FDA Seeks Comments on New Info Collection for ITACS User Accounts
The Food and Drug Administration is seeking comments (here) on new information it says it will have to collect in order to implement a user account management function in its Import Trade Auxiliary Communications System (ITACS). The new function, which…
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is the subject of a pilot FDA plans to conclude by October (see 1606220042), would allow FDA to distribute Notices of FDA Action electronically, enable users to access Notices of FDA Action within ITACS, and allow users to view the details of specific FDA information requests in ITACS. “ITACS user account management functionality would also allow for potential future ITACS enhancements, requested by the import trade community, that require user authentication,” FDA said. FDA would have to ask users to enter “basic information such as the person's name, their employer's name, a contact email address, an account password, etc., into ITACS via the user account management function interface,” it said. That should take users about 30 minutes each, it said. Comments are due Oct. 25.