June 21, 2016 – Federal Register Recent Federal Regulation Documents
Results 101 - 139 of 139
Determination of Regulatory Review Period for Purposes of Patent Extension; XOFIGO
The Food and Drug Administration (FDA) has determined the regulatory review period for XOFIGO 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.
Meeting of the Advisory Committee; Meeting
The Executive Director of the Joint Board for the Enrollment of Actuaries gives notice of a meeting of the Advisory Committee on Actuarial Examinations (portions of which will be open to the public) in Arlington, VA, on July 14-15, 2016.
Special Local Regulation; Bucksport/Southeastern Drag Boat Summer Extravaganza, Atlantic Intracoastal Waterway; Bucksport, SC
The Coast Guard is establishing a special local regulation on the Atlantic Intracoastal Waterway in Bucksport, South Carolina during the Bucksport/Southeastern Drag Boat Summer Extravaganza, on July 9, 2016 and July 10, 2016. This special local regulation is necessary to ensure the safety of participants, spectators, and the general public during the event. This regulation prohibits persons and vessels from being in the regulated area unless authorized by the Captain of the Port Charleston or a designated representative.
Disapproval of Interstate Transport Requirements for the 2008 Ozone National Ambient Air Quality Standards; New York
EPA is proposing to partially approve and partially disapprove elements of New York's State Implementation Plan (SIP) submission regarding the infrastructure requirements of section 110(a)(1) and (2) of the Clean Air Act (CAA) for the 2008 ozone national ambient air quality standards (NAAQS). The infrastructure requirements are designed to ensure that the structural components of each state's air quality management program are adequate to meet the state's responsibilities under the CAA. This action pertains specifically to infrastructure requirements concerning interstate transport provisions.
Addition of Certain Persons and Removal of Certain Persons From the Entity List
This final rule amends the Export Administration Regulations (EAR) by adding twenty-eight persons under thirty-one entries to the Entity List. The twenty-eight persons who are added to the Entity List have been determined by the U.S. Government to be acting contrary to the national security or foreign policy interests of the United States. These twenty-eight persons will be listed on the Entity List under the destinations of Afghanistan, Austria, China, Hong Kong, Iran, Israel, Panama, Taiwan, and the United Arab Emirates (U.A.E.). This final rule also removes three entities from the Entity List under the destinations of Finland, Pakistan and Turkey as the result of requests for removal received by BIS pursuant to the section of the EAR used for requesting removal or modification of an Entity List entity and the End-User Review Committee's (ERC) review of the information provided in the removal requests.
Revisions to the Unverified List (UVL)
The Bureau of Industry and Security (BIS) is amending the Export Administration Regulations (EAR) by adding thirty-six (36) persons to the Unverified List (the ``Unverified List'' or UVL), and adding an additional address for one (1) person currently listed on the UVL. The 36 persons are being added to the UVL on the basis that BIS could not verify their bona fides because an end-use check could not be completed satisfactorily for reasons outside the U.S. Government's control. A new address is added for one current UVL person as BIS has determined that this person has changed its registered address.
Final NIH Policy on the Use of a Single Institutional Review Board for Multi-Site Research
The National Institutes of Health (NIH) is issuing this policy on the use of a single Institutional Review Board (IRB) for multi-site research to establish the expectation that a single IRB (sIRB) of record will be used in the ethical review of non-exempt human subjects research protocols funded by the NIH that are carried out at more than one site in the United States. The goal of this policy is to enhance and streamline the IRB review process in the context of multi-site research so that research can proceed as effectively and expeditiously as possible. Eliminating duplicative IRB review is expected to reduce unnecessary administrative burdens and systemic inefficiencies without diminishing human subjects protections. The shift in workload away from conducting redundant reviews is also expected to allow IRBs to concentrate more time and attention on the review of single site protocols, thereby enhancing research oversight.
Connect America Fund, ETC Annual Reports and Certification, Rural Broadband Experiments
In this document, the Federal Communications Commission (Commission) seeks comment on several specific procedures that will apply in the Phase II auction. Pursuant to the Commission's existing rules for competitive bidding for universal service support, ``[d]etailed competitive bidding procedures shall be established by public notice prior to the commencement of competitive bidding. With this Further Notice, the Commission begins the process of seeking comment. The Commission seeks comment on three discrete sets of issues relating to the process for determining winning bidders: How to apply weights to the different levels of performance adopted in the Order above; measures to achieve the public interest objective of ensuring appropriate support for all of the states; and measures to achieve the public interest objective of expanding broadband on Tribal lands.
Biweekly Notice: Applications and Amendments to Facility Operating Licenses and Combined Licenses Involving No Significant Hazards Considerations
Pursuant to Section 189a.(2) of the Atomic Energy Act of 1954, as amended (the Act), the U.S. Nuclear Regulatory Commission (NRC) is publishing this regular biweekly notice. The Act requires the Commission to publish notice of any amendments issued, or proposed to be issued, and grants the Commission the authority to issue and make immediately effective any amendment to an operating license or combined license, as applicable, upon a determination by the Commission that such amendment involves no significant hazards consideration, notwithstanding the pendency before the Commission of a request for a hearing from any person. This biweekly notice includes all notices of amendments issued, or proposed to be issued from May 24, 2016, to June 6, 2016. The last biweekly notice was published on June 7, 2016 (81 FR 36613).
Energy Conservation Program: Energy Conservation Standards for Compressors; Extension of Comment Period
On May 19, 2016, the U.S. Department of Energy (DOE) published in the Federal Register a notice of proposed rulemaking (NOPR) for compressor energy conservation standards. This document announces an extension of the public comment period for submitting comments on the NOPR or any other aspect of the energy conservation standards rulemaking for compressors. The comment period is extended to August 17, 2016.
Notice of Proposed New Special Recreation Permit Fee
The Wallowa-Whitman National Forest is proposing to implement a Special Recreation Permit Fee on the Wild and Scenic Snake River which flows between Oregon and Idaho. Implementing a Special Recreation Permit Fee would allow the Forest Service to manage the specialized recreation use associated with float and power boating on the Wild and Scenic Snake River, and result in improved services and experiences. Fees are assessed based on the level of amenities and services provided, cost of operation and maintenance of river-related facilities, market assessment, and public comments received. Boaters using the Wild and Scenic Snake River would be subject to a Special Recreation Permit Fee (boater-use permit fee) of $5.00 to $10.00 per person that would be collected from all private and commercial boaters and their occupants. The implementation of the fee on the Wild and Scenic Snake River is comparable to other federal day- use fees within the current Four Rivers reservation system for the Selway, Middle Fork Salmon, Main Salmon and other sections of the Snake Rivers. The area subject to the fee is the Snake River beginning at Hells Canyon Dam to Cache Creek Ranch (approximately 70 miles). The exceptions to this boater-use permit fee are: Travel by private, noncommercial boat to any land in which the person has property rights. Any person who has right of access for hunting or fishing privileges under specific provisions of treaty or law. Individual outfitter/guides and their associated employees, while acting in an official capacity under the terms of their permit. At this time there is no boater-use permit fee on the Wild and Scenic Snake River for float or power boats. Boater-use for private float and power boats is currently managed though a national reservation system, which limits the amount of boats during the primary use season to meet management plan direction. A $6.00 transaction cost is associated with this reservation permit and is completely retained by the reservation contractor. In the future the reservation permit fee will be continued in conjunction with the application of this proposed boater-use permit fee for private boaters. At this time the listed boater-use permit fee is only a proposal and further analysis and public comment will occur before a decision is made. Funds from the proposed fee would be used for administrative and operational needs in the recreation area to enhance user experience and safety, sustain natural and cultural resources, and facility maintenance and improvements.
Airworthiness Directives; Airbus Helicopters Deutschland GmbH
We propose to adopt a new airworthiness directive (AD) for Airbus Helicopters Deutschland GmbH (Airbus Helicopters) Model MBB-BK 117 C-2 and MBB-BK 117 D-2 helicopters. This proposed AD would require repetitive visual inspections and a one-time torque of each hydraulic module plate assembly attachment point (attachment point). This proposed AD is prompted by a design reassessment showing the current attachment point design is insufficient in preventing an attachment point failure. The proposed actions are intended to prevent failure of an attachment point, loss of the hydraulic module plate, and subsequent loss of control of the helicopter.
Airworthiness Directives; Airbus Airplanes
We propose to adopt a new airworthiness directive (AD) for certain Airbus Model A330-200, -200 Freighter, and -300 series airplanes; and Model A340-500 and -600 series airplanes. This proposed AD was prompted by a quality control review on the final assembly line, which determined that the wrong aluminum alloy was used to manufacture several structural parts. This proposed AD would require a one-time eddy current conductivity measurement of certain cabin and cargo compartment structural parts to determine if an incorrect aluminum alloy was used, and replacement of any affected part with a serviceable part. We are proposing this AD to detect and replace structural parts made of incorrect aluminum alloy. This condition could result in reduced structural integrity of the airplane.
Texas Disaster #TX-00472
This is a Notice of the Presidential declaration of a major disaster for the State of Texas (FEMA-4272-DR), dated 06/11/2016. Incident: Severe Storms and Flooding. Incident Period: 05/26/2016 and continuing. Effective Date: 06/11/2016. Physical Loan Application Deadline Date: 08/10/2016. Economic Injury (EIDL) Loan Application Deadline Date: 03/11/2017.
Airworthiness Directives; Turbomeca S.A. Turboshaft Engines
We are superseding airworthiness directive (AD) 2010-11-10 for all Turbomeca S.A. Astazou XIV B and XIV H turboshaft engines. AD 2010- 11-10 requires inspection of certain third stage turbine wheels and removal of any damaged wheel. This AD requires expanding the population and frequency of repetitive inspections. This AD was prompted by a report of a third stage turbine wheel crack detected during engine overhaul. We are issuing this AD to prevent uncontained failure of the third stage turbine wheel, which could result in damage to the engine and damage to the helicopter.
Commercial Fishing Industry Vessels
The Coast Guard announces the withdrawal of this regulatory project, which involved possible amendments to Coast Guard regulations affecting uninspected United States commercial fishing, fish processing, and fish tender vessels. The possible amendments involved vessel stability and watertight integrity, risk awareness and minimization, personnel instruction and drill requirements, safety and survival equipment, and compliance documentation. Withdrawal of this regulatory project will allow the Coast Guard to focus on a new rulemaking project implementing 2010 and 2012 legislation that affects the commercial fishing industry.
Commercial Fishing Vessels-Implementation of 2010 and 2012 Legislation
The Coast Guard proposes to align its commercial fishing industry vessel regulations with the mandatory provisions of 2010 and 2012 legislation passed by Congress that took effect upon enactment. The alignments would change the applicability of current regulations, and add new requirements for safety equipment, vessel examinations, vessel safety standards, the documentation of maintenance, and the termination of unsafe operations. This rule only proposes to implement these legislative mandates, would exercise no Coast Guard regulatory discretion, and would promote the Coast Guard's maritime safety mission. It does not reflect any provision of the Coast Guard Authorization Act of 2015, but the preamble to this document discusses its likely impact where appropriate. That Act will be the subject of future Coast Guard regulatory action.
Proposed Amendment of Class E Airspace, Glasgow, KY
This action proposes to amend Class E airspace at Glasgow, KY as the Beaver Creek Non-Directional Beacon (NDB) has been decommissioned, requiring airspace reconfiguration at Glasgow Municipal Airport. Controlled airspace is necessary for the safety and management of instrument flight rules (IFR) operations at the airport. This action also would update the geographic coordinates of the airport.
Establishment of Class D Airspace: Destin, FL; Duke Field, Eglin AFB, FL; Revocation of Class D Airspace; Eglin AF Aux No 3 Duke Field, FL; and Amendment of Class D and E Airspace; Eglin Air Force Base, FL; Eglin Hurlburt Field, FL; and Crestview, FL
This action establishes Class D airspace at Destin, FL, providing the controlled airspace required for the Air Traffic Control Tower at Destin Executive Airport, (formerly Destin-Fort Walton Beach Airport). Additionally, this action removes Eglin AF Aux No 3 Duke Field from the Class D designation, and establishes Duke Field, Eglin AFB, FL in its place. Controlled airspace is necessary for the safety and management of instrument flight rules (IFR) operations at the airport. This action also changes the existing Class D airspace designation at Duke Field, Eglin Air Force Base (AFB), FL, and adjusts the geographic coordinates of Eglin AFB, Destin Executive Airport, Duke Field, and Hurlburt Field, to stay in concert with the FAA's database.
Proposed Amendment of Class D and E Airspace, Falmouth, MA
This action proposes to amend Class E airspace designated as an extension at Cape Cod Coast Guard Air Station, (formerly Otis ANGB), Falmouth, MA, as the Otis TACAN has been decommissioned, requiring airspace reconfiguration. Controlled airspace is necessary for the safety and management of instrument flight rules (IFR) operations at the airport. This action also would update the geographic coordinates of the airport in the existing Class D and E airspace areas, as well as Falmouth Airpark, Barnstable Municipal Airport-Boardman/Polando Field, Chatham Municipal Airport, Martha's Vineyard Airport, (formerly Martha's Vineyard Municipal Airport), and the BOGEY LOM.
Proposed Amendment of Class D and E Airspace, and Revocation of Class E Airspace; Troy, AL
This action proposes to amend Class D and E airspace, and remove Class E airspace designated as an extension at Troy Municipal Airport at N. Kenneth Campbell Field (formerly Troy Municipal Airport), Troy, AL. The Troy VHF Omnidirectional Radio Range (VOR) has been decommissioned, therefore Class E extension airspace is no longer needed, and new Standard Instrument Approach Procedures have been developed for Class D airspace and Class E airspace extending upward from 700 feet above the surface at the airport. This action would enhance the safety and airspace management of Instrument Flight Rules (IFR) operations at the airport. This action also would update the geographic coordinates of the airport and recognize the name change of the airport.
Amendment of Class D and Class E Airspace Orlando, FL; and Amendment of Class E Airspace; Gainesville, FL
This action amends Class E Airspace at Gainesville Regional Airport, Gainesville, FL; and Orlando Executive Airport, Orlando, FL, by eliminating the Notice to Airmen (NOTAM) part time status of the Class E airspace designated as an extension at each airport. This is an administrative change to coincide with the FAA's aeronautical database. This action also updates the geographic coordinates of Orlando Executive Airport in existing Class D and E airspace.
Amendments To Streamline Importation of Distilled Spirits, Wine, Beer, Malt Beverages, Tobacco Products, Processed Tobacco, and Cigarette Papers and Tubes, and Facilitate Use of the International Trade Data System
In this document, the Alcohol and Tobacco Tax and Trade Bureau (TTB) proposes to amend its regulations governing the importation of distilled spirits, wine, beer and malt beverages, tobacco products, processed tobacco, and cigarette papers and tubes. The proposed amendments are intended to clarify and streamline import procedures, and support the implementation of the International Trade Data System and the filing of import information electronically in conjunction with an electronic import filing with U.S. Customs and Border Protection (CBP). The proposed amendments include providing the option for importers to file import-related data electronically when filing entry or entry summary data electronically with CBP, as an alternative to the current TTB requirements that importers submit paper documents to CBP upon importation.
Importer Permit Requirements for Tobacco Products and Processed Tobacco, and Other Requirements for Tobacco Products, Processed Tobacco and Cigarette Papers and Tubes
The Alcohol and Tobacco Tax and Trade Bureau is adopting as a final rule, without change, a temporary rule concerning permit and other requirements related to importers and manufacturers of tobacco products and processed tobacco published in the Federal Register on June 27, 2013. The regulatory amendments adopted in this final rule include an extension in the duration of new permits for importers of tobacco products and processed tobacco from three years to five years, a technical correction amending the definition of ``Manufacturer of tobacco products'' to reflect a statutory change, and a technical correction related to references to the sale price of large cigars. This final rule also permanently incorporates and reissues other TTB regulations pertaining to importer permit requirements for tobacco products as well as minimum manufacturing and marking requirements for tobacco products and cigarette papers and tubes that also were incorporated in the June 27, 2013, temporary rule.
Airworthiness Directives; Airbus Airplanes
We are superseding Airworthiness Directive (AD) 2016-07-30 for all Airbus Model A330-200, -200 Freighter, and -300 series airplanes, and all Airbus Model A340-200, -300, -500, and -600 series airplanes. For certain airplanes, AD 2016-07-30 required replacing certain Angle of Attack (AOA) sensors (probes) with certain new AOA sensors. For certain other airplanes, AD 2016-07-30 also required inspections and functional heat testing of certain AOA sensors for discrepancies, and replacement if necessary. This new AD requires the same actions as AD 2016-07-30. This new AD was prompted by a report of a typographical error in the regulatory text of AD 2016-07-30. We are issuing this AD to prevent erroneous AOA information and Alpha Protection (Alpha Prot) activation due to blocked AOA probes, which could result in a continuous nose-down command and consequent loss of control of the airplane.
Airworthiness Directives; Airbus Airplanes
We propose to supersede Airworthiness Directive (AD) 98-13-14, for certain Airbus Model A320-211, -212, and -231 airplanes. AD 98-13- 14 currently requires repetitive rotating probe inspections of fastener holes and/or the adjacent tooling hole of a former junction of the aft fuselage, as applicable, and corrective action, if necessary. AD 98-13- 14 also provides for an optional terminating action for the repetitive inspections. Since we issued AD 98-13-14, an evaluation by the design approval holder (DAH) indicates that the former junction of the aft fuselage is subject to fatigue damage. This proposed AD would continue to require the actions in AD 98-13-14, with revised inspection compliance times. We are proposing this AD to detect and correct fatigue cracks in the former junction of the aft fuselage; fatigue cracking could propagate and could adversely affect the structural integrity of the airplane.
Airworthiness Directives; The Boeing Company Airplanes
We propose to adopt a new airworthiness directive (AD) for certain The Boeing Company Model 737-600, -700, -700C, -800, and -900 series airplanes. This proposed AD was prompted by an evaluation by the design approval holder (DAH) indicating that the aft pressure bulkhead is subject to widespread fatigue damage (WFD). This proposed AD would require repetitive inspections of the aft pressure bulkhead web for any cracking, crack indications, discrepant fastener holes, and corrosion; and corrective actions if necessary. We are proposing this AD to detect and correct cracks in the aft pressure bulkhead web, which could result in an uncontrolled decompression of the fuselage.
Airworthiness Directives; The Boeing Company Airplanes
We propose to adopt a new airworthiness directive (AD) for certain The Boeing Company Model 747-200B, 747-300, 747-400, 747-400D, and 747-400F series airplanes. This proposed AD was prompted by a report of cracking in both the aluminum strut side skin, and corrosion resistant steel (CRES) outer spring beam support fitting. This proposed AD would require repetitive high frequency eddy current (HFEC) inspections for cracking in the strut side skin; an open-hole HFEC inspection for cracking, applicable related investigative and corrective actions; and a fastener installation modification. We are proposing this AD to detect and correct cracking of the strut side skin; such cracking could result in the failure of the outer spring beam support fitting, which could cause separation of a strut and engine from the airplane during flight.
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