🌊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.
Learn More📜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previous version of the guidance, of the same title, issued on November 17, 2023, and finalizes the concurrently issued draft guidance entitled "Select Updates for the 506J Guidance: 506J Device List and Additional Notifications."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).
Learn More📦Postal Regulatory Commission Notice on New Service Agreements
The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning a negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Learn More🩺FDA Draft Guidance on Pulse Oximeters for Regulatory Compliance
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Pulse Oximeters for Medical Purposes--Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations." This draft guidance document, when finalized, will provide recommendations regarding non-clinical and clinical performance testing of certain pulse oximeters for medical purposes, including devices with a pulse oximeter function that estimates the amount of oxygen in arterial blood and pulse rate. These recommendations are being proposed based in part on concerns that the accuracy of pulse oximeters can be affected by, among other factors, a person's skin pigmentation. The recommendations are being proposed to inform the performance evaluation for these devices, to support premarket submissions, regardless of submission type, and to promote consistency and facilitate efficient review of these submissions. Among other topics, the draft guidance also proposes recommendations for labeling, which are intended to promote the safe and effective use of pulse oximeters and help users understand the benefits and risks associated with the use of the device. This draft guidance is not final nor is it for implementation at this time.
Learn More✈️Amendment of Class E Airspace in Pontiac, IL by FAA
This action amends the Class E airspace at Pontiac, IL. This action is the result of an airspace review conducted due to the decommissioning of the Pontiac 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) procedures and operations.
Learn More🥣FDA Sets New Lead Action Levels for Baby Food Compliance
The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled "Action Levels for Lead in Processed Food Intended for Babies and Young Children." The guidance establishes action levels for lead in certain processed foods intended for babies and young children less than 2 years old. The guidance is intended to set achievable action levels that will help further reduce lead in the food supply.
Learn More⚖️USITC Notice of Antidumping Investigation on Slag Pots from China
The Commission hereby gives notice of the institution of investigations and commencement of preliminary phase antidumping and countervailing duty investigation Nos. 701-TA-753 and 731-TA-1731 (Preliminary) pursuant to the Tariff Act of 1930 ("the Act") to determine whether there is a reasonable indication that 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 slag pots from China, provided for in subheading 7309.00.00 of the Harmonized Tariff Schedule of the United States, that are alleged to be sold in the United States at less than fair value and alleged to be subsidized by the Government of China. Unless the Department of Commerce ("Commerce") extends the time for initiation, the Commission must reach a preliminary determination in antidumping and countervailing duty investigations in 45 days, or in this case by February 14, 2025. The Commission's views must be transmitted to Commerce within five business days thereafter, or by February 24, 2025.
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.
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