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📜FDA Guidance on Device Manufacturing Discontinuances and Notifications

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing of a Device Under Section 506J of the FD&C Act." This guidance updates the previous version of the guidance, of the same title, issued on November 17, 2023, and finalizes the concurrently issued draft guidance entitled "Select Updates for the 506J Guidance: 506J Device List and Additional Notifications." This guidance finalizes a list of device product codes for which a manufacturer of such devices is required to notify FDA in accordance with the Federal Food, Drug, and Cosmetic Act (FD&C Act) (hereafter referred to as the "506J Device List") and clarifies that manufacturers may submit voluntary notifications regarding supply chain issues at any time, unrelated to the declaration or potential declaration of a public health emergency (PHE).

🌊NOAA Announces New Advisory Council for Chumash Heritage Sanctuary

Notice is hereby given that NOAA is establishing a national marine sanctuary advisory council for the Chumash Heritage National Marine Sanctuary (CHNMS), the designation of which became effective on November 30, 2024. The council will provide guidance to ONMS and will serve as liaisons with constituents and community groups. As a result, ONMS is adding the new council to the list of established national marine sanctuary advisory councils. ONMS solicits applications to fill council seats on an as needed basis and is seeking applicants for seats on the CHNMS Advisory Council. This notice contains web page links and contact information for CHNMS and application materials to apply for the newly established advisory council.

📄PCAOB Amendment Impacts on Registration Compliance for Firms

⚓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.

📦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.

📦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.

📊Change in Bank Control Notices and Compliance Requirements, 2025

✈️Decision Notice for Air National Guard Environmental Impact Statement

On December 19, 2024, the Department of the Air Force (DAF) signed the Record of Decision (ROD) for the Air National Guard F-15EX Eagle II & F-35A Lightning II Operational Beddowns Environmental Impact Statement.

☀️USITC Investigation on Crystalline Silicon Photovoltaic Products

The Commission hereby gives notice of the scheduling of the final phase of antidumping and countervailing duty investigation Nos. 701-TA-722-725 and 731-TA-1690-1693 (Final) pursuant to the Tariff Act of 1930 ("the Act") to determine whether 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 crystalline silicon photovoltaic products (solar panels) from Cambodia, Malaysia, Thailand, and Vietnam, provided for in statistical reporting numbers 8541.42.0010 and 8541.43.0010 of the Harmonized Tariff Schedule of the United States. Crystalline silicon photovoltaic cells, whether or not assemabled into modules, may also be imported under subheadings 8501.71, 8501.72, and 8501.80 and statistical reporting number 8507.20.8010, preliminarily determined by the Department of Commerce ("Commerce") to be subsidized and sold at less-than-fair-value.

🐾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.