2011 – Federal Register Recent Federal Regulation Documents
Results 51 - 100 of 33,060
Agency Information Collection Activities; Submission for OMB Review; Comment Request; Notice of Controversion of Right to Compensation
The Department of Labor (DOL) is submitting the Office of Workers' Compensation Programs (OWCP) sponsored information collection request (ICR) titled, Notice of Controversion of Right to Compensation,'' to the Office of Management and Budget (OMB) for review and approval for continued use in accordance with the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501 et seq.).
Agency Information Collection Activities; Proposed Collection; Comment Request; Revisions to Labeling Requirements for Blood and Blood Components, Including Source Plasma
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on certain labeling requirements for blood and blood components, including Source Plasma. These requirements will facilitate the use of a labeling system using machine-readable information that would be acceptable as a system for labeling blood and blood components, and the use of new labeling systems that may be developed in the future. Additionally, these requirements are issued to help ensure the continued safety of the blood supply and facilitate consistency in labeling.
Draft Guidance for Industry on Use of Histology in Biomarker Qualification Studies; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Use of Histology in Biomarker Qualification Studies.'' This guidance is intended to assist sponsors that conduct biomarker qualification studies for which histology is a reference standard. This guidance discusses the processes that should be considered to ensure the quality and integrity of histology data in biomarker studies, and outlines the scientific standards for histology used in biomarker characterization and qualification. The recommendations in this guidance are intended for studies in biomarker qualification designated to justify the proposed context of use, where scientifically rigorous evaluation of biomarker performance in relation to histologic changes is essential. The principles outlined in this guidance are also applicable to exploratory biomarker studies.
Oncologic Drugs Advisory Committee; Notice of Meeting
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices: Humanitarian Use Devices
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.
Draft Guidance for Industry on Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices.'' This draft guidance responds to stakeholder requests for specific guidance on FDA's current views on how manufacturers and distributors (firms) of prescription human and animal drug products and medical devices can respond to unsolicited requests for information about unapproved or uncleared indications or conditions of use (off- label information) related to their FDA-approved or cleared products. This draft guidance updates and clarifies FDA's policies on unsolicited requests for off-label information, including those that firms may encounter through emerging electronic media.
Determination That HYCODAN (Hydrocodone Bitartrate and Homatropine Methylbromide) Tablets, 5 Milligrams/1.5 Milligrams, and HYCODAN (Hydrocodone Bitartrate and Homatropine Methylbromide) Oral Solution, 5 Milligrams/5 Milliliters and 1.5 Milligrams/5 Milliliters, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that HYCODAN (hydrocodone bitartrate and homatropine methylbromide) tablets, 5 milligrams (mg)/1.5 mg, and HYCODAN (hydrocodone bitartrate and homatropine methylbromide) oral solution, 5 mg/5 milliliters (mL) and 1.5 mg/5 mL, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for hydrocodone bitartrate and homatropine methylbromide tablets, 5 mg/1.5 mg, and HYCODAN (hydrocodone bitartrate and homatropine methylbromide) oral solution, 5 mg/5 mL and 1.5 mg/5 mL, if all other legal and regulatory requirements are met.
Oncologic Drugs Advisory Committee; Notice of Meeting
Highly Erodible Land and Wetland Conservation
Existing Department of Agriculture (USDA) regulations specify the conditions that may make a producer ineligible for certain USDA benefits, such as disaster assistance payments from the Farm Service Agency (FSA), in certain cases in which agricultural commodities are planted on highly erodible land or a converted wetland, or the production of agricultural commodities on acreage is made possible by the conversion of a wetland. Those regulations also specify the authorized exemptions, which include an exemption based on a ``good faith'' determination. The ``good faith'' provisions in the USDA regulations allow violators of highly erodible land conservation (HELC) or wetland conservation (WC) provisions to retain eligibility for USDA program benefits if certain conditions are met. This rule revises the ``good faith'' provisions in two ways, first, by requiring higher level concurrence within USDA with the good faith determination and second, by reducing the amount of the benefit to be received in an amount commensurate with the seriousness of a HELC violation. These changes to the regulations are made to implement provisions specified in the Food, Conservation, and Energy Act of 2008 (the 2008 Farm Bill).
Design, Inspection, and Testing Criteria for Air Filtration and Adsorption Units
The U.S. Nuclear Regulatory Commission (NRC or the Commission) is issuing for public comment draft regulatory guide (DG), DG-1274, ``Design, Inspection, and Testing Criteria for Air Filtration and Adsorption Units of Postaccident Engineered-Safety-Feature Atmosphere Cleanup Systems in Light-Water-Cooled Nuclear Power Plants.'' This guide applies to the design, inspection, and testing of air filtration and iodine adsorption units of engineered-safety-feature (ESF) atmosphere cleanup systems in light-water-cooled nuclear power plants.
Airworthiness Directives; The Boeing Company Airplanes
We propose to adopt a new airworthiness directive (AD) for certain The Boeing Company Model 777-200 and -300 series airplanes. This proposed AD was prompted by reports of cracked retract actuator fuse pins that can fail earlier than the previously determined safe life limit of the pins. A fractured retract actuator fuse pin can cause the main landing gear (MLG) to extend without restriction and attempt to lock into position under high dynamic loads. This proposed AD would require an inspection for the part number of the fuse pin, and replacement of the pin if necessary. We are proposing this AD to prevent structural damage to the side and drag brace lock assemblies, which could result in landing gear collapse during touchdown, rollout, or taxi.
Procurement List; Proposed Additions and Deletion
The Committee is proposing to add services to the Procurement List that will be provided by nonprofit agencies employing persons who are blind or have other severe disabilities and deletes a service previously provided by such agency. Comments Must Be Received On or Before: 1/30/2012.
Procurement List; Additions
This action adds products and services to the Procurement List that will be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities.
Nomination of Existing Marine Protected Areas to the National System of Marine Protected Areas
In July 2011, NOAA and the Department of the Interior (DOI) invited federal, state, commonwealth, and territorial marine protected area (MPA) programs with potentially eligible existing MPAs to nominate their sites to the National System of MPAs (national system). The national system and the nomination process are described in the Framework for the National System of Marine Protected Areas of the United States (Framework), developed in response to Executive Order 13158 on Marine Protected Areas. The final Framework was published on November 19, 2008, (73 FR 69608) and provides guidance for collaborative efforts among federal, state, commonwealth, territorial, tribal and local governments and stakeholders to develop an effective and well coordinated national system of MPAs that includes existing MPAs meeting national system criteria as well as new sites that may be established by managing agencies to fill key conservation gaps in important ocean areas.
Electronic Delivery of Search Results From the United States Patent and Trademark Office to the European Patent Office
The United States Patent and Trademark Office (USPTO) has recently begun electronic delivery of search results from U.S. patent applications to the European Patent Office (EPO) to assist U.S. applicants who later file in the EPO to comply with amended Rule 141(1) of the EPO's implementing regulations to the European Patent Convention (EPC). As a result, U.S. applicants subject to amended Rule 141(1) EPC will not need to separately file their U.S. search results with the EPO, thereby providing time and cost savings to these applicants.
Extension of Public Scoping Period for the Draft Environmental Impact Statement for Adoption of a Long-term Experimental and Management Plan for the Operation of Glen Canyon Dam
The Department of the Interior, through the Bureau of Reclamation and the National Park Service, is extending the public scoping period for the Draft Environmental Impact Statement (EIS) for Adoption of a Long-term Experimental and Management Plan (LTEMP) for the Operation of Glen Canyon Dam to January 31, 2012. The Notice to Solicit Comments and Hold Public Scoping Meetings was published in the Federal Register on October 17, 2011 (76 FR 64104). The public scoping period was originally scheduled to end on Friday, December 30, 2011.
Notice of Proposals To Engage in or To Acquire Companies Engaged in Permissible Nonbanking Activities
Airworthiness Directives; International Aero Engines AG Turbofan Engines
We propose to supersede an existing airworthiness directive (AD), for all International Aero Engines AG (IAE) V2500-A1, V2525-D5 and V2528-D5 turbofan engines, and certain serial numbers (S/Ns) of IAE V2522-A5, V2524-A5, V2527-A5, V2527E-A5, V2527M-A5, V2530-A5, and V2533-A5 turbofan engines. The existing AD currently requires initial and repetitive on-wing ultrasonic inspections (USIs) of certain high- pressure compressor (HPC) stage 3 to 8 drums, and replacement of drum attachment nuts. This proposed AD would expand the affected population for initial and repetitive on-wing inspections of the HPC stage 3 to 8 drum, introduce an eddy current inspection (ECI) procedure, and require additional cleaning and repetitive on-wing USI or ECI of some HPC stage 3 to 8 drums. We are proposing this AD to prevent failure of the HPC stage 3 to 8 drum, uncontained engine failure, and damage to the airplane.
Central Power & Lime LLC; Notice of Filing
Combined Notice of Filings #1
Prompt Payment Interest Rate; Contract Disputes Act
For the period beginning January 1, 2012, and ending on June 30, 2012, the prompt payment interest rate is 2 per centum per annum.
Notice and Request for Comments
As required by the Paperwork Reduction Act of 1995, 44 U.S.C. 3501-3519 (PRA), the Surface Transportation Board (STB or Board) gives notice that it has submitted a request to the Office of Management and Budget (OMB) for an extension of approval with revision of a currently approved collection: Application to Open a Billing Account. The revision consists of a reduction in burden hours due to the agency's revised estimate of the number of annual respondents. The Board previously published a notice about this collection in the Federal Register on September 30, 2011, at 76 FR 60,964. That notice allowed for a 60-day public review and comment period. No comments were received. The application to open a billing account is described in detail below. Comments may now be submitted to OMB concerning: (1) The accuracy of the Board's burden estimates; (2) ways to enhance the quality, utility, and clarity of the information collected; (3) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology, when appropriate; and (4) whether this collection of information is necessary for the proper performance of the functions of the Board, including whether the collection has practical utility.
Chicago, Central & Pacific Railroad Company-Trackage Rights Exemption-Cedar River Railroad Company
Wage Methodology for the Temporary Non-Agricultural Employment H-2B Program; Delay of Effective Date; Impact on Prevailing Wage Determinations
The Department of Labor (we or the Department), as a result of Congressional appropriations language, recently delayed the effective date of the Wage Methodology for Temporary Non-agricultural Employment H-2B Program Final Rule (the Wage Rule) to January 1, 2012. This Notice provides additional guidance to those employers who have received from the Department either a supplemental or dual prevailing wage determinations based on a previous effective date of the new prevailing wage methodology. This guidance provides additional clarification regarding the wage payment requirements for employers participating in the H-2B Temporary Non-agricultural program.
Release of Waybill Data
Wage Methodology for the Temporary Non-Agricultural Employment H-2B Program; Delay of Effective Date
The Department of Labor (Department) is delaying the effective date of the Wage Methodology for the Temporary Non-agricultural Employment H-2B Program (the Wage Rule) to October 1, 2012 in response to recently enacted legislation that prohibits any funds from being used to implement the Wage Rule for the remainder of fiscal year (FY) 2012. The Wage Rule revised the methodology by which we calculate the prevailing wages to be paid to H-2B workers and United States (U.S.) workers recruited in connection with a temporary labor certification for use in petitioning the Department of Homeland Security to employ a nonimmigrant worker in H-2B status.
Intent To Request Renewal From OMB of One Current Public Collection of Information: Transportation Security Officer (TSO) Medical Questionnaire
The Transportation Security Administration (TSA) invites public comment on one currently approved Information Collection Request (ICR), OMB control number 1652-0032, abstracted below, that we will submit to the Office of Management and Budget (OMB) for renewal in compliance with the Paperwork Reduction Act. The ICR describes the nature of the information collection and its expected burden. The collection involves using a questionnaire to collect medical information from candidates for the job of Transportation Security Officer (TSO) to ensure their qualifications to perform TSO duties pursuant to 49 U.S.C 44965. In certain cases, TSO candidates' health care providers may be asked to complete supplemental forms.
Combined Notice of Filings #1
Combined Notice of Filings
Combined Notice of Filings #1
Combined Notice of Filings #2
Amendments to the Reef Fish, Spiny Lobster, Queen Conch and Coral and Reef Associated Plants and Invertebrates Fishery Management Plans of Puerto Rico and the U.S. Virgin Islands
NMFS issues this final rule to implement Amendment 6 to the Fishery Management Plan (FMP) for the Reef Fish Fishery of Puerto Rico and the U.S. Virgin Islands (Reef Fish FMP), Amendment 5 to the FMP for the Spiny Lobster Fishery of Puerto Rico and the U.S. Virgin Islands (Spiny Lobster FMP), Amendment 3 to the FMP for the Queen Conch Resources of Puerto Rico and the U.S. Virgin Islands (Queen Conch FMP), and Amendment 3 to the FMP for Corals and Reef Associated Plants and Invertebrates of Puerto Rico and the U.S. Virgin Islands (Corals and Reef Associated Plants and Invertebrates FMP). In combination, the amendments represent the 2011 Caribbean ACL Amendment prepared by the Caribbean Fishery Management Council (Council). This final rule will: Establish annual catch limits (ACLs) and accountability measures (AMs) for reef fish, spiny lobster, and aquarium trade species which are not determined to be undergoing overfishing; allocate ACLs among island management areas; establish recreational bag limits for reef fish and spiny lobster; remove eight conch species from the Queen Conch FMP; and establish framework procedures for the Spiny Lobster and Corals and Reef Associated Plants and Invertebrates FMPs. The 2011 Caribbean ACL Amendment will also revise management reference points and status determination criteria for selected reef fish, spiny lobster, and aquarium trade species. The intended effect of the rule is to prevent overfishing of reef fish, spiny lobster, and aquarium trade species while maintaining catch levels consistent with achieving optimum yield (OY).
Airworthiness Directives; Thielert Aircraft Engines GmbH Reciprocating Engines
We are revising an existing airworthiness directive (AD) for Thielert Aircraft Engines GmbH models TAE 125-02-99 and TAE 125-01 reciprocating engines. That AD currently requires replacing the existing rail pressure control valve with an improved rail pressure control valve. This new AD requires the same actions but relaxes the initial compliance time from within 100 flight hours to within 600 flight hours for TAE 125-01 reciprocating engines. This AD was prompted by the determination that our AD was inadvertently more restrictive than European Aviation Safety Agency AD 2008-0128. We are issuing this AD to prevent engine in-flight shutdown, possibly resulting in reduced control of the aircraft.
Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Amendments to the Queen Conch and Reef Fish Fishery Management Plans of Puerto Rico and the U.S. Virgin Islands
NMFS issues this final rule to implement Amendment 2 to the Fishery Management Plan for Queen Conch Resources of Puerto Rico and the U.S. Virgin Islands, and Amendment 5 to the Fishery Management Plan for the Reef Fish Fishery of Puerto Rico and the U.S. Virgin Islands (Amendments 2 and 5), prepared by the Caribbean Fishery Management Council (Council). This final rule: Establishes annual catch limits (ACLs) and accountability measures (AMs) for queen conch and for all reef fish units or sub-units that are classified as undergoing overfishing (i.e., snapper, grouper and parrotfish); allocates ACLs among island management areas; revises the composition of the snapper and grouper complexes; prohibits fishing for and possession of three parrotfish species; establishes recreational bag limits for snappers, groupers, and parrotfishes; and establishes framework procedures for the queen conch and reef fish fishery management plans. Amendments 2 and 5 also revise management reference points and status determination criteria. The intended effect of the rule is to prevent overfishing of queen conch and reef fish species while maintaining catch levels consistent with achieving optimum yield (OY).
Norfolk Southern Railway Company-Abandonment Exemption-in Marietta, Lancaster County, PA
Difenoconazole; Pesticide Tolerances
This regulation establishes tolerances for residues of difenoconazole in or on oat and rye commodities, and wheat, hay. Syngenta Crop Protection, Incorporated requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Cyhalofop-butyl; Pesticide Tolerances
This regulation amends tolerances for residues of cyhalofop- butyl in or on rice, grain and rice, wild, grain. Dow AgroSciences, LLC requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Tepraloxydim; Pesticide Tolerances
This regulation establishes tolerances for residues of tepraloxydim in or on the imported commodities ``Pea and bean, dried shelled, except soybean, subgroup 6C'' and ``Sunflower subgroup 20B''. BASF Corporation requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA). This regulation also removes established tolerances for residues of tepraloxydim on ``Lentil, seed'' and ``Pea, dry, seed,'' as residues on these commodities will be covered by the new tolerance on the pea and bean subgroup (6C).
Approval and Promulgation of Air Quality Implementation Plans; California; Determinations of Failure To Attain the One-Hour Ozone Standard
The EPA is taking final action to determine that three areas in California, previously designated nonattainment for the now-revoked one-hour ozone national ambient air quality standard (NAAQS), did not attain that standard by their applicable attainment dates: the Los Angeles-South Coast Air Basin Area (``South Coast''), the San Joaquin Valley Area (``San Joaquin Valley''), and the Southeast Desert Modified Air Quality Maintenance Area (``Southeast Desert''). These determinations are based on three years of quality-assured and certified ambient air quality monitoring data for the period preceding the applicable attainment deadline.
Amendment of VOR Federal Airways V-320 and V-440; Alaska
This action amends two VHF Omnidirectional Range (VOR) Federal airways in Alaska, V-320 and V-440, due to the relocation of the Anchorage VOR navigation aid. The FAA is taking this action to ensure the continued safe and efficient management of Instrument Flight Rules (IFR) operations within the National Airspace System.
Fisheries of the Northeastern United States; Summer Flounder, Scup, and Black Sea Bass Fisheries; Interim 2012 Summer Flounder, Scup, and Black Sea Bass Specifications; 2012 Research Set-Aside Projects
NMFS is implementing interim catch levels and management measures, called specifications, for the 2012 summer flounder, scup, and black sea bass fisheries, and is also providing notice of projects likely to request research set-aside related to exempted fishing permits. Interim specifications are necessary to ensure that fishing quotas for the summer flounder, scup, and black sea bass fisheries are in place at the start of the fishing year on January 1, 2012, to ensure the three species are not overfished or subject to overfishing in 2012. Notice of exempted fishing permit requests is necessary to allow public comment on the fishing regulation exemptions requested by research set- aside participants.
Receipt of Several Pesticide Petitions Filed for Residues of Pesticide Chemicals in or on Various Commodities
This document announces the Agency's receipt of several initial filings of pesticide petitions requesting the establishment or modification of regulations for residues of pesticide chemicals in or on various commodities.
Pyrethrins/Pyrethroid Cumulative Risk Assessment; Extension of Comment Period
EPA issued a notice in the Federal Register of November 9, 2011, concerning the availability of EPA's cumulative risk assessment for the naturally occurring pyrethrins and synthetic pyrethroid pesticides (often collectively called ``the pyrethroids'') and opened a public comment period on this document and other supporting documents. This notice extends the comment period for 30 days, from January 9, 2012 to February 8, 2012.
Grants for Transportation of Veterans in Highly Rural Areas
The Department of Veterans Affairs (VA) proposes to amend its regulations in part 17 to establish a new program to provide grants to eligible entities to assist veterans in highly rural areas through innovative transportation services to travel to VA medical centers, and to otherwise assist in providing transportation services in connection with the provision of VA medical care to these veterans. This rulemaking is necessary to implement new statutory authority by establishing procedures for evaluating grant applications under the new grant program, and otherwise administering the new grant program. This proposed rule would implement section 307 of title III of the Caregivers and Veterans Omnibus Health Services Act of 2010 (the 2010 Act).
Food Ingredients and Sources of Radiation Listed or Approved for Use in the Production of Meat and Poultry Products; Technical Amendment
This document contains technical amendments to the final labeling regulations that were published in the Federal Register on December 23, 1999. The regulations related to harmonizing and improving the efficiency of the procedures used by the Food Safety and Inspection Service (FSIS) and the Food and Drug Administration (FDA) for reviewing and listing the food ingredients and sources of radiation listed or approved for use in the production of meat and poultry products.
Clinical Laboratory Improvement Advisory Committee (CLIAC)
Hazardous Materials: Harmonization With the United Nations Recommendations on the Transport of Dangerous Goods: Model Regulations, International Maritime Dangerous Goods Code, and the International Civil Aviation Organization Technical Instructions for the Safe Transport of Dangerous Goods by Air
This document responds to administrative appeals, provides clarifications, and corrects typographical and other minor errors adopted in an international harmonization final rule published January 19, 2011 (HM-215K; 76 FR 3308). The final rule amended the Hazardous Materials Regulations (HMR) by revising, removing or adding proper shipping names, the hazard class of a material, packing group assignments, special provisions, packaging authorizations, packaging sections, air transport quantity limitations, and vessel stowage requirements. The amendments were necessary to align the HMR with recent revisions to international standards for the transport of hazardous materials by all modes.
Fisheries of the Northeastern United States; Northeast Multispecies Fishery; Recreational Accountability Measures
This interim final rule implements a possession limit and increases the minimum fish size for haddock caught in the Gulf of Maine by recreational anglers aboard private or charter/party vessels. This action is intended to address an overage of the fishing year 2010 GOM haddock sub-annual catch limit by the recreational fishery, and prevent a similar overage from occurring in the future. NMFS implements this interim final rule pursuant to its authority under the Magnuson-Stevens Fishery Conservation and Management Act and the Northeast Multispecies Fishery Management Plan and its implementing regulations.
Federal Property Suitable as Facilities To Assist the Homeless
This Notice identifies unutilized, underutilized, excess, and surplus Federal property reviewed by HUD for suitability for use to assist the homeless.
Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Comprehensive Ecosystem-Based Amendment 2 for the South Atlantic Region
NMFS issues this final rule to implement the Comprehensive Ecosystem-Based Amendment 2 (CE-BA 2) to implement the following South Atlantic fishery management plan (FMP) amendments: Amendment 1 to the FMP for Pelagic Sargassum Habitat of the South Atlantic Region (Sargassum FMP); Amendment 7 to the FMP for Coral, Coral reefs, and Live/Hard Bottom Habitats of the South Atlantic Region (Coral FMP); and Amendment 25 to the FMP for the Snapper-Grouper Fishery of the South Atlantic Region (Snapper-Grouper FMP), as prepared and submitted by the South Atlantic Fishery Management Council (Council); as well as Amendment 21 to the FMP for Coastal Migratory Pelagic (CMP) Resources (CMP FMP) as prepared and submitted by the South Atlantic and Gulf of Mexico Fishery Management Councils. This rule modifies the fishery management unit (FMU) for octocorals in the South Atlantic exclusive economic zone (EEZ), establishes an annual catch limit (ACL) for octocorals, modifies management in special management zones (SMZs) off South Carolina, and modifies sea turtle and smalltooth sawfish release gear specifications in the South Atlantic region. CE-BA 2 also designates new Essential Fish Habitat (EFH) for Sargassum, and EFH- Habitat Areas of Particular Concern (EFH-HAPCs) for the Snapper- Grouper, Coral FMPs. This rule specifies ACLs for species not undergoing overfishing (octocorals), implements management measures to ensure overfishing does not occur for these species but optimum yield may be achieved, and conserves and protects habitat in the South Atlantic region.