October 2018 – Federal Register Recent Federal Regulation Documents

Results 401 - 450 of 2,585
Combined Notice of Filings #1
Document Number: 2018-23441
Type: Notice
Date: 2018-10-26
Agency: Department of Energy, Federal Energy Regulatory Commission
Gulf South Pipeline Company, LP; Notice of Application
Document Number: 2018-23440
Type: Notice
Date: 2018-10-26
Agency: Department of Energy, Federal Energy Regulatory Commission
Combined Notice of Filings #1
Document Number: 2018-23439
Type: Notice
Date: 2018-10-26
Agency: Department of Energy, Federal Energy Regulatory Commission
Determination of Regulatory Review Period for Purposes of Patent Extension; TALTZ
Document Number: 2018-23438
Type: Notice
Date: 2018-10-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for TALTZ 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.
Determination of Regulatory Review Period for Purposes of Patent Extension; REBINYN
Document Number: 2018-23437
Type: Notice
Date: 2018-10-26
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Transportation and Related Equipment Technical Advisory Committee; Notice of Partially Closed Meeting
Document Number: 2018-23435
Type: Notice
Date: 2018-10-26
Agency: Department of Commerce, Bureau of Industry and Security
Senior Executive Service Departmental Performance Review Board
Document Number: 2018-23432
Type: Notice
Date: 2018-10-26
Agency: Department of the Treasury
This notice announces the appointment of members of the Departmental PRB. The purpose of this PRB is to review and make recommendations concerning proposed performance appraisals, ratings, bonuses and other appropriate personnel actions for incumbents of SES positions for which the Secretary or Deputy Secretary is the appointing authority. These positions include SES bureau heads, deputy bureau heads and certain other positions. The Board will perform PRB functions for other key bureau positions if requested.
Fisheries of the Northeastern United States; Golden Tilefish Fishery; 2019 Specifications
Document Number: 2018-23431
Type: Rule
Date: 2018-10-26
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
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.
Senior Executive Service Departmental Offices Performance Review Board
Document Number: 2018-23430
Type: Notice
Date: 2018-10-26
Agency: Department of the Treasury
This notice announces the appointment of members of the Departmental Offices Performance Review Board (PRB). The purpose of this Board is to review and make recommendations concerning proposed performance appraisals, ratings, bonuses and other appropriate personnel actions for incumbents of SES positions in the Departmental Offices, excluding the Legal Division. The Board will perform PRB functions for other bureau positions if requested.
National Institute of Nursing Research; Notice to Close Meeting
Document Number: 2018-23429
Type: Notice
Date: 2018-10-26
Agency: Department of Health and Human Services, National Institutes of Health
Notice of Final Federal Agency Actions on Proposed Highway In Utah
Document Number: 2018-23428
Type: Notice
Date: 2018-10-26
Agency: Federal Highway Administration, Department of Transportation
This notice announces certain actions taken by UDOT that are final Federal agency actions. These actions relate to a proposed highway project on State Route 30 (SR-30), from SR-23 to 1000 West, in the County of Cache, State of Utah. Those actions grant licenses, permits and/or approvals for the project.
Shawnee Fossil Plant Coal Combustion Residual Management
Document Number: 2018-23427
Type: Notice
Date: 2018-10-26
Agency: Tennessee Valley Authority, Agencies and Commissions
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.
Agency Information Collection Activities; Submitted to OMB for Review and Approval; Comment Request; Pesticide Program Public Sector Collections (FIFRA Sections 18 & 24(c)) (Renewal)
Document Number: 2018-23426
Type: Notice
Date: 2018-10-26
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) has submitted the following information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (PRA): Pesticide Program Public Sector Collections (FIFRA Sections 18 & 24(c)) (EPA ICR Number 2311.03 and OMB Control Number 2070-0182). The ICR, which is available in the docket along with other related materials, provides a detailed explanation of the collection activities and the burden estimate that is only briefly summarized in this document. This is a request to renew the approval of an existing ICR, which is currently approved through October 31, 2018. EPA did not receive any comments in response to the previously provided public review opportunity issued in the Federal Register on May 18, 2018. With this submission, EPA is providing an additional 30 days for public review.
Biopharmaceutics Classification System-Based Biowaivers; International Council for Harmonisation; Draft Guidance for Industry; Availability
Document Number: 2018-23425
Type: Notice
Date: 2018-10-26
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Agency Information Collection Activities; Proposed eCollection eComments Requested; New Collection
Document Number: 2018-23424
Type: Notice
Date: 2018-10-26
Agency: Department of Justice
The Department of Justice, Justice Management Division, Security and Emergency Planning Staff (SEPS), will be submitting 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.
Maritime Advisory Committee for Occupational Safety and Health (MACOSH): Request for Nominations
Document Number: 2018-23423
Type: Notice
Date: 2018-10-26
Agency: Department of Labor, Occupational Safety and Health Administration
OSHA invites interested persons to submit nominations for membership on the Maritime Advisory Committee for Occupational Safety and Health.
Agency Information Collection Activities; Proposed Collection; Comment Request; Prescription Drug Product Labeling; Medication Guide Requirements
Document Number: 2018-23422
Type: Notice
Date: 2018-10-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or Agency) 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 regulations requiring distribution of patient labeling, called Medication Guides, for certain products that pose a serious and significant public health concern.
Proposed Extension of Information Collection; Main Fan Operation and Inspection (I-A, II-A, III, and V-A Mines)
Document Number: 2018-23421
Type: Notice
Date: 2018-10-26
Agency: Department of Labor, Mine Safety and Health Administration
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).
VA Acquisition Regulation: Describing Agency Needs; Contract Financing; Correction
Document Number: 2018-23420
Type: Rule
Date: 2018-10-26
Agency: Department of Veterans Affairs
The Department of Veterans Affairs is correcting a final rule that published in the Federal Register on October 1, 2018 amending and updating its VA Acquisition Regulation (VAAR). Two instructions in the rule are unneeded and are being removed.
The Occupational Exposure to Hazardous Chemicals in Laboratories Standard; Extension of the Office of Management and Budget's (OMB) Approval of Information Collection (Paperwork) Requirements
Document Number: 2018-23419
Type: Notice
Date: 2018-10-26
Agency: Department of Labor, Occupational Safety and Health Administration
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.
Proposed Extension of Information Collection; Explosive Materials and Blasting Units
Document Number: 2018-23418
Type: Notice
Date: 2018-10-26
Agency: Department of Labor, Mine Safety and Health Administration
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 Explosive Materials and Blasting Units.
Proposed Extension of Information Collection; Escape and Evacuation Plans for Surface Coal Mines, Surface Facilities and Surface Work Areas of Underground Coal Mines.
Document Number: 2018-23417
Type: Notice
Date: 2018-10-26
Agency: Department of Labor, Mine Safety and Health Administration
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.
Certain Network Devices, Related Software and Components Thereof (I); Institution of Modification Proceeding; Request for Briefing
Document Number: 2018-23414
Type: Notice
Date: 2018-10-26
Agency: International Trade Commission, Agencies and Commissions
Notice is hereby given that the U.S. International Trade Commission has determined to institute a modification proceeding in the above-captioned investigation.
Notice of Public Meeting of the Washington Advisory Committee
Document Number: 2018-23413
Type: Notice
Date: 2018-10-26
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 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.
Medical Devices; Ear, Nose, and Throat Devices; Classification of the Active Implantable Bone Conduction Hearing System
Document Number: 2018-23412
Type: Rule
Date: 2018-10-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is classifying the active implantable bone conduction hearing 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 active implantable bone conduction hearing 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.
Certain Mobile Electronic Devices and Radio Frequency and Processing Components Thereof; Notice of Request for Statements on the Public Interest
Document Number: 2018-23411
Type: Notice
Date: 2018-10-26
Agency: International Trade Commission, Agencies and Commissions
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.
Proposed Collection; Comment Request
Document Number: 2018-23410
Type: Notice
Date: 2018-10-26
Agency: Department of Defense, Office of the Secretary
In compliance with the Paperwork Reduction Act of 1995, the Office of the Under Secretary of Defense for Research and Engineering announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; the accuracy of the agency's estimate of the burden of the proposed information collection; ways to enhance the quality, utility, and clarity of the information to be collected; and ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.
Medical Devices; Anesthesiology Devices; Classification of the High Flow Humidified Oxygen Delivery Device
Document Number: 2018-23409
Type: Rule
Date: 2018-10-26
Agency: Food and Drug Administration, Department of Health and Human Services
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.
Certain Insulated Beverage Containers, Components, Labels, and Packaging Materials Thereof; Commission's Determination Not To Review an Initial Determination Finding Two Respondents in Default and Terminating the Investigation With Respect to Three Respondents; Request for Written Submissions on Remedy, the Public Interest, and Bonding
Document Number: 2018-23408
Type: Notice
Date: 2018-10-26
Agency: International Trade Commission, Agencies and Commissions
Notice is hereby given that the U.S. International Trade Commission has determined not to review the presiding administrative law judge's (``ALJ'') initial determination (``ID'') (Order No. 29) finding two respondents in default and terminating the investigation with respect to the three remaining respondents. The Commission requests written submissions, under the schedule set forth below, on remedy, public interest, and bonding.
Notice of Intent to Award-Grant Awards for the Provision of Civil Legal Services to Eligible Low-Income Clients Beginning January 1, 2019
Document Number: 2018-23406
Type: Notice
Date: 2018-10-26
Agency: Legal Services Corporation, Agencies and Commissions
The Legal Services Corporation (LSC) hereby announces its intention to award grants to provide economical and effective delivery of high quality civil legal services to eligible low-income clients, beginning January 1, 2019.
Taking and Importing Marine Mammals; Taking Marine Mammals Incidental to Oil and Gas Activities in Cook Inlet, Alaska
Document Number: 2018-23405
Type: Notice
Date: 2018-10-26
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
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.
Receipt of Noise Compatibility Program and Request for Review for San Francisco International Airport, San Francisco, California
Document Number: 2018-23404
Type: Notice
Date: 2018-10-26
Agency: Federal Aviation Administration, Department of Transportation
The Federal Aviation Administration (FAA) announces that it is reviewing a proposed noise compatibility program 2018 update that was submitted for San Francisco International Airport by the City and County of San Francisco, Airport Commission, under the provisions of the Aviation Safety and Noise Abatement Act, hereinafter referred to as ``the Act'' and the Code of Federal Regulations (CFR). This program update was submitted subsequent to a determination by FAA that associated noise exposure maps submitted for San Francisco International Airport were in compliance with applicable requirements, effective January 29, 2016. The existing noise compatibility program for San Francisco International Airport was approved by the FAA on September 7, 1983. The proposed 2018 update to the noise compatibility program will be approved or disapproved on or before April 16, 2019.
Amendment of Class E Airspace; Cambridge, MD
Document Number: 2018-23403
Type: Rule
Date: 2018-10-26
Agency: Federal Aviation Administration, Department of Transportation
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.
Establishment of Class E Airspace; Crystal Springs, MS
Document Number: 2018-23402
Type: Rule
Date: 2018-10-26
Agency: Federal Aviation Administration, Department of Transportation
This action establishes Class E airspace extending upward from 700 feet above the surface at Copiah County Airport, Crystal Springs, MS, to accommodate new area navigation (RNAV) global positioning system (GPS) standard instrument approach procedures serving the airport. Controlled airspace is necessary for the safety and management of instrument flight rules (IFR) operations at this airport.
Amendment of Class D Airspace; Tulsa, OK
Document Number: 2018-23401
Type: Rule
Date: 2018-10-26
Agency: Federal Aviation Administration, Department of Transportation
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''.
Amendment of Class E Airspace, Augusta, GA, and Establishment of Class E Airspace, Waynesboro, GA
Document Number: 2018-23399
Type: Rule
Date: 2018-10-26
Agency: Federal Aviation Administration, Department of Transportation
This action amends Class E airspace extending upward from 700 feet above the surface in Augusta, GA, by recognizing the name change of Augusta Regional Airport at Bush Field (formerly Augusta Regional at Bush Field Airport); removing Burke County Airport and Millen Airport from the airspace designation and establishing these two airports under Waynesboro, GA, designation; and updating the geographic coordinates of Daniel Field, Augusta, GA, and Millen Airport, Waynesboro, GA. This action accommodates airspace reconfiguration due to the decommissioning of the Millen non-directional radio beacon (NDB) and cancellation of the NDB approach at Millen Airport. Controlled airspace is necessary for the safety and management of instrument flight rules (IFR) operations at these airports.
Prohibition Against Certain Flights in the Baghdad Flight Information Region (FIR) (ORBB)
Document Number: 2018-23398
Type: Rule
Date: 2018-10-26
Agency: Federal Aviation Administration, Department of Transportation
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.
Notice of Issuance of the U.S. Department of Veterans Affairs Program Comment for Vacant and Underutilized Properties
Document Number: 2018-23397
Type: Notice
Date: 2018-10-26
Agency: Historic Preservation, Advisory Council, Agencies and Commissions
The Advisory Council on Historic Preservation (ACHP) has a program comment for the U.S. Department of Veterans Affairs (VA) that sets forth the way in which VA complies with Section 106 of the National Historic Preservation Act (NHPA) for its real property actions related to the transfer of property rights of vacant and underutilized buildings, structures and land, including out leases, exchanges, sales, transfers, conveyances, deconstructions and demolitions, and for certain maintenance and repairs.
Agency Information Collection Activities: Information Collection Renewal; Comment Request; Interagency Appraisal Complaint Form
Document Number: 2018-23395
Type: Notice
Date: 2018-10-26
Agency: Office of the Comptroller of the Currency, Department of Treasury, Department of the Treasury
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.''
National Institute on Alcohol Abuse and Alcoholism; Notice of Closed Meetings
Document Number: 2018-23394
Type: Notice
Date: 2018-10-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Allergy and Infectious Diseases; Notice of Closed Meeting
Document Number: 2018-23393
Type: Notice
Date: 2018-10-26
Agency: Department of Health and Human Services, National Institutes of Health
National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings
Document Number: 2018-23392
Type: Notice
Date: 2018-10-26
Agency: Department of Health and Human Services, National Institutes of Health
National Eye Institute; Notice of Closed Meeting
Document Number: 2018-23391
Type: Notice
Date: 2018-10-26
Agency: Department of Health and Human Services, National Institutes of Health
Product-Specific Guidance; Revised Draft Guidance for Industry on Sucralfate; Reopening of Comment Period
Document Number: 2018-23386
Type: Notice
Date: 2018-10-26
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or the Agency) is reopening the comment period for a revised draft product-specific guidance on Sucralfate that appeared in a notice of availability, published in the Federal Register of October 20, 2017. In that notice, FDA requested comments on the revised draft guidance for industry on Sucralfate, as well as comments on other product-specific guidances. FDA is reopening the comment period for the Draft Guidance on Sucralfate (revised October 2017) to facilitate submission of comments pertaining to this draft guidance following an FDA response to two citizen petitions. The petition response suggests that the petitioners submit to the docket comments relating to the guidance.