Notice_of_Intent_to_SS__1209568.pdf

September 7, 2019

Notice of Intent to Sole Source for a

Vitrocell/Gasmet CX4000 FTIR Gas Analyzer System

FDA_SS_1209568

The Food and Drug Administration (FDA) intends to award a Sole Source firm-fixed price purchase order to Vitrocell Systems GMBH, located at Fabrik Sonntag 3, Waldkirch, Germany 79183.

In accordance with FAR part 6.302-1, the contractor is the only responsible source who can provide the required services as no other source has been identified who can provide the requirements listed below.

The purpose of this notice is to inform the public that FDA anticipates issuing an award for the purchase of a Vitrocell/Gasmet CX4000 Fourier Transform Infrared Spectrometer (FTIR) Gas Analyzer System to conduct in vitro inhalation toxicity studies for a Base Year:

Technical Requirements:

1. The system shall quantify gases in the concentration ranges of ppm or ppb.

2. The system shall simultaneously monitor the concentrations of multiple gases, including those in corrosive gas mixtures and e-cigarette vapors.

3. The system shall incorporate a heated sample cell and heated sample lines and controller to prevent condensation of gas/vapors from gas/vapor generator to FTIR.

4. The system shall be compatible with our exiting inhalation exposure setups, i.e., Vitrocell VC10 S-

Type Smoking robot and Vitrocell Spiking system, so it can be connected in-line to these instruments for real-time concentration monitoring.

5. The system shall be able to be calibrated for common e-cigarette aerosols & gases.

The associated North American Industrial Classification System (NAICS) Code is 334516: Analytical Laboratory Instrument Manufacturing

This notice is not a request for competitive proposals. However, any party that believes it is capable of meeting this requirement as stated herein may submit a written capability statement that clearly supports and demonstrates their ability to perform the requirement.

Capability statements must be received by the response date and time of this notice. Submissions will be reviewed to determine if they can meet the requirement. A determination by the Government to compete this proposed contract based upon responses to this notice is solely within the discretion of the Government.

It is anticipated that an award will be issued to Vitrocell Systems GMBH, within approximately ten

(10) days after the date of this notice unless the Government determines that any other organization has the capability to meet this requirement.

Response Date: Friday, September 13, 2019 by 7:00AM Eastern Time. Please email responses to Janae Hughes at janae.hughes@fda.hhs.gov. No phone calls will be accepted.

mailto:janae.hughes@fda.hhs.gov