October 2018 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is withdrawing approval of 10 new drug applications (NDAs) from multiple applicants. The applicants notified the Agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

We are adopting a new airworthiness directive (AD) for all Pratt & Whitney (PW) PW2037, PW2037M, and PW2040 turbofan engines. This AD was prompted by an uncommanded high thrust event that occurred during approach on January 16, 2016, and during landing on April 6, 2016. This AD requires removal of the metering valve pilot valve (MVPV) within certain fuel control units (FCUs) and the MVPV's replacement with a part eligible for installation. We are issuing this AD to address the unsafe condition on these products.

The Food and Drug Administration (FDA or the Agency) is reopening the period for public comment on modified risk tobacco product applications (MRTPAs) for specific General Snus products submitted by Swedish Match North America Inc. and announcing the availability for public comment of a recently received amendment to the MRTPAs. The original notice of availability for the applications appeared in the Federal Register of August 27, 2014. In that notice, FDA requested comments on the originally filed MRTPAs that are posted on https://www.regulations.gov and FDA's website. In the Federal Register of July 31, 2015, FDA issued a notice to reopen and extended the comment period for comments on amendments to the MRTPAs. That comment period closed on August 31, 2015. FDA is now reopening the comment period to seek comment specifically on a recent amendment to the MRTPAs.

In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.

The Department of State has submitted the information collection described below to the Office of Management and Budget (OMB) for approval. In accordance with the Paperwork Reduction Act of 1995 we are requesting comments on this collection from all interested individuals and organizations. The purpose of this Notice is to allow 30 days for public comment.

This document amends the Department of Veterans Affairs (VA) Schedule for Rating Disabilities (VASRD) by revising the section of the Rating Schedule that addresses the hematologic and lymphatic systems. This action will ensure VA uses current medical terminology and provides detailed and updated criteria for evaluating conditions pertaining to the hematologic and lymphatic systems.

The Department of the Treasury will submit the following information collection requests to the Office of Management and Budget (OMB) for review and clearance in accordance with the Paperwork Reduction Act of 1995, on or after the date of publication of this notice. The public is invited to submit comments on these requests.

The U.S. Nuclear Regulatory Commission (NRC) is considering renewal of Water Remediation Technology, LLC (WRT) Source Materials License No. SUC-1591, as well as WRT's request to expand the scope of its licensed activities. License SUC-1591 was originally issued by the NRC on January 25, 2007, and is a performance-based, multisite license that authorizes WRT to use its ion exchange technology to remove uranium from community drinking water systems (CWSs). WRT submitted its request for license renewal and to expand the scope of licensed activities on December 21, 2016, and on January 16, 2018, WRT revised its application to request a 20-year renewal term.

The Department of Veterans Affairs (VA), Veterans Benefits Administration (VBA), is seeking nominations of qualified candidates to be considered for appointment as a member of the Veterans' Advisory Committee on Rehabilitation (hereinafter referred to as ``the Committee'').

This is an amendment of the Presidential declaration of a major disaster for the State of Florida (FEMA-4399-DR), dated 10/11/ 2018. Incident: Hurricane Michael. Incident Period: 10/07/2018 through 10/19/2018.

In accordance with the Paperwork Reduction Act of 1995, the United States Department of Agriculture's (USDA) Rural Utilities Service (RUS) invites comments on this information collection for which the Agency intends to request approval from the Office of Management and Budget (OMB).

This is an amendment of the Presidential declaration of a major disaster for Public Assistance Only for the State of North Carolina (FEMA-4393-DR), dated 10/12/2018. Incident: Hurricane Florence. Incident Period: 09/07/2018 through 09/29/2018.

This notice sets forth the agenda for the November 15-17, 2018 Quarterly Board Meeting of the National Assessment Governing Board (hereafter referred to as Governing Board). This notice provides information to members of the public who may be interested in attending the meeting or providing written comments related to the work of the Governing Board. Notice of this meeting is required under the Federal Advisory Committee Act (FACA).

The U.S. Nuclear Regulatory Commission (NRC) invites public comment on the renewal of Office of Management and Budget (OMB) approval for an existing collection of information. The information collection is entitled, ``Physical Protection of Category 1 and Category 2 Quantities of Radioactive Material.''

In accordance with the Federal Advisory Committee Act, as amended, the National Aeronautics and Space Administration (NASA) announces amended WebEx information for the upcoming meeting of the Aeronautics Committee of the NASA Advisory Council (NAC). As noted in previous Federal Register notice, same subject (see REF), this meeting will be held for soliciting, from the aeronautics community and other persons, research and technical information relevant to program planning.

This action modifies Class E surface airspace and Class E airspace extending upward from 700 feet above the surface at Merced Regional/Macready Field, Merced, CA, to accommodate airspace redesign due to the decommissioning of the El Nido VHF Omnidirectional Range/ Distance Measuring Equipment (VOR/DME) as the FAA transitions from ground-based to satellite-based navigation. This action also removes Class E airspace extending upward from 1,200 feet above the surface; updates the airport name to match the FAA's aeronautical database; and replaces the outdated term Airport/Facility Directory with Chart Supplement. These actions are necessary for the safety and management of instrument flight rules (IFR) operations at this airport.

The Office of Fossil Energy (FE) of the Department of Energy (DOE) gives notice of receipt of an application (Application), filed on September 27, 2018, by Energ[iacute]a Costa Azul S. de R.L. de C.V (Energ[iacute]a Costa Azul), a subsidiary of Infrastructura Energetica Nova, S.A.B. de C.V. (IEnova) and IEnova's subsidiaries. A majority of the ownership interests in IEnova (66.43%) is held by indirect, wholly- owned subsidiaries of Sempra Energy, a publicly traded California corporation. The Application requests long-term, multi-contract authorization to export domestically produced natural gas to Mexico in a volume up to 545 billion cubic feet (Bcf) per year (Bcf/yr) (1.5 Bcf per day), and to re-export a portion of this natural gas as liquefied natural gas (LNG) in a volume equivalent to 475 Bcf/yr of natural gas (1.3 Bcf per day). Energ[iacute]a Costa Azul seeks to export this LNG from the proposed Energ[iacute]a Costa Azul Large-Scale Project, which consists of certain liquefaction and export terminal facilities located on the site of Energ[iacute]a Costa Azul's existing LNG import terminal north of Ensenada, Baja California, Mexico. The volumes for which Energ[iacute]a Costa Azul seeks authorization in this Application would be additive to the volumes for which Energ[iacute]a Costa Azul seeks authorization in its application in FE Docket No. 18-144-LNG. Energ[iacute]a Costa Azul requests authorization to export this; LNG to: (i) Countries with which the United States has entered into a free trade agreement (FTA) requiring national treatment for trade in natural gas (FTA countries) and (ii) any other countries with which trade is not prohibited by U.S. law or policy (non-FTA countries). Energ[iacute]a Costa Azul seeks to export the requested volume of natural gas and the requested volume of LNG on its own behalf and as agent for other entities who hold title to the natural gas at the time of export. Energ[iacute]a Costa Azul requests the authorization for a 20-year term to commence on the earlier of the date of first export or seven years from the issuance of the requested authorization. Energ[iacute]a Costa Azul further requests authorization to continue exporting for a total of three years following the end of the 20-year authorization term requested herein, solely to export any volumes that it is unable to export during the 20-year authorization term (Make-Up Volumes). Energ[iacute]a Costa Azul filed the Application under section 3 of the Natural Gas Act (NGA). Additional details and related procedural history can be found in Energ[iacute]a Costa Azul's Application, posted on the DOE/FE website at: https://www.energy.gov/ fe/downloads/energ-costa-azul-s-de-rl-de-cv-dkt-no-18-145-lng . Protests, motions to intervene, notices of intervention, and written comments are invited.

The Federal Aviation Administration (FAA) is withdrawing a previously published notice of proposed rulemaking that proposed to restrict U.S. civil flight operations below flight level (FL) 160 within the territory and airspace of Afghanistan.

This document contains proposed regulations that provide guidance under new section 1400Z-2 of the Internal Revenue Code (Code) relating to gains that may be deferred as a result of a taxpayer's investment in a qualified opportunity fund (QOF). Specifically, the proposed regulations address the type of gains that may be deferred by investors, the time by which corresponding amounts must be invested in QOFs, and the manner in which investors may elect to defer specified gains. This document also contains proposed regulations applicable to QOFs, including rules for self-certification, valuation of QOF assets, and guidance on qualified opportunity zone businesses. The proposed regulations affect QOFs and their investors. This document also provides notice of a public hearing on these proposed regulations.

This final rule amends FHWA and FTA regulations implementing the National Environmental Policy Act (NEPA) and Section 4(f) requirements. In addition, through this final rule, FRA is joining those regulations, making them FRA's NEPA and Section 4(f) implementing regulations. The FHWA, FRA and FTA (hereafter collectively referred to as ``the Agencies'') modified the NEPA and Section 4(f) regulations to reflect various provisions of the Moving Ahead for Progress in the 21st Century Act (MAP-21) and the Fixing America's Surface Transportation (FAST) Act. The Agencies have also revised the Environmental Impact and Related Procedures regulations to reflect various procedural changes, such as including a new section on combined final environmental impact statement/record of decision documents, and to improve readability and reflect current practice. This final rule also amends the Parks, Recreation Areas, Wildlife and Waterfowl Refuges, and Historic Sites regulations to reflect new exceptions created by the FAST Act.