U.S. Federal Register Tool

Accelerating Medical Treatments for Serious Mental Illness

Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Setmelanotide Eligibility Gene Variant Detection System

The Food and Drug Administration (FDA, the Agency, or we) is classifying the setmelanotide eligibility gene variant detection system into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the setmelanotide eligibility gene variant detection system. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Medical Devices; Anesthesiology Devices; Classification of the Device for Sleep Apnea Testing Based on Mandibular Movement

The Food and Drug Administration (FDA) is classifying the device for sleep apnea testing based on mandibular movement into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the device for sleep apnea testing based on mandibular movement. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Medical Devices; Ophthalmic Devices; Classification of the Digital Therapy Device for Amblyopia

The Food and Drug Administration (FDA, the Agency, or we) is classifying the digital therapy device for amblyopia into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the digital therapy device for amblyopia. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Medical Devices; Immunology and Microbiology Devices; Classification of the Alzheimer's Disease Pathology Assessment Test

The Food and Drug Administration (FDA, the Agency, or we) is classifying the Alzheimer's disease pathology assessment test into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for classification of the Alzheimer's disease pathology assessment test. We are taking this action because we have determined that classifying the device into class II will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices, in part by reducing regulatory burdens.

Saba Capital Income & Opportunities Fund II, et al.

Agency Information Collection Activities: Submission for OMB Review; Comment Request

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension or reinstatement of an existing collection of information, and to allow a second opportunity for public comment on the notice. Interested persons are invited to send comments regarding the burden estimate or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

Agency Information Collection Activities: Proposed Collection; Comment Request

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

Sunshine Act Meetings

Hazardous Materials: Notice of Public Meetings in 2026 for International Standards on the Transport of Dangerous Goods

This notice announces that the Pipeline and Hazardous Materials Safety Administration (PHMSA) Office of Hazardous Materials Safety (OHMS) will host three public meetings during 2026 in advance of certain international meetings. The first meeting will be held in preparation for the 68th session of the United Nations Sub-Committee of Experts on the Transport of Dangerous Goods (UNSCOE TDG) scheduled for June 29 to July 8, 2026, in Geneva, Switzerland. The second meeting will be held in preparation for the International Civil Aviation Organization's (ICAO) Dangerous Goods Panel (DGP) Working Group 26 (WG/ 26) tentatively scheduled for October 2026 in Montreal, Canada. The third meeting will be held in preparation for the 69th session of the UNSCOE TDG scheduled for November 23 to December 1, 2026, in Geneva, Switzerland. For each of these meetings, PHMSA will solicit public input on current proposals. Time and Location: Each public meeting will take place approximately five weeks preceding the international meeting either at Department of Transportation Headquarters, West Building, 1200 New Jersey Avenue SE, Washington, DC 20590-0001 with a remote participation option, or in a fully remote capacity. Specific information for each meeting will be posted when available on the PHMSA website at www.phmsa.dot.gov/international-program/international-program-overview under "Upcoming Events." This information will include the public meeting date, time, remote access login, conference dial-in number, and details for advance registration.