Regulatory Compliance, Pharmaceutical Industry 15 Jan 2025 healthcare, fda, pharmaceutical regulation, drug approvals, teva pharmaceuticals

🚫FDA Withdraws Approval of 23 Abbreviated New Drug Applications

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 23 abbreviated new drug applications (ANDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

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Financial Assistance, Regulatory Compliance, Grant Opportunities 15 Jan 2025 compliance, healthcare, grants, nih, federal funding, mental health
Compliance, Regulatory Changes 15 Jan 2025 compliance, treasury department, labor department, health insurance, affordable care act, preventive services

📋Withdrawal of Proposed Rule on Preventive Services Coverage

This document withdraws a notice of proposed rulemaking that appeared in the Federal Register on October 28, 2024, regarding coverage of certain preventive services under the Affordable Care Act.

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Grant Opportunities, Professional Events 15 Jan 2025 financial assistance, grants, meetings, national endowment for the arts, arts education, arts advisory panel

🎭National Endowment for the Arts Advisory Panel Meeting Notice

Pursuant to the Federal Advisory Committee Act, as amended, notice is hereby given that 4 meetings of the Arts Advisory Panel to the National Council on the Arts will be held by teleconference or videoconference.

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Regulatory Compliance, Environmental Impact 15 Jan 2025 regulations, epa, natural gas, environmental compliance, oil and gas, emissions, flaring

🌍EPA Proposes Changes to Oil and Gas Emission Standards

The Environmental Protection Agency (EPA) is proposing amendments to the New Source Performance Standards and Emission Guidelines for Existing Sources for the Crude Oil and Natural Gas Source Category in response to petitions for reconsideration. Specifically, this action proposes discrete technical changes to two different aspects of the rules. First, this action proposes discrete technical changes to the temporary flaring provisions for associated gas in certain situations. Second, this action proposes discrete technical changes to the vent gas net heating value (NHV) continuous monitoring requirements and alternative performance test (sampling demonstration) option for flares and enclosed combustion devices. In a letter dated May 6, 2024, the EPA notified petitioners and the public that the Agency granted reconsideration on these two aspects of the March 8, 2024 (89 FR 16820) final rule. These amendments neither propose changes to any other aspect of the final rule, nor propose to alter the substance of any emission standards within the final rule. Also, in this action, the EPA proposes to make formatting changes to the regulatory text to meet the required formatting standards of the Office of the Federal Register.

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Compliance, Regulatory Requirements 15 Jan 2025 environmental protection, administrative practice and procedure, reporting and recordkeeping requirements, business compliance, nuclear energy, penalties, claims, nuclear regulatory commission, hazardous waste, fraud, civil penalties, freedom of information, confidential business information, organization and functions (government agencies), antitrust, classified information, waste treatment and disposal, nuclear materials, sex discrimination, atomic energy act, program fraud, nuclear power plants and reactors

⚖️NRC Adjusts Civil Penalties for Inflation in FY2025

The U.S. Nuclear Regulatory Commission (NRC) is amending its regulations to adjust the maximum civil monetary penalties it can assess under statutes enforced by the agency. These changes are mandated by the Federal Civil Penalties Inflation Adjustment Act of 1990, as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015. The NRC is amending its regulations to adjust the maximum civil monetary penalty for a violation of the Atomic Energy Act of 1954, as amended, or any regulation or order issued under the Atomic Energy Act from $362,814 to $372,240 per violation, per day. Additionally, the NRC is amending provisions concerning program fraud civil penalties by adjusting the maximum civil monetary penalty under the Program Fraud Civil Remedies Act from $13,946 to $14,308 for each false claim or statement.

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Compliance, Grant Opportunities, Professional Events 15 Jan 2025 health, business opportunities, minority health, innovation, tribal, equity

🌍Nomination Notice for Indigenous Health Advisory Committee Delegates

On January 8, 2025, we published a Federal Register Notice requesting nomination letters for the CIIHE TAC delegates. This correcting amendment corrects two errors: the submission deadline and the notification timeframe for nominee selection.

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Regulatory Compliance, Business Operations 15 Jan 2025 postal service, shipping, priority mail, business logistics, negotiated agreements

📦Notice

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 Compliance, Social Services 15 Jan 2025 compliance, federal register, legal regulations, child support, family services

⚖️Withdrawal of Proposed Rule on Child Support Services Impact

This document withdraws a proposed rule that was published in the Federal Register on September 26, 2023. The proposed rule would have amended the Child Support Services Program to be inclusive of all family structures served by the child support services program.

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Regulatory Compliance, Professional Events 15 Jan 2025 compliance, public meeting, regulatory notice, noaa, fishery management, southeast fisheries

🐟South Atlantic Fishery Management Council Public Meeting Notice

The South Atlantic Fishery Management Council (Council) will hold a meeting of the Ad Hoc For-Hire Reporting Advisory Panel in January.

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