Regulatory Requirements, Financial Data 7 Jan 2025 public meeting, business compliance, sunshine act, financial auditing, national science foundation
Regulatory Compliance, Environmental Impact 7 Jan 2025 compliance, environmental impact statement, nuclear regulatory commission, peach bottom, license renewal

⚛️NRC Notice on Environmental Impact for Peach Bottom License Renewal

The U.S. Nuclear Regulatory Commission (NRC, the Commission) staff will prepare a supplement to NUREG-1437, "Generic Environmental Impact Statement for License Renewal of Nuclear Plants," Supplement 10, Second Renewal, "Regarding Subsequent License Renewal for Peach Bottom Atomic Power Station Units 2 and 3," dated January 2020 (the final supplemental environmental impact statement (SEIS)) in order to complete its evaluation of the environmental impacts of the subsequent license renewal (SLR) of Renewed Facility Operating License Nos. DPR-44 and DPR-56 for Peach Bottom Atomic Power Station (Peach Bottom), Units 2 and 3, respectively. The supplement will address new information since the issuance of the final SEIS. A draft of the supplement will be issued for public comment.

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Regulatory, Business Development 7 Jan 2025 regulatory compliance, postal service, logistics, shipping, business agreements

📦Postal Service Notice on New Shipping Agreement Impacting Businesses

The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.

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Regulatory Compliance, Business Agreements 7 Jan 2025 postal service, shipping, usps, priority mail, business agreements

📦USPS Notice

The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.

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Compliance, Grant Opportunities, Economic Development 7 Jan 2025 compliance, workplace safety, support programs, national stalking awareness month, gender-based violence
Compliance, Regulatory, Healthcare 7 Jan 2025 regulatory compliance, healthcare, fda, clinical trials, drug approval

📋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.

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Regulatory Compliance, Energy Sector 7 Jan 2025 compliance, energy, regulations, water quality, certification, michigan
Regulatory Compliance, Pharmaceutical Industry 7 Jan 2025 healthcare, fda, drug compounding, pharmacy regulations, bulk drug substances

⚖️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.

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Regulatory Requirements, Trade Compliance 7 Jan 2025 compliance, international trade, antidumping, japan, trade regulations, usa, steel products

⚖️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.

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Compliance, Environmental Regulation 7 Jan 2025 regulatory compliance, environmental protection, epa, administrative practice and procedure, reporting and recordkeeping requirements, intergovernmental relations, air pollution control, clean air act, hazardous substances, air pollution, environmental standards

🌍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.

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