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MARKET RESEARCH PURPOSES ONLY NOT A REQUEST FOR PROPOSAL OR SOLICITATION The U.S. Food and Drug Administration (FDA) is conducting market research to support the Center for Biologics Evaluation and Research (CBER), requirement for Preventive Maintenance and Repair Service Agreement for Cozzoli Vial Filling Machine. The FDA is seeking small business sources to determine the availability and capability of small businesses capable of providing the required supplies. Other than small business concerns are also encouraged to submit capability statements. The following information is provided to assist the FDA in conducting Market Research to identify potential contractors for this effort. The associated North American Industry Classification System (NAICS) Code is- 811210 - Electronic and Precision Equipment Repair and Maintenance; the applicable Small Business Size Standard is $34 million. Statement of Work Purchase of On-site preventive maintenance for COZZOLI® Filling Machine Part I: General Information A. Objective This requirement is for annual on-site preventive maintenance for COZZOLI® Filling Machine of Division of Biological Standards and Quality Control (DBSQC) within CBER. The COZZOLI® Vial Filling Machine is used for the preparation of CBER standards in support of vaccines and other biological products submitted for licensure and/or other regulatory decisions. B. Background Division of Biological Standards and Quality Control (DBSQC) serves as a Standards Preparation facility for CBER. DBSQC maintains a well-equipped Standards preparation capacity to prepare standards for potency testing and share them with manufacturers and other regulatory agencies. Standards are used to test assay validity for products. An important part of the laboratory activities involves testing influenza vaccines for potency and identity. The COZZOLI® Vial Filling Machine is used for filling measured volume of biological standards in the vials for lyophilization and subsequent distribution. The use of a filling machine is critical for the preparation of Standards and for the mission of CBER, since the standards prepared support testing for licensing, lot release, and other regulatory decisions. C. Scope This SOW is for the purchase of on-site preventive maintenance for COZZOLI® Filling Machine of Division of Biological Standards and Quality Control (DBSQC). The COZZOLI® Vial Filling Machine is in the Sterility Suite, Room 5297. Bldg. 52/72 at White Oak campus. Part II: Work Requirements Technical Requirements One on-site preventive maintenance per year for a COZZOLI® Vial Filling Machine. Equipment: Cozzoli Filling Line; Cozzoli Serial Number: UT42-974; Cozzoli Serial Number: CR200i-CWS-69; Cozzoli Serial Number: BT15-75. A service contract under 75F40123P00100 was previously in place for the preventive maintenance and repair of the Cozzoli Filling Machine. The previous contract ended on October 16, 2025 and have been without service contract. All compone…

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