Genomics Information Management System (GIMS) License Renewal, Support,

Summary (Newest Update)

Background The U.S. Food and Drug Administration (FDA) is responsible for ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, food supply, cosmetics, and radiation-emitting products. The FDA Human Foods Program (HFP) focuses on oversight of products, compliance with food labeling, pre-market approval of specific products, and consumer protection activities related to food and nutritional products. The Genomics Information Management System (GIMS) utilizes the Scientific Laboratory Information Management System (SLIMS) software to facilitate genomic data collection and analysis within the Whole Genome Sequencing Program (WGS). This solicitation aims to renew SLIMS User and Server licenses to support ongoing operations in genomic data management. Work Details The contractor is required to provide the following licenses: - 7 Premium Named User SLIMS Licenses - 10 Standard Named User SLIMS Licenses - 72 Basic Named User SLIMS Licenses - 2 SLIMS Server Licenses All licenses must be delivered by September 21, 2026. The licenses must include functionalities such as LIMS, ELN, ELS applications; configuration for onsite and cloud use; microbial regulatory environments; workflow management; sample tracking; audit trails; eSignature compliance with 21 CFR Part 11; integration with sequencing and robotics systems; scalability; helpdesk support; API access; and large data handling capabilities. Licenses must be compatible with existing GIMS architecture without lag time for users. Period of Performance The required delivery date for the items is on or before July 31, 2026. Place of Performance U.S. Food and Drug Administration, White Oak Data Center, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993. Bidder Requirements Bidders must ensure that quoted licenses meet FDA IT Security Requirements. They must also provide proof of information technology security accreditation with a valid Authority to Operate (ATO) as per HHS policy. Additionally, contractors are required to submit an Information System Security Plan within 60 days after contract award. Incumbent Analysis (see Incumbents section for more detail) This opportunity appears to have a confirmed incumbent, with Agilent Technologies listed on prior GIMS-related contracts for SLIMS license renewal and support. The most recent award (75F40125P00276) provided “GIMS LICENSE RENEWAL, SUPPORT, AND MODERNIZATION” for $119,162 (09/24/25–09/23/26), and an earlier contract (75F40122P00590) covered “GIMS AND CUSTOMIZATION” for $42,993 (09/29/22–08/19/23). The current requirement to renew SLIMS user and server licenses to continue GIMS use for FDA Whole Genome Sequencing aligns closely with these prior license/support efforts and appears to be a continuation of the same system’s ongoing operations.