⚓Coast Guard Notification of Expired Temporary Safety Zones
This document provides notification of substantive rules issued by the Coast Guard that were made temporarily effective but expired before they could be published in the Federal Register. This document lists temporary safety zones, security zones, and special local regulations, all of limited duration and for which timely publication in the Federal Register was not possible. This document also announces notifications of enforcement for existing reoccurring regulations that we issued but were unable to be published before the enforcement period ended.
Learn More💊FDA Approves ALYFTREK Under Pediatric Disease Priority Program
The Food and Drug Administration (FDA) is announcing the issuance of approval of a product redeeming a priority review voucher. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the issuance of priority review vouchers as well as the approval of products redeeming a priority review voucher. FDA has determined that the application for ALYFTREK (vanzacaftor, tezacaftor, and deutivacaftor), approved December 20, 2024, meets the criteria for redeeming a priority review voucher.
Learn More🦎Salamander Regulations and Their Economic Impact on Businesses
The U.S. Fish and Wildlife Service is affirming as final the 2016 interim rule that added all species of salamanders from 20 genera to the list of injurious amphibians. Under the injurious wildlife prohibitions of the Lacey Act, this final rule prohibits the importation into the United States and shipment between the continental United States, District of Columbia, Hawaii, Commonwealth of Puerto Rico, or any territory or possession of the United States of any live or dead specimen, including hybrids and parts, of those 20 genera of salamanders, except by permit for certain purposes or by Federal agencies solely for their own use. In addition to finalizing the listing of those 20 genera, we are publishing a new interim rule to add to the injurious amphibian list 16 genera that recent studies determined are also carriers of the fungus and to clarify some provisions from the final rule. This interim rule includes any live or dead specimen, hybrid, or parts of the 16 genera and opens a public comment period. We take these actions to protect U.S. ecosystems from the introduction, establishment, and spread of the lethal chytrid fungus Batrachochytrium salamandrivorans, which infects and is carried by salamanders, and which is not yet known to be found in the United States.
Learn More🌍Air Quality Regulation Updates for Maricopa County Businesses
The Environmental Protection Agency (EPA) is finalizing a limited approval and limited disapproval of revisions to the Maricopa County Air Quality Department (MCAQD or "County") portion of the Arizona State Implementation Plan (SIP). These revisions concern emissions of volatile organic compounds (VOCs) from loading of organic liquids and gasoline. Under the authority of the Clean Air Act (CAA or "Act"), this action simultaneously approves local rules that regulate these emission sources and directs Arizona to correct rule deficiencies. We are also finalizing a disapproval of MCAQD's reasonably available control technology (RACT) demonstration for the source categories associated with these rules for the 2008 8-hour ozone national ambient air quality standard (NAAQS) in the Phoenix-Mesa ozone nonattainment area.
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