September 29, 2015 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled ``E6(R2) Good Clinical Practice.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance amends the guidance entitled ``E6 Good Clinical Practice: Consolidated Guidance'' (E6(R1)) to encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording, and reporting, and also updates standards regarding electronic records and essential documents. The draft guidance is intended to improve clinical trial quality and efficiency while maintaining human subject protection. FDA is making this draft guidance available for comment on the sections that are additions to ICH E6(R1) and marked as ``ADDENDUM.''

The Food and Drug Administration (FDA or Agency) is announcing the availability of a guidance for industry entitled ``Controlled Correspondence Related to Generic Drug Development''. The guidance document provides information regarding the process by which human generic drug manufacturers and related industry can submit correspondence to FDA requesting information on generic drug development. This guidance also describes FDA's process for providing communications related to such correspondence.

The Food and Drug Administration (FDA or Agency) has determined that PONDIMIN (fenfluramine hydrochloride (HCl)) tablets, 20 milligrams (mg) and 60 mg, and PONDEREX (fenfluramine HCl) capsules, 20 mg, were withdrawn from sale for reasons of safety or effectiveness. The Agency will not accept or approve abbreviated new drug applications (ANDAs) for fenfluramine HCl tablets, 20 mg or 60 mg, or fenfluramine HCl capsules, 20 mg.

On September 30, 2015, the Department of Labor (DOL) will submit the Mine Safety and Health Administration (MSHA) sponsored information collection request (ICR) revision titled, ``Refuge Alternatives for Underground Coal Mines,'' to the Office of Management and Budget (OMB) for review and approval for use in accordance with the Paperwork Reduction Act of 1995 (PRA), 44 U.S.C. 3501 et seq. Public comments on the ICR are invited.

The Department of Defense has submitted to OMB for clearance, the following proposal for collection of information under the provisions of the Paperwork Reduction Act.

This notice contains a summary of a petition seeking relief from specified requirements of Title 14 of the Code of Federal Regulations. The purpose of this notice is to improve the public's awareness of, and participation in, the FAA's exemption process. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.

On November 15, 2013, the Commodity Futures Trading Commission (``Commission'' or ``CFTC'') published in the Federal Register a notice of proposed modifications to part 150 of the Commission's regulations. The modifications addressed the policy for aggregation under the Commission's position limits regime for futures and option contracts on nine agricultural commodities set forth in part 150. The Commission also noted that if the Commission's proposed position limits regime for 28 exempt and agricultural commodity futures and options contracts and the physical commodity swaps that are economically equivalent to such contracts are finalized, the proposed modifications would also apply to the position limits regime for those contracts and swaps. The Commission is now proposing a revision to its proposed modification to the aggregation provisions of part 150, which addresses when aggregation is required on the basis of ownership of a greater than 50 percent interest in another entity.

The Commission hereby gives notice of the scheduling of the final phase of antidumping and countervailing duty investigation Nos. 701-TA-528-529 and 731-TA-1264-1268 (Final) pursuant to the Tariff Act of 1930 (``the Act'') to determine whether an industry in the United States is materially injured or threatened with material injury, or the establishment of an industry in the United States is materially retarded, by reason of imports of certain uncoated paper from Australia, Brazil, China, Indonesia, and Portugal, provided for in subheadings 4802.56 and 4802.57 of the Harmonized Tariff Schedule of the United States, preliminarily determined by the Department of Commerce to be subsidized and sold at less-than-fair-value.\1\

We propose to adopt a new airworthiness directive (AD) for certain The Boeing Company Model MD-11 and MD-11F airplanes. This proposed AD was prompted by a report of fuel odor in the cabin. Fuel was found leaking from a cracked fuel line shroud in the left cargo compartment equipment tunnel. This proposed AD would require a check for the presence of fuel at the fuel shroud drain; a high frequency eddy current (HFEC) inspection for cracked fuel line shrouds; a pressure test of the drain system of the tail tank fuel shroud and a pressure test of the drain system of the aft fuselage fuel shroud to determine cracking; and corrective actions, if necessary. We are proposing this AD to detect and correct fuel leaking from a cracked fuel line shroud, which could result in fuel accumulation below the cargo compartment floor and consequent increased risk of fire.

We are adopting a new airworthiness directive (AD) for PILATUS AIRCRAFT LTD. Models PC-12, PC-12/45, and PC-12/47E airplanes. This AD results from mandatory continuing airworthiness information (MCAI) issued 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 malfunction of the universal joint. We are issuing this AD to require actions to address the unsafe condition on these products.

This document seeks comment on proposals to amend the Commission's rules to provide railroad police with access to public safety interoperability and mutual aid channels. By this action, the Commission affords interested parties an opportunity to submit comments on these proposed rule changes.

This action proposes to establish Class E airspace at U.S. Coast Guard Station Neah Bay Heliport, Neah Bay, WA, to accommodate new Standard Instrument Approach Procedures for developed at the heliport. Controlled airspace is necessary for the safety and management of Instrument Flight Rules (IFR) operations at the heliport.

The Secretary of Agriculture is authorized to delegate functions, powers, and duties as the Secretary deems appropriate. This document amends the existing delegations of authority by adding and modifying certain delegations, as explained in the Supplementary Information section below.

The Environmental Protection Agency (EPA) is planning to submit an information collection request (ICR), ``Renewal of the ICR for the Regional Haze Regulations'' (EPA ICR No. 1813.09, OMB Control No. 2060.0421) to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.). Before doing so, the EPA is soliciting public comments on specific aspects of the proposed information collection as described below. This is a proposed extension of the ICR, which is currently approved through March 31, 2016. An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number.

The Federal Energy Regulatory Commission (Commission) is proposing to revise its regulations to require that each regional transmission organization (RTO) and independent system operator (ISO) settle energy transactions in its real-time markets at the same time interval it dispatches energy and settle operating reserves transactions in its real-time markets at the same time interval it prices operating reserves. The Commission also proposes to revise its regulations to require that each RTO/ISO trigger shortage pricing for any dispatch interval during which a shortage of energy or operating reserves occurs. Adopting these reforms would align prices with resource dispatch instructions and operating needs, providing appropriate incentives for resource performance.

The Federal Energy Regulatory Commission (Commission) proposes to amend its regulations to require each regional transmission organization (RTO) and independent system operator (ISO) to electronically deliver to the Commission, on an ongoing basis, data required from its market participants that would; first identify the market participants by means of a common alpha-numeric identifier; and secondly list their ``Connected Entities,'' which includes entities that have certain ownership, employment, debt, or contractual relationships to the market participants, as specified in this NOPR; and finally describe in brief the nature of the relationship of each Connected Entity. Such information will assist screening and investigative efforts to detect market manipulation, an enforcement priority of the Commission. The initiative would also assist market monitors for the RTOs and ISOs in their individual and joint investigations of potential cross-market manipulation. Unless the RTOs and ISOs request continuation of existing affiliate disclosure requirements based on a particularized need, the Commission expects that this new disclosure obligation will supplant all existing affiliate disclosures requirements contained in the RTOs and ISOs tariffs. The proposed definitional uniformity of the term ``Connected Entity'' across all of the RTOs and ISOs may help ease compliance burdens on market participants that are active in more than one RTO or ISO, and that are now required to submit affiliate information that may be unique to each of the organized markets in which they participate.

We are adopting a new airworthiness directive (AD) for Airbus Helicopters Model BO-105A, BO-105C, and BO-105S helicopters. This AD requires inspections to detect oil contamination in the main gearbox (MGB). This AD was prompted by initial findings from an accident investigation of a Model BO-105 helicopter, which indicated deterioration of the MGB caused by a contaminated oil supply. The actions of this AD are intended to detect oil contamination in the MGB, which could result in MGB deterioration, MGB failure, and subsequent loss of control of the helicopter.

We are superseding Airworthiness Directive (AD) 97-02-02 for certain Models SA26-AT, SA26-T, SA226-AT, SA226-T, SA226-T(B), SA226- TC, SA227-AC (C-26A), SA227-AT, SA227-BC (C-26A), SA227-CC, SA227-DC (C-26B), and SA227-TT airplanes. AD 97-02-02 required applying torque to the control column pitch bearing attaching nuts, inspecting the bearing assembly, inspecting the elevator control rod end bearing retainer/dust seals, and replacing or installing new parts as necessary. This new AD requires inspecting for movement and correct torque of the elevator control pivot bearing, inspecting the elevator control rod for damage and correct configuration, and replacing parts as necessary. This AD also requires a 10,000-hour time-in-service (TIS) repetitive replacement of the control column pivot bearing and elevator control rod bolt and requires replacement of the control column pivot bearing with the improved design by 35,000 hours TIS. This AD was prompted by loss of elevator control due to failure of the bolt attaching the elevator control rod to the elevator walking beam under the cockpit floor. We are issuing this AD to correct the unsafe condition on these products.

We are adopting a new airworthiness directive (AD) for all The Boeing Company Model 787-8 airplanes. This AD was prompted by reports of a potential latent failure of the fuel shutoff valve actuator circuitry, which was not identified during actuator development. This AD requires replacing certain engine and auxiliary power unit (APU) fuel shutoff valve actuators with new actuators, and also requires revising the maintenance or inspection program to include a new airworthiness limitation into the Airworthiness Limitations Section (ALS) of the Instructions for Continued Airworthiness (ICA). We are issuing this AD to detect and correct latent failures of the fuel shutoff valve to the engine and auxiliary power unit (APU), which could result in the inability to shut off fuel to the engine and APU and, in case of certain fires, an uncontrollable fire that could lead to structural failure.