Department of Health and Human Services November 14, 2017 – Federal Register Recent Federal Regulation Documents

Submission for OMB Review; Comment Request
Document Number: 2017-24609
Type: Notice
Date: 2017-11-14
Agency: Department of Health and Human Services, Administration for Children and Families
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2017-24603
Type: Notice
Date: 2017-11-14
Agency: Department of Health and Human Services
National Institute of Neurological Disorders and Stroke; Notice of Closed Meetings
Document Number: 2017-24602
Type: Notice
Date: 2017-11-14
Agency: Department of Health and Human Services, National Institutes of Health
Proposed Information Collection Activity; Comment Request
Document Number: 2017-24587
Type: Notice
Date: 2017-11-14
Agency: Department of Health and Human Services, Administration for Children and Families
Medical Devices; Gastroenterology-Urology Devices; Classification of the Prostatic Artery Embolization Device
Document Number: 2017-24586
Type: Rule
Date: 2017-11-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the prostatic artery embolization device 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 prostatic artery embolization device'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, in part by reducing regulatory burdens.
Medical Devices; Immunology and Microbiology Devices; Classification of the Automated Indirect Immunofluorescence Microscope and Software-Assisted System
Document Number: 2017-24585
Type: Rule
Date: 2017-11-14
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the automated indirect immunofluorescence microscope and software- assisted 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 automated indirect immunofluorescence microscope and software-assisted 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, in part by reducing regulatory burdens.
National Heart, Lung, and Blood Institute; Notice of Meeting
Document Number: 2017-24572
Type: Notice
Date: 2017-11-14
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-24571
Type: Notice
Date: 2017-11-14
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2017-24570
Type: Notice
Date: 2017-11-14
Agency: Department of Health and Human Services, National Institutes of Health