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Federal Register Highlights – 8/28/15

August 28, 2015

Unpublished, time-sensitive and proposed rules for August 28, 2015:

TEMPORARY RULE: The Coast Guard has issued a temporary deviation from the operating schedule that governs the Devon Bridge, across the Housatonic River, mile 3.9, at Stratford, CT. This deviation is necessary to perform superstructure repairs and timber ties replacement. This deviation allows the bridge to remain in the closed position for 50 days. This deviation is effective from 8 a.m. on October 5, 2015 to 8 a.m. on November 23, 2015.

TEMPORARY RULE: The Coast Guard has issued a temporary deviation from the operating schedule that governs the Lehigh Valley Drawbridge, across Newark Bay, mile 4.3, at Newark, New Jersey. This deviation is necessary to replace bridge timbers and miter rails. This deviation allows the bridge to remain in the closed position for 10 hours for two days. This deviation is effective from 7 a.m. to 5 p.m. on September 13, 2015 and from 7 a.m. to 5 p.m. on September 14, 2015, with a rain date on September 20, 2015 from 7 a.m. to 5 p.m.

TEMPORARY RULE: The Coast Guard is establishing a temporary safety zone for all waters of the Upper Mississippi River, surface to bottom, between mile 180.0 and 180.5. This temporary safety zone is necessary to protect persons and property from potential damage and safety hazards during Lumiere Place Fireworks displays. During the periods of enforcement, no vessels may be located within the Coast Guard safety zone. Entry into this Coast Guard safety zone is prohibited unless specifically authorized by the Captain of the Port (COTP) Upper Mississippi River or other designated representative. This rule is effective from 9:30 p.m. to 10:30 p.m. on August 29, 2015.

RULE: We are adopting a new airworthiness directive (AD) for all Airbus Model A319, A320, and A321 series airplanes. This AD was prompted by reports that during a full scale fatigue test, several broken frames in certain areas of the cargo compartment have been found, especially on the cargo floor support fittings and open tack holes on the left-hand side. This AD requires a rototest inspection of the open tack holes and rivet holes at the cargo floor support fittings of the fuselage, including doing all applicable related investigative actions, and repair if necessary. We are issuing this AD to detect and correct cracking in the open tack holes and rivet holes at the cargo floor support fittings of the fuselage, which could affect the structural integrity of the airplane. This AD becomes effective October 2, 2015.

RULE: We are adopting a new airworthiness directive (AD) for certain Bombardier, Inc. Model CL–600–2B19 (Regional Jet Series 100 & 440) airplanes. This AD was prompted by results of a design review indicating that the burst pressure of the flexible hose, used to vent oxygen from the high-pressure relief valve of the oxygen cylinder overboard, was lower than the opening pressure of the high-pressure relief valve, which could cause the flexible hose to burst before it can vent the excess oxygen overboard. This AD requires replacing the oxygen hose assembly with a new, improved assembly. We are issuing this AD to prevent the accumulation of oxygen in an enclosed space, which could result in an uncontrolled oxygen-fed fire if an ignition source is nearby. This AD becomes effective October 2, 2015.

RULE: We are adopting a new airworthiness directive (AD) for certain Bombardier, Inc. Model CL–600–2C10 (Regional Jet Series 700, 701, & 702) airplanes, Model CL–600–2D15 (Regional Jet Series 705) airplanes, Model CL–600–2D24 (Regional Jet Series 900) airplanes, and Model CL– 600–2E25 (Regional Jet Series 1000) airplanes. This AD was prompted by results of a design review indicating that the burst pressure of the flexible hose, used to vent oxygen from the high- pressure relief valve of the oxygen cylinder overboard, was lower than the opening pressure of the high-pressure relief valve, which could cause the flexible hose to burst before it can vent the excess oxygen overboard. This AD requires replacing the oxygen hose assembly with a new, improved assembly. We are issuing this AD to prevent the accumulation of oxygen in an enclosed space, which could result in an uncontrolled oxygen-fed fire if an ignition source is nearby. This AD becomes effective October 2, 2015.

RULE: We are adopting a new airworthiness directive (AD) for all Pratt & Whitney (PW) PW4164–1D, PW4168–1D, PW4168A–1D and PW4170 engines, and certain PW4164, PW4168, and PW4168A turbofan engines. This AD was prompted by fuel nozzle-to-fuel supply manifold interface fuel leaks. This AD requires inspecting fuel nozzles for signs of leakage, replacing hardware as required, and torqueing to specified requirement. We are issuing this AD to prevent fuel leaks which could result in engine fire and damage to the airplane. This AD is effective October 2, 2015.

RULE: We are adopting a new airworthiness directive (AD) for certain Turbomeca S.A. Arrius 2F turboshaft engines with a certain part number oil pump installed. This AD requires inspection, and if necessary, replacement before further flight of the oil pump driver assembly and/or the oil pump shaft, or the oil pump itself. This AD was prompted by cases of deterioration of the gas generator front bearing due to a link loss between the pump driver and the oil pump shaft. We are issuing this AD to prevent link loss between the pump driver and the oil pump shaft, which could lead to an engine in-flight shutdown, forced landing, and damage to the helicopter. This AD becomes effective October 2, 2015.

PROPOSED RULE: The Food and Drug Administration (FDA) is proposing a regulation to designate official names and proper names for certain biological products. These products are filgrastim- sndz (Biologics License Application (BLA) 125553), filgrastim (BLA 103353), tbo-filgrastim (BLA 125294), pegfilgrastim (BLA 125031), epoetin alfa (BLA 103234), and infliximab (BLA 103772). The official names and proper names of these products would include distinguishing suffixes composed of four lowercase letters and would be designated as filgrastim-bflm (BLA 125553), filgrastim-jcwp (BLA 103353), filgrastim-vkzt (BLA 125294), pegfilgrastim-ljfd (BLA 125031), epoetin alfa-cgkn (BLA 103234), and infliximab- hjmt (BLA 103772). Although FDA is continuing to consider the appropriate naming convention for biological products, including how such a convention would be applied retrospectively to currently licensed products, FDA is proposing to take action with respect to these six products because of the need to encourage routine usage of designated suffixes in ordering, prescribing, dispensing, recordkeeping, and pharmacovigilance practices for the biological products subject to this rulemaking, and to avoid inaccurate perceptions of the safety and effectiveness of biological products based on their licensure pathway. Submit either electronic or written comments on the proposed rule by November 12, 2015. (To submit comments, visit www.regulations.gov, reference docket number FDA-2015-N-0648.)

PROPOSED RULE: This document contains proposed regulations that provide guidance regarding the amount of the penalty under section 6707A of the Internal Revenue Code (Code) for failure to include on any return or statement any information required to be disclosed under section 6011 with respect to a reportable transaction. The proposed regulations are necessary to clarify the amount of the penalty under section 6707A, as amended by the Small Business Jobs Act of 2010. The proposed regulations would affect any taxpayer who fails to properly disclose participation in a reportable transaction. Written or electronic comments and requests for a public hearing must be received by November 27, 2015. (To submit comments, visit www.regulations.gov, reference docket number IRS-REG-103033-11.)

TEMPORARY RULE: NMFS apportions amounts of the non-specified reserve to the initial total allowable catch (ITAC) of Bering Sea and Aleutian Islands (BSAI) northern rockfish, BSAI squids, Bering Sea (BS) Greenland turbot, and BS Pacific ocean perch in the BSAI management area. This action is necessary to allow the fisheries to continue operating. It is intended to promote the goals and objectives of the fishery management plan for the BSAI management area. Effective August 27, 2015, through 2400 hrs, Alaska local time, December 31, 2015.

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