January 2018 – Federal Register Recent Federal Regulation Documents

Results 1 - 50 of 2,222
Reader Aids
Document Number: FR-2018-01-31-ReaderAids
Type: Reader Aids
Date: 2018-01-31
Medicare Program: Hospital Outpatient Prospective Payment and Ambulatory Surgical Center Payment Systems and Quality Reporting Programs
Document Number: C1-2017-27949
Type: Rule
Date: 2018-01-31
Agency: Centers for Medicare & Medicaid Services, Department of Health and Human Services
Deletion of Items From Sunshine Act Meeting
Document Number: 2018-02030
Type: Notice
Date: 2018-01-31
Agency: Federal Communications Commission, Agencies and Commissions
The Commission will consider an Order deleting rules made obsolete by the Digital TV transition.
Common Crop Insurance Regulations; Nursery Crop Insurance Provisions
Document Number: 2018-01964
Type: Rule
Date: 2018-01-31
Agency: Department of Agriculture, Federal Crop Insurance Corporation
The Federal Crop Insurance Corporation (FCIC) amends the Common Crop Insurance Regulations, Nursery Crop Insurance Provisions. The intended effect of this action is to clarify existing policy provisions, increase risk management choices allowed by the policy provisions, and expand availability to more producers. The changes will be effective for the 2019 and succeeding crop years.
Parts and Accessories Necessary for Safe Operation; Daimler Trucks North America LLC Application for Exemption
Document Number: 2018-01943
Type: Notice
Date: 2018-01-31
Agency: Federal Motor Carrier Safety Administration, Department of Transportation
The Federal Motor Carrier Safety Administration (FMCSA) announces its decision to grant Daimler Trucks North America LLC's (DTNA) application for a limited 5-year exemption allowing motor carriers operating commercial motor vehicles (CMVs) manufactured by the company to use an Attention Assist and Lane Departure Warning system camera mounted lower in the windshield than is currently permitted. The Agency has determined that lower placement of the Attention Assist and Lane Departure Warning system camera would not have an adverse impact on safety and that adherence to the terms and conditions of the exemption would achieve a level of safety equivalent to or greater than the level of safety provided by the regulation.
Agency Information Collection Activities; Approval of a New Information Collection Request: National Consumer Complaint Database
Document Number: 2018-01941
Type: Notice
Date: 2018-01-31
Agency: Federal Motor Carrier Safety Administration, Department of Transportation
In accordance with the Paperwork Reduction Act of 1995, FMCSA announces its plan to submit the Information Collection Request (ICR) described below to the Office of Management and Budget (OMB) for review and approval and invites public comment. This new collection of information is for the National Consumer Complaint Database (NCCDB), which is an online interface allowing consumers, drivers and others to file complaints against unsafe and unscrupulous motor carriers and/or their employees. The NCCDB also allows complaints to be filed about shippers, receivers and transportation intermediaries. Complaints cover a wide range of issues, including but not limited to safety, driver harassment, coercion, movement of household goods (HHG), financial responsibility instruments for brokers and freight forwarders, and Americans with Disabilities Act (ADA) complaints.
Hours of Service of Drivers: Electronic Logging Devices; Application for Exemption; Old Dominion and Other Motor Carriers Experiencing Problems Integrating PeopleNet ELD System Updates Into Their Fleet Management Systems
Document Number: 2018-01939
Type: Notice
Date: 2018-01-31
Agency: Federal Motor Carrier Safety Administration, Department of Transportation
FMCSA announces that Old Dominion Freight Line Inc. (Old Dominion) has requested an exemption from the electronic logging device (ELD) requirements. Old Dominion request this exemption to allow the company to install ELD devices running on automatic on-board recording device (AOBRD) software in commercial motor vehicles (CMVs) added to the company's fleet for up to one year from the December 18, 2017, ELD mandate compliance date. If granted, this modified ELD phase-in period will allow Old Dominion's AORBD/ELD provider, PeopleNet, to complete the development of the software necessary to integrate ELD data with the company's fleet management and safety systems to fully meet the ELD mandate. FMCSA considers the request to be on behalf of all motor carriers in similar situations concerning the integration of PeopleNet's ELD software into fleet management systems.
Qualification of Drivers; Exemption Applications; Vision
Document Number: 2018-01938
Type: Notice
Date: 2018-01-31
Agency: Federal Motor Carrier Safety Administration, Department of Transportation
FMCSA announces its decision to renew exemptions for 86 individuals from the vision requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) for interstate commercial motor vehicle (CMV) drivers. The exemptions enable these individuals to continue to operate CMVs in interstate commerce without meeting the vision requirements in one eye.
Qualification of Drivers; Exemption Applications; Implantable Cardioverter Defibrillators
Document Number: 2018-01937
Type: Notice
Date: 2018-01-31
Agency: Federal Motor Carrier Safety Administration, Department of Transportation
FMCSA announces receipt of applications from seven individuals for an exemption from the prohibition in the Federal Motor Carrier Safety Regulations (FMCSRs) against operation of a commercial motor vehicle (CMV) by persons with a current clinical diagnosis of myocardial infarction, angina pectoris, coronary insufficiency, thrombosis, or any other cardiovascular disease of a variety known to be accompanied by syncope, dyspnea, collapse, or congestive heart failure. If granted, the exemptions would enable these individuals with implantable cardioverter defibrillators (ICDs) to operate CMVs in interstate commerce.
Qualification of Drivers; Exemption Applications; Epilepsy and Seizure Disorders
Document Number: 2018-01935
Type: Notice
Date: 2018-01-31
Agency: Federal Motor Carrier Safety Administration, Department of Transportation
FMCSA announces its decision to renew exemptions for three individuals from the requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) that interstate commercial motor vehicle (CMV) drivers have ``no established medical history or clinical diagnosis of epilepsy or any other condition which is likely to cause loss of consciousness or any loss of ability to control a CMV.'' The exemptions enable these individuals who have had one or more seizures and are taking anti-seizure medication to continue to operate CMVs in interstate commerce.
Qualification of Drivers; Exemption Applications; Epilepsy and Seizure Disorders
Document Number: 2018-01934
Type: Notice
Date: 2018-01-31
Agency: Federal Motor Carrier Safety Administration, Department of Transportation
FMCSA announces its decision to renew exemptions for six individuals from the requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) that interstate commercial motor vehicle (CMV) drivers have ``no established medical history or clinical diagnosis of epilepsy or any other condition which is likely to cause loss of consciousness or any loss of ability to control a CMV.'' The exemptions enable these individuals who have had one or more seizures and are taking anti-seizure medication to continue to operate CMVs in interstate commerce.
Qualification of Drivers; Exemption Applications; Epilepsy and Seizure Disorders
Document Number: 2018-01933
Type: Notice
Date: 2018-01-31
Agency: Federal Motor Carrier Safety Administration, Department of Transportation
FMCSA announces its decision to exempt two individuals from the requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) that interstate commercial motor vehicle (CMV) drivers have ``no established medical history or clinical diagnosis of epilepsy or any other condition which is likely to cause loss of consciousness or any loss of ability to control a CMV.'' The exemptions enable these individuals who have had one or more seizures and are taking anti- seizure medication to operate CMVs in interstate commerce.
Qualification of Drivers; Exemption Applications; Epilepsy and Seizure Disorders
Document Number: 2018-01932
Type: Notice
Date: 2018-01-31
Agency: Federal Motor Carrier Safety Administration, Department of Transportation
FMCSA announces its decision to renew exemptions for 10 individuals from the requirement in the Federal Motor Carrier Safety Regulations (FMCSRs) that interstate commercial motor vehicle (CMV) drivers have ``no established medical history or clinical diagnosis of epilepsy or any other condition which is likely to cause loss of consciousness or any loss of ability to control a CMV.'' The exemptions enable these individuals who have had one or more seizures and are taking anti-seizure medication to continue to operate CMVs in interstate commerce.
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2018-01930
Type: Notice
Date: 2018-01-31
Agency: Department of Health and Human Services, National Institutes of Health
National Heart, Lung, and Blood Institute; Notice of Closed Meeting
Document Number: 2018-01929
Type: Notice
Date: 2018-01-31
Agency: Department of Health and Human Services, National Institutes of Health
Government-Owned Inventions; Availability for Licensing
Document Number: 2018-01928
Type: Notice
Date: 2018-01-31
Agency: Department of Health and Human Services, National Institutes of Health
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S.
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2018-01927
Type: Notice
Date: 2018-01-31
Agency: Department of Health and Human Services, National Institutes of Health
Center for Scientific Review; Amended Notice of Meeting
Document Number: 2018-01926
Type: Notice
Date: 2018-01-31
Agency: Department of Health and Human Services, National Institutes of Health
Public Meeting of the Glen Canyon Dam Adaptive Management Work Group
Document Number: 2018-01922
Type: Notice
Date: 2018-01-31
Agency: Department of the Interior, Bureau of Reclamation
In accordance with the Federal Advisory Committee Act of 1972, the Bureau of Reclamation (Reclamation) is publishing this notice to announce that a Federal Advisory Committee meeting of the Glen Canyon Dam Adaptive Management Work Group (AMWG) will take place.
Amendment of Statement of Organization and Functions; Restructuring of National Labor Relations Board's Field Organization
Document Number: 2018-01921
Type: Notice
Date: 2018-01-31
Agency: National Labor Relations Board, Agencies and Commissions
The National Labor Relations Board has closed its Anchorage, Alaska Resident Office because it has determined that closing the office and serving the area with resident agents working in the area, will result in significant savings while continuing to effectively serve the area currently served by this office.
Determination of Regulatory Review Period for Purposes of Patent Extension; LENVIMA
Document Number: 2018-01920
Type: Notice
Date: 2018-01-31
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 LENVIMA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application 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 drug product.
Agency Information Collection Activities; Extension, Without Change, of a Currently Approved Collection: Application for Provisional Unlawful Presence Waiver of Inadmissibility
Document Number: 2018-01919
Type: Notice
Date: 2018-01-31
Agency: Department of Homeland Security, U.S. Citizenship and Immigration Services
The Department of Homeland Security (DHS), U.S. Citizenship and Immigration (USCIS) invites the general public and other Federal agencies to comment upon this proposed extension of a currently approved collection of information. In accordance with the Paperwork Reduction Act (PRA) of 1995, the information collection notice is published in the Federal Register to obtain comments regarding the nature of the information collection, the categories of respondents, the estimated burden (i.e. the time, effort, and resources used by the respondents to respond), the estimated cost to the respondent, and the actual information collection instruments.
Auction of FM Translator Construction Permits Scheduled for June 21, 2018; Comment Sought on Competitive Bidding Procedures for Auction 83
Document Number: 2018-01918
Type: Proposed Rule
Date: 2018-01-31
Agency: Federal Communications Commission, Agencies and Commissions
In this document, the Wireless Telecommunications and Media Bureaus (the Bureaus) announce an auction of certain FM translator construction permits. This document also seeks comment on competitive bidding procedures and proposed minimum opening bids for Auction 83.
Agency Information Collection Activities; Revision of a Currently Approved Collection: Nonimmigrant Petition Based on Blanket L Petition
Document Number: 2018-01917
Type: Notice
Date: 2018-01-31
Agency: Department of Homeland Security, U.S. Citizenship and Immigration Services
The Department of Homeland Security (DHS), U.S. Citizenship and Immigration (USCIS) invites the general public and other Federal agencies to comment upon this proposed revision of a currently approved collection of information or new collection of information. In accordance with the Paperwork Reduction Act (PRA) of 1995, the information collection notice is published in the Federal Register to obtain comments regarding the nature of the information collection, the categories of respondents, the estimated burden (i.e. the time, effort, and resources used by the respondents to respond), the estimated cost to the respondent, and the actual information collection instruments.
National Oil and Hazardous Substances Pollution Contingency Plan National Priorities List: Deletion of the Hatheway & Patterson Superfund Site
Document Number: 2018-01916
Type: Rule
Date: 2018-01-31
Agency: Environmental Protection Agency
On December 1, 2017 EPA published a direct final Notice of Deletion for the Hatheway & Patterson Superfund Site from the National Priorities List. The EPA is withdrawing the direct final Notice of Deletion due to adverse comments that were received during the public comment period.
Availability of the Integrated Risk Information System (IRIS) Assessment Plan for Uranium
Document Number: 2018-01915
Type: Notice
Date: 2018-01-31
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is announcing a 30- day public comment period associated with release of the draft IRIS Assessment Plan for Uranium. This document communicates information on the scoping needs identified by EPA program and regional offices and the IRIS Program's initial problem formulation activities. Specifically, the assessment plan outlines the objectives for each assessment and the type of evidence considered most pertinent to address the scoping needs. EPA is releasing this draft IRIS Assessment Plan for public comment at least 60 days in advance of a public science webinar planned on March 22, 2018.
Availability of the Systematic Review Protocol for the Chloroform Integrated Risk Information System (IRIS) Assessment.
Document Number: 2018-01914
Type: Notice
Date: 2018-01-31
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is announcing a 30- day public comment period associated with the Systematic Review Protocol for the IRIS Chloroform Assessment. The protocol describes the systematic review procedures and other methodology planned for use in developing the chloroform assessment. EPA is making this Protocol available to the public via the docket and the IRIS website. These documents were prepared by the National Center for Environmental Assessment (NCEA) within EPA's Office of Research and Development (ORD).
Drawbridge Operation Regulation Canaveral Barge Canal, Canaveral, FL
Document Number: 2018-01913
Type: Rule
Date: 2018-01-31
Agency: Coast Guard, Department of Homeland Security
The Coast Guard is modifying the operating schedule that governs the SR 401 Drawbridges across the Canaveral Barge Canal, mile 5.5, at Port Canaveral, Florida. This modification is necessary to reduce vehicular traffic congestion and to ensure the safety of roadways while passengers are transiting to and from the cruise ship terminals. Since the arrival of additional cruise ships to the Port of Canaveral, traffic back-ups have been caused by the on demand drawbridge openings. This modification allows the bridges to not open to navigation during prime cruise ship passenger loading and unloading times on Saturdays and Sundays.
Listing of Color Additives Exempt From Certification; Calcium Carbonate; Confirmation of Effective Date
Document Number: 2018-01912
Type: Rule
Date: 2018-01-31
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA or we) is confirming the effective date of December 8, 2017, for the final rule that appeared in the Federal Register of November 7, 2017, and that amended the color additive regulations to provide for the safe use of calcium carbonate to color hard and soft candy, mints, and in inks used on the surface of chewing gum.
Notice To Ensure State Workforce Agencies Are Aware of the Revised Schedule of Remuneration for the Unemployment Compensation for Ex-Servicemembers Program That Reflects the Military Pay Increase Effective January 1, 2018
Document Number: 2018-01911
Type: Notice
Date: 2018-01-31
Agency: Employment and Training Administration, Department of Labor
Each year, the Department of Defense issues a Schedule of Remuneration that may be used by states, as needed, for UCX purposes. States must use the schedule to determine Federal military wages for UCX ``first claims'' only when the Federal Claims Control Center (FCCC) responds to a request for information indicating that there is no Copy 5 of the Certificate of Release or Discharge from Active Duty (DD Form 214) for an individual under the social security number provided. A response from the FCCC that indicates ``no DD214 on file'' will prompt the state to start the affidavit process and to use the attached schedule to calculate the Federal military wages for an unemployment insurance or UCX monetary determination. The schedule applies to UCX ``first claims'' filed beginning with the first day of the first week that begins on or after January 1, 2018, pursuant to the UCX program regulations (see 20 CFR 614.12(c)). States must continue to use the 2017 schedule (or other appropriate schedule) for UCX ``first claims'' filed before the effective date of the revised schedule.
Agency Information Collection Activities; Extension, Without Change, of a Currently Approved Collection
Document Number: 2018-01910
Type: Notice
Date: 2018-01-31
Agency: Department of Homeland Security, U.S. Citizenship and Immigration Services
The Department of Homeland Security (DHS), U.S. Citizenship and Immigration (USCIS) invites the general public and other Federal agencies to comment upon this proposed extension of a currently approved collection of information. In accordance with the Paperwork Reduction Act (PRA) of 1995, the information collection notice is published in the Federal Register to obtain comments regarding the nature of the information collection, the categories of respondents, the estimated burden (i.e. the time, effort, and resources used by the respondents to respond), the estimated cost to the respondent, and the actual information collection instruments.
Agency Information Collection Activities; Revision of a Currently Approved Collection: Application for Replacement Naturalization/Citizenship Document
Document Number: 2018-01909
Type: Notice
Date: 2018-01-31
Agency: Department of Homeland Security, U.S. Citizenship and Immigration Services
The Department of Homeland Security (DHS), U.S. Citizenship and Immigration (USCIS) invites the general public and other Federal agencies to comment upon this proposed revision of a currently approved collection of information or new collection of information. In accordance with the Paperwork Reduction Act (PRA) of 1995, the information collection notice is published in the Federal Register to obtain comments regarding the nature of the information collection, the categories of respondents, the estimated burden (i.e. the time, effort, and resources used by the respondents to respond), the estimated cost to the respondent, and the actual information collection instruments.
Notice of Agreements Filed
Document Number: 2018-01908
Type: Notice
Date: 2018-01-31
Agency: Federal Maritime Commission, Agencies and Commissions
Final National Occupational Research Agenda for Manufacturing
Document Number: 2018-01906
Type: Notice
Date: 2018-01-31
Agency: Centers for Disease Control and Prevention, Department of Health and Human Services
NIOSH announces the availability of the final National Occupational Research Agenda for Manufacturing
BNP Paribas USA, Inc., et al.; Notice of Application and Temporary Order
Document Number: 2018-01905
Type: Notice
Date: 2018-01-31
Agency: Securities and Exchange Commission, Agencies and Commissions
Notice of Applications for Deregistration Under Section 8(f) of the Investment Company Act of 1940
Document Number: 2018-01904
Type: Notice
Date: 2018-01-31
Agency: Securities and Exchange Commission, Agencies and Commissions
Applicant, a closed-end investment company, seeks an order declaring that it has ceased to be an investment company. Applicant has never made a public offering of its securities and does not propose to make a public offering or engage in business of any kind. Filing Date: The application was filed on October 20, 2017, and amended on January 10, 2018. Applicant's Address: 61 Aldwych, London, WC2B 4AE, England.
EquBot LLC and ETF Series Solutions
Document Number: 2018-01903
Type: Notice
Date: 2018-01-31
Agency: Securities and Exchange Commission, Agencies and Commissions
An Approach for Using Probabilistic Risk Assessment in Risk-Informed Decisions on Plant-Specific Changes to the Licensing Basis
Document Number: 2018-01901
Type: Notice
Date: 2018-01-31
Agency: Nuclear Regulatory Commission, Agencies and Commissions
The U.S. Nuclear Regulatory Commission (NRC) is issuing Revision 3 to Regulatory Guide (RG) 1.174, ``An Approach for Using Probabilistic Risk Assessment in Risk-Informed Decisions on Plant- Specific Changes to the Licensing Basis.'' This proposed guide, Revision 3, has been revised to incorporate additional information related to the evaluation of defense-in-depth since Revision 2 of RG 1.174 was issued in 2011. The proposed revision includes additional guidance on defense-in-depth to assure the defense-in-depth philosophy is interpreted and implemented consistently.
Information Collection Request Submitted to OMB for Review and Approval; Comment Request; Laboratory Quality Assurance Evaluation Program for Analysis of Cryptosporidium Under the Safe Drinking Water Act (Renewal)
Document Number: 2018-01899
Type: Notice
Date: 2018-01-31
Agency: Environmental Protection Agency
The Environmental Protection Agency has submitted an information collection request (ICR)Laboratory Quality Assurance Evaluation Program for Analysis of Cryptosporidium Under the Safe Drinking Water Act, EPA ICR No. 2067.06, OMB Control No. 2040-0246to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act. This is a proposed extension of the ICR, which is currently approved through March 31, 2018. Public comments were previously requested via the Federal Register on October 16, 2017, during a 60-day comment period. This notice allows for an additional 30 days for public comments. A fuller description of the ICR is given below, including its estimated burden and cost to the public. An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.
Submission for OMB Review; Comment Request
Document Number: 2018-01898
Type: Notice
Date: 2018-01-31
Agency: Department of Agriculture
Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Oil Shale Management
Document Number: 2018-01897
Type: Notice
Date: 2018-01-31
Agency: Department of the Interior, Bureau of Land Management
In accordance with the Paperwork Reduction Act of 1995, we, the Bureau of Land Management (BLM), are proposing to renew an information collection.
Freeport LNG Expansion, L.P., et al.; Application for Blanket Authorization To Export Liquefied Natural Gas to Non-Free Trade Agreement Countries on a Short-Term Basis
Document Number: 2018-01896
Type: Notice
Date: 2018-01-31
Agency: Department of Energy
The Office of Fossil Energy (FE) of the Department of Energy (DOE) gives notice of receipt of an application (Application), filed on January 4, 2018, by Freeport LNG Expansion, L.P., FLNG Liquefaction LLC, FLNG Liquefaction 2, LLC, and FLNG Liquefaction 3, LLC (collectively, FLEX). The Application requests blanket authorization to export domestically produced liquefied natural gas (LNG) in an amount up to the equivalent of 782 billion cubic feet (Bcf) of natural gas on a cumulative basis over a two-year period, commencing on the earlier of the date of first short-term export or September 1, 2018. The LNG would be exported from the Freeport LNG Liquefaction Project (Liquefaction Project), which is currently under construction at the Freeport LNG Terminal on Quintana Island, Texas. FLEX requests authorization to export the LNG to any country with the capacity to import LNG via ocean-going carrier and with which trade is not prohibited by U.S. law or policy, including both 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 all other countries (non- FTA countries). FLEX seeks to export this LNG both before and after commercial operations at the Liquefaction Project begin. FLEX requests this authorization on its own behalf and as agent for other entities who hold title to the natural gas at the time of export. Additional details can be found in FLEX's Application, posted on the DOE/FE website at: https://energy.gov/fe/downloads/freeport-lng-expansion-lp- fe-dkt-no-18-03-lng. Protests, motions to intervene, notices of intervention, and written comments are invited.
Galveston Bay LNG, LLC; Application for Long-Term, Multi-Contract Authorization To Export Liquefied Natural Gas to Non-Free Trade Agreement Nations
Document Number: 2018-01895
Type: Notice
Date: 2018-01-31
Agency: Department of Energy
The Office of Fossil Energy (FE) of the Department of Energy (DOE) gives notice of receipt of an application (Application), filed on December 22, 2017, by Galveston Bay LNG, LLC (Galveston Bay LNG), requesting long-term, multi-contract authorization to export domestically produced liquefied natural gas (LNG) in a volume equivalent to 785.7 billion cubic feet (Bcf) per year of natural gas. Galveston Bay LNG seeks authorization to export this LNG from its proposed natural gas liquefaction facility to be located in Texas City, Texas (Galveston Bay LNG Project). Galveston Bay LNG seeks authorization to export this LNG to countries with which trade is not prohibited by U.S. law or policy, including both 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 all other countries (non-FTA countries). Galveston Bay LNG requests the non-FTA authorization for a term of 20 years, to begin on the date of first export following the commencement of operations or seven years from the date of a final order granting export authorization, whichever is first. In addition, Galveston Bay LNG is requesting that it be afforded a three-year make- up period for the purpose of exporting any volume it is unable to export during the original export period, consistent with DOE/FE precedent. Galveston Bay LNG further requests this authorization on its own behalf and as agent for other entities who hold title to the natural gas at the time of export. Galveston Bay LNG filed the Application under section 3 of the Natural Gas Act (NGA). Additional details can be found in Galveston Bay LNG's Application, posted on the DOE/FE website at https://energy.gov/fe/downloads/galveston-bay-lng- llc-fe-dkt-no-17-167-lng. Protests, motions to intervene, notices of intervention, and written comments are invited.
Determination of Regulatory Review Period for Purposes of Patent Extension; DUAVEE
Document Number: 2018-01894
Type: Notice
Date: 2018-01-31
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 DUAVEE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application 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 drug product.
Determination of Regulatory Review Period for Purposes of Patent Extension; CRESEMBA-New Drug Application 207501
Document Number: 2018-01892
Type: Notice
Date: 2018-01-31
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 CRESEMBA as approved under new drug application (NDA) 207501 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 drug product as approved under NDA 207501.
Determination of Regulatory Review Period for Purposes of Patent Extension; SAPIEN XT TRANSCATHETER HEART VALVE
Document Number: 2018-01891
Type: Notice
Date: 2018-01-31
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 SAPIEN XT TRANSCATHETER HEART VALVE 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 medical device.
Determination of Regulatory Review Period for Purposes of Patent Extension; KEYTRUDA
Document Number: 2018-01890
Type: Notice
Date: 2018-01-31
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 KEYTRUDA and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application 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.
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