April 30, 2014 – Federal Register Recent Federal Regulation Documents
Results 101 - 127 of 127
Determination of Regulatory Review Period for Purposes of Patent Extension; BRILINTA
The Food and Drug Administration (FDA) has determined the regulatory review period for BRILINTA 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 Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.
Allergy Laboratories, Inc., Opportunity for Hearing on Proposal To Revoke U.S.; License No. 103
The Food and Drug Administration (FDA) is announcing an opportunity for a hearing on a proposal to revoke the biologics license (U.S. License No. 103) issued to Allergy Laboratories, Inc. for the manufacture of nonstandardized allergenic extract Dust, House Mixture. The proposed revocation is based on available scientific and medical information that does not support the safety and effectiveness of this nonstandardized allergenic extract.
Periodic Reporting
The Commission is eliminating a requirement that the Postal Service prepare the annual cost and revenue analysis report in an alternative format. The reason for the change is that the alternative format's usefulness as an analytical tool has been overtaken by developments since passage of postal reform legislation in 2006. Adoption of this change means the Postal Service will prepare and submit only one version of this report.
United Nuclear Corporation
The U.S. Nuclear Regulatory Commission (NRC) is seeking comment from interested parties on the license amendment application request from United Nuclear Corporation (UNC or the licensee), a subsidiary of General Electric (GE), for a 5-year extension for the final emplacement of the radon barrier and erosion protection for the UNC Church Rock Mill site located in McKinley County, New Mexico. Specifically, UNC is requesting an amendment to Source Material License No. SUA-1475, for License Conditions 35.A(3) and 35.B(1), which would extend the dates for emplacement of the final radon barrier and the erosion protection from December 31, 2014, to December 31, 2019.
Approval and Promulgation of Air Quality Implementation Plans; Pennsylvania; Regional Haze State Implementation Plan
The Environmental Protection Agency (EPA) is reissuing its final limited approval of the Pennsylvania State Implementation Plan (SIP) to implement the regional haze program for the first planning period through 2018. EPA originally finalized a limited approval of the Pennsylvania regional haze SIP on July 13, 2012. In response to a petition for review of that final action in the United States Court of Appeals for the Third Circuit, EPA successfully moved for a voluntary remand, without vacatur, to more adequately respond to certain public comments. EPA is providing new responses to those comments in this rulemaking notice.
Approval and Promulgation of Implementation Plans; Wisconsin; Nitrogen Oxide Combustion Turbine Alternative Control Requirements for the Milwaukee-Racine Former Nonattainment Area
On February 24, 2014, the Wisconsin Department of Natural Resources (WDNR) submitted revisions to its nitrogen oxide (NOX) combustion turbine rule for the Milwaukee-Racine former nonattainment area. This revision is contained in ``2013 Wisconsin Act 91Senate Bill 371'' which allows alternative NOX emission requirements for simple cycle combustion turbines that undergo a modification on or after February 1, 2001, if dry low NOX combustion is not technically or economically feasible. This revision is approvable because it provides for alternative NOX requirements subject to Environmental Protection Agency (EPA) approval on a case-by-case basis and therefore satisfies the reasonably available control technology (RACT) requirements of the Clean Air Act (CAA).
Approval and Promulgation of Implementation Plans; Wisconsin; Nitrogen Oxide Combustion Turbine Alternative Control Requirements for the Milwaukee-Racine Area
On February 24, 2014, the Wisconsin Department of Natural Resources (WDNR) submitted revisions to its nitrogen oxide (NOX) combustion turbine rule for the Milwaukee-Racine area. This revision is contained in ``2013 Wisconsin Act 91Senate Bill 371'' which allows alternative NOX emission requirements for simple cycle combustion turbines that undergo a modification on or after February 1, 2001, if dry low NOX combustion is not technically or economically feasible. This revision is approvable because it provides for alternative NOX requirements subject to Environmental Protection Agency (EPA) approval on a case-by-case basis and therefore satisfies the reasonably available control technology (RACT) requirements of the Clean Air Act.
Review of Floating Houses
The Tennessee Valley Authority (TVA) is conducting a review of) the recent growth in the Tennessee River Watershed of floating houses and nonnavigable houseboats designed and used primarily for human habitation and potential management actions TVA may take in response to the proliferation of these structures. As part of the study, TVA intends to prepare an environmental assessment (EA) or environmental impact statement (EIS) to assess the impacts associated with TVA's management and oversight of these structures on its reservoirs. TVA will use the environmental review process to learn the values and concerns of stakeholders; identify issues, trends, events and tradeoffs affecting TVA's policies; formulate, evaluate and compare alternative management options; provide opportunities for public review and comment; and ensure that TVA's evaluation of alternative management and policy strategies reflects a full range of stakeholder input. Public comment is invited concerning the scope of the review and environmental issues that should be addressed. This notice is provided in accordance with the Council on Environmental Quality's regulations (40 CFR parts 1500 to 1508) and TVA's procedures for implementing the National Environmental Policy Act (NEPA).
Willamette National Forest, McKenzie River Ranger District; Oregon; Goose Project
We propose to commercially harvest approximately 2,134 acres, reduce hazardous fuels through non-commercial thinning on ~588 acres, and implement understory prescribe fire on ~80 to ~679 acres within the McKenzie Bridge Wildland-Urban Interface. Commercial harvest treatments would be comprised of variable density thinning on ~2,085 acres (that includes gap creations and no-cut leave areas) and regeneration harvest on ~49 acres (through a two-aged system that would allow for the regeneration of younger trees underneath residual trees left from the original canopy). The proposed action would also include maintenance of approximately 43 miles of road and creation of approximately 8 miles of temporary roads. The project area surrounds the community of McKenzie Bridge and is intermixed with private and national forest lands. The proposed project would manage stands to improve stand conditions: Diversity, density, and structure; reduce hazardous fuel levels in the McKenzie Bridge Wildland-Urban Interface; and provide for a sustainable supply of timber products from within the project area.
Environmental Impact Statement for the Power Fire, Eldorado National Forest
The Eldorado National Forest will prepare an environmental impact statement (EIS) to reforest portions of the Power Fire as well as manage existing plantations within the Power Fire. The EIS will analyze planting of small trees, mechanical and chemical site preparation for planting, mechanical and chemical removal of competing vegetation, control of invasive plant species, and oak stand improvement.
Amendment of a Pesticide Experimental Use Permit; Notice of Receipt of Application; Comment Request
This notice announces EPA's receipt of an application from Robert I. Rose, Ph.D., on behalf of James Mains, Ph.D., Mosquito Mate, Inc., requesting to amend 89668-EUP-1 experimental use permit (EUP) to allow the applicant to add release and monitoring sites in California for Aedes albopictus male mosquitoes with Wolbachia pipientis ZAP strain bacteria and to extend the permit for the currently approved sites. The Agency has determined that the amendment request for the permit may be of regional and national significance. Therefore, because of the potential significance, and pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA is hereby providing notice of receipt and is seeking comments on this application.
Diflubenzuron; Receipt of Application for Emergency Exemption, Solicitation of Public Comment
EPA has received a specific exemption request from the Wyoming Department of Agriculture to use the pesticide diflubenzuron (CAS No. 35367-38-5) to treat up to 26,000 acres of alfalfa to control grasshoppers and Mormon crickets. The applicant proposes a use which is supported by the Interregional (IR)-4 program and has been requested in 5 or more previous years, and a petition for tolerance has not yet been submitted to the Agency. EPA is soliciting public comment before making the decision whether or not to grant the exemption.
Meeting of the Regional Energy Resource Council
The TVA Regional Energy Resource Council (RERC) will hold a meeting on Tuesday, May 13, 2014, regarding regional energy related issues in the Tennessee Valley. The RERC was established to advise TVA on its energy resource activities and the priorities among competing objectives and values. Notice of this meeting is given under the Federal Advisory Committee Act (FACA), 5 U.S.C. App. 2. The meeting agenda includes the following:
Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures; Miscellaneous Amendments
This rule establishes, amends, suspends, or revokes Standard Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums and Obstacle Departure Procedures for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.
Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures; Miscellaneous Amendments
This rule amends, suspends, or revokes Standard Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums and Obstacle Departure Procedures for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.
Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures; Miscellaneous Amendments
This rule amends, suspends, or revokes Standard Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums and Obstacle Departure Procedures for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.
Standard Instrument Approach Procedures, and Takeoff Minimums and Obstacle Departure Procedures; Miscellaneous Amendments
This rule establishes, amends, suspends, or revokes Standard Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums and Obstacle Departure Procedures for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.
Migratory Bird Hunting; Proposed 2014-15 Migratory Game Bird Hunting Regulations (Preliminary) With Requests for Indian Tribal Proposals and Requests for 2016 Spring and Summer Migratory Bird Subsistence Harvest Proposals in Alaska
The U.S. Fish and Wildlife Service (hereinafter the Service or we) proposes to establish annual hunting regulations for certain migratory game birds for the 2014-15 hunting season. We annually prescribe outside limits (frameworks) within which States may select hunting seasons. This proposed rule provides the regulatory schedule, describes the proposed regulatory alternatives for the 2014-15 duck hunting seasons, requests proposals from Indian tribes that wish to establish special migratory game bird hunting regulations on Federal Indian reservations and ceded lands, and requests proposals for the 2016 spring and summer migratory bird subsistence season in Alaska. Migratory game bird hunting seasons provide opportunities for recreation and sustenance; aid Federal, State, and tribal governments in the management of migratory game birds; and permit harvests at levels compatible with migratory game bird population status and habitat conditions.
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