February 2012 – Federal Register Recent Federal Regulation Documents

Results 351 - 400 of 2,339
Environmental Impacts Statements; Notice of Availability
Document Number: 2012-4331
Type: Notice
Date: 2012-02-24
Agency: Environmental Protection Agency
Small Business Size Standards: Transportation and Warehousing
Document Number: 2012-4330
Type: Rule
Date: 2012-02-24
Agency: Small Business Administration, Agencies and Commissions
The United States Small Business Administration (SBA) is increasing the small business size standards for 22 industries in North American Industry Classification System (NAICS) Sector 48-49, Transportation and Warehousing, and retaining the current standards for the remaining 37 industries in that Sector. As part of its ongoing comprehensive review of all size standards, SBA has evaluated all receipts based standards for industries in NAICS Sector 48-49 to determine whether they should be retained or revised. SBA did not review the employee based standards for industries in NAICS Sector 48- 49, but will do so at a later date with other employee based size standards.
Small Business Size Standards: Health Care and Social Assistance
Document Number: 2012-4329
Type: Proposed Rule
Date: 2012-02-24
Agency: Small Business Administration, Agencies and Commissions
The U.S. Small Business Administration (SBA) proposes to increase small business size standards for 28 industries in North American Industry Classification System (NAICS) Sector 62, Health Care and Social Assistance. As part of its ongoing comprehensive review of all size standards, SBA has evaluated all size standards in NAICS Sector 62 to determine whether the existing size standards should be retained or revised. This proposed rule is one of a series of proposed rules that will review size standards of industries grouped by NAICS Sector. SBA issued a White Paper entitled ``Size Standards Methodology'' and published a notice in the October 21, 2009 issue of the Federal Register that the ``Size Standards Methodology'' White Paper was available on its Web site at www.sba.gov/size for public review and comments (74 FR 53940). The ``Size Standards Methodology'' White Paper explains how SBA establishes, reviews, and modifies its receipts based and employee based small business size standards. In this proposed rule, SBA has applied its methodology that pertains to establishing, reviewing, and modifying a receipts based size standard.
Mortgagee Review Board: Administrative Actions
Document Number: 2012-4328
Type: Notice
Date: 2012-02-24
Agency: Department of Housing and Urban Development
In compliance with Section 202(c)(5) of the National Housing Act, this notice advises of the cause and description of administrative actions taken by HUD's Mortgagee Review Board against HUD-approved mortgagees.
Approval and Promulgation of Implementation Plans; State of Alaska; Regional Haze State Implementation Plan
Document Number: 2012-4326
Type: Proposed Rule
Date: 2012-02-24
Agency: Environmental Protection Agency
EPA is proposing to approve a State Implementation Plan (SIP) revision, submitted by the State of Alaska on April 4, 2011, as meeting the requirements of Clean Air Act (CAA) sections169A and 169B, and Federal Regulations 40 CFR 51.308, to implement a regional haze program in the State of Alaska for the first planning period through July 31, 2018. This revision addresses the requirements of the Clean Air Act (CAA) and EPA's rules that require states to prevent any future and remedy any existing anthropogenic impairment of visibility in mandatory Class I areas caused by emissions of air pollutants from numerous sources located over a wide geographic area (also referred to as the ``regional haze program''). Additionally, EPA proposes to approve the Alaska Department of Environmental Conservation Best Available Retrofit Technology regulations at 18 AAC 50.260.
Assessment of Potential Large-Scale Mining on the Bristol Bay Watershed of Alaska: Nomination of Peer Reviewers
Document Number: 2012-4325
Type: Notice
Date: 2012-02-24
Agency: Environmental Protection Agency
EPA anticipates releasing a draft report for public comment and external peer review describing impacts associated with potential large-scale mining development in the Nushagak and Kvichak watersheds of Bristol Bay, Alaska. An external, independent panel of experts will be formed to review and provide comments on EPA's draft report. EPA invites the public to nominate qualified experts to be considered for this external peer review panel.
Order Approving Application Regarding Proposed Corporate Merger and Indirect Transfer of Licenses
Document Number: 2012-4323
Type: Notice
Date: 2012-02-24
Agency: Nuclear Regulatory Commission, Agencies and Commissions
Notice of Proposed Reinstatement of Terminated Oil and Gas Lease COC73670
Document Number: 2012-4322
Type: Notice
Date: 2012-02-24
Agency: Department of the Interior, Bureau of Land Management
Under the provisions of 30 U.S.C. 188(d) and (e), and 43 CFR 3108.2-3(a) and (b)(1), the Bureau of Land Management (BLM) received a petition for reinstatement of oil and gas lease COC73670 from Hannon & Associates Inc., for lands in Huerfano County, Colorado. The petition was filed on time and was accompanied by all the rentals due since the date the lease terminated under the law.
Fluopyram; Pesticide Tolerances
Document Number: 2012-4321
Type: Rule
Date: 2012-02-24
Agency: Environmental Protection Agency
This regulation establishes tolerances for residues of fluopyram in or on multiple commodities which are identified and discussed later in this document. Bayer Crop Science requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).
Proposed Confidentiality Determinations for the Petroleum and Natural Gas Systems Source Category, and Amendments to Table A-7, of the Greenhouse Gas Reporting Rule
Document Number: 2012-4320
Type: Proposed Rule
Date: 2012-02-24
Agency: Environmental Protection Agency
This action re-proposes confidentiality determinations for the data elements in subpart W, the petroleum and natural gas systems category, of the Mandatory Reporting of Greenhouse Gases Rule. On July 7, 2010, the EPA proposed confidentiality determinations for then- proposed subpart W data elements and is now issuing this re-proposal due to significant changes to certain data elements in the final subpart W reporting requirements. The EPA is also proposing to assign 10 recently added reporting elements as ``Inputs to Emission Equations'' and to defer their reporting deadline to March 31, 2015, consistent with the agency's approach in the August 25, 2011 rule which finalized the deferral of some reporting data elements that are inputs to emissions equations.
Defense Federal Acquisition Regulation Supplement; Technical Amendment
Document Number: 2012-4319
Type: Rule
Date: 2012-02-24
Agency: Defense Acquisition Regulations System, Department of Defense
DoD is making technical amendments to the Defense Federal Acquisition Regulation Supplement (DFARS) to provide needed editorial changes.
Proposed Approval of the Central Characterization Project's Remote-Handled Transuranic Waste Characterization Program at the Savannah River Site
Document Number: 2012-4318
Type: Notice
Date: 2012-02-24
Agency: Environmental Protection Agency
The Environmental Protection Agency (EPA) is announcing the availability of, and soliciting public comments for 45 days on, the proposed approval of the radioactive, remote-handled (RH), transuranic (TRU) waste characterization program implemented by the Central Characterization Project (CCP) at the Savannah River Site (SRS) in Aiken, South Carolina. This waste is intended for disposal at the Waste Isolation Pilot Plant (WIPP) in New Mexico. In accordance with the WIPP Compliance Criteria, EPA evaluated the characterization of RH TRU debris waste from SRS-CCP during an inspection on August 30-September 1, 2011, with a follow-up inspection on December 6-7, 2011, at SRS. Using the systems and processes developed as part of the U.S. Department of Energy's (DOE's) Carlsbad Field Office (CBFO) program, EPA verified whether DOE could adequately characterize RH TRU waste consistent with the Compliance Criteria. The results of EPA's evaluation of SRS-CCP's RH program and its proposed approval are described in the Agency's inspection report, which is available for review in the public dockets listed in ADDRESSES. EPA will consider public comments received on or before the due date mentioned in DATES. This notice summarizes the waste characterization processes evaluated by EPA and EPA's proposed approval. As required by the 40 CFR 194.8, at the end of a 45-day comment period EPA will evaluate all relevant public comments and revise the inspection report as necessary. If appropriate, the Agency will then issue a final approval letter and inspection report.
Request for Comments on a New Information Collection
Document Number: 2012-4317
Type: Notice
Date: 2012-02-24
Agency: Department of Transportation
In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), this notice announces that the Information Collection Request (ICR) abstracted below is being forwarded to the Office of Management and Budget (OMB) for review and comments. A Federal Register Notice with a 60-day comment period soliciting comments on the following information collection was published on August 23, 2011 (76 FR 52731).
Notice Seeking Comment on the Extractive Industries Transparency Initiative
Document Number: 2012-4316
Type: Notice
Date: 2012-02-24
Agency: Department of the Interior
The Department of the Interior (Department) requests comments and suggestions from affected parties and the interested public prior to convening a multi-stakeholder group tasked to implement the Extractive Industries Transparency Initiative (EITI). This notice solicits comments and suggestions for review by a third party neutral facilitator for possible stakeholders who should be considered for inclusion in the multi-stakeholder group. Getting feedback upfront and involving all affected stakeholders in the EITI process are the hallmarks of good government and smart business practice. Additionally, this notice seeks comments for the facilitator on effective and productive processes for convening the multi-stakeholder group. Finally, this notice seeks comments and suggestions for the facilitator for effective collaboration by the multi-stakeholder group in order to implement EITI. The Department will announce any public listening sessions in a future Federal Register notice.
License Renewal Application for Callaway Plant, Unit 1, Union Electric Company
Document Number: 2012-4315
Type: Notice
Date: 2012-02-24
Agency: Nuclear Regulatory Commission, Agencies and Commissions
Union Electric Company, a subsidiary of Ameren Corporation and doing business as Ameren Missouri (Ameren), has submitted to the U.S. Nuclear Regulatory Commission (NRC) an application for renewal of Facility Operating License NPF-30 for an additional 20 years of operation at Callaway Plant, Unit 1 (Callaway). Callaway is located in Callaway County, MO. The current operating license for Callaway expires on October 18, 2024.
Announcement of Competition Under the America COMPETES Reauthorization Act of 2011: Badges for Veterans Contest
Document Number: 2012-4314
Type: Notice
Date: 2012-02-24
Agency: Department of Veterans Affairs
To encourage creation of systems which help good jobs find Veterans and Veterans find good jobs, the Secretary of Veterans Affairs (VA) announces a prize contest under Section 105 of the America COMPETES Reauthorization Act of 2011, Public Law 111-358 (2011) (the ``Act'').
Intent To Prepare a Draft Environmental Impact Statement/Environmental Impact Report for the Proposed Cambria Water Supply Project, San Luis Obispo County, CA
Document Number: 2012-4313
Type: Notice
Date: 2012-02-24
Agency: Department of Defense, Department of the Army, Corps of Engineers
The Los Angeles District of the U.S. Army Corps of Engineers (Corps) and Cambria Community Services District (CCSD), the non-Federal sponsor under a Project Cooperation Agreement dated March 27, 2006, intend to jointly prepare an Environmental Impact Statement/ Environmental Impact Report (EIS/EIR) to study, plan, and implement a project to provide for a reliable water supply for the community of Cambria in San Luis Obispo County. The relatively remote location of Cambria has resulted in the area relying solely upon local groundwater for its current water supply. The groundwater supplies from the Santa Rosa and San Simeon groundwater basins no longer are adequate to meet existing demand under extreme drought conditions or to meet projected future demand in most years.
Procurement List; Proposed Additions
Document Number: 2012-4312
Type: Notice
Date: 2012-02-24
Agency: Committee for Purchase From People Who Are Blind or Severely Disabled, Agencies and Commissions
The Committee is proposing to add a product and service to the Procurement List that will be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities. Comments Must Be Received on or Before: 3/26/2012.
Procurement List; Additions and Deletions
Document Number: 2012-4311
Type: Notice
Date: 2012-02-24
Agency: Committee for Purchase From People Who Are Blind or Severely Disabled, Agencies and Commissions
This action adds services to the Procurement List that will be provided by nonprofit agencies employing persons who are blind or have other severe disabilities, and deletes products and services from the Procurement List previously furnished by such agencies.
Government-Owned Inventions; Availability for Licensing
Document Number: 2012-4310
Type: Notice
Date: 2012-02-24
Agency: Department of Health and Human Services, National Institutes of Health
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Renewal of Facility Operating License No. NPF-30, Union Electric Company, Callaway Plant, Unit 1
Document Number: 2012-4309
Type: Notice
Date: 2012-02-24
Agency: Nuclear Regulatory Commission, Agencies and Commissions
The U.S. Nuclear Regulatory Commission (NRC or the Commission) is considering an application for the renewal of an operating license, which authorizes Union Electric Company to operate the Callaway Plant, Unit 1 (Callaway), at 3565 megawatts thermal. The renewed license would authorize the applicant to operate Callaway for an additional 20 years beyond the period specified in the current license. Callaway is located in Callaway County, Missouri and its current operating license expires on October 18, 2024.
Proposed Agency Information Collection
Document Number: 2012-4308
Type: Notice
Date: 2012-02-24
Agency: Department of Energy
The Department of Energy (DOE) invites public comment on a proposed collection of information that DOE is developing for submission to the Office of Management and Budget (OMB) pursuant to the Paperwork Reduction Act of 1995. Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.
Revised Notice of Intent To Prepare a Draft Environmental Impact Statement for the Brunswick County Beaches, NC, Coastal Storm Damage Reduction Project
Document Number: 2012-4307
Type: Notice
Date: 2012-02-24
Agency: Department of Defense, Department of the Army, Corps of Engineers
The U.S. Army Corps of Engineers (USACE), Wilmington District (Corps) is currently conducting a General Reevaluation Report (GRR) for the Brunswick County Beaches, NC, Coastal Storm Damage Reduction (CSDR) Project. The Corps intends to prepare a Draft Environmental Impact Statement (DEIS) to evaluate the impacts of the proposed CSDR alternatives to reduce coastal storm damages from beach erosion in the towns of Holden Beach, Oak Island, and Caswell Beach, North Carolina. An array of structural, non-structural, and no action alternatives are being evaluated. Current analyses suggest that the dune and berm beach fill alternative maximizes net CSDR benefits for the project area beaches and provides additional environmental and recreation benefits. An offshore borrow area has been identified within the Southwestern portion of Frying Pan Shoals (FPS) (located off the coast of Cape Fear, North Carolina) to provide beach compatible sediment for the 50-year life of the project. The DEIS is being prepared in accordance with the requirements of the National Environmental Policy Act (NEPA) of 1969, as amended, and will address the relationship of the proposed action to all other applicable Federal and State Laws and Executive Orders.
Notice of Proposal Review Meetings
Document Number: 2012-4306
Type: Notice
Date: 2012-02-24
Agency: National Science Foundation, Agencies and Commissions
Intent To Prepare a Draft Environmental Impact Statement (EIS) for the Installation of a Terminal Groin Structure at Lockwood Folly Inlet and to Conduct Supplemental Beach Nourishment Along the Eastern Oceanfront Shoreline of Holden Beach, in Brunswick County, NC
Document Number: 2012-4305
Type: Notice
Date: 2012-02-24
Agency: Department of Defense, Department of the Army, Corps of Engineers
The U.S. Army Corps of Engineers (USACE), Wilmington District, Wilmington Regulatory Field Office has received a request for Department of the Army authorization, pursuant to Section 404 of the Clean Water Act and Section 10 of the Rivers and Harbor Act, from the Town of Holden Beach to develop and implement a shoreline protection plan that includes the installation of a terminal groin structure on the west side of Lockwood Folly Inlet (a federally maintained navigational channel) and the nourishment of the oceanfront shoreline along the eastern end of Holden Beach.
Army Education Advisory Committee Meeting
Document Number: 2012-4304
Type: Notice
Date: 2012-02-24
Agency: Department of Defense, Department of the Army
Pursuant to the Federal Advisory Committee Act of 1972 (5 U.S.C., Appendix, as amended), the Sunshine in the Government Act of 1976 (U.S.C. 552b, as amended) and 41 Code of the Federal Regulations (CFR 102-3. 140 through 160, the Department of the Army announces the following committee meeting: Name of Committee: Army Education Advisory Committee (AEAC). Date of Meeting: March 14-15, 2012. Time of Meeting: 0800-1600. Place of Meeting: Deputy Chief of Staff G-3/5/7 Conference Room, 950 Jefferson Ave., Building 950, 3rd Floor, Ft. Eustis, VA. Proposed Agenda: Purpose of the meeting is to gather and review information, discuss, and deliberate issues related to shifting Army training from an instructor-centric to a learner-centric paradigm required by the Army 2020 learning environment. The agenda will include topics relating Arm Learning Model 2015 and to support context-based, collaborative, problem-centered instruction.
Combined Notice of Filings #1
Document Number: 2012-4303
Type: Notice
Date: 2012-02-24
Agency: Department of Energy, Federal Energy Regulatory Commission
Reactive Power Resources; Notice of Technical Conference
Document Number: 2012-4302
Type: Notice
Date: 2012-02-24
Agency: Department of Energy, Federal Energy Regulatory Commission
Combined Notice of Filings #2
Document Number: 2012-4301
Type: Notice
Date: 2012-02-24
Agency: Department of Energy, Federal Energy Regulatory Commission
Cedar River Railroad Company-Trackage Rights Exemption-Chicago, Central & Pacific Railroad Company
Document Number: 2012-4300
Type: Notice
Date: 2012-02-24
Agency: Surface Transportation Board, Department of Transportation
Request for Comments of a Previously Approved Information Collection
Document Number: 2012-4299
Type: Notice
Date: 2012-02-24
Agency: Department of Transportation
In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), this notice announces that the Information Collection Request (ICR) abstracted below is being forwarded to the Office of Management and Budget (OMB) for review and comments. A Federal Register Notice with a 60-day comment period soliciting comments on the following information collection was published on September 16, 2011 (76 FR 57795).
Request for Comments of a Reinstatement of a Previously Approved Information Collection
Document Number: 2012-4298
Type: Notice
Date: 2012-02-24
Agency: Department of Transportation
In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), this notice announces that the Information Collection Request (ICR) abstracted below is being forwarded to the Office of Management and Budget (OMB) for review and comments. A Federal Register Notice with a 60-day comment period soliciting comments on the following information collection was published on November 8, 2011 (76 FR 69320). No comments were received.
Yokohama Tire Corporation, Denial of Petition for Decision of Inconsequential Noncompliance
Document Number: 2012-4297
Type: Notice
Date: 2012-02-24
Agency: National Highway Traffic Safety Administration, Department of Transportation
Yokohama Tire Corporation, (YTC),\1\ replacement tires for passenger cars, manufactured between December 2, 2007, and September 19, 2009, failed to comply with paragraph S5.5.1(b) of Federal Motor Vehicle Safety Standard (FMVSS) No. 139, New Pneumatic Radial Tires for Light Vehicles. YTC has filed an appropriate report pursuant to 49 CFR Part 573, Defect and Noncompliance Responsibility and Reports (dated January 19, 2010).
Yokohama Tire Company, Denial of Petition for Decision of Inconsequential Noncompliance
Document Number: 2012-4296
Type: Notice
Date: 2012-02-24
Agency: National Highway Traffic Safety Administration, Department of Transportation
Yokohama Tire Company (YTC),\1\ has determined that certain P215/60R15 93H AVID H4S passenger car replacement tires failed to comply with paragraph S5.5.1 of Federal Motor Vehicle Safety Standard (FMVSS) No. 139, New Pneumatic Radial Tires for Light Vehicles. YTC has filed an appropriate report pursuant to 49 CFR Part 573, Defect and Noncompliance Responsibility and Reports (dated January 21, 2010).
Notice of a Change in Status of an Extended Benefit (EB) Period for Maine and Michigan
Document Number: 2012-4295
Type: Notice
Date: 2012-02-24
Agency: Employment and Training Administration, Department of Labor
This notice announces a change in status of payable periods under the EB program for Maine and Michigan. The following changes have occurred since the publication of the last notice regarding these States' EB status: Based on data released by the Bureau of Labor Statistics on January 24, 2012, Maine and Michigan do not meet one of the necessary criteria to remain on in the EB program: Having a TUR trigger rate at least ten percent greater than the rate for a comparable period in any of the three prior years. This triggered Maine and Michigan ``off'' the EB program with the week ending January 28, 2012. The end of the payable period in both states in the EB program will be February 18, 2012. The trigger notice covering state eligibility for the EB program can be found at: https://ows.doleta.gov/unemploy/claims_arch.asp.
Notice of a Change in Status of the Payable Periods in the Emergency Unemployment Compensation 2008 (EUC08) Program for Connecticut and Missouri
Document Number: 2012-4294
Type: Notice
Date: 2012-02-24
Agency: Employment and Training Administration, Department of Labor
This notice announces a change in status of the payable periods in the Emergency Unemployment Compensation 2008 (EUC08) program for Connecticut and Missouri. Public Law 111-312 extended provisions in Public Law 111-92 which amended prior laws to create a Third and Fourth Tier of benefits within the EUC08 program for qualified unemployed workers claiming benefits in high unemployment states. The Department of Labor produces a trigger notice indicating which states qualify for EUC08 benefits within Tiers Three and Four and provides the beginning and ending dates of payable periods for each qualifying state. The trigger notice covering state eligibility for the EUC08 program can be found at: https:// ows.doleta.gov/unemploy/claimsarch.asp. The following changes have occurred since the publication of the last notice regarding these States' EUC08 status: Based on data released by the Bureau of Labor Statistics on January 24, 2012, the three month average, seasonally adjusted total unemployment rate for Connecticut and Missouri fell below the 8.5% threshold to remain ``on'' in Tier 4 of the EUC08 program. As a result, the current maximum potential entitlement for Connecticut and Missouri in the EUC08 program will decrease from 53 weeks to 47 weeks. The week ending February 18, 2012 will be the last week in which EUC claimants in Connecticut and Missouri can exhaust Tier 3, and establish Tier 4 eligibility. Under the phase-out provisions, claimants can receive any remaining entitlement they have in Tier 4 after February 18, 2012.
Notice of Intent To Prepare an Environmental Impact Statement on the Pojoaque Basin Regional Water System, Santa Fe County, NM
Document Number: 2012-4293
Type: Notice
Date: 2012-02-24
Agency: Department of the Interior, Bureau of Reclamation
The Bureau of Reclamation (Reclamation) intends to prepare an environmental impact statement (EIS) on the Pojoaque Basin Regional Water System. Reclamation will serve as the lead Federal agency. The U.S. Army Corp of Engineers, Bureau of Indian Affairs, U.S. Fish and Wildlife Service, New Mexico Interstate Stream Commission, New Mexico Office of the State Engineer, County of Santa Fe, and the Pueblos of Namb[eacute], Pojoaque, San Ildefonso, and Tesuque will be invited to participate as cooperating agencies for the EIS. Other entities will be considered as necessary during the EIS process. The proposed Pojoaque Basin Regional Water System will divert, treat, and distribute potable water to the Pueblo and non-Pueblo residents of the Pojoaque Basin. The Regional Water System will consist of surface water diversion and water treatment facilities at San Ildefonso Pueblo on the Rio Grande and storage tanks, transmission and distribution pipelines, and aquifer storage and recovery well fields that will supply up to 4,000 acre-feet of water annually to customers within the Pojoaque Basin.
Fisheries of the Gulf of Mexico; Southeast Data, Assessment, and Review (SEDAR); Public Meetings
Document Number: 2012-4292
Type: Notice
Date: 2012-02-24
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
The SEDAR assessment of the HMS stocks of Gulf of Mexico blacktip sharks will consist of one workshop and a series of webinars.
Fisheries of the Gulf of Mexico and South Atlantic; Southeast Data, Assessment, and Review (SEDAR); Public Meetings
Document Number: 2012-4291
Type: Notice
Date: 2012-02-24
Agency: Department of Commerce, National Oceanic and Atmospheric Administration
The SEDAR 28 assessments of the Gulf of Mexico and South Atlantic stocks of Spanish mackerel and cobia will consist of a series of workshops and webinars: a Data Workshop, a series of Assessment webinars, and a Review Workshop. See SUPPLEMENTARY INFORMATION.
Draft Guidance for Industry on Complicated Urinary Tract Infections: Developing Drugs for Treatment; Availability
Document Number: 2012-4290
Type: Notice
Date: 2012-02-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Complicated Urinary Tract Infections: Developing Drugs for Treatment.'' The purpose of this guidance is to assist sponsors in the clinical development of drugs for the treatment of complicated urinary tract infections (cUTIs). Specifically, this guidance addresses FDA's current thinking regarding the overall drug development program for the treatment of cUTIs, including clinical trial designs to support approval of drugs.
Agency Information Collection Activities; Proposed Collection; Comment Request; Improving Food Safety and Defense Capacity of the State and Local Level: Review of State and Local Capacities
Document Number: 2012-4289
Type: Notice
Date: 2012-02-24
Agency: Food and Drug Administration, Department of Health and Human Services
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 a survey entitled ``Improving Food Safety and Defense Capacity of the State and Local Level: Review of State and Local Capacities.'' The data collection will obtain knowledge of State and local capacities including food safety defense staffing and expertise, laboratory capacities, and information systems to support food and feed safety and defense.
Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic; Availability
Document Number: 2012-4288
Type: Notice
Date: 2012-02-24
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic.'' The guidance discusses FDA's intended approach to enforcement of adverse event reporting requirements for drugs, biologics, medical devices, and dietary supplements during an influenza pandemic. The Agency makes recommendations to industry for focusing limited resources on reports related to products indicated for the prevention and treatment of influenza and other specific types of reports indicated in the guidance.
Airworthiness Directives; Rolls-Royce Deutschland Ltd & Co KG Turbofan Engines
Document Number: 2012-4287
Type: Proposed Rule
Date: 2012-02-24
Agency: Federal Aviation Administration, Department of Transportation
We propose to adopt a new airworthiness directive (AD) for certain Rolls-Royce Deutschland Ltd & Co KG (RRD) BR700-715A1-30, BR700-715B1-30, and BR700-715C1-30 turbofan engines. This proposed AD was prompted by the discovery of a manufacturing defect on certain part number (P/N) and serial number (S/N) low-pressure (LP) compressor booster rotors. This proposed AD would require initial and repetitive fluorescent penetrant inspections of certain P/N and S/N LP compressor booster rotors and rework or replacement of them as terminating action to the repetitive inspections. We are proposing this AD to prevent failure of the LP compressor booster rotor, uncontained engine failure, and damage to the airplane.
Airworthiness Directives; Pratt & Whitney (PW) Models PW4074 and PW4077 Turbofan Engines
Document Number: 2012-4286
Type: Proposed Rule
Date: 2012-02-24
Agency: Federal Aviation Administration, Department of Transportation
We propose to supersede an existing airworthiness directive (AD) that applies to all PW PW4074 and PW4077 turbofan engines. The existing AD currently requires removing the 15th stage high pressure compressor (HPC) disk within 12,000 cycles since new (CSN) or using a drawdown removal plan for disks that exceed 12,000 CSN. Since we issued that AD, we received a request from an operator that we clarify our inspection schedule for 15th stage HPC disks. This proposed AD would clarify that 15th stage HPC disks that have accumulated more than 9,685 CSN require a borescope inspection (BSI) or eddy current inspection (ECI) of the disk outer rim front rail for cracks prior to accumulating 12,000 CSN. We are proposing this AD to prevent cracks from propagating into the disk bolt holes, which could result in a failure of the 15th stage HPC disk, uncontained engine failure, and damage to the airplane.
Airworthiness Directives; CFM International S.A. Model CFM56 Turbofan Engines
Document Number: 2012-4285
Type: Rule
Date: 2012-02-24
Agency: Federal Aviation Administration, Department of Transportation
The FAA is correcting an airworthiness directive (AD) that published in the Federal Register. That AD applies to CFM International S.A. CFM56-2, CFM56-3, CFM56-5A, CFM56-5B, CFM56-5C, and CFM56-7B series turbofan engines with certain part number (P/N) and serial number (SN) high-pressure compressor (HPC) 4-9 spools installed. In Table 1 of the AD, the HPC 4-9 spool SN GWN05AMO in the 2nd column of the Table is incorrect. This document corrects that error. In all other respects, the original document remains the same.
Airworthiness Directives; General Electric Company (GE) Turbofan Engines
Document Number: 2012-4284
Type: Rule
Date: 2012-02-24
Agency: Federal Aviation Administration, Department of Transportation
We are superseding an existing airworthiness directive (AD) for all GE CF6-80C2B series turbofan engines. That AD currently requires installing software version 8.2.Q1 to the engine electronic control unit (ECU), which increases the engine's margin to flameout. This new AD requires the removal of the affected ECUs from service. This AD was prompted by two reports of engine flameout events during flight in inclement weather conditions, eight reports of engine in- flight shutdown (IFSD) events caused by dual-channel central processing unit (CPU) faults in the ECU, and four reports of engine flameout ground events. We are issuing this AD to prevent engine flameout or un- commanded engine IFSD of one or more engines, leading to an emergency or forced landing of the airplane.
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