CBP Ends Collection of FCC Import Data for Entry Filing, for Now
And
FDA: Guidance to Industry On Requirements for Prior Notice
of Imported Food (Edition 3)
And
Proposed Changes to Import Requirements And Aluminum
Extrusions from China: Notice of ITC Decision To
Conduct Full Five-Year Review


July 14, 2016

CBP Ends Collect of FCC Import Data

Effective July 1, 2016, FCC flags were removed to comply with the Federal Register Notice allowing the trade to be exempt from filing FCC data until the regulations are updated to no longer require the submission of FCC data on electronic entry summaries.

This requirement to file FCC data is based on the import date rather than the date of entry summary filing. If the import date is prior to July 1, 2016, the FCC data must still be provided on the entry summary. Imports after July 1, 2016 will not be required to supply FCC data.

Additionally, on July 23, 2016, system validations will be in place to reject any ACE transactions that include the OGA Message Set data, and modifications will be made to ACE to no longer require FCC data regardless of the import date since the OGA Message Set will no longer be accepted.

See Administrative Message CSMS# 16-000583 - Explanation of FCC Data Requirements for July, 2016.

FDA Action Prior Notice of Imported Food 

Separately, in June, the FDA announced the availability of a guidance for industry entitled “Prior Notice of Imported Food Questions and Answers (Edition 3): Guidance for Industry.” The guidance provides updated information pertaining to prior notice of imported food under the Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Food Safety Modernization Act (FSMA) on January 4, 2011. The guidance is intended to help the food industry and others comply with prior notice requirements. The guidance document may be accessed at either http://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/default.htm  or http://www.regulations.gov.

Submission of FDA Import Data in ACE

The FDA is soliciting comments on a 24-page proposal to establish requirements for electronic filing of entries of FDA-regulated products in the Automated Commercial Environment (ACE), or any other electronic data interchange (EDI) system for 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) and automate import and export processing. See 81 FR 43155, dated July 1, 2016 for proposed rule.

The proposed rule would add Subpart D to Part 1 of 21 CFR Chapter I to require that data elements be submitted in ACE or any other CBP authorized EDI system, at the time of entry in order to facilitate admissibility review by the Agency of FDA-regulated products being imported or offered for import into the United States.

The proposed rule would also make technical revisions to certain sections of 21 CFR Chapter I to update them, including:

  • Revise 21 CFR 1.83 and 21 CFR 1005.2 to update the definition of owner or consignee in order to make that definition consistent with Title 19 of the U.S. Code.
  • Revise 21 CFR 1.90 to allow FDA to provide notice of sampling directly to an owner or consignee.
  • Revise 21 CFR 1.94 to clarify that written notice can be provided electronically by FDA to owners or consignees of FDA actions to detain, refuse, and/or subject certain products to administrative destruction. Under § 1.94, owners or consignees will receive notice that FDA intends to take a certain action against an FDA regulated product that is being imported or offered for import and the owner or consignee will have an opportunity to introduce testimony to the Agency in opposition to such action.
  • Amend 21 CFR 1271.420 to make clear that, unless otherwise exempt, importers of record of human cells, tissues and cellular and tissue based products (HCT/Ps) that are regulated solely under section 361 of the Public Health Service Act (42 U.S.C. 264) and 21 CFR part 1271 would be required to submit the applicable data elements included in the proposed rule in ACE. 

Comments on the proposed rule are due by August 30, 2016.

Aluminum Extrusions from China

On July 13, 2016, the International Trade Commission published notice of intention to proceed with a full review to determine whether revocation of the antidumping and countervailing duty orders on certain aluminum extrusions would be likely to lead to continuation or recurrence of material injury within a reasonably foreseeable time. A schedule for the reviews will be established and announced at a later date.

Interested parties, including importers of Aluminum Extrusions and exporters can participate in these proceedings. FOR FURTHER INFORMATION CONTACT Edward Petronzio (202) 205-3176, Office of Investigations, U.S. International Trade Commission, 500 E Street SW., Washington, DC 20436.

Other July notices on Antidumping can be found at:  https://www.federalregister.gov/international-trade-anti-dumping-

If you have any questions about these or other customs matters, please contact George R. Tuttle, III at george.tuttle.iii@tuttlelaw.com or at (415) 986-8780.

George R. Tuttle, III is an attorney with the Law Offices of George R. Tuttle in the San Francisco Bay Area.

The information in this article is general in nature, and is not intended to constitute legal advice or to create an attorney-client relationship with respect to any event or occurrence, and may not be considered as such.

Copyright © 2016 by Tuttle Law Offices.  

All rights reserved.  Information has been obtained from sources believed to be reliable.  However, because of the possibility of human or mechanical error by our offices or by others, we do not guarantee the accuracy, adequacy, or completeness of any information and are not responsible for any errors, omissions, or for the results obtained from the use of such information.

 

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