March 18, 2014 – Federal Register Recent Federal Regulation Documents
Results 101 - 128 of 128
Privacy Act of 1974; System of Records
The Department of the Navy proposes to alter the system of records, N05820-1, entitled ``Foreign Criminal Jurisdiction Files'' in its inventory of record systems subject to the Privacy Act of 1974, as amended. This system will be used by International and Operational Law Division personnel in the performance of their official duties when monitoring and reporting foreign criminal litigation, foreign confinement, and legal hold status of the individuals involved.
Draft Guidance for Industry on Bioavailability and Bioequivalence Studies Submitted in New Drug Applications or Investigational New Drug Applications-General Considerations; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Bioavailability and Bioequivalence Studies Submitted in NDAs or INDsGeneral Considerations'' (draft BA and BE guidance for NDAs). The draft guidance provides recommendations to sponsors and/or applicants planning to include bioavailability (BA) and bioequivalence (BE) information for drug products in investigational new drug applications (INDs), new drug applications (NDAs), and NDA supplements. This draft guidance revises those parts of the March 2003 guidance entitled ``Bioavailability and Bioequivalence Studies for Orally Administered Drug ProductsGeneral Considerations'' relating to BA and BE studies for INDs, NDAs, and NDA supplements.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Agency Information Collection Activities; Proposed Collection; Comment Request; Extension
The FTC intends to ask the Office of Management and Budget (``OMB'') to extend for an additional three years the current Paperwork Reduction Act (``PRA'') clearance for information collection requirements contained in its Funeral Industry Practice Rule (``Funeral Rule'' or ``Rule''). That clearance expires on September 30, 2014.
Agency Information Collection Activities;
In compliance with the Paperwork Reduction Act (PRA) of 1995, the FTC is seeking public comments on its request to OMB for a three- year extension of the current PRA clearance for the information collection requirements contained in the Informal Dispute Settlement Procedures Rule. That clearance expires on March 31, 2014.
Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Fiscal Year 2014 Rates; Quality Reporting Requirements for Specific Providers; Hospital Conditions of Participation; Payment Policies Related to Patient Status; Corrections
This document corrects technical errors in the final rules that appeared in the August 19, 2013 Federal Register titled ``Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Fiscal Year 2014 Rates; Quality Reporting Requirements for Specific Providers; Hospital Conditions of Participation; Payment Policies Related to Patient Status.''
Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long Term Care Hospital Prospective Payment System and Fiscal Year 2013 Rates; Hospitals' Resident Caps for Graduate Medical Education Payment Purposes; Quality Reporting Requirements for Specific Providers and for Ambulatory Surgical Centers; Corrections
This document corrects technical errors that appeared in the final rule that appeared in the August 31, 2012 Federal Register entitled ``Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long Term Care Hospital Prospective Payment System and Fiscal Year 2013 Rates; Hospitals' Resident Caps for Graduate Medical Education Payment Purposes; Quality Reporting Requirements for Specific Providers and for Ambulatory Surgical Centers.''
Pistachios Grown in California, Arizona, and New Mexico; Modification of Aflatoxin Regulations
This proposed rule invites comments on revisions to the aflatoxin sampling regulations currently prescribed under the California, Arizona, and New Mexico pistachio marketing order (order). The order regulates the handling of pistachios grown in California, Arizona, and New Mexico, and is administered locally by the Administrative Committee for Pistachios (Committee). This action would allow the use of mechanical samplers (auto-samplers) for in-line sampling as a method to obtain samples for aflatoxin analysis. The use of auto-samplers is expected to reduce handler costs by providing a more efficient and cost-effective process.
Approval and Promulgation of Implementation Plans; State of Missouri
The Environmental Protection Agency (EPA) is proposing to approve revisions to the Missouri State Implementation Plan (SIP) which were submitted to EPA on July 12, 2012. This submission revises two heavy duty diesel vehicle idling rules that are applicable in Kansas City and St. Louis. This revision provides clarity to the rules in the applicability section by listing owners and operators of passenger load/unload locations where commercial, public and institutional heavy- duty vehicles load or unload passengers. The affected parties were unintentionally omitted from the applicability section of the rule even though they are required to comply with the rule in the general provisions section. These revisions do not have an adverse affect on air quality. EPA's approval of these SIP revisions is being done in accordance with the requirements of the Clean Air Act (CAA).
[EPA-R07-OAR-2013-0817; FRL-9908-02-Region 7] Approval and Promulgation of Implementation Plans; State of Missouri
The Environmental Protection Agency (EPA) is taking direct final action to approve revisions to the Missouri State Implementation Plan (SIP) which were submitted to EPA on July 12, 2012. This submission revises two heavy duty diesel vehicle idling rules that are applicable in Kansas City and St. Louis. This revision provides clarity to the rules in the applicability section by listing owners and operators of passenger load/unload locations where commercial, public and institutional heavy-duty vehicles load or unload passengers. The affected parties were unintentionally omitted from the applicability section of the rule even though they are required to comply with the rule in the general provisions section. These revisions do not have an adverse affect on air quality. EPA's approval of these SIP revisions is being done in accordance with the requirements of the Clean Air Act (CAA).
Agency Information Collection Activities: Proposed Collection Renewal; Comment Request Re: Retail Foreign Exchange Transactions
In accordance with the requirements of the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. chapter 35), the FDIC may not conduct or sponsor, and the respondent is not required to respond to, an information collection unless it displays a currently valid Office of Management and Budget (OMB) control number. As part of its continuing effort to reduce paperwork and respondent burden, the FDIC invites the general public and other Federal agencies to take this opportunity to comment on renewal of its information collection entitled Retail Foreign Exchange Transactions (OMB No. 3064-0182). At the end of the comment period, any comments and recommendations received will be analyzed to determine the extent to which the collection should be modified prior to submission to OMB for review and approval.
Approval and Promulgation of Air Quality Implementation Plans; Virginia; Section 110(a)(2) Infrastructure Requirements for the 2010 Nitrogen Dioxide National Ambient Air Quality Standards
The Environmental Protection Agency (EPA) is approving a State Implementation Plan (SIP) revision submitted by the Commonwealth of Virginia pursuant to the Clean Air Act (CAA). Whenever new or revised National Ambient Air Quality Standards (NAAQS) are promulgated, the CAA requires states to submit a plan for the implementation, maintenance, and enforcement of such NAAQS. The plan is required to address basic program elements, including, but not limited to regulatory structure, monitoring, modeling, legal authority, and adequate resources necessary to assure attainment and maintenance of the standards. These elements are referred to as infrastructure requirements. The Commonwealth of Virginia has made a submittal addressing the infrastructure requirements for the 2010 nitrogen dioxide (NO2) NAAQS.
Approval and Promulgation of Air Quality Implementation Plans; West Virginia; Approval of Redesignation Requests of the West Virginia Portion of the Steubenville-Weirton, OH-WV Nonattainment Area for the 1997 Annual and 2006 24-Hour Fine Particulate Matter Standards
The Environmental Protection Agency (EPA) is approving the State of West Virginia's requests to redesignate to attainment the West Virginia portion of the Steubenville-Weirton, OH-WV nonattainment area (hereafter ``the Steubenville-Weirton Area'' or ``the Area'') for both the 1997 annual and the 2006 24-hour fine particulate matter (PM2.5) National Ambient Air Quality Standards (NAAQS or standards). EPA is also approving as a revision to the West Virginia State Implementation Plan (SIP), the associated maintenance plans to show maintenance of the 1997 annual and the 2006 24-hour PM2.5 NAAQS through 2025 for the West Virginia portion of the Area. West Virginia's maintenance plans include insignificance findings for the mobile source contribution of PM2.5 and nitrogen oxides (NOX) emissions to the West Virginia portion of the Area for both the 1997 annual and 2006 24-hour PM2.5 standards, which EPA agrees with and is approving for transportation conformity purposes. In addition, EPA is approving the 2008 emissions inventory for the West Virginia portion of the Area for the 2006 24- hour PM2.5 NAAQS. EPA has taken a separate rulemaking action to approve the redesignation of the Ohio portion of the Steubenville- Weirton Area for the 1997 annual and 2006 24-hour PM2.5 NAAQS. These actions are being taken under the Clean Air Act (CAA).
Energy Conservation Program: Data Collection and Comparison With Forecasted Unit Sales of Five Lamp Types
The U.S. Department of Energy (DOE) is informing the public of its collection of shipment data and creation of spreadsheet models to provide comparisons between actual and benchmark estimate unit sales of five lamp types (i.e., rough service lamps, vibration service lamps, 3- way incandescent lamps, 2,601-3,300 lumen general service incandescent lamps, and shatter-resistant lamps) that are currently exempt from energy conservation standards. As the actual sales do not exceed the forecasted estimate by 100 percent for any lamp type (i.e., the threshold triggering a rulemaking for an energy conservation standard for that lamp type has not been exceeded), DOE has determined that no regulatory action is necessary at this time. However, DOE will continue to track sales data for these exempted lamps. Relating to this activity, DOE has prepared, and is making available on its Web site, a spreadsheet showing the comparisons of anticipated versus actual sales, as well as the model used to generate the original sales estimates. The spreadsheet is available online: https://www1.eere.energy.gov/buildings/ appliancestandards/product.aspx/productid/63.
IFR Altitudes; Miscellaneous Amendments
This amendment adopts miscellaneous amendments to the required IFR (instrument flight rules) altitudes and changeover points for certain Federal airways, jet routes, or direct routes for which a minimum or maximum en route authorized IFR altitude is prescribed. This regulatory action is needed because of changes occurring in the National Airspace System. These changes are designed to provide for the safe and efficient use of the navigable airspace under instrument conditions in the affected areas.
Safety zone; Sea World San Diego Fireworks, Mission Bay; San Diego, CA
The Coast Guard is establishing a temporary safety zone within the navigable waters of Mission Bay for Sea World firework shows. This temporary safety zone covers four evening events held in March 2014. The temporary safety zones provide for the safety of participants, crew, rescue personnel, and other users of the waterway. Persons and vessels are prohibited from entering into, transiting through, or anchoring within this safety zone unless authorized by the Captain of the Port or his designated representative.
Hazardous Materials: Adoption of Certain Special Permits and Competent Authorities Into Regulations
The Pipeline and Hazardous Materials Safety Administration is amending the Hazardous Materials Regulations (HMR) to adopt provisions contained in certain widely used or longstanding special permits and certain competent authority approvals (``approvals'') that have established safety records. Special permits allow a company or individual to package or ship a hazardous material in a manner that varies from the regulations provided an equivalent level of safety is maintained. An approval is a written consent (document) required under an international standard (i.e., International Maritime Dangerous Goods (IMDG) Code, International Civil Aviation Organization's Technical Instructions for the Safe Transport of Dangerous Goods by Air (ICAO TI)), or is specifically provided for in the HMR, and is issued by the Associate Administrator for Hazardous Materials Safety. These revisions are intended to provide wider access to the regulatory flexibility offered in special permits and approvals and eliminate the need for numerous renewal requests, reducing paperwork burdens and facilitating commerce while maintaining an appropriate level of safety.
Methodology and Formulas for Allocation of Loan and Grant Program Funds
The Rural Business-Cooperative Service (RBS) is proposing to amend its regulations found in 7 CFR part 1940, subpart L for allocating program funds to its State Offices. RBS is proposing to amend 7 CFR part 1940, subpart L to add three programsthe Rural Energy for America Program, the Value-Added Producer Grant program, and the Intermediary Relending Program. In addition, RBS is proposing revisions to its state allocation formulae for existing programs within 7 CFR part 1940, subpart L to account for changes in data reported by the U.S. Bureau of the Census' decennial Census. RBS is also proposing to make various other changes including: revising the weight percentages associated with each of the allocation criteria; providing flexibility in determining when not to make state allocations for a program; restricting the use of the transition formula and changing the limitations on how much program funds can change when the transition formula is used; adding provisions for making state allocation for other RBS programs, including new ones; and providing consistency, where necessary, in the allocation of RBS program funds to State Offices.
Airworthiness Directives; Bombardier, Inc.
We are adopting a new airworthiness directive (AD) for all Bombardier, Inc. Model DHC-8-400 series airplanes. This AD was prompted by a report that a batch of main landing gear (MLG) door actuators with a certain part number having certain serial numbers could be assembled with the scraper installed backward. This AD requires repetitive functional checks of the MLG alternate extension system (AES) and eventual replacement of certain MLG door actuators with actuators that have either been reworked or do not have certain serial numbers. We are issuing this AD to prevent incorrectly installed scrapers, which could hinder the operation of the MLG AES, and result in failure of the MLG AES on one side, and consequent unsafe asymmetrical landing configuration.
Airworthiness Directives; The Boeing Company Airplanes
We are adopting a new airworthiness directive (AD) for all The Boeing Company Model 757 airplanes. This AD was prompted by reports of fractured rudder pedal pushrod connecting bolts in a rudder pedal assembly. This AD requires repetitive replacements of the rudder pedal pushrod connecting bolts and repetitive inspections of the rudder pedal assembly bolt holes in each of the captain and the first officer rudder pedal assemblies, and if necessary, repair or replacement of worn rudder pedal assemblies. We are issuing this AD to prevent fracture of the rudder pedal pushrod connecting bolts during pedal use, which could result in large involuntary inputs to the rudder and nose-wheel steering and an asymmetric application of braking, if pedal brakes are applied, leading to a runway excursion.
Airworthiness Directives; The Boeing Company Airplanes
We are superseding airworthiness directive (AD) 2008-11-04 for all The Boeing Company Model 737-100, -200, -200C, -300, -400, and -500 series airplanes. AD 2008-11-04 required repetitive inspections for cracking in and around the upper and lower hinge cutouts of the forward entry and forward galley service doorways, and corrective actions if necessary. This new AD reduces the inspection threshold for cracking in and around the galley service doorway hinge cutouts, adds inspections of certain repaired structure at the forward entry and galley service doorway upper and lower hinge cutouts, expands the inspection area at the forward entry and galley service doorway upper and lower hinge cutouts, and removes certain airplanes from the applicability. This AD was prompted by multiple reports of cracks in the skin and/or bear strap at the forward galley service doorway hinge cutouts, and multiple reports of cracking under the repairs installed at the hinge cutouts. We are issuing this AD to detect and correct such cracking, which could result in rapid decompression of the airplane.
Airworthiness Directives; The Boeing Company Airplanes
We are superseding Airworthiness Directive (AD) 2004-12-07 for certain The Boeing Company Model 757 series airplanes equipped with Rolls-Royce RB211 engines. AD 2004-12-07 required modification of the nacelle strut and wing structure; and for certain airplanes, repetitive detailed inspections of certain aft bulkhead fasteners for loose or missing fasteners, and corrective action if necessary. For certain other airplanes, AD 2004-12-07 required a one-time detailed inspection of the middle gusset of the inboard side load fitting for proper alignment, and realignment if necessary; a one-time eddy current inspection of certain fastener holes for cracking, and repair if necessary; and a detailed inspection of certain fasteners for loose or missing fasteners, and replacement with new fasteners if necessary. This new AD specifies a maximum compliance time limit. This AD was prompted by reports indicating that the actual operational loads applied to the nacelle are higher than the analytical loads that were used during the initial design. We are issuing this AD to prevent fatigue cracking in primary strut structure and consequent reduced structural integrity of the strut.
Airworthiness Directives; The Boeing Company Airplanes
We are superseding Airworthiness Directive (AD) 2010-15-08 for all The Boeing Company Model 737-100, -200, -200C, -300, -400, and -500 series airplanes. AD 2010-15-08 required repetitive inspections for discrepancies of each carriage spindle of the outboard mid-flaps; repetitive gap checks of the inboard and outboard carriages of the outboard mid-flaps to detect fractured carriage spindles; measuring to ensure that any new or serviceable carriage spindle meets minimum allowable diameter measurements taken at three locations; repetitive inspections, measurements, and overhaul of the carriage spindles; replacement of any carriage spindle when it has reached its maximum life limit; and corrective actions if necessary. This new AD requires reducing the life limit of the carriages, reducing the repetitive interval for certain inspections and gap checks for certain carriages. This new AD also adds an option, for certain replacements, of doing an inspection, and related investigative and corrective actions if necessary. This AD was prompted by a report of failure of both flap carriages. We are issuing this AD to detect and correct cracked, corroded, or fractured carriage spindles, which could lead to severe flap asymmetry, and could result in reduced control or loss of controllability of the airplane.
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