2014 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is proposing to reclassify iontophoresis devices intended for any other purposes, a preamendments class III device, into class II (special controls), and to amend the device identification. FDA is proposing this reclassification on its own initiative based on new information. This action implements certain statutory requirements.

The Coast Guard is establishing a temporary safety zone for all waters of the Missouri River, covering all waters within a 700 foot radius of the barge located at mile 372.0. This temporary safety zone is necessary to protect persons and property from potential damage and safety hazards during the Riverside Music Festival. Entry into, transit through or remaining within this zone is prohibited unless specifically authorized by the Captain of the Port (COTP) Upper Mississippi River or a designated representative.

The Federal Maritime Commission proposes to amend its rules governing dismissals of actions by complainants, by order of the presiding officer, and by respondents when complainant fails to prosecute.

The Comprehensive Environmental Response, Compensation, and Liability Act (``CERCLA'' or ``the Act''), as amended, requires that the National Oil and Hazardous Substances Pollution Contingency Plan (``NCP'') include a list of national priorities among the known releases or threatened releases of hazardous substances, pollutants or contaminants throughout the United States. The National Priorities List (``NPL'') constitutes this list. The NPL is intended primarily to guide the Environmental Protection Agency (``EPA'' or ``the agency'') in determining which sites warrant further investigation. These further investigations will allow the EPA to assess the nature and extent of public health and environmental risks associated with the site and to determine what CERCLA-financed remedial action(s), if any, may be appropriate. This rule proposes to add three sites to the General Superfund section of the NPL.

EPA proposes to approve the State Implementation Plan (SIP) revision submitted by the State of West Virginia for the purpose of amending their Legislative Rule on Ambient Air Quality Standards. In the Final Rules section of this Federal Register, EPA is approving the State's SIP submittal as a direct final rule without prior proposal because EPA views this as a noncontroversial submittal and anticipates no adverse comments. A detailed rationale for the approval is set forth in the direct final rule. If no adverse comments are received in response to this action, no further activity is contemplated. If EPA receives adverse comments, the direct final rule will be withdrawn and all public comments received will be addressed in a subsequent final rule based on this proposed rule. EPA will not institute a second comment period. Any parties interested in commenting on this action should do so at this time.

Western Area Power Administration (Western) published in the Federal Register two proposed changes to Western's Final Principles of Integrated Resource Planning (IRP) in the Federal Register on June 29, 2011. The Final Principles of IRP were last published in the Federal Register on June 9, 1995. First, Western proposed that its current practice of developing project-by-project evaluation criteria to determine the quantity, length, and source of a long-term energy purchase be replaced with uniform, Western-wide evaluation criteria. Western will make no changes to its current practice of developing project-by-project evaluation criteria to evaluate long-term energy- purchases. Second, Western proposed eliminating transmission planning principles that are unnecessary as a result of changes in the planning area made since 1995. Western will eliminate the transmission planning principles now accomplished by other means consistent with its proposal.

These special conditions are issued for Airbus Model A350-900 airplanes. These airplanes will have a novel or unusual design feature associated with general limiting requirements of its flight-envelope protection features. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These 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.

NARA has revised our regulations governing Freedom of Information Act (FOIA) access to NARA's archival holdings and NARA's own operational records. The revisions include clarification as to which records are subject to the FOIA, NARA's authority to grant access, and adjustments to our FOIA procedures to incorporate changes resulting from the OPEN FOIA Act of 2009, the OPEN Government Act of 2007, and the Electronic Freedom of Information Act Amendments of 1996 (E-FOIA). The rule affects individuals and organizations that file FOIA requests for access to NARA operational records and archival holdings.

The Board and the Bureau are publishing final rules amending the official interpretations and commentary for the agencies' regulations that implement the Consumer Leasing Act (CLA). The Dodd- Frank Wall Street Reform and Consumer Protection Act (Dodd-Frank Act) amended the CLA by requiring that the dollar threshold for exempt consumer leases be adjusted annually by any annual percentage increase in the Consumer Price Index for Urban Wage Earners and Clerical Workers (CPI-W). Based on the annual percentage increase in the CPI-W as of June 1, 2014, the Board and the Bureau are adjusting the exemption threshold to $54,600, effective January 1, 2015. Because the Dodd-Frank Act also requires similar adjustments in the Truth in Lending Act's threshold for exempt consumer credit transactions, the Board and the Bureau are making similar amendments to each of their respective regulations implementing the Truth in Lending Act in a rule published elsewhere in the Federal Register.

The Coast Guard proposes to revise and consolidate existing regulated navigation areas, security zones and safety zones currently in place in Apra Harbor, Guam. This action is intended to replace a number of redundant, potentially confusing and outdated navigation regulations with a cogent regulatory framework. The goal of this rulemaking is to better meet the needs of the community today and help ensure the safe and efficient use of the harbor by clarifying and streamlining, thereby reducing vessel operator confusion while transiting the waters of Apra Harbor, Guam.

The Environmental Protection Agency (EPA) is announcing that the period for providing public comments on the August 6, 2014, proposed ``Protection of Stratospheric Ozone: Change of Listing Status for Certain Substitutes Under the Significant New Alternatives Policy Program'' is being extended by 14 days.

DoD is proposing to amend the Defense Federal Acquisition Regulation Supplement (DFARS) to implement the statutory domestic source restrictions on acquisition of certain naval vessel components.

NMFS is prohibiting directed fishing for pollock in Statistical Area 620 in the Gulf of Alaska (GOA). This action is necessary to prevent exceeding the C season allowance of the 2014 total allowable catch of pollock for Statistical Area 620 in the GOA.

The Rural Business-Cooperative Service (RBS) is publishing this final rule for allocating program funds to its State Offices. This final rule adds two programsthe Rural Energy for America Program (REAP) and the Intermediary Relending Program (IRP). In addition, this final rule revises State allocation formulae to account for changes in data reported by the U.S. Bureau of the Census' decennial Census. Finally, this final rule revises the weight percentages associated with each of the allocation criteria; provides flexibility in determining when not to make State allocations for a program; restricts the use of the transition formula and changes the limitations on how much program funds can change when the transition formula is used; adds provisions for making State allocation for other RBS programs, including new ones; and provides consistency, where necessary, in the allocation of RBS program funds to State Offices.

This document contains proposed regulations that would provide guidance regarding certain amendments to applicable defined benefit plans. Applicable defined benefit plans are defined benefit plans that use a lump sum-based benefit formula, including cash balance plans and pension equity plans, as well as other hybrid retirement plans that have a similar effect. These proposed regulations would permit an applicable defined benefit plan that does not comply with the requirement that the plan not provide for interest credits (or equivalent amounts) at an effective rate that is greater than a market rate of return to comply with that requirement by changing to an interest crediting rate that is permitted under the final hybrid plan regulations, without violating the anti-cutback rules of section 411(d)(6). These regulations would affect sponsors, administrators, participants, and beneficiaries of these plans. This document also provides a notice of a public hearing on these proposed regulations.

This regulation establishes an exemption from the requirement of a tolerance for residues of 2-propenoic acid, butyl ester, polymer with 1,6-diisocyanatohexane, N-(hydroxymethyl)-2-methyl-2-propenamide and 2-propenenitrile (CAS Reg. No. 1469998-09-1) when used as an inert ingredient in a pesticide formulation. BASF Corporation submitted a petition to EPA under the Federal Food, Drug, and Cosmetic Act (FFDCA), requesting an exemption from the requirement of a tolerance. This regulation eliminates the need to establish a maximum permissible level for residues of 2-propenoic acid, butyl ester, polymer with 1,6- diisocyanatohexane, N-(hydroxymethyl)-2-methyl-2-propenamide and 2- propenenitrile on food or feed commodities.

This proposed rule would implement new authority authorizing an over-the-counter (OTC) drug program, make several administrative changes to the TRICARE Pharmacy Benefits Program regulation in order to conform it more closely to the statute, and clarify some procedures regarding the operation of the uniform formulary. Specifically, the proposed rule would: provide implementing regulations for the OTC drug program that has recently been given permanent statutory authority; conform the pharmacy program regulation to the statute regarding point- of-service availability of non-formulary drugs and copayments for all categories of drugs; clarify the process for formulary placement of newly approved drugs; and clarify several other uniform formulary practices.

The U.S. Nuclear Regulatory Commission (NRC) is revising its generic determination regarding the environmental impacts of the continued storage of spent nuclear fuel beyond a reactor's licensed life for operation and prior to ultimate disposal. The NRC prepared a final generic environmental impact statement that provides a regulatory basis for this final rule. The Commission concludes that the generic environmental impact statement generically determines the environmental impacts of continued storage of spent nuclear fuel beyond the licensed life for operation of a reactor. The final rule also clarifies that the generic determination applies to license renewal for an independent spent fuel storage installation (ISFSI), reactor construction permits, and early site permits. The final rule clarifies how the generic determination will be used in future NRC environmental reviews, and makes changes to improve readability. Finally, the final rule makes conforming amendments to the determinations on the environmental effects of renewing the operating license of a nuclear power plant to address issues related to the onsite storage of spent nuclear fuel and offsite radiological impacts of spent nuclear fuel and high-level waste disposal.

The Food Safety and Inspection Service (FSIS) is amending the meat, poultry, and egg products import regulations to provide for the Agency's Public Health Information System (PHIS) Import Component. The PHIS Import Component, launched on May 29, 2012, provides an electronic alternative to the paper-based import inspection application and the foreign inspection and foreign establishment certificate processes. The Agency is also removing from the regulations the discontinued ``streamlined'' import inspection procedures for Canadian product and is requiring Sanitation Standard Operating Procedures (SOPs) at official import inspection establishments. In addition to the regulatory amendments outlined above, FSIS is discontinuing its practice of conducting imported product reinspection based on a foreign government's guarantee to replace a lost or incorrect foreign inspection certificate and is clarifying its policy of addressing imported product that is not presented for reinspection.

We are adopting a new airworthiness directive (AD) for certain Bombardier, Inc. Model DHC-8-400, -401, and -402 airplanes. This AD was prompted by reports of rudder bearings falling out of the fore rudder hinge bracket during assembly. This AD requires a proof load test and detailed inspections; and installation of a new bearing, reaming, or repair of the bearing if necessary. We are issuing this AD to detect and correct improper bearing installation, which could result in abnormal wear and potential increased freeplay in the rudder system, and resultant airframe vibration, leading to compromise of the flutter margins of the airplane.

This rulemaking would replace Special Federal Aviation Regulation No. 106 with acceptance criteria for portable oxygen concentrators to be used by passengers in air carrier operations, commercial operations and certain other operations using large aircraft. Currently, the agency assesses each portable oxygen concentrator on a case-by-case basis to determine whether it is safe for use on board aircraft. If the agency determines that a portable oxygen concentrator is safe for use on board aircraft, the specific model is identified in regulations. This rulemaking would replace the burdensome approval process with acceptance criteria and a requirement for manufacturers to demonstrate compliance by affixing a label on the exterior of the portable oxygen concentrator applied in a manner that ensures it will remain affixed for the life of the device. The proposed acceptance criteria and labeling requirement would only affect portable oxygen concentrators intended for use on board aircraft. Portable oxygen concentrators currently approved for use on board aircraft would not be affected by this proposal and will be listed in this rule as approved. This rulemaking would also eliminate redundant requirements and paperwork requirements that are not necessary for aviation safety thereby reducing burdens for portable oxygen concentrator manufacturers, passengers who use portable oxygen concentrators while traveling, and aircraft operators conducting air carrier operations, commercial operations or certain operations using large aircraft.

We are amending the veterinary biological product regulations by defining the terms used for reporting the results of tests performed on veterinary biological products. Licensees and permittees of veterinary biological products must conduct these tests and report the results to the Animal and Plant Health Inspection Service so that the Agency can determine if the products are eligible for release. Defining these terms will clarify the circumstances under which the results of a prescribed test can be reported as satisfactory, unsatisfactory, inconclusive, or a No Test. We are also removing several obsolete testing standard requirements from the regulations. These changes will update our regulations and improve communication between regulators and product licensees and permittees with respect to reporting test results.

NMFS is issuing regulations under the Tuna Conventions Act to implement a resolution of the Inter-American Tropical Tuna Commission (IATTC) intended to conserve whale sharks (Rhincodon typus) in the Eastern Pacific Ocean (EPO). This final rule would prohibit setting a purse seine net on whale sharks, and would require certain measures to protect whale sharks in the event that a whale shark is encircled in a purse seine net. This rulemaking is necessary for the United States to satisfy its obligations as a member of the IATTC.

We propose to adopt a new airworthiness directive (AD) for all Pilatus Aircraft Ltd. Models PC-6, PC-6-H1, PC-6-H2, PC-6/350, PC-6/ 350-H1, PC-6/350-H2, PC-6/A, PC-6/A-H1, PC-6/A-H2, PC-6/B-H2, PC-6/B1- H2, PC-6/B2-H2, PC-6/B2-H4, PC-6/C-H2, and PC-6/C1-H2 airplanes that would supersede AD 2013-11-08. 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 a need to incorporate new revisions into the aircraft maintenance manual or in the limitations document of the FAA-approved maintenance program. We are issuing this proposed AD to require actions to address the unsafe condition on these products.

The Food and Drug Administration (FDA) is proposing to reclassify salivary stimulatory system, a class III device, into class II (special controls), subject to premarket notification. FDA is also identifying the proposed special controls that the Agency believes will provide a reasonable assurance of safety and effectiveness of the device. The Agency is proposing to rename the device ``electrical salivary stimulatory system.''