Notice 29 May 2025 regulatory compliance, environmental impact, energy, oregon, hydroelectric

⚡Notice for Installing Load Bank in Hydroelectric Project

The Federal Energy Regulatory Commission has filed a notice on Eugene Water & Electric Board's application to install a load bank for the Carmen-Smith Hydroelectric Project. This change aims to minimize environmental impact by maintaining necessary flow into the Trail Bridge Reservoir while allowing continuous operation of the power plant during outages. The document also invites comments and motions to intervene from the public and agencies.

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Notice 29 May 2025 regulatory compliance, information collection, cybersecurity, infrastructure, cisa, public engagement

🛡️CISA Cybersecurity Speaker Request Form Information Collection Notice

The External Affairs (EA) within Cybersecurity and Infrastructure Security Agency (CISA) submits the following information collection request (ICR) to the Office of Management and Budget (OMB) for review and clearance.

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Rule 29 May 2025 regulatory compliance, healthcare, fda, medical devices, plazomicin

🩺FDA Classifies Plazomicin Test System as Class II Device

The Food and Drug Administration (FDA, Agency, or we) is classifying the plazomicin test system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the plazomicin test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

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Rule 29 May 2025 regulatory compliance, coast guard, safety zone, maritime industry, fireworks, lake michigan

🎆Coast Guard Enforces Safety Zone for Fireworks at Lakeshore State Park

The Coast Guard will enforce the Safety Zone, Lakeshore State Park, Milwaukee, WI on a portion of Lake Michigan in Milwaukee, WI. This action is intended to protect personnel, vessels, and the marine environment from potential hazards created by a land-based fireworks display. During the enforcement period listed below, entry into, transiting, or anchoring within the safety zone is prohibited unless authorized by the Captain of the Port Lake Michigan or a designated representative.

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Notice 29 May 2025 regulatory compliance, washington, environmental assessment, ferc, hydroelectric, pacificorp

🌊Environmental Assessment for PacifiCorp Yale Hydroelectric Project

The Department of Energy's Federal Energy Regulatory Commission has released an Environmental Assessment for PacifiCorp's proposed modifications to the Yale Hydroelectric Project. The assessment evaluates the environmental effects of proposed changes, including dam improvements and potential public comments on these modifications. The findings indicate no major federal action with significant adverse effects on the environment.

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Notice 29 May 2025 regulatory compliance, pharmaceuticals, fda, debarment, health, importation

🚫FDA Debarment Order

The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Justin Cole Henry for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Henry was convicted of a felony under Federal law for possession with intent to distribute a Schedule III controlled substance. The factual basis supporting Mr. Henry's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Henry was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of February 24, 2025 (30 days after receipt of the notice), Mr. Henry had not responded. Mr. Henry's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.

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Notice 29 May 2025 regulatory compliance, energy, infrastructure, meeting, historic preservation, project management

⚡Notice of Meeting for Goldendale Energy Storage Project

The Department of Energy announces a meeting for FFP Project 101, LLC's Goldendale Energy Storage Project, scheduled for June 4, 2025. This virtual meeting aims to discuss revisions to the draft Programmatic Agreement with the Advisory Council on Historic Preservation and relevant stakeholders, ensuring compliance with historic preservation laws during project development.

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Notice 29 May 2025 regulatory compliance, fda, health, guidance, medical devices, q-submission

💊FDA Guidance on Medical Device Submission Feedback Availability

The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program." This guidance document provides an overview of the mechanisms available to submitters through which they can request interactions with FDA related to medical device submissions. This guidance supersedes the document entitled "Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program" issued on June 2, 2023, and provides clarification and additional information on the scope of Q-Submission (Q-Sub) types, better delineation of how to obtain feedback for different types of questions (i.e., informal communication vs. Pre-Submission or other Q-Sub types), and improved examples.

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Notice 29 May 2025 regulatory compliance, aviation, faa, safety, event management, large gatherings

✈️FAA Meeting Notice on Event Scheduling Conflicts

The Federal Aviation Administration (FAA) announces a virtual meeting regarding the identification of potential scheduling conflicts pursuant to section 1115 of the FAA Reauthorization Act of 2024. This meeting is open to all representatives of FAA-approved air shows, the general aviation community, stadiums and other large outdoor events and venues or organizations that run such events, the Department of Homeland Security, and the Department of Justice. The goal of this meeting is to identify potential scheduling conflicts so the FAA can develop appropriate operational and communication procedures to ensure the safety and security of both events.

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Notice 29 May 2025 regulatory compliance, energy, public comments, hydroelectric, massachusetts

💧Holyoke Gas & Electric Seeks Extension for Hydroelectric License

The Department of Energy's Federal Energy Regulatory Commission announces the acceptance of an application from the City of Holyoke Gas & Electric Department for a 9-year extension of the Station No. 5 Hydroelectric Project license. The request aims to synchronize expiration dates with other related projects, facilitating a streamlined relicensing process. Public comments and participation are encouraged regarding this application.

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