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🛡️National Stalking Awareness Month 2025

📋FDA Guidance on Accelerated Drug Approval and Confirmatory Trials

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway." For drugs granted accelerated approval, sponsors conduct confirmatory studies that must be completed postapproval to verify and describe the anticipated effect on irreversible morbidity or mortality or other clinical benefit. This draft guidance describes FDA's interpretation of the term "underway" and discusses policies for implementing this requirement, including factors FDA intends to consider when determining whether a confirmatory trial is underway prior to accelerated approval.

⚖️Notice of Water Quality Certification for Northern States Power Project

⚖️FDA's Final Guidance on Bulk Drug Substances Compounding Released

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act." This guidance describes FDA's interim policy concerning compounding by human drug product compounders that are not outsourcing facilities using bulk drug substances while FDA develops the list of bulk drug substances that can be used in compounding under the applicable section of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance finalizes the draft guidance of the same title issued in December 2023 and replaces the final guidance of the same title issued in January 2017.

⚖️Final Results on Antidumping Duty for Nickel-Plated Steel Products

As a result of this expedited sunset review, the U.S. Department of Commerce (Commerce) finds that revocation of the antidumping duty (AD) order on diffusion-annealed, nickel-plated flat- rolled steel products (nickel-plated steel products) from Japan would be likely to lead to the continuation or recurrence of dumping at the dumping margins identified in the "Final Results of Review" section of this notice.

🌍EPA Final Rule on Source Reclassification

The Environmental Protection Agency (EPA) is making corrections to the Review of Final Rule Reclassification of Major Sources as Area Sources Under Section 112 of the Clean Air Act (CAA) final rule that appeared in the Federal Register on September 10, 2024. Following publication of this final rule, the EPA discovered an inadvertent typographical error in the regulatory text and is correcting the error in this action.

🚂Carload Express Secures Control of Maryland and Delaware Railroad

⚖️USITC Notice of Antidumping Investigation on Slag Pots from China

The Commission hereby gives notice of the institution of investigations and commencement of preliminary phase antidumping and countervailing duty investigation Nos. 701-TA-753 and 731-TA-1731 (Preliminary) pursuant to the Tariff Act of 1930 ("the Act") to determine whether there is a reasonable indication that an industry in the United States is materially injured or threatened with material injury, or the establishment of an industry in the United States is materially retarded, by reason of imports of slag pots from China, provided for in subheading 7309.00.00 of the Harmonized Tariff Schedule of the United States, that are alleged to be sold in the United States at less than fair value and alleged to be subsidized by the Government of China. Unless the Department of Commerce ("Commerce") extends the time for initiation, the Commission must reach a preliminary determination in antidumping and countervailing duty investigations in 45 days, or in this case by February 14, 2025. The Commission's views must be transmitted to Commerce within five business days thereafter, or by February 24, 2025.

🥣FDA Sets New Lead Action Levels for Baby Food Compliance

The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled "Action Levels for Lead in Processed Food Intended for Babies and Young Children." The guidance establishes action levels for lead in certain processed foods intended for babies and young children less than 2 years old. The guidance is intended to set achievable action levels that will help further reduce lead in the food supply.

✈️Amendment of Class E Airspace in Pontiac, IL by FAA

This action amends the Class E airspace at Pontiac, IL. This action is the result of an airspace review conducted due to the decommissioning of the Pontiac very high frequency omnidirectional range (VOR) as part of the VOR Minimum Operational Network (MON) Program. The geographic coordinates of the airport are also being updated to coincide with the FAA's aeronautical database. This action brings the airspace into compliance with FAA orders and supports instrument flight rule (IFR) procedures and operations.