The Daily Bugle Weekly Highlights: Week 13 (23-27 March 2020)

Every Monday we post the highlights out of last week’s FCC Export/Import Daily Update (“The Daily Bugle”). Send out every business day to approximately 8,000 readers of changes to defense and high-tech trade laws and regulations, The Daily Bugle is a free daily newsletter from Full Circle Compliance, edited by James E. Bartlett III, Alexander Witt, Salvatore Di Misa, and Elina Tsapouri.

We check the following sources daily: Federal Register, Congressional Record, Commerce/AES, Commerce/BIS, DHS/CBP, DOE/NRC, DOJ/ATF, DoD/DSS, DoD/DTSA, FAR/DFARS, State/DDTC, Treasury/OFAC, White House, and similar websites of Australia, Canada, U.K., and other countries and international organizations.  Due to space limitations, we do not post Arms Sales notifications, Denied Party listings, or Customs AD/CVD items. To subscribe, click here.

Last week’s highlights of The Daily Bugle included in this edition are:

 

1. USTR: Response to Coronavirus Crisis; The Daily Bugle; Monday, 23 March 2020; Item #6.
2. DHS/FDA: “Information for Filing Personal Protective Equipment and Medical Devices During COVID-19”; The Daily Bugle; Tuesday, 24 March 2020; Item #3.
3. USTR Removes Additional Duties of China From Medial-Care to Address the COVID-19 Outbreak; The Daily Bugle, Wednesday, 25 March 2020; Item #1.
4. DHS/CBP Postpones April’s 2020 Customs Broker’s License Examination; The Daily Bugle, Thursday, 26 March; Item #1.
5. DHS/CBP: “Update to the AESTIR Appendix D Export Port Codes”; The Daily Bugle; Friday, 27 March 2020; Item # 4.

 

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USTR: Response to Coronavirus Crisis

(Source: US Trade Representative, 20 Mar 2020)

 

Washington, DC – Throughout the process of administering its Section 301 action to combat China’s acts, policies and practices related to technology transfer, intellectual property, and innovation, the United States has prioritized health considerations, and it is taking additional action for that objective today.

In imposing tariffs on goods from China as part of the Section 301 action, the United States determined to not impose tariffs on certain critical products such as ventilators, oxygen masks, and nubilators.  In addition, over the past year, USTR granted exclusions for a large number of health-related products.  Notably, the imposition of tariffs on certain Chinese imports has not resulted in an overall decline in the availability of needed medical equipment and supplies.  In fact, U.S. imports in 2019 of all critical medical and pharmaceutical products were up over 20 percent since 2017, before Section 301 tariffs were imposed.

Prior to the coronavirus outbreak, USTR and the Department of Health and Human Services worked together to ensure that critical medicines and other essential medical products were not subject to additional Section 301 tariffs, including parts needed for MRI devices, combined PET/CT scanners, certain radiation therapy equipment, air purification equipment, and parts of homecare beds; sterile electrosurgical tools; digital clinical thermometers; and more.

Today, in an effort to keep current on developments in our national fight against the coronavirus pandemic, USTR has opened a docket for members of the public, businesses, and government agencies to submit comments if they believe further modifications to the 301 tariffs may be necessary.  This comment process does not replace the current exclusion process and supplements that process.  Submissions are limited to comments on products subject to the tariff actions and relevant to the medical response to the coronavirus.

Interested parties wishing to provide comments can do so here.

 

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DHS/FDA: “Information for Filing Personal Protective Equipment and Medical Devices During COVID-19”

(Source: DHS/FDA, 23 Mar 2020)

 

The U.S. Food and Drug Administration is providing instruction to the import community regarding the submission of entry information for personal protective equipment and certain other devices. Following the instructions below will help facilitate the import process for all; especially for products related to the Coronavirus Disease-2019 (COVID-19) public health emergency. It is in the best interest of the U.S. to facilitate and expedite the importation of products into the U.S. market that address immediate, urgent public health needs.

For further information regarding entry submission requirements, see the FDA Supplemental Guidance for ACE

1. Non-FDA-regulated general purpose personal protective equipment (masks, respirators, gloves, etc.):

Personal protective equipment for general purpose or industrial use (that is, products that are not intended for use to prevent disease or illness) is not regulated by FDA.

For these types of products, entry information should not be transmitted to FDA. At the time of entry for these products, Importers should transmit entry information to US Customs and Border Protection (CBP) using an appropriate HTS code with no FD Flag; or using an appropriate HTS code with an FD1 flag and do a ‘disclaim’ for FDA.

2. Products authorized for emergency use pursuant to an Emergency Use Authorization (EUA)

When importing such products, entry information should be submitted to FDA; however reduced FDA information is required for review.

At the time of entry, Importers should transmit an Intended Use Code of 940.000: Compassionate Use/Emergency Use, and an appropriate FDA product code.

Below is a list of products and the appropriate product codes that are currently authorized by an EUA:

• Diagnostic tests: QPK, OTG, QKO, QJR
• Masks/Respirators: NZJ

Questions regarding appropriate product coding can be submitted to FDA at: COVID19FDAIMPORTINQUIRIES@fda.hhs.gov.

Requests for Emergency Use Authorization can be submitted to FDA at: CDRH-EUA-Templates@fda.hhs.gov (for diagnostic devices) and CDRH-NonDiagnosticEUA-Templates@fda.hhs.gov(for non-diagnostic devices)

3. Products regulated by FDA as a device, not authorized by an EUA, but where an enforcement discretion policy has been published in guidance.

When importing such devices, entry information should be submitted to FDA.

At the time of entry, Importers should transmit an Intended Use Code of 081.006: Enforcement discretion per final guidance, and an appropriate FDA product code.

Below is a listing of guidance documents that have been issued for specific products related to COVID-19, which contain product codes within the scope of each guidance:

• Non-Invasive Remote Monitoring Devices
• Ventilators and Accessories and Other Respiratory Devices

A full list of all guidance documents related to COVID-19 is also available on FDA’s website.

All questions regarding these instructions, or to resolve entry issues for shipments can be submitted to FDA at: COVID19FDAIMPORTINQUIRIES@fda.hhs.gov or 301-796-0356.

Check Updates on CSMS

 

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USTR Removes Additional Duties of China From Medial-Care to Address the COVID-19 Outbreak

(Source: Federal Register, 25 Mar 2020) [Excerpts]

 

85 FR 16987: Request for Comments on Additional Modifications to the 301 Action To Address COVID–19: China’s Acts, Policies, and Practices Related to Technology Transfer, Intellectual Property, and Innovation

* AGENCY: Office of the United States Trade Representative.

* ACTION: Notice and request for Comments

* SUMMARY: In prior notices, the U.S. Trade Representative has modified the action in the Section 301 investigation of China’s acts, policies, and practices related to technology transfer,

intellectual property, and innovation by removing additional duties from medical-care products needed to address the COVID–19 outbreak. In light of ongoing developments, the Office of the U.S. Trade Representative (USTR) is requesting public comments on possible further modifications to remove duties

from additional medical-care products.

* DATES: The docket for comments will remain open at least until June 25, 2020, and may be extended as appropriate. To facilitate timely consideration of possible modifications, interested parties should submit comments as promptly as possible. To be assured of consideration, any responses to comments should be submitted within three business days after a comment is posted in the docket.

 

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DHS/CBP Postpones April’s 2020 Customs Broker’s License Examination

(Source: Federal Register, 26 Mar 2020)

 

85 FR 17091-17092: Postponement of the April 2020 Customs Broker’s License Examination

* AGENCY: U.S. Customs and Border Protection, Department of Homeland Security.

* ACTION: General notice.

* SUMMARY: This document announces that U.S. Customs and Border Protection (CBP) has postponed the customs broker’s license examination scheduled for April 1, 2020. The examination is postponed due to the unprecedented situation related to the coronavirus (COVID-19), which is having a nationwide impact on CBP’s ability to conduct the examination.

* DATES: The customs broker’s license examination scheduled for April 1, 2020 is postponed.

* FOR FURTHER INFORMATION CONTACT: Randy Mitchell, Director, Commercial Operations, Revenue and Entry, Office of Trade, 1-202-325-6532, or brokermanagement@cbp.dhs.gov.

 

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DHS/CBP: “Update to the AESTIR Appendix D Export Port Codes”

(Source: DHS/CBP, 26 Mar 2020)

 

The following Port of Export Codes have been deactivated and will no longer be allowed in new Electronic Export Information (EEI) submissions. They have also been removed from the AESTIR Appendix D Export Port Codes.

The following facilities are no longer operable.

Port of Export Code            Description

2770                                       DHL, RIVERSIDE, CA

2870                                       DHL, SAN FRANCISCO, CA

3295                                       UPS, HONOLULU, HI

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