Department of Health and Human Services June 8, 2018 – Federal Register Recent Federal Regulation Documents

The Centers for Medicare & Medicaid Services (CMS) is announcing an opportunity for the public to comment on CMS' intention to collect information from the public. Under the Paperwork Reduction Act of 1995 (the PRA), federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information (including each proposed extension or reinstatement of an existing collection of information) and to allow 60 days for public comment on the proposed action. Interested persons are invited to send comments regarding our burden estimates or any other aspect of this collection of information, including the necessity and utility of the proposed information collection for the proper performance of the agency's functions, the accuracy of the estimated burden, ways to enhance the quality, utility, and clarity of the information to be collected, and the use of automated collection techniques or other forms of information technology to minimize the information collection burden.

This final rule finalizes a policy that provides flexibility in the determination of episode spending for Comprehensive Care for Joint Replacement Payment Model (CJR) participant hospitals located in areas impacted by extreme and uncontrollable circumstances for performance years 3 through 5.

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 a proposed information collection project titled Undetermined cause of Serratia marcescens infectionsMultiple States, 2018. The goal of this investigation is to identify potential risk factors leading to an outbreak of Serratia marcescens infections among U.S. healthcare patients. Data will be used to identify a cause of the infections and prevent additional events from occurring.

The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice of availability (NOA) that appeared in the Federal Register of March 16, 2018. In the NOA, FDA requested public comment on the draft concept paper regarding the potential for illicit trade markets to develop in response to a tobacco product standard. The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.

The Food and Drug Administration (FDA or the Agency) is extending the comment period for the advance notice of proposed rulemaking (ANPRM) that appeared in the Federal Register of March 16, 2018. In the ANPRM, FDA requested information for consideration in developing a tobacco product standard to set a maximum nicotine level in combusted cigarettes so that they are minimally addictive or nonaddictive. The Agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

The National Institute for Occupational Safety and Health of the Centers for Disease Control and Prevention announces the availability of three (3) draft Immediately Dangerous to Life or Health (IDLH) Value Profiles now available for public comment for the chemicals bromine trifluoride, chlorine trifluoride, and ethylene dibromide. To view the notice and related materials, visit www.regulations.gov and enter CDC-2018-0055 in the search field and click ``Search.''

The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public workshop entitled ``Development of Inhaled Antibacterial Drugs for Cystic Fibrosis and Non-Cystic Fibrosis Bronchiectasis.'' The purpose of the public workshop is to discuss the clinical trial design challenges and future considerations for inhaled antibacterial products to treat cystic fibrosis (CF) and non-CF bronchiectasis.

The Food and Drug Administration (FDA or we) is classifying the in vivo cured intramedullary fixation rod 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 in vivo cured intramedullary fixation rod'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) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Agency for Healthcare Research and Quality published a correction document in the Federal Register of May 29, 2018 regarding AHRQ Seeking Input on Library of Patient-Centered Outcomes Research Resources. This document contained an error in the email address where comments should be submitted.