Regulatory Notice 3 Jan 2025 meeting notice, sunshine act, regulatory compliance, enforcement, sec
Regulatory Compliance, Professional Events 3 Jan 2025 fda, pharmaceuticals, regulatory compliance, drug development, pediatric research, public health

💊FDA Meeting

The Food and Drug Administration's (FDA, Agency, or we) Office of Pediatric Therapeutics, the Center for Drug Evaluation and Research, and the Center for Biologics Evaluation and Research are announcing a public meeting entitled "Interested Parties Meeting: Implementation of the Best Pharmaceuticals for Children Act and Pediatric Research Equity Act." The purpose of the public meeting is to seek input from interested parties, including patient/parent/ caregiver groups, consumer groups, regulated industry, academia, and others. This input will enable FDA to obtain any recommendations or information relevant to the report to Congress that FDA is required to submit concerning pediatric drug and biologic development and labeling, as outlined in section 508 of the Food and Drug Administration Safety and Innovation Act (FDASIA).

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Regulatory Compliance, Environmental Impact 3 Jan 2025 business operations, regulatory compliance, arizona, endangered species, conservation

🌿Eagle Creek Conservation Permit Notice for Freeport Minerals

We, the U.S. Fish and Wildlife Service, have received an application from Freeport Minerals, a subsidiary of Freeport-McMoRan Inc., for a 10(a)(1)(A) enhancement of survival permit supported by the proposed Eagle Creek Multi-Species Conservation Benefit Agreement (CBA) in Greenlee and Graham Counties, Arizona. With this notice, we announce the availability for public comment of the permit application, the proposed CBA, and the draft environmental assessment (EA). We invite comments from the public and Federal, Tribal, State, and local governments.

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Regulatory Changes, Business Impact 3 Jan 2025 procurement, federal contracts, small business, blind services, regulatory compliance

📉Impact of Procurement List Deletions on Small Businesses

This action deletes product(s) from the Procurement List that were furnished by nonprofit agencies employing persons who are blind or have other severe disabilities.

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Regulatory Requirements, Compliance 3 Jan 2025 nitrogen dioxide, ozone, air pollution control, reporting and recordkeeping requirements, air quality, ozone standards, incorporation by reference, environmental protection, ohio, regulatory compliance, volatile organic compounds, business implications, intergovernmental relations

🌍Ohio's Air Quality Regulation Impacts for Businesses in 2025

The Environmental Protection Agency (EPA) is proposing to approve the following portions of Ohio's State Implementation Plan (SIP) submission for the Cleveland 2015 ozone national ambient air quality standard (NAAQS or standard) Moderate nonattainment area: the base year emissions inventory, the reasonable further progress (RFP) demonstration, the motor vehicle inspection and maintenance (I/M) program, and the nonattainment new source review (NNSR) program. EPA is proposing to approve these portions of the State's submission as a SIP revision pursuant to section 110 and part D of the CAA and EPA's regulations. EPA is also initiating the adequacy process and proposing approval of the 2023 motor vehicle emissions budgets (budgets) associated with the Cleveland Moderate ozone nonattainment RFP demonstration.

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