U.S. Department of the Treasury’s Office of Foreign Assets Control (OFAC)

• The U.S. Department of the Treasury’s Office of Foreign Assets Control (OFAC) is publishing the names of one or more persons that have been placed on OFAC’s List of Specially Designated Nationals and Blocked Persons (SDN List) based on OFAC’s determination that one or more applicable legal criteria were satisfied. 
• OFAC is publishing the names of one or more persons that have been placed on OFAC’s Specially Designated Nationals and Blocked Persons List (SDN List) based on OFAC’s determination that one or more applicable legal criteria were satisfied. 
• OFAC is publishing the names of one or more persons that have been placed on OFAC’s Specially Designated Nationals and Blocked Persons List (SDN List) based on OFAC’s determination that one or more applicable legal criteria were satisfied.
• OFAC is publishing the names of one or more persons that have been placed on OFAC’s Specially Designated Nationals and Blocked Persons List (SDN List) based on OFAC’s determination that one or more applicable legal criteria were satisfied.
•  On November 26th, the Unitary Platform and the Maduro regime announced the resumption of talks in Mexico City; a humanitarian agreement focused on education, health, food security, flood response, and electricity programs that will benefit the Venezuelan people; and agreement on the continuation of talks focused on the 2024 elections. Following this announcement and consistent with U.S. government policy, OFAC issued Venezuela General License (GL) 41, authorizing Chevron Corporation to resume limited natural resource extraction operations in Venezuela.
• OFAC is issuing Venezuela-related General License 8K, “Authorizing Transactions Involving Petróleos de Venezuela, S.A. (PdVSA) Necessary for the Limited Maintenance of Essential Operations in Venezuela or the Wind Down of Operations in Venezuela for Certain Entities” and Venezuela-related General License 41, “Authorizing Certain Transactions Related to Chevron Corporation’s Joint Ventures in Venezuela”.  Additionally, OFAC is issuing two new Venezuela-related Frequently Asked Questions (FAQs 1098 and 1099).
• OFAC announced a settlement with Payward, Inc. d/b/a Kraken, a Delaware-incorporated virtual currency exchange with operations in the United States and elsewhere.  Kraken agreed to remit $362,158.70 to settle its potential civil liability for apparent violations of sanctions against Iran. 

U.S. International Trade Commission (USITC) 

• The U.S. International Trade Commission (USITC) has received a complaint entitled Certain Location-Sharing Systems, Related Software, Components Thereof, and Products Containing Same, DN 3655; the Commission is soliciting comments on any public interest issues raised by the complaint or complainant’s filing pursuant to the Commission’s Rules of Practice and Procedure.
• USITC has determined to review in part the final initial determination issued by the presiding chief administrative law judge  on September 9, 2022. The Commission requests briefing from the parties on certain issues under review, as indicated in this notice.
• USITC has determined to review in part the final initial determination issued by the presiding chief administrative law judge on September 9, 2022. The Commission requests briefing from the parties on certain issues under review, as indicated in this notice.
• USITC as received a complaint entitled Certain Cabinet X-ray and Optical Camera Systems and Components Thereof, DN 3656; the Commission is soliciting comments on any public interest issues raised by the complaint or complainant’s filing pursuant to the Commission’s Rules of Practice and Procedure.

U.S. Department of State (DOS)

• The Department of State (DOS) has submitted the information collection described below to the Office of Management and Budget (OMB) for approval. In accordance with the Paperwork Reduction Act of 1995 we are requesting comments on this collection from all interested individuals and organizations. The purpose of this Notice is to allow 30 days for public comment.

U.S. Consumer Product Safety Commission (CPSC)

• The U.S. Consumer Product Safety Commission (CPSC) has determined that there is an unreasonable risk of injury and death, particularly to children, associated with clothing storage units (CSUs) tipping over. To address this risk, the Commission is issuing a rule regarding the stability of CSUs. 

Department of Commerce (DOC)

• The Department of Commerce (DOC) updated two limits for the European Union Steel Tariff Rate Quota (TRQ) Program effective November 30, 2022 to align with production capabilities in Germany and Luxembourg. The effected steel HTS is 7301.10.0000 “Sheet Piling” under Chapter 99 HTS 9903.81.13. The quantity formerly listed for Country of Origin Germany has been reassigned to the quota limit for Country of Origin Luxembourg effective November 30, 2022.

United States Trade Representative (USTR)

• The U.S. Trade Representative  (USTR) modified the actions in the Section 301 investigation of China’s acts, policies, and practices related to technology transfer, intellectual property, and innovation by excluding from additional duties certain medical-care products needed to address COVID, and subsequently extended certain of these exclusions. The current COVID exclusions — covering 81 medical-care products — are scheduled to expire on November 30, 2022. This notice announces the U.S. Trade Representative’s determination to further extend the 81 COVID exclusions for an additional three months.
•  USTR announced the United States and United Kingdom jointly hosted the 6^th U.S.-UK Small- and Medium-Sized (SME) Dialogue yesterday, bringing together business representatives from both sides of the Atlantic to identify ways to expand bilateral trade and investment and to enhance broad and inclusive SME participation in that trade and investment.

U.S. Customs and Border Protection (CBP) 

• U.S. Customs and Border Protection (CBP) personnel at all U.S. ports of entry will detain raw sugar and sugar-based products produced in the Dominican Republic by Central Romana Corporation Limited. CBP issued a Withhold Release Order (WRO) against Central Romana based on information that reasonably indicates the use of forced labor in its operations.
  • CBP identified five of the International Labour Organization’s 11 indicators of forced labor during its investigation:  abuse of vulnerability, isolation, withholding of wages, abusive working and living conditions, and excessive overtime.
• CBP released a reminder for transportation carrier companies that transact with CBP’s ACE systems to please pay the Annual SCAC Code Renewal fee for this year (2022) by Monday, December 5th, to the National Motor Freight Traffic Association (NMFTA) if you have not done so already.  The NMFTA SCAC Code Renewal web link is SCAC Renewal and Application Wizard (nmfta.org).  If you have any questions about the renewal, please email customerservice@nmfta.org

Ocean Energy Management Bureau 

• The Bureau of Ocean Energy Management (BOEM) will open and publicly announce bids received for blocks offered in the Cook Inlet Planning Area Outer Continental Shelf Oil and Gas Lease Sale 258 (Cook Inlet Sale 258), in accordance with the provisions of the Outer Continental Shelf Lands Act (OCSLA), as amended, and its implementing regulations.

U.S. Department of  Energy (DOE)

• The U.S. Department of Energy (DOE) announces the availability of the preliminary analysis it has conducted for purposes of evaluating the need for amended energy conservation standards for non-weatherized oil-fired furnaces (NWOFs), mobile home oil-fired furnaces (MHOFs‘), weatherized gas furnaces (WGFs), weatherized oil-fired furnaces (WOFs‘), and electric furnaces (EFs).

U.S. Department of Agriculture (USDA) 

• The United States Department of Agriculture’s (USDA) electronic system for propagative shipment processing will be offline for routine service maintenance, starting Friday, December 2, 2022, beginning at 6:00 p.m. EST, until Saturday, December 3, 2022, at 7:00 p.m. EST.
  • To ensure expedited agriculture clearance of propagative shipments during this time, we recommend the following:
    • For shipments requiring clearance on Saturday December 3, please contact the USDA plant inspection station that you currently work with regarding propagative shipments. This will avoid delays and ensure that all relevant information is available to conduct clearance activities. All shipments will be inspected per normal procedures; however, the document review, sample selection, and cargo release will take place outside of the system and will be processed electronically after the system is back online.

If you have questions about these updates, contact our Diaz Trade Law attorneys at info@diaztradelaw.com or call us at 305-456-3830.

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• African Growth and Opportunity Act (AGOA) Textile Certificate of Origin
  • The African Growth and Opportunity Act (AGOA) was adopted by the U.S. with the enactment of the Trade and Development Act of 2000 (Pub. L. 106–200). The objectives of AGOA are (1) to provide for extension of duty-free treatment under the Generalized System of Preferences (GSP) to import sensitive articles normally excluded from GSP duty treatment, and (2) to provide for the entry of specific textile and apparel articles free of duty and free of any quantitative limits from eligible countries of sub-Saharan Africa.
  • For preferential treatment of textile and apparel articles under AGOA, the exporter or producer is required to prepare a certificate of origin and provide it to the importer. The certificate of origin includes information such as name and address of the exporter, producer, and importer; the basis for which preferential treatment is claimed; and a description of the imported article(s). The importers are required to have the certificate in their possession at the time of the claim, and to provide it to Customs and Border Protection (CBP) upon request. The collection of this information is provided for in 19 CFR 10.214, 10.215, and 10.216.
  • CBP invites the general public and other Federal agencies to comment on the proposed and/or continuing information collections pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). This proposed information collection was previously published in the Federal Register (87 FR 37881) on June 24, 2022, allowing for a 60-day comment period. This notice allows for an additional 30 days for public comments. This process is conducted in accordance with 5 CFR 1320.8.
  • Written comments and suggestions from the public and affected agencies should address one or more of the following four points: (1) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) suggestions to enhance the quality, utility, and clarity of the information to be collected; and (4) suggestions to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. The comments that are submitted will be summarized and included in the request for approval. All comments will become a matter of public record.
• Accreditation of Commercial Testing Laboratories and Approval of Commercial Gaugers
  • Commercial laboratories seeking to become a Customs and Border Protection (CBP) Accredited Laboratory and commercial gaugers seeking to become a CBP Approved Gauger must submit the information specified in 19 CFR 151.12 and 19 CFR 151.13, respectively, to CBP on CBP Form 6478. After the initial accreditation and/or approval, a private company may apply to include additional facilities under its accreditation and/or approval by submitting a formal written request to CBP. This application process is authorized by Section 613 of Public Law 103–182 (North American Free Trade Agreement Implementation Act), codified at 19 U.S.C. 1499(b), which directs CBP to establish a procedure to accredit privately owned testing laboratories. The information collected is used by CBP in deciding whether to approve individuals or businesses desiring to measure bulk products or to analyze importations.
  • U.S. Customs and Border Protection (CBP) invites the general public and other Federal agencies to comment on the proposed and/or continuing information collections pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). This proposed information collection was previously published in the Federal Register (87 FR 39107) on June 30, 2022, allowing for a 60-day comment period. This notice allows for an additional 30 days for public comments. This process is conducted in accordance with 5 CFR 1320.8.
  • Written comments and suggestions from the public and affected agencies should address one or more of the following four points: (1) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) suggestions to enhance the quality, utility, and clarity of the information to be collected; and (4) suggestions to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. The comments that are submitted will be summarized and included in the request for approval. All comments will become a matter of public record.
• Cargo Container and Road Vehicle Certification for Transport Under Customs Seal
  • The United States is a signatory to several international Customs conventions governing cargo container and road vehicle certification procedures that specify the technical requirements that containers and road vehicles must meet to be acceptable for transport under Customs seal. U.S. Customs and Border Protection (CBP) has the responsibility of administering the procedures within Title 19, Part 115 for the purpose of certifying U.S.-manufactured containers and road vehicles for use in international transport under Customs seal. The certification process involves container and road vehicle manufacturers, owners, or operators submitting applications for approval to the certifying authorities (the entities designated in 19 CFR 115.6: The American Bureau of Shipping; International Cargo Gear Bureau, Inc.; The National Cargo Bureau, Inc.). Applications to request certification approvals from the above-mentioned certifying authorities are submitted directly to these organizations on the appropriate forms (i.e., that are created by the organizations themselves).
  • The certification process is voluntary for manufacturers, and therefore Part 115 does not require certification of said container and road vehicles. A certification of compliance facilitates the efficient movement of containers and road vehicles across international territories. The procedures for obtaining a certification of a container or vehicle are set forth in 19 CFR part 115.
  • CBP invites the general public and other Federal agencies to comment on the proposed and/or continuing information collections pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). This proposed information collection was previously published in the Federal Register (87 FR 34895) on June 8, 2022, allowing for a 60-day comment period. This notice allows for an additional 30 days for public comments. This process is conducted in accordance with 5 CFR 1320.8. Written comments and suggestions from the public and affected agencies should address one or more of the following four points: (1) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) suggestions to enhance the quality, utility, and clarity of the information to be collected; and (4) suggestions to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. The comments that are submitted will be summarized and included in the request for approval. All comments will become a matter of public record.
• Protest (CBP Form 19)
  • U.S. Customs and Border Protection (CBP) Form 19, Protest, is filed to seek the review of a CBP decision. This review may be conducted by CBP personnel who participated directly in the underlying decision. This form is also used to request ‘‘Further Review,’’ which means a request for review of the protest to be performed by CBP personnel who did not participate directly in the protested decision or by the Commissioner, or his designee, as provided in the CBP regulations. The matters that may be protested include: the appraised value of merchandise; the classification and rate and amount of duties chargeable; all charges within the jurisdiction of the Secretary of Homeland Security or the Secretary of the Treasury; exclusion of merchandise from entry or delivery, or demand for redelivery; the liquidation or reliquidation of an entry or any modification of an entry; the refusal to pay a claim for drawback; refusal to reliquidate an entry made before December 18, 2004 under section 520(c) of the Tariff Act of 1930; or refusal to reliquidate an entry under section 520(d) of the Tariff Act of 1930. The parties who may file a protest or application for further review include: the importer or consignee shown on the entry papers, or their sureties; any person paying any charge or exaction; any person seeking entry or delivery, with respect to a determination of origin under 19 CFR 181 Subpart G any exporter or producer of the merchandise subject to that determination, if the exporter or producer completed and signed a Certification of Origin covering the merchandise as provided for in 19 CR 181.11(a); of any person filing a claim for drawback; or any authorized agent of any of the persons described above.
  • CBP Form 19 collects information such as the name and address of the protesting party, information about the entry being protested, detailed reasons for the protest, and justification for applying for further review.
  • CBP invites the general public and other Federal agencies to comment on the proposed and/or continuing information collections pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). This proposed information collection was previously published in the Federal Register (87 FR 34894) on June 8, 2022, allowing for a 60-day comment period. This notice allows for an additional 30 days for public comments. This process is conducted in accordance with 5 CFR 1320.8. Written comments and suggestions from the public and affected agencies should address one or more of the following four points: (1) whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) suggestions to enhance the quality, utility, and clarity of the information to be collected; and (4) suggestions to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. The comments that are submitted will be summarized and included in the request for approval. All comments will become a matter of public record.
• Administrative Rulings
  • The collection of information in 19 CFR part 177 is necessary in order to enable Customs and Border Protection (CBP) to respond to requests by importers and other interested persons for the issuance of administrative rulings. These rulings pertain to the interpretation of applicable laws related to prospective and current or completed transactions involving, but not limited to classification, marking, valuation, carrier, and country of origin. The collection of information in Part 177 of the CBP Regulations is also necessary to enable CBP to make proper decisions regarding the issuance of binding rulings that modify or revoke prior CBP binding rulings. This collection of information is authorized by 5 U.S.C. 301, 19 U.S.C. 66, 1202, (General Note 3(i), Harmonized Tariff Schedule of the United States), 1502, 1624, 1625. The application to obtain an administrative ruling is accessible at: https://erulings.cbp.gov/s/ or the public can submit a ruling request by mail (or email).
  • CBP invites the general public and other Federal agencies to comment on the proposed and/or continuing information collections pursuant to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.). This proposed information collection was previously published in the Federal Register (87 FR 35563) on June 10, 2022, allowing for a 60-day comment period. This notice allows for an additional 30 days for public comments. This process is conducted in accordance with 5 CFR 1320.8. Written comments and suggestions from the public and affected agencies should address one or more of the following four points: (1) whether the proposed collection of is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) suggestions to enhance the quality, utility, and clarity of the information to be collected; and (4) suggestions to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. The comments that are submitted will be summarized and included in the request for approval. All comments will become a matter of public record.
• Ajmal Steel Tubes & Pipes Industries v. United States
  • This action is a challenge to the final determination made by the United States Department of Commerce (“Commerce”) in the periodic review of the antidumping (“AD”) order for carbon-quality pipe from the United Arab Emirates (“UAE”) covering the period from December 1, 2018, through November 30, 2019.
  • Plaintiff requests that the court hold aspects of Commerce’s final determination unsupported by substantial evidence or otherwise not in accordance with law. The United States (“Government”) asks that the court sustain Commerce’s final determination.
  • Ajmal Steel Tubes & Pipes Ind. LLC (“Ajmal”) is a producer of carbon-quality pipe from the UAE. Since 2016, this product has been subject to an AD order. On March 3, 2020, Commerce selected Ajmal and Universal Tube and Plastic Industries, Ltd. (“Universal”) as mandatory respondents for an administrative review of the anti-dumping order and issued questionnaires with the Section A responses due March 24, 2020. Subsequently, Ajmal submitted an extension of time request (“EOT”) on March 19, 2020, and another EOT on April 3, 2020, for delays “due to the COVID-19 global pandemic.”
  • The Court held that Commerce abused its discretion in denying Ajmal’s First Request for Reconsideration. The Court remanded to Commerce to accept and consider Ajaml’s Section A filing and complete the review.

United States Department of Commerce (DOC)

• The U.S. Department of Commerce (DOC) determines that carbon and alloy steel threaded rod (steel threaded rod) from India is not being sold in the United States at below normal value.  
•  As a result of the respective determinations by the DOC and the U.S. International Trade Commission (ITC) that termination of the 2016 Agreement Suspending the Antidumping Duty Investigation on Lemon Juice from Argentina (2016 Agreement) and the underlying antidumping duty investigation on lemon juice from Argentina would likely lead to continuation or recurrence of dumping 
• The DOC preliminarily finds that Hangzhou Ailong Metal Products Co., Ltd. (Ailong) made sales of subject merchandise at prices below normal value (NV) 
• On July 29, 2022, the DOC published the preliminary results of the changed circumstances review (CCR) of the antidumping duty (AD) order on multilayered wood flooring (MLWF) from the People’s Republic of China (China). 
• The DOC published a notice in the Federal Register on August 2, 2022, for the preliminary results and partial recission of the 2020–2021 administrative review of the antidumping duty order on certain pasta (pasta) from Italy 
• The DOC preliminarily finds that large power transformers from the Republic of Korea were not sold in the United States at less than normal value during the period of review (POR), August 1, 2020, through July 31, 2021. 
• The DOC preliminarily determines that certain preserved mushrooms (preserved mushrooms) from France are being, or are likely to be, sold in the United States at less than fair value (LTFV). 
• The DOC determines that 15 companies had no shipments of certain frozen fish fillets from the Socialist Republic of Vietnam (Vietnam) during the period of review (POR) August 1, 2020, through July 31, 2021. 

U.S. Court of International Trade (CIT)

• On August 29, 2022, the U.S. Court of International Trade (CIT) issued its final judgment in SeAH Steel Corporation v. United States, Consol. Court No. 20-00150, Slip Op. 22-101, sustaining the DOC’s (Commerce) remand results pertaining to the administrative review of the antidumping duty (AD) order on certain oil country tubular goods (OCTG) from the Republic of Korea (Korea) covering the period September 1, 2017, through August 31, 2018. 
• On August 26, 2022, the CIT issued its final judgment in SeAH Steel Corp. v. United States, Consol. Court No. 19-00086, Slip Op. 22-100, sustaining the U.S. Department of Commerce’s (Commerce) remand results pertaining to the administrative review of the antidumping duty (AD) order on certain oil country tubular goods (OCTG) from the Republic of Korea (Korea) covering the period September 1, 2016, through August 31, 2017. 

U.S. Department of the Treasury’s Office of Foreign Assets Control (OFAC)

• The U.S. Department of the Treasury’s Office of Foreign Assets Control (OFAC) designated Iran’s Ministry of Intelligence and Security (MOIS) and its Minister of Intelligence for engaging in cyber-enabled activities against the United States and its allies. 
• The OFAC is issuing Russia-related General License 13B. 

Food and Drug Administration (FDA)

• FDA is issuing a final rule to reflect changes to the organizational structure of FDA, make the FOIA process easier for the public to navigate, and make certain provisions clearer. Taken together, these changes enhance transparency for the public about FDA activities.

United States International Trade Commission (USITC)

• Purple Innovation, LLC filed a complaint with the U.S. International Trade Commission (USITC) on August 5,2022 alleging violations of patent design and trademark registration based upon the importation, sale for importation, and sale within the United States.  

Office of the U.S. Trade Representative (USTR)

• United States Trade Representative Katherine Tai and Secretary of Commerce Gina M. Raimondo hosted counterparts from the 13 Indo-Pacific Economic Framework for Prosperity (IPEF) partner countries at the first official in-person Ministerial meeting. The ministers announced a substantial milestone in their pursuit of a high-standard and inclusive economic framework.

G7 Germany

• The G7 Finance Ministers met on September 2, 2022 to discuss their response to Russia’s war against Ukraine and its economic impact. They reiterated their support for Ukraine and condemned Russia for their actions.

The White House

• Senior government officials from the United States and Mexico met in Mexico City on September 12th to convene the U.S.-Mexico High-Level Economic Dialogue (HLED).
• On September 11, 2022, the White House released plans to broaden curbs on U.S shipments to China of semiconductors used for artificial intelligence and chipmaking tools.

Bloomberg News

• According to Bloomberg, in Chengdu, famous for its giant pandas, residents in locked-down areas need to remain at home and get tested daily for COVID-19. Those living outside areas deemed to be high risk are only allowed to go out every other day for two hours for groceries and medical needs. 

What we learned

Both medical device transition plans follow a similar structure, with some minor differences, in what is asked for from the trade community. Under the issued medical device transition plans, the entire plan follows a 180-day cycle in which by day 90 notifications of intent must be submitted to the FDA and by day 180, marketing submissions must be submitted and accepted by FDA. Please see below for a more thorough breakdown of each of the transition plans.

Devices Issued Emergency Use Authorizations (EUA)

Day 0: Advance notice of termination in Federal Register – EUAs are still active for the full 180-day transition time period

By Day 90:

• FDA recommends that manufacturers of certain life-supporting or life-sustaining devices submit to FDA a “letter of intent”, with information regarding their intention to submit a marketing submission to continue the distribution of their product. or their intention to cease distribution of their product and how they intend on doing so.  The draft guidance recommends that manufacturers of such devices include in this notification:
  • General information (e.g., contact information).
  • The EUA request number.
  • A list of all model numbers or other device identifying information.
  • Whether the manufacturer plans to submit a marketing submission.
  • If not planning to submit a marketing submission, the manufacturer should discuss, as applicable, its plan to stop distribution of the device, to restore the device to a previously FDA-cleared or approved version, to provide a physical copy or electronic updated labeling, and any other efforts to address or mitigate potential risks of devices that remain distributed after the EUA termination date.
• The manufacturer should submit this information designated with the EUA number as an “EUA report.” FDA recommends that manufacturers notate the following on the cover letter of the submission: “Attention: Notification of Intent.”

By Day 180:

• Manufacturers should have a marketing submission submitted and accepted by the FDA meaning FDA has confirmed receipt of the marketing submission.  You are allowed to continue the importation and distribution of your device until the FDA issues a final action on your marketing submission.
• According to the draft guidance, marketing submissions should be considered “transition implementation plan that addresses the manufacturers’ plans for devices already distributed in the case of a positive decision or a negative decision on its marketing submission”. This marketing submission should include the following:
  • Information regarding the estimated number of devices distributed under an EUA currently in U.S. distribution.
  • A benefit-risk based plan for disposition of distributed product as detailed in the draft guidance.
  • A plan on how the manufacturer would cease distribution of their product should they receive a negative decision from the FDA.

Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 Public Health Emergency (PHE)

Day 0: A Final ruling will be issued by the FDA ending the Public Health Emergency and changing the enforcement policies, but the trade community will still have the 18o day time period to become compliant with the “new” laws and regulations.

By Day 90:

• FDA recommends that manufacturers of certain life-supporting or life-sustaining devices submit to FDA a “letter of intent”, with information regarding their intent to submit a marketing submission or not. The guidance recommends that manufacturers of such devices include in this notification,
  • General information (e.g., contact information).
  • The title of the relevant enforcement policy guidance.
  • Submission number(s) for related premarket submissions.
  • A list of all model numbers or other device identifying information.
  • Whether the manufacturer plans to submit a marketing submission.
  • If not planning to submit a marketing submission, the manufacturer should discuss, as applicable, its plan to
    • discontinue distribution of the device
    • to restore the device to a previously FDA-cleared or -approved version (if applicable)
    • to provide a physical copy or electronic updated labeling
    • any other efforts to address or mitigate potential risks of devices that remain distributed after the transition period has ended and the guidances in List 1 of the draft guidance have been withdrawn.
• If the medical device was previously compliant before the declaration of the PHE, and a modified version was distributed after the declaration of the PHE the manufacturer should submit this information as a premarket notification ( i.e., 510(k)) or premarket approval application (PMA) “amendment” to the manufacturer’s existing device submission that was previously cleared or approved.
• FDA recommends that manufacturers notate the following on the cover letter of the submission: “Attention: Notification of Intent”.

By Day 180: Manufacturers should have a marketing submission submitted and accepted by the FDA, meaning FDA has confirmed receipt of the marketing submission.

• The marketing submission/transition implementation plan should address and include:
  • The manufacturers’ plans for devices already distributed in the case of a positive decision or a negative decision.
  • Information regarding the estimated number of devices distributed under the enforcement policy currently in U.S. distribution.
  • A benefit-risk based plan for disposition of distributed product as detailed in the draft guidance.

Moving Forward 

If you do not submit a notification of intent or a marketing submission the FDA is interpreting this as your responsibility to cease distribution of your product. A failure to do so, could leave YOU open to enforcement from the FDA. For scenarios not addressed throughout the transition plan, the FDA allows for manufacturer-initiated discussions with FDA to resolve any issues with medical device registrations. The FDA also invites the trade community to submit comments on these draft guidances before its March 23, 2022 deadline. Please contact us at info@diaztradelaw.com for help submitting your comment!

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Below we share some of our top 2021 success stories with you.

Successfully Mitigated Liquidated Damages Claims 

• For failure to timely refile rejected entries subject to AD/CV duties:
  • After DTL’s strategic involvement CBP substantially mitigated approximately $5 MILLION in claims down to $26,365.00, successfully saving our client over $4.7 MILLION dollars
  • Our client received 36 liquidated damages notices from CBP totaling over $567,000. After Diaz Trade Law’s successful negotiation with CBP, all 36 cases were canceled by CBP, saving our client $over $567,000!!
• CBP sent our client a liquidated damages claim in the amount of $150,000. As a result of Diaz Trade Law’s successful petition, CBP mitigated the liquidated damages claim down to $1,500!
• CBP issued a liquidated damages claim in the amount of $50,000.00. After DTL successfully petitioned CBP, the claim was cancelled!
• CBP issued a liquidated damages claim in the amount of $36,033.00. After DTL successfully petitioned CBP, the claim was mitigated to $360.33 (the best potential mitigation!).

CBP Detention Assistance 

• Mere days after being retained, Diaz Trade Law successfully assisted in negotiating with CBP and numerous trademark owners proving that our clients detained goods (collectively valued over $1,000,000.00) were legitimate, receiving either consent TM holder, and/or convincing CBP to release legitimate merchandise that should not have been detained.
• After CBP detained our client’s electronic merchandise to verify admissibility with the Department of Transportation (DOT)
  • CBP released the electronic goods after DTL proved the merchandise, LED driving lights, were eligible for an “off road” use exception and DOT providing such confirmation.
• After CBP detained our client’s electronic merchandise to verify the validity of a trademark on the product packaging.
  • Diaz Trade Law proactively communicated with the trademark holder and CBP, who, with the authorization of the trademark holder, permitted the importer to manipulate the merchandise and import the goods saving our client from a costly and lengthy seizure case that potentially exposed our client to CBP penalties.
• After CBP detained our client’s electronic merchandise to verify the validity of a trademark on the product packaging.
  • After Diaz Trade Law’s immediate involvement in arguing the product was “confusingly similar” and not counterfeit, DTL persuaded CBP to apply the relief afforded to “confusingly similar” seized merchandise and ultimately CBP permitted the exportation – which is relief that is rarely granted for detained products. DTL saved our client from a seizure case and potential penalties.
• CBP detained 28 containers of our client’s cargo.
  • Diaz Trade Law successfully negotiated with CBP to permit the goods to be reexported and avoid substantial demurrage expenses.

4647 Responses 

• CBP issued our client a CBP Form 4647 – Notice to Mark, because its electronic car accessories labels had both a country of origin marking and a “Designed in the USA” claim (in separate locations on the label).
  • After 48 hours of Diaz Trade Law’s successful escalation and negotiation with the Electronic Center of Excellence and Expertise, CBP granted a rarely used marking waiver permitting the merchandise to be imported as is, saving our client both money and time.
• CBP issued our client a CBP Form 4647 – Notice to Mark, because over 1,000 electronic car accessory units did not bear a country of origin marking.
  • Diaz Trade Law successfully and efficiently guided our client through the marking process. Ultimately, the goods were marked and authorized for distribution within recording timing – less than 10 days from the issuance of the 4647, saving our client both money and time.
• CBPO’s at Port Everglades detained two of our client’s shipments and issued two separate CBP Form 4647s – Notices to Mark because the imported merchandise valued at $98,744.00 did not bear a country of origin marking.
  • Diaz Trade Law successfully and efficiently guided our client through the marking process. Ultimately, the goods were marked and authorized for distribution with record timing – within 7 days from the issuance of the 4647, saving our client both money and time.
• Diaz Trade Law successfully assisted our client in responding to CBP’s Notice to Redeliver (CBP Form 4647) and provided CBP confirmation that the intellectual property rights displayed on the goods was authorized and our client’s merchandise was released in record timing!

Successfully Assisted Numerous Importers Battle Alleged Intellectual Property Rights Violations

• Our client’s merchandise was seized by CBP due to an alleged trademark violation.
  • After Diaz Trade Law’s successful petition, CBP issued a decision authorizing our client to relabel and export its legitimate merchandise.
• CBP detained several shipments of our client’s cargo for both Country of Origin (COO) and Intellectual Property Rights (IPR) reasons.
  • Diaz Trade Law advocated for our client and within less than one week convinced CBP to release our client’s legitimate merchandise detained at numerous ports of entry nationwide.
• Our client’s designer handbags were seized by CBP due to an alleged counterfeit violation.
  • After Diaz Trade Law’s successful petition, proving that the handbags were legitimate, CBP released our client’s legitimate merchandise.
• CBP detained our client’s goods valued at $98,744.00 for an alleged IPR validation.
  • Our firm immediately communicated with the appropriate CBP CEE and submitted evidence supporting the legitimacy of the imported goods requesting their immediate release. The CBP CEE agreed with our request and recommended the local port release the shipment, saving our client from a costly and lengthy seizure case.
• Diaz Trade Law successfully negotiated with CBP on behalf of an aftermarket car part importer to permit the exportation of goods detained for alleged IPR violations, saving the importer from a costly and lengthy seizure and potential penalty.
• Our client imported electronic merchandise which contained a trademark-violating processing system.
  • After Diaz Trade Law’s successful intervention, Diaz Trade Law received authorization from the trademark holder to permit the violative components to be removed and destroyed, and the larger shell merchandise to be imported in its current form. CBP agreed to these terms, and issued a disposition order authorizing the manipulation and release of the goods as Diaz Trade Law had requested.

Successfully Mitigated Penalty Actions Issued by CBP to our Clients 

• For importing noncompliant Wood Packaging Material:
  • $91,714 mitigated to 3% of penalty to $2,751.42, saving our client $88,962
  • $69,900 mitigated to 3% of penalty to $6,990, saving our client $60,000
  • $28,478 mitigated to 10% of penalty to $2,847, saving our client $25,631
  • $27,857 mitigated to 10% of penalty to $2,786, saving our client $25,071
  • $19,980.00 mitigated to 10% of penalty to $1,998, saving our client $17,982
• For filing incorrect Electronic Export Information (EEI)
  • $14,194 mitigated down to $500 (the best possible relief)!
  • $14,194 mitigated to 10% of penalty to $1500, saving our client $12,694

CBP 28 / CBP 29 Responses / CBP Investigations and Rejections

• Our client received a CBP 28 for a U.S. Australia Free Trade Agreement verification.
  • After Diaz Trade Law filed a successful response proving the imported goods were eligible for preferential duty-free treatment, CBP closed the 28 with a positive CBP 29 (Notice of Action).
• Our client received a CBP 28 Request for Information from U.S. Customs to verify GSP eligibility.
  • After Diaz Trade Law submitted a substantive response proving the GSP claim was valid, CBP issued a CBP 29 determining that the merchandise qualifies for GSP and no duties are owed to CBP!
• Our client received a Request for Information (CBP 28) from CBP.
  • Diaz Trade Law filed a 28 response which included a Prior Disclosure. The 28 was closed out, and the disclosure was accepted by CBP resulting in no 1592 penalties being issued to our client.
• CBP physically inspected our client’s cargo at the time of entry and identified that the commercial invoice and packing slip submitted to CBP did not include one model number included in the cargo. Diaz Trade Law immediately negotiated with CBP to accept an updated invoice and packing list. CBP accepted and released the complete cargo with no further enforcement action taken, saving our client costly demerge fees and other expenses.
• CBP rejected and refused an importation of tires because CBP alleged the importer did not have a right to make entry. After three uphill battles with CBP and DTL’s strategic recommendation to change the import transaction model, the importer was successfully able to act as IOR and its merchandise was admitted into the US.

USTR/China Tariffs

• Diaz Trade Law assisted over 100 importers in filing complaints with the Court of International Trade challenging Section 301 tariffs imposed for imported goods under for List 3 and List 4a, requesting full refunds.
• Diaz Trade Law filed numerous exclusions for goods subject to the Section 301 List 3 and List 4. USTR agreed and granted our client’s exclusion!
• Numerous clients that were subject to 301 duties used Diaz Trade Law to actively monitor 301 exclusions to ensure they were notified when refunds were a possibility. Diaz Trade Law assisted with not only actively monitoring the relevant exclusions, but also interpreting the applicability, and fighting for refunds via the Protest or PSC process. CBP has accepted numerous Protests, and hundreds of thousands of dollars of refunds were sent to our clients!
• As a result of Diaz Trade Law’s closely monitoring Section 301 China tariff exclusions, Diaz Trade Law found an applicable exclusion for our client to use and filed two Protests with CBP requesting that CBP refund the China tariffs paid. Our client’s protests were approved by CBP, resulting in a refund of $64,678.00.

Export Compliance and Enforcement Mitigation Assistance

• Diaz Trade Law is actively assisting exporters:
  • Vetting proposed export transactions
  • Providing voluntary self-disclosures to Census and OFAC
  • Developing an effective export compliance plan
  • Developing export compliance training
  • Mitigation and corrective action
  • Presenting export report cards to clients based upon an analysis of ACE data
  • Analyze export trade data
  • With mitigation of export seizures and penalties
• Our client needed urgent assistance to ensure it understood the requirements to properly export hazardous materials. Diaz Trade Law successfully and expeditiously secured Competent Authority Approvals for the hazardous material from the U.S. DEPARTMENT OF TRANSPORTATION Pipeline and Hazardous Materials Safety Administration (PHMSA) as well as the Competent Authority of Turkey and Finland.

OFAC/FAA/HSI 

• Our client’s incoming wire payments of $842,918.92 from Venezuela were blocked by its U.S. bank for possible violations of U.S. sanctions laws.
  • After Diaz Trade Law filed a specific license application with the U.S. Treasury Department’s Office of Foreign Assets Control (OFAC), OFAC issued a specific license authorizing the legitimate funds to be unblocked and returned to our client.
• Our client was being investigated by FAA as a result of a hazardous materials incident.
  • As a result of Diaz Trade Law’s successful involvement, the FAA closed the matter with an informal action!
• Our client was being investigated by HSI for possible criminal liability.
  • After Diaz Trade Law’s intervention, HSI closed its investigation into our client.

 Protests

• Diaz Trade Law successfully assisted our client in filing two Protests with CBP. These approvals saved our client over $600,000!!
• After Diaz Trade Law’s successful Protest of CBP’s AD/CVD bills, our client’s protest was approved by CBP, saving our client over $200,000!!

Binding Rulings

• Diaz Trade Law successfully requested and received binding rulings for numerous clients confirming:
  • the correct country of origin for its prospective imported merchandise.
  • the correct harmonized tariff schedule (HTSUS) for its imported merchandise.
  • both the origin of their merchandise and appropriate CBP country of origin marking
  • the applicability of a free trade agreement.

Assisted Numerous Importers in Filing Prior Disclosures and Voluntary Self-Disclosures Accepted by CBP 

• Diaz Trade Law successfully submitted a perfected prior disclosure for underlying classification, valuation, quantity, and 301/China tariff errors. While reviewing ACE data, we identified offsets for the duties owed to CBP. Ultimately, CBP agreed with our assessment and accepted our prior disclosure and tender, resulting in a refund of over $25,000 to our client and ensuring no future penalties would be assessed for our client’s past importing errors.
• After discovering Electronic Export Information (EEI) filing errors made by one of our clients, Diaz Trade Law assisted our client in proactively filing a Voluntary Self-Disclosure (VSD) with the U.S. Census Bureau and assisting our client in fixing all past errors. The VSD filing was accepted and resulted in the U.S. Census Bureau closing out the matter without penalties being assessed.
• On behalf of a client, Diaz Trade Law filed a voluntary disclosure with the Office of Foreign Assets Control (OFAC), disclosing potential sanctions violations.
  • Diaz Trade Law worked proactively with OFAC and received this “No Action letter” with no penalties assessed to our client.
• Diaz Trade Law successfully assisted our client in filing a Voluntary Self-Disclosure (VSD) with the U.S. Census Bureau for violations of the Foreign Trade Regulations.
  • Diaz Trade Law proactively worked with the Census Bureau and corrected past filing errors. The VSD was successfully closed out with no penalties assessed.
• Diaz Trade Law successfully assisted our client in filing a Prior Disclosure. CBP accepted the prior disclosure with no 1592 penalties being assessed!

Bonded Warehouse

• After Diaz Trade Law’s successful application, our client’s Bonded Warehouse Application was approved!
• After its bonded warehouse was activated by CBP, our client realized it wanted to change the total square footage. Diaz Trade Law successfully assisted our client alter its customs bonded warehouse space.

Successfully Assisted Numerous Importers in Various Seizure Cases 

• CBP seized our client’s vehicle after believing it could have been used to import illegal substances. After Diaz Trade Law’s successful petition proving our client’s innocence, CBP released the vehicle with no penalty assessed
• $20,868.81 of our client’s currency was seized by CBP. After Diaz Trade Law’s successful petition, $19,868.81 was returned to our client!
• $15,795 of our client’s currency was seized by CBP. After Diaz Trade Law’s successful petition, $14,795 was returned to our client!
• $12,157.95 worth of jewelry was seized by Customs after our client failed to declare it. After Diaz Trade Law’s successful Petition, CBP released the jewelry within 22 days.

Awards

• In 2021, Diaz Trade Law founder Jennifer Diaz was again Chambers ranked in International Trade: Customs – USA – Nationwide

Publications

Key publications written by Diaz Trade Law in 2021 were:

• Bloomberg Law, Introduction to U.S. Export Controls: Part 2, November, 2021.
• Bloomberg Law, Protecting Intellectual Property Rights in China, October 2021.
• Bloomberg Law, Incoterms 2020, May 2021.
• Bloomberg Law, Submitting Voluntary Self-Disclosures to Bureau of Industry & Security, May 2021.
• Bloomberg Law, Submitting a Voluntary Self-Disclosure to Census, April 2021.
• Bloomberg Law, Submitting a Voluntary Self-Disclosure to OFAC, April 2021.
• Bloomberg Law, U.S. Customs Targets Use of Forced Labor, January 2021.
• Customs and International Trade Bar Association, An Overview of China’s New Export Controls Regime,
• Customs and International Trade Bar Association, COVID-19’s Impact on 2020 Trade Flows,

Customized Training Programs & Webinars

Key compliance programs taught by Diaz Trade Law in 2021 were:

• Intellectual Property Rights and Customs – Amazon Brand Registry
• CTPAT Program: Is CTPAT a Right Fit
• Successfully Navigating the U.S. Customs Detention and Seizure Process
• How to Navigate FDA Enforcement Action: Detentions, Warning Letters, and Import Alerts
• Requests For Information (CBP Form 28) and Prior Disclosures
• How to Build and Maintain an Effective Import Compliance Plan
• How to Build and Maintain an Effective Export Compliance Plan
• Importing Food in Compliance With U.S. FDA and Surviving A FSVP Audit
• Importing Medical Devices in Compliance With U.S. FDA
• 6 Months In – Insights on Biden & Congress on Trade
• Is it a Cosmetic, a Drug, or Both? FDA Enforcement Actions
• ACE: Auditing Your Export History
• ACE: Auditing Your Import History
• Introduction to Export Controls
• Importing 101 – Introduction to U.S. Customs
• Anti-Circumvention / EAPA / Dumping Duties & the Spreadability of Cases (Coated Paper)
• Other Trade Remedies 101 – Every Administration has a Favorite!
• Basics on AD/CVD
• Cleaning for Covid-19 – Importing Cleaning Products: Who Regulates You?
• Forecasting the Next 4 Years of Biden on Trade

Diaz Trade Law values you and appreciates your trust in us to be your Customs and International Trade Law Expert! Contact us at info@diaztradelaw.com to schedule your consultation or customized training today.

BIS

• BIS Publishes Report on Effect of Uranium Imports on National Security
• BIS Publishes First Military End User List

Bloomberg

• Bloomberg Law – Introduction to U.S. Export Controls: Part 2
• Protecting Intellectual Property Rights in China
• Incoterms 2020
• Submitting Voluntary Self-Disclosures to Bureau of Industry & Security
• Submitting a Voluntary Self-Disclosure to Census
• Submitting a Voluntary Self-Disclosure to OFAC
• U.S. Customs Targets Use of Forced Labor

Customs and International Trade Bar Association 

• New CITBA Article – An Overview of China’s New Export Controls Regime
• COVID-19’s Impact on 2020 Trade Flows

China

• OFAC Issues Clarifying Guidance on Communist Chinese Military Companies Sanctions
• Hong Kong’s Initiates Dispute Regarding U.S.-Origin Marking Requirement
• CBP Issues WRO on Cotton, Tomato, & Downstream Products Made in Xinjiang
• Future of First Sale Rule in Question

Crypto

• OFAC Targets Russian Crypto Platform
• Why China’s Cryptocurrency Miners are Moving to Texas

Covid-19

• Recent Government Data Indicates that Florida Trade is Rebounding Fast Despite Pandemic Hit

Export

• What are Routed Export Transactions?
• Understanding the Computer Export License Exception (APP)
• Understanding the GOV Export License Exception
• Vegas Woman Charged with Iran Sanctions Violations
• Do’s and Don’ts of Filing a Commodity Jurisdiction Request
• Understanding Strategic Trade Authorization
• Building a Strong Export Compliance Plan
• Commerce Department Issues Rule Securing Digital Supply Chains Against Foreign Adversaries

Import/CBP

• UK Joins Kimberley Diamond-Trading Process
• FTC issues a Record Breaking $1.2 Million Penalty
• Customs Issues Notice of Proposed Rulemaking on Broker Continuing Education – Comments Open
• Comment Now – CBP Proposed Rule on Country of Origin Determination for Imports under USMCA
• 9801.00.10: Updated Requirements for Returned Goods
• Customs Valuation 101
• Breaking News – New Federal Law Expands Furniture Flammability Testing Standard

AD/CVD

• New Antidumping Petition Against Imports of Certain Honey Products
• New AD/CVD Petition Against Imports of Certain Chinese Mobile Access Equipment

Buy America

• Biden Executive Order Strengthens Buy American Government Procurement Laws

U.S. Fish and Wildlife Service

• Trading in Wildlife? You May Need a License

U.S. Food and Drug Administration

• FDA Seeks Public Comments on Proposed Final Order for OTC Sunscreen Safety
• FDA OPENS NEW FSVP PORTAL FOR IMPORTERS
• FDA Further Extends UFI Flexibility For Food Facility Registrations
• OTC Drug Manufacturers are Required to Pay FDA Facility User Fees by May 10, 2021
• FDA Import Alert on Mexican Hand Sanitizer
• Comment on FDA’s Proposed Rule – French Dressing

USITC

• An Introduction to Safeguard Investigations

OFAC 

• Between a Rock and a Hard Place – Conflicting U.S. & EU Sanctions Policies Towards Iran
• OFAC Sanctions & Licensing
• The CAPTA List – An Introduction
• Treasury Imposes Further Sanctions on Iran
• Trump Administration Designates Cuba State Sponsor of Terrorism

Section 301

• Want Your 301 Exclusion Back? Comment Now!
• Potential Relief from China Tariffs Coming
• 301 Exclusion Extensions for COVID-19 Related Products
• Proposed 25% Tariffs on Section 301 Digital Service Taxes – Comment Now
• USTR Announces Special 301 Review – Comments Due January 28
• US Imposes Additional Tariffs on EU Goods
• USCIT Invalidates 232 Tariffs on Steel and Aluminum Derivatives

Podcasts

• 3-Part Podcast Miniseries – Importing, Exporting, and AD/CVD

Trade Snapshots

• Customs and Trade Law Snapshot
• Customs and Trade Law Weekly Snapshot

USDA 

• Understanding Organic Equivalency Arrangements
• USDA National Organic Program – Enforcement & Compliance Overview

Webinar

• Want Customs to Police Your IPR at all 328 Ports of Entry?
• Customs Classification – A Key Component of an Import Compliance Manual
• Keysight Technologies Pays $6.6M to State Department for Export Violations
• Food Importers: How to Import Food Compliantly & Survive a FSVP Audit
• Don’t Let FDA Target Your Medical Device Company
• Insight on Last 6 Months of Biden/Congress on Trade
• Diaz Trade Law Invites the Trade Community to Two Free Webinars this Summer!
• Don’t be a Target, Learn Best Practices to Mitigate FDA Enforcement
• ACE: Auditing Your Export History
• ACE: Auditing Your Import History
• Exporting 101 – Introduction to Export Controls
• Anti-Circumvention, EAPA, Dumping Duties & the Spreadability of Cases
• Cleaning for COVID-19 – Importing Cleaning Products: Who Regulates You?
• REGISTER TODAY! NEI Accredited Webinar Importing 101 – Introduction to U.S. Customs
• Biden Administration Commits to Modernizing Regulatory Review

If you have any questions on the topics above, contact us at info@diaztradelaw.com.

Did you know FDA has issued 1,569 enforcement actions against  medical device companies? Now is the time to ensure your medical devices are in compliance with FDA laws and regulations prior to importation. If your business is manufacturing, repackaging, relabeling, and/or importing medical devices into the U.S., or wants to start, our one-hour webinar on “Importing Medical Devices in Compliance with U.S. FDA” is for you. We will provide TOP tips to avoid U.S. Food and Drug Administration (FDA) enforcement action, and best practices to navigate and mitigate FDA enforcement.

Register today to to hear directly from DTL’s president, Jennifer Diaz, and Associate Attorney, Denise Calle, on the pathway to legally market a medical device and best practices for avoiding and responding to enforcement actions.

Why Should I Register for this Webinar?

The FDA is actively enforcing its laws and regulations against non-compliant importers of medical devices. In FY21 alone the FDA has issued 53 warning letters  against medical devices companies.  Manufacturers, repackagers, relabelers, importers, and others engaged in the production or sale of medical devices must be aware of FDA’s various enforcement mechanisms, and more importantly,  how to avoid and/or mitigate such actions.  FDA’s most common enforcement activities include notices of FDA action, warning letters, import alerts, seizures, voluntary recalls, injunctions, and criminal prosecution.

In response to the increase in enforcement discussed below, Diaz Trade Law is hosting a NEI accredited webinar, FDA – Is it a Cosmetic, a Drug, or Both? Mitigating FDA Enforcement Actions to train industry on top compliance tips to avoid enforcement, and best practices in responding to various FDA enforcement.

Warning Letters issued in FY21:

• Of the 53 warning letters issued to medical device companies in FY2021, 50% of these warning letters were issued against firms that marketed their medical devices as devices that treat or mitigate Covid-19. FDA found these devices (including  “KN95 Face Mask” and “3-ply Surgical Mask Disposable Face Mask”) to be “Unapproved Drugs, Misbranded, and/or Adulterated Products Related to Coronavirus Disease 2019 (COVID-19)”.
• In FY21, FDA warning letters have been issued against firms for offering medical devices for sale in the United States without marketing approval, clearance, or authorization from the FDA as well as poor current Good Manufacturing Practices (cGMPs).
• Interestingly enough 40 of the 52 warning letters were against U.S. and Chinese companies.

Recalled Medical Devices in 2020 and 2021:

• In FY21, FDA has recalled a total of 2161 medical devices, including the recall of 132 Class I devices, 1986 Class II devices, and 43 Class III devices have been recalled in FY21! 
• In FY20 a total of 3042 medical devices were recalled. 
• There are a total of 304 firms currently performing medical device recalls. Don’t be one of them!

In this webinar, you will receive an overview of FDA regulations and requirements for importing medical devices. Presenters will discuss how FDA defines and regulates a medical device, as well as what requirements FDA imposes when importing a medical device. The objective of the webinar is to teach participants how to navigate FDA’s regulatory framework, provide TOP compliance tips to avoid FDA enforcement actions, and top strategies to implement when you are faced with an enforcement action.

Manufacturers, importers, distributors, and others engaged in the production or sale of medical devices are encouraged to attend either live on August 25, 2021 at 12:00 PM, or on demand thereafter. Register Here!

A lot has happened in the first 6 months of the Biden administration. Notable developments include (at least temporary) resolutions in the large civil aircraft and digital service tax disputes, consensus around a global minimum corporate tax of 15%, lawsuits pertaining to Section 232, increased export controls enforcement, shifting U.S. policy stances on Cuba, and more. However, the most important developments pertain to the ongoing U.S.-China trade war. The U.S. and China are engaged in ongoing negotiations while tensions have risen, a lawsuit challenging Trump’s imposition of 301 tariffs are underway, and a massive U.S. competitiveness bill is being considered in Congress that could bring back broad China tariff exclusions. Join us for a jam-packed hour where we discuss everything that has happened in the world of U.S. trade policy over the past 6 months, and provide insight into how Biden’s trade policies affect industry.

Register today to hear from this experienced trio:

• Todd C. Owen is the former Executive Assistant Commissioner, U.S. Customs and Border Protection (CBP), Office of Field Operations (OFO). As the senior executive for the Office of Field Operations for over 5 years, Mr. Owen was responsible for all operations at the 328 ports of entry in the United States, as well as overseas operations in 32 countries.
• President and Founder of Diaz Trade Law, Jennifer (Jen) Diaz is a Chambers ranked, Board Certified International Attorney specializing in customs and international trade.
• Associate Attorney of Diaz Trade Law, Sharath Patil, assists U.S. manufacturers, distributors, and importers with a range of export compliance and enforcement matters pertaining to the U.S. Department of Commerce; the U.S. Treasury Department; the U.S. State Department; and more.

This one-hour webinar provides an overview of President Biden’s Trade Policy six months into his presidency, an update on CBP enforcement actions, and a summary of Congressional actions pertaining to trade policy.

In This Webinar You Will Learn:

• An Update on the Status of the Section 301 Lawsuit
• An Overview of Key Developments in the U.S.-China Trade War under Biden’s Administration
• Congressional Developments under Biden
• Status of CBP Enforcement Efforts under Biden
• Recent Developments in the Miscellaneous Tariff Bill and Generalized System of Preferences
• The Impact of Economic Stimulus Efforts on Trade Flows
• An Update on USMCA Implementation
• The Latest on U.S.-Cuba Trade
• And Many Other Developments

Who Should Attend:

• Importers/Exporters
• Customs Brokers
• Regulatory Affairs Professionals
• In-house Legal Counsel
• Product Development Managers
• Others Interested in Trade Policy

This webinar is eligible for continuing education credit from the NCBFAA Educational Institute. Space is limited, registration required! Access instructions will be provided after your registration is complete. Don’t just take our word for how awesome Diaz Trade Law webinars are. Click here to see what our past attendees had to say. Be sure to join us on July 28, 2021!

Diaz Trade Law’s President, Jennifer Diaz,  and Associate Attorney, Sharath Patil, are enthusiastic to announce that our article, “COVID-19’S IMPACT ON 2020 TRADE FLOWS” was published by the Customs and International Trade Bar Association (CITBA) in its Spring 2021 newsletter. Below is the article for your reading pleasure.

You can read the article here (where you’ll have the ability to access all of the great hyperlinks). Please note you cannot click on the hyperlinks below.

We’d love to hear your feedback!

In CSMS #46607637, CBP also provides guidance for importers, brokers, and other related parties:

• Per 85 FR 85831 Annex A, in addition to reporting the regular Chapters 84, 85, and 90 classifications of the HTS for the imported merchandise, importers shall report the HTS classification 9903.88.62 (Articles, the product of China related to Tranche 1 – $34B Action, as provided for in U.S. note 20(ooo) to this subchapter, each covered by an exclusion granted by the USTR for imported merchandise subject to the exclusion).
• Per 85 FR 85831 Annex B, in addition to reporting the regular Chapters 39, 84, and 90 classifications of the HTS for the imported merchandise, importers shall report the HTS classification 9903.88.63 (Articles, the product of China related to Tranche 2 – $16B Action, as provided for in U.S. note 20(ppp) to this subchapter, each covered by an exclusion granted by the USTR for imported merchandise subject to the exclusion).
• Per 85 FR 85831 Annex C, in addition to reporting the regular Chapters 28, 34, 38, 39, 40, 48, 56, 65, 84, 85, and 90 classifications of the HTS for the imported merchandise, importers shall report the HTS classification 9903.88.64 (Articles, the product of China related to Tranche 3 – $200B Action, as provided for in U.S. note 20(qqq) to this subchapter, each covered by an exclusion granted by the USTR for imported merchandise subject to the exclusion).
• Per 85 FR 85831 Annex D, in addition to reporting the regular Chapters 34, 39, 40, 48, 52, 55, 61, 62, 63, and 90 classifications of the HTS for the imported merchandise, importers shall report the HTS classification 9903.88.65 (Articles, the product of China related to Tranche 4A – $300B Action, as provided for in U.S. note 20(rrr) to this subchapter, each covered by an exclusion granted by the USTR for imported merchandise subject to the exclusion).
• Importers shall not submit the corresponding Chapter 99 HTS number for the Section 301 duties when HTS 9903.88.62, 9903.88.63, 9903.88.64, or 9903.88.65 are submitted.

Further, USTR may make additional modifications to remove Section 301 duties from other medical-care products to address COVID-19. CBP issued guidance on the 301 exclusion extensions and modifications on December 30, 2020, explaining its intentions to modify the 301 duties as appropriate.

Contact Us

For background information on Section 301 China tariffs and numerous ways to mitigate the effect of the China tariffs, check out our previous blogs. Diaz Trade Law has assisted clients in assessing their best options to prepare or mitigate the China tariffs and submitted comments and exclusion requests. If you need assistance understanding the USTR announcement or navigating China 301 tariffs, our Customs and International Law attorneys are available at 305-456-3830 or info@diaztradelaw.com.

***

Detailed Scope of Extension

Effective with respect to goods entered for consumption, or withdrawn from warehouse for consumption, on or after 12:01 a.m. eastern daylight time on April 1, 2021, and before 11:59 p.m. eastern daylight time on September 30, 2021, each of the article descriptions of headings 9903.88.62, 9903.88.63, 9903.88.64 and 9903.88.65 of the Harmonized Tariff Schedule of the United States are modified by deleting “March 31, 2021,” and by inserting “September 30, 2021,” in lieu thereof.

ANNEXES A—D:

1. by inserting the following new heading 9903.88.62, 9903.88.63, 9903.88.64, or 9903.88.65, respectively, in numerical sequence, with the new material in the new heading inserted in the columns of the HTSUS labeled “Heading/Subheading”, “Article Description”, and “Rates of Duty 1-General”, respectively:

ANNEX A – 9903.88.62: by inserting the following new U.S. note 20(ooo) to subchapter 99 in numerical sequence: “(ooo) The USTR determined to establish a process by which particular products classified in heading 9903.88.01 and provided for in U.S. notes 20(a) and 20(b) to this subchapter could be excluded from the additional duties imposed by heading 9903.88.01. See 83 FR 28710 (June 20, 2018) and 83 FR 32181 (July 11, 2018). Following its request for public comment in March, USTR determined that, as provided for in heading 9903.88.62, the additional duties provided for in heading 9903.88.01 shall not apply to the following particular products, which are provided for in the enumerated statistical reporting numbers:

The technical amendments to the exclusions to certain Notes to Subchapter III of Chapter 99 of the HTSUS can be found below:

Effective with respect to goods entered for consumption, or withdrawn from warehouse for consumption, on or after 12:01 a.m. eastern daylight time on January 1, 2021, the exclusion for certain inoculator sets of plastics that is provided for in heading 9903.88.06 and U.S. note 20(i)(32) to subchapter III of chapter 99 of the HTSUS is deleted.

ANNEX B – 9903.88.63: by inserting the following new U.S. note 20(ppp) to subchapter 99 in numerical sequence: “(ppp) The USTR determined to establish a process by which particular products classified in heading 9903.88.02 and provided for in U.S. notes 20(c) and 20(d) to this subchapter could be excluded from the additional duties imposed by heading 9903.88.02. See 83 FR 40823 (August 16, 2018) and 83 FR 47326 (September 18, 2018).  Following its request for public comment in March, USTR determined that, as provided for in heading 9903.88.63, the additional duties provided for in heading 9903.88.02 shall not apply to the following particular products, which are provided for in the enumerated statistical reporting numbers:

The technical amendments to the exclusions to certain Notes to Subchapter III of Chapter 99 of the HTSUS can be found below:

ANNEX C – 9903.88.64: by inserting the following new U.S. note 20(qqq) to subchapter 99 in numerical sequence: “(qqq) The USTR determined to establish a process by which particular products classified in heading 9903.88.03 and provided for in U.S. notes 20(e) and 20(f) to this subchapter could be excluded from the additional duties imposed by heading 9903.88.03, and by which particular products classified in heading 9903.88.04 and provided for in U.S. note 20(g) to this subchapter could be excluded from the additional duties imposed by heading 9903.88.04. See 83 FR 47974 (September 21, 2018) and 84 FR 29576 (June 24, 2019).  Following its request for public comment in March, USTR determined that, as provided for in heading 9903.88.64, the additional duties provided for in heading 9903.88.03 or in heading 9903.88.04 shall not apply to the following particular products, which are provided for in the enumerated statistical reporting numbers:

The technical amendments to the exclusions to certain Notes to Subchapter III of Chapter 99 of the HTSUS can be found below:

ANNEX D – 9903.88.65: by inserting the following new U.S. note 20(rrr) to subchapter 99 in numerical sequence: “(rrr) The USTR determined to establish a process by which particular products classified in heading 9903.88.15 and provided for in U.S. notes 20(r) and 20(s) to this subchapter could be excluded from the additional duties imposed by heading 9903.88.15. See 84 FR 43304 (August 20, 2019) and 84 FR 45821 (August 30, 2019); 84 FR 57144 (October 24, 2019) 85 FR 3741 (January 22, 2020). Following its request for public comment in March, USTR determined that, as provided for in heading 9903.88.65, the additional duties provided for in heading 9903.88.15 shall not apply to the following particular products, which are provided for in the enumerated statistical reporting numbers:

The technical amendments to the exclusions to certain Notes to Subchapter III of Chapter 99 of the HTSUS can be found below:

Table A contains a list of the original exclusions and corresponding Chapter 99 Heading and Note 20 Subdivision for the first extension and the current extension. Additionally, the table indicates which Annex to this notice the extension appears:

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