💊FDA Notice on Regulatory Review Period and Patent Extension for PIASKY
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for PIASKY and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Learn More🐟Notice of Mid-Atlantic Fishery Management Council Public Meeting
The Scientific and Statistical Committee (SSC) of the Mid- Atlantic Fishery Management Council (Council) will hold a meeting.
Learn More💊FDA Determines Heparin Sodium Products Not Withdrawn for Safety
The Food and Drug Administration (FDA or Agency) has determined that HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER (heparin sodium) injectable, 5,000 units/100 milliliters (mL); HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER (heparin sodium) injectable, 5,000 units/100 mL; HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER (heparin sodium) injectable, 10,000 units/100 mL; and HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER (heparin sodium) injectable, 5,000 units/100 mL under new drug application (NDA) 019802 were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) that refer to these products if all other legal and regulatory requirements are met.
Learn More📊Proposed Information Collection for NCI Data Sharing Forms
In compliance with the requirement of the Paperwork Reduction Act of 1995 to provide an opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval.
Learn More🌊Temporary Safety Zone Regulation for Chesapeake Bay, Baltimore, MD
The Coast Guard is establishing a safety zone for certain waters of the Chesapeake Bay near Baltimore, MD within 500 yards of the M/V W SAPPHIRE in position 39[deg]01.40' N, 76[deg]22.1' W. The Coast Guard is establishing this safety zone to protect personnel, vessels, and the marine environment from potential hazards during multi-agency firefighting and salvage operations. Additionally, the safety zone is needed to ensure a safe working environment for the first responders and dive teams from passing traffic. This rule will prohibit persons or vessels from entering this zone unless specifically authorized by the Captain of the Port (COTP) Sector Maryland-National Capital Region (NCR) or a designated representative.
Learn More🗓️Advisory Committee on Disability Compensation Meeting Cancelled
The Department of Veterans Affairs has announced the cancellation of the scheduled meeting for the Advisory Committee on Disability Compensation, which was set for September 2025. Further information can be obtained from the designated officer at the Veterans Benefits Administration.
Learn More⚡Notice of Filings for Exempt Wholesale Generators by DOE
The Department of Energy announces receipt of filings from several companies seeking self-certification as exempt wholesale generators. This includes various electric rate filings that contain specific effective dates and comment deadlines, emphasizing the regulatory process surrounding energy generation and distribution.
Learn More📈SEC Extends Decision Period for MX2 Options Trading Rules
The Securities and Exchange Commission (SEC) has published a notice regarding MX2 LLC's proposed rule change to govern the trading of options on a new facility named MX2 Options. The notice indicates an extended timeframe for the SEC to review and act on this proposal to ensure thorough consideration.
Learn More🛩️New Restricted Areas R-6319A&B Established Near South Padre Island
This action proposes to establish restricted areas R-6319 (A and B) in the vicinity of South Padre Island, TX. The new restricted areas would provide U.S. Customs and Border Protection (CBP) with the ability to deploy a tethered aerostat in support of homeland security and national defense.
Learn More🐟SEDAR 98 Assessment Webinar IV
The SEDAR 98 assessment process for Gulf red snapper will consist of a Data Workshop, a series of assessment webinars, and a Review Workshop. See SUPPLEMENTARY INFORMATION.
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