💊FDA Determination on COREG CR Drug Approval and Implications
The Food and Drug Administration (FDA, Agency, or we) has determined that COREG CR (carvedilol phosphate) extended-release capsules, 10 milligrams (mg), 20 mg, 40 mg, and 80 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Learn More🪖Notice of Proposed Arms Sales to Morocco - Javelin Missiles
The DoD is publishing the unclassified text of an arms sales notification.
Learn More📊Cboe BYX Updates Data Disclosure Rules for NYSE Texas
The Cboe BYX Exchange proposes to amend Rule 11.26(a) to reflect the name change of NYSE Chicago, Inc. to NYSE Texas, Inc., ensuring accurate public disclosure of data sources used in order processing. The changes aim to enhance transparency and improve compliance in securities transactions.
Learn More🚌NHTSA Proposes to Remove Obsolete School Bus Safety Requirements
NHTSA is proposing to remove obsolete requirements from Federal Motor Vehicle Safety Standard (FMVSS) No. 222, "School bus passenger seating and crash protection."
Learn More🚚Proposed Rule to Eliminate CDL Self-Reporting Requirement
FMCSA proposes to revise its regulations requiring commercial driver's license (CDL) holders to self-report motor vehicle violations to their State of domicile. With the implementation of the exclusive electronic exchange of violations between State drivers licensing agencies (SDLAs) in 2024, self-reporting is no longer necessary. This action supports the Administration's deregulatory efforts.
Learn More🛣️FHWA Rescinds Outdated Transportation Management Regulations
This final rule rescinds the regulations issued on December 10, 1996, and amended on February 14, 2007, Management and Monitoring, thereby removing obsolete regulations governing transportation management and monitoring systems. Further, FWHA finalizes the proposed updates to the regulations governing risk-based Asset Management Plans by determining that no further action is needed.
Learn More📉Analysis of Procurement List Deletions and Business Impacts
This action deletes product(s) and service(s) to the Procurement List that were furnished by nonprofit agencies employing persons who are blind or have other severe disabilities.
Learn More⚡NRC Notice on Browns Ferry Nuclear Plant License Renewal
The U.S. Nuclear Regulatory Commission (NRC) is issuing for public comment Draft Supplement 21, Second Renewal, to the Generic Environmental Impact Statement (GEIS) for License Renewal of Nuclear Plants, NUREG-1437, regarding the proposed subsequent license renewal (SLR) of Renewed Facility Operating License Nos. DPR-33, DPR-52, and DPR-68, for an additional 20 years of operation for Browns Ferry Nuclear Plant, Units 1, 2, and 3 (Browns Ferry). Browns Ferry is located on the north shore of Wheeler Reservoir at Tennessee River Mile 294, approximately 10 miles northwest of Decatur, Alabama, and 10 miles southwest of Athens, Alabama. Possible alternatives to the proposed action of SLR include no action and reasonable replacement power alternatives.
Learn More🛥️Special Local Regulations for Marine Events in Cape May, NJ
The Coast Guard will enforce a special local regulation for the Around the Island Paddle on June 22, 2025. This action is necessary to provide for the safety of life on navigable waterways during this event. Our regulation for marine events within the Fifth Coast Guard District identifies the regulated area for this event. During the enforcement period, the operator of any vessel in the regulated area must comply with directions from the Patrol Commander or any Official Patrol displaying a Coast Guard ensign. Non-participants must request permission to enter the regulated area.
Learn More🎣Business Opportunities from Exempted Fishing Permits Regulation
The Assistant Regional Administrator for Sustainable Fisheries, Greater Atlantic Region, NMFS, has made a preliminary determination that an Exempted Fishing Permit (EFP) application contains all of the required information and warrants further consideration. The EFP would allow federally permitted fishing vessels to fish outside fishery regulations in support of exempted fishing activities proposed by the Commercial Fisheries Research Foundation (CFRF). Regulations under the Magnuson-Stevens Fishery Conservation and Management Act and the Atlantic Coastal Fisheries Cooperative Management Act require publication of this notification to provide interested parties the opportunity to comment on applications for proposed EFPs.
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