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Federal Register Notices:

Recently, we provided an update on FDA-wide activities we are engaged in related to the novel coronavirus outbreak:  COVID-19. We continue to take a multi-pronged approach to this public health emergency, including focusing on actively facilitating efforts to diagnose, treat and prevent the disease; surveilling the medical product supply chain for potential shortages or disruptions and helping to mitigate such impacts, as necessary; and leveraging the full breadth of our public health tools, including enforcement tools to stop fraudulent activity as we oversee the safety and quality of FDA-regulated products for American patients and consumers. 

Today, we are providing updated and more detailed information about the status of FDA inspections in China and the agency’s oversight of imported products from China, which have been impacted by this outbreak. While we are not able to conduct inspections in China right now, this is not hindering our efforts to monitor medical products and food safety. We have additional tools we are utilizing to monitor the safety of products from China, and in the meantime, we continue monitoring the global drug supply chain by  prioritizing risk-based inspections in other parts of the world. The FDA is not currently conducting inspections in China in response to the U.S. Department of State’s Travel Advisory to not travel to China due to the novel coronavirus outbreak. We will continue to closely monitor the situation in China so that, when the travel advisory is changed, we will be prepared to resume routine inspections as soon as feasible.

We already use other tools to help complement our inspections, including import screening, examinations, sampling, and import alerts, relying on a firm’s previous compliance history, and we use information from foreign governments as part of mutual recognition agreements. Thus, at this time, we can rely on these other tools to give us comprehensive oversight of FDA-regulated products entering this country. This is all part of our agency’s risk-based approach to ensuring quality, as well as compliance with applicable FDA requirements.

It is important to reiterate that inspections are one of many tools that the agency uses to inform our risk strategy for imported FDA-regulated products and to help prevent products that do not meet the FDA’s standards from entering the U.S. market.  A wide variety of FDA-regulated products are imported from China, which makes it important to assure the public of the quality of these products. At this time, over 60% of FDA-regulated products imported from China are medical devices and 20% are housewares (like food packaging).  

In response to the COVID-19 outbreak, the FDA will utilize, where appropriate, our authority to request records from firms “in advance or in lieu of” drug surveillance inspections in China. The Federal Food, Drug, and Cosmetic Act, as amended by the FDA Safety and Innovation Act (FDASIA) of 2012, gives the FDA authority to request records “in advance of or in lieu of” on-site drug inspections. Congress enacted this provision to improve the effectiveness and efficiency of inspections, given the increasing globalization of drug production.  Along with other FDASIA provisions, this inspection record request authority was viewed as a way to “level the playing field” between foreign and domestic drug inspections by allowing the FDA to review records ahead of time and take a more risk-based approach to conducting both domestic and foreign inspections. These records will help the agency when we resume drug inspections in China. By applying the use of paper records in our risk-based inspection framework, we can prioritize our early inspections on those deemed most needed, based on the records . By doing so, we hope to rapidly assess what could become a backlog number of on-the-ground surveillance inspections this fiscal year if travel restrictions persist.

In addition to records requests, the FDA will continue working with U.S. Customs and Border Protection to target products intended for importation into the U.S. that violate applicable legal requirements for FDA-regulated products, which may come from a variety of sources, such as first time importers unfamiliar with regulatory requirements or repeat offenders trying to skirt the law. FDA has the ability through our risk-based import screening tool (PREDICT) to focus our examinations and sample collections based on heightened concerns of specific products being entered into U.S. commerce. The PREDICT screening continues to adjust risk scores as necessary throughout the COVID-19 outbreak.  We are keeping a close eye out for indications of port shopping or cargo diversion and will continue our oversight of shipments through potentially higher-risk venues such as International Mail Facilities. We can refuse admission of products that fail sample testing or may violate other applicable legal requirements.

Fortunately, currently, we are not seeing the impacts of this outbreak resulting in an increased public health risk for American consumers from imported products. There is no evidence to support transmission of COVID-19 associated with imported goods and there have not been any cases of COVID-19 in the United States associated with imported goods. As noted, this remains a dynamic situation and we will continue to assess, and update guidance as needed. 

We also continue to aggressively monitor the market for any firms marketing products with fraudulent COVID-19 prevention and treatment claims. The FDA can and will use every authority at our disposal to protect consumers from bad actors who would take advantage of a crisis to deceive the public, including pursuing warning letters, seizures, or injunctions against products on the market that are not in compliance with the law, or against firms or individuals who violate the law.

We know the public may have questions or concerns for the FDA as a result of this outbreak, including you and your family’s risk of exposure, or whether your critical medical products are safe and will continue to be available in the future. We assure you that the FDA is working around the clock to monitor and mitigate emerging coronavirus issues through collaborative efforts with U.S. regulators, international partners, and medical product developers and manufacturers to help advance response efforts to combat the COVID-19 outbreak. 


U.S. Department of Commerce Finds Dumping and Countervailable Subsidization of Imports of Wooden Cabinets and Vanities from China  - U.S. Customs & Border Protection

WASHINGTON – Today, the U.S. Department of Commerce announced affirmative final determinations in the antidumping duty (AD) and countervailing duty (CVD) investigations of imports of wooden cabinets and vanities from China. 

Commerce determined that producers and/or exporters from China have sold wooden cabinets and vanities at less than fair value in the United States at rates ranging from 4.37 percent to 262.18 percent. 

In addition, Commerce determined that producers and/or exporters from China received countervailable subsidies at rates ranging from 13.33 percent to 293.45 percent.
 
In 2018, imports of wooden cabinets and vanities from China were valued at an estimated $4.4 billion. 
 
The petitioner in this case is the American Kitchen Cabinet Alliance.
 
The strict enforcement of U.S. trade law is a primary focus of the Trump administration. Since the beginning of the current administration, Commerce has initiated 201 new AD and CVD investigations – this is a 172 percent increase from the comparable period in the previous administration.
 
AD and CVD laws provide American businesses and workers with an internationally accepted mechanism to seek relief from the harmful effects of unfair pricing of imports into the United States. Commerce currently maintains 516 AD and CVD orders which provide relief to American companies and industries impacted by unfair trade.
 
The U.S. International Trade Commission (ITC) is currently scheduled to make its final injury determinations on or about April 6. If the ITC makes affirmative final injury determinations, Commerce will issue AD and CVD orders. If the ITC makes negative final determinations of injury, the investigations will be terminated, and no orders will be issued.
 
Read the fact sheet on today’s decisions.
 
The U.S. Department of Commerce’s Enforcement and Compliance unit within the International Trade Administration is responsible for vigorously enforcing U.S. trade laws and does so through an impartial, transparent process that abides by international rules and is based on factual evidence provided on the record.
 
Foreign companies that price their products in the U.S. market below the cost of production or below prices in their home markets are subject to AD duties. Foreign companies that receive countervailable subsidies from their governments, such as grants, loans, equity infusions, tax breaks, or production inputs, are subject to CVD duties aimed at directly countering those subsidies.


Rules and Regulations Under the Textile Fiber Products Identification Act - Federal Trade Commission

AGENCY: Federal Trade Commission.

ACTION: Notice of proposed rulemaking.

SUMMARY: The Federal Trade Commission (‘‘FTC’’ or ‘‘Commission’’) proposes amending the Rules and Regulations under the Textile Fiber Products Identification Act (‘‘Textile Rules’’ or ‘‘Rules’’) to incorporate the most recent ISO 2076 standard for generic fiber names. The proposed amendment should reduce compliance costs and increase flexibility for firms providing textile fiber information to consumers. DATES: Written comments must be received on or before March 19, 2020.   

Federal Register Proposed Rule


FTC Sending More Than $34 Million in Refunds to Office Depot Customers - Federal Trade Commission

The Federal Trade Commission is sending refund checks totaling more than $34 million to consumers who allegedly were tricked by Office Depot, Inc. and a software provider into buying computer repair products and services.

Office Depot paid $25 million while its software supplier, Support.com, Inc., paid $10 million as part of 2019 settlements with the FTC. The FTC alleged that Office Depot and Support.com configured a virus scanning program to report that it found symptoms of malware or infections—even when that was not true—whenever consumers answered yes to at least one of four “diagnostic” questions. The false scan results were then used to persuade consumers to purchase computer repair and technical services that could cost hundreds of dollars.

The FTC is sending out 541,247 checks averaging $63.35 per check. Recipients should deposit or cash checks within 60 days, as indicated on the check. The FTC never requires people to pay money or provide account information to cash a refund check. If recipients have questions about the refunds, they should contact the FTC’s refund administrator, Epiq, at 1-855-915-0916.

The FTC’s new interactive dashboards for refund data provide a state-by-state breakdown of the Office Depot refunds, as well as refund programs from other FTC cases. In 2019, FTC actions led to more than $232 million in refunds to consumers across the country.


Miami Tire Importers Indicted for Excise Tax Conspiracy and Tax Evasion - Department of Justice

A federal grand jury returned an indictment yesterday charging the owners of a Miami, Florida, tire import business with conspiracy to defraud the government and tax evasion, announced Principal Deputy Assistant Attorney General Richard E. Zuckerman of the Justice Department’s Tax Division and U.S. Attorney Ariana Fajardo Orshan for the Southern District of Florida.

According to the indictment, Marco Parra and Eira Luces-Parra, a married couple, owned and operated Road Tire Plus Corp (Road Tire), a tire importer located in Miami, Florida. From 2013 through 2016, the Parras allegedly conspired with others in the tire industry to evade paying federal excise taxes on tires.

Truck tires marked for highway use are subject to excise taxes. A tire importer is liable for the excise tax when the truck tires are sold. Tire importers typically pass on the cost of the excise tax to the tire retailers, their customers, and collect the excise taxes from them. But if the tires are later exported rather than sold domestically, the law provides for a credit for the excise taxes paid.

From 2013 through 2016, the Parras sold taxable truck tires to various tire retailers in South Florida. According to the indictment, the Parras collected from some customers the excise taxes that were due, but did not remit those taxes to the Internal Revenue Service (IRS) and did not file tax returns reporting the tire sales as they were obligated to do.

For other customers, the Parras allegedly never collected the federal excise taxes due on the tire sales. Instead, the Parras allegedly obtained from these coconspirators false bills of lading claiming that the tires were exported, so that the Parras could obtain an excise tax credit even though they knew the tires were not exported. 

If convicted, the Parras face a maximum sentence of five years in prison for each count. They also face a period of supervised release, restitution, and monetary penalties.

An indictment merely alleges that crimes have been committed. The defendant is presumed innocent until proven guilty beyond a reasonable doubt. 

Principal Deputy Assistant Attorney General Zuckerman and U.S. Attorney Fajardo Orshan commended special agents of IRS-Criminal Investigation, who conducted the investigation, and Trial Attorney Mara Strier and Assistant Chief Greg Tortella of the Tax Division and Assistant U.S. Attorney Kevin Larsen, who are prosecuting the case.
 
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