2014 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is classifying hemoglobin A1c test system into class II (special controls). The special controls that will apply to this device are identified in this order and will be part of the codified language for the hemoglobin A1c test system classification. The Agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device.

The United States Coast Guard proposes to establish a regulated navigation area (RNA) on the navigable waters of the Piscataqua River under and surrounding the Sarah Mildred Long Bridge between Portsmouth, NH and Kittery, ME. This RNA would allow the Coast Guard to enforce speed and wake restrictions and prohibit all vessel traffic through the RNA during bridge replacement operations, both planned and unforeseen, which could pose an imminent hazard to persons and vessels operating in the area. This rule is necessary to provide for the safety of life on the navigable waters during bridge structural repair operations.

PHMSA proposes to amend the Hazardous Materials Regulations to maintain alignment with international standards by incorporating various amendments, including changes to proper shipping names, hazard classes, packing groups, special provisions, packaging authorizations, air transport quantity limitations, and vessel stowage requirements. These revisions are necessary to harmonize the Hazardous Materials Regulations with recent changes made to the International Maritime Dangerous Goods Code, the International Civil Aviation Organization's Technical Instructions for the Safe Transport of Dangerous Goods by Air, the United Nations Recommendations on the Transport of Dangerous GoodsModel Regulations and subsequently address three petitions for rulemaking.

The Gulf Coast Ecosystem Restoration Council (Council) is issuing a final regulation authorizing the Gulf Coast State members of the Council, or their administrative agents, and the Gulf Consortium of Florida counties to apply for grants to fund planning activities to develop individual State Expenditure Plans (SEP) using funds up to the statutory minimum that each Gulf Coast State must receive under the Spill Impact Component of the Resources and Ecosystem Sustainability, Tourist Opportunities, and Revived Economies of the Gulf Coast States Act of 2012 (RESTORE Act).

The Environmental Protection Agency (EPA) is proposing to approve a State Implementation Plan (SIP) revision submitted by the Commonwealth of Virginia pursuant to the Clean Air Act (CAA). Whenever new or revised National Ambient Air Quality Standards (NAAQS) are promulgated, the CAA requires states to submit a plan for the implementation, maintenance, and enforcement of such NAAQS. The plan is required to address basic program elements including, but not limited to, regulatory structure, monitoring, modeling, legal authority, and adequate resources necessary to assure attainment and maintenance of the standards. These elements are referred to as infrastructure requirements. The Commonwealth of Virginia has made a submittal addressing the infrastructure requirements for the 2010 sulfur dioxide (SO2) NAAQS.

The Coast Guard has issued a temporary deviation from the operating schedule that governs the Montlake Bridge across the Lake Washington Ship Canal, mile 5.2, at Seattle, WA. The deviation continues to allow the Washington State Department of Transportation to accommodate vehicular traffic attending football games, and maintain the bridge in the closed to navigation position. This deviation modifies the previously approved deviation under the same docket number.

The Coast Guard has issued a temporary deviation from the operating schedule that governs the San Joaquin County highway bridge across Bishop Cut, mile 1.0 between King Island and Bishop Tract, CA. The deviation is necessary to allow the bridge owner to make necessary bridge repairs. This deviation allows the bridge to remain in the closed-to-navigation position during the deviation period.

The Coast Guard is changing the enforcement period of a security zone regulation within the Baltimore COTP Zone. This regulation applies to a recurring event that takes place on the William P. Lane Jr. Memorial Bridges, across the Chesapeake Bay, between Sandy Point and Kent Island, MD. This action is necessary to protect persons and property, and prevent terrorist acts or incidents on navigable waters during the event. This rule prohibits vessels and people from entering the security zone and requires vessels and persons in the security zone to depart the security zone, unless specifically exempt under the provisions in this rule or granted specific permission from the Coast Guard Captain of the Port Baltimore.

The Coast Guard will enforce a special local regulation for the Wheeling Vintage Raceboat Regatta on the Ohio River, from mile 90.2 to 90.8, extending the entire width of the river. This zone will be in effect on August 30-31, 2014 from 9:00 a.m. until 6:00 p.m. This regulated area is necessary to protect vessels participating in the event and event spectators from the hazards associated with a boat race on the waterway. During the enforcement period, entry into, transiting, or anchoring in the safety zone is prohibited to all vessels not registered with the sponsor as participants or official patrol vessels, unless specifically authorized by the Captain of the Port (COTP) Pittsburgh or a designated representative.

The U.S. Census Bureau issues this interim final rule to amend its regulations to reflect changes related to the implementation of the International Trade Data System (ITDS) and subsequent changes to the access to the electronic export information (EEI). The ITDS was established to eliminate redundant information requirements, efficiently regulate the flow of commerce and to effectively enforce laws and regulations relating to international trade by establishing a single portal system for the collection and distribution of standard electronic import and export data required by all participating federal agencies. Therefore, the Automated Export System (AES) will include export information collected under other federal agencies' authority, which is subject to those agencies' disclosure mandates. This rule clarifies the confidentiality provisions of the EEI and facilitates the legitimate sharing of export data consistent with the goals for the ITDS.

NMFS is prohibiting retention of Pacific cod by catcher/ processors using trawl gear in the Central Regulatory Area of the Gulf of Alaska (GOA). This action is necessary because the 2014 total allowable catch of Pacific cod apportioned to trawl catcher/processors in the Central Regulatory Area of the GOA has been reached.

NMFS is prohibiting directed fishing for the rex sole sideboard limit by non-exempt American Fisheries Act (AFA) catcher vessels in the Central Regulatory Area of the Gulf of Alaska (GOA). This action is necessary because the 2014 rex sole sideboard limit for non-exempt AFA catcher vessels in the Central Regulatory Area of the GOA has been reached.

With the issuance of this final rule, the Administrator of the Drug Enforcement Administration reschedules hydrocodone combination products from schedule III to schedule II of the Controlled Substances Act. This scheduling action is pursuant to the Controlled Substances Act which requires that such actions be made on the record after opportunity for a hearing through formal rulemaking. This action imposes the regulatory controls and administrative, civil, and criminal sanctions applicable to schedule II controlled substances on persons who handle (manufacture, distribute, dispense, import, export, engage in research, conduct instructional activities with, conduct chemical analysis with, or possess) or propose to handle hydrocodone combination products.

The Food and Drug Administration (FDA) is proposing to amend the biologics regulations by removing the general safety test (GST) requirements for biological products. FDA is proposing this action because the existing codified GST regulations are duplicative of requirements that are also specified in biologics licenses, or are no longer necessary or appropriate to help ensure the safety, purity, and potency of licensed biological products. FDA is taking this action as part of its retrospective review of its regulations to promote improvement and innovation, in response to an Executive order.

The Fish and Wildlife Service (hereinafter Service or we) is proposing to establish the 2014-15 late-season hunting regulations for certain migratory game birds. We annually prescribe frameworks, or outer limits, for dates and times when hunting may occur and the number of birds that may be taken and possessed in late seasons. These frameworks are necessary to allow State selections of seasons and limits and to allow recreational harvest at levels compatible with population and habitat conditions.

We are revising the Medicare hospital inpatient prospective payment systems (IPPS) for operating and capital-related costs of acute care hospitals to implement changes arising from our continuing experience with these systems. Some of these changes implement certain statutory provisions contained in the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010 (collectively known as the Affordable Care Act), the Protecting Access to Medicare Act of 2014, and other legislation. These changes are applicable to discharges occurring on or after October 1, 2014, unless otherwise specified in this final rule. We also are updating the rate- of-increase limits for certain hospitals excluded from the IPPS that are paid on a reasonable cost basis subject to these limits. The updated rate-of-increase limits are effective for cost reporting periods beginning on or after October 1, 2014. We also are updating the payment policies and the annual payment rates for the Medicare prospective payment system (PPS) for inpatient hospital services provided by long-term care hospitals (LTCHs) and implementing certain statutory changes to the LTCH PPS under the Affordable Care Act and the Pathway for Sustainable Growth Rate (SGR) Reform Act of 2013 and the Protecting Access to Medicare Act of 2014. In addition, we discuss our proposals on the interruption of stay policy for LTCHs and on retiring the ``5 percent'' payment adjustment for co-located LTCHs. While many of the statutory mandates of the Pathway for SGR Reform Act apply to discharges occurring on or after October 1, 2014, others will not begin to apply until 2016 and beyond. In addition, we are making a number of changes relating to direct graduate medical education (GME) and indirect medical education (IME) payments. We are establishing new requirements or revising requirements for quality reporting by specific providers (acute care hospitals, PPS- exempt cancer hospitals, and LTCHs) that are participating in Medicare. We are updating policies relating to the Hospital Value-Based Purchasing (VBP) Program, the Hospital Readmissions Reduction Program, and the Hospital-Acquired Condition (HAC) Reduction Program. In addition, we are making technical corrections to the regulations governing provider administrative appeals and judicial review; updating the reasonable compensation equivalent (RCE) limits, and revising the methodology for determining such limits, for services furnished by physicians to certain teaching hospitals and hospitals excluded from the IPPS; making regulatory revisions to broaden the specified uses of Medicare Advantage (MA) risk adjustment data and to specify the conditions for release of such risk adjustment data to entities outside of CMS; and making changes to the enforcement procedures for organ transplant centers. We are aligning the reporting and submission timelines for clinical quality measures for the Medicare EHR Incentive Program for eligible hospitals and critical access hospitals (CAHs) with the reporting and submission timelines for the Hospital IQR Program. In addition, we provide guidance and clarification of certain policies for eligible hospitals and CAHs such as our policy for reporting zero denominators on clinical quality measures and our policy for case threshold exemptions. In this document, we are finalizing two interim final rules with comment period relating to criteria for disproportionate share hospital uncompensated care payments and extensions of temporary changes to the payment adjustment for low-volume hospitals and of the Medicare- Dependent, Small Rural Hospital (MDH) Program.

The Environmental Protection Agency (EPA) is proposing to approve the State of Maryland's request to redesignate to attainment the Maryland portion of the Martinsburg-Hagerstown, WV-MD Nonattainment Area (Martinsburg Area or Area) for the 1997 annual fine particulate matter (PM2.5) national ambient air quality standard (NAAQS). The Maryland portion of the Martinsburg Area is comprised of Washington County, Maryland. EPA has determined that the Martinsburg Area attained the standard and continues to attain the standard. In addition, EPA is proposing to approve, as a revision to the Maryland State Implementation Plan (SIP), the Washington County maintenance plan to show maintenance of the 1997 annual PM2.5 NAAQS through 2025 for the Maryland portion of the Area. The maintenance plan includes the 2017 and 2025 PM2.5 and nitrogen oxides (NOX) mobile vehicle emissions budgets (MVEBs) for Washington County, Maryland for the 1997 annual PM2.5 NAAQS, which EPA is proposing to approve for transportation conformity purposes. These actions are being taken under the Clean Air Act (CAA).

NMFS is reallocating the projected unused amount of Pacific cod from vessels using jig gear, catcher vessels greater than or equal to 60 feet (18.3 meters) length overall (LOA) using hook-and-line gear, and catcher vessels using trawl gear to catcher vessels less than 60 feet (18.3 meters) LOA using hook-and-line or pot gear in the Bering Sea and Aleutian Islands management area. This action is necessary to allow the 2014 total allowable catch of Pacific cod to be harvested.

The Employee Benefits Security Administration of the U.S. Department of Labor (the Department) is publishing this Notice as part of its review of the use of brokerage windows (including self-directed brokerage accounts or similar arrangements) in participant-directed individual account retirement plans covered by the Employee Retirement Income Security Act of 1974 (ERISA). Some plans offer participants access to brokerage windows in addition to, or in place of, specific investment options selected by the plans' fiduciaries. Through these arrangements, plan participants may be able to choose among the full range of investment options available in the investment marketplace. The Request for Information contained in this Notice will assist the Department in determining whether, and to what extent, regulatory standards or other guidance concerning the use of brokerage windows by plans are necessary to protect participants' retirement savings. It also will assist the Department in preparing any analyses that it may need to perform pursuant to Executive Order 12866, the Paperwork Reduction Act, and the Regulatory Flexibility Act.

This action closes the Georges Bank cod Trimester Total Allowable Catch Area for the remainder of Trimester 1, through August 31, 2014. Based on our projection, the common pool fishery has caught over 90 percent of its Georges Bank cod Trimester 1 total allowable catch triggering the regulatory requirement to close the area for the remainder of the trimester. This action is intended to prevent an overage of the common pool's annual quota of Georges Bank cod.

These special conditions are issued for Airbus Model A350-900 series airplanes. These airplanes will have a novel or unusual design feature associated with the post-crash fire survivability of composite fuel tanks. 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.

These special conditions are issued for Airbus Model A350-900 airplanes. This airplane will have a novel or unusual design feature associated with permanently installed rechargeable lithium-ion batteries and battery systems. These batteries have certain failure, operational, and maintenance characteristics that differ significantly from those of the nickel-cadmium and lead-acid rechargeable batteries currently approved for installation on large transport-category airplanes. 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.

The Environmental Protection Agency (EPA) is approving elements of a State Implementation Plan (SIP) revision submitted by the State of Hawaii on April 4, 2014, pursuant to the requirements of the Clean Air Act (CAA or the Act) for the 8-Hour Ozone and the 2010 Nitrogen Dioxide national ambient air quality standards (NAAQS). Section 110(a) of the CAA requires that each state adopt and submit a SIP for the implementation, maintenance, and enforcement of each NAAQS promulgated by EPA.

We are adopting a new airworthiness directive (AD) for all Airbus Model A330-200 Freighter, A330-200, A330-300, and A340-200, A340-300, A340-500, and A340-600 series airplanes. This AD was prompted by a determination that the service life limits of the cabin pressure control system (CPCS) safety valves installed on the aft pressure bulkhead were being exceeded. This AD requires repetitive replacement of the CPCS safety valves with serviceable valves. We are issuing this AD to prevent exceeding the service life limits of the CPCS safety valves, which, in the event of a failure, could result in excessive positive or negative differential pressure in the fuselage and consequent incapacitation or injuries to airplane occupants.

The National Archives and Records Administration (NARA) is changing its list of facilities to include the new George W. Bush Presidential Library and to update addresses and contact numbers for records centers and archival research rooms outside of the Washington, DC area.