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FDA Seeks Comments on New Info Collection for ITACS User Accounts
August 26, 2016 |FDA

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 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.

FDA Releases Guidances on FSMA Compliance, Animal Food Rules
August 24, 2016 |FDA

The Food and Drug Administration released a draft guidance (here) meant to help food businesses determine what Food Safety Modernization Act rules apply, the agency said (here). "The draft guidance includes several examples of hypothetical operations," it said. The FDA also released draft guidances on Current Good Manufacturing Practice (CGMP) requirements (here) and human food by-product requirements (here) under the FDA's FSMA Preventive Controls for Animal Food Rule. The FDA’s 2015 final rule (see 1509100073) set CGMP requirements and mandates a written preventive controls plan similar to that for human food for animal food facilities required to register with the FDA. The agency will accept public comments on the guidance starting Aug. 25, when related notices are published in the Federal Register, the FDA said.

FDA Posts Guide on ACE Rejects
August 24, 2016 |FDA

The Food and Drug Administration released a guide (here) on "rejects from FDA that are passed to the filer in the ACE Cargo Release Status Notification (SO) or the Status Notification for Stand-alone PE Data Submission (PO) transactions," CBP said in a CSMS message (here). "This document details the reject messages FDA sends if the Agency receives an entry with: missing data, data in an incorrect format, or certain data that is incorrect and prevents further processing," the FDA said.

FDA Posts Draft Guidance on Compliance With New Human Food Preventive Controls Regulations
August 23, 2016 |FDA

The Food and Drug Administration released a draft guidance document (here) on the agency’s recently issued regulations on hazard analysis and risk-based preventive controls for human food. Under the regulations, issued in September 2015, any U.S. or foreign establishment that is required to register with FDA as a “food facility” must compile a written food safety plan, conduct a hazard analysis and implement preventive controls for mitigation of those hazards, among other requirements, with the first compliance dates coming in September (see 1509100021). Once finalized, FDA’s guidance will help facilities covered by the regulations comply with specific preventive controls requirements, FDA said. Comments must be submitted by Feb. 21 to receive consideration before FDA finalizes the guidance, the agency said (here).