As some organizations announce procedural changes because of the coronavirus (COVID-19), the US Food and Drug Administration (FDA) provided reassurance to the National Customs Brokers and Forwarders Association of America (NCBFAA) that they remain functional and operational. Normal FDA functions are continuing, including FDA prior notice review, entry processing, sampling/examination of high-risk shipments, FSVP inspections, filer assessments, and compliance activities. However, the FDA has stopped most foreign inspections of food, medicine, and medical devices; they will rely on other methods to ensure product safety, such as inspections at the port and assistance from other government agencies.
Due to capacity constraints, the FDA has encouraged those importing FDA-regulated goods to utilize the FDA Import Trade Auxiliary Communication System (ITACS) for current entry status and to create an ITACS account to receive FDA notices electronically. “The ITACS Account Management functionality enables the electronic distribution of Notices of FDA Action via email and as downloads from within ITACS. It also allows account holders to view the details of specific information requests, versus delivery of hard copy Notices of FDA Action.”
- ITACS basic functionality may be accessed at https://itacs.fda.gov.
- ITACS accounts can be requested via the FDA Unified Registration and Listing System (FURLS) at https://www.access.fda.gov/oaa.
Additionally, the Animal and Plant Health Inspection Service (APHIS) sent a communication advising that they will “balance safety with service.” As the COVID-19 situation continues to develop, they will make adjustments as necessary to accomplish their “mission of protecting the health and value of America’s agriculture and natural resources.” As a precaution, APHIS has decided to close all of its offices to visitors. However, many meetings are being moved to conference calls or will be rescheduled.