November 7, 2017 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA, the Agency, or we) is classifying the total 25-hydroxyvitamin D mass spectrometry test system 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 total 25-hydroxyvitamin D mass spectrometry test system'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, the Agency, or we) is classifying the genetic health risk assessment system 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 genetic health risk assessment system'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.

In accordance with the Federal Advisory Committee Act, this notice advises interested persons that the Federal Communications Commission's (FCC) Technological Advisory Council will hold a meeting.

The Centers for Disease Control and Prevention (CDC) is seeking nominations for membership on the STAC. The STAC consists of 17 members including experts in fields associated with occupational medicine, environmental medicine, environmental health, industrial hygiene, epidemiology, toxicology, mental health, and representatives of World Trade Center (WTC) responders as well as representatives of certified-eligible WTC survivors. Members may be invited to serve for three-year terms. Selection of members is based on candidates' qualifications to contribute to the accomplishment of STAC objectives https://www.cdc.gov/wtc/stac.html.

Notice is hereby given, pursuant to the provisions of the rules and regulations of the U.S. Commission on Civil Rights (Commission) and the Federal Advisory Committee Act (FACA) that a meeting of the Alaska Advisory Committee (Committee) to the Commission will be held on December 14, 2017 at 1:00 p.m. (Alaska Time). On Thursday, January 18, 2018; Thursday, February 8, 2018 and Thursday, March 8, 2018 at 12:00 p.m. (Alaska Time). The purpose of the meeting is for the Committee to discuss findings that will be included in an advisory memorandum on Alaska Native voting rights.

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.

The U.S. Nuclear Regulatory Commission (NRC) is revising its licensing guidance for licenses authorizing the use of Yttrium-90 (Y- 90) Microsphere Brachytherapy Sources and Devices TheraSphere[supreg] and SIR-Spheres[supreg]. The NRC is requesting public comment on the draft revision of the licensing guidance (Rev. 10). The document has been revised to significantly update the criteria for training and experience, medical event reporting, inventory requirement specifications, and waste disposal issues. The revised guidance document also provides new information regarding cremation and autopsy. This guidance is intended for use by NRC applicants, NRC licensees, and the NRC staff.

We propose to adopt a new airworthiness directive (AD) for certain Piper Aircraft, Inc. Models PA-28-140, PA-28-150, PA-28-160, PA-28-180, PA-28-235, PA-32-260, and PA-32-300 airplanes. This proposed AD was prompted by reports of corrosion found in an area of the main wing spar not easily accessible for inspection. This proposed AD would require installing an inspection access panel in the lower wing skin near the left and the right main wing spars if not already there, inspecting the left and the right main wing spars for corrosion, and taking all necessary corrective actions. We are proposing this AD to address the unsafe condition on these products.

This final rule updates the home health prospective payment system (HH PPS) payment rates, including the national, standardized 60- day episode payment rates, the national per-visit rates, and the non- routine medical supply (NRS) conversion factor, effective for home health episodes of care ending on or after January 1, 2018. This rule also: Updates the HH PPS case-mix weights using the most current, complete data available at the time of rulemaking; implements the third year of a 3-year phase-in of a reduction to the national, standardized 60-day episode payment to account for estimated case-mix growth unrelated to increases in patient acuity (that is, nominal case-mix growth) between calendar year (CY) 2012 and CY 2014; and discusses our efforts to monitor the potential impacts of the rebasing adjustments that were implemented in CY 2014 through CY 2017. In addition, this rule finalizes changes to the Home Health Value-Based Purchasing (HHVBP) Model and to the Home Health Quality Reporting Program (HH QRP). We are not finalizing the implementation of the Home Health Groupings Model (HHGM) in this final rule.

The Environmental Protection Agency (EPA) is proposing to approve a revision to the Wisconsin State Implementation Plan (SIP) submitted by the Wisconsin Department of Natural Resources (WDNR) to EPA on May 16, 2017. The revision replaces the definition of ``emergency electric generator'' with a broader definition of ``restricted internal combustion engine''. In addition, the revision makes amendments to procedures for revoking construction permits as well as language changes and other administrative updates. Lastly, WDNR is withdrawing two Wisconsin Administrative Code provisions that affect eligibility under general and construction permits. WDNR requested these changes to align state and Federal requirements and ensure consistency. EPA is proposing approval of Wisconsin's May 16, 2017, request because the Agency has made the preliminary determination that this SIP revision is consistent with the Clean Air Act and applicable EPA regulations regarding PSD.