Department of Health and Human Services September 16, 2024 – Federal Register Recent Federal Regulation Documents
Results 1 - 18 of 18
Meeting of the Board of Scientific Counselors Infectious Diseases
In accordance with the Federal Advisory Committee Act, the Centers for Disease Control and Prevention (CDC) announces the following meeting of the Board of Scientific Counselors Infectious Diseases (BSC ID). This virtual meeting is open to the public via Zoom, limited only by the number of web conference lines available (500 lines). Registration in advance is required by accessing the link below in the addresses section. Time will be available for public comment.
Electronic Common Technical Document; Data Standards; Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research Supporting Electronic Common Technical Document Version 4.0
The Food and Drug Administration's (FDA or Agency) Center for Drug Evaluation and Research and Center for Biologics Evaluation and Research are announcing support for Electronic Common Technical Document (eCTD) Version 4.0 (v4.0)-based electronic submissions.
Medical Devices; Immunology and Microbiology Devices; Classification of the Device To Detect or Measure Nucleic Acid From Viruses Associated With Head and Neck Cancers
The Food and Drug Administration (FDA, Agency, or we) is classifying the device to detect or measure nucleic acid from viruses associated with head and neck cancers 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 the device to detect or measure nucleic acid from viruses associated with head and neck cancers' classification. We are taking this action because we have determined that classifying the device into class II (special controls) 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.
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Clozapine Test System
The Food and Drug Administration (FDA, Agency, or we) is classifying the clozapine test 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 the clozapine test system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) 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.
Determination of Regulatory Review Period for Purposes of Patent Extension; REZZAYO
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for REZZAYO and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications 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.
Determination of Regulatory Review Period for Purposes of Patent Extension; ORSERDU
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for ORSERDU and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications 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.
Interagency Coordinating Committee on the Validation of Alternative Methods Biennial Progress Report: 2022-2023; Availability of Report
The National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) announces availability of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Biennial Progress Report: 2022-2023.
Medical Devices; Therapeutic Devices; Classification of the Pediatric Continuous Renal Replacement Therapy System
The Food and Drug Administration (FDA, Agency, or we) is classifying the pediatric continuous renal replacement therapy 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 the pediatric continuous renal replacement therapy system's classification. We are taking this action because we have determined that classifying the device into class II (special controls) 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.
Proposed Information Collection Activity; Sexual Risk Avoidance Education Program Performance Analysis Study-Extension (Office of Management and Budget (OMB) #0970-0536)
The Office of Planning, Research, and Evaluation (OPRE) and the Family and Youth Services Bureau in the Administration for Children and Families (ACF) request an extension without changes of a currently approved information collection activity as part of the Sexual Risk Avoidance Education (SRAE) Program Performance Analysis Study (PAS). The goal of the study is to collect, analyze, and report on performance measures data for the SRAE program (OMB Control No. 0970-0536; expiration date 1/31/2025). The purpose of the requested extension is to continue the ongoing data collection and submission of the performance measures by SRAE grant recipients.
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