DSI HD-XG Implantable Insulin Transmitters

The Food and Drug Administration (FDA) intends to negotiate on a sole-source basis with Data Sciences International, Inc. (DSI) for 180 HD-XG implantable insulin transmitters (item # 270-0194-003) – 60 base (FY21); 60 optional (FY22); and 60 optional (FY23). Background Information and Basis for Sole Source The FDA’s Center for Drug Evaluation and Research’s (CDER’s) Office of Biotechnology Products protects and advances the public health through review, regulation, and research of biological products and biosimilar biological products. To fulfill its mission, the Office of Biotechnology Products’ Division of Biotechnology Review & Research II has established an in vivo murine model to study acute inflammatory reactions and drug quality studies using DSI HD-X11 implantable telemetry device. To continue expanding the in vivo model and maintain scientific integrity, the Division of Biotechnology Review & Research II requires 180 ( i.e. 60 base + 120 optional ) implantable insulin transmitters for glucose monitoring to study biosimilar insulin with respect to the aforementioned in vivo model. The Institutional Animal Care and Use Committee (IACUC) protocols for the aforementioned study have been established based on the DSI HD-X11. The DSI HD-X11 is controlled by DSI Dataquest Art v4.3. This software is not capable of controlling and reading data from non-DSI transmitters. Deviating to an alternate manufacturer puts the Government at risk of realizing excessive redundant expenses and timely delays for the integral in vivo model insulin study. DSI has no authorized resellers or distributors capable of providing the required implantable insulin transmitters. General The North American Classification System (NAICS) code for this acquisition is 334516 – Analytical Laboratory Instrument Manufacturing. The small business size standard is 1,000 employees. No solicitation package will be issued. This notice of intent is not a request for competitive quotations; however, responses received by 1:30 p.m. Eastern Time on July 20, 2021 will be considered by the Government. A determination by the Government not to compete the proposed acquisition based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive procurement. Interested parties that believe they could satisfy the requirements listed above for FDA may clearly and unambiguously identify their capability in writing on or before the response date for this notice. This notice of intent is not a solicitation. Any questions regarding this notice must be submitted in writing via email to Adam Powell at [email protected]. All responses to this notice of intent must be submitted so that they are received at [email protected] no later than the aforementioned due date.