FDA Finalizes New Import Data Requirements

The Automated Commercial Environment system "serves to protect public health by allowing FDA to focus its limited resources on those FDA-regulated products being offered for import that may be associated with a greater public health risk," wrote Howard Sklamberg, J.D., deputy commissioner for Global Regulatory Operations and Policy.

The U.S. Food and Drug Administration published a final rule Nov. 29 specifying data that must be submitted electronically when an FDA-regulated product is offered for import into the United States. The effective date of the rule is Dec. 29, 30 days from the date of publication. The rule clarifies that FDA may reject an import filing that fails to provide complete and accurate information as required.

Import entries of products regulated by FDA are submitted through an electronic system called the Automated Commercial Environment (ACE). Howard Sklamberg, J.D., FDA's deputy commissioner for Global Regulatory Operations and Policy, explained in an FDA blog post that the trade community helped the agency pilot ACE, which is operated by U.S. Customs and Border Protection, from August 2015 to May 2016, and ACE became in July 2016 the sole Customs-authorized system for electronic submissions of entries that contain FDA-regulated products.

The rule includes technical revisions to certain sections of FDA regulations, he explained. For example, the owner or consignee of an FDA-regulated product is now defined as the importer of record, which brings FDA regulations up to date with previous revisions to customs laws, and FDA will now directly provide a notice that an FDA-regulated product is to be sampled, rather than having to go through CBP to provide that notice.

FDA will continue to provide assistance to filers working to properly submit the required data, through telephone meetings, an ACE Support Center that is staffed 24/7, and assisting directly in a filer's first ACE submission or, for filers who import various commodities, with every first submission of a particular commodity.

Sklamberg wrote that the system "serves to protect public health by allowing FDA to focus its limited resources on those FDA-regulated products being offered for import that may be associated with a greater public health risk."

Download Center

HTML - No Current Item Deck
  • Free Safety Management Software Demo

    IndustrySafe Safety Management Software helps organizations to improve safety by providing a comprehensive toolset of software modules to help businesses identify trouble spots; reduce claims, lost days, OSHA fines; and more.

  • Get the Ultimate Guide to OSHA Recordkeeping

    When it comes to OSHA recordkeeping there are always questions regarding the requirements and in and outs. IndustrySafe is here to help. We put together this page with critical information to help answer your key questions about OSHA recordkeeping.

  • Safety Training 101

    When it comes to safety training, no matter the industry, there are always questions regarding requirements and certifications. We put together a guide that’s easy to digest so you can ensure you're complying with OSHA's training standards.

  • Conduct EHS Inspections and Audits

    Record and manage your organization’s inspection data with IndustrySafe’s Inspections module. IndustrySafe’s pre-built forms and checklists may be used as is, or can be customized to better suit the needs of your organization.

  • Track Key Safety Performance Indicators

    IndustrySafe’s Dashboard Module allows organizations to easily track safety KPIs and metrics. Gain increased visibility into your business’ operations and safety data.

  • Industry Safe
comments powered by Disqus