📦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.
Learn More📦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.
Learn More⚓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.
Learn More🌍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.
Learn More📋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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Accelerated Approval and Considerations for Determining Whether a Confirmatory Trial is Underway."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 This draft guidance describes FDA's interpretation of the term "underway" and discusses policies for implementing this requirement, including factors FDA intends to consider when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.
Learn More✈️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.
Learn More📦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.
Learn More⚖️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.
Learn More📊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.
Learn More⚖️FDA Guidance on Sex Differences in Clinical Evaluations Available
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Study of Sex Differences in the Clinical Evaluation of Medical Products." Clinical trials and non-interventional studies of medical products should be designed to enroll sufficient numbers of females and males to reflect the prevalence of the disease or condition for which the medical product is being investigated to help ensure the generalizability of results and facilitate exploration of potential differences in effects by sex. This guidance provides recommendations for increasing enrollment of females in clinical trials, analyzing and interpreting sex-specific data, and including sex-specific information in regulatory submissions of medical products. When finalized, this guidance will replace the guidance entitled "Guideline for the Study and Evaluation of Gender Differences in the Clinical Evaluation of Drugs" issued in July 1993.
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