October 2018 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for REBINYN and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.

We are finalizing specifications for the 2019 commercial golden tilefish fishery, including the annual catch and total allowable landings limits. 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.

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 close the Shawnee Fossil Plant (SHF) Special Waste Landfill (SWL) and Ash Impoundment 2 and construct a new process water basin (PWB). A notice of availability (NOA) of the Final Supplemental Environmental Impact Statement (SEIS) for Shawnee Fossil Plant Coal Combustion Residual (CCR) Management was published in the Federal Register on August 31, 2018. The Final SEIS identified TVA's preferred alternative as Alternative CClosure-in-Place and Regrading of the SWL and Ash Impoundment 2 and Construction of a New PWB. TVA's decision would achieve the purpose and need to manage the disposal of CCR materials on a dry basis and to meet the U.S. Environmental Protection Agency's 2015 CCR regulations, as well as the Commonwealth of Kentucky's regulations.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Biopharmaceutics Classification System-Based Biowaivers.'' The draft guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The draft guidance will provide recommendations to support the biopharmaceutics classification of drug substances and the Biopharmaceutics Classification System (BCS)-based waiver of in vivo bioequivalence (BE) studies for drug products. In vivo BE studies are needed to demonstrate lack of impact of significant formulation changes on a drug's bioavailability during its development, for post-approval line extensions, and when developing a generic product. Utilizing the critical properties of the drug substance and the drug product, and applying the BCS framework, assurance of in vivo BE findings can be obtained using extensive in vitro studies. The draft guidance is intended to avoid unnecessary human BE trials based on extensive in vitro characterization of the drug substance and drug product properties.

OSHA invites interested persons to submit nominations for membership on the Maritime Advisory Committee for Occupational Safety and Health.

The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed collections of information in accordance with the Paperwork Reduction Act of 1995. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the Mine Safety and Health Administration (MSHA) is soliciting comments on the information collection for main fan operation and inspection (I-A, II-A, III, and V-A mines).

OSHA solicits public comments concerning the proposal to extend OMB approval of the information collection requirements contained in the Occupational Exposure to Hazardous Chemicals in Laboratories.

The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed collections of information in accordance with the Paperwork Reduction Act of 1995. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the Mine Safety and Health Administration (MSHA) is soliciting comments on the information collection for Escape and Evacuation Plans for Surface Coal Mines, Surface Facilities and Surface Work Areas of Underground Coal Mines.

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 Washington Advisory Committee (Committee) to the Commission will be held at 1 p.m. (Pacific Time) Friday, November 16, 2018. The purpose of this meeting is for the Committee to discuss their project proposals.

Notice is hereby given that the presiding administrative law judge has issued a Final Initial Determination on Section 337 Violation and a Recommended Determination on Remedy and Bonding in the above- captioned investigation. The Commission is soliciting comments on public interest issues raised by the recommended relief, should the Commission find a violation. This notice is soliciting public interest comments from the public only. Parties are to file public interest submissions pursuant to Commission rules.

The Food and Drug Administration (FDA or we) is classifying the high flow humidified oxygen delivery device 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 high flow humidified oxygen delivery device'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.

NMFS has received a request from Hilcorp Alaska, LLC (Hilcorp) for authorization to take small numbers of marine mammals incidental to oil and gas activities in Cook Inlet, Alaska over the course of five years from the date of issuance. Pursuant to regulations implementing the Marine Mammal Protection Act (MMPA), NMFS is announcing receipt of the Hilcorp's request for the development and implementation of regulations governing the incidental taking of marine mammals. NMFS invites the public to provide information, suggestions, and comments on the Hilcorp's application and request.

This action amends Class E airspace extending upward from 700 feet or more above the surface at Cambridge-Dorchester Regional Airport, Cambridge, MD, to accommodate airspace reconfiguration due to the decommissioning of the Cambridge non-directional radio beacon and cancellation of the NDB approach. Controlled airspace is necessary for the safety and management of instrument flight rules (IFR) operations at this airport. This action also corrects the region identifier in the description header, and updates the airport name and geographic coordinates.

This action amends Class D airspace designated as an extension at Tulsa Lloyd Jones Jr. Airport, Tulsa, OK. This action is a result of an airspace review caused by the decommissioning of the Glenpool VHF omnidirectional range (VOR) navigation aid as part of the VOR Minimum Operational Newtork (MON) Program and the cancellation of the associated instrument procedures. The geographic coordinates of the airport are also updated; to coincide with the FAA's aeronautical database, as well as an editorial change removing the city associated with the airport name in the airspace legal description. Also, the outdated term ``Airport/Facility Directory'' is replaced with ``Chart Supplement''.

This action reissues, with modifications to reflect changed conditions in Iraq, the Special Federal Aviation Regulation (SFAR) that prohibits certain flights in the Baghdad Flight Information Region (FIR) (ORBB) by all: U.S. air carriers; U.S. commercial operators; persons exercising the privileges of an airman certificate issued by the FAA, except when such persons are operating U.S.-registered aircraft for a foreign air carrier; and operators of U.S.-registered civil aircraft, except where the operator of such aircraft is a foreign air carrier.

The Office of the Comptroller of the Currency (OCC) as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other federal agencies to take this opportunity to comment on an information collection renewal as required by the Paperwork Reduction Act of 1995. An agency may not conduct or sponsor, and a respondent is not required to respond to, an information collection unless it displays a currently valid OMB control number. The OCC is soliciting comment concerning the renewal of its information collection titled ``Interagency Appraisal Complaint Form.''