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.

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

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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, Economic Development 16 Jan 2025 regulatory compliance, faa, transportation, incorporation by reference, class e airspace, airspace, navigation (air), north conway, nh

✈️FAA Proposes Class E Airspace in North Conway, NH - Implications for Businesses

This action proposes to establish Class E airspace extending upward from 700 feet above the surface for Memorial Hospital Heliport, North Conway, NH. This action would accommodate a new instrument approach procedure for Memorial Hospital Heliport, North Conway, NH.

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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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