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HHS/FDA RIN: 0910-AH41 Publication ID: Fall 2016 
Title: ●Submission of Food and Drug Administration Import Data in the Automated Commercial Environment(Section 610 Review) 

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. 

Agency: Department of Health and Human Services(HHS)  Priority: Economically Significant 
RIN Status: First time published in the Unified Agenda Agenda Stage of Rulemaking: Final Rule Stage 
Major: No  Unfunded Mandates: No 
RFA Section 610 Review: Section 610 Review 
CFR Citation: None     (To search for a specific CFR, visit the Code of Federal Regulations.)
Legal Authority: Not Yet Determined   
Legal Deadline:  None
Action Date FR Cite
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 
Regulatory Flexibility Analysis Required: No  Government Levels Affected: Federal, Local, State 
Small Entities Affected: No  Federalism: No 
Included in the Regulatory Plan: No 
International Impacts: This regulatory action will be likely to have international trade and investment effects, or otherwise be of international interest.
RIN Data Printed in the FR: Yes 
Agency Contact:
Ann Marie Metayer
Senior Regulatory Counsel
Department of Health and Human Services
Food and Drug Administration
10903 New Hampshire Avenue, Building 32, Room 4338,
Silver Spring, MD 20993
Phone:301 796-3324