CSMS# 17-000596 - FDA Announces New Import Trade Auxiliary Communication Sys(ITACS) AcctMgmnt Functionality
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09/19/2017 03:15 PM EDT
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FDA Announces New Import Trade Auxiliary Communication System (ITACS) Account Management Functionality
FDA is announcing the release of Import Trade Auxiliary Communication System (ITACS) Account Management functionality for use by the import trade community. This is being implemented in order to improve communication between FDA and the import trade community.
Current ITACS web access 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.
The new 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 may be used by Filers, Importers of Record and Consignees with an approved ITACS account. Account applicants must have been a party to previous FDA entries for account approval. Please limit ITACS account requests to one individual per firm at the corporate level. That applicant should be a high ranking individual within the firm because 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 can be requested via the FDA Unified Registration and Listing System (FURLS).
Presentations providing overviews of basic ITACS functionality and the new ITACS Account Management functionality, and how to use both, are available on FDA’s ITACS for Industry internet page.
Please direct any questions to ITACSSupport@fda.hhs.gov .
FDA Announces New Import Trade Auxiliary Communication System (ITACS) Account Management Functionality
FDA is announcing the release of Import Trade Auxiliary Communication System (ITACS) Account Management functionality for use by the import trade community. This is being implemented in order to improve communication between FDA and the import trade community.
Current ITACS web access 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.
The new 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 may be used by Filers, Importers of Record and Consignees with an approved ITACS account. Account applicants must have been a party to previous FDA entries for account approval. Please limit ITACS account requests to one individual per firm at the corporate level. That applicant should be a high ranking individual within the firm because 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 can be requested via the FDA Unified Registration and Listing System (FURLS).
Presentations providing overviews of basic ITACS functionality and the new ITACS Account Management functionality, and how to use both, are available on FDA’s ITACS for Industry internet page.
Please direct any questions to ITACSSupport@fda.hhs.gov .
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