Notice of Intent - TA Instruments Discovery Hybrid Rheometer & Maintenance Support Services

The Food and Drug Administration (FDA) intends to negotiate on a sole-source basis with TA INSTRUMENTS - WATERS L.L.C. for a Discovery Hybrid Rheometer (HR 30; Part number 534003.901) and maintenance support services for a base period of one-year with four one-year option periods. The authority for this requirement is 41 U.S.C. 1901. Background Information and Basis for Sole Source The FDA’s Center for Devices and Radiological Health (CDRH) Office of Science and Engineering Laboratories (OSEL) Division of Biology, Chemistry, and Materials Science (DBCMS) studies the molecular mechanisms of durability and degradation of soft polymeric device materials (e.g. surgical adhesives, gel plugs for controlling blood flow, 3D printed scaffolds). The most direct way to study these mechanisms is to measure rheological properties using a rheometer. A rheometer is essential for evaluating soft materials, which are often low-viscosity liquids or thin gels and have no structural integrity (unlike materials which can be assessed in a solids analyzer). To fulfill its mission for approximately the past 15-years, DBCMS has been utilizing an AR-G2 magnetic bearing rheometer manufactured by TA Instruments. Throughout the DBCMS’s use of the AR-G2, DBCMS has conducted a bevy of experiments and has recently commenced several experiments utilizing pre-existing geometries (cone-plate and cup) via the AR-G2. Rheological measurements are highly sensitive. Therefore, it is imperative to minimize inter-instrument variability in an effort to mitigate differences in geometries, which would inherently jeopardize the integrity of FDA’s pre-existing and ongoing data. Acquiring TA Instruments Discovery Hybrid Rheometer mitigates the FDA’s risk of sustaining duplication of effort by having to conduct a high volume of experiments over. TA Instruments Discovery Hybrid Rheometer ultimately ensures continuity, consistency, and interchangeability of pre-existing data through the use of the aforementioned pre-established cones, plates, and cup geometries. TA Instruments does not have authorized resellers or distributors capable of providing the required equipment and services. 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 1:00 p.m. Eastern Time on August 13, 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.