Department of Health and Human Services January 22, 2020 – Federal Register Recent Federal Regulation Documents
Results 1 - 14 of 14
Proposed Data Collection Submitted for Public Comment and Recommendations
The Centers for Disease Control and Prevention (CDC), as part of its continuing effort to reduce public burden and maximize the utility of government information, invites the general public and other Federal agencies the opportunity to comment on a proposed and/or continuing information collection, as required by the Paperwork Reduction Act of 1995. This notice invites comment on Statements in Support of Application of Waiver of Inadmissibility (0920-0006). CDC uses the information collected in 0920-0006 to review Class A medical waiver applications for prospective immigrants to the United States. CDC assists DHS/USCIS in determining whether or not a prospective immigrant with a Class A mental health designation may be admitted into the United States.
Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: The Teaching Health Center Graduate Medical Education (THCGME) Program Reconciliation Tool, OMB No. 0915-0342-Extension
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: Advanced Nursing Education Workforce (ANEW), OMB No. 0915-0375 Extension
In compliance with the requirement for opportunity for public comment on proposed data collection projects of the Paperwork Reduction Act of 1995, HRSA announces plans to submit an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB). Prior to submitting the ICR to OMB, HRSA seeks comments from the public regarding the burden estimate, below, or any other aspect of the ICR.
Determination of Regulatory Review Period for Purposes of Patent Extension; MAVYRET
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for MAVYRET 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 patents which claims that human drug product.
Submission for OMB Review; Community Services Block Grant Annual Report
The Administration of Children and Families (ACF), Office of Community Services (OCS) is requesting a three-year extension with minor changes of the Community Services Block Grant (CSBG) Annual Report (OMB No.: 0970-0492, expiration 1/31/2020). This request will support the currently utilized CSBG Annual Report, comprised of Modules 1-4, and incorporates performance management.
Notice of Purchased/Referred Care Delivery Area Designations for the Chickahominy Indian Tribe, the Chickahominy Indian Tribe-Eastern Division, the Upper Mattaponi Tribe, the Rappahannock Tribe, Inc., the Monacan Indian Nation, and the Nansemond Indian Tribe
Notice is hereby given that the Indian Health Service (IHS) is establishing the geographic boundaries of the Purchased/Referred Care Delivery Area (PRCDA) (formerly Contract Health Service Delivery Area or CHSDA) for six newly recognized Tribes: The Chickahominy Indian Tribe, the Chickahominy Indian TribeEastern Division, the Upper Mattaponi Tribe, the Rappahannock Tribe, Inc., the Monacan Indian Nation, and the Nansemond Indian Tribe.
Supplemental Evidence and Data Request on Mixed Methods Review-Integrating Palliative Care With Chronic Disease Management in Ambulatory Care
The Agency for Healthcare Research and Quality (AHRQ) is seeking scientific information submissions from the public. Scientific information is being solicited to inform our review on Mixed Methods ReviewIntegrating Palliative Care with Chronic Disease Management in Ambulatory Care, which is currently being conducted by the AHRQ's Evidence-based Practice Centers (EPC) Program. Access to published and unpublished pertinent scientific information will improve the quality of this review.
Medical Devices; Radiology Devices; Classification of the Radiological Computer-Assisted Diagnostic Software for Lesions Suspicious for Cancer
The Food and Drug Administration (FDA or we) is classifying the radiological computer-assisted diagnostic (CADx) software for lesions suspicious for cancer 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 radiological CADx software for lesions suspicious for cancer'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; Radiology Devices; Classification of the Radiological Computer Aided Triage and Notification Software
The Food and Drug Administration (FDA or we) is classifying the radiological computer aided triage and notification software 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 radiological computer aided triage and notification software'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.
Radiology Devices; Reclassification of Medical Image Analyzers
The Food and Drug Administration (FDA or the Agency) is issuing a final order to reclassify medical image analyzers applied to mammography breast cancer, ultrasound breast lesions, radiograph lung nodules, and radiograph dental caries detection, postamendments class III devices (regulated under product code MYN), into class II (special controls), subject to premarket notification. These devices are intended to direct the clinician's attention to portions of an image that may reveal abnormalities during interpretation of patient radiology images by the clinician. FDA is also identifying the special controls that the Agency believes are necessary to provide a reasonable assurance of safety and effectiveness of the device type.
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