December 2009 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor's name from Schering- Plough Animal Health Corp. to Intervet, Inc., and to change the

The Department of the Treasury (``Treasury'') is issuing this final rule as part of its implementation of Title I of the Terrorism Risk Insurance Act of 2002 (``TRIA'' or ``the Act''), as amended by the Terrorism Risk Insurance Program Reauthorization Act of 2007 (``Reauthorization Act''). The Act established a temporary Terrorism Risk Insurance Program (``TRIP'' or ``Program'') under which the Federal Government would share with commercial property and casualty insurers the risk of insured losses from certified acts of terrorism. The Reauthorization Act has now extended the Program until December 31, 2014. This rule was published in proposed form on September 30, 2008, for public comment. Some clarifying changes have been made in the final rule in response to comments. The rule incorporates and implements statutory requirements in section 103(e) of the Act, as amended by the Reauthorization Act, for capping the annual liability for insured losses at $100 billion. In particular, the rule describes how Treasury intends to determine the pro rata share of insured losses under the Program when insured losses would otherwise exceed the cap on annual liability. The rule builds upon previous rules issued by Treasury.

The Postal Service is filing this proposed rule to describe the applicable prices for commercial flat-size mail failing to meet new deflection standards, to be effective on June 7, 2010.

We are adopting a new airworthiness directive (AD) for certain Cirrus Design Corporation Model SR22 airplanes equipped with an anti- ice system approved for flight into known icing. This AD requires you to inspect the compression fittings on the anti-ice fluid distribution lines for proper installation and repair any fittings that were not properly installed. This AD results from the manufacturer finding some anti-ice fluid distribution lines where the compression fittings were not properly installed. We are issuing this AD to detect and correct anti-ice fluid distribution lines with improperly installed compression fittings, which could result in anti-ice fluid distribution line separation. A line separation could result in a total loss of ice protection fluid supply to the protected surfaces, which would allow ice to build on the airplane and degrade the handling qualities and performance.

The FAA is correcting airworthiness directive (AD) 2009-21-07, which published in the Federal Register. That AD applies to General Electric Company (GE) CF6-80C2 series turbofan engines with certain thrust reverser ballscrew gearbox assembly adjustable-length end actuators installed. The unsafe condition statement of ``We are issuing this AD to prevent loss of asymmetric thrust and thrust control'', and rod-end part number ``MS2124S06'' in paragraph (j) are incorrect. This document corrects the unsafe condition statement and the part number. In all other respects, the original document remains the same.

We are adopting a new airworthiness directive (AD) for the specified Eurocopter France (Eurocopter) helicopters. This AD results from a mandatory continuing airworthiness information (MCAI) AD issued by the European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community. The MCAI Emergency AD states that there has been a report of the failure of a flexible coupling on one of the main gearbox (MGB) inputs, which may be the result of loss of the tightening torque load, or insufficient tightening of the nuts on the bolts fixing the discs of the flexible coupling to its sliding and fixed hinges. This condition, if not corrected, could result in failure of the coupling discs, and if this condition develops on both the left-hand (LH) and right-hand (RH) MGB inputs, a complete loss of power to the transmission and subsequent loss of control of the helicopter.

NMFS proposes revisions to the guidelines for National Standard 2 (NS2) of the Magnuson-Stevens Fishery Conservation and Management Act (MSA) regarding scientific information. This action is necessary to provide guidance on the use of best scientific information available (BSIA) for the effective conservation and management of the nation's marine living resources. NMFS proposes to modify the existing NS2 guidelines on BSIA and establish new guidelines for scientific peer review to ensure the reliability, credibility, and integrity of the scientific information used in fishery conservation and management measures. Further, NMFS is proposing to add language to the guidelines regarding the role of the Scientific and Statistical Committees (SSCs) of the Regional Fishery Management Councils (Councils), and the relationship of SSCs to the peer review process. The proposed NS2 guidelines will also clarify the content and purpose of the Stock Assessment and Fishery Evaluation (SAFE) Report and related documents. These actions are necessary to ensure the use of BSIA in the development of fishery management plans and plan amendments, as required by NS2 of the MSA. The intended effect of these actions is to ensure that scientific information, including its collection and analysis, has been validated through formal peer review or other appropriate review, is transparent, and is used appropriately by SSCs, Councils, and NMFS in the conservation and management of marine fisheries. These guidelines are designed to provide quality standards for the collection and provision of biological, ecological, economic, and sociological information to fishery managers, Councils, and the public, while recognizing regional differences in fisheries and their management.

EPA is proposing to allocate essential use allowances for import and production of Class I ozone-depleting substances (ODSs) for calendar year 2010. Essential use allowances enable a person to obtain controlled Class I ODSs through an exemption to the regulatory ban on the production and import of these chemicals, which became effective as of January 1, 1996. EPA allocates essential use allowances for production or import of a specific quantity of Class I substances solely for the designated essential purpose. The proposed allocation in this action is 30.0 metric tons (MT) of chlorofluorocarbons (CFCs) for use in metered dose inhalers (MDIs) for 2010.

PHMSA is confirming the effective date of its direct final rule, published under Docket No. PHMSA-2009-0238 (HM-224G) on October 15, 2009, to amend the Hazardous Materials Regulations by revising the quantity limitation from 25 kg ``gross'' to 25 kg ``net'' for packages of chemical oxygen generators transported aboard cargo aircraft only. The direct final rule stated that it would become effective on November 16, 2009 unless an adverse comment or notice of intent to file an adverse comment was received by November 16, 2009. PHMSA did not receive any adverse comments or notice of intent to file an adverse comment to its October 15, 2009 direct final rule.

The Food and Drug Administration (FDA) is extending to January 29, 2009, the comment period for the proposed rule that appeared in the Federal Register of October 1, 2009. In the proposed rule, FDA requested comments on postmarketing safety reporting requirements for combination products. The agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

This supplemental NPRM revises an earlier proposed airworthiness directive (AD), for Honeywell International Inc. TFE731 series turbofan engines with certain second stage low-pressure compressor rotor (LPCR) discs and/or certain third stage LPCR discs installed. That proposed AD would have required removing from service certain second stage LPCR discs and/or certain third stage LPCR discs. That proposed AD resulted from a report of cracks found during a fluorescent penetrant inspection (FPI) of the disc bore. This supplemental NPRM revises the proposed AD to correct a P/N error, to clarify the applicability, and to clarify the instructions in the compliance section. This supplemental proposed AD results from a report of cracks found during an FPI of the disc bore. We are proposing this supplemental proposed AD to prevent an uncontained failure of a second stage LPCR disc and or a third stage LPCR disc due to cracks in the bore, which could result in damage to the airplane.

We are adopting a new airworthiness directive (AD) for the BHTC Model 407 and Model 427 helicopters. This AD results from mandatory continuing airworthiness information (MCAI) ADs issued by the aviation authority of Canada. The MCAI ADs state that some hydraulic pump driveshaft assemblies may have been delivered with a missing internal plug or fastening rivet. This condition, if not corrected, could result in a loss of hydraulic pressure and subsequent loss of control of the helicopter.

This document publishes in the Federal Register an amendment adopting Airworthiness Directive (AD) 2009-09-51, which was sent previously to all known U.S. owners and operators of Eurocopter France (Eurocopter) Model EC225LP helicopters by individual letters. This AD requires, before further flight, determining if the ``CHIP'' detector light on the instrument panel (Vehicle Monitoring System Screen) previously illuminated. If the ``CHIP'' detector light did illuminate and it illuminated because of a metal particle on the magnetic plug of the epicyclic reduction gear module (module) of the main gearbox (MGB), or if you cannot determine from the maintenance records which chip detector caused the ``CHIP'' detector light to illuminate or whether the detector light stayed illuminated after the ``CHIP'' detector switch was turned to the ``CHIP PULSE'' setting, replacing the module with an airworthy module is required before further flight. Also required before further flight is inspecting the MGB module magnetic chip detector electrical circuit and determining whether the system is functioning properly, including whether the ``CHIP'' detector light annunciates on the instrument panel (Vehicle Monitoring System Screen). Finally, this AD requires replacing the module with an airworthy module if the ``CHIP'' detector light illuminates, stays illuminated after the ``CHIP'' detector switch is turned to the ``CHIP PULSE'' setting, and you determine that a metal particle on the module magnetic plug caused that illumination. This amendment is prompted by a mandatory continuing airworthiness information (MCAI) AD issued by the European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community. EASA notified us of an accident that occurred April 1, 2009 on a Eurocopter Model AS332L2 helicopter and EASA advises that the ``cause of the accident seems to be connected with degradation of the epicyclic module of the MGB, the root cause of which is still to be determined.'' The actions specified by this AD are intended to prevent failure of the MGB and subsequent loss of control of the helicopter.

This action modifies Jet Route J-20 by terminating the route at the Orlando, FL, very high frequency omnidirectional range/tactical air navigation (VORTAC) facility, thereby eliminating a portion of J-20 that is no longer needed. This action will ensure the efficient use of airspace within the National Airspace System (NAS).

EPA is making an interim final determination to provide an additional stay of the regulations concerning the inclusion of fugitive emissions.

The Energy Policy and Conservation Act (EPCA) prescribes energy conservation standards for various consumer products and commercial and industrial equipment, including residential water heaters, direct heating equipment (DHE), and pool heaters. EPCA also requires the U.S. Department of Energy (DOE) to determine whether more stringent, amended standards for these products would be technologically feasible and economically justified, and would save a significant amount of energy. In this notice, DOE is proposing amended energy conservation standards for residential water heaters (other than tabletop and electric instantaneous models), gas-fired DHE, and gas- fired pool heaters. DOE also is announcing a public meeting to receive comment on these proposed standards and associated analyses and results.

This final rule revises the 2010 Optimum Yield and the January-December 2010 management measures for petrale sole taken in the U.S. exclusive economic zone (EEZ) off the coasts of Washington, Oregon, and California.

This rule increases the rail equipment accident/incident reporting threshold from $8,900 to $9,200 for certain railroad accidents/incidents involving property damage that occur during calendar year 2010. This action is needed to ensure that FRA's reporting requirements reflect cost increases that have occurred since the reporting threshold was last computed in December of 2008.

We propose to adopt a new airworthiness directive (AD) for the products listed above that would supersede an existing AD. This proposed AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as:

This interim final rule allows a TRICARE retail network pharmacy to be an authorized provider for the administration of three TRICARE-covered vaccines in the retail pharmacy setting. The three immunizations are H1N1 vaccine, seasonal influenza vaccine, and pneumococcal vaccine. In addition, this interim final rule solicits public comment on also including other TRICARE-covered immunizations in the future for which retail network pharmacies will be authorized providers. As part of DoD preparations for a possible public health emergency involving H1N1 influenza this fall and winter, this is being issued as an interim final rule.

This document proposes adopting a new airworthiness directive (AD) for the Sikorsky Model S-92A helicopters. The AD would require revising the Rotorcraft Flight Manual (RFM), Operating Limitations section, to make it clear to operators that this model helicopter was not certificated to the standards that allow for the carriage of human external cargo. This proposal is prompted by a mistake in the RFM, which allows ``Class D'' rotorcraft load combinations for human external cargo load (HEC) operations for this model. The Model S-92A RFM does not include the required one-engine inoperative (OEI) hover performance and procedures. The actions specified by the proposed AD are intended to correct the Limitations section of the RFM to prevent HEC operations, which could result in injury or loss of life.

The Coast Guard will enforce the Navy Pier Southeast Safety Zone in Chicago Harbor from December 4, 2009, through January 1, 2010. This action is necessary and intended to ensure safety of life on the navigable waters immediately prior to, during, and immediately after fireworks events. This rule will establish restrictions upon, and control movement of, vessels in a specified area immediately prior to, during, and immediately after fireworks events. During the enforcement period, no person or vessel may enter the safety zones without permission of the Captain of the Port Lake Michigan.

This action proposes special conditions for the Dassault Aviation Falcon Model 2000EX airplane. This airplane will have a novel or unusual design features associated with the autobraking system for use during landing. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These proposed special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

We are adopting a new airworthiness directive (AD) for the products listed above. This AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as:

The FAA is revising an existing airworthiness directive (AD), which applies to all Airbus Model A300-600 series airplanes. That AD currently requires revising the Airworthiness Limitations section of the Instructions for Continued Airworthiness to incorporate new limitations for fuel tank systems. This AD clarifies the intended effect of the AD on spare and on-airplane fuel tank system components. This AD results from fuel system reviews conducted by the manufacturer. We are issuing this AD to prevent the potential of ignition sources inside fuel tanks, which, in combination with flammable fuel vapors caused by latent failures, alterations, repairs, or maintenance actions, could result in fuel tank explosions and consequent loss of the airplane.