66 Notificaciones OMC occupants of compact and subcompact passenger cars im-pacting the rear of trailers at 56 kilometers per hour (km/h) (35 miles per hour (mph)). NHTSA is issuing this NPRM in response to a petition for rulemaking from the Insurance Ins-titute for Highway Safety (IIHS), and from Ms. Marianne Karth and the Truck Safety Coalition (TSC). This is the second of two documents issued in response to the Karth/TSC petition. Earlier, NHTSA published an advanced notice of proposed rulemaking requesting comment on strategies pertaining to underride protection afforded by single unit trucks. Objeto y razón de ser: Prevention of deceptive practices and consumer protection. Notificación: G/TBT/N/USA/1060 Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Mono-graph (20 pages, in English). TITLE: Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over the Counter Monograph AGENCY: Food and Drug Administration, HHS ACTION: Proposed rule SUMMARY: The Food and Drug Administration (FDA or the Agency) is proposing to revise its regulations on prescription fixed-combination drugs to apply the regulations to both pres-cription and nonprescription fixed-combination and co-packa-ged drugs and combinations of active ingredients under consi-deration for inclusion in an over-the-counter (OTC) monograph. These products must meet specific evidentiary requirements for approval. The proposed revisions would harmonize the require-ments for prescription and nonprescription products and make them consistent with long-standing Agency policy. Objeto y razón de ser: Protection of human health or safety. Notificación: G/TBT/N/USA/1066 Minimum Quality and Handling Standards for Domestic and Imported Peanuts Marketed in the United States; Change to the Quality and Handling Requirements (8 pages, in English). This proposed rule would implement a recommendation from the Peanut Standards Board (Board) to revise the minimum quality and handling standards for domestic and imported peanuts marketed in the United States (Standards). The Board advises the Secretary of Agriculture regarding potential changes to the Standards and is comprised of producers and industry representatives. This proposed rule would revise the minimum quality, positive lot identification, and reporting and recordkee-ping requirements under the Standards. It would also make numerous other changes to better reflect current industry prac-tices and to revise outdated language. The Board believes these changes would make additional peanuts available for sale, help increase efficiencies, and reduce costs to the industry. Objeto y razón de ser: Prevention of deceptive practices and consumer protection. FILIPINAS Notificación: G/TBT/N/PHL/194 Guidelines on the Environmentally Sound Management (ESM) of Waste Electrical and Electronic Equipment (WEEE) (26 pages, English). The Philippines is a traditional importer and exporter of electri-cal and electronic equipment (EEE), both new and used, inclu-ding scraps. With the global rapid advances in technology for commercial, industrial, and household products and appliances, there is a corollary increase in Waste Electrical and Electronic Equipment (WEEE) as well as hazardous substances from the source materials involved in their manufacture and use. Recog-nizing the risks of these materials in part or in whole to hu-man health and the environment and in compliance with the Basel Convention, the Department of Environment and Natural Resources (DENR), through the Environmental Management Bureau (EMB), has developed this Technical Guidelines on the Environmentally Sound management (ESM) of WEEE. The draft guidelines provides the compliance framework for producers, manufacturers, consumers, distributors, retailers, treatment facilities, and other stakeholders involved in the life cycle of WEEE. Objeto y razón de ser: The objectives of the draft guidelines are to a) Provide the framework mechanism for the appropriate management of WEEE; b) Reduce the amount of electrical and electronic equipment (EEE) type of waste and the ha-zards brought about by its components; c) Promote the reuse of EEE and valorisation of its waste components; d) Encou-rage involvement of all relevant agencies and stakeholders in the life cycle of EEE through design innovation leading to their more efficient dismantling, recycling, and reuse; and e) institutionalize the principle of “extended producers res-ponsibility” (EPR) in addressing the financial requirements involved in the implementation of the WEEE Guidelines. FRANCIA Notificación: G/TBT/N/FRA/166 Décret relatif aux modalités de mise en oeuvre de la limita-tion des sacs en matières plastiques à usage unique (3 pages, en français). Le texte définit les conditions d’application des dispositions législatives du code de l’environnement visant à interdire la mise à disposition des sacs en matières plastiques à usage unique à l’exception, s’agissant des sacs autres que les sacs de caisse, des sacs compostables en compostage domestique et constitués, pour tout ou partie, de matières biosourcées. Il précise à ce titre les modalités d’application du II de l’article L. 541-10-5 du code de l’environnement et en particulier la définition et les caractéristiques des sacs en matières plasti-ques à usage unique, des sacs de caisse, des sacs compos-tables en compostage domestique ainsi que la composition attendue des sacs plastiques dit «biosourcés». Il précise enfin les indications qui devront figurer sur les sacs en matières plastiques pour informer le consommateur sur leur compo-sition et leur utilisation. Ce texte est pris en application de la Directive n°2015/720 du Parlement européen et du Conseil du 29 avril 2015 modifiant la Directive 94/62/CE en ce qui concerne la réduction de la con-sommation de sacs en plastique légers, notamment son article premier, et constitue l’acte de transposition de cette directive. Objeto y razón de ser: Ce texte est pris en application de la Di-rective n°2015/720 du Parlement européen et du Conseil du 29 avril 2015 modifiant la Directive 94/62/CE en ce qui con-cerne la réduction de la consommation de sacs en plastique légers, notamment son article premier, et constitue l’acte de transposition de cette directive.
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