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⚖️Notice of Water Quality Certification for Northern States Power Project

🏥FDA Issues Interim Guidance on Compounding Bulk Drug Substances

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act." This guidance describes FDA's interim regulatory policy concerning compounding by outsourcing facilities using bulk drug substances while FDA develops the list of bulk drug substances that outsourcing facilities can use in compounding under the applicable section of the Federal Food, Drug, and Cosmetic Act (FD&C Act). This guidance finalizes the draft guidance of the same title issued in December 2023 and replaces the final guidance of the same title issued in January 2017.

🏥FDA Guidance on Unapproved Medical Product Communications

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers." This guidance describes FDA's enforcement policy regarding certain firm-initiated communications of scientific information on unapproved use(s) of the firm's approved/ cleared medical products to health care providers (HCPs) engaged in prescribing or administering medical products to individual patients. This guidance finalizes the revised draft guidance of the same title issued in October 2023. The October 2023 revised draft guidance revised and replaced the draft guidance entitled "Distributing Scientific and Medical Publications on Unapproved New Uses--Recommended Practices," issued in March 2014, which itself revised the final guidance entitled "Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approved or Cleared Medical Devices," issued in January 2009. This guidance is not for current implementation, pending the Office of Management and Budget's (OMB's) decision on the collection of information.

🤖FDA Draft Guidance on AI Use in Drug Regulation Available for Comments

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products." In accordance with its mission of protecting, promoting, and advancing public health, FDA's Center for Drug Evaluation and Research (CDER), in collaboration with the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), the Center for Veterinary Medicine (CVM), the Oncology Center of Excellence (OCE), the Office of Combination Products (OCP), and the Office of Inspections and Investigations (OII), is issuing this draft guidance to provide recommendations to industry on the use of artificial intelligence (AI) to produce information or data intended to support regulatory decision-making regarding the safety, effectiveness, or quality for drug and biological products.

🌊Incidental Take Authorization for Hoonah Cargo Dock Project

NMFS has received a request from the City of Hoonah (Hoonah) for authorization to take marine mammals incidental to pile driving and removal activities associated with the Hoonah Cargo Dock project in Hoonah, Alaska. Pursuant to the Marine Mammal Protection Act (MMPA), NMFS is requesting comments on its proposal to issue an incidental harassment authorization (IHA) to incidentally take marine mammals during the specified activities. NMFS is also requesting comments on a possible one-time, 1-year renewal that could be issued under certain circumstances and if all requirements are met. NMFS will consider public comments prior to making any final decision on the issuance of the requested MMPA authorization and agency responses will be summarized in the final notice of our decision.

📄PCAOB Amendment Impacts on Registration Compliance for Firms

🩺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