Department of Health and Human Services January 30, 2018 – Federal Register Recent Federal Regulation Documents

This document announces the extension of statewide temporary moratoria on the enrollment of new Medicare Part B non-emergency ground ambulance providers and suppliers and Medicare home health agencies, subunits, and branch locations in Florida, Illinois, Michigan, Texas, Pennsylvania, and New Jersey, as applicable, to prevent and combat fraud, waste, and abuse. This extension also applies to the enrollment of new non-emergency ground ambulance suppliers and home health agencies, subunits, and branch locations in Medicaid and the Children's Health Insurance Program in those states. For purposes of these moratoria, providers that were participating as network providers in one or more Medicaid managed care organizations prior to January 1, 2018 will not be considered ``newly enrolling'' when they are required to enroll with the State Medicaid agency pursuant to a new statutory requirement, and thus will not be subject to the moratoria.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for SAPIEN 3 TRANSCATHETER HEART VALVE 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 medical device.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for CRESEMBA as approved under new drug application (NDA) 207500 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 as approved under NDA 207500.

The Food and Drug Administration (FDA, the Agency, or we) is announcing a public meeting entitled ``Evaluating Inclusion and Exclusion Criteria in Clinical Trials.'' Convened by the Duke-Robert J. Margolis, MD, Center for Health Policy at Duke University and supported by a cooperative agreement with FDA, the purpose of the public meeting is to bring the stakeholder community together to discuss a variety of topics related to eligibility criteria in clinical trials and their potential impact on patient access to investigational drugs, and how to facilitate the enrollment of a diverse patient population.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for LONSURF 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.

The Food and Drug Administration (FDA or we) is classifying the surgical smoke precipitator 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 surgical smoke precipitator'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.

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for UPTRAVI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application 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.