💊FDA Approves ALYFTREK Under Pediatric Disease Priority Program
The Food and Drug Administration (FDA) is announcing the issuance of approval of a product redeeming a priority review voucher. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the issuance of priority review vouchers as well as the approval of products redeeming a priority review voucher. FDA has determined that the application for ALYFTREK (vanzacaftor, tezacaftor, and deutivacaftor), approved December 20, 2024, meets the criteria for redeeming a priority review voucher.
Learn More⚓Coast Guard Notification of Expired Temporary Safety Zones
This document provides notification of substantive rules issued by the Coast Guard that were made temporarily effective but expired before they could be published in the Federal Register. This document lists temporary safety zones, security zones, and special local regulations, all of limited duration and for which timely publication in the Federal Register was not possible. This document also announces notifications of enforcement for existing reoccurring regulations that we issued but were unable to be published before the enforcement period ended.
Learn More♿Proposed Changes to Randolph-Sheppard Vending Program Definitions
The U.S. Department of Education (Department) proposes to amend certain definitions and add a new definition in the Randolph- Sheppard Act (R-S Act) regulations to clarify statutory requirements and make other conforming changes necessary for Federal agencies, States, and non-governmental stakeholders to better implement the R-S Act, thereby allowing the Randolph-Sheppard Vending Facilities Program (RSVFP) to evolve with technology and ever-changing customer demand.
Learn More🚗NHTSA Proposes New Electronic Recall Notification Requirements
In accordance with the Moving Ahead for Progress in the 21st Century Act (MAP-21) and the Fixing America's Surface Transportation Act (FAST Act), NHTSA is proposing to amend the means of required recall notification to include notification by electronic means, in addition to first-class mail, and proposing certain other attendant obligations related to this requirement. NHTSA is also proposing to revise certain language that is currently required for recall notifications, as well as to update certain language in the regulation and the office designation for NHTSA's Recall Management Division and NHTSA's web address.
Learn More💊FDA Issues Priority Review Voucher for CRENESSITY (Crinecerfont)
The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that CRENESSITY (crinecerfont), approved on December 13, 2024, manufactured by Neurocrine Biosciences, Inc., meets the criteria for a priority review voucher.
Learn More🌊Workshop on Recovery Planning for Endangered Seals in Alaska
NMFS announces its intent to convene a workshop to solicit facts and information from experts to inform recovery planning for the Beringia Distinct Population Segment (DPS) bearded Seal (Erignathus barbatus nauticus) and the Arctic ringed seal (Phoca hispida hispida). We will not be asking for any consensus recommendations on how to recover these species. This workshop will be open to the public. We also request submission of information that might inform the development of the recovery plans.
Learn More🏢Business Implications of the 2026 Census Data Collection Notice
The Department of Commerce, in accordance with the Paperwork Reduction Act (PRA) of 1995, invites the general public and other Federal agencies to comment on proposed, and continuing information collections, which helps us assess the impact of our information collection requirements and minimize the public's reporting burden. The purpose of this notice is to allow for 60 days of public comment on the proposed new information collection, for the 2026 Census Test, prior to the submission of the information collection request (ICR) to Office of Management and Budget (OMB) for approval.
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