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  1. Economic Impact Analyses of FDA Regulations

Summary: Submission of FDA Import Data in the Automated Commercial Environment (Proposed Rule)

Pursuant to Executive Order 13569, the U.S. Customs and Border Protection (CBP) agency established a new Automated Commercial Environment (ACE) system that will replace the existing Automated Commercial System (ACS) currently used by CBP for import admissibility decisions.  The Food and Drug Administration (FDA, Agency, or we) is issuing a proposed rule to establish requirements for the entry of certain FDA-regulated products in ACE in order for an import filing to be accepted by CBP and to help FDA in determining admissibility.  

Regulatory Impact Analysis

Submission of FDA Import Data in the Automated Commercial Environment (Proposed Rule) (PDF - 387KB)

Federal Register: 81 FR 43155, July 1, 2016

Docket: FDA-2016-N-1487