💊FDA Notice on LUMISIGHT Patent Extension Review Period
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for LUMISIGHT and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application 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 drug product.
Learn More💊FDA Notice on CAMZYOS Patent Extension and Review Period
The Food and Drug Administration (FDA or the Agency) published a notice in the Federal Register of February 29, 2024. After review of the calculation of the applicable regulatory review period of the biologic product CAMZYOS (U.S. patent numbers 9,181,200; 9,585,883) in that notice, FDA has determined that a revision of the supplementary information section is warranted. This notice corrects the applicable regulatory review period language.
Learn More🚤Coast Guard Information Collection Request for Aquaculture Operations
In compliance with the Paperwork Reduction Act of 1995, the U.S. Coast Guard intends to submit an Information Collection Request (ICR) to the Office of Management and Budget (OMB), Office of Information and Regulatory Affairs (OIRA), requesting an extension of its approval for the following collection of information: 1625-0126, Requirements for Vessels that Perform Certain Aquaculture Support Operations; without change. Our ICR describes the information we seek to collect from the public. Before submitting this ICR to OIRA, the Coast Guard is inviting comments as described below.
Learn More🧬Meeting Update for National Advisory Council on Human Genome Research
The National Institutes of Health has announced a change in the timing of the National Advisory Council for Human Genome Research meeting. The meeting is set for September 16, 2025, now starting at 09
Learn More📅CPAAC Meeting Announcement - Federal Communications Commission
In this document, the Commission announces the first meeting of the current term of its Consumer Protection and Accessibility Advisory Committee (CPAAC or Committee).
Learn More🚨FCC Proposes Modernization of Emergency Alert Systems
In this document, the Federal Communications Commission (Commission) begins a reexamination of the Emergency Alert System (EAS) and Wireless Emergency Alerts (WEA) from the ground up and seeks comment on whether fundamental changes could make these alerting systems more effective, efficient, and better able to serve the public's needs. EAS was introduced 31 years ago, and WEA was introduced 13 years ago, using the technology available at the time. The Commission seeks comment on what goals these alerting systems should aim to achieve, whether these systems are currently effective at achieving these goals, and what steps should be taken to modernize these systems to improve their usefulness and better leverage modern technology while minimizing burdens on stakeholders.
Learn More🔥EPA Allows Temporary Incinerator Use During Disaster Recovery
The U.S. Environmental Protection Agency (EPA) is taking interim final action to provide for the temporary use of incineration units subject to commercial and industrial solid waste incinerator (CISWI) regulations during disaster recovery. Currently, only other solid waste incinerators (OSWI) are authorized to combust debris from a disaster or emergency on a temporary basis without having to comply with applicable Clean Air Act (CAA) section 129 requirements. We are also authorizing such temporary use for incinerators (including air curtain incinerators (ACI)) subject to CISWI regulations by adding temporary-use provisions that essentially mirror those in the OSWI regulations to existing Federal CISWI rule subparts. The EPA is requesting comments on all aspects of this interim final rule and will consider all comments received after the conclusion of the comment period.
Learn More📦Final Investigation on Polypropylene Corrugated Boxes Imports
The Commission hereby gives notice of the scheduling of the final phase of countervailing duty investigation No. 701-TA-757 (Final) pursuant to the Tariff Act of 1930 to determine whether an industry in the United States is materially injured or threatened with material injury, or the establishment of an industry in the United States is materially retarded, by reason of imports of polypropylene corrugated boxes ("PC boxes") from China, provided for in subheadings 3923.10.90 and 3923.50.00 of the Harmonized Tariff Schedule of the United States, preliminarily determined by the Department of Commerce ("Commerce") to be subsidized by the Government of China. Commerce's preliminary determinations with respect to PC boxes from China and Vietnam, alleged to be sold in the United States at less than fair value, are pending.
Learn More📄FCC Notice
As part of its continuing effort to reduce paperwork burdens, as required by the Paperwork Reduction Act (PRA) of 1995, the Federal Communications Commission (FCC or the Commission) invites the general public and other Federal Agencies to take this opportunity to comment on the following information collection. Pursuant to the Small Business Paperwork Relief Act of 2002, the FCC seeks specific comment on how it might further reduce the information collection burden for small business concerns with fewer than 25 employees. The Commission may not conduct or sponsor a collection of information unless it displays a currently valid Office of Management and Budget (OMB) control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the PRA that does not display a valid OMB control number.
Learn More💊FDA Regulatory Review Period Determination for VORANIGO
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for VORANIGO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application 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 drug product.
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