FDA - SS NOI - 1228735.doc

FDA-Sole Source-1228735 Purchase of a Nativas Polymer Microcompounder

The Food and Drug Administration intends to make a sole source award for a Nativas Polymer Microcompounder. The award will be made to:

Nativas Sciences LLC 137 Glenwood Ave Leonia NJ 07605 In accordance with FAR 6.302-1, FAR 13.106(b) and FAR 5.203, Only one responsible source and no other supplies or services will satisfy agency requirements.

The FDA’s CFSAN office has a need to replace a polymer microcompounder with a new model to successfully complete current and upcoming research projects related to food contact material safety. To meet project milestones, the FDA manufacturers polymer test materials in its own laboratories using a twin-screw microcompounder that interfaces with a cast film line and injection molder. The polymer microcompounder needs to be fully compatible with other polymer processing equipment such as the microinjection molder and film line currently installed in FDA laboratories. Nativas Sciences is the only company licensed to sell a polymer microcompounder compatible with equipment currently installed in the FDA laboratory. Compatibility with the currently installed equipment is crucial for the FDA’s ongoing projects; The polymer extruded by the microcompounder is always transferred to the film line or injection molder for further processing. Purchasing microcompounder equipment from a company other than Nativas Sciences would require purchasing a new film line and new injection molder, which together have an estimated cost of $80,000 to $100,000. The compatibility with currently installed FDA equipment is an essential requirement for this acquisition, therefore it is in the best interest of the government to plan an award to Nativas Sciences.

This notice of intent is not a request for competitive quotes. However, all responsible sources may submit a capability statement within ten (10) days after the publication of this synopsis which shall be considered by the agency. Responses received after 10 days or without the required information may not be considered. For information concerning this acquisition contact:

Nikola Zuber Contract Specialist Nikola.Zuber@fda.hhs.gov

(301) 796 - 9671 A determination by the Government not to compete because of information received is solely within the discretion of the Government. Information received will normally be considered solely for determining whether to conduct a competitive procurement.

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