Two Low-Temp Dispensing Heads

Document Type: Notice of Intent to Sole Source Solicitation Number: FDA - Sole Source - 1212598 Posted Date: 04/22/2019 Response Date: 04/29/2019 NAICS Code: The Food and Drug Administration intends to make a sole source award for the Acquisition of 2 (TWO) Low-Temp dispensing heads award will be made to: Envisiontec 15162 S. Commerce Drive Dearborn, MI 48120 In accordance with FAR 6.302-1, Only one responsible source and no other supplies or services will satisfy agency requirements. The Division of Product Quality Research (DPQR) conducts research on assessing the quality and safety of drug products. One of the on-going research activities is to conduct research on assessing the performance, quality and safety of 3D printed drug products. These studies are critical in assessing the quality of intermediate and marketed drug products. To support this function, DPQR needs additional Low-Temp dispensing heads (with accessories) that can be installed on the existed EnvisionTEC 3D Bioplotter system in DPQR. The Low-Temp dispensing heads will extend DPQR capability to understand the manufacturing of multicompartment 3D printed products that require the use of several print heads simultaneously. This instrument and these studies will provide valuable information regarding safety and quality of 3D printed drug products and support the Center for Drug Evaluation and Research (CDER) critical missions. The current configuration of existed EnvisionTEC 3D Bioplotter system has only 2 printing heads that are available for operation. Addition of 2 more Low-Temp dispensing heads will expand the capability of the Bioplotter for priming 4 materials simultaneously. This additional capability is needed for the current projects where multiple APIs and excipients can be loaded into same dosage form. These studies are critical in assessing the quality of marketed 3D printed drug products. The Low-Temp dispensing heads must adhere to specifications outlined below: - Each low-temp dispensing head shall be compatible with 4th generation EnvisionTEC 3D Bioplotter system - Each head shall be heatable up to 70'C and coolable down to 2'C - Each head shall be LOW-TEMP dispensing head - Each head shall have Cartridge holder for 30cc PP cartridges - Each head shall have Luer-Lock Adapter Tool Changer Module/Head Identification - Each head shall be supplied with additional ten (10) Luer-Lock Adapters Deliverables Low-Temp dispensing heads are to be delivered to and installed at: U.S. Food and Drug Administration Center for Drug Evaluation and Research Division of Product Quality Research Attention: Ahmed Zidan 10903 New Hampshire Avenue White Oak Building 64 Room 1066 Silver Spring, MD 20993 Schedule: Delivery shall be no later than 30 days after contract award. This notice of intent is not a request for competitive quotes. However, all responsible sources may submit a capability statement within five (5) days after the publication of this synopsis which shall be considered by the agency. Responses received after 5 days or without the required information may not be considered. For information concerning this acquisition contact: Susan Bechtel Contract Specialist Susan.Bechtel@fda.hhs.gov No phone calls please 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.