- Country: USA
- Summary: Procurement of 48 each Hd-Xg: High Density Xg Small Animal (Size) Implantable Telemeters
- UST Ref No: 80468517
- Deadline: 27 Mar 2023
- Financier: Self Financed
- Purchaser Ownership: Government
- Tender Value: Refer Document
- Notice Type: Tender
- Document Ref. No.: FDA-NOI-SS-116796
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- Description:
- Description
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 col... - Documents:
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CLICK HERE TO LOGINProcurement of 48 each Hd-Xg: High Density Xg Small Animal (Size) Implantable Telemeters - USA Tender
The HEALTH AND HUMAN SERVICES, DEPARTMENT OF, a Government sector organization in USA, has announced a new tender for Procurement of 48 each Hd-Xg: High Density Xg Small Animal (Size) Implantable Telemeters. This tender is published on USARFP under UST Ref No: 80468517 and is categorized as a Tender. Interested and eligible suppliers are invited to participate by reviewing the tender documents and submitting their bids before the deadline on 2023-03-27.
The estimated tender value is Refer Document, and full details, including technical specifications and submission requirements, are provided in the official tender documents. Ensure all submissions meet the criteria outlined to be considered for evaluation.
