📄FDA Draft Guidance on 510(k) Clearance Transfer Available
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Transfer of a Premarket Notification (510(k)) Clearance--Questions and Answers." This guidance provides information on the most frequently asked questions regarding transfer of ownership from one 510(k) holder to another. This draft guidance is not final nor is it for implementation at this time.
Learn More📅Montana Advisory Committee Public Meeting Notice on Civil Rights
Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act, that the Montana Advisory Committee (Committee) to the U.S. Commission on Civil Rights will hold a public business meeting via Zoom at 2 p.m. MT on Thursday, June 26, 2025. The purpose of this meeting is to discuss civil rights concerns in the state as their study topic.
Learn More⚖️Antidumping Duty Review Results for Stainless Steel Flanges from India
The U.S. Department of Commerce (Commerce) finds that producers/exporters of stainless steel flanges (flanges) from India subject to this administrative review made sales of subject merchandise in the United States at prices below normal value during the period of review (POR) October 1, 2022, through September 30, 2023.
Learn More🐋Regulations for Taking Endangered Marine Mammals in Fishing
NMFS is issuing a permit to authorize the incidental, but not intentional, take of specific Endangered Species Act (ESA)-listed marine mammal species or stocks under the Marine Mammal Protection Act (MMPA), in the Category II California (CA) thresher shark/swordfish drift gillnet (>=14 inch (in) mesh) fishery and the corresponding high seas component of the fishery defined on the MMPA List of Fisheries (LOF) as the Pacific highly migratory species drift gillnet fishery (hereinafter, collectively referred to as the CA thresher shark/ swordfish drift gillnet (>=14 in mesh)/Pacific highly migratory species drift gillnet fishery.
Learn More📈NYSE Texas Proposes Rule Change for Affiliate Securities Listing
The Securities and Exchange Commission has published a notice regarding NYSE Texas's proposal to amend Article 22, Rule 24, which would introduce requirements for the listing and trading of Affiliate Securities. This amendment aims to ensure that these listings meet the same rigorous standards as other securities, enhancing regulatory oversight and potentially expanding the market's offerings.
Learn More📈MIAX Pearl Proposes Rule Change for PAC Routing Options
The MIAX PEARL, LLC proposes an amendment to Exchange Rule 2617 to enhance the PAC routing option by eliminating unnecessary specification of primary listing markets. This change aims to simplify regulatory compliance, ensuring relevant practices remain dynamic and accurate as the number of primary listing markets evolves, benefiting equity market participants.
Learn More📋FDA Releases Guidance on Raw Data Submission for Animal Drugs
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry (GFI) #287 entitled "Raw Data for Safety and Effectiveness Studies." This guidance provides information to animal drug sponsors (sponsors) on the use of raw data in the Center for Veterinary Medicine's (CVM) review of safety and effectiveness studies submitted in support of new animal drug applications. This guidance also describes our recommendations for submitting raw data.
Learn More💰Sequestration Order for Fiscal Year 2026
This document outlines a sequestration order issued by the President, mandating reductions to direct spending budgetary resources for fiscal year 2026. It specifies compliance protocols under the Balanced Budget and Emergency Deficit Control Act, indicating a significant measure to control federal expenditures and its implications on budget allocations across various sectors.
Learn More🚂CPKC Seeks Extension of Waiver for Rail Dispatch Compliance
This document provides the public notice that Canadian Pacific Kansas City Limited (CPKC) petitioned FRA for relief from certain regulations concerning extraterritorial dispatching.
Learn More⚖️USPTO Notice on Practitioner Conduct and Discipline Information Collection
The United States Patent and Trademark Office (USPTO) will submit the following information collection request to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, on or after the date of publication of this notice. The USPTO invites comments on this information collection renewal, which helps the USPTO assess the impact of its information collection requirements and minimize the reporting burden to the public. Public comments were previously requested via the Federal Register on March 11, 2025, during a 60-day comment period. This notice allows for an additional 30 days for public comments.
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