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MedWatch - The FDA Safety Information and Adverse Event Reporting Program
An update to a previous MedWatch Safety Alert: Infants’ Ibuprofen Concentrated Oral Suspension by Tris Pharma: Recall - Due to Potential Higher Concentrations of Ibuprofen wasjust updated on the FDA Recalls webpage. Three additional lots of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, have been added.
Nature’s Rx Issues Voluntary Nationwide Recall of Silver Bullet 10x to Undeclared PDF-5 Inhibitors in the ProductNature’s Rx is voluntarily recalling quantity lots of Silver Bullet 10x, description of dosage form to the hospital, retail or consumer level. This recall has been initiated because the product was found to contain undeclared sildenafil and tadalafil, the active ingredient in Viagra and Cialis respectively, which are PDE-5 inhibitors. The undeclared PDE-5 inhibitors in the product may pose serious health risks because consumers with underlying medical issues may take the products without knowing that they can cause serious harm or interact in dangerous ways with other drugs they may be taking. For example, PDE-5 inhibitors may interact with nitrates found in some prescription drugs (such as nitroglycerin) and thus can lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, or heart disease often take nitrates.
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Monmouth Junction, NJ, Tris Pharma, Inc. is expanding the scope of its November 2018 recall by adding three (3) additional lots of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL, to the retail (pharmacy) level. Some units from these batches have been found to have higher levels of Ibuprofen concentration.
Infants already susceptible to the adverse effects of ibuprofen may be at a slightly higher risk if they receive medication from an impacted bottle. There is a remote probability that infants, who may be more susceptible to a higher potency level of drug, may be more vulnerable to permanent NSAID-associated renal injury
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Oskri Organics Corporation Recalls All Nut Butters because of Possible Health Risk
Oskri Organics Corporation of Lake Mills, WI is recalling ALL Oskri Corporation manufactured nut butters.
This recall has been initiated due to positive test results for Listeria monocytogenesfound in multiple Oskri Corporation manufactured nut butters. Consumption of this product may cause potential health risk.
Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain, and diarrhea. Listeria monocytogenes infection can cause miscarriages and stillbirths among pregnant women.
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In response to a recall by Satur Farms, Whole Foods Market is voluntarily recalling various prepared foods items in eight states containing baby spinach because of a potential contamination of Salmonella.
Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.
MedWatch - The FDA Safety Information and Adverse Event Reporting Program
A new MedWatch Safety Alert recall: VentStar and ID Breathing Circuits and Anesthesia Sets by Draeger Medical: Class I Recall - Due to a Risk of the Devices Being Incorrectly Assembledwas just added to the FDA Recalls webpage.
MedWatch - The FDA Safety Information and Adverse Event Reporting Program
A new MedWatch Safety Alert recall: Silver Bullet 10x by Nature’s Rx: Recall - Due Undeclared PDF-5 Inhibitors in the Product was just added to the FDA Recalls webpage.
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Final Rule Effective Beginning April 1, 2019
WASHINGTON—The Department of Homeland Security (DHS) posted today for public inspection, a final rule amending regulations governing H-1B cap-subject petitions, including those that may be eligible for the advanced degree exemption. The final rule reverses the order by which U.S. Citizenship and Immigration Services (USCIS) selects H-1B petitions under the H-1B regular cap and the advanced degree exemption, and it introduces an electronic registration requirement for petitioners seeking to file H-1B cap-subject petitions. The rule will be published in the Federal Register on Jan. 31, and will go into effect on April 1, though the electronic registration requirement will be suspended for the fiscal year (FY) 2020 cap season.
“These simple and smart changes are a positive benefit for employers, the foreign workers they seek to employ, and the agency’s adjudicators, helping the H-1B visa program work better,” said USCIS Director L. Francis Cissna. “The new registration system, once implemented, will lower overall costs for employers and increase government efficiency. We are also furthering President Trump’s goal of improving our immigration system by making a simple adjustment to the H-1B cap selection process. As a result, U.S. employers seeking to employ foreign workers with a U.S. master’s or higher degree will have a greater chance of selection in the H-1B lottery in years of excess demand for new H-1B visas.”
Effective April 1, USCIS will first select H-1B petitions (or registrations, once the registration requirement is implemented) submitted on behalf of all beneficiaries, including those that may be eligible for the advanced degree exemption. USCIS will then select from the remaining eligible petitions, a number projected to reach the advanced degree exemption. Changing the order in which USCIS counts these allocations will likely increase the number of petitions for beneficiaries with a master’s or higher degree from a U.S. institution of higher education to be selected under the H-1B numerical allocations. Specifically, the change will result in an estimated increase of up to 16% (or 5,340 workers) in the number of selected petitions for H-1B beneficiaries with a master’s degree or higher from a U.S. institution of higher education.
USCIS will begin accepting H-1B cap petitions for FY 2020 on April 1, 2019. The reverse selection order will apply to petitions filed for the FY 2020 H-1B cap season. Petitioners may file an H-1B petition no more than six months before the employment start date requested for the beneficiary. USCIS will provide H-1B cap filing instruction on uscis.gov in advance of the filing season.
Importantly, after considering public feedback, USCIS will be suspending the electronic registration requirement for the FY 2020 cap season to complete user testing and ensure the system and process are fully functional. Once implemented, the electronic registration requirement will require petitioners seeking to file H-1B cap petitions, including those that may be eligible for the advanced degree exemption, to first electronically register with USCIS during a designated registration period. Only those whose registrations are selected will be eligible to file an H-1B cap-subject petition. USCIS expects that the electronic registration requirement, once implemented, will reduce overall costs for petitioners and create a more efficient and cost-effective H-1B cap petition process for USCIS and petitioners.
Additionally, USCIS will publish a notice in the Federal Register to announce the initial implementation of the H-1B registration process in advance of the cap season in which it will implement the requirement. Prior to implementation, USCIS will conduct outreach to ensure petitioners understand how to access and use the system. Once implemented, USCIS will announce the designated electronic registration period at least 30 days in advance for each fiscal year it is required.
On April 18, 2017, President Trump issued the Buy American and Hire American Executive Order, instructing DHS to “propose new rules and issue new guidance, to supersede or revise previous rules and guidance if appropriate, to protect the interests of U.S. workers in the administration of our immigration system.” The executive order specifically mentioned the H-1B program and directed DHS and other agencies to “suggest reforms to help ensure that H-1B visas are awarded to the most-skilled or highest-paid petition beneficiaries.”
For more information on USCIS and our programs, please visit uscis.gov or follow us on Twitter (@uscis), Instagram (/uscis), YouTube (/uscis), Facebook (/uscis), and Linkedin (/uscis).
Applicants Can Now Request Certificates of Citizenship Online
WASHINGTON – U.S. Citizenship and Immigration Services (USCIS) announced today that applicants can now complete and file Form N-600, Application for Certificate of Citizenship, and Form N-600K, Application for Citizenship and Issuance of Certificate Under Section 322 online.
“One of the major burdens to both benefit seekers and the agency’s adjudicators is the costly, time consuming, and cumbersome process of traditional paper filing,” said USCIS Director L. Francis Cissna. “This addition to our online capabilities is yet another positive advancement toward a more efficient and convenient filing experience for everyone involved.”
Applicants can file Form N-600 to obtain a Certificate of Citizenship for themselves or their minor children if they:
- Were born abroad and are claiming U.S. citizenship at birth through their parents; or
- Automatically became a U.S. citizen after birth, but before they turned 18 years old.
Applicants can file Form N-600K if they regularly reside in a foreign country and want to claim U.S. citizenship based on their parents. Applicants must secure lawful admission to the U.S. to complete Form N-600K processing. Children of U.S. service members have separate requirements for naturalization under INA Section 322.
Forms N-600 and N-600K are part of the growing number of documents that USCIS has made available for easy and convenient online filing. This list includes:
- Form I-90, Application to Replace Permanent Resident Card;
- Form N-336, Request for a Hearing on a Decision in Naturalization Proceedings;
- Form N-400, Application for Naturalization; and
- Form N-565, Application for Replacement Naturalization/Citizenship Document.
To file a Form N-600 or N-600K online, an applicant must first create a USCIS online account. Through an online account, the applicant can securely and conveniently:
- Complete Form N-600 or N-600K;
- Submit accompanying evidence;
- Upload passport-style photos;
- Pay the filing fee;
- Respond to USCIS requests for evidence;
- Monitor the status of their application; and
- Manage their contact information, including updating their address.
Attorneys and accredited representatives who have an online account can also file online for their clients and perform the above listed functions.
USCIS still accepts the latest paper version of Forms N-600 and N-600K. Because military service members do not pay a filing fee when submitting Form N-600 on their own behalf, they cannot currently file this application online.
USCIS is using innovation and technology to meet the needs of applicants, employees, and stakeholders. Regardless of the paper or electronic format of an application, USCIS is committed to ensuring a secure and efficient process for all applicants.
For more information on USCIS and our programs, please visit uscis.gov or follow us on Twitter (@uscis), YouTube (/uscis), and Facebook (/uscis).
WASHINGTON—U.S. Citizenship and Immigration Services (USCIS) announced today that applicants who have a pending affirmative asylum application with USCIS can now check the status of their applications online at uscis.gov/casestatus. Only asylum applicants with an application pending with USCIS will be able to use this new feature to check their case status online. It will not cover defensive asylum applicants whose cases are pending in immigration court.
“The new capability increases transparency and assures applicants that they have the most up-to-date and accurate information about their case, 24 hours a day, seven days a week,” said USCIS Director L. Francis Cissna. “We strive to adjudicate all applications and petitions in a timely manner and are working to reduce the impact on processing times by aligning resources appropriately.”
Previously, asylum applicants could only check their case status through an asylum office in person or by phone, fax, or email. Non-governmental organizations and stakeholders within the legal community informed USCIS that asylum applicants have found this process is very difficult. Furthermore, giving asylum applicants the ability to check their case status online allows asylum office staff to better focus their resources on scheduling interviews and adjudicating pending cases.
This enhancement is a part of our overall modernization efforts to provide a more efficient and effective user experience.
For more information on USCIS and its programs, please visit uscis.gov or follow us on Twitter (@uscis), Instagram (/uscis), YouTube (/uscis), and Facebook(/uscis). |
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=================================== FTC Imposes Conditions on Staples’ Acquisition of Office Supply Wholesaler Essendant Inc.Settlement will prevent anticompetitive harm by restricting Staples’ access to Essendant’s commercially sensitive data Office supply distributors Staples Inc. and Essendant Inc. have agreed to a settlement as part of the companies’ proposed $482.7 million merger in order to resolve Federal Trade Commission allegations that the deal may have harmed competition in the market for office supply products sold to small- and mid-sized businesses. Staples, which is owned by the private-equity firm Sycamore Partners, will establish a firewall separating Staples’ business-to-business sales operations from Essendant’s wholesale business, under the settlement order with the FTC. This firewall will restrict Staples’ access to the commercially sensitive information of Essendant’s customers. Staples is the largest vertically integrated reseller of office products in the United States, and one of only two retail office supply superstores in the United States. Essendant is the largest U.S. wholesale distributor of office products, including sales of office products, janitorial products, breakroom supplies, technology products, office furniture, and industrial and automotive products. It sells a range of office products to office supply resellers and owns a network of distribution centers and trucks. In a complaint filed along with the proposed consent agreement, the FTC alleged that Staples competes with Essendant-sourced independent dealers to sell office supplies to mid-sized business customers. As a result of the acquisition, Staples would have access to commercially sensitive business information on Essendant’s reseller customers, and those resellers’ end customers, which could allow Staples to offer higher prices than it otherwise would when bidding against a reseller for an end customer’s business. The proposed settlement order will limit access to commercially sensitive information of dealers who buy from Essendant, including those dealers’ data about their customers, to only those Staples employees who will be performing wholesale functions. Further details about the consent agreement, which allows the Commission to appoint a monitor and requires prior notice to the Commission for certain acquisitions, are set forth in the analysis to aid public comment for this matter. The Commission vote to issue the complaint and accept the proposed consent order for public comment was 3-2. Chairman Simons, Commissioner Phillips, and Commissioner Wilson issued a statement. Commissioner Wilson also issued a separate statement, and Commissioner Chopra and Commissioner Slaughter issued dissenting statements. The FTC will publish the consent agreement package in the Federal Register shortly. The agreement will be subject to public comment for 30 days, beginning today and continuing through Feb. 27, 2019. The Commission issued the accompanying Decision and Order as final prior to seeking public comment, as provided in Section 2.34(c) of the Commission’s Rules. This will allow the Commission to enforce the Order if there are any violations of its provisions during the public comment period. Comments received during this period will become part of the public record. After 30 days, the Commission again will review the proposed Consent Agreement and comments received, and decide whether it should withdraw from the Consent Agreement, or modify the accompanying Order. Comments can be filed electronically or in paper form by following the instructions in the “Supplementary Information” section of the Federal Register notice. NOTE: The Commission issues an administrative complaint when it has “reason to believe” that the law has been or is being violated, and it appears to the Commission that a proceeding is in the public interest. When the Commission issues a consent order on a final basis, it carries the force of law with respect to future actions. Each violation of such an order may result in a civil penalty of up to $41,484. The Federal Trade Commission works to promote competition, and protect and educate consumers. You can learn more about how competition benefits consumers or file an antitrust complaint. Like the FTC on Facebook, follow us on Twitter, read our blogs, and subscribe to press releases for the latest FTC news and resources. Related Case Sycamore Partners II, L.P., Staples, Inc. and Essendant Inc., In the Matter ofRelated Actions Statement of Chairman Simons, Commissioner Phillips, and Commissioner Wilson In the Matter of Sycamore Partners II, L.P., Staples, Inc. and Essendant Inc.Statement of Commissioner Chopra In the Matter of Sycamore Partners II, L.P., Staples, Inc. and Essendant Inc.Statement of Commissioner Slaughter In the Matter of Sycamore Partners II, L.P., Staples, Inc. and Essendant Inc.Statement of Commissioner Wilson In the Matter of Sycamore Partners II, L.P., Staples, Inc. and Essendant Inc.More news from the FTC >>
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