FDA has awarded a sole source extension for up to one year for IT lifecycle support services for the FDA Unified Registration and Listing System to Information Innovators Inc. (Triple i), a wholly owned subsidiary of Salient CRGT.
“The purpose of this acquisition is to acquire Information Technology (IT) lifecycle support services for the FDA Unified Registration and Listing System (FURLS) from Information Innovators, Inc. (Triple-i) as a sole source extension to the existing Enterprise System Life Cycle Management Support (ELMS) IDIQ FURLS II task order, HHSF223200950015I / HHSF22301013T.
The objective of this continuation of FURLS software life cycle support is to ensure FDA remains able to meet its critical mission of protecting public health by providing the means for industry to comply with, and for FDA to enforce, existing regulations of the Food, Drug and Cosmetic Act (FDCA). These regulations are detailed and amended in the FDA Modernization Act (FDAMA)(1997), Bioterrorism Act (2002), Food Safety Modernization Act (FSM A)(2011), FDA Export Reform and Enhancement Act (EREA), and the recently updated Section 905 of the FDCA pertaining to tobacco products. As a result of these legislative acts, the FURLS IT solution has been developed and used by all FDA centers since 2003 so as to protect the safety of the American public by ensuring all regulated products such as drugs, medical devices, biological product s, food, cosmetic, dietary ingredients, and tobacco products are properly registered and listed with FDA. In addition, the FURLS IT solution enables FDA and other government agencies to access critical information relating to food imports and to implement some of the FSMA mandates such as accreditation and certification bodies to prevent potentially harmful food from reaching U.S. consumers. Specifically, FURLS enables FDA to…”