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.

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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.

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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.

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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.

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Public Announcements, Regulatory Information 17 Jan 2025 regulatory compliance, sunshine act, nuclear regulatory commission, public meetings, meeting schedule
Regulatory Compliance, Business Impact 16 Jan 2025 regulatory compliance, postal service, shipping agreements, priority mail, business implications

📦USPS Notice on Priority Mail Express and Negotiated Service Agreements

The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.

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Regulatory Changes, Business Operations 16 Jan 2025 regulatory compliance, postal service, shipping, contract, business, service agreement

📦Notice of Priority Mail Express and USPS Ground Advantage Contract

The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.

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Compliance, Regulatory 16 Jan 2025 regulatory compliance, business implications, native american, forestry, nagpra, cultural heritage, human remains

⚖️Notice of Intended Disposition Under NAGPRA

In accordance with the Native American Graves Protection and Repatriation Act (NAGPRA), the U.S. Department of Agriculture, Forest Service, Nebraska National Forests and Grasslands intends to carry out the disposition of human remains and associated funerary objects removed from Federal or Tribal lands to the lineal descendants, Indian Tribe, or Native Hawaiian organization with priority for disposition in this notice.

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Regulatory Changes, Business Operations 16 Jan 2025 regulatory compliance, postal service, shipping, negotiated service agreement, business logistics

📦Notice of Changes to Priority Mail and USPS Ground Advantage Services

The Postal Service gives notice of filing a request with the Postal Regulatory Commission to add a domestic shipping services contract to the list of Negotiated Service Agreements in the Mail Classification Schedule's Competitive Products List.

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Grants, Compliance, Financial Assistance 16 Jan 2025 regulatory compliance, grants, funding, department of education, uniform guidance

📄Revised Uniform Guidance for Department Grants Effective 2025

The Secretary announces updates to awardees' Grant Award Notices (GANs) to apply the 2024 revision of the Uniform Administrative Requirements, Cost Principles, And Audit Requirements for Federal Awards the Uniform Guidance to all Department grants that are subject to the Uniform Guidance.

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