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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)
Abstract: 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

Timetable:

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 Regulatory Counsel Department of Health and Human Services Food and Drug Administration 10903 New Hampshire Avenue, Building 32, Room 4375, Silver Spring, MD 20993 Phone:301 796-3324 Email: ann.metayer@fda.hhs.gov