🚫OFAC Sanctions Notice
The U.S. Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing the names of one or more persons that have been placed on OFAC's Specially Designated Nationals and Blocked Persons List (SDN List) based on OFAC's determination that one or more applicable legal criteria were satisfied. All property and interests in property subject to U.S. jurisdiction of these persons are blocked, and U.S. persons are generally prohibited from engaging in transactions with them.
Learn More🚆Claims Limitation on METRO Blue Line Light Rail Project Announced
This notice announces final environmental actions taken by the Federal Transit Administration (FTA) regarding the METRO Blue Line Light Rail Extension Project in the Cities of Minneapolis, Robbinsdale, Crystal, and Brooklyn Park, Hennepin County, Minnesota. The purpose of this notice is to publicly announce FTA's environmental decisions on the subject project and to activate the limitation on any claims that may challenge these final environmental actions.
Learn More🎓New Education Grant Priorities and Definitions Announced
The Department of Education (Department) announces three priorities and related definitions for use in currently authorized discretionary grant programs or programs that may be authorized in the future. The Secretary may choose to use an entire priority for a grant program or a particular competition or use one or more of the priority's component parts. These priorities and definitions replace the Secretary's supplemental priorities published in the Federal Register on December 10, 2021 (86 FR 70612) and all other agency-wide supplemental priorities published prior to January 20, 2025.
Learn More🚢Comments Requested on Foreign-Built Vessel Use in Coastwise Trade
The Secretary of Transportation, as represented by MARAD, is authorized to make determinations regarding the coastwise use of foreign built; certain U.S. built; and U.S. and foreign rebuilt vessels that solely carry no more than twelve passengers for hire. MARAD has received such a determination request and is publishing this notice to solicit comments to assist with determining whether the proposed use of the vessel set forth in the request would have an adverse effect on U.S. vessel builders or U.S. coastwise trade businesses that use U.S.- built vessels in those businesses. Information about the requestor's vessel, including a description of the proposed service, is in the SUPPLEMENTARY INFORMATION section below.
Learn More📋FDA Guidance on Biosimilar Classification Categories Released
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Classification Categories for Certain Supplements Under BsUFA III." This guidance provides recommendations for applicants on classification categories A, B, C, D, E, and F for original and resubmitted prior approval supplements submitted to approved applications for biosimilar and interchangeable biosimilar products under the Public Health Service Act (PHS Act). The commitment letter associated with the Biosimilar User Fee Amendments of 2022 (BsUFA III) sets forth these supplement classification categories and their associated review performance goals. This guidance is intended to help applicants identify the appropriate classification category and review goal date of the supplement being submitted. This guidance finalizes and replaces the draft guidance of the same title issued on August 11, 2023.
Learn More💉FDA Guidance on Therapeutic Protein Biosimilars
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations." This guidance describes the Agency's recommendations on the design and evaluation of comparative analytical studies intended to support a demonstration that a proposed therapeutic protein product is biosimilar to a reference product licensed under the Public Health Service Act (PHS Act). Additionally, this guidance is intended to provide recommendations to sponsors on the scientific and technical information for the chemistry, manufacturing, and controls (CMC) portion of a marketing application for a proposed product submitted under the PHS Act. This guidance finalizes and replaces the draft guidance of the same title issued on May 22, 2019, and replaces the final guidance "Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product" issued on April 30, 2015.
Learn More📊Cboe Unveils Monthly Fees for All Cancels Market Data Report
The Securities and Exchange Commission published a notice regarding the Cboe C2 Exchange's proposed rule change to adopt fees for the All Cancels Report. This new market data product will aid Trading Permit Holders in understanding cancel behaviors and will assess a monthly fee of $1,500, which is intended to provide enhanced insight on trading activities.
Learn More⚛️NRC Scoping Process for Global Laser Enrichment Facility EIS
The U.S. Nuclear Regulatory Commission (NRC) will conduct a scoping process to gather information necessary to prepare an environmental impact statement (EIS) to evaluate the environmental impacts of issuing a license to Global Laser Enrichment, LLC (GLE) to construct and operate a uranium enrichment facility in McCracken County, Kentucky. As part of the EIS development process, the NRC is seeking comments on the scope of the EIS.
Learn More🏥Closed Meeting Notice for National Institute of Allergy and Infectious Diseases
The Department of Health and Human Services announces a closed meeting of the Division of Intramural Research Board of Scientific Counselors, NIAID. The meeting aims to review individual programs and performance, ensuring privacy for involved personnel. Key details include the meeting's date, time, and location, as well as contact information for inquiries.
Learn More❌Notice of Withdrawal by Paradigm Shift Hydro, LLC
The Department of Energy issued a notice regarding the effectiveness of the withdrawal of Paradigm Shift Hydro, LLC's Declaration of Intention for the Last Chance Energy Project. No opposition was filed, leading to the acceptance of the withdrawal, indicating a significant procedural step in the project's regulatory timeline.
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