Request for Information: Next-Generation Imports Screening Decision Support Risk Targeting System

FDA’s Import Program is responsible for ensuring that all imported products comply with FDA regulations. If FDA determines through examination, sampling, or otherwise that a product is adulterated or misbranded, the product is subject to refusal of admission into the United States in accordance with Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act.

FDA receives large quantities of product and product-associated information, and, upon receipt in the form of import entries, a best course of action needs to be decided to protect public health. Legacy systems handling these data are generally siloed and limited, with the creation of interfaces or expansions being time-consuming.

Given advancing technologies, it is sought to transition to more flexible decision support systems for screening these entries that are capable of handling large amounts of data while supporting the general operational processes already in place.