FDA to Add Account Management to ITACS on Sept. 18
The Food and Drug Administration plans to release its new Import Trade Auxiliary Communication System (ITACS) account management functionality on Sept. 18, it said. The new capabilities, which were the subject of a pilot conducted in 2016 (see 1606220042), will enable electronic distribution of FDA Notices of Action via email and as downloads in ITACS, and will also allow account holders to “view the details of specific information requests, which are currently delivered via hard copy” notices, FDA said. Benefits include faster receipt of FDA notices of action and requests for information and no need to maintain copies of paper notices, the agency said.
Sign up for a free preview to unlock the rest of this article
If your job depends on informed compliance, you need International Trade Today. Delivered every business day and available any time online, only International Trade Today helps you stay current on the increasingly complex international trade regulatory environment.
The new functionality will be available to filers, importers of record and consignees with an approved ITACS account, FDA said. “To be granted an account a firm must have been a party to a previously transmitted FDA entry. ITACS accounts are limited to one individual per firm at the corporate level. This person should be a high ranking individual within the firm as they will have the responsibility to create and manage ITACS accounts for other users within their firm,” it said.
FDA will hold webinars on the new ITACS account management functionality on Sept. 5, Sept. 7 and Sept. 11, it said. The webinars will include information on creating an ITACS account; retrieving FDA notices of action from ITACS; managing ITACS accounts, users and groups; and where to find ITACS and ITACS account management resources, FDA said. FDA also posted slides from a presentation on the new account management functionality. The new capability will also eventually allow for future ITACS enhancements requested by the trade community that require user authentication, FDA has said.