview, MN, under the authority of FAR 13.106-1(b)(1).

The U.S. Food and Drug Administration’s (FDA), National Center for Toxicological Research (NCTR), Division of Biochemical Toxicology has a requirement for the purchase of six (6) aerosol diluters to support Center for Tobacco Products (CTP) animal inhalation studies at NCTR. Since the lab has started using an aqueous based aerosol system for the delivery of nicotine at the request of CTP, they now must use a real-time aerosol particle sizer to confirm that the aerosol is in the correct respirable range suitable for animal exposures. The TSI model 3302a is the only Aerosol Diluter manufactured small enough to fit inside the class III glovebox used in the NCTR animal exposure studies. Past research highlighted a problem with the difficultly of sizing the optically clear aqueous particles that are at the edge of size range of the instrument. Research showed that additional dilution was necessary to accurately determine particle size. The additional six (6) aerosol diluters are imperative to ensure there are no disruptions in research funded by the CTP.

Acquiring the six (6) Model 3302a diluters which are matched to fit into the lab’s tight footprint and work seamlessly with their current model 3321 APS and 3302a diluter stack will allow sufficiently diluted aerosol for the lab to accurately and repeatably measure particle size ensuring lengthy and complicated animal aerosol exposures are successful. The addition of 6 model 3302a Diluters will ensure that lengthy animal exposures are not disrupted if any instruments were to go out of calibration during an animal exposure.

This notice is being published in accordance with Federal Acquisition Regulation (FAR) Part 5.101(a)(2) requiring the dissemination of information on proposed contract actions. This is a notice of intent to award a brand name contract and is not a request for competitive proposals. The statutory authority for this sole-source procurement is FAR 13.106-1(b)(1).

This notice of intent is not a request for competitive proposals. Interested parties that believe they can meet the requirement may submit a capability statement to Suzanne Martella at suzanne.martella@fda.hhs.gov before June 22, 2023 at 2:00 pm Central Time (CT). A determination not to compete this requirement, based upon responses to this notice, is solely within the discretion of the Government. If no responsive statements are received before the closing date and time, an award will subsequently be made to TSI Incorporated.

mailto:suzanne.martella@fda.hhs.gov