Department of Health and Human Services February 11, 2019 – Federal Register Recent Federal Regulation Documents

Medicaid Program; Final FY 2017 and Preliminary FY 2019 Disproportionate Share Hospital Allotments, and Final FY 2017 and Preliminary FY 2019 Institutions for Mental Diseases Disproportionate Share Hospital Limits
Document Number: 2019-01928
Type: Notice
Date: 2019-02-11
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This notice announces the final federal share disproportionate share hospital (DSH) allotments for federal fiscal year (FY) 2017 and the preliminary federal share DSH allotments for FY 2019. This notice also announces the final FY 2017 and the preliminary FY 2019 limitations on aggregate DSH payments that states may make to institutions for mental disease and other mental health facilities. In addition, this notice includes background information describing the methodology for determining the amounts of states' FY DSH allotments.
Medicare Program; Approval of Request for an Exception to the Prohibition on Expansion of Facility Capacity Under the Hospital Ownership and Rural Provider Exceptions to the Physician Self-Referral Prohibition
Document Number: 2019-01927
Type: Notice
Date: 2019-02-11
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
This final notice announces our decision to approve the request of St. James Behavioral Health Hospital Inc for an exception to the prohibition on expansion of facility capacity.
National Institute of Mental Health; Notice of Closed Meetings
Document Number: 2019-01900
Type: Notice
Date: 2019-02-11
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meetings
Document Number: 2019-01899
Type: Notice
Date: 2019-02-11
Agency: Department of Health and Human Services, National Institutes of Health
Eunice Kennedy Shriver National Institute of Child Health & Human Development; Notice of Closed Meetings
Document Number: 2019-01898
Type: Notice
Date: 2019-02-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences: Notice of Closed Meeting
Document Number: 2019-01897
Type: Notice
Date: 2019-02-11
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-01896
Type: Notice
Date: 2019-02-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Mental Health; Notice of Meetings
Document Number: 2019-01885
Type: Notice
Date: 2019-02-11
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Meeting
Document Number: 2019-01884
Type: Notice
Date: 2019-02-11
Agency: Department of Health and Human Services, National Institutes of Health
Determination of Regulatory Review Period for Purposes of Patent Extension; EXONDYS 51
Document Number: 2019-01851
Type: Notice
Date: 2019-02-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for EXONDYS 51 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.
Enhancing the Incorporation of Patient Perspectives on Clinical Trials; Public Workshop; Request for Comments
Document Number: 2019-01826
Type: Notice
Date: 2019-02-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``Enhancing the Incorporation of Patient Perspectives on Clinical Trials'' and an opportunity for public comment. The workshop will be convened by the Clinical Trials Transformation Initiative (CTTI). The topic to be discussed is stakeholders' (including patients, caregivers, industry, academic researchers, and expert practitioners) perspectives on challenges and barriers to patients participating in clinical trials and best practices and key considerations for enhancing the incorporation of patient perspectives on clinical trial access, design, conduct, and post-trial followup. The workshop will result in a publicly available report from CTTI on proceedings and recommendations from discussions at the workshop. This workshop is intended to meet an FDA commitment included in the sixth authorization of the Prescription Drug User Fee Amendments of 2017 (PDUFA VI).
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: 2019-01820
Type: Notice
Date: 2019-02-11
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Proposed Collection; Comment Request; Experimental Study on Measuring Consumer Comprehension of Displays of Harmful and Potentially Harmful Constituents in Tobacco Products and Tobacco Smoke
Document Number: 2019-01819
Type: Notice
Date: 2019-02-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 and to allow 60 days for public comment in response to the notice. This notice solicits comments on an experimental study on measuring consumer comprehension of displays of harmful and potentially harmful constituents (HPHCs) in tobacco products and tobacco smoke.
National Human Genome Research Institute; Notice of Closed Meeting
Document Number: 2019-01818
Type: Notice
Date: 2019-02-11
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-01816
Type: Notice
Date: 2019-02-11
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-01814
Type: Notice
Date: 2019-02-11
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-01813
Type: Notice
Date: 2019-02-11
Agency: Department of Health and Human Services, National Institutes of Health
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
Document Number: 2019-01812
Type: Notice
Date: 2019-02-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is publishing a list of information collections that have been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Proposed Collection; Comment Request; Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act
Document Number: 2019-01793
Type: Notice
Date: 2019-02-11
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. 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 of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on certain labeling statements for nonprescription human drug products marketed without an approved application.
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2019-01789
Type: Notice
Date: 2019-02-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2019-01788
Type: Notice
Date: 2019-02-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2019-01787
Type: Notice
Date: 2019-02-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2019-01786
Type: Notice
Date: 2019-02-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2019-01785
Type: Notice
Date: 2019-02-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2019-01784
Type: Notice
Date: 2019-02-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2019-01783
Type: Notice
Date: 2019-02-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2019-01782
Type: Notice
Date: 2019-02-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2019-01781
Type: Notice
Date: 2019-02-11
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2019-01780
Type: Notice
Date: 2019-02-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2019-01779
Type: Notice
Date: 2019-02-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2019-01778
Type: Notice
Date: 2019-02-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2019-01777
Type: Notice
Date: 2019-02-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of General Medical Sciences; Notice of Closed Meeting
Document Number: 2019-01776
Type: Notice
Date: 2019-02-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2019-01775
Type: Notice
Date: 2019-02-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2019-01774
Type: Notice
Date: 2019-02-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2019-01773
Type: Notice
Date: 2019-02-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2019-01772
Type: Notice
Date: 2019-02-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meeting
Document Number: 2019-01771
Type: Notice
Date: 2019-02-11
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2019-01770
Type: Notice
Date: 2019-02-11
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2019-01769
Type: Notice
Date: 2019-02-11
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Document Number: 2019-01768
Type: Notice
Date: 2019-02-11
Agency: Department of Health and Human Services, National Institutes of Health
Office of the Director, National Institutes of Health; Notice of Meeting
Document Number: 2019-01767
Type: Notice
Date: 2019-02-11
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: 2019-01761
Type: Notice
Date: 2019-02-11
Agency: Department of Health and Human Services, National Institutes of Health
National Cancer Institute; Notice of Closed Meeting
Document Number: 2019-01760
Type: Notice
Date: 2019-02-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meetings
Document Number: 2019-01759
Type: Notice
Date: 2019-02-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meetings
Document Number: 2019-01758
Type: Notice
Date: 2019-02-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2019-01757
Type: Notice
Date: 2019-02-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2019-01756
Type: Notice
Date: 2019-02-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2019-01755
Type: Notice
Date: 2019-02-11
Agency: Department of Health and Human Services, National Institutes of Health
National Institute on Aging; Notice of Closed Meeting
Document Number: 2019-01754
Type: Notice
Date: 2019-02-11
Agency: Department of Health and Human Services, National Institutes of Health
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