November 2014 – Federal Register Recent Federal Regulation Documents

This Notice of Proposed Rulemaking proposes requirements for submitting registration and summary results information, including adverse event information, for specified clinical trials of drugs (including biological products) and devices and for pediatric postmarket surveillances of a device to ClinicalTrials.gov, the clinical trial registry and results data bank operated by the National Library of Medicine (NLM). This proposed rule provides for the expanded registry and results data bank specified in Title VIII of the Food and Drug Administration Amendments Act of 2007 (FDAAA) to enhance patient enrollment, provide a mechanism to track subsequent progress of clinical trials, provide more complete results information, and enhance patient access to and understanding of the results of clinical trials. The proposed requirements would apply to the responsible party (meaning the sponsor or designated principal investigator) for certain clinical trials of drugs (including biological products) and devices that are regulated by the Food and Drug Administration (FDA) and for pediatric postmarket surveillances of a device that are ordered by FDA.

The Audio Division, at the request of Bryan King (``petitioner''), deletes FM Channel 227A and allots FM Channel 277A at Pearsall, Texas. Channel 277A can be allotted at Pearsall, consistent with the minimum distance separation requirements of the Commission's rules, at coordinates 28-56-40 NL and 99-11-44 WL, with a site restriction of 11.4 km (7.1 miles) northwest of the community. The Government of Mexico has concurred with the allotment of Channel 277A at Pearsall, which is located within 320 kilometers (199 miles) of the U.S.-Mexican border. See Supplementary Information infra.

The Audio Division, at the request of Threshold Communications, substitutes FM Channel 235C1 for Channel 249C1 at Altamont, Oregon. Channel 235C1 can be allotted at Altamont in compliance with the Commission's minimum distance separation requirements with a site restriction of 20 km (12.6 miles) northeast of Altamont, at 42-08-37 North Latitude and 121-30-19 West Longitude.

The Environmental Protection Agency (EPA) is proposing to approve the July 20, 2012, State Implementation Plan (SIP) submission, provided by the North Carolina Department of Environment and Natural Resources (NC DENR), Division of Air Quality (NCDAQ) for inclusion into the North Carolina SIP. This proposal pertains to the Clean Air Act (CAA or the Act) infrastructure requirements for the 2008 Lead national ambient air quality standards (NAAQS). The CAA requires that each state adopt and submit a SIP for the implementation, maintenance, and enforcement of each NAAQS promulgated by EPA, which is commonly referred to as an ``infrastructure'' SIP. NCDAQ certified that the North Carolina SIP contains provisions that ensure the 2008 Lead NAAQS is implemented, enforced, and maintained in North Carolina (hereafter referred to as an ``infrastructure SIP submission''). With the exception of provisions pertaining to prevention of significant deterioration (PSD) permitting and state boards requirements, EPA is proposing to determine that North Carolina's infrastructure SIP submission, provided to EPA on July 20, 2012, addresses the required infrastructure elements for the 2008 Lead NAAQS.

NMFS is prohibiting directed fishing for Pacific ocean perch in the Western Regulatory Area of the Gulf of Alaska (GOA). This action is necessary to prevent exceeding the 2014 total allowable catch of Pacific ocean perch in the Western Regulatory Area of the GOA.

NMFS is prohibiting directed fishing for dusky rockfish in the Western Regulatory Area of the Gulf of Alaska (GOA). This action is necessary to prevent exceeding the 2014 total allowable catch of dusky rockfish in the Western Regulatory Area of the GOA.

In this document, the Wireline Competition Bureau, the Wireless Telecommunications Bureau, and the Office of Engineering and Technology seek to further develop the record on how compliance with speed obligations should be determined for recipients of high-cost support that deploy broadband networks to serve fixed locations.

The United States Department of Justice (``the Department'') is publishing this final rule to amend the regulations implementing the National Instant Criminal Background Check System (``NICS'') pursuant to the Brady Handgun Violence Prevention Act (``Brady Act''). This final rule authorizes tribal criminal justice agencies to access the NICS Index for purposes of issuing firearm-related permits and licenses, authorizes criminal justice agencies to access the NICS Index for purposes of disposing of firearms in their possession, and updates the storage location of NICS Audit Log records relating to denied transactions.

This document announces the Commission's decision to extend the conditional stay of enforcement of special packaging requirements for over-the-counter and prescription products containing the equivalent of 0.08 milligrams or more of a specified imidazoline (tetrahydrozoline, naphazoline, oxymetazoline, or xylometazoline) in a single package. Firms that meet the conditions of the stay have until June 10, 2015 to comply with the special packaging requirements.

In accordance with section 712(d)(4) of the Dodd-Frank Wall Street Reform and Consumer Protection Act (the ``Dodd-Frank Act''), the Commodity Futures Trading Commission (the ``CFTC'') and the Securities and Exchange Commission (``SEC''), after consultation with the Board of Governors of the Federal Reserve System (``Board of Governors''), are jointly issuing the CFTC's proposed clarification of its interpretation concerning forward contracts with embedded volumetric optionality. The CFTC invites public comment on all aspects of its proposed interpretation.

We, the U.S. Fish and Wildlife Service (Service), designate critical habitat for the Gunnison sage-grouse (Centrocercus minimus) under the Endangered Species Act (Act). In total, approximately 1,429,551 acres (ac) (578,515 hectares (ha)) are designated as critical habitat in Delta, Dolores, Gunnison, Hinsdale, Mesa, Montrose, Ouray, Saguache, and San Miguel Counties in Colorado; and in Grand and San Juan Counties in Utah. The effect of this regulation is to conserve Gunnison sage-grouse habitat under the Act.

The Environmental Protection Agency (EPA) is taking direct final action to approve State Implementation Plan (SIP) revisions submitted by the State of North Carolina, through the North Carolina Department of Environment and Natural Resources (NC DENR) on January 31, 2008, May 24, 2010, October 11, 2013, and February 11, 2014, pertaining to rules for changes to the North Carolina Inspection and Maintenance (I/M) program. Specifically, these SIP revisions update the North Carolina I/M program as well as repeal one rule that is included in the federally-approved SIP.

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 a report indicating that inboard and outboard hydraulic lines of the brakes were found connected to the incorrect ports on the swivel assembly of the main landing gear (MLG). This AD requires modifying the MLG by installing a new bracket on the left and right lower aft-wing planks. We are issuing this AD to prevent incorrect installation of the brake hydraulic lines, which could cause the brakes and the anti-skid system to operate incorrectly, and consequent catastrophic failure of the airplane during a high-speed rejected takeoff.

We are adopting a new airworthiness directive (AD) for certain The Boeing Company Model 777-200LR, -300, -300ER, and 777F series airplanes. This AD was prompted by reports of dual pitch rate sensor (PRS) failures causing the primary flight computers to transition from primary mode to secondary mode, resulting in autopilot disconnects. This AD requires an inspection to determine the PRS part number, and replacement if necessary. We are issuing this AD to prevent a dual PRS failure that could cause an automatic disengagement of the autopilot and autoland, which may prevent continued safe flight and landing if disengagement occurs at low altitude and the flight crew is unable to safely assume control and execute a go-around or manual landing.

NMFS is adjusting the 2014 seasonal apportionments of the total allowable catch (TAC) in the Gulf of Alaska (GOA) by re- apportioning unharvested pollock TAC from Statistical Areas 610 to Statistical Areas 620 and 630 of the GOA. This action is necessary to provide opportunity for harvest of the 2014 pollock TAC, consistent with the goals and objectives of the Fishery Management Plan for Groundfish of the Gulf of Alaska.

This rule identifies communities where the sale of flood insurance has been authorized under the National Flood Insurance Program (NFIP) that are scheduled for suspension on the effective dates listed within this rule because of noncompliance with the floodplain management requirements of the program. If the Federal Emergency Management Agency (FEMA) receives documentation that the community has adopted the required floodplain management measures prior to the effective suspension date given in this rule, the suspension will not occur and a notice of this will be provided by publication in the Federal Register on a subsequent date. Also, information identifying the current participation status of a community can be obtained from FEMA's Community Status Book (CSB). The CSB is available at https:// www.fema.gov/fema/csb.shtm.

The Department of the Interior is issuing a final rule to amend its regulations to exempt certain records in the Insider Threat Program from one or more provisions of the Privacy Act because of criminal, civil, and administrative law enforcement requirements.

This action proposes to establish Class E airspace at Seattle, WA, to facilitate vectoring of Instrument Flight Rules (IFR) aircraft under control of Seattle Air Route Traffic Control Center (ARTCC). The FAA is proposing this action to enhance the safety and management of IFR operations within the National Airspace System (NAS).

This action proposes to establish Class E airspace at Bend, OR, to facilitate vectoring of Instrument Flight Rules (IFR) aircraft under control of Seattle Air Route Traffic Control Center (ARTCC). The FAA is proposing this action to enhance the safety and management of IFR operations within the National Airspace System.

NMFS issues this final rule to implement management measures described in a framework action to the Fishery Management Plan for the Coastal Migratory Pelagic Resources in the Gulf of Mexico and Atlantic Region (FMP) (Framework Action), as prepared by the South Atlantic and Gulf of Mexico Fishery Management Councils (Councils). This final rule allows transfer of Atlantic migratory group Spanish mackerel caught in excess of the trip limit with gillnet gear from one vessel with a Federal Spanish mackerel commercial permit to another vessel with a Federal Spanish mackerel commercial permit that has not yet harvested the trip limit; allows the receiving vessel involved in a Spanish mackerel transfer-at-sea to have three gillnets onboard instead of two; and modifies the commercial trip limits for king mackerel in the Florida east coast subzone. This rule also implements an administrative change to correct an inadvertent error in a prior rulemaking unrelated to this Framework Action. The purpose of this final rule is to modify the restrictions on transfer-at-sea and gillnet allowances for Atlantic migratory group Spanish mackerel to minimize dead discards of Spanish mackerel and modify the king mackerel trip limit in the Florida east coast subzone to optimize utilization of the resource.

The Environmental Protection Agency (EPA) is proposing to amend the National Emission Standards for Hazardous Air Pollutants: Coal- and Oil-Fired Electric Steam Generating Units (Mercury and Air Toxics Standards (MATS)). In addition to this proposed rule the EPA is publishing a direct final rule that amends the reporting requirements of the MATS rule by temporarily requiring affected sources to submit all required emissions and compliance reports to the EPA through the Emissions Collection and Monitoring Plan System Client Tool and temporarily suspending the requirement for affected sources to submit certain reports using the Electronic Reporting Tool and the Compliance and Emissions Data Reporting Interface. If we receive no adverse comment, we will not take further action on this proposed rule.

The Environmental Protection Agency (EPA) is taking final action on its reconsideration of the startup and shutdown provisions in the final rules titled, ``National Emission Standards for Hazardous Air Pollutants from Coal- and Oil-fired Electric Utility Steam Generating Units and Standards of Performance for Fossil-Fuel-Fired Electric Utility, Industrial-Commercial-Institutional, and Small Industrial- Commercial-Institutional Steam Generating Units.'' The national emission standards for hazardous air pollutants (NESHAP) issued pursuant to Clean Air Act (CAA) section 112 are referred to as the Mercury and Air Toxics Standards (MATS), and the new source performance standards (NSPS) issued pursuant to CAA section 111 are referred to as the Utility NSPS. On November 30, 2012, the U.S. Environmental Protection Agency (EPA) granted reconsideration of, proposed, and requested comment on a limited set of issues in the February 16, 2012, final MATS and Utility NSPS, including certain issues related to the final work practice standards applicable during startup periods and shutdown periods. On June 25, 2013, the EPA reopened the public comment period for the reconsideration issues related to the startup and shutdown provisions of MATS and the startup and shutdown provisions related to the particulate matter (PM) standard in the Utility NSPS. The EPA is now taking final action on the standards applicable during startup periods and shutdown periods in MATS and on startup and shutdown provisions related to the PM standard in the Utility NSPS.

The U.S. Consumer Product Safety Commission has determined preliminarily that there may be an unreasonable risk of injury and death associated with recreational off-highway vehicles (ROVs). To address these risks, the Commission proposes a rule that includes: lateral stability and vehicle handling requirements that specify a minimum level of rollover resistance for ROVs and require that ROVs exhibit sublimit understeer characteristics; occupant retention requirements that would limit the maximum speed of an ROV to no more than 15 miles per hour (mph), unless the seat belts of both the driver and front passengers, if any, are fastened, and would require ROVs to have a passive means, such as a barrier or structure, to limit further the ejection of a belted occupant in the event of a rollover; and information requirements.

The U.S. Copyright Office is adopting a final rule that establishes a new regulation allowing copyright owners to audit the statements of account that cable operators and satellite carriers file with the Office reflecting royalty payments due for secondary transmissions of copyrighted broadcast programming made pursuant to statutory licenses.

The U.S. Copyright Office recently adopted amended regulations to allow remitters to submit title lists in electronic format when recording documents that reference 100 or more titles. Those regulations also provide a process for correcting inaccuracies in the Office's online Public Catalog resulting from errors in electronic title lists. To avoid delay in implementing the electronic title list option, the Office decided to issue that final rule without imposition of a fee for corrections until such time as a fee could be set in accordance with this separate rulemaking. Today, the Office is amending its regulations to set that fee at a rate of seven dollars per corrected title.