Preventive Maintenance and Repair Service Agreement for Cozzoli Vial Filling Machine.

The U.S. Food and Drug Administration (FDA) is conducting market research to support the Center for Biologics Evaluation and Research (CBER) requirement for a Preventive Maintenance and Repair Service Agreement for a Cozzoli Vial Filling Machine. The 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. The FDA is seeking small business sources to determine the availability and capability of small businesses capable of providing the required supplies. The scope of work includes on-site preventive maintenance for the Cozzoli Vial Filling Machine, with a base period of July 1, 2026, through June 30, 2027, and four option years. The contractor shall provide one scheduled on-site planned preventive maintenance visit per year, including consumables, labor, travel, and parts. • The contractor shall provide unlimited software and firmware updates during the entire coverage period. • The contractor shall provide unlimited technical support (via phone and email) on software and hardware-related issues and trouble-shooting capabilities, Monday through Friday (excluding Federal Holidays). • The contractor shall include access by the FDA Technical Representative (TR) and system operator personnel to the manufacturer's call center for technical assistance. • The contractor shall provide service records and reports after each preventive maintenance visit.