2018 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA, Agency, or we) 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 the use of the FDA Electronic Submission Gateway (ESG) and the Safety Reporting Portal (SRP) to collect adverse event reports and other safety information for FDA- regulated products.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Bone, Reproductive and Urologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

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 the meeting of the Wyoming Advisory Committee (Committee) to the Commission will be held at 1:00 p.m. (Mountain Time) Wednesday, December 12, 2018. The purpose of this meeting is for the Committee to discuss project topics and receive information on USCCR project process.

The U.S. International Trade Commission (``Commission'') hereby gives notice of the procedures it intends to follow to comply with the court-ordered remand of its final determinations in the antidumping and countervailing duty investigations of truck and bus tires (``TBTs'') from China. For further information concerning the conduct of these remand proceedings and rules of general application, consult the Commission's Rules of Practice and Procedure, part 201, subparts A through E (19 CFR part 201), and part 207, subpart A (19 CFR part 207).

On October 19, 2018, the U.S. Nuclear Regulatory Commission (NRC) announced appointments to the NRC Performance Review Board (PRB) responsible for making recommendations on performance appraisal ratings and performance awards for NRC Senior Executives and Senior Level System employees and appointments to the NRC PRB Panel responsible for making recommendations to the appointing and awarding authorities for NRC PRB members. Since then, the NRC has made revisions to the list of PRB member appointees.

The National Cancer Institute, an institute of the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an Exclusive Patent License to practice the inventions embodied in the Patents and Patent Applications listed in the Supplementary Information section of this notice to Bull Run Capital, Inc. located in Vancouver, BC, Canada.

The Commission hereby gives notice of the scheduling of the final phase of antidumping and countervailing duty investigation Nos. 701-TA-602 and 731-TA-1412 (Final) pursuant to the Tariff Act of 1930 (``the Act'') to determine whether an industry in the United States is materially injured or threatened with material injury, or the establishment of an industry in the United States is materially retarded, by reason of imports of steel wheels from China, provided for in subheadings 8708.70.45, 8708.70.60, and 8716.90.50 of the Harmonized Tariff Schedule of the United States, preliminarily determined by the Department of Commerce (``Commerce'') to be subsidized and sold at less-than-fair-value.

This notice amends the notice of a major disaster declaration for the Commonwealth of Virginia (FEMA-4401-DR), dated October 15, 2018, and related determinations.

Flood hazard determinations, which may include additions or modifications of Base Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, or regulatory floodways on the Flood Insurance Rate Maps (FIRMs) and where applicable, in the supporting Flood Insurance Study (FIS) reports have been made final for the communities listed in the table below. The FIRM and FIS report are the basis of the floodplain management measures that a community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the Federal Emergency Management Agency's (FEMA's) National Flood Insurance Program (NFIP). In addition, the FIRM and FIS report are used by insurance agents and others to calculate appropriate flood insurance premium rates for buildings and the contents of those buildings.

The Federal Railroad Administration (FRA) is issuing this notice to advise the public that FRA is rescinding the Notices of Intent (NOI) for the following Environmental Impact Statements (EIS): The Pennsylvania Maglev Proposal; the Tupelo Railroad Relocation Planning and Environmental Study; the Tier 2 EIS for the Chicago to Joliet High-Speed Rail (HSR) Project; the Tier 2 EIS for the HSR Project between Granite City, IL to St. Louis, MO HSR Project; EIS for the ACEforward Program; EIS for the Milwaukee, WI to Minneapolis, MN Rail Corridor; 7) the Los Angeles to San Louis Obispo North (LOSSAN) Rail Corridor Project; and 8) the Chicago to Detroit/Pontiac Corridor Investment Program.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Arthritis Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The general function of the committees is to provide advice and recommendations to FDA on regulatory issues. The meeting will be open to the public. FDA is establishing a docket for public comment on this document.

NMFS publishes standard prices and fee percentages for cost recovery for the Amendment 80 Program, the American Fisheries Act (AFA) Program, the Aleutian Islands Pollock (AIP) Program, and the Western Alaska Community Development Quota (CDQ) groundfish and halibut Programs. The fee percentage for 2018 is 0.75 percent for the Amendment 80 Program, 0.24 percent for the AFA inshore cooperatives, 0.34 percent for the AFA mothership cooperative, 3.0 percent for the AIP program, and 0.66 percent for the CDQ groundfish and halibut Programs. This action is intended to provide the 2018 standard prices and fee percentages to calculate the required payment for cost recovery fees due by December 31, 2018.

In accordance with the Endangered Species Act (ESA) and the National Environmental Policy Act, we, the U.S. Fish and Wildlife Service (Service), announce the availability of a draft habitat conservation plan (HCP) in support of an application from Skookumchuck Wind Energy Project, LLC, an affiliate of Renewable Energy Services (applicant), for an incidental take permit (ITP) for the marbled murrelet, listed as threatened under the ESA, and the bald eagle and golden eagle, both of which are protected under the Bald and Golden Eagle Protection Act. Incidental take is expected to result from the operation of 38 commercial wind turbines and associated infrastructure located near Centralia, Washington, in Lewis and Thurston Counties. Also available for review is the Service's draft environmental impact statement (DEIS), which was prepared in response to the application. We are seeking public comments on the draft HCP and DEIS.

The Tennessee Valley Authority (TVA) intends to prepare an Environmental Impact Statement (EIS) to address the potential environmental effects associated with the future management of coal combustion residual (CCR) material at the Allen Fossil Plant (ALF) located in Shelby County, Tennessee, southwest of the City of Memphis. The purpose of this EIS is to support the implementation of TVA's goal to eliminate all wet CCR storage at its coal plants by closing CCR surface impoundments across the TVA system, and to assist TVA in complying with the Environmental Protection Agency's (EPA) CCR Rule. In addition, the proposed actions would make the ALF closure area land available for future economic development projects in the greater Memphis area. TVA will evaluate closure of the East Ash Pond Complex, the West Ash Pond, and the Metal Cleaning Pond. In addition to these closures, TVA will analyze potential location requirements and associated environmental impacts associated with construction and utilization of a proposed beneficial re-use facility to process CCR materials. TVA will also evaluate potential impacts associated with actions requiring use of permitted borrow sites and the disposal of CCR at existing offsite permitted landfills. TVA will develop and evaluate various alternatives to these actions, including the No Action Alternative. Public comments are invited concerning both the scope of the review and environmental issues that should be addressed.

The Environmental Protection Agency (EPA) is issuing this interim final rule in response to the urgent public health issue posed by recalled Takata airbag inflators still installed in vehicles. With this rule, EPA is facilitating a more expedited removal of defective Takata airbag inflators from vehicles by dealerships, salvage yards and other locations for safe and environmentally sound disposal by exempting the collection of airbag waste from hazardous waste requirements so long as certain conditions are met. The Agency is also seeking comment on this interim final rule.