September 2015 – Federal Register Recent Federal Regulation Documents
Results 201 - 250 of 2,488
Proposed Collection; Comment Request
In compliance with the Paperwork Reduction Act of 1995, the Department of the Army announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed information collection; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.
Agency Information Collection Activities; Proposed Collection; Comments Requested; Request To Be Included on the List of Pro Bono Legal Service Providers for Individuals in Immigration Proceedings (Form EOIR-56)
The Department of Justice (DOJ), Executive Office for Immigration Review, will submit the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. This proposed information collection was developed pursuant to public comment received in connection with the Federal Register publication of a Notice of Proposed Rule Making (NPRM), List of Pro Bono Legal Service Providers for Aliens in Immigration Proceedings, allowing for a 60 day comment period. See 79 FR 180, at 55662 (Sept. 17, 2014).
Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the Agency's Division of Dockets Management.
E6(R2) Good Clinical Practice; International Conference on Harmonisation; Draft Guidance for Industry; Availability
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled ``E6(R2) Good Clinical Practice.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use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.''
Determination That ORTHO EVRA (Norelgestromin/Ethinyl Estradiol) Transdermal System, 0.15 Milligrams/24 Hours Norelgestromin and 0.035 Milligrams/24 Hours Ethinyl Estradiol, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA or Agency) has determined that ORTHO EVRA (norelgestromin/ethinyl estradiol) Transdermal System, 0.15 milligrams (mg)/24 hours (hr) norelgestromin and 0.035 mg/24hr ethinyl estradiol was not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to this drug product, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
Controlled Correspondence Related to Generic Drug Development; Guidance for Industry; Availability
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Determination That PONDIMIN (Fenfluramine Hydrochloride) Tablets, 20 Milligrams and 60 Milligrams, and PONDEREX (Fenfluramine Hydrochloride) Capsules, 20 Milligrams Were Withdrawn From Sale for Reasons of Safety or Effectiveness
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.
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Refuge Alternatives for Underground Coal Mines
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.
Motor Carrier Safety Advisory Committee; Charter Renewal
FMCSA announces the charter renewal of the MCSAC, a Federal Advisory Committee that provides the Agency with advice and recommendations on motor carrier safety programs and motor carrier safety regulations through a consensus process. This charter renewal will take effect on October 1, 2015, and will expire after 2 years.
Submission for OMB Review; Comment Request
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.
Proposed Collection; Comment Request
In compliance with the Paperwork Reduction Act of 1995, the Department of the Army announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed information collection; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.
Proposed Collection; Comment Request
In compliance with the Paperwork Reduction Act of 1995, the Department of the Army announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed information collection; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.
Petition for Exemption; Summary of Petition Received; Delta Air Lines, Inc.
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.
Proposed Collection; Comment Request
In compliance with the Paperwork Reduction Act of 1995, the Department of the Army announces a proposed public information collection and seeks public comment on the provisions thereof. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed information collection; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the information collection on respondents, including through the use of automated collection techniques or other forms of information technology.
Aggregation of Positions
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.
Strategic Environmental Research and Development Program, Scientific Advisory Board; Notice of Federal Advisory Committee Meeting
The Department of Defense is publishing this notice to announce an open meeting of the Strategic Environmental Research and Development Program, Scientific Advisory Board (SAB). This meeting will be open to the public.
Certain Uncoated Paper from Australia, Brazil, China, Indonesia, and Portugal; Scheduling of the Final Phase of Countervailing Duty and Antidumping Duty Investigations
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\
Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Snapper-Grouper Fishery and Golden Crab Fishery of the South Atlantic, and Dolphin and Wahoo Fishery of the Atlantic
NMFS proposes to implement management measures described in Amendment 34 to the Fishery Management Plan (FMP) for the Snapper- Grouper Fishery of the South Atlantic Region, Amendment 9 to the FMP for the Golden Crab Fishery of the South Atlantic Region, and Amendment 8 to the FMP for the Dolphin and Wahoo Fishery of the Atlantic; collectively referred to as the Generic Accountability Measures (AM) and Dolphin Allocation Amendment (Generic AM Amendment), as prepared and submitted by the South Atlantic Fishery Management Council (Council). If implemented, this proposed rule would revise the commercial and recreational AMs for numerous snapper-grouper species and golden crab. This proposed rule would also revise commercial and recreational sector allocations for dolphin in the Atlantic. The proposed actions are intended to make the AMs consistent for snapper- grouper species addressed in this proposed rule and for golden crab, and revise the allocations between the commercial and recreational sectors for dolphin.
Airworthiness Directives; The Boeing Company Airplanes
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.
Biweekly Notice; Applications and Amendments to Facility Operating Licenses and Combined Licenses Involving No Significant Hazards Considerations
Pursuant to Section 189a. (2) of the Atomic Energy Act of 1954, as amended (the Act), the U.S. Nuclear Regulatory Commission (NRC) is publishing this regular biweekly notice. The Act requires the Commission to publish notice of any amendments issued, or proposed to be issued, and grants the Commission the authority to issue and make immediately effective any amendment to an operating license or combined license, as applicable, upon a determination by the Commission that such amendment involves no significant hazards consideration, notwithstanding the pendency before the Commission of a request for a hearing from any person. This biweekly notice includes all notices of amendments issued, or proposed to be issued from September 1 to September 14, 2015. The last biweekly notice was published on September 15, 2015.
Airworthiness Directives; Pilatus Aircraft Ltd. Airplanes
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.
Approval and Promulgation of Air Quality Implementation Plans; Missouri; Regional Haze Five-Year Progress Report State Implementation Plan
The Environmental Protection Agency (EPA) is proposing approval of a revision to the Missouri State Implementation Plan (SIP) submitted by the State of Missouri on August 5, 2014. Missouri's SIP submission (``progress report SIP'') addresses requirements of the Clean Air Act (CAA or Act) and EPA's rules that require states to submit periodic reports describing progress toward reasonable progress goals (RPGs) established for regional haze and a determination of the adequacy of the state's existing SIP addressing regional haze (``regional haze SIP''). EPA is proposing approval of Missouri's progress report SIP submission on the basis that it addresses the progress report and adequacy determination requirements for the first implementation period for regional haze.
Enable Railroad Police Officers To Access Public Safety Interoperability and Mutual Aid Channels
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.
Notice of Intent To Prepare an Environmental Impact Statement for the Proposed Greater Phoenix Mine Project, Lander County, NV
In compliance with the National Environmental Policy Act of 1969, as amended (NEPA), and the Federal Land Policy and Management Act of 1976, as amended, the Bureau of Land Management (BLM) Mount Lewis Field Office, Battle Mountain, Nevada, intends to prepare an Environmental Impact Statement (EIS) and by this notice is announcing the beginning of the scoping process to solicit public comments and identify issues.
Proposed Establishment of Class E Airspace, Neah Bay, WA
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.
Revised Environmental Assessment for Virginia Offshore Wind Technology Advancement Project on the Atlantic Outer Continental Shelf Offshore Virginia; MMAA104000
BOEM is announcing the availability of a revised Environmental Assessment (EA) and Finding of No Significant Impact (FONSI) for the approval of the Virginia Offshore Wind Technology Advancement Project (VOWTAP). The revised EA provides a discussion of potential impacts of the proposed action and an analysis of reasonable alternatives to the proposed action. As a result of the analysis in the revised EA, BOEM issued a FONSI concluding that the reasonably foreseeable environmental impacts associated with the proposed action and alternatives would not significantly impact the quality of the human environment. These documents and associated information are available on BOEM's Web site at https://www.boem.gov/VOWTAP/.
Revision of Delegations of Authority
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.
Agency Information Collection Activities: Submission for OMB Review; Comment Request
In accordance with the Paperwork Reduction Act of 1995 (PRA), the Consumer Financial Protection Bureau (Bureau) is proposing a new information collection titled, ``Consumer Response Government and Congressional Boarding Forms.''
Proposed Information Collection Request; Comment Request; Regional Haze Regulations (Renewal)
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.
Endangered and Threatened Wildlife and Plants; Endangered Species Status for Chamaecrista lineata var. keyensis (Big Pine Partridge Pea), Chamaesyce deltoidea ssp. serpyllum (Wedge Spurge), and Linum arenicola (Sand Flax), and Threatened Species Status for Argythamnia blodgettii (Blodgett's Silverbush)
We, the U.S. Fish and Wildlife Service (Service or USFWS), propose to list four plants from south Florida under the Endangered Species Act of 1973, as amended (Act): Chamaecrista lineata var. keyensis (Big Pine partridge pea), Chamaesyce deltoidea ssp. serpyllum (wedge spurge), and Linum arenicola (sand flax) as endangered species, and Argythamnia blodgettii (Blodgett's silverbush) as a threatened species. If we finalize this rule as proposed, it would extend the Act's protections to these plants.
Settlement Intervals and Shortage Pricing in Markets Operated by Regional Transmission Organizations and Independent System Operators
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.
Availability of Certain North American Electric Reliability Corporation Databases to the Commission
The Federal Energy Regulatory Commission (Commission) proposes to amend its regulations to require the North American Electric Reliability Corporation (NERC) to provide the Commission, and Commission staff, with access, on a non-public and ongoing basis, to certain databases compiled and maintained by NERC. The Commission's proposal applies to the following NERC databases: The Transmission Availability Data System, the Generating Availability Data System, and the protection system misoperations database. Access to these databases, which will be limited to data regarding U.S. facilities, will provide the Commission with information necessary to determine the need for new or modified Reliability Standards and to better understand NERC's periodic reliability and adequacy assessments.
Collection of Connected Entity Data From Regional Transmission Organizations and Independent System Operators
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.
Airworthiness Directives; Piaggio Aero Industries S.p.A. Airplanes
We are adopting a new airworthiness directive (AD) for Piaggio Aero Industries S.p.A. Model P-180 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 the need to restore the safe fatigue life of the bulkhead structure. We are issuing this AD to require actions to address the unsafe condition on these products.
Airworthiness Directives; Airbus Helicopters Deutschland GmbH (formerly Eurocopter Deutschland GmbH) (Airbus Helicopters) Helicopters
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.
Airworthiness Directives; Bombardier, Inc. Airplanes
We are adopting a new airworthiness directive (AD) for certain Bombardier, Inc. Model DHC-8-400 series airplanes. This AD was prompted by reports of inadvertent deployment of a single outboard spoiler during flight. This AD requires replacement of the power control units (PCUs) for the outboard spoilers with upgraded PCUs. We are issuing this AD to prevent leakage of the piston head seal and piston rod seals of the outboard spoiler PCUs, which could result in inadvertent spoiler deployment and reduced controllability of the airplane.
Airworthiness Directives; M7 Aerospace LLC Airplanes
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.
Airworthiness Directives; The Boeing Company Airplanes
We are adopting a new airworthiness directive (AD) for certain The Boeing Company Model 767 airplanes. This AD was prompted by reports that six fasteners may not have been installed in the left and right stringer 37 (S-37) between body stations (BS) 428 and 431 lap splices on certain airplanes. This AD requires a general visual inspection of S-37 lap splices for missing fasteners, and all applicable related investigative and corrective actions. We are issuing this AD to detect and correct missing fasteners, which could result in cracks in the fuselage skin that could adversely affect the structural integrity of the airplane.
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