🐾FDA's Guidance on Animal Food Ingredient Consultation Released
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry #294 entitled "Animal Food Ingredient Consultation (AFIC)." This guidance describes FDA's interim AFIC process and explains one way FDA will work with firms that are developing animal food ingredients now that the Memorandum of Understanding (MOU) with the Association of American Feed Control Officials (AAFCO) expired on October 1, 2024, and while FDA evaluates the animal Food Additive Petition and Generally Recognized as Safe (GRAS) Notification programs. The AFIC process provides an additional way for engagement with FDA regarding ingredients for which firms may otherwise have used the AAFCO ingredient definition process. AFIC will help FDA identify any potential safety concerns associated with such ingredients. The AFIC process also allows for public awareness of and input on such ingredients. In addition, this guidance describes FDA's enforcement policy for certain ingredients assessed using the AFIC process.
Learn More📦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📦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.
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.
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