79 for emergency waivers of inspection and weighing, revise GIPSA’s fee structure, revise exceptions to official agency geographic boundaries, extend the length of licenses and designations, and impose new requirements for delegated States. Objeto y razón de ser: Prevention of deceptive practices and consumer protection. Notificación: G/TBT/N/USA/1072 Neurological Devices; Reclassification of Cranial Electrotherapy Stimulator Intended To Treat Insomnia and/or Anxiety; Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Intended To Treat Depression (12 pages, in English). The Food and Drug Administration (FDA) is issuing a proposed administrative order to reclassify the cranial electrotherapy stimulator (CES) devices intended to treat insomnia and/or anxiety, a preamendments class III device, into class II (special controls) and subject to premarket notification, and to require the filing of a premarket approval application (PMA) for CES devices intended to treat depression. FDA is proposing the reclassification of CES devices intended to treat insomnia and/or anxiety under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) based on new information pertaining to the device. This proposed action would implement certain statutory requirements. FDA is also clarifying the identification for CES devices in this proposed order by identifying CES as a prescription device that applies electrical current that is not intended to induce a seizure to a patient’s head to treat psychiatric conditions. This clarification distinguishes CES from electroconvulsive therapy (ECT). Objeto y razón de ser: Protection of human health or safety. GUATEMALA Notificación: G/TBT/N/GTM/89 Acuerdo gubernativo no. 342-2010 Reglamento para el registro de fertilizantes, enmiendas y sustancias afines a fertilizantes o a enmiendas ante el ministerio de agricultura, ganadería y alimentación (8 páginas, en español). ESTADOS UNIDOS Notificación: G/TBT/N/USA/1069 Manufactured Home Procedural and Enforcement Regulations; Revision of Exemption for Recreational Vehicles (5 pages, in English). This rulemaking proposes to revise the exemption for recreational vehicles that are not self-propelled from HUD’s Manufactured Housing Procedural and Enforcement Regulations. This proposed rule is based on a recommendation adopted by the Manufactured Housing Consensus Committee (MHCC) which would define a recreational vehicle as one built on a vehicular structure, not certified as a manufactured home, designed only for recreational use and not as a primary residence or for permanent occupancy, and built and certified in accordance with either the National Fire Protection Association (NFPA) 1192-15 or American National Standards Institute (ANSI) A119.5- 09 consensus standards for recreational vehicles. HUD is adopting the MHCC’s recommendation but modifying it to require certification with the updated ANSI standard, A119.5-15, and by including a requirement that units claiming the ANSI A119.5-15 exemption prominently display a notice stating that the unit is designed only for recreational use, and not as a primary residence or permanent dwelling. Objeto y razón de ser: Prevention of deceptive practices and consumer protection. Notificación: G/TBT/N/USA/1070 Protection of Stratospheric Ozone: Revisions to Reporting and Recordkeeping for Imports and Exports (2 pages, in English). EPA is proposing to make minor conforming edits to the stratospheric protection regulations to implement the International Trade Data System. In the “Rules and Regulations” section of this Federal Register, we are making these edits as a direct final rule without a prior proposed rule. If we receive no adverse comment, we will not take further action on this proposed rule. This system allows businesses to transmit the transactional data required by multiple Federal agencies for the import and export of cargo through a single “window.” As businesses currently must submit trade data to multiple agencies, in multiple ways, and often on paper, the transition to electronic filing is expected to save businesses time and money. Specifically, this rulemaking would remove the requirement that the petition for used ozone-depleting substances accompany the shipment through U.S. Customs and remove references to Customs forms that are obsolete under the new system. Objeto y razón de ser: Protection of the environment. Notificación: G/TBT/N/USA/1071 Reauthorization of the United States Grain Standards Act (7 pages, in English). The Department of Agriculture (USDA) Grain Inspection, Packers and Stockyards Administration (GIPSA) is proposing to revise existing regulations and add new regulations under the United States Grain Standards Act (USGSA), as amended, in order to comply with amendments to the USGSA made by the Agriculture Reauthorizations Act of 2015. Specifically, this rulemaking proposes to eliminate mandatory barge weighing, remove the discretion formación AENOR está presente en el campo de la formación mediante cursos y seminarios que ponen a disposición de los profesionales de todos los sectores técnicas y herramientas de gestión avanzadas cuya aplicación es imprescindible para mantener una posición de competitividad en el mercado. Contacte con el Tel. 902 102 201 Fax 913 10 36 95 formación@aenor.es http://www.aenor.es
normasaldia313
To see the actual publication please follow the link above