December 13, 2011 – Federal Register Recent Federal Regulation Documents
Results 101 - 143 of 143
Draft Guidance for Industry and Food and Drug Administration Staff on Humanitarian Use Device Designations; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and FDA staff entitled ``Humanitarian Use Device (HUD) Designations.'' Devices are eligible for HUD designation if they are designed to treat or diagnose a disease or condition that affects or is manifested in fewer than 4,000 individuals in the United States per year. Devices that receive HUD designation may be eligible for marketing approval under the Humanitarian Device Exemption (HDE) marketing pathway. This guidance document is intended to assist applicants in the preparation and submission of HUD designation requests and FDA reviewers in evaluating such requests.
Patient Protection and Affordable Care Act; Establishment of Consumer Operated and Oriented Plan (CO-OP) Program
This final rule implements the Consumer Operated and Oriented Plan (CO-OP) program, which provides loans to foster the creation of consumer-governed, private, nonprofit health insurance issuers to offer qualified health plans in the Affordable Insurance Exchanges (Exchanges). The goal of this program is to create a new CO-OP in every State in order to expand the number of health plans available in the Exchanges with a focus on integrated care and greater plan accountability.
Amendment to Agency Rules of Practice
FMCSA proposes to amend its Rules of Practice for Motor Carrier, Intermodal Equipment Provider, Broker, Freight Forwarder, and Hazardous Materials Proceedings in three respects. First, the Agency proposes to clarify that paying the full proposed civil penalty in an enforcement proceeding, either in response to a Notice of Claim (NOC) or later in the proceeding, would not allow respondents to unilaterally avoid an admission of liability for the violations charged. Second, FMCSA proposes to establish procedures for issuing out-of-service orders to motor carriers, intermodal equipment providers, brokers, and freight forwarders it determines are reincarnations of other entities with a history of failing to comply with statutory or regulatory requirements. These procedures would provide for administrative review before the out-of-service order takes effect. Finally, the Agency proposes procedures for consolidating Agency records of reincarnated companies with their predecessor entities.
Proposed Establishment of Class E Airspace; Piseco, NY
This action proposes to establish Class E Airspace at Piseco, NY, to accommodate new Area Navigation (RNAV) Global Positioning System (GPS) Standard Instrument Approach Procedures at Piseco Airport. This action would enhance the safety and airspace management of Instrument Flight Rules (IFR) operations at the airport.
Certain Light-Emitting Diodes and Products Containing Same; Determination Not To Review an Initial Determination Granting-in-Part Complainants' Motion To Amend the Complaint; Notice of Investigation
Notice is hereby given that the U.S. International Trade Commission has determined not to review the presiding administrative law judge's (``ALJ'') initial determination (``ID'') (Order No. 15) granting-in-part the motion of complainants Samsung LED Co., Ltd. of Suwon City, South Korea and Samsung LED America, Inc. of Atlanta, Georgia (collectively ``SLED'') to amend the Complaint and Notice of Investigation (NOI).
New Markets Tax Credit Non-Real Estate Investments; Hearing Cancellation
This document cancels a public hearing on proposed rulemaking providing guidance on which costs incurred by estates or trusts other than grantor trusts (non-grantor trusts) are subject to the 2-percent floor for miscellaneous itemized deductions under section 67(a) of the Internal Revenue Code (Code).
Amendment to and Establishment of Restricted Areas; Warren Grove, NJ
This action establishes two new restricted areas at the Warren Grove Range, NJ. In addition, the using agency for all Warren Grove restricted areas is updated to reflect the current organization tasked with that responsibility. The FAA is taking this action to provide the airspace needed for realistic military training so that aircrews can acquire and maintain proficiency in high altitude weapons employment and other modern tactics.
Proposed Collection; Comment Request for Form 14242
The Department of the Treasury, 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)). Currently, the IRS is soliciting comments concerning Form 14242, Reporting Abusive Tax Promotions or Preparers.
Proposed Collection; Comment Request for Form 1099-MA
The Department of the Treasury, 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)). Currently, the IRS is soliciting comments concerning Form 1098-MA, Mortgage Assistance Payments.
Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB) Review; Comment Request
The U.S. Nuclear Regulatory Commission (NRC) has recently submitted to OMB for review the following proposal for the collection of information under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). The NRC hereby informs potential respondents that an agency may not conduct or sponsor, and that a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The NRC published a Federal Register notice with a 60-day comment period on this information collection on August 23, 2011 (76 FR 52698). 1. Type of submission, new, revision, or extension: Extension. 2. The title of the information collection: NRC Form 483, Registration CertificateIn Vitro Testing with Byproduct Material Under General License. 3. Current OMB approval number: 3150-0038. 4. The form number if applicable: NRC Form 483. 5. How often the collection is required: There is a one-time submittal of information to receive a validated copy of NRC Form 483 with an assigned registration number. In addition, any changes in the information reported on NRC Form 483 must be reported in writing to the NRC within 30 days after the effective date of such change. 6. Who will be required or asked to report: Any physician, veterinarian in the practice of veterinary medicine, clinical laboratory or hospital which desires a general license to receive, acquire, possess, transfer, or use specified units of byproduct material in certain in vitro clinical or laboratory tests. 7. An estimate of the number of annual responses: 87 (7 NRC licensees + 80 Agreement State licensees). 8. The estimated number of annual respondents: 87 (7 NRC licensees + 80 Agreement State licensees). 9. An estimate of the total number of hours needed annually to complete the requirement or request: 12.87 hours (1 hour for NRC licensees + 10.7 hours for Agreement State licensees + 1.17 hours recordkeeping). 10. Abstract: Title 10 of the Code of Federal Regulations (10 CFR) 31.11 establishes a general license authorizing any physician, clinical laboratory, veterinarian in the practice of veterinary medicine, or hospital to possess certain small quantities of byproduct material for in vitro clinical or laboratory tests not involving the internal or external administration of the byproduct material or the radiation there from to human beings or animals. Possession of byproduct material under 10 CFR 31.11 is not authorized until the physician, clinical laboratory, veterinarian in the practice of veterinary medicine, or hospital has filed NRC Form 483 and received from the Commission a validated copy of NRC Form 483 with a registration number. The public may examine and have copied for a fee, publicly available documents, including the final supporting statement, at the NRC's Public Document Room, Room O1-F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland 20874. OMB clearance requests are available at the NRC Web site: https://www.nrc.gov/public-involve/doc- comment/omb/. The document will be available on the NRC home page site for 60 days after the signature date of this notice. Comments and questions should be directed to the OMB reviewer listed below by January 12, 2012. Comments received after this date will be considered if it is practical to do so, but assurance of consideration cannot be given to comments received after this date. Chad Whiteman, Desk Officer, Office of Information and Regulatory Affairs (3150-0038), NEOB-10202, Office of Management and Budget, Washington, DC 20503. Comments can also be emailed to CWhiteman@omb.eop.gov or submitted by telephone at (202) 395-4718. The NRC Clearance Officer is Tremaine Donnell, (301) 415-6258.
Agency Information Collection Activities: Proposed Collection; Comment Request
This document corrects a notice appearing in the Federal Register on November 28, 2011 (76 FR 72983). This action is necessary to correct an erroneous NRC Web site for submission of public comments.
Amendment of Class C Airspace; Palm Beach International Airport, FL
This action modifies the Palm Beach International Airport, FL, Class C airspace area by raising the floor of Class C airspace over Palm Beach County Park Airport. The FAA is taking this action to enhance safety and increase the efficiency of air traffic operations in the Palm Beach, FL, terminal area.
Meeting of Humanities Panel
Pursuant to the provisions of the Federal Advisory Committee Act (Pub. L. 92-463, as amended), notice is hereby given that a meeting of the Humanities Panel will be held at the Old Post Office, 1100 Pennsylvania Avenue NW., Washington, DC 20506.
Proposed Amendment of Class E Airspace; Decatur, IL
This action proposes to amend Class E airspace at Decatur, IL. Additional controlled airspace is necessary to accommodate new Standard Instrument Approach Procedures (SIAP) at Decatur Airport. The geographic coordinates of the airport also would be adjusted. The FAA is taking this action to enhance the safety and management of Instrument Flight Rules (IFR) operations for SIAPs at the airport.
Proposed Amendment of Class E Airspace; Omaha, NE
This action proposes to amend Class E airspace at Omaha, NE. Additional controlled airspace is necessary to accommodate new Standard Instrument Approach Procedures (SIAP) at Eppley Airfield. The FAA is taking this action to enhance the safety and management of Instrument Flight Rules (IFR) operations for SIAPs at the airport.
Proposed Amendment of Class E Airspace; Omaha, NE
This action proposes to amend Class E airspace at Omaha, NE. Additional controlled airspace is necessary to accommodate new Standard Instrument Approach Procedures (SIAP) at Eppley Airfield. The FAA is taking this action to enhance the safety and management of Instrument Flight Rules (IFR) operations for SIAPs at the airport.
Privacy Act of 1974; System of Records
The Department of the Air Force proposes to alter a system of records to its inventory of record systems subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended.
Notice of Final Federal Agency Actions on Proposed Highway in Utah
This notice announces actions taken by the FHWA that are final within the meaning of 23 U.S.C. 139(l)(1). The actions relate to a proposed transportation corridor project (Hyde Park to North Logan Transportation Corridor) in Cache County in the State of Utah. Those actions grant licenses, permits, and approvals for the project.
Financial Management Service; Proposed Collection of Information: Request for Payment of Federal Benefit by Check, EFT Waiver Form
The Financial Management Service, 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 a continuing information collection. By this notice, ``Request for Payment of Federal Benefit by Check, EFT Waiver Form.''
Surety Companies Acceptable on Federal Bonds: Aspen American Insurance Company
This is Supplement No. 3 to the Treasury Department Circular 570, 2011 Revision, published July 1, 2011, at 76 FR 38892.
Airworthiness Directives; Turbomeca S.A. Turboshaft Engines
We propose to supersede an existing airworthiness directive (AD) that applies to Turbomeca S.A. Arrius 2F turboshaft engines with P3 air pipe (first section) part number (P/N) 0 319 71 918 0, installed. The existing AD currently requires inspections of the P3 air pipe (first section) and right-hand (RH) rear half-wall for proper clearance, and readjustment of the pipe if necessary. Since we issued that AD, Turbomeca S.A. has redesigned the RH rear half-wall to ensure sufficient clearance between the P3 air pipe (first section) and RH rear half-wall. This proposed AD would require the same inspections for installed engines, eliminate readjusting of the P3 air pipe (first section), require replacement of the RH rear half-wall under certain conditions, and adding an optional terminating action. We are proposing this AD to prevent an uncommanded power loss to flight idle, which could result in an emergency autorotation landing or accident.
Airworthiness Directives; Turbomeca Arriel 1 Series Turboshaft Engines
We are revising an existing airworthiness directive (AD) for the products listed above. This AD was prompted by Turbomeca restoring all or part of the life limits of the affected discs, and European Aviation Safety Agency's (EASA) issuance of AD 2010-0101R2, dated March 24, 2011, to do the same. Turbomeca has introduced a reinforced eddy- current inspection (ECI) which, combined with a revised analysis, allows the life limit of the affected discs to be extended. We are issuing this revision to prevent failure of the gas generator (GG) second stage turbine disc which could result in the release of high energy debris and damage to the helicopter.
Airworthiness Directives; Continental Motors, Inc. (CMI) Reciprocating Engines
We are adopting a new airworthiness directive (AD) for certain Continental Motors, Inc. (CMI) models TSIO-520, TSIO-550-K, TSIOF-550K, and IO-550-N series reciprocating engines. This emergency AD was sent previously to all known U.S. owners and operators of these engines. This AD requires replacing affected CMI starter adapters with starter adapters eligible for installation. This AD was prompted by 5 reports received of fractures in starter adapter shaft gears in certain part number (P/N) CMI starter adapters. We are issuing this AD to prevent failure of the starter adapter gear shaft, leading to an inoperable oil scavenge pump and engine in-flight shutdown.
Privacy Act of 1974, as Amended; System of Records
Pursuant to the provisions of the Privacy Act of 1974, as amended, 5 U.S.C. 552a(e)(4) and OMB Circular A-130, the Federal Deposit Insurance Corporation (``FDIC'') has conducted required reviews of its systems of records and is publishing this notice regarding its proposal to introduce two new systems of records, alter four existing systems of records, and to incorporate minor editorial and administrative changes in other existing systems of records that do not meet the threshold criteria established by the Office of Management and Budget for either a new or altered system of records. We hereby publish this notice for comment on the proposed actions.
Coordination of Federal Authorizations for Electric Transmission Facilities
The Department of Energy (DOE) proposes to amend its regulations for the timely coordination of Federal authorizations for proposed interstate electric transmission facilities pursuant to section 216(h) of the Federal Power Act (FPA). The proposed rule would require permitting entities to inform DOE of requests for authorizations required under Federal law for Qualifying Projects as defined in the rule, as well as establish a process whereby applicants for Federal authorizations for interstate electric transmission facilities that are not Qualifying Projects can request DOE assistance in the Federal authorization process. Also, the proposed rule provides for the selection of a Federal Lead Agency responsible for compiling a single environmental review document, and a consolidated administrative record, for Qualifying Projects. In addition, the proposed rule provides for the establishment of intermediate and final deadlines for the review of Federal authorization decisions, as well as establishing a date certain after which all permit decisions and related environmental reviews under all applicable Federal laws shall be completed within one year, or as soon thereafter as practicable in compliance with Federal law.
Proposed Exemptions From Certain Prohibited Transaction Restrictions
This document contains notices of pendency before the Department of Labor (the Department) of proposed exemptions from certain of the prohibited transaction restrictions of the Employee Retirement Income Security Act of 1974 (ERISA or the Act) and/or the Internal Revenue Code of 1986 (the Code). This notice includes the following proposed exemptions: D-11517, JPMorgan Chase & Co. and its Current and Future Affiliates and Subsidiaries (JPMorgan Chase); D- 11579, Delaware Charter Guarantee & Trust Co. d\b\a\ Principle Trust Company (Principle Trust); D-11628, Aztec Well Servicing Company and Related Companies Medical Plan Trust Fund (the Plan); D-11669, Genzyme Corporation 401(k) Plan (the Plan or the Applicant); and Retirement Program for Employees of EnPro Industries (the Plan), D-11662 et al.
Gettysburg National Military Park Advisory Commission
This notice sets forth the dates of April 19, 2012 and September 6, 2012 of the Gettysburg National Military Park Advisory Commission.
Office of Hazardous Materials Safety; Notice of Applications for Modification of Special Permit
In accordance with the procedures governing the application for, and the processing of, special permits from the Department of Transportation's Hazardous Material Regulations (49 CFR part 107, subpart B), notice is hereby given that the Office of Hazardous Materials Safety has received the applications described herein. This notice is abbreviated to expedite docketing and public notice. Because the sections affected, modes of transportation, and the nature of application have been shown in earlier Federal Register publications, they are not repeated here. Requests for modification of special permits (e.g. to provide for additional hazardous materials, packaging design changes, additional mode of transportation, etc.) are described in footnotes to the application number. Application numbers with the suffix ``M'' denote a modification request. These applications have been separated from the new application for special permits to facilitate processing.
Office of Hazardous Materials Safety; Notice of Application for Special Permits
In accordance with the procedures governing the application for, and the processing of, special permits from the Department of Transportation's Hazardous Material Regulations (49 CFR part 107, subpart B), notice is hereby given that the Office of Hazardous Materials Safety has received the application described herein. Each mode of transportation for which a particular special permit is requested is indicated by a number in the ``Nature of Application'' portion of the table below as follows: 1Motor vehicle, 2Rail freight, 3Cargo vessel, 4Cargo aircraft only, 5Passenger-carrying aircraft.
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 baggage door lockpins not engaging properly and the baggage door open light illuminating when the baggage door is not open, which could lead to the pilot disregarding a valid warning. We are issuing this AD to require actions to address the unsafe condition on these products.
Airworthiness Directives; The Boeing Company Airplanes
We are superseding an existing airworthiness directive (AD) for all The Boeing Company 757-200, 757-200PF, 757-200CB, 757-300, 767- 200, 767-300, and 767-300F series airplanes. That AD currently requires revising the Limitations section of the airplane flight manual (AFM) to advise the flightcrew of procedures to follow to ensure that a fuel filter impending bypass condition due to gross fuel contamination is detected in a timely manner. This new AD requires installing new operating program software (OPS) (Version 7) of the engine indication and crew alerting system (EICAS) in the EICAS computers. This AD also requires various concurrent actions. This AD also retains the existing AD provision that relieves certain airplanes (those equipped with certain EICAS OPS versions) from the requirements. Accomplishment of the new actions terminates the requirements of the existing AD. This AD was prompted by an error in the EICAS OPS. The error prevents the display of an advisory message to the flightcrew of a left engine fuel filter contamination and imminent bypass condition, which may indicate an imminent multiple engine thrust loss or engine malfunction event due to fuel contamination. We are issuing this AD to correct the unsafe condition on these products.
Airworthiness Directives; BAE Systems (Operations) Limited Airplanes
We are adopting a new airworthiness directive (AD) for all BAE Systems (Operations) Limited Model 4101 airplanes. This AD results from mandatory continuing airworthiness information (MCAI) originated 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:
Airworthiness Directives; The Boeing Company Airplanes
We are adopting a new airworthiness directive (AD) for certain The Boeing Company Model MD-11 and MD-11F airplanes. This AD was prompted by a report that the rub strips attached to the horizontal stabilizer front spar access door location were manufactured improperly using anodized aluminum. This AD requires replacing the anodized rub strips with new alodined rub strips to prevent inadequate electrical bonding between the rub strips and the fuel access door, which can contribute to possible ignition of flammable fuel vapor in the tail fuel tank as a result of a lightning strike. We are issuing this AD to correct the unsafe condition on these products.
Airworthiness Directives; Apical Industries, Inc., (Apical) Emergency Float Kits
This amendment adopts a new airworthiness directive (AD) for the Apical emergency float kits installed on certain model helicopters under supplemental type certificates. This AD requires adding placards on each side of the fuselage to identify the location and operation of the liferaft external inflation handle. This AD also requires replacing each liferaft operation placard to state that external liferafts are installed. This amendment is prompted by a report of a helicopter that crashed into the water, and the pilot did not deploy the floats and liferafts. Two external T-handles were available for deployment of the liferafts but were not used by the passengers because they were unaware of their location. The actions specified by this AD are intended to prevent helicopter occupants from further injury due to unnecessary exposure to harsh water conditions and to aid in deploying liferafts when liferafts are available on the helicopter and can be activated after a water landing.
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