Inactive Total Small Business Set-Aside (FAR 19.5)

The U.S. Food & Drug Administration (FDA), intends to issue a Sole Source follow-on award to Specialty Measurements Inc. (SMI) for procurement of one (1) each Compacta II Tablet Compression Machine (T... The U.S. Food & Drug Administration (FDA), intends to issue a Sole Source follow-on award to Specialty Measurements Inc. (SMI) for procurement of one (1) each Compacta II Tablet Compression Machine (TCM). 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. FDA Division of Product Quality and Research (DPQR), currently owns two small scale low throughput tablet press which are: Piccola Classic B-D TSM and Minipress MII. The manufacturer of the two (2) existing tablet press is Specialty Measurements Inc. (SMI). FDA is seeking a pilot scale tablet press from the same source to ensure seamless transferability of the knowledge and parameters from small scale tablet presses to pilot scale press. Additionally, the FDA is requesting compatibility and a copy of license of the data acquisition software “Director” currently used in the existing tablet presses, Piccola Classic B-D TSM and Minipress MII. Compacta II Tablet Press configured to B & D tooling is the only known source to be capable of providing seamless transfer of parameters and support the data acquisition software existing in the FDA lab. SMI is the sole source distributor in the United States for the Compacta II Tablet Press, as well as the “Director” Data Acquisition software. SMI provides installation, training, support and preventative maintenance calibration services for the complete line of tablet presses available from the company. Previous award to SMI has been made for the small scale low throughput tablet press, this award will be to procure pilot scale tablet press. This will be a firm fixed price award. The NAICS Code is: 424210 Drugs and Druggists' Sundries Merchant Wholesalers Specialty Measurements Inc. (SMI) 2420 Emrick Boulevard Bethlehem, PA 18020 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 seven (7) 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.