Regulatory Change, Business Strategy 7 Jan 2025 regulatory compliance, postal service, shipping, usps, business contracts

📦USPS Notice of Product Change for Priority Mail and Ground Advantage

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, Shipping Services 7 Jan 2025 regulatory compliance, business operations, postal service, negotiated service agreements, shipping

📦Notice of Postal Service Product Change for Business Shipping Options

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, Marine Safety 7 Jan 2025 regulatory compliance, reporting and recordkeeping requirements, security measures, harbors, coast guard, waterways, marine operations, marine safety, navigation (water), safety zone, atchafalaya river

⚓Temporary Safety Zone Established for Cypress Passage Powerline Demolition

The Coast Guard is establishing a temporary safety zone for navigable waters within a 500-yard radius of 29[deg]47'38.18" N, 91[deg]21'50.52" W, approximately MM 105.5, on the Atchafalaya River, locally known as Cypress Passage, during an overhead electrical powerline structure demolition operation on Thursday, January 9, 2025. The safety zone is needed to protect personnel, vessels, and the marine environment from potential hazards created by the demolition of the powerline structures resulting in electrical powerlines on the navigational water's surface. Entry of vessels or persons into this zone is prohibited unless specifically authorized by the Captain of the Port Marine Safety Unit Houma.

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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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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, 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, Aviation 7 Jan 2025 regulatory compliance, aviation, faa, business operations, airspace, giddings

✈️Class E Airspace Amendment for Giddings, TX -FAA Final Rule

This action amends the Class E airspace at Giddings, TX. This action is the result of airspace reviews conducted due to the decommissioning of the Industry 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) operations and procedures.

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Regulatory Compliance, Financial Planning 7 Jan 2025 regulatory compliance, postal service, negotiated service agreements, shipping, business logistics

📦USPS Notice on Priority Mail Express Contract Changes for 2025

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, Legal, Shipping 7 Jan 2025 regulatory compliance, federal maritime commission, class action, litigation, policy statement

⚖️FCA Policy on Class Action Complaints

The Federal Maritime Commission (Commission) is issuing this document to advise the public of the availability of a new policy statement. The policy statement explains that private parties are not precluded from bringing class action complaints at the Commission.

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Compliance, Regulatory 7 Jan 2025 regulatory compliance, fda, guidance, tobacco products, analytical testing

📊FDA Guidance on Analytical Testing Methods for Tobacco Products

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry entitled "Validation and Verification of Analytical Testing Methods Used for Tobacco Products." The guidance provides information and recommendations related to the validation and verification of analytical test methods, including analytical testing of tobacco product constituents, ingredients, and additives, as well as stability testing of tobacco products. This guidance is intended to help industry produce more consistent and reliable analytical data used to support regulatory submissions for finished tobacco products. This guidance finalizes the draft guidance of the same title issued in December 2021.

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