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PNCT & Maher Terminal:  Monday, February 12th, PNCT will be CLOSED for Lincoln’s Birthday holiday


Local Closure - Port of New Orleans – February 13, 2018 - U.S. Customs & Border Protection

 Due to local Mardi Gras Day, the Port of New Orleans Customhouse Office (Port Code 2002) will be closed for business to the public on Tuesday, February 13, 2018. Filers with businesses located in or have filed (RLF) entries in New Orleans will be granted an additional day without penalty for late-filed entries or payment of duties that would become due on February 13, 2018. The new due date for payment of duties will be February 14, 2018


 Update on Informed Compliance For NMFS SIMP - U.S. Customs & Border Protection

 This announcement is to inform trade that that all filings covered by the Seafood Import Monitoring Program regulations must comply with the electronic filing requirements in order for an entry to receive a “may proceed” beginning April 7, 2018.

On January 1, 2018, mandatory compliance with regulations requiring the electronic filing of certain data at the time of entry and retention of chain of custody records for certain imported fisheries products under the Seafood Import Monitoring Program (SIMP) became effective. See 50 CFR Part 300 Subpart Q. Pursuant to CSMS # 17-000783 issued December 18, 2017, the National Marine Fisheries Service (NMFS) initially adopted an “informed compliance” approach, working with Customs and Border Protection (CBP) and filers to facilitate their full and timely compliance with SIMP without impeding the release and clearance of shipments for which the entry filer had incomplete information or was unable to successfully submit those data into ACE. NOAA has observed an encouraging and steadily increasing rate of compliance with SIMP filings. Therefore, NMFS is providing notice that SIMP informed compliance provisions will cease on April 7, 2018.

Beginning April 7, filings for products flagged for NMFS SIM (NM8) data, with no SIMP data, that are incomplete, or that contain erroneous SIM PGA data, must be corrected before they will be accepted. Filers are also reminded that the SIMP program includes a records retention provision, and all entries subject to SIMP may be audited and became subject to enforcement action beginning January 1, 2018. Those engaged in the import, export or re-export of covered species must also comply with all other requirements of NOAA trade monitoring programs including the TTVP/NOAA 370, HMS ITP, and AMLR trade programs, as applicable.

For questions regarding compliance and submissions with SIMP data that are rejected and cannot be resolved by the filer, filers are encouraged to contact NMFS at SIMPsupport@noaa.gov or call the SIMP Support Line at 301-427-8301 with an explanation of the problem.

NOTE: The code for enforcing the SIM HTS flags with a reject, will be in the ACE CERT environment by March 20, 2018.

Additional information can be obtained by using the following links:
Federal Register Notice (81 FR 88975, December 9, 2016) establishing the Seafood Import Monitoring Program: https://www.gpo.gov/fdsys/pkg/FR-2016-12-09/pdf/2016-29324.pdf

Additional Guidance on Seafood Import Monitoring Program details, contacts and requirements are posted online at: here


USITC: New Releases, Documents, Announcements

WASHINGTON, D.C. – If you, or anyone you know, uses an infant sling carrier, a new federal standard aimed at making sling carriers safer is now in effect. The U.S. Consumer Product Safety Commission (CPSC) approved the standard to prevent deaths and injuries to young children. The new standard applies to any infant sling carrier manufactured or imported after January 30th 2018.

What are the new rules?

Among other things, all infant slings must have permanently attached warning labels and come with instructions, like illustrated diagrams, to show the proper position of a child in the sling. Warning labels must include statements about:

  • The suffocation hazards posed by slings and prevention measures,
  • The hazards of children falling out of slings, and
  • A reminder for caregivers to check the buckles, snaps, rings and other hardware to make sure no parts are broken

The mandatory standard also requires sling carriers to:

  • Be able to carry up to three times the manufacturer’s maximum recommended weight,
  • Be more durable to avoid seam separations, fabric tears, breakage, etc., and
  • Be able to keep the child being carried from falling out of the sling during normal use.

What the Data Show

Between January 2003 and September 2016, 159 incidents were reported to CPSC involving sling carriers, including 17 deaths and 67 injuries to infants during use of the product.

CPSC Safety Tips for Using Infant Sling Carriers

Make sure you know how to prevent deaths and injuries when using sling carrier

  • Make sure the infant’s face is not covered and is visible at all times to the sling’s wearer.
  • If nursing the baby in a sling, change the baby’s position after feeding so the baby’s head is facing up and is clear of the sling and the mother’s body.
  • It is so important to frequently check the baby in a sling, always making sure nothing is blocking baby’s nose and mouth and baby’s chin is away from its chest.


Statement from FDA Commissioner Scott Gottlieb, M.D., on Ongoing Efforts to Mitigate Impact of Saline Shortages During This Flu Season - U.S. Food & Drug Administration

As flu activity remains widespread across the U.S., the FDA continues to monitor this situation closely and in coordination with our colleagues at the U.S. Centers for Disease Control and Prevention. We’re continuing to take steps to help ensure that people with the flu have access to critical medical products, including antivirals, saline and other supportive care drugs and devices.

This year’s flu season has been particularly challenging, with a notable number of cases leading to hospitalization. The season started earlier than usual and seemed to spread across many states quickly. H3N2, the predominant strain of the influenza A virus this season, has led to health complications that are more severe than those seen during an H1N1-predominant season. We recognize that managing the thousands of flu-related hospitalizations has increased the demand for certain saline products – which are commonly used to both hydrate and deliver medications via intravenous routes. As we’ve shared over the past several months, across the country, there remains a shortage of IV saline bags, which have long faced supply issues. These supply issues were worsened by the impact of Hurricane Maria on the medical products manufacturing sector in Puerto Rico, which impacted small volume IV bags. Although the saline shortage is improving, this year’s worse-than-normal flu season and workarounds deployed by health care providers in the wake of this shortage have increased demand for saline and other products.The products include large volume saline bags typically used to hydrate patients; small volume IV saline bags (generally in 50 and 100 ml sizes) that are often used to deliver other medicines; as well as empty IV containers of varying sizes that are being used by many health care providers to compound their own IV saline solutions by filling these empty containers. As such, we’re actively working to improve the large and small IV bag shortage and tracking potential shortages of critical medical products, such as the empty IV containers.

We are also hearing from some health care providers that there are spot shortages of some antivirals used to treat the flu and flu tests; however, at this time, there is no nationwide shortage of these products. The FDA is carefully monitoring the situation and we will provide updates as needed. Along with antivirals and device products we are also monitoring influenza vaccine supplies. While there have been some reported spot shortages, flu vaccines are still available. I strongly encourage anyone who hasn’t had a flu shot to get one and anyone experiencing flu-like symptoms to promptly consult with their health care provider about appropriate treatment options.

We continue to work closely with the companies that manufacture saline to limit and improve the shortage issues using all our various tools and resources. We’re committed to updating you on the ongoing saline shortage. With the increased demands for saline due to the flu season, I wanted to share more about our new and ongoing work to address cascading supply issues.

While we expect supplies of saline to increase over the next month, having adequate supplies, especially during this severe flu season, is a critical matter of public health. Most recently, the FDA was able to extend the expiration dates of certain products, including some 500 ml size saline bags, after carefully examining the data submitted by the company to ensure that it meets the FDA’s quality and safety standards. We continue to encourage companies to submit data to extend expiration dates for drugs in shortage. We’ve also been working with manufacturers such as Baxter and B. Braun to import products into the U.S. from their foreign facilities, including most recently additional products from a Baxter facility in Brazil.

We’ve also been proactively engaging with providers, manufacturers, distributors and other partners to identify and address issues impacting other products – like the empty IV containers I mentioned. By engaging with these partners, we can better identify the types of empty IV containers and other medical products that are most in demand. We’re also working to identify the specific features of products that are preferred or required by health care providers, such as size or function of the containers. We’re using this aggregated information -- and sharing it with existing and new manufacturers -- to help identify existing supply gaps. We’re taking steps to fill these gaps. Several manufacturers have indicated to us that they have the potential to initiate or ramp up production of empty IV containers to help address these public health risks. We’re grateful that they have indicated a willingness to do their part to help mitigate these challenges. We’re communicating directly with these companies, which include Douglas Medical Products Inc., Summit Medical Products Inc. and Valmed SRL.

While we expect that the flu season will peak soon, we’re committed to working with our partners to address the challenges we face until this severe flu season ends. We are also optimistic that saline supplies will continue to improve over the coming weeks. But, we recognize that rising demand for these products may continue to put a strain on availability, even as production and supply grow. We remain committed to looking at innovative ways that we can connect partners across the supply chain to find solutions and foster communication. The hurricanes and flu season have underscored the importance of preparedness and connectivity across the agency, the industries we regulate, as well as distributors and health care providers to best serve patients that need access to these critical products.

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 https://www.fda.gov/Drugs/DrugSafety/DrugShortages/default.htmsafety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.


Notice to Passengers: NCL NORWEGIAN BREAKAWAY - Federal Maritime Commission

Norwegian Cruise Line (NCL) has advised the Federal Maritime Commission that it intends to offer some compensation to passengers who were on board the NORWEGIAN BREAKAWAY when that vessel encountered severe weather on a voyage returning to New York on January 5, 2018.

For details and restrictions on the offer NCL will make to affected parties, including expiration date, contact your travel professional or the NCL Reservation Department at 1-800-327-7030.

The Federal Maritime Commission reminds cruise passengers that they should always carefully read their ticket contract, which states the cruise line’s obligations with respect to cancelled voyages and changes in itinerary due to weather.

If cruise passengers have purchased travel insurance, they should consult their policy to determine whether to file a claim.

The Federal Maritime Commission has limited authority over cruise lines and administers the legal requirements that Passenger Vessel Operators (PVOs) maintain financial responsibility for the protection of passengers for non-performance of a cruise or a death or injury while on a cruise.

To request assistance regarding a dispute with a cruise line, contact the Federal Maritime Commission’s Office of Consumer Affairs & Dispute Resolution Services at 202-523-5807 or at complaints@fmc.gov.

 
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