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As part of your estate and advance health care planning, having a power of attorney is a critical component of protecting your interests. Unlike a will which outlines your wishes, and how your wealth and property will be distributed after you are gone; this legal document authorizes another person to act on your behalf when you are not able to manage your affairs on your own. Documenting your requests can be difficult to address but doing so could resolve certain legal issues if done in advance. By designating someone to make decisions for you means your wishes will be carried out when you may not have a voice. Take action on this vital document today. Learn more about navigating power of attorneys on USA.gov. The Department of Homeland Security (DHS) has recently established a new web page to communicate up-to-date information on recent executive orders about immigration, travel, and protecting our homeland. Find information about executive orders regarding immigration and homeland security. Learn more about immigration and travel on USA.gov. Sunday, April 2, is World Autism Day. Autism Spectrum Disorder (ASD) is a development disability that can cause significant social, communication and behavioral challenges. Review this list of developmental milestones for children for general information. If you have questions, consult your child’s pediatrician to address your concerns. For more health resources from the government, visit us at USA.gov.  edWatch - The FDA Safety Information and Adverse Event Reporting Program EpiPen and and EpiPen Jr Auto-Injector: Recall - Failure to Activate Device AUDIENCE: Consumer, Pharmacy ISSUE: Mylan N.V. announced that Meridian Medical Technologies, a Pfizer company and Mylan’s manufacturing partner for EpiPen Auto-Injector, has expanded a voluntary recall of select lots of EpiPen (epinephrine injection, USP) and EpiPen Jr (epinephrine injection, USP) Auto-Injectors to now include additional lots distributed in the U.S. and other markets. This recall is being conducted as a result of the receipt of two previously disclosed reports outside of the U.S. of failure to activate the device due to a potential defect in a supplier component. The potential defect could make the device difficult to activate in an emergency (failure to activate or increased force needed to activate) and have significant health consequences for a patient experiencing a life-threatening allergic reaction (anaphylaxis). Both reports are related to the single lot that was previously recalled. The recall impacts the 0.3 mg and 0.15 mg strengths of EpiPen Auto-Injector. The recalled product was manufactured by Meridian Medical Technologies and distributed by Mylan Specialty between December 2015 and July 2016. None of the recalled lots include the authorized generic for EpiPen Auto-Injector, which is also manufactured by Meridian Medical Technologies. See the news release for a list of affected product lot numbers. BACKGROUND: The expanded voluntary recall is being initiated in the U.S. and also will extend to additional markets in Europe, Asia, North and South America. RECOMMENDATION: Patients, customers and distributors are being notified and should refer to Mylan.com/EpiPenRecall for updates on product return and replacement instructions. We are asking patients to keep their existing product until their replacement product can be secured. Patients may receive either EpiPen Auto-Injector or the authorized generic for EpiPen Auto-Injector at the pharmacy as a replacement based on availability. The authorized generic has the exact same drug formulation, has the exact same operating instructions and is therapeutically equivalent to EpiPen Auto Injector, and may be substituted for EpiPen Auto Injector. It is important that patients continue to carry their current EpiPen Auto-Injector until they receive a replacement device.  Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report Online: www.fda.gov/MedWatch/report Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 Read the MedWatch safety alert, including a link to the news release, at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm550165.htm Prelude Short Sheath Introducer by Merit Medical Systems: Class I Recall - Sheath May Separate During Use AUDIENCE: Risk Manager, Surgery, Cardiology, Nephrology ISSUE: Merit Medical Systems Inc. is recalling the Prelude Short Sheath Introducer due to a manufacturing defect which may cause the tip to separate from the sheath during the insertion procedure. If this occurs, the tip could enter the patient's bloodstream. This may result in prolonged procedure times, additional surgery to remove the tip from the patient, blood clots, internal tears and perforation to arteries or veins, excessive bleeding, and death. Recalled Product: Merit 7F Prelude Short Sheath Introducers Lot Numbers: H1041469, H1041473, H1036880, H1041464 Catalog Numbers: K15-00070, K15-00170, PSS-7F-4-035MT, PSS-7F-4MT Manufacturing Dates: November 23, 2016 to November 30, 2016 Distribution Dates: December 15, 2016 to January 18, 2017 Devices Recalled in the U.S.:  1,265 units BACKGROUND: The Merit Prelude Short Sheath Introducer is used to guide the placement of catheters, grafts, and other medical devices into the veins and arteries. The device is also used during temporary hemodialysis, a treatment for kidney failure. RECOMMENDATION: On February 16, 2017, Merit Medical Inc. sent an Urgent Product Recall Notice to affected customers. The notice also asked customers to: Ensure appropriate staff is aware of the notice. Quarantine any affected products and discontinue use. Complete the Customer Response Form attached to the notice and return by email at response@merit.com. Return all affected lots in possession to Merit Medical Inc. per the instructions found in the Customer Response Form. Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: Complete and submit the report Online: www.fda.gov/MedWatch/report Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 Read the MedWatch safety alert, including a link to the FDA Recall Notice, at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm550080.htm Center for Food Safety and Applied Nutrition Constituent Update FDA Recognizes DUNS Number as Acceptable for Importer Identification March 31, 2017 Today, the U.S. Food and Drug Administration took a step towards ensuring the accuracy of its inventory of importers responsible for meeting the requirements of the Foreign Supplier Verification Programs (FSVP) rule. The FDA issued guidance formally recognizing the Data Universal Numbering System (DUNS) number as an acceptable unique facility identifier (UFI) for FSVP. The identification of importers will help the FDA effectively implement, monitor compliance with, and enforce the FSVP requirements, which are designed to help ensure that imported foods meet U.S. safety standards. The final FSVP rule, mandated by the FDA Food Safety Modernization Act (FSMA), requires that an importer provide its legal business name, electronic mailing address, and UFI recognized as acceptable by the FDA for each line entry of food product offered for importation into the United States. In the preamble to the final rule, FDA stated that it anticipated issuing guidance specifying which UFI(s) we recognize as acceptable and that we expected to recognize DUNS numbers as acceptable. The DUNS number, assigned and managed by Dun & Bradstreet, is available free of charge to importers. It can be obtained by contacting D&B by phone at 866-705-5711, via email at govt@dnb.com, by visiting D&B’s Website or fdadunslookup.com. The first compliance date for importers subject to the FSVP rule is May 30, 2017. For More Information: Guidance for Industry: Recognition of Acceptable Unique Facility Identifier (UFI) for the Foreign Supplier Verification Programs Regulation Compliance Dates for the Final Rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals FSVP Factsheet (PDF: 265KB) Am I Subject to FSVP? (PDF: 69KB) Απρ 1 τις 1:23 π.μ. NetSpend Settles FTC Charges NetSpend Corporation has agreed to settle Federal Trade Commission allegations that the prepaid card company deceived people about access to funds deposited on NetSpend debit cards. The Commission vote approving the stipulated final order was 2-1, with Acting Chairman Ohlhausen dissenting and issuing a statement. Commissioner McSweeny also issued a statement. On March 31, 2017, the Commission filed a stipulation requesting entry of the order in the United States District Court for the Northern District of Georgia. NOTE: Stipulated final orders have the force of law when approved and signed by the District Court judge. Then-Commissioner (and former Chairwoman) Edith Ramirez registered a vote in the affirmative for the motion to approve this settlement before she left the Commission. 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. NetSpend Settles FTC Charges NetSpend Corporation has agreed to settle Federal Trade Commission allegations that the prepaid card company deceived people about access to funds deposited on NetSpend debit cards. The Commission vote approving the stipulated final order was 2-1, with Acting Chairman Ohlhausen dissenting and issuing a statement. Commissioner McSweeny also issued a statement. The U.S. District Court for the Northern District of Georgia entered the order on March 31, 2017. NOTE: Stipulated final orders have the force of law when approved and signed by the District Court judge. Then-Commissioner (and former Chairwoman) Edith Ramirez registered a vote in the affirmative for the motion to approve this settlement before she left the Commission. 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. American Guild of Organists Agrees to Eliminate Rules that Restrict Competition among Members Rules likely raised prices for consumers, complaint alleges The American Guild of Organists has agreed to eliminate rules that restrict its members from competing for opportunities to perform. The agreement between the FTC and the American Guild of Organists resolves a complaint by the agency alleging that the guild’s rules restrained competition and harmed consumers in violation of the FTC Act. According to the FTC, the guild rules generated complaints from consumers and organists. The guild represents approximately 15,000 member organists and choral directors in 300 chapters in the United States and abroad. Under the guild’s code of ethics, if a consumer wished to have someone other than an “incumbent musician” play at a venue for a wedding, funeral or other service, the consumer was required to pay both the incumbent and the consumer’s chosen musician. The code of ethics stated that “members are advised to protect themselves as incumbents” through contracts that secure fees even if they don’t perform. The guild also developed and publicized compensation schedules and formulas, and instructed its chapters and members to develop and use regionally applicable versions to determine charges for their services. The proposed consent order settling the FTC’s charges requires the American Guild of Organists to stop restraining its members from soliciting work as musicians, and to stop issuing compensation schedules, guidance, or model contract provisions for members to use to determine their compensation. The guild must implement an antitrust compliance program, and is required under the order to stop recognizing chapters that fail to certify their compliance with the order’s provisions. Details about the case are set forth in the analysis to aid public comment for this matter. The Commission vote to accept the consent agreement containing the proposed consent order for public comment was 2-0. The FTC will publish the consent package in the Federal Register shortly. The agreement will be subject to public comment for 30 days, beginning today and continuing through May 2, 2017, after which the Commission will decide whether to make the proposed consent order final. 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 $40,654. 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. American Guild of Organists Agrees to Eliminate Rules that Restrict Competition among Members Rules likely raised prices for consumers, complaint alleges The American Guild of Organists has agreed to eliminate rules that restrict its members from competing for opportunities to perform. The agreement between the FTC and the American Guild of Organists resolves a complaint by the agency alleging that the guild’s rules restrained competition and harmed consumers in violation of the FTC Act. According to the FTC, the guild rules generated complaints from consumers and organists. The guild represents approximately 15,000 member organists and choral directors in 300 chapters in the United States and abroad.   Under the guild’s code of ethics, if a consumer wished to have someone other than an “incumbent musician” play at a venue for a wedding, funeral or other service, the consumer was required to pay both the incumbent and the consumer’s chosen musician. The code of ethics stated that “members are advised to protect themselves as incumbents” through contracts that secure fees even if they don’t perform. The guild also developed and publicized compensation schedules and formulas, and instructed its chapters and members to develop and use regionally applicable versions to determine charges for their services. The proposed consent order settling the FTC’s charges requires the American Guild of Organists to stop restraining its members from soliciting work as musicians, and to stop issuing compensation schedules, guidance, or model contract provisions for members to use to determine their compensation. The guild must implement an antitrust compliance program, and is required under the order to stop recognizing chapters that fail to certify their compliance with the order’s provisions. Details about the case are set forth in the analysis to aid public comment for this matter. The Commission vote to accept the consent agreement containing the proposed consent order for public comment was 2-0. The FTC will publish the consent package in the Federal Register shortly. The agreement will be subject to public comment for 30 days, beginning today and continuing through May 2, 2017, after which the Commission will decide whether to make the proposed consent order final. 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 $40,654. 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. FTC Approves Final Orders Settling Charges That Used Auto Dealers Touted Inspections Without Disclosing That Some Cars Were Subject to Unrepaired Safety Recalls Following a public comment period, the Federal Trade Commission has approved final consent orders with CarMax, Asbury Automotive Group and West-Herr Automotive Group, settling charges that they touted how rigorously they inspect their used cars, yet failed to adequately disclose that some of the cars were subject to unrepaired safety recalls. The final orders announced today prohibit CarMax, Asbury and West-Herr from claiming that their used vehicles are safe, have been repaired for safety issues, or have been subject to a rigorous inspection, unless they are free of open recalls, or the companies clearly and conspicuously disclose that their vehicles may be subject to unrepaired recalls for safety issues and explain how consumers can determine a vehicle’s recall status. The orders also prohibit the companies from misrepresenting material facts about the safety or recall status of the used cars they advertise. In addition, the orders require the companies to inform recent customers, by mail, that vehicles they bought as far back as July 1, 2013, may be subject to open recalls. The Commission vote approving the final orders against CarMax, Asbury and West-Herr GM, and letters to commenters was 2-0. 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.