Import

FDA Further Extends UFI Flexibility For Food Facility Registrations

Background on Food Facility Registration

The Federal Food, Drug, and Cosmetic Act (“FD&C”) requires domestic and foreign facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with the U.S. Food and Drug Administration (“FDA”). Additionally, the FDA Food Safety Modernization Act (“FSMA”) amended the food facility registration requirements in the  FD&C to require domestic and foreign facilities to submit certain additional new information to the FDA and renew their registrations every other year during the period beginning on October 1 and ending on December 31 of each even-numbered year.

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Anti-Circumvention, EAPA, Dumping Duties & the Spreadability of Cases

This one-hour webinar will provide an overview of AD/CVD, U.S. Customs and Border Protection’s enforcement actions and investigative process, as well as a review of EAPA regulations and provide insights on best practices to protect your company in this contentious area of U.S. Customs and Border Protection enforcement.

Background on EAPA

The Enforce and Protect Act of 2015 (EAPA) allows U.S. Customs and Border Protection (“CBP”) to investigate whether a company has evaded anti-dumping and countervailing (AD/CVD) duties in an on-the-record investigation. EAPA enforcement has increased considerably in recent years. In fact, in Fiscal Year 2020, CBP collected $287 million in duties via EAPA enforcement – this is a 500 percent increase since the beginning of the EAPA program in FY 2017.

On April 21, 2021 at 12:00 PM, Jennifer Diaz and David Craven will present a webinar on Anti-Circumvention/EAPA/Dumping Duties & the Spreadability of Cases.

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301 Exclusion Extensions for COVID-19 Related Products

On March 10, 2021, via Federal Register Notice ( 86 FR 13785), the United States Trade Representative (USTR) announced that 99 medical product exclusions will be extended from March 31, 2021, to September 30, 2021. This action extends a previous USTR action which extended these exclusions from December 31, 2020, to March 31, 2020 (85 FR 85831). […]

OTC Drug Manufacturers are Required to Pay FDA Facility User Fees by May 10, 2021

Co-Authored by Denise Calle.

On March 26, 2021, Food and Drug Administration (FDA) published the Federal Register Notice, “Fee Rates Under the Over-the-Counter Monograph Drug User Fee Program for Fiscal Year 2021,” announcing the OTC Monograph Drug user fee program fee rates for FY 2021. This is the first year FDA has expanded user fees to OTC Drug Manufacturers and submitters of OTC monograph order requests.

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Future of First Sale Rule in Question

On March 1, 2021, the Court of International Trade (CIT) denied Meyer Corporation’s claim for duty-free treatment under its attempted use of the first sale valuation and the Generalized System of Preferences (GSP), in Meyer Corporation, U.S. v. United States, Court No. 13-00154 (Meyer). This case sent a ripple through the trade-community as many speculate whether the decision signals an end of first sale for non-market countries.

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