The U.S. Food and Drug Administration (FDA) announced that it is planning to release its new ITACS Account Management functionality on Monday September 18, 2017.
FDA is providing trade outreach via WebEx on Tuesday September 5, 2017, Thursday September 7, 2017, and Monday September 11, 2017 to ensure that trade users are familiar with and understand the new ITACS Account Management functionality. Please see the attached document for outreach session registration information.
The webinars will include the following:
- An overview of current ITACS functionality
- Background and overview of the new ITACS Account Management functionality
- Creating an ITACS Account
- Retrieving Notices of FDA Action from ITACS
- Managing your ITACS Account, Users and Groups
- Where to find ITACS and ITACS Account Management resources
All webinar sessions will contain the same material. You will only need to register for and attend one session.
ITACS basic functionality provides the import trade community with four functions: the ability to check the status of FDA-regulated entries and lines, the ability to submit entry documentation electronically, the ability to electronically submit the location of goods availability for those lines targeted for FDA exam and the ability to check the estimated laboratory analysis completion dates for lines which have been sampled. No login accounts are necessary to access these functions. All that is needed is a valid Customs entry number that has been successfully transmitted to FDA.
ITACS account management functionality enables the electronic distribution of Notices of FDA Action via email and as downloads from within ITACS. It will also allow account holders to view the details of specific information requests, which are currently delivered via hard copy Notices of FDA Action. Implementation of login accounts will also allow for future enhancements requested by the Import Trade Community which require user verification.
Benefits to the trade include faster receipt of Notices of FDA Action via email or download in ITACS, no need to maintain paper copies of Notices of FDA Action as they will continue to be available in ITACS even after an entry is closed, and faster receipt of requests for specific information by email or ITACS. Note: If a firm chooses to receive their Notices of FDA Action electronically, paper copies will no longer be mailed to that firm.
ITACS account management functionality will be available to Importers of Record, Filers, and/or Consignees which have been associated with at least one previous FDA entry. ITACS accounts will be limited to one individual per firm at the corporate level. That person will have the responsibility to create and manage ITACS accounts for other users within the same firm, regardless of their location. ITACS accounts will be requested via the FDA Unified Registration and Listing System (FURLS).
More information can be found on FDA’s ITACS for Industry web page.