Search Results for keywords:"Regulatory Compliance"

The Food and Drug Administration (FDA) is inviting public feedback on its proposed collection of information related to adverse events and product experiences for FDA-regulated products. As part of fulfilling requirements under the Paperwork Reduction Act, the FDA seeks comments on whether this information collection is necessary, its accuracy, and ways to minimize the burden on respondents. They have updated forms and processes to standardize data collection, improve quality and clarity, and ensure confidentiality where necessary. The deadline for providing comments, either electronically or by mail, is March 18, 2025.

The Food and Drug Administration (FDA) is inviting public comments on its proposed information collection related to adverse experience reporting for licensed biological products. This reporting is crucial for identifying serious safety issues with these products after they have been marketed. The FDA requires that manufacturers report adverse experiences quickly and periodically, and also maintain detailed records for a certain number of years. Public comments can be submitted through the designated OMB website by March 25, 2021.

The Coast Guard is making corrections to a rule that was published in the Federal Register on November 25, 2024. This rule requires Coast Guard-approved training providers to submit course completion data electronically within 5 business days and introduces some editorial changes. However, the document had four errors that needed fixing, which are addressed in this correction. The corrections are effective on January 17, 2025, and involve updates to various sections and instructions in the original document.

The U.S. Nuclear Regulatory Commission (NRC) has submitted a request to renew an existing information collection related to the "Domestic Licensing of Special Nuclear Material" to the Office of Management and Budget (OMB) for review. This collection requires certain entities to provide information about their use of special nuclear material and is crucial for the NRC's licensing and regulatory decisions. The public is invited to submit comments on this proposal by February 22, 2021. The estimated annual response involves 1,214 responses from 200 respondents, requiring a total of 37,050 hours to comply with the requirements.

The United States Department of Justice filed a complaint against XCL Resources Holdings, Verdun Oil Company II, and EP Energy, alleging that they violated the Hart-Scott-Rodino Act by assuming control over EP Energy before completing the required regulatory waiting period. They were accused of illegal coordination, including halting drilling activities and sharing sensitive information, which caused supply shortages and market disruptions. To resolve these allegations, the companies agreed to pay a civil penalty totaling over $5.6 million and implement compliance measures to prevent future violations. The court will oversee the agreement to ensure it aligns with public interest standards.

The National Marine Fisheries Service (NMFS) is considering an application from the Massachusetts Division of Marine Fisheries for a special fishing permit. This permit would allow some boats to fish outside usual regulations to collect data on lobster and Jonah crab populations. The gathered information aims to help with scientific research on these species. Interested parties can send comments via email until April 7, 2025.

The Board of Governors of the Federal Reserve System is extending, with revisions, the rules for recordkeeping and disclosure related to real estate appraisal standards, known as FR Y-30. This extension is set for three years and takes effect immediately. These rules are mandatory for state member banks and nonbank subsidiaries of bank holding companies, aiming to ensure compliance with uniform appraisal standards as required by law. No public comments were received during the notice period despite an invitation for input.

The Occupational Safety and Health Administration (OSHA) is asking for public comments on its plan to continue the information collection requirements for the Coke Oven Emissions Standard. This standard is in place to protect workers from the health risks associated with exposure to coke oven emissions. OSHA wants feedback on the necessity, accuracy, and clarity of the information it collects and on ways to reduce the burden on employers. Comments must be submitted by April 29, 2025.

The Cboe BYX Exchange, Inc. has proposed a rule change to increase the monthly fees for 10 Gb physical ports, which was submitted to the Securities and Exchange Commission (SEC) on February 14, 2025. The proposal has been designated for immediate effectiveness, allowing it to take effect quickly, but is open for public comments until March 19, 2025. Interested parties can submit their comments through the SEC's website or by email. The SEC will review all feedback and decide whether to approve or disapprove the rule change based on public interest and investor protection.

DOD, GSA, and NASA have issued a Small Entity Compliance Guide summarizing changes to the Federal Acquisition Regulation (FAR) as per Federal Acquisition Circular (FAC) 2021-03. These changes include rules about violations of arms control treaties, criteria for using the lowest price technically acceptable (LPTA) source selection process, and the type of assets individual sureties must pledge. Additionally, it includes various technical amendments across multiple regulations. The guide helps small businesses understand how these changes might impact them.