NOI_CDRH-2023-117782.pdf

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Attached to
Contrast Anthropomorphic Breast Phantoms Federal contract opportunity
Solicitation number
75F40123Q00399
Issued by
Department of Health and Human Services Food and Drug Administration Office of Acquisition and Grant Services

About this file

This notice of intent to sole source announces that the U.S. Food and Drug Administration intends to award a sole source contract to Phantomx GMBH to provide contrast anthropomorphic breast phantoms. The scope of work requires one breast phantom with uniform adipose tissue background and cylindrical masses of varying iodine concentrations, and four additional phantoms with anthropomorphic breast structure to match a virtual breast phantom supplied by FDA. The NAICS code is 334516 for analytical laboratory instrument manufacturing. The award will be a firm fixed price contract for a base period and four one-year option periods. Interested parties may submit a capability statement to the point of contact within five days for consideration, though a determination not to compete is at the agency's discretion.

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Text version

Notice of Intent to Sole Source

Date: September 11, 2023

Subject: Contrast Anthropomorphic Breast Phantoms

The U.S. Food & Drug Administration (FDA) intends to issue a Sole Source award to Phantomx GMBH.

The Government intends to issue a sole source award in accordance with FAR 6.302-1, only one responsible source and no other will satisfy the agency requirements for the above stated service.

The scope of the work is to provide breast phantoms. One phantom shall have a uniform background breast shape emulating x-ray attenuation of adipose tissue with 10, 10 mm long cylinders of radius 5 mm , two masses with each iodine concentration of 0.25 mg/ml, 0.5 mg/ml, 1.0 mg/ml, and 2.0 mg/ml

The other four phantoms shall have anthropomorphic breast background structure matching a virtual breast phantom supplied by the FDA.

The NAICS Code is: 334516 Analytical Laboratory Instrument Manufacturing.

The Vendor to be awarded:

Phantomx GMBH

Schwedenster.14

Berlin

Germany

This will be a firm fixed price award for a Base Period and four (4) one (1) year Option Periods.

This notice of intent is not a request for competitive quotes. However, all responsible sources may submit a capability statement to Iris Johnson, Iris.Johnson1@fda.hhs.gov in writing and must be within five (5) days after date of publication of this notice which may be considered by the agency. A determination by the Government not to compete as a result of information received is solely within the discretion of the

Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement.

No phone calls will be accepted.

File details come from the government source that posted it. Updated .