💊FDA Guidance on Medical Device Submission Feedback Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled "Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program." This guidance document provides an overview of the mechanisms available to submitters through which they can request interactions with FDA related to medical device submissions. This guidance supersedes the document entitled "Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program" issued on June 2, 2023, and provides clarification and additional information on the scope of Q-Submission (Q-Sub) types, better delineation of how to obtain feedback for different types of questions (i.e., informal communication vs. Pre-Submission or other Q-Sub types), and improved examples.
Learn More⚛️Executive Order 14302
Executive Order 14302 focuses on revitalizing America's nuclear industrial base to enhance energy independence, security, and global competitiveness. The order emphasizes regulatory reforms, workforce development, and strategic funding initiatives, aiming to increase domestic nuclear energy production and associated supply chains. This aims to secure affordable and reliable energy for the nation.
Learn More📄SEC Proposed Collection
The SEC is seeking comments on information collection related to Rule 19d-1, which requires SROs to report certain actions, including disciplinary measures and delistings. The rule aims to ensure proper oversight and compliance within the financial sector, anticipating around 850 submissions annually from approximately 17 respondents.
Learn More🚫FDA Issues Final Debarment Order Against Michael Dominic Diaz
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (FD&C Act) debarring Michael Dominic Diaz for a period of 5 years from importing or offering for import any drug into the United States. FDA bases this order on a finding that Mr. Diaz was convicted of one felony count under Federal law. The factual basis supporting Mr. Diaz's conviction, as described below, is conduct relating to the importation into the United States of a drug or controlled substance. Mr. Diaz was given notice of the proposed debarment and was given an opportunity to request a hearing to show why he should not be debarred. As of May 16, 2024 (30 days after receipt of the notice), Mr. Diaz had not responded. Mr. Diaz's failure to respond and request a hearing constitutes a waiver of his right to a hearing concerning this matter.
Learn More⚡Notice for Installing Load Bank in Hydroelectric Project
The Federal Energy Regulatory Commission has filed a notice on Eugene Water & Electric Board's application to install a load bank for the Carmen-Smith Hydroelectric Project. This change aims to minimize environmental impact by maintaining necessary flow into the Trail Bridge Reservoir while allowing continuous operation of the power plant during outages. The document also invites comments and motions to intervene from the public and agencies.
Learn More🛡️CISA Cybersecurity Speaker Request Form Information Collection Notice
The External Affairs (EA) within Cybersecurity and Infrastructure Security Agency (CISA) submits the following information collection request (ICR) to the Office of Management and Budget (OMB) for review and clearance.
Learn More🏦Notice on Bank Holding Company Formations and Acquisitions
The Federal Reserve has issued a notice regarding applications for the formation of bank holding companies, acquisitions, and mergers. The public can review these applications and comment on them, with details concerning how to submit feedback. This aligns with the Bank Holding Company Act and regulatory requirements in the financial sector.
Learn More📦New Postal Products Regulatory Notice
The Commission is noticing a recent Postal Service filing for the Commission's consideration concerning a negotiated service agreement. This notice informs the public of the filing, invites public comment, and takes other administrative steps.
Learn More🚤Proposed Safety Zone Impacting Businesses on Ohio and Licking Rivers
The Coast Guard is proposing to establish a temporary safety zone from Mile Marker 469.5-Mile Marker 470.5 of the Ohio River and from Mile Marker 0.0-Mile Marker 0.3 of the Licking River. This action is necessary to provide for the safety of life on these navigable waters near Cincinnati, OH, during the Red Bull Flugtag sporting event occurring on August 9, 2025. This safety zone prohibits persons and vessels from transiting through the safety zone unless authorized by the Captain of the Port Sector Ohio Valley or a designated representative.
Learn More🔥Proposed Extension of Information Collection for Coal Mine Fire Safety
The Department of Labor (DOL), as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre- clearance consultation program for all information collections, to provide the public and Federal agencies with an opportunity to comment on proposed collections of information, in accordance with the Paperwork Reduction Act of 1995. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. The Mine Safety and Health Administration (MSHA) is soliciting comments on the information collection entitled Underground Coal Mine Fire Protection.
Learn More