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USCIS Reminds Beneficiaries of Temporary Protected Status for Guinea, Liberia, and Sierra Leone of May 21 Termination USCIS is reminding the public that the designations of Temporary Protected Status (TPS) for Guinea, Liberia, and Sierra Leone terminate effective May 21, 2017. To provide sufficient time for an orderly transition, the Department of Homeland Security gave beneficiaries under these three designations 8 months advance notice of the expiration by publishing 3 notices in the Federal Register on Sept. 22, 2016 (one for each country). These notices urged individuals who did not have another immigration status to use the time before the terminations became effective in May to prepare for and arrange their departure from the United States or to apply for other immigration benefits for which they may be eligible. Although TPS benefits will no longer be in effect starting May 21, 2017, TPS beneficiaries will continue to hold any other immigration status that they have maintained or acquired while registered for TPS. Individuals with no other lawful immigration status on May 21, 2017, will no longer be protected from removal or eligible for employment authorization based on TPS. TPS-related Employment Authorization Documents issued under the Guinea, Liberia, and Sierra Leone designations are only valid through May 20, 2017, and will not be renewed or extended. After reviewing country conditions and consulting with the appropriate U.S. government agencies, former Secretary of Homeland Security Jeh Johnson determined that conditions in Guinea, Liberia, and Sierra Leone no longer support their designations for TPS. The widespread transmission of Ebola virus in the three countries that led to the designations has ended. Additional information about TPS is available at uscis.gov/tps. For more information about USCIS, visit uscis.gov or follow us on Twitter (@uscis), YouTube (/uscis), Facebook (/uscis), and Instagram(/uscis). U.S. Citizenship and Immigration Services today announced a redesign to the Permanent Resident Card (also known as a Green Card) and the Employment Authorization Document (EAD) as part of the Next Generation Secure Identification Document Project. USCIS will begin issuing the new cards on May 1, 2017. These redesigns use enhanced graphics and fraud-resistant security features to create cards that are highly secure and more tamper-resistant than the ones currently in use. The new card designs demonstrate USCIS’ commitment to continue taking a proactive approach against the threat of document tampering and fraud. They are also part of an ongoing effort between USCIS, U.S. Customs and Border Protection, and U.S. Immigration and Customs Enforcement to enhance document security and deter counterfeiting and fraud. The Redesigned Cards The new Green Cards and EADs will: Display the individual’s photos on both sides; Show a unique graphic image and color palette: Green Cards will have an image of the Statue of Liberty and a predominately green palette; EAD cards will have an image of a bald eagle and a predominately red palette; Have embedded holographic images; and No longer display the individual’s signature. Also, Green Cards will no longer have an optical stripe on the back. How To Tell If Your Card Is Valid Some Green Cards and EADs issued after May 1, 2017, may still display the existing design format as USCIS will continue using existing card stock until current supplies are depleted. Both the existing and the new Green Cards and EADs will remain valid until the expiration date shown on the card. Certain EADs held by individuals with Temporary Protected Status (TPS) and other designated categories have been automatically extended beyond the validity date on the card. For additional information on which EADs are covered, please visit the Temporary Protected Status and American Competitiveness in the 21st Century Act web pages on uscis.gov. Both versions are acceptable for Form I-9, Employment Eligibility Verification, E-Verify, and Systematic Alien Verification for Entitlements (SAVE). Some older Green Cards do not have an expiration date.  These older Green Cards without an expiration date remain valid. Individuals who have Green Cards without an expiration date may want to consider applying for a replacement card bearing an expiration date. Obtaining the replacement card will reduce the likelihood of fraud or tampering if the card is ever lost or stolen.  Eligibility for Green Cards and EADs For more information about the Green Card application process, please visit USCIS.gov/greencard. To request an EAD, you must file Form I-765, Application for Employment Authorization. Visit uscis.gov for more information about EADs.  Απρ 19 τις 6:35 μ.μ. FTC Staff Reminds Influencers and Brands to Clearly Disclose Relationship Commission aims to improve disclosures in social media endorsements After reviewing numerous Instagram posts by celebrities, athletes, and other influencers, Federal Trade Commission staff recently sent out more than 90 letters reminding influencers and marketers that influencers should clearly and conspicuously disclose their relationships to brands when promoting or endorsing products through social media. The letters were informed by petitions filed by Public Citizen and affiliated organizations regarding influencer advertising on Instagram, and Instagram posts reviewed by FTC staff. They mark the first time that FTC staff has reached out directly to educate social media influencers themselves. The FTC’s Endorsement Guides provide that if there is a “material connection” between an endorser and an advertiser – in other words, a connection that might affect the weight or credibility that consumers give the endorsement – that connection should be clearly and conspicuously disclosed, unless it is already clear from the context of the communication. A material connection could be a business or family relationship, monetary payment, or the gift of a free product. Importantly, the Endorsement Guides apply to both marketers and endorsers. In addition to providing background information on when and how marketers and influencers should disclose a material connection in an advertisement, the letters each addressed one point specific to Instagram posts -- consumers viewing Instagram posts on mobile devices typically see only the first three lines of a longer post unless they click “more,” which many may not do. The staff’s letters informed recipients that when making endorsements on Instagram, they should disclose any material connection above the “more” button. The letters also noted that when multiple tags, hashtags, or links are used, readers may just skip over them, especially when they appear at the end of a long post – meaning that a disclosure placed in such a string is not likely to be conspicuous. Some of the letters addressed particular disclosures that are not sufficiently clear, pointing out that many consumers will not understand a disclosure like “#sp,” “Thanks [Brand],” or “#partner” in an Instagram post to mean that the post is sponsored. The staff’s letters were sent in response to a sample of Instagram posts making endorsements or referencing brands. In sending the letters, the staff did not predetermine in every instance whether the brand mention was in fact sponsored, as opposed to an organic mention. In addition to the Endorsement Guides, the FTC has previously addressed the need for endorsers to adequately disclose connections to brands through law enforcement actions and the staff’s business education efforts. The staff also issued FTC’s Endorsement Guides: What People are Asking, an informal business guidance document that answers frequently asked questions. The staff’s letters to endorsers and brands enclosed copies of both guidance documents. The FTC is not publicly releasing the letters or the names of the recipients at this time. The Federal Trade Commission works to promote competition, and protect and educate consumers. You can learn more about consumer topics and file a consumer complaint online or by calling 1-877-FTC-HELP (382-4357). Like the FTC on Facebook, follow us on Twitter, read our blogs and subscribe to press releases for the latest FTC news and resources.  Απρ 19 τις 6:24 μ.μ. Influencers, are your #materialconnection #disclosures #clearandconspicuous? By Lesley Fair If Instagram is the home of Throwback Thursday and Flashback Friday, #IGers should think of today as Word to the Wise Wednesday. Read more >  Απρ 19 τις 5:41 μ.μ. April 18, 2017 Drug Firm Annual Registration Status (updated) Drug Firm Annual Registration Status Download File (updated) Drug Trials Snapshots: OCREVUS FDA Drug Shortages Estradiol Valerate Injection, USP (Updated - Currently in Shortage) National Drug Code Directory Wholesale Distributor and Third-Party Logistics Providers Reporting (updated) New and Generic Drug Approvals Drugs@FDA: FDA Approved Drug Products April 18, 2017 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Dabigatran Etexilate  ANDA #207984 Dabigatran Etexilate Capsule; Oral ORIG-1 Glenmark Pharms Ltd   Tentative Approval Eptifibatide  ANDA #204589 Eptifibatide Injectable; Injection ORIG-1 Akorn   Approved Lopid  NDA #018422 Gemfibrozil Capsule; Oral SUPPL-56 Pfizer Pharms LABELING Approved Lopid  NDA #018422 Gemfibrozil Tablet; Oral SUPPL-56 Pfizer Pharms LABELING Approved April 17, 2017 Drug Name and Application Number Active Ingredient Dosage Form/ Route Submission Company Submission Classification Submission Status Bupropion Hydrochloride  ANDA #205794 Bupropion Hydrochloride Tablet, Extended Release; Oral SUPPL-1 Sciegen Pharms Inc LABELING Approved Bupropion Hydrochloride  ANDA #206674 Bupropion Hydrochloride Tablet, Extended Release; Oral SUPPL-1 Invagen Pharms LABELING Approved Glimepiride  ANDA #076802 Glimepiride Tablet; Oral SUPPL-18 Teva LABELING Approved Glimepiride  ANDA #077274 Glimepiride Tablet; Oral SUPPL-8 Corepharma LABELING Approved Glimepiride  ANDA #077624 Glimepiride Tablet; Oral SUPPL-6 Mylan LABELING Approved Myoview  NDA #020372 Technetium Tc-99m Tetrofosmin Kit Injectable; Injection SUPPL-28 Ge Healthcare LABELING Approved Myoview 30ml  NDA #020372 Technetium Tc-99m Tetrofosmin Kit Injectable; Injection SUPPL-28 Ge Healthcare LABELING Approved Nicotine Polacrilex  ANDA #074507 Nicotine Polacrilex Gum, Chewing; Buccal SUPPL-59 Actavis Labs Ny Inc LABELING Approved Nicotine Polacrilex  ANDA #076789 Nicotine Polacrilex Gum, Chewing; Buccal SUPPL-23 Perrigo LABELING Approved Tecentriq  BLA #761034 Atezolizumab Injectable; Injection SUPPL-1 Genentech Inc EFFICACY Approved Zelboraf  NDA #202429 Vemurafenib Tablet; Oral SUPPL-12 Hoffmann La Roche LABELING Approved The FDA Supports Research to Reduce Health Disparities Scientific researchers now are working on how to reduce health disparities (differences in health outcomes) among racial and ethnic minorities. And they're doing it with the help of funding from—and by working with—the U.S. Food and Drug Administration. Get the scoop on what the FDA is doing. Watch our YouTube video to learn more about Consumer Updates. Center for Food Safety and Applied Nutrition Constituent Update FDA Recognizes Australia as Having a Comparable Food Safety System to the U.S. April 19, 2017 The U.S. Food and Drug Administration has signed an arrangement with the Australian Department of Agriculture and Water Resources recognizing each other’s food safety systems as comparable to each other. This is the third time that the FDA has recognized a foreign food safety system as comparable, the first being New Zealand in 2012 and Canada in 2016.    By recognizing each other’s systems, the FDA and Australian Department of Agriculture and Water Resources have confidence that they can leverage each other’s science-based regulatory systems to help ensure food safety. For example, each partner intends to consider the oversight of the other when prioritizing inspection activities, but the benefits go beyond inspection and admissibility. Systems recognition establishes a framework for regulatory cooperation in a variety of areas that range from scientific collaboration to outbreak response. Systems recognition involves reviewing a foreign country’s domestic food safety regulatory system to determine if it has a food safety system that provides a similar system of food safety protection to that provided by the FDA. Domestic systems provide the baseline level of public health protection that helps assure the safety of exported foods from that country. Systems recognition also helps the FDA focus more on potential risks when planning the scope and frequency of its inspection activities, including foreign facility inspections, import field exams, and import sampling.  The FDA, working with Australian Department of Agriculture and Water Resources, conducted a systems recognition review and assessment using the International Comparability Assessment Tool. The process includes a comprehensive review of key elements of the country’s national food safety control system such as its relevant laws and regulations, inspection programs, response to food-related illness and outbreaks, compliance and enforcement and laboratory support. Systems recognition is voluntary and not required in order for a country to export foods to the U.S. The FDA continues to have inspection authority over food imported from any country with which it has an arrangement and can exercise this authority as needed. Imports from Australia must continue to comply with U.S. statutory and regulatory requirements to ensure safety and proper labeling, including the new standards adopted under the FDA Food Safety Modernization Act. For more information see: International Cooperation International Comparability Assessment Tool (ICAT) (PDF: 394KB) Report of the Systems Recognition Review of Australia by the U.S. FDA (PDF: 605KB) FDA Issues Information for Foreign Governments: Frequently Asked Questions on Systems Recognition La Granja INC. Recalls Mango Flavored Ice cream Because of Possible Health Risk 04/18/2017 08:46 PM EDT La Granja INC of Doraville Georgia is recalling 4000 units of Hand crafted Paleteria, Mango Flavored Ice cream, because it has the potential to be contaminated with Salmonella Enteritidis, 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 pain and diarrhea. Long term complications can include severe arthritis. For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.  Northern California Whole Foods Market Stores Issue Recall for Undeclared Allergens in Some Cookies 04/16/2017 09:55 PM EDT Nine Whole Foods Market stores in Northern California are voluntarily recalling some decorated (iced) cookies from the self-service cookie displays because the products contained egg allergen that was not listed on the product sign. People who have an allergy or severe sensitivity to eggs run the risk of serious or life-threatening allergic reaction if they consume these products. For detailed information pertaining to this Recalls, Market Withdrawals and Safety Alerts message, please click the link at the beginning of this bulletin.