Inactive

The U.S. Food & Drug Administration (FDA), intends to issue a Sole Source award to VITROCELL Systems GmbH for procurement of one (1) each In Vitro Exposure System (IVES). The Government intends to iss... The U.S. Food & Drug Administration (FDA), intends to issue a Sole Source award to VITROCELL Systems GmbH for procurement of one (1) each In Vitro Exposure System (IVES). 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 equipment. The Food and Drug Administration (FDA), the Center for Drug Evaluation and Research (CDER) is in need of an in vitro exposure system and smoking machine to facilitate the research of human cell cultures in direct exposure to airborne substances such as smoke generated by electronic cigarettes. FDA intends to connect the in vitro exposure system to a specific smoking machine for vaping study. Therefore, the selected system shall be compatible/configurable with VITROCELL® Smoking Machine VC 1. This criterion will help in comparing the epithelial permeability of marketed nasal products. The data generated is valuable information regarding safety and quality of drug products to support CDER’s mission critical missions. VITROCELL® Cloud Alpha 12 exposure system is the only known source that is compatible with the VITROCELL® VC 1 Smoking machine. VITROCELL is the sole source manufacturer and sales organization for the VITROCELL® Cloud system in the United States and worldwide. VITROCELL is solely authorized to provide installation, training, support and any preventative maintenance services including factory parts for its products. This will be a firm fixed price award. The NAICS Code is: 334516, Analytical Laboratory Instrument Manufacturing. VITROCELL Systems GmbH Fabrik Sonntag 3 79183 Waldkirch, Germany This notice of intent is not a request for competitive quotes. However, all responsible sources may submit a capability statement to Sarah Hussain, sarah.hussain@fda.hhs.gov in writing and must be within seven (7) 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.