June 7, 2018 – Federal Register Recent Federal Regulation Documents

This notice amends the notice of a major disaster declaration for the State of Ohio (FEMA-4360-DR), dated April 17, 2018, and related determinations.

This notice announces final environmental actions taken by the Federal Transit Administration (FTA) for a project extending the METRO Green Line from downtown Minneapolis through the communities of St. Louis Park, Hopkins, Minnetonka, and Eden Prairie, passing near Edina, Minnesota. The purpose of this notice is to announce publicly the environmental decisions by FTA on the subject project and to activate the limitation on any claims that may challenge this final environmental action.

This notice is provided in accordance with the Council on Environmental Quality's regulations and Tennessee Valley Authority's (TVA) procedures for implementing the National Environmental Policy Act (NEPA). TVA has decided to construct and operate a bottom ash dewatering facility, process water basins, and an onsite landfill at the Cumberland Fossil Plant (CUF). The notice of availability (NOA) of the Final Environmental Impact Statement (EIS) for the Cumberland Fossil Plant Coal Combustion Residuals Managment Operations was published in the Federal Register on April 20, 2018. The Final EIS identified TVA's preferred alternative as Alternative C, which includes the Construction and Operation of a Bottom Ash Dewatering Facility, Closure-In-Place of the Bottom Ash Impoundment, and a combination of Closure-in-Place and Closure-by-Removal of the Main Ash Impoundment and Stilling Impoundment. The portion of the Main Ash Impoundment and the Stilling Impoundment that would be Closed-by-Removal would be repurposed as Process Water Basin 1 and Process Water Basin 2, with coal combustion residuals (CCR) that are removed from the impoundment transported to an existing onsite landfill. In addition, under Alternative C, TVA would construct an onsite landfill to manage future CCR produced at CUF. TVA's current decision pertains only to the construction and operation of a Bottom Ash Dewatering Facility, construction and operation of the new onsite CCR Landfill, and construction of the Processs Water Basins, which includes removal of CCR from a portion of the Main Ash Impoundment and the Stilling Impoundment. TVA is electing to further consider the location for permanent disposal of the ash excavated from the Main Ash Impoundment and the Stilling Impoundment. CCR removed for construction of the basins would be staged temporarily within the Main Ash Impoundment footprint until a final decision is made (following any necessary supplemental environmental review) on a location for permanent disposal of the material. The preferred alternative would achieve the project purpose and need of converting the wet storage of CCR to a dry system and promoting the future management of dry CCR at CUF by converting to dry bottom ash handling and providing additional long-term disposal for dry CCR materials produced at CUF. In addition to state and federal water and waste regulations, TVA's CCR disposal areas at CUF, including the impoundments, are subject to the 2015 Commissioner's Order entered by the Tennessee Department of Environment and Conservation (TDEC). Investigations at CUF under that Order are ongoing. Therefore, TVA is electing to further consider the proposed in-place closure of the Bottom Ash Impoundment and a portion of the Main Ash Impoundment before making a decision on closure of these facilities. In addition, TVA is electing to further consider the location for permanent disposal of the ash excavated from the Main Ash Impoundment and the Stilling Impoundment.

This request for information solicits public comment on a planned initiative of the Office of the Deputy Secretary of HHS to develop a workgroup to facilitate constructive, high-level dialogue between HHS leadership and those focused on innovating and investing in the healthcare industry. HHS seeks comment on how to structure a workgroup, or other form of interaction between the Department and such participants in the healthcare industry, in order to best support communication and understanding between these parties that will spur investment, increase competition, accelerate innovation, and allow capital investment in the healthcare sector to have a more significant impact on the health and wellbeing of Americans. HHS also seeks comment more broadly on opportunities for increased engagement and dialogue between HHS and those focused on innovating and investing in the healthcare industry.

NASA hereby gives notice of its intent to grant a partially exclusive patent license in the United States to practice the inventions described and claimed in U.S. Patent Application No. 15/ 014,608 titled ``Nuclear Thermionic Avalanche Cells with Thermoelectric (NTAC-TE) Generator in Tandem Model,'' NASA Case Number LAR-17981-1; U.S. Patent Application No. 62/513,497 titled ``Portable Compact Thermionic Power Cell,'' NASA Case Number LAR-18860-P2; U.S. Patent Application No. 15/479,679 titled ``Metallic Junction Thermoelectric Generator,'' NASA Case Number LAR-18866-1; U.S. Patent Application No. 62/621,930 titled ``Selective and Direct Deposition Technique for Streamlined CMOS Processing,'' NASA Case Number LAR-18925-P2; U.S. Patent Application No. 62/643,292 titled ``Portable Miniaturized Thermionic Power Cell with Multiple Regenerative Layers,'' NASA Case No. LAR-18926-P; U.S. Patent Application No. 62/643,303 titled ``High Performance Electric Generators Boosted by Nuclear Electorn Avalanche (NEA),'' NASA Case No. LAR-19112-P, to Braidy Industries, Inc., having its principal place of business in Ashland, Kentucky. The fields of use may be limited to power generators, generation of electricity and/or similar fields of use thereto.

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Pulmonary-Allergy 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.

The Food and Drug Administration (FDA or Agency) is announcing a publication containing modifications the Agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA Recognized Consensus Standards). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 049'' (Recognition List Number: 049), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register on February 23, 2018. The notice announced the voluntary withdrawal of approval of 24 abbreviated new drug applications (ANDAs) from multiple applicants, effective March 26, 2018. The notice indicated that FDA was withdrawing approval of the following ANDA after receiving a withdrawal request from Sun Pharmaceutical Industries, Ltd., c/o Sun Pharmaceutical Industries, Inc. (Sun Pharmaceutical), 2 Independence Way, Princeton, NJ 08540: ANDA 077483, Benazepril Hydrochloride and Hydrochlorothiazide Tablets, 5 milligrams (mg)/6.25 mg, 10 mg/12.5 mg, 20 mg/12.5 mg, and 20 mg/25 mg. Before withdrawal of this ANDA became effective, however, Sun Pharmaceutical informed FDA that it did not want approval of the ANDA withdrawn. Because Sun Pharmaceutical timely requested that approval of this ANDA not be withdrawn, the approval of ANDA 077483 is still in effect.

The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of D&C Black No. 4 for coloring ultra-high molecular weight polyethylene (UHMWPE) non- absorbable sutures for use in general surgery. This action is in response to a color additive petition (CAP) submitted by DSM Biomedical.

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 (PRA).

The Department of Justice (DOJ), Bureau of Alcohol, Tobacco, Firearms and Explosives (ATF), will submit the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The proposed information collection was previously published in the Federal Register, on April 6, 2018, allowing for a 60-day comment period.

An open meeting of the Taxpayer Advocacy Panel Taxpayer Communications Project Committee will be conducted. The Taxpayer Advocacy Panel is soliciting public comments, ideas, and suggestions on improving customer service at the Internal Revenue Service.

An open meeting of the Taxpayer Advocacy Panel Joint Committee will be conducted. The Taxpayer Advocacy Panel is soliciting public comments, ideas, and suggestions on improving customer service at the Internal Revenue Service.

The Taxpayer Advocacy Panel Taxpayer Assistance Center Improvements Project Committee will conduct an open meeting and will solicit public comments, ideas, and suggestions on improving customer service at the Internal Revenue Service.

An open meeting of the Taxpayer Advocacy Panel Notices and Correspondence Project Committee will be conducted. The Taxpayer Advocacy Panel is soliciting public comments, ideas, and suggestions on improving customer service at the Internal Revenue Service.

The Food and Drug Administration is correcting a proposed rule to amend its regulations concerning the classification of products as biological products, devices, drugs, or combination products, and their assignment to Agency components for premarket review and regulation that appeared in the Federal Register of May 15, 2018. The document was published with an error in the discussion of the preliminary economic analysis impact. This document corrects that error.

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 Idaho Advisory Committee (Committee) to the Commission will be held at 1:00 p.m. (Mountain Time) Wednesday, June 20, 2018, for the purpose of discussing potential civil rights topics of study.

This notice sets forth the proposed schedule and agenda of a forthcoming meeting of the Marine Fisheries Advisory Committee (MAFAC). The members will discuss and provide advice on issues outlined under SUPPLEMENTARY INFORMATION below.