November 7, 2017 – Federal Register Recent Federal Regulation Documents

Medical Devices; Exemption From Premarket Notification; Class II Devices; Autosomal Recessive Carrier Screening Gene Mutation Detection System
Document Number: 2017-24162
Type: Rule
Date: 2017-11-07
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) is publishing an order to exempt autosomal recessive carrier screening gene mutation detection systems from the premarket notification requirements, subject to certain limitations. This exemption from 510(k), subject to certain limitations, is immediately in effect for autosomal recessive carrier screening gene mutation detection systems. This exemption will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures required to comply with certain Federal regulations. FDA is also amending the codified language for the autosomal recessive carrier screening gene mutation detection system devices classification regulation to reflect this final determination.
Medical Devices; Clinical Chemistry and Clinical Toxicology Devices; Classification of the Total 25-Hydroxyvitamin D Mass Spectrometry Test System
Document Number: 2017-24161
Type: Rule
Date: 2017-11-07
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Notice of Determinations; Culturally Significant Objects Imported for Exhibition Determinations: “Paper Promises: Early American Photography” Exhibition
Document Number: 2017-24160
Type: Notice
Date: 2017-11-07
Agency: Department of State
Notice is hereby given of the following determinations: I hereby determine that certain objects to be included in the exhibition ``Paper Promises: Early American Photography,'' imported from abroad for temporary exhibition within the United States, are of cultural significance. The objects are imported pursuant to a loan agreement with the foreign owner or custodian. I also determine that the exhibition or display of the exhibit objects at The J. Paul Getty Museum at the Getty Center, Los Angeles, California, from on or about February 27, 2018, until on or about May 27, 2018, and at possible additional exhibitions or venues yet to be determined, is in the national interest.
Medical Devices; Immunology and Microbiology Devices; Classification of the Genetic Health Risk Assessment System
Document Number: 2017-24159
Type: Rule
Date: 2017-11-07
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Twenty Fifth RTCA SC-223 IPS and AeroMACS Plenary
Document Number: 2017-24158
Type: Notice
Date: 2017-11-07
Agency: Federal Aviation Administration, Department of Transportation
The FAA is issuing this notice to advise the public of a meeting of Twenty Fifth RTCA SC-223 IPS and AeroMACS Plenary.
Federal Advisory Committee Act; Meeting of Technological Advisory Council
Document Number: 2017-24157
Type: Notice
Date: 2017-11-07
Agency: Federal Communications Commission, Agencies and Commissions
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.
Airworthiness Directives; Rolls-Royce plc Turbofan Engines
Document Number: 2017-24156
Type: Rule
Date: 2017-11-07
Agency: Federal Aviation Administration, Department of Transportation
We are adopting a new airworthiness directive (AD) for all Rolls-Royce plc (RR) RB211-Trent 970-84 and RB211-Trent 972-84 turbofan engines. This AD requires an inspection of the drains mast. This AD was prompted by cracks found in the transition duct area of the drains mast. We are issuing this AD to address the unsafe condition on these products.
Solicitation of Nominations for Appointment to the World Trade Center Health Program Scientific/Technical Advisory Committee (STAC)
Document Number: 2017-24155
Type: Notice
Date: 2017-11-07
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
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 of Petition for Declaratory Order; Permian Express Terminal LLC; Permian Express Partners LLC
Document Number: 2017-24154
Type: Notice
Date: 2017-11-07
Agency: Department of Energy, Federal Energy Regulatory Commission
Notice of Application Accepted for Filing, Soliciting Comments, Protests and Motions To Intervene; Sappi Cloquet LLC
Document Number: 2017-24153
Type: Notice
Date: 2017-11-07
Agency: Department of Energy, Federal Energy Regulatory Commission
Notice of Petition for Declaratory Order; BridgeTex Pipeline Company, LLC
Document Number: 2017-24152
Type: Notice
Date: 2017-11-07
Agency: Department of Energy, Federal Energy Regulatory Commission
Combined Notice of Filings #2
Document Number: 2017-24150
Type: Notice
Date: 2017-11-07
Agency: Department of Energy, Federal Energy Regulatory Commission
Combined Notice of Filings
Document Number: 2017-24149
Type: Notice
Date: 2017-11-07
Agency: Department of Energy, Federal Energy Regulatory Commission
Combined Notice of Filings #1
Document Number: 2017-24148
Type: Notice
Date: 2017-11-07
Agency: Department of Energy, Federal Energy Regulatory Commission
Combined Notice of Filings
Document Number: 2017-24147
Type: Notice
Date: 2017-11-07
Agency: Department of Energy, Federal Energy Regulatory Commission
Notice of Application; Texas Eastern Transmission, LP
Document Number: 2017-24146
Type: Notice
Date: 2017-11-07
Agency: Department of Energy, Federal Energy Regulatory Commission
Combined Notice of Filings #1
Document Number: 2017-24145
Type: Notice
Date: 2017-11-07
Agency: Department of Energy, Federal Energy Regulatory Commission
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2017-24144
Type: Notice
Date: 2017-11-07
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
Document Number: 2017-24143
Type: Notice
Date: 2017-11-07
Agency: Department of Health and Human Services, National Institutes of Health
Records Governing Off-the-Record Communications; Public Notice
Document Number: 2017-24141
Type: Notice
Date: 2017-11-07
Agency: Department of Energy, Federal Energy Regulatory Commission
Notice of Performance Review Board Members
Document Number: 2017-24139
Type: Notice
Date: 2017-11-07
Agency: Department of Veterans Affairs
Under provisions of law agencies are required to publish a notice in the Federal Register of the appointment of Performance Review Board (PRB) members. This notice announces the appointment of individuals to serve on the PRB of the Department of Veterans Affairs.
Reinhart Partners, Inc., et al.
Document Number: 2017-24138
Type: Notice
Date: 2017-11-07
Agency: Securities and Exchange Commission, Agencies and Commissions
Notice of Public Meeting of the Alaska Advisory Committee
Document Number: 2017-24137
Type: Notice
Date: 2017-11-07
Agency: Commission on Civil Rights
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 at 1:00 p.m. (Alaska Time) Thursday, November 9, 2017. 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.
Notice of Public Meeting of the Alaska Advisory Committee
Document Number: 2017-24136
Type: Notice
Date: 2017-11-07
Agency: Commission on Civil Rights
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.
Fisheries of the Northeastern United States; Golden Tilefish Fishery; 2018 and Projected 2019-2020 Specifications
Document Number: 2017-24135
Type: Rule
Date: 2017-11-07
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
NMFS issues final specifications for the 2018 commercial golden tilefish fishery and projected specifications for 2019 and 2020. This action establishes allowable harvest levels and other management measures to prevent overfishing while allowing optimum yield, consistent with the Magnuson-Stevens Fishery Conservation and Management Act and the Tilefish Fishery Management Plan. It is also intended to inform the public of these specifications for the 2018 fishing year and projected specifications for 2019-2020.
Agency Information Collection Activities: Proposed Collection; Comment Request
Document Number: 2017-24134
Type: Notice
Date: 2017-11-07
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
Yttrium-90 Microsphere Brachytherapy Sources and Devices TheraSphere® and SIR-Spheres®
Document Number: 2017-24129
Type: Notice
Date: 2017-11-07
Agency: Nuclear Regulatory Commission, Agencies and Commissions
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.
Airworthiness Directives; IPECO Pilot and Co-Pilot Seats
Document Number: 2017-24127
Type: Rule
Date: 2017-11-07
Agency: Federal Aviation Administration, Department of Transportation
We are adopting a new airworthiness directive (AD) for certain Ipeco Holdings Ltd. (Ipeco) pilot and co-pilot seats. This AD requires modification and reidentification of the affected seats. This AD was prompted by reports of unexpected movement of pilot and co-pilot seats on takeoff and landing. We are issuing this AD to address the unsafe condition on these products.
Airworthiness Criteria: Glider Design Criteria for Alexander Schleicher GmbH & Co. Models ASG 32 & ASG 32 Mi Gliders
Document Number: 2017-24102
Type: Rule
Date: 2017-11-07
Agency: Federal Aviation Administration, Department of Transportation
These airworthiness design criteria for the Alexander Schleicher GmbH & Co. models ASG 32 & ASG 32 Mi gliders. The administrator finds the design criteria, which make up the certification basis for the ASG 32 & ASG 32 Mi gliders, acceptable.
Airworthiness Directives; Piper Aircraft, Inc. Airplanes
Document Number: 2017-24083
Type: Proposed Rule
Date: 2017-11-07
Agency: Federal Aviation Administration, Department of Transportation
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.
Determination of Rates and Terms for Public Broadcasting (PB III)
Document Number: 2017-23991
Type: Proposed Rule
Date: 2017-11-07
Agency: Copyright Royalty Board, Library of Congress, Library of Congress, Agencies and Commissions
The Copyright Royalty Judges solicit comments on proposed rates and terms for use of certain works in connection with noncommercial broadcasting for the period commencing January 1, 2018, and ending on December 31, 2022.
Medicare and Medicaid Programs; CY 2018 Home Health Prospective Payment System Rate Update and CY 2019 Case-Mix Adjustment Methodology Refinements; Home Health Value-Based Purchasing Model; and Home Health Quality Reporting Requirements
Document Number: 2017-23935
Type: Rule
Date: 2017-11-07
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
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.
Biweekly Notice; Applications and Amendments to Facility Operating Licenses and Combined Licenses Involving No Significant Hazards Considerations
Document Number: 2017-23749
Type: Notice
Date: 2017-11-07
Agency: Nuclear Regulatory Commission, Agencies and Commissions
Pursuant to Section 189a. (2) of the Atomic Energy Act of 1954, as amended (the Act), the U.S. Nuclear Regulatory Commission (NRC) is publishing this regular biweekly notice. The Act requires the Commission to publish notice of any amendments issued, or proposed to be issued, and grants the Commission the authority to issue and make immediately effective any amendment to an operating license or combined license, as applicable, upon a determination by the Commission that such amendment involves no significant hazards consideration, notwithstanding the pendency before the Commission of a request for a hearing from any person. This biweekly notice includes all notices of amendments issued, or proposed to be issued, from October 7 to October 23, 2017. The last biweekly notice was published on October 24, 2017.
Air Plan Approval; Wisconsin; 2017 Revisions to NR 400 and 406
Document Number: 2017-23448
Type: Proposed Rule
Date: 2017-11-07
Agency: Environmental Protection Agency
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.
Air Plan Approval; Wisconsin; 2017 Revisions to NR 400 and 406
Document Number: 2017-23048
Type: Rule
Date: 2017-11-07
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is taking direct final action 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 removing from the SIP two Wisconsin Administrative Code provisions that affect eligibility of coverage under general and construction permits.