Procurement of 48 each HD-XG: High Density XG small animal (Size) Implantable Telemeters

Notice of Intent to Sole Source (FDA-NOI-SS-116796) Subject: Procurement of Forty Eight (48) each HD-XG: High Density XG small animal (Size) Implantable Telemeters The U.S. Food & Drug Administration (FDA) intends to issue a Sole Source award to Data Sciences International, Inc. (DSI) for procurement of 48 each HD-XG Implantable Telemeters. 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 FDA’s Center for Drug Evaluation and Research’s (CDER’s) Office of Biotechnology Products (OBP) protects and advances the public health through review, regulation, and research of biological products and biosimilar biological products. To fulfill its mission, the OBP’s Division of Biotechnology Review & Research II has established a real time in-vivo murine model using HD-XG to study insulin stressors and kinetics. To continue expanding the in-vivo model

and maintain scientific integrity, OBP research requires additional 48 implantable insulin telemeters for glucose monitoring to study biosimilar insulin with respect to the aforementioned in-vivo model. The FDA research center OBP has established Institutional Animal Care and Use Committee (IACUC) protocols for the aforementioned study based on the DSI Implantable telemeters HD-XG. Further, the FDA research center generated study data using DATAQuest ART software for the study, so the additional implantable telemeters need to be compatible with existing software. This will ensure that the added telemeter maintain consistency with the existing software and FDA protocols to continue to support the FDA Centers mission of protecting human and animal health. The DSI Implantable telemeters provide real-time in vivo glucose mg/dl monitoring. The small size of the telemetry allows it to fit inside the subject, thereby making it possible to collect the data in real-time monitoring conditions. This crucial feature and many of the specifications and benefits of the technology are not known to be available in other commercially available instruments that may perform similar functions. The DSI HD-XG implantable telemeter is the only known source to be capable of providing seamless consistency and continuation of parameters and protocol to support FDA program office requirement. DSI, Inc. is the sole source provider of the XG-HD implantable telemeter and proprietary software which is solely developed by DSI. This will be a firm fixed price award. The NAICS Code is: 334516 Analytical Laboratory Instrument Manufacturing Data Sciences International (DSI) 119 14th St NW Suite 100 St. Paul, MN 55112 U.S.A. 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 12 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.