Compliance, Professional Events 17 Jan 2025 regulatory compliance, public meeting, department of energy, environmental management, nevada, clean-up activities

🏛️Notice of Environmental Management Advisory Board Meeting in Nevada

This notice announces an in-person/virtual hybrid meeting of the Environmental Management Site-Specific Advisory Board (EM SSAB), Nevada. The Federal Advisory Committee Act requires that public notice of this meeting be announced in the Federal Register.

Learn More
Regulatory Requirements, Financial Implications 17 Jan 2025 regulatory compliance, corporate filings, department of energy, federal energy regulatory commission, renewable energy
Regulatory Requirements, Security Measures 17 Jan 2025 regulatory compliance, law enforcement, nuclear regulatory commission, physical protection, power reactor

🔒Proposed Law Enforcement Response Rules for Power Reactors

The U.S. Nuclear Regulatory Commission (NRC) is issuing a notice of proposed interpretation of regulatory requirements to clarify that a power reactor applicant or licensee may, when designing or updating its physical protection program, incorporate law enforcement response into its site physical protection program through the implementation of a site-specific Security Bounding Time. This proposed interpretation would provide flexibility to applicants and licensees by allowing them to consider the assistance of law enforcement responders as part of the physical protection program. The NRC is requesting comment on the proposed interpretation and will hold a public meeting during the public comment period to address questions regarding the proposed interpretation and to facilitate public comments.

Learn More
Regulatory Requirements, Compliance 17 Jan 2025 regulatory compliance, healthcare, reporting, fda, adverse events, food and drug, submission guidelines

📋FDA Adverse Event Reporting

The Food and Drug Administration (FDA, the Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with FDA's adverse event reports and product experience reports for FDA-regulated products.

Learn More
Regulatory Notice 17 Jan 2025 regulatory compliance, healthcare, information collection, fda

🚫FDA Withdraws Notice on Treatment Center Program Data Collection

The Food and Drug Administration (FDA) is announcing the withdrawal of a notice that was published in the Federal Register of October 18, 2023.

Learn More
Regulatory Compliance, Industry Standards 17 Jan 2025 regulatory compliance, fda, pharmaceutical industry, drug master file, abbreviated new drug applications

💊FDA Notice on Type V Drug Master Files for ANDA Support

The Food and Drug Administration (FDA or Agency), Center for Drug Evaluation and Research (CDER), Office of Generic Drugs is establishing a public docket entitled "Use of a Type V Drug Master File (DMF) for Model Master File (MMF) Submissions to Support Abbreviated New Drug Applications (ANDAs)." The purpose of this docket to solicit input from interested parties on this topic.

Learn More
Compliance, Regulatory Changes 17 Jan 2025 regulatory compliance, administrative practice and procedure, penalties, whistleblowing, confidential business information, mining industry, federal mine safety, mine safety and health, business practices, procedural rules

⚖️Regulatory Updates for Federal Mine Safety and Health Compliance

The Federal Mine Safety and Health Review Commission (the "Commission") is an independent adjudicatory agency that provides trials and appellate review of cases arising under the Federal Mine Safety and Health Act of 1977 (the "Mine Act"). Trials are held before the Commission's Administrative Law Judges, and appellate review is provided by a five-member Review Commission appointed by the President and confirmed by the Senate. This rule makes final revisions to many of the Commission's procedural rules. The Commission makes these changes in a continued effort to ensure the just, speedy, and inexpensive determination of all proceedings before the Commission.

Learn More
Regulatory Compliance, Business Impact 17 Jan 2025 regulatory compliance, public comment, postal services, business contracts

📬New Postal Service Agreements Open for Public Comment and Impact

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
Compliance, Regulatory 17 Jan 2025 regulatory compliance, administrative practice and procedure, inflation adjustment, penalties, indian gaming, indians-lands, gambling, civil monetary penalty, national indian gaming commission

📈Annual Civil Penalty Adjustment for Indian Gaming Effective 2025

In compliance with the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (the Act) and Office of Management and Budget (OMB) guidance, the National Indian Gaming Commission (NIGC or Commission) is amending its civil monetary penalty rule to reflect an annual adjustment for inflation in order to improve the penalty's effectiveness and maintain its deterrent effect. The Act provides that the new penalty level must apply to penalties assessed after the effective date of the increase, including when the penalties whose associated violation predate the increase.

Learn More
Public Announcements, Regulatory Information 17 Jan 2025 regulatory compliance, sunshine act, nuclear regulatory commission, public meetings, meeting schedule