Department of Health and Human Services February 11, 2019 – Federal Register Recent Federal Regulation Documents
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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
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
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.
Determination of Regulatory Review Period for Purposes of Patent Extension; EXONDYS 51
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
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).
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
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.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approvals
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
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.
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