EREA Certs. Program (FURLS II/CDER eCATS System)

The contract supports the continued development and modernization of CDEReCATS, the FDA’s electronic system for managing Certificates of Pharmaceutical Product applications submitted by external entities. This system enables the electronic submission of CPP requests and integrates with internal FDA databases to streamline review processes, improve data accuracy, and enhance operational efficiency within CDER. The funding will advance key enhancements aimed at increasing office productivity, ensuring higher quality information in certificate applications, and accelerating the issuance of both paper and electronic CPPs to better serve global pharmaceutical stakeholders. This initiative falls under the broader FDA Enterprise Performance Life Cycle framework and is categorized under NAICS code 541519, reflecting its focus on custom software development and systems integration. The program is managed by the Food and Drug Administration, with program oversight coordinated through the CDER Acquisition Liaison at cderacquisitions@fda.hhs.gov, while the contracting officer position remains to be determined. The forecasted opportunity was posted in May 2026, signaling future acquisition intent for contractors to support ongoing system improvements and modernization efforts critical to the efficient international trade of pharmaceutical products.