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🩺FDA Draft Guidance on Pulse Oximeters for Regulatory Compliance

The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Pulse Oximeters for Medical Purposes--Non-Clinical and Clinical Performance Testing, Labeling, and Premarket Submission Recommendations." This draft guidance document, when finalized, will provide recommendations regarding non-clinical and clinical performance testing of certain pulse oximeters for medical purposes,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 Among other topics, the draft guidance also proposes recommendations for labeling, which are intended to promote the safe and effective use of pulse oximeters and help users understand the benefits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 This draft guidance is not final nor is it for implementation at this time.

✈️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.

⚖️Final Results on Antidumping Duty for Nickel-Plated Steel Products

As a result of this expedited sunset review, the U.S. Department of Commerce (Commerce) finds that revocation of the antidumping duty (AD) order on diffusion-annealed, nickel-plated flat- rolled steel products (nickel-plated steel products) from Japan would be likely to lead to the continuation or recurrence of dumping at the dumping margins identified in the "Final Results of Review" section of this notice.

🛡️National Stalking Awareness Month 2025

⚛️NRC Notice on Environmental Impact for Peach Bottom License Renewal

The U.S. Nuclear Regulatory Commission (NRC, the Commission) staff will prepare a supplement to NUREG-1437, "Generic Environmental Impact Statement for License Renewal of Nuclear Plants," Supplement 10, Second Renewal, "Regarding Subsequent License Renewal for Peach Bottom Atomic Power Station Units 2 and 3," dated January 2020 (the final supplemental environmental impact statement (SEIS)) in order to complete its evaluation of the environmental impacts of the subsequent license renewal (SLR) of Renewed Facility Operating License Nos. DPR-44 and DPR-56 for Peach Bottom Atomic Power Station (Peach Bottom), Units 2 and 3, respectively. The supplement will address new information since the issuance of the final SEIS. A draft of the supplement will be issued for public comment.

🏭New Regulations for Energy Efficiency in Central Air Conditioners

This final rule amends the Federal test procedure for central air conditioners and heat pumps ("CAC/HPs") to incorporate by reference the latest versions of the applicable industry standards. Specifically, DOE is incorporating by reference the latest version of the relevant industry consensus test standard, AHRI 210/240-2024 (I-P) for the current test procedure for CAC/HPs ("appendix M1") for measuring the current cooling and heating metrics--seasonal energy efficiency ratio 2 ("SEER2") and heating seasonal performance factor 2 ("HSPF2"). DOE is incorporating by reference the new industry consensus test standard, AHRI 1600-2024 (I-P), for a new test procedure ("appendix M2") for CAC/HPs that adopts two new metrics--seasonal cooling and off-mode rating efficiency ("SCORE") and seasonal heating and off-mode rating efficiency ("SHORE"). Testing to the SCORE and SHORE metrics would not be required until such time as compliance is required with any amended energy conservation standard based on the new metrics. Additionally, DOE is amending certain provisions of DOE's regulations related to representations and enforcement for CAC/HPs.

♻️EPA's Final Rule on Perchloroethylene Emission Standards for Dry Cleaners

This action finalizes the Clean Air Act (CAA) technology review (TR) conducted for the commercial and industrial dry cleaning facilities using perchloroethylene (PCE) as the cleaning solvent (PCE Dry Cleaning) source categories regulated under National Emission Standards for Hazardous air Pollutants (NESHAP). This final rule does not finalize the changes made at proposal and makes no amendments to the current NESHAP given the recently finalized action under the Toxic Substance Control Act (TSCA) which has instituted a 10-year phaseout of the use of PCE for dry cleaning.

📄Compliance Notice

The Department of Labor (the Department), in accordance with the Paperwork Reduction Act, provides the general public and Federal agencies with an opportunity to comment on proposed and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the public's reporting burden. It also helps the public understand the Department's information collection requirements and provide the requested data in the desired format. The Employee Benefits Security Administration (EBSA) is soliciting comments on the extension of the information collection requests (ICRs) contained in the documents described below. A copy of the ICRs may be obtained by contacting the office listed in the ADDRESSES section of this notice. ICRs also are available at reginfo.gov (https://www.reginfo.gov/public/do/PRAMain).

💊FDA Draft Guidance on Complying with 21 CFR 211.110 Available

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Considerations for Complying With 21 CFR 211.110." This guidance, when finalized, will describe considerations for complying with the requirements for ensuring batch uniformity and drug product integrity. In addition, this guidance discusses related quality considerations for drug products that are manufactured using advanced manufacturing. FDA is committed to supporting and enabling pharmaceutical innovation and modernization as part of the Agency's mission to protect and promote the public health. FDA encourages industry representatives and manufactures who are interested in using innovative control strategies to contact the Agency.

🏠HUD Updates HOME Investment Program Regulations for 2023

HUD's HOME Investment Partnerships Program (HOME program or HOME) provides formula grants to States and units of general local government to fund a wide range of activities to produce and maintain affordable rental and homeownership housing and provides tenant-based rental assistance for low-income and very low-income households. This final rule revises the current HOME regulations to update, simplify, or streamline requirements, better align the program with other Federal housing programs, and implement recent amendments to the HOME statute. This final rule also includes minor revisions to the regulations for the Community Development Block Grant and Section 8 Housing Choice Voucher Programs consistent with the implementation of the changes to the HOME program. This final rule follows the publication of a proposed rule on May 29, 2024, and takes into consideration the comments received in response to that proposed rule.