Regulatory Counsel

0910-AH41 201610 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS Submission of Food and Drug Administration Import Data in the Automated Commercial Environment

The Food and Drug Administration (FDA, the Agency, or we) will establish requirements for the electronic filing of entries of FDA-regulated products in the Automated Commercial Environment (ACE) or any other electronic data interchange (EDI) system authorized by the U.S. Customs and Border Protection (CBP), in order for the filing to be processed by CBP and to help FDA in determining admissibility of that product.

]]> Economically Significant First Time Published in The Unified Agenda Final Rule Stage No No Section 610 Review None Not Yet Determined No ANPRM 07/01/2016 81 FR 43155 ANPRM Comment Period End 08/30/2016 Final Rule 11/00/2016 Final Rule Effective 12/00/2016 No No Federal Local State No No Yes Yes Ann Metayer Marie Regulatory Counsel 0910 Food and Drug Administration FDA 301 796-3324 ann.metayer@fda.hhs.gov 10903 New Hampshire Avenue, Building 32, Room 4375, Silver Spring MD 20993