December 2, 2014 – Federal Register Recent Federal Regulation Documents
Results 101 - 141 of 141
Fisheries Off West Coast States; Pacific Coast Groundfish Fishery Management Plan; Trawl Rationalization Program; Chafing Gear Modifications
This action modifies the existing chafing gear regulations for midwater trawl gear. This action includes regulations that affect all trawl sectors (Shorebased Individual Fishing Quota Program (IFQ), Mothership Cooperative Program (MS), Catcher/Processor Cooperative Program (C/P), and tribal fishery) managed under the Pacific Coast Groundfish Fishery Management Plan (PCGFMP). Many Pacific whiting vessels also fish in the Alaska groundfish fisheries. This action establishes chafing gear restrictions for the Pacific Coast groundfish fishery that are more compatible with those for the Gulf of Alaska groundfish and Bering Sea and Aleutian Islands groundfish fisheries.
Infusion Pumps Total Product Life Cycle; Guidance for Industry and Food and Drug Administration Staff; Availability
Food and Drug Administration (FDA) is announcing the availability of the final guidance entitled, ``Infusion Pumps Total Product Life Cycle; Guidance for Industry and FDA Staff.'' The recommendations in this guidance are intended to improve the safety and effectiveness of these devices. This guidance also describes considerations in preparing premarket submissions for infusion pumps and identifies device features that manufacturers should address throughout the total product life cycle.
Recommendations for Labeling Medical Products To Inform Users That the Product or Product Container Is Not Made With Natural Rubber Latex; Guidance for Industry and Food and Drug Administration Staff; Availability
The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ``Recommendations for Labeling Medical Products to Inform Users That the Product or Product Container Is Not Made With Natural Rubber Latex; Guidance for Industry and Food and Drug Administration Staff.'' The purpose of this guidance is to make recommendations on the appropriate language to include in the labeling of a medical product to convey that natural rubber latex was not used as a material in the manufacture of the product, product container, and/or packaging. FDA is concerned that statements submitted for inclusion in medical product labeling, such as ``latex-free,'' ``does not contain natural rubber latex,'' or ``does not contain latex'' are not accurate because it is not possible to reliably assure that there is a complete absence of the allergens associated with hypersensitivity reactions to natural rubber latex in the medical product.
Establishment of a Public Docket; Electronic Cigarettes and the Public Health Workshop
The Food and Drug Administration (FDA), Center for Tobacco Products, is establishing a public docket in conjunction with the first public workshop to gather scientific information about electronic cigarettes (e-cigarettes) as announced in Docket No. FDA-2014-N-0001- 0079. Regardless of attendance at the public workshop, interested parties are invited to submit comments, supported by research and data, regarding electronic cigarettes and the public health.
Allowance for Private Purchase of an Outer Burial Receptacle in Lieu of a Government-Furnished Graveliner for a Grave in a VA National Cemetery
The Department of Veterans Affairs (VA) is updating the monetary allowance payable for qualifying interments that occur during calendar year 2015, which applies toward the private purchase of an outer burial receptacle (or ``graveliner'') for use in a VA national cemetery. The allowance is equal to the average cost of Government- furnished graveliners less any administrative costs to VA. The purpose of this Notice is to notify interested parties of the average cost of Government-furnished graveliners, administrative costs that relate to processing and paying the allowance and the amount of the allowance payable for qualifying interments that occur during calendar year 2015.
Guidance for Industry on Scale-Up Post-Approval Changes: Manufacturing Equipment Addendum; Availability
The Food and Drug Administration (FDA) is announcing the availability of a scale-up and post-approval changes (SUPAC) guidance for industry entitled ``SUPAC: Manufacturing Equipment Addendum.'' This replaces the draft guidance of the same name that combined and superseded ``SUPAC IR/MR: Immediate Release and Modified Release Solid Oral Dosage Forms: Manufacturing Equipment Addendum,'' published on January 1, 1999; and ``SUPAC-SS: Nonsterile Semisolid Dosage Forms; Manufacturing Equipment Addendum,'' published as a draft on December 1, 1998. FDA revised the draft manufacturing equipment addenda to remove the equipment examples and to clarify the types of processes being referenced.
Service Rules Governing Narrowband Operations in the 769-775/799-805 MHz Bands
In this document the Commission implements certain changes to the rules governing the 700 MHz public safety narrowband spectrum (769- 775/799-805 MHz). We eliminate the requirement for licensees to narrowband to 6.25 kHz technology by December 2016, thereby enabling licensees to extend the life of existing systems and providing public safety with greater flexibility in determining the optimal future use of the band. In addition, we revise and update the technical rules for the band to enhance interoperability and open up certain channels to new uses, and we release reserve spectrum to provide additional capacity, particularly for public safety licensees relocating to the 700 MHz band from the T-Band (470-512 MHz). These rule changes enhance the ability of public safety licensees to use this spectrum to protect the safety of life and property.
Proposed Information Collection; Comment Request; 2015 National Content Test
The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)).
Agency Information Collection Activities: Proposed Collection; Comment Request
The U.S. Nuclear Regulatory Commission (NRC) invites public comment about our intention to request the Office of Management and Budget's (OMB) approval for renewal of an existing information collection that is summarized below. We are required to publish this notice in the Federal Register under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). Information pertaining to the requirement to be submitted: 1. The title of the information collection: 10 CFR part 20, ``Standards for Protection Against Radiation.'' 2. Current OMB approval number: 3150-0014. 3. How often the collection is required: Annually for most reports and at license termination for reports dealing with decommissioning. 4. Who is required or asked to report: NRC licensees and Agreement State licensees, including those requesting license terminations. Types of licensees include civilian commercial, industrial, academic, and medical users of nuclear materials. Licenses are issued for, among other things, the possession, use, processing, handling, and importing and exporting of nuclear materials, and for the operation of nuclear reactors. 5. The number of annual respondents: 21,018 (3,003 NRC licensees and 18,015 Agreement State licensees). 6. The number of hours needed annually to complete the requirement or request: 640,776 hours (91,545 hours for NRC licensees and 549,231 hours for Agreement State licensees). 7. Abstract: 10 CFR part 20 establishes standards for protection against ionizing radiation resulting from activities conducted under licenses issued by the NRC and by Agreement States. These standards require the establishment of radiation protection programs, maintenance of radiation protection programs, maintenance of radiation records recording of radiation received by workers, reporting of incidents which could cause exposure to radiation, submittal of an annual report to NRC and to Agreement States of the results of individual monitoring, and submittal of license termination information. These mandatory requirements are needed to protect occupationally exposed individuals from undue risks of excessive exposure to ionizing radiation and to protect the health and safety of the public. Submit, by February 2, 2015, comments that address the following questions: 1. Is the proposed collection of information necessary for the NRC to properly perform its functions? Does the information have practical utility? 2. Is the burden estimate accurate? 3. Is there a way to enhance the quality, utility, and clarity of the information to be collected? 4. How can the burden of the information collection be minimized, including the use of automated collection techniques or other forms of information technology? The public may examine and purchase copies of the publicly- available documents, including the draft supporting statement, at the NRC's Public Document Room, Room O-1F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20852. The OMB clearance requests are available at the NRC's Web site: https://www.nrc.gov/public-involve/ doc-comment/omb/. The document will be available on the NRC's home page site for 60 days after the signature date of this notice. Comments submitted in writing or in electronic form will be made available for public inspection. Because your comments will not be edited to remove any identifying or contact information, the NRC cautions you against including any information in your submission that you do not want to be publicly disclosed. Comments submitted should reference Docket No. NRC-2014-0245. You may submit your comments by any of the following methods. Electronic comments go to https://www.regulations.gov and search for Docket No. NRC-2014-0245. Mail comments to NRC Clearance Officer, Tremaine Donnell (T-5 F53), U.S. Nuclear Regulatory Commission, Washington, DC 20555- 0001. Questions about the information collection requirements may be directed to the NRC Clearance Officer, Tremaine Donnell (T-5 F53), U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, by telephone at 301-415-6258, or by email to INFOCOLLECTS.Resource@NRC.GOV.
Notice of Passenger Facility Charge (PFC) Approvals and Disapprovals
The FAA publishes a monthly notice, as appropriate, of PFC approvals and disapprovals under the provisions of the Aviation Safety and Capacity Expansion Act of 1990 (Title IX of the Omnibus Budget Reconciliation Act of 1990) (Pub. L.101-508) and Part 158 of the Federal Aviation Regulations (14 CFR part 158). This notice is published pursuant to paragraph d of Sec. 158.29.
Economic Simplified Boiling-Water Reactor Design Certification
The U.S. Nuclear Regulatory Commission (NRC) is issuing NUREG- 1966, Supplement 1, ``Final Safety Evaluation Report Related to the Certification of the Economic Simplified Boiling-Water Reactor Standard Design, Supplement 1.''
Establishment of Class D and E Airspace, and Amendment of Class E Airspace; Hammond, LA
This action establishes Class D airspace and Class E airspace designated as an extension, at Hammond, LA. The establishment of an air traffic control tower has made this action necessary for the safety and management of Instrument Flight Rules (IFR) operations within the airspace at Hammond Northshore Regional Airport. This action also amends the airport name and adjusts the geographic coordinates for the current Class E airspace area.
Proposed Establishment of Class E Airspace; Tucumcari, NM
This action withdraws the NPRM published in the Federal Register on December 20, 2013. In that action, the FAA proposed to establish Class E airspace at the Tucumcari VORTAC, Tucumcari, NM. The FAA has determined that withdrawal of the NPRM is warranted as a result of objections raised during the comment period.
Amendment of Class E Airspace; Roanoke Rapids, NC
This action amends Class E Airspace at Roanoke Rapids, NC, as Halifax County Airport has been abandoned, no longer requiring controlled airspace.
Amendment of Class E Airspace; Apalachicola, FL
This action amends Class E Airspace at Apalachicola, FL, as Apalachicola Municipal Airport has been renamed Apalachicola Regional Airport. This action also updates the geographic coordinates of the airport.
Amendment of Class D Airspace; MacDill AFB, FL
This action amends Class D Airspace at MacDill AFB, FL, by adding the words ``to but not including 1,200 feet MSL,'' further clarifying the ceiling in the descriptor of the Class D airspace. This action does not change the boundaries or operating requirements of the airspace.
Airworthiness Directives; Rolls-Royce plc Turbofan Engines
We are superseding airworthiness directive (AD) 98-07-07 for all Rolls-Royce plc (RR) RB211-535E4 and RB211-535E4-B turbofan engines. AD 98-07-07 required removing certain part number (P/N) low- pressure (LP) fuel filter-to-high-pressure (HP) fuel pump tube assemblies and installing flexible LP fuel filter-to-HP fuel pump tube assemblies. This AD expands the applicability of AD 98-07-07 to include the RB211-535E4-C-37 turbofan engine and requires removal from service of additional P/N LP fuel filter-to-high-pressure HP fuel pump tube assemblies. This AD was prompted by reports of fuel leaks that have resulted in a number of engine in-flight shutdowns. We are issuing this AD to prevent loss of fuel supply to the engine, which could lead to an in-flight shutdown of one or more engines, loss of thrust control, and damage to the airplane.
Environmental Assessment for Virginia Offshore Wind Technology Advancement Project on the Atlantic Outer Continental Shelf Offshore Virginia
The Bureau of Ocean Energy Management (BOEM) has prepared an Environmental Assessment (EA) to consider the reasonably foreseeable environmental consequences associated with the approval of wind energy- related research activities offshore Virginia as proposed by the Virginia Department of Mines, Mineral, and Energy (DMME). The purpose of this notice is to inform the public of the availability of the EA and to solicit public comment on the EA for a 30-day public comment period.
Atlantic Highly Migratory Species; 2015 Atlantic Shark Commercial Fishing Seasons
This final rule establishes opening dates and adjusts quotas for the 2015 fishing seasons for the Atlantic commercial shark fisheries. The quota adjustments are based on over- and/or underharvests experienced during 2014 and previous fishing seasons. In addition, NMFS establishes season opening dates based on adaptive management measures to provide, to the extent practicable, fishing opportunities for commercial shark fishermen in all regions and areas. These actions could affect fishing opportunities for commercial shark fishermen in the northwestern Atlantic Ocean, including the Gulf of Mexico and Caribbean Sea.
Fisheries of the Exclusive Economic Zone Off Alaska; Pacific Cod Pot Gear Fishing Closure in the Pribilof Islands Habitat Conservation Zone in the Bering Sea; Amendment 103
NMFS issues this final rule to implement Amendment 103 to the Fishery Management Plan for Groundfish of the Bering Sea and Aleutian Islands Management Area (BSAI FMP). This rule closes year-round the Pribilof Islands Habitat Conservation Zone (PIHCZ) to directed fishing for Pacific cod with pot gear to minimize bycatch and prevent overfishing of Pribilof Islands blue king crab (PIBKC). This action is intended to promote the goals and objectives of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), the BSAI FMP, and other applicable laws.
International Fisheries; Western and Central Pacific Fisheries for Highly Migratory Species; Restrictions on the Use of Fish Aggregating Devices in Purse Seine Fisheries for 2015
NMFS issues regulations under authority of the Western and Central Pacific Fisheries Convention Implementation Act (WCPFC Implementation Act) to establish restrictions on the use of fish aggregating devices (FADs) by U.S. purse seine vessels in the western and central Pacific Ocean (WCPO). The restrictions include a prohibition on setting on FADs and other specific uses of FADs during January and February, and July through September of 2015, and a limit of 3,061 sets that may be made on FADs in 2015. This action is necessary for the United States to implement provisions of a conservation and management measure (CMM) adopted by the Commission for the Conservation and Management of Highly Migratory Fish Stocks in the Western and Central Pacific Ocean (WCPFC or Commission) and to satisfy the obligations of the United States under the Convention on the Conservation and Management of Highly Migratory Fish Stocks in the Western and Central Pacific Ocean (Convention), to which it is a Contracting Party.
Fisheries of the Exclusive Economic Zone Off Alaska; Chinook Salmon Bycatch Management in the Gulf of Alaska Non-Pollock Trawl Fisheries; Amendment 97
NMFS adopts a final rule to implement Amendment 97 to the Fishery Management Plan for Groundfish of the Gulf of Alaska (FMP). Amendment 97 limits Chinook salmon prohibited species catch (PSC) in Western and Central Gulf of Alaska (GOA) non-pollock trawl catcher/ processor (C/P) and catcher vessel (CV) fisheries. This action establishes separate annual Chinook salmon PSC limits for three sectors fishing for groundfish species other than pollock: trawl C/Ps, trawl CVs participating in the Central GOA Rockfish Program, and trawl CVs not participating in the Central GOA Rockfish Program. If a sector reaches its Chinook salmon PSC limit, NMFS will prohibit further fishing for non-pollock groundfish by vessels in that sector. This action also establishes and clarifies Chinook salmon retention and discard requirements for vessels and processors participating in both the GOA pollock and non-pollock groundfish trawl fisheries. This action is necessary to minimize the catch of Chinook salmon to the extent practicable in the GOA non-pollock trawl fisheries. Amendment 97 is intended to promote the goals and objectives of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), the FMP, and other applicable laws.
Fisheries of the Exclusive Economic Zone Off Alaska; Gulf of Alaska Trawl Economic Data Report
NMFS issues a final rule to implement the Gulf of Alaska (GOA) Trawl Economic Data Report Program to evaluate the economic effects of current and potential future fishery management measures for the GOA trawl fisheries. This data collection program will provide the North Pacific Fishery Management Council (Council) and NMFS with baseline economic information on harvesters, crew, processors, and communities active in the GOA trawl fisheries, which will be used to assess the impacts of anticipated future GOA trawl groundfish management measures on stakeholders. The data collected for this program will be submitted by owners and leaseholders of GOA trawl vessels, owners and leaseholders of processors receiving deliveries from those trawl vessels, and owners and leaseholders of trawl catcher/processors. The types of data collected will include, but not be limited to, labor data, revenues, capital and operational expenses, and other operational or financial data. This action is intended to promote the goals and objectives of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), the Fishery Management Plan for Groundfish of the Gulf of Alaska, and other applicable laws.
Atlantic Highly Migratory Species; 2006 Consolidated Atlantic Highly Migratory Species (HMS) Fishery Management Plan; Amendment 7
This final rule implements Amendment 7 to the 2006 Consolidated Atlantic Highly Migratory Species Fishery Management Plan (2006 Consolidated HMS FMP) to ensure sustainable management of bluefin tuna consistent with the 2006 HMS FMP and address ongoing management challenges in the Atlantic bluefin tuna fisheries. This final rule also implements minor regulatory changes related to the management of Atlantic HMS. Amendment 7 management measures were developed by NMFS under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) and the Atlantic Tunas Convention Act (ATCA). This final rule: Allocates U.S. bluefin tuna quota among domestic fishing categories; implements measures applicable to the pelagic longline fishery, including Individual Bluefin Quotas (IBQs), two new Gear Restricted Areas, closure of the pelagic longline fishery when annual bluefin tuna quota is reached, elimination of target catch requirements associated with retention of incidental bluefin tuna in the pelagic longline fishery, mandatory retention of legal-sized bluefin tuna caught as bycatch, expanded monitoring requirements, including electronic monitoring via cameras and bluefin tuna catch reporting via Vessel Monitoring System (VMS), and transiting provisions for pelagic and bottom longline vessels; requires VMS use and reporting by the Purse Seine category; changes the start date of the Purse Seine category from July 15 to a date within a range of June 1 to August 15, to be established by an annual action; requires use of the Automated Catch Reporting System by the General and Harpoon categories; provides additional flexibility for inseason adjustment of the General category quota and Harpoon category retention limits; and changes the allocation of the Angling category Trophy South subquota for the Gulf of Mexico. Finally, this rule implements several measures not directly related to bluefin tuna management, including a U.S. North Atlantic albacore tuna quota; modified rules regarding permit category changes; and minor changes in the HMS regulations for administrative or clarification purposes.
Applications and Amendments to Facility Operating Licenses and Combined Licenses Involving Proposed No Significant Hazards Considerations and Containing Sensitive Unclassified Non-Safeguards Information and Order Imposing Procedures for Access to Sensitive Unclassified Non-Safeguards Information
The U.S. Nuclear Regulatory Commission (NRC) received and is considering approval of 4 amendment requests. The amendment requests are for Grand Gulf Nuclear Station, Unit 1; Peach Bottom Atomic Power Station, Units 2 and 3; Vogtle Electric Generating Plant, Units 1 and 2 and Joseph M. Farley Nuclear Plant, Units 1 and 2; and South Texas Project, Units 1 and 2. The NRC proposes to determine that each amendment request involves no significant hazards consideration. In addition, each amendment request contains sensitive unclassified non-safeguards information (SUNSI).
Proposed Information Collection (Appeal to Board of Veterans' Appeals) Activity Comment Request
The Board of Veterans' Appeals (BVA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed revision of a currently approved collection, and allow 60 days for public comment in response to the notice. This notice solicits comments on the information needed to process appeals for denial of VA benefits.
Recommendations for Providers Counseling Male Patients and Parents Regarding Male Circumcision and the Prevention of HIV Infection, STIs, and Other Health Outcomes
The Centers for Disease Control and Prevention (CDC), located within the Department of Health and Human Services (HHS), is seeking public comment on draft recommendations for health care providers who deliver information and counseling about elective male circumcision and the prevention of HIV and other adverse health outcomes to male patients and parents in the United States. The draft recommendations include information about the health benefits and risks of elective male circumcision performed by health care providers.
Airworthiness Directives; Various de Havilland Airplanes
We are adopting a new airworthiness directive (AD) for all Harry E. Williams de Havilland Model DH 82A airplanes, all Cliff Robertson de Havilland Model DH 82A airplanes, and all de Havilland Model DH 83 airplanes. This AD was prompted by reports of structural failure of the attachment of the wing to the fuselage that resulted from failed lateral fuselage tie rods. This AD requires inspecting the aircraft maintenance records to determine the date of installation or the date of last replacement of the lateral fuselage tie rods. This AD also requires repetitively replacing all lateral fuselage tie rods and attaching nuts at a specified life limit interval. We are issuing this AD to correct the unsafe condition on these products.
Airworthiness Directives; Airbus Airplanes
We are superseding Airworthiness Directive (AD) 2013-20-06 for all Airbus Model A340-211, -212, -213, -311, -312, -313, -541, and -642 airplanes. AD 2013-20-06 required revising the maintenance program to incorporate certain maintenance requirements and airworthiness limitations. This new AD requires revising the maintenance or inspection program to incorporate certain other maintenance requirements and airworthiness limitations. This AD was prompted by a determination that existing maintenance requirements are not adequate to address the aging effects of aircraft systems. We are issuing this AD to address the aging effects of aircraft systems. Such aging effects could change the characteristics of systems' life-limited components leading to an increased potential for failure, which, in isolation or in combination with one or more other specific failures or events, could result in failure of certain life limited parts, which could reduce the structural integrity or the controllability of the airplane.
Notice of Initial Determination Revising the List of Products Requiring Federal Contractor Certification as to Forced or Indentured Child Labor Pursuant to Executive Order 13126
This initial determination proposes to revise the list (EO List) required by Executive Order No. 13126 (``Prohibition of Acquisition of Products Produced by Forced or Indentured Child Labor'') in accordance with the Department of Labor's ``Procedural Guidelines for the Maintenance of the List of Products Requiring Federal Contractor Certification as to Forced or Indentured Child Labor'' (the Procedural Guidelines). The EO List identifies products, by their country of origin, that the Department of Labor (DOL), in consultation and cooperation with the Departments of State and Homeland Security (the three Departments), has a reasonable basis to believe might have been mined, produced, or manufactured by forced or indentured child labor. This notice proposes to add one new line item (carpets from India) to the EO List. DOL invites public comment on this initial determination. The three Departments will consider all public comments prior to publishing a final determination revising the EO List.
Airworthiness Directives; The Boeing Company Airplanes
We are superseding Airworthiness Directive (AD) 2008-17-03 for certain The Boeing Company Model 737-100, -200, -200C, -300, -400, and -500 series airplanes. AD 2008-17-03 required repetitive inspections to detect fuselage frame cracking, and corrective action if necessary. AD 2008-17-03 also provided for optional terminating action (repair/ preventive change) for the repetitive inspections. This new AD adds airplanes to the applicability, but does not provide terminating action for the newly added airplanes. This AD was prompted by reports of cracks found at the cutout in the web of body station frame 303.9 inboard of stringer 16L, as well as a new report of cracking found on an airplane not identified in the applicability of AD 2008-17-03. We are issuing this AD to detect and correct fuselage frame cracking, which could prevent the left forward entry door from sealing correctly, and could cause in-flight decompression of the airplane.
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