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Toothfish (Chilean Seabass) Imports – Pre-Approval Authorization and Catch Certification - US Customs & Border Protection

This message informs importers and filers that until further notice, all shipments of frozen

Patagonian Toothfish (Chilean Seabass) arriving at a CBP Port of Entry (POE) without the required NOAA pre-approval authorization and associated catch document certification as required by 50 CFR 300 (Subpart G), and classified under those Harmonized Tariff Schedule of the United States (HTSUS) codes listed below, will be rejected and prohibited from entry without all required documents. 

NOTE: With regard to this CSMS, the NOAA requirement for both pre-approval authorization and associated catch document certification applies only to frozen Patagonian Toothfish (Chilean Seabass).  

Shipments of fresh Patagonian Toothfish (Chilean Seabass) classified under those corresponding HTSUS codes listed below must have associated catch document certification filed in ACE prior to entry but are not required to secure and file NOAA pre-approval authorization prior to entry. 

This action is necessary due to the ongoing partial government shutdown which prevents NOAA and its National Seafood Inspection Lab from verifying that toothfish products comply with all applicable conservation measures of the Commission for the Conservation of Antarctic Marine Living Resources (CCAMLR) as required by international obligations as a Member of CCAMLR, as well as U.S. domestic regulations pertaining to international fisheries and imports. 

This interim procedure will continue during the current partial government shutdown and until NOAA is able to resume normal operations following conclusion of the current shutdown.
 
Any questions of CBP regarding this message should be forwarded to the Commercial Targeting & Analysis Center (CTAC) at CTAC@cbp.dhs.gov

FROZEN CHILEAN SEABASS HTSUS CODES REQUIRING NOAA-NMFS PRE-APPROVAL AUTHORIZATION AND ASSOCIATED CATCH CERTIFICATION FILED IN ACE PRIOR TO ENTRY:
 
0303620000 (TOOTHFISH, FROZEN, EXCEPT FILLETS, LIVERS AND ROES),
0304220000 (TOOTHFISH FILLETS, FROZEN),
0304921000 (TOOTHFISH IN BULK CONTAINERS > 6.8 KGS),
0304220003 (PATAGONIAN TOOTHFISH FILLETS, FROZEN),
0304229000 (TOOTHFISH FILLETS, FROZEN, NESOI),
0304206093 (FROZEN FILLTS, AND OTHER FISH MEAT, PTGNIAN TOOTHFISH),
0303620090 (OTHER TOOTHFISH, FRZ EXCL. FISH FILLETS, OTHER FISH MEAT),
0304929000 (OTHER TOOTHFISH, FRESH CHILLED OR FROZEN),
0304220006 (TOOTHFISH (DISSOSTISHUS MAWSONI) ANTARCTIC FLT, FROZEN),
0304850000 (FISH FILLETS, FROZEN, TOOTHFISH (DISSOSTISHUS SPP)),
0303830000 (TOOTHFISH, FROZEN, EXCLUDING FISH FILLET AND OTHER FISH MEAT),
0303621000 (PATAGONIAN TOOTHFISH, FROZN, EXCEPT FILLETS/LIVER),
0304221000 (PATAGONIAN TOOTHFISH FILLETS, FROZEN),
0304920000 (TOOTHFISH (DISSOSTICHUS SPP), MEAT, FROZEN, NESOI),
0303629000 (TOOTHFISH, FROZEN, EXCPT FILLETS, LIVERS, ROE, NES),
0303794094 (OTHR FISH, FROZEN, EXCLUDING FILLETS, ANTARCTIC TOOTHFISH),
0303620005 (PATAGONIAN TOOTHFISH, FROZN, EXCEPT FILLETS/LIVER),
0303620010 (OTHR FISH, FROZEN, EXCLUDING FILLETS, ANTARCTIC TOOTHFISH),
0304206094 (FROZEN FILLETS, AND OTHER FISH MEAT, ANTARCTIC TOOTHFISH, OTHER) 

FRESH/CHILLED CHILEAN SEABASS HTSUS CODES REQUIRING ASSOCIATED CATCH CERTIFICATION FILED IN ACE PRIOR TO ENTRY: 

0302394097 (FISH NESOI, PATAGONIAN TOOTHFISH),
0304120000 (TOOTHFISH, FRESH/CHILLED, EXCLUDING STEAK),
0302680090 (TOOTHFISH, FRESH OR CHILLED EXCLUDING LIVERS & ROES, OTHER),
0302680010 (TOOTHFISH, PATAGONIAN (CHILEAN SEABASS EXC LIVERS & ROES),
0302680000 (TOOTHFISH, FRESH/CHILLED, EXCEPT FILLETS/LIVERS/ROE),
0304550000 (TOOTHFISH (DISSOSTISHUS SPP) FILTS & MEAT, FRESH, CHILLED),
0304460000 (TOOTHFISH (DISSOSTISHUS SPP) FILTS & MEAT, FRESH, CHILLED),
0302830000 (TOOTHFISH, FRESH OR CHILLED EXCLUDING LIVERS & ROES, OTHER),
0302694097 (PATAGONIAN TOOTHFISH (CHILEAN SEABASS), OTHER, FRESH/CHILLED)


In the News:  

ISLAMABAD:  As the tariff war between China and the United States has not eased, Pakistan’s textile industry is likely to get higher orders from US importers.

“Owing to trade tensions between the US and China, Pakistan’s textile industry is receiving a large number of import queries from the US,” an official of the textile industry disclosed.Already, the duties on the import of cotton – a major input for the textile industry – have been withdrawn by the Economic Coordination Committee (ECC) in order to reduce the cost of industrial inputs.  See website for photos and entire article 

Washington – Today (1/18/19), the U.S. Department of the Treasury issued final regulations and other guidance on a substantial provision of the Tax Cuts and Jobs Act, which allows owners of sole proprietorships, partnerships, trusts, and S corporations to deduct up to 20 percent of their qualified business income. The final regulations ensure that this historic tax cut will be available to the broadest spectrum of American businesses, consistent with the law, while minimizing compliance costs and streamlining the process for claiming the deduction.
 
“Small and mid-size businesses are the engines of growth for the U.S. economy,” said Secretary Steven T. Mnuchin. “The pass-through deduction will drive more investment in U.S. companies and higher wages for American workers. This provision will reduce pass-through business tax rates to their lowest rate in more than 80 years.”
 
It is estimated that between 17 and 40 million American business owners will be able to take advantage of this deduction. The deduction is generally available to small business owners with income below $315,000 for married couples filing jointly and $157,500 for single filers without limitations. For business owners above those thresholds, the regulations also provide certainty and flexibility by clarifying the definitions of “specified service trade or business” and “unadjusted basis immediately after acquisition” of qualified property, and by including “aggregation rules” for filers with pass-through income from multiple sources. Treasury also issued a revenue procedure on computing W-2 wages for purposes of the limitations that apply to owners with income above the threshold amounts.
 
The Treasury issued further related proposed regulations that provide further certainty for determining the deduction for REIT dividends taxpayers own through mutual funds and a proposed revenue procedure providing a safe harbor, so that certain rental real estate enterprises may be treated as a trade or business for purposes of the deduction.


TSA Statement on Checkpoint Operations for January 23 Transportation Security Administration

WASHINGTON – Nationwide, the Transportation Security Administration screened 1.8 million passengers yesterday, Tuesday, Jan. 22. Overall, 99.9 percent of passengers waited less than 30 minutes and 94.8 percent of passengers waited less than 15 minutes. In TSA Pre✓® lanes, passengers on average waited less than 10 minutes. Please refer to the table below for top airport specific wait times.
 
Yesterday’s complete figures show that TSA experienced a national rate of 7.4 percent of unscheduled absences compared to a 3.2 percent rate one year ago on the same weekday, Tuesday, Jan. 23, 2018; many employees are reporting that they are not able to report to work due to financial limitations.
 
While national average wait times are within normal TSA times of 30 minutes for standard lanes and 10 minutes for TSA Pre✓®, some airports experienced longer than usual wait times. Below are yesterday’s maximum wait times experienced by passengers in standard and TSA Pre✓® lanes at the top 42 U.S. airports.

See waittime chart for January 22, 2019

In coordination with airport and airlines partners, TSA continues to carry out its mission by optimizing resources, managing consolidation efforts, and ensuring screening lanes are properly staffed. Security will never be compromised. Airports may exercise contingency plans due to call-outs and traveler volume in order to maintain effective security standards. Travelers should seek current airline and airport information and should allow enough time to get through the airport and board their flight.
 
Every day, TSA officers continue to demonstrate great resilience and dedication as they report for duty, ensuring travelers get to their destinations safely. Public support from passengers, industry groups, and community organizations underscores the importance of TSA’s work in securing aviation.


FDA Statement from Commissioner Scott Gottlieb, M.D. Announcing Efforts to Improve the Quality of the Information Used to Assess the Effectiveness of REMS Programs in Supporting the Safe Use of Medications - Food & Drug Administration

In making decisions about whether the benefits of a drug outweighs its risks, there are many times when a drug provides important benefits, but also has serious risks. In some cases, if there is a greater assurance that those risks can be properly managed, then the benefits can support approval. This is the field of risk management, and it’s a critical function here at the agency.

Today, we’re announcing the availability of two draft guidances that will help improve our ability to ensure that the risk mitigation programs put in place for certain drugs and biologics as a requirement of their approval are working. These risk mitigation programs can help make sure that benefits of these products continue to outweigh the risks.

Risk management involves four key areas: assessing a drug’s benefit-risk balance; developing and implementing tools to minimize risks while preserving benefits; evaluating the effectiveness of such tools and re-assessing the drug’s benefit-risk balance; and making adjustments, as appropriate, to risk minimization tools to further improve the benefit-risk balance. Our primary risk management tool is communicating through FDA-approved product labeling, often referred to as the “package insert” or the “prescribing information,” which includes a summary of the essential information needed by health care providers for the safe and effective use of the drug. Labeling is sufficient for most drugs to ensure that the benefits outweigh the risks. But in a limited number of cases – 75 currently – the FDA may determine that a Risk Evaluation and Mitigation Strategy (REMS) will also be needed to help ensure that the benefits of the drug outweigh its risks. A REMS is a drug safety program that the FDA can require for certain medications with serious safety concerns to help ensure the benefits of the medication outweigh its risks. REMS are designed to reinforce medication use behaviors and actions that support the safe use of that medication.

Most REMS include a requirement to foster communication between a doctor and patient, for example, about the specific safety risk or risks that the REMS is intended to mitigate. Some REMS also include additional elements that may ensure providers have, or provide to patients, all the appropriate information to appropriately prescribe or dispense the medication. This may include limiting access until health care providers complete an educational program, assess certain confirmatory laboratory tests, or document that they counseled patient about the potential risks.

But just as important as setting the strategy for managing the risk is established, and setting clear goals for the program, is ensuring it is having the desired impact. From the onset of the REMS, the FDA works closely with companies that sell these products to determine the best way to assess its effectiveness in meeting its goals and maintaining the benefit-risk balance of the product. There’s no “one-size-fits-all” approach to assess REMS programs, as each REMS assessment  is specifically designed for the specific REMS program. As with any public health initiative, evaluating the effectiveness of a REMS is an iterative process consisting of  periodic assessment and REMS modification if necessary.

To that end, today we’re advancing new guidance on the assessment of REMS programs. The draft guidances (“REMS Assessment: Planning and Reporting Guidance for Industry” and “Survey Methodologies to Assess REMS Goals That Relate to Knowledge Guidance for Industry”) provide a framework for companies to develop a REMS Assessment Plan at the same time that the REMS program is being developed in order to improve the quality of the information used to assess the effectiveness of a REMS program, and provide post-market evidence that the REMS is meeting its risk mitigation goals.

The REMS Assessment draft guidance describes how to develop a REMS Assessment Plan by specifically considering how the REMS program goals, objectives and REMS design may impact the types of metrics and data sources that could be used to assess whether the program is meeting its risk mitigation goals. The draft guidance recommends incorporating both process indicators (i.e., the number of patients or health care providers who are enrolled or certified in the REMS) and outcome measures (i.e., the number of prevented fetal exposures to a teratogenic drug) in the REMS Assessment Plan.

Examples of metrics and data sources to evaluate the performance of the REMS are provided in the guidance. For example, drug utilization data, surveys of stakeholders, postmarket adverse event data, observational or epidemiological data as well as stakeholder input may all be helpful in assessing a REMS program. We’ve also outlined considerations for assessing the impact of REMS on patient access to the drug or the burden that the REMS impose on the health care delivery system. These considerations are critical implications of instituting REMS and can impact patient care. Properly assessing these isues can help in the design and implementation of more efficient, effective REMS.

The second guidance we are issuing today, the REMS Survey Methodologies draft guidance, provides recommendations on conducting REMS assessment surveys to evaluate patient or health care provider knowledge of REMS-related information, such as the serious risks and safe use of a medication. The draft guidance discusses general principles and recommendations related to conducting REMS assessment knowledge surveys, including study design, survey data collection and processing and data analysis.

During this period without a Fiscal Year 2019 appropriation for the FDA, the agency has been focused on making sure it continues critical aspects of our work, to the extent permitted by law. At this time, for products covered by a user fee program, such as those under a REMS, our review of existing medical product applications and associated policy development is funded by limited carryover user fee balances. The FDA will continue to update the public on how we’re approaching our work.

It’s critical that we develop and implement rigorous ways to assess the effectiveness of REMS in real-world settings. We need to make sure that the REMS are achieving their public health goals, and that we’re designing and implementing these approaches in ways that minimize burdens to patients and providers. We know there’s still much to learn about the science of risk management. Approaches and scientific methods for assessing the effectiveness of REMS continue to evolve. Our goal in providing this latest thinking on assessing REMS programs is to ensure we’re constantly improving the programs we have in place today, and establishing the most efficient and effective programs moving forward, to optimize patient care and keep Americans safe and healthy.


The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
 
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