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MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) is issuing this source sought announcement on behalf of the Office of Pharmaceutical Quality Research (OPQR), in order to determine if there are existing small business sources capable of providing a “Brand Name or Equal” Nanalysis AUTOsample-100 autosampler. Other than small business concerns, especially vendors who may be able to offer domestic products are also encouraged to submit a capability statement that provides company information, as well as information demonstrating that it can meet all of the minimum requirements included below, to include the country of manufacture of products offered. If your firm is considered a small business source under North American Industry Classification System (NAICS) Code 334516 - Analytical Laboratory Instrument Manufacturing; with a Small Business Size Standard of 1,000 employees and you believe that your firm would be able to provide the FDA with the supplies/services described below, please submit an email to Warren.Dutter@fda.hhs.gov. Background: The U.S. Food and Drug Administration (FDA), Office of Pharmaceutical Quality Research (OPQR) in Saint Louis, MO (OPQR-STL), is a laboratory-based office focused on the quality assessment of drug products. OPQR conducts research to support the establishment of scientific standards for product quality, performance, and the therapeutic equivalence of generic drug products. The purpose of this acquisition is to procure a “Brand Name or Equal” Nanalysis AUTOsample-100 autosampler for use with an existing Nanalysis 100 MHz benchtop NMR system. Benchtop NMR systems utilize low magnetic field strength permanent magnets, which are more cost-effective per MHz than traditional high-field NMR systems and require less maintenance. These systems are well suited for high-throughput screening applications. The addition of an autosampler will significantly improve laboratory efficiency by automating sample handling, eliminating the need for analysts to manually exchange samples between runs. It will also enable unattended operation, including overnight experiment execution, thereby increasing throughput and optimizing staff time efficiency. This is a Brand Name or Equal requirement. Products other than the specified Nanalysis AUTOsample-100 autosampler are acceptable but shall meet all the salient characteristics contained in the Minimum Technical Requirements below. Minimum Technical Requirements (Salient Characteristics): The autosampler shall be compatible with and capable of full integration with the existing Government-owned Nanalysis 100-PRO benchtop NMR system (magnet), Serial Number C109122022. The autosampler shall support automated queuing and execution of multiple NMR experiments. The autosampler shall support automated queuing and processing of multiple samples without operator intervention betw…
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