United States Government Publishing Office publisher pbl distributor dst United States National Archives and Records Administration Office of the Federal Register author aut Government Organization text government publication eng FR Regulatory Information 2016_register executive 2016-07-14 article Proposed Rules D09002ee1c7f5e72d D09002ee1c7f5e7b8 United States Department of Health and Human Services originator org United States Government Agency or Subagency United States Food and Drug Administration originator org United States Government Agency or Subagency The Food and Drug Administration (FDA, the Agency, or we) is proposing to 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 Agency (CBP), in order for the filing to be processed by CBP and to help FDA in determining admissibility of that product. ACE is a commercial trade processing system operated by CBP that is designed to implement the International Trade Data System (ITDS), automate import and export processing, enhance border security, foster U.S. economic security through lawful international trade and policy, and to replace the Automated Commercial System (ACS). FDA is a Partner Government Agency (PGA) in the initiative to establish ITDS, the "single window" for the submission of import and export data to the United States Government. The proposed rule would also update certain sections of FDA regulations related to imports. This rule, as proposed, does not affect the ability of filers to continue to submit their import entries and entry summaries by paper for FDA-regulated products that are being imported or offered for import. Once finalized, this action will facilitate effective and efficient admissibility review by the Agency and protect public health by allowing FDA to focus its limited resources on those FDA-regulated products being imported or offered for import that may be associated with a greater public health risk. 81 FR 43155 https://www.govinfo.gov/app/details/FR-2016-07-01/2016-15684 2016-15684 fr01jy16-42 4164-01-P Docket No. FDA-2016-N-1487 https://www.govinfo.gov/app/details/FR-2016-07-01/2016-15684 https://www.govinfo.gov/content/pkg/FR-2016-07-01/html/2016-15684.htm https://www.govinfo.gov/content/pkg/FR-2016-07-01/pdf/2016-15684.pdf Cosmetics Drugs Exports Food Labeling Imports Labeling Reporting and Recordkeeping Requirements Administrative Practice and Procedure Electronic Products Radiation Protection Surety Bonds Biologics Human Cells and Tissue-Based Products Medical Devices 24 p. 43155 43178 81 FR 43155 Title 21 Part 1005 21 CFR Part 1005 Title 21 Part 1271 21 CFR Part 1271 Title 21 Part 1 21 CFR Part 1 Submission of Food and Drug Administration Import Data in the Automated Commercial Environment; Federal Register Vol. 81, Issue PRORULE 2016-15684 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 2016-08-30 Docket No. FDA-2016-N-1487 4164-01-P 2016-15684 Proposed rule.

The Food and Drug Administration (FDA, the Agency, or we) is proposing to 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 Agency (CBP), in order for the filing to be processed by CBP and to help FDA in determining admissibility of that product. ACE is a commercial trade processing system operated by CBP that is designed to implement the International Trade Data System (ITDS), automate import and export processing, enhance border security, foster U.S. economic security through lawful international trade and policy, and to replace the Automated Commercial System (ACS). FDA is a Partner Government Agency (PGA) in the initiative to establish ITDS, the "single window" for the submission of import and export data to the United States Government. The proposed rule would also update certain sections of FDA regulations related to imports. This rule, as proposed, does not affect the ability of filers to continue to submit their import entries and entry summaries by paper for FDA-regulated products that are being imported or offered for import. Once finalized, this action will facilitate effective and efficient admissibility review by the Agency and protect public health by allowing FDA to focus its limited resources on those FDA-regulated products being imported or offered for import that may be associated with a greater public health risk.

Submit either electronic or written comments on the proposed rule by August 30, 2016. Ann M. Metayer, Office of Regulatory Affairs, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 4338, Silver Spring, MD 20993-0002, 301-796-3324, Ann.Metayer@fda.hhs.gov. Cosmetics Drugs Exports Food Labeling Imports Labeling Reporting and Recordkeeping Requirements Administrative Practice and Procedure Electronic Products Radiation Protection Surety Bonds Biologics Human Cells and Tissue-Based Products Medical Devices Submission of Food and Drug Administration Import Data in the Automated Commercial Environment , Ann.Metayer@fda.hhs.gov Jonnalynn.Capezzuto@fda.hhs.gov oira_submission@omb.eop.gov http://www.accessdata.fda.gov/SCRIPTS/ORA/PCB/PCB.HTM http://www.cbp.gov/trade/acs/catair http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm http://www.fda.gov/AnimalVeterinary/DevelopmentApprovalProcess/MinorUseMinorSpecies/ucm125452.htm http://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm490264.pdf http://www.fda.gov/downloads/ForIndustry/ImportProgram/UCM459926.pdf http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm309376.htm http://www.fda.gov/forindustry/importprogram/entryprocess/entrysubmissionprocess/ucm461234.htm http://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf http://www.regulations.gov https://www.accessdata.fda.gov/scripts/cber/CFAppsPub/tiss/index.cfm Vol. 81, no. 127 Office of the Federal Register, National Archives and Records Administration 2016-07-01 continuing daily deposited born digital 490 p. Table of Contents: AE 2.7: GS 4.107: AE 2.106: KF70.A2 https://www.govinfo.gov/app/details/FR-2016-07-01 P0b002ee190426857 0097-6326 0042-1219 0364-1406 769-004-00000-9 000582072 f:fr01jy16 https://www.govinfo.gov/app/details/FR-2016-07-01 https://www.govinfo.gov/content/pkg/FR-2016-07-01/pdf/FR-2016-07-01.pdf https://www.govinfo.gov/content/pkg/FR-2016-07-01/xml/FR-2016-07-01.xml fdlp 42983 43461 DGPO 2016-07-14 2024-06-01 FR-2016-07-01 machine generated eng FR FR-2016-07-01 81 127