2005 – Federal Register Recent Federal Regulation Documents
Results 10,151 - 10,200 of 32,488
Agency Information Collection Activities Under OMB Review
In compliance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.), this notice announces that the Information Collection Request (ICR) abstracted below has been forwarded to the Office of Management and Budget (OMB) for review and comment. The ICF describes the nature of the information collection and its expected costs and burden; it includes the actual data collection instrument [if any].
Medical Devices; Availability of Safety and Effectiveness Summaries for Premarket Approval Applications
The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the agency's Division of Dockets Management.
Committee Management; Notice of Public Meeting; Advisory Committee on Acoustic Impacts on Marine Mammals
The Marine Mammal Commission (Commission) will hold the sixth meeting of its Advisory Committee on Acoustic Impacts on Marine Mammals (Committee) 20 to 22 September, 2005 in Bethesda, Maryland.
International Conference on Harmonisation; Draft Guidance on M5 Data Elements and Standards for Drug Dictionaries; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``M5 Data Elements and Standards for Drug Dictionaries.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft guidance describes the data elements and standards that ICH recommends be made available to interested parties to assist in the development and maintenance of drug dictionaries. The draft guidance is intended to facilitate the exchange and practical use of medicinal product information at the international level, such as with postmarketing safety reporting.
Federal Management Regulation; Redesignations of Federal Buildings
The attached bulletin announces the redesignations of eight (8) Federal buildings.
Meeting of the President's Council of Advisors on Science and Technology
This notice sets forth the schedule and summary agenda for a meeting of the President's Council of Advisors on Science and Technology (PCAST), and describes the functions of the Council. Notice of this meeting is required under the Federal Advisory Committee Act (FACA). Dates and Place: September 20, 2005, Washington, DC. The meeting will be held in Room 100 of the National Academies Keck Center located at 500 Fifth Street, NW., Washington, DC 20001. Type of Meeting: Open. Further details on the meeting agenda will be posted on the PCAST Web site at: https://www.ostp.gov/PCAST/ pcast.html. Proposed Schedule and Agenda: The President's Council of Advisors on Science and Technology is scheduled to meet in open session on Tuesday, September 20, 2005, at approximately 9 a.m. The PCAST is tentatively scheduled to hear presentations on research and commercialization activities in the areas of pharmacogenomics (or personalized medicine) and alternative energy. These are both areas in which PCAST may undertake studies regarding the Federal role in research and development and the barriers and possible implications surrounding widespread adoption. A review and update of other PCAST topics (e.g., nanotechnology) is also tentatively scheduled to occur. This session will end at approximately 5 p.m. Additional information on the agenda will be posted at the PCAST Web site at: https:// www.ostp.gov/PCAST/pcast.html. Public Comments: There will be time allocated for the public to speak on the above agenda items. This public comment time is designed for substantive commentary on PCAST's work topics, not for business marketing purposes. Please submit a request for the opportunity to make a public comment five (5) days in advance of the meeting. The time for public comments will be limited to no more than 5 minutes per person. Written comments are also welcome at any time following the meeting. Please notify Celia Merzbacher, PCAST Executive Director, at (202) 456- 7116, or fax your request/comments to (202) 456-6021.
Head of Contracting Activity (HCA) Change for NASA Shared Services Center (NSSC)
This final rule revises the NASA FAR Supplement (NFS) by amending the definition of ``Contracting activity'' and ``Head of the contracting activity (HCA)'' consistent with the mission of the NASA Shared Services Center (NSSC) which is to provide selected services in support of Human Resources, Procurement, Financial Management and Information Technology operations across the Agency.
Packaging, Handling, and Transportation
This is a final rule to amend the NASA FAR Supplement (NFS) to delete the ``alpha'' and ``date'' associated with NASA's Procedural Requirements (NPR) 6000.1 referred to in the clause entitled Packaging, Handling, and Transportation (NOVEMBER 2004).
Announcement of Availability of Funds for a Cooperative Agreement To Improve and Sustain the Leadership and Management Capacity and To Improve Operations and Delivery of Quality Health Care Within the Rabia Balkhi Women's Hospital
The Office of Global Health Affairs (OGHA) announces that an estimated $1.5 million in fiscal year (FY) 2005 funds are available for one (1) cooperative agreement to strengthen leadership, healthcare administration and facility management and to improve operations and improve health care delivery at Rabia Balkhi Women's Hospital (RBH) in Kabul, Afghanistan. This effort is a joint undertaking by the U.S. Department of Health and Human Services (HHS) and the Afghanistan Ministry of Public Health (MOPH). The goal of this project is to create equitable and high quality care at Rabia Balkhi Women's Hospital by developing effective leadership and management and improving operations. The funding will provide essential material resources within budgetary limitations for patient care, operations, facility management and for grant activities related to leadership and management development at RBH. A Memorandum of Understanding (MOU) between the grantee and the Afghan MOPH will detail the differentiated responsibilities of the awardee toward RBH and the conditions under which the MOPH will transfer operational and logistical authority and responsibility for management and operations of RBH to the awardee. Alongside this support, through a separate, ongoing cooperative agreement, HHS is currently providing support for staff development and continuing education at RBH, and the Department of Defense is providing approximately $1.4M in infrastructure upgrades. This new cooperative agreement is not anticipated to involve training of the clinical staff at RBH, but should include limited training and capacity-building of administrative or executive management staff. HHS, in partnership with other relevant United States Government (USG) agencies anticipates involvement in the development, administration and oversight of this hospital management improvement program. The program will be approved initially for a three-year period. It is estimated that approximately $1.5 million (including indirect costs) will be available in the first year. Funding for the cooperative agreement in subsequent years is contingent upon the availability of funds.
Robert H. Leyse; Denial of Petition for Rulemaking
The Nuclear Regulatory Commission (NRC) is denying a petition for rulemaking submitted by Mr. Robert H. Leyse (PRM-50-76). The petitioner requests that the NRC's regulations concerning the specified evaluation models for emergency core cooling systems (ECCS) and associated guidance documents be amended. The petitioner asserts that amendments are necessary to correct technical deficiencies in the correlations and data used for calculation of metal-water oxidation. The petitioner states that the correlations and data do not consider the complex thermal-hydraulic conditions present during a loss-of- coolant accident (LOCA), including the potential for very high fluid temperature. The Commission is denying Mr. Leyse's petition for rulemaking (PRM-50-76). None of the specific technical issues raised by the petitioner have shown safety-significant deficiencies in the research, calculation methods, or data used to support ECCS performance evaluations. NRC's technical safety analysis demonstrates that current procedures for evaluating ECCS performance are based on sound science and that no amendments to the NRC's regulations and guidance documents are necessary.
Changes to the Income and Resources Provisions for Supplemental Security Income (SSI) Based on Sections 430, 435, and 436 of the Social Security Protection Act (SSPA) of 2004
We propose to revise our regulations on how we determine an individual's income and resources under the SSI program based on the SSPA of 2004, enacted on March 2, 2004. Some of the provisions of the SSPA make a number of changes in the way we determine income and resources including: how we calculate infrequent and irregular income; what interest and dividend income we exclude; how we count cash military compensation; and when we exclude gifts for tuition or educational expenses from income or resources. We are also proposing to apply the exclusions required by the SSPA when determining the countable income and resources of an ineligible spouse or ineligible parent.
Maine Disaster Number ME-00003
This is an amendment of the Presidential declaration of a major disaster for public assistance only for the State of Maine (FEMA- 1591-DR), dated 06/29/2005. Incident: Severe Storms, Flooding, Snow Melt, and Ice Jams. Incident Period: 03/29/2005 through 05/03/2005.
Small Business Size Standards: Waiver of the Nonmanufacturer Rule
The U.S. Small Business Administration (SBA) is terminating the waiver of the Nonmanufacturer Rule for Sporting and Athletic Goods Manufacturing based on our recent discovery of a small business manufacturer for this class of products. Terminating this waiver will require recipients of contracts set aside for small businesses, service-disabled veteran-owned small businesses, or SBA's 8(a) Business Development Program to provide the products of small business manufacturers or processors on such contracts.
FLORIDA Disaster # FL-00007
This is a notice of an Administrative declaration of a disaster for the State of Florida dated 08/25/2005. Incident: Severe Storms and Flooding. Incident Period: 07/29/2005 through 08/14/2005.
Wyoming Disaster #WY-00002
This is a Notice of the Presidential declaration of a major diaster for the State of Wyoming (FEMA-1599-DR), dated 08/22/2005. Incident: Tornado. Incident Period: 08/12/2005.
Precanvass Operation for the 2007 Economic Census Covering Transportation of Commodities
The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)).
Quarterly Survey of the Finances of Public-Employee Retirement Systems
The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3506(c)(2)(A)).
Notice of Intent to Request Renewal From the Office of Management and Budget (OMB) of Five Current Public Collections of Information
In compliance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.) the FAA invites public comment on five currently approved public information collections which will be submitted to OMB for renewal.
Establishment of Class D Airspace; Eau Claire, WI
This document establishes Class D airspace at Eau Clair, WI. A control tower is currently under construction at Chippewa Valley Regional Airport. Controlled airspace extending upward from the surface is required when the control tower is operational. This action establishes a radius of controlled airspace for Eau Clair, WI.
Modification of Class E Airspace; Washington, MO
This document confirms the effective date of the direct final rule which revises Class E airspace at Washington, MO.
Modification of Class E Airspace; Abilene Municipal Airport, KS
This document confirms the effective date of the direct final rule which revises Class E airspace at Abilene Municipal Airport, KS.
Modification of Class E Airspace; Meade Municipal Airport, KS
This document confirms the effective date of the direct final rule which revises Class E airspace at Meade Municipal Airport, KS
Commission Meeting
The Commission will hold its next public meeting on Thursday, September 8, 2005, and Friday, September 9, 2005, at the Ronald Reagan Building, International Trade Center, 1300 Pennsylvania Avenue, NW., Washington, DC. The meeting is tentatively scheduled to begin at 11 a.m. on September 8, and at 9:15 a.m. on September 9. Topics for discussion include findings on two congressionally mandated studies: home health margins, and payments for oncology drugs and administration services in the Medicare system. The Commission will also discuss issues related to the Medicare wage index, outpatient therapy, valuing services in the physician fee schedule, and physician resource use. The Commission will also host a panel on quality measures in managed care organizations. Agendas will be e-mailed approximately one week prior to the meeting. The final agenda will be available on the Commission's Web site (https://www.medpac.gov). This will be the last notice placed in the Federal Register by the Commission. We will continue to e-mail meeting agendas, which you can sign up to receive at https://www.medpac.gov. They will also be posted on our Web site. In addition, we will now e-mail a meeting notice two weeks prior to the meeting date. If you have any comments on this action, please contact Annissa McDonald at amcdonald@medpac.gov or (202) 220-3700.
False Island Timber Sale(s), Sitka Ranger District, Tongass National Forest
The Department of Agriculture, Forest Service is issuing this notice to advise the public that we are canceling the notice of intent (NOI) to prepare an Environmental Impact Statement (EIS) for the False Island Timber Sale(s) project.
Section 1446 Regulations; Withholding on Effectively-Connected Taxable Income Allocable to Foreign Partners; Correction
This document corrects a notice of proposed rulemaking (REG- 108524-00) that was published in the Federal Register on Wednesday, May 18, 2005 (70 FR 28743). The document contains regulations providing guidance under section 1446 of the Internal Revenue Code relating to the circumstances under which a partnership may take partner-level deductions and losses into account in computing its withholding tax obligation with respect to a foreign partner's allocable share of effectively connected taxable income.
Open meeting of the Taxpayer Advocacy Panel Earned Income Tax Credit Issue Committee
An open meeting of the Taxpayer Advocacy Panel Earned Income Tax Credit Issue Committee will be conducted (via teleconference). The Taxpayer Advocacy Panel is soliciting public comments, ideas and suggestions on improving customer service at the Internal Revenue Service.
Determination That Penthrane (Methoxyflurane) Inhalation Liquid, 99.9 Percent, Was Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that Penthrane (methoxyflurane) Inhalation Liquid, 99.9 percent, was withdrawn from sale for reasons of safety or effectiveness. The agency will not accept or approve abbreviated new drug applications (ANDAs) for methoxyflurane inhalation liquid, 99.9 percent.
General Services Administration Acquisition Regulation; Information Collection; Solicitation Provisions and Contract Clauses, Placement of Orders Clause, and Ordering Information Clause
Under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the General Services Administration has submitted to the Office of Management and Budget (OMB) a request to review and approve a renewal of a currently approved information collection requirement regarding solicitation provisions and contract clauses, placement of orders clause, and ordering information clause. A request for public comments was published at 70 FR 37858, June 30, 2005. No comments were received. Public comments are particularly invited on: Whether this collection of information is necessary and whether it will have practical utility; whether our estimate of the public burden of this collection of information is accurate, and based on valid assumptions and methodology; ways to enhance the quality, utility, and clarity of the information to be collected.
Dimethoate Revised Risk Assessments; Notice of Availability and Solicitation of Risk Reduction Options
This notice announces the availability of EPA's revised risk assessments for the organophosphate pesticide dimethoate. In addition, this notice solicits public comment on risk reduction options for dimethoate. The public is encouraged to suggest risk management ideas or proposals to address the risks identified. EPA is developing an Interim Reregistration Eligibility Decision (IRED) for dimethoate through the full, 6-Phase public participation process that the Agency uses to involve the public in developing pesticide reregistration and tolerance reassessment decisions. Through these programs, EPA is ensuring that all pesticides meet current health and safety standards.
Oil and Gas and Sulphur Operations in the Outer Continental Shelf (OCS)-Plans and Information-Protection of Marine Mammals and Threatened and Endangered Species
This proposed rule would require lessees of federal oil and gas leases in the OCS to provide information on how they will meet the requirements of the Endangered Species Act (ESA) and the Marine Mammal Protection Act (MMPA). It identifies environmental, monitoring, and mitigation information that lessees must submit with plans for exploration and development and production. This rulemaking clarifies our regulations about what information MMS needs to ensure compliance with the ESA and MMPA requirements. The proposed rule would assure that lessees conduct their activities in a manner consistent with the provisions of the ESA and MMPA.
Approval and Promulgation of Implementation Plans and Designation of Areas for Air Quality Planning Purposes; Arizona; Correction of Redesignation of Phoenix To Attainment for the Carbon Monoxide Standard
EPA is proposing to amend the regulations that identify revisions to the Arizona state implementation plan and the regulations that identify area designations within Arizona. In so doing, EPA is acting pursuant to the Agency's authority under the Clean Air Act to correct errors made in approving plan revisions and area redesignations. The purpose of this proposed rule is to correct an error in the adoption and submittal date shown for a revision to the implementation plan that EPA recently approved and to correct a transcription error in, and to make a more general correction to, the boundary description of the metropolitan Phoenix carbon monoxide area that EPA recently redesignated to attainment.
Approval and Promulgation of Implementation Plans and Designation of Areas for Air Quality Planning Purposes; Arizona; Correction of Redesignation of Phoenix to Attainment for the Carbon Monoxide Standard
In today's action, EPA is taking direct final action to amend the regulations that identify revisions to the Arizona state implementation plan and the regulations that identify area designations within Arizona. In so doing, EPA is acting pursuant to the Agency's authority under the Clean Air Act to correct errors made in approving plan revisions and area redesignations. The purpose of this action is to correct an error in the adoption and submittal date shown for a revision to the implementation plan that EPA recently approved and to correct a transcription error in, and to make a more general correction to, the boundary description of the metropolitan Phoenix carbon monoxide area that EPA recently redesignated to attainment.
Approval and Promulgation of Air Quality Implementation Plans; District of Columbia; Update to Materials Incorporated by Reference
EPA is updating the materials submitted by the District of Columbia that are incorporated by reference (IBR) into the State implementation plan (SIP). The regulations affected by this update have been previously submitted by the State agency and approved by EPA. This update affects the SIP materials that are available for public inspection at the National Archives and Records Administration (NARA), the Air and Radiation Docket and Information Center located at EPA Headquarters in Washington, DC, and the EPA Regional Office.
Approval and Promulgation of State Implementation Plans: Oregon; Portland Carbon Monoxide Second 10-Year Maintenance Plan
The EPA proposes to approve the second 10-year maintenance plan for carbon monoxide (CO) for the Portland, Oregon CO Attainment Area. Specifically, in this action EPA proposes to approve the following: Oregon's demonstration that the Portland CO Attainment Area will maintain air quality standards for CO through the year 2017; a revised CO motor vehicle emissions budget for transportation conformity purposes using the MOBILE6.2 emissions model and latest growth and planning assumptions; and revised state implementation plan (SIP) control strategies and contingency measures.
Licenses, Certifications, and Approvals for Nuclear Power Plants
The Nuclear Regulatory Commission (NRC) is making available the draft wording of a proposed amendment of its regulations. The proposal would amend Title 10 of the Code of Federal Regulations (10 CFR) part 52, ``Early Site Permits; Standard Design Certifications; and Combined Licenses for Nuclear Power Plants,'' and associated regulations based on experience gained from early site permit (ESP) and design certification reviews and discussions with stakeholders on the ESP and combined license (COL) processes. The changes should improve the effectiveness and efficiency of the licensing processes for future applicants. The availability of the draft rule language is intended to inform stakeholders of the current status of the NRC staff's activities to amend 10 CFR part 52. Publicly available documents related to this rulemaking may be viewed electronically on the public computers located at the NRC's Public Document Room (PDR), O1 F21, One White Flint North, 11555 Rockville Pike, Rockville, Maryland. The PDR reproduction contractor will copy documents for a fee. Selected documents can be viewed and downloaded electronically via the NRC rulemaking Web site at https:// ruleforum.llnl.gov. Publicly available documents created or received at the NRC after November 1, 1999, are available electronically at the NRC's Electronic Reading Room at https://www.nrc.gov/NRC/ADAMS/. From this site, the public can gain entry into the NRC's Agencywide Document Access and Management System (ADAMS), which provides text and image files of NRC's public documents. If you do not have access to ADAMS or if there are problems in accessing the documents located in ADAMS, contact the NRC PDR Reference staff at 1-800-397-4209, 301-415-4737, or by e-mail to pdr@nrc.gov.
Wekiva River System Advisory Management Committee Meeting
This notice announces a September 20, 2005, meeting of the Wekiva River System Advisory Management Committee.
Airworthiness Directives; Boeing Model 737-100, -200, -200C, and -300 Series Airplanes
The FAA is adopting a new airworthiness directive (AD) for certain Boeing Model 737-100, -200, -200C, and -300 series airplanes. This AD requires repetitive detailed inspections to detect discrepancies of the retaining pin lugs on the support fitting of the main landing gear (MLG) beam, and rework of the support fitting, or replacement of the fitting if necessary. This AD is prompted by reports of discrepancies of the lugs. We are issuing this AD to prevent separation of the support beam of the MLG from the rear spar, which could cause cracking of the MLG support fitting and a consequent leak in the wing fuel tank or collapse of the MLG.
Airworthiness Directives; Bombardier Model CL-600-2B19 (Regional Jet Series 100 & 440) Airplanes
This amendment adopts a new airworthiness directive (AD), applicable to certain Bombardier Model CL-600-2B19 (Regional Jet Series 100& 440) airplanes, that requires performing an inspection of the electrical harnesses of the spoiler and the brake pressure sensor unit on both sides of the wing root to detect any chafing or wire damage, and repairing or replacing any damaged or chafed harness or wire with a new harness, as applicable. This action also provides/requires a terminating modification for the one-time inspection. The actions specified by this AD are intended to detect and correct chafing of the electrical cables of the spoiler and brake pressure sensor unit on both sides of the wing root, which could result in loss of the flight control system and consequent reduced controllability of the airplane. This action is intended to address the identified unsafe condition.
Certification Requirements for Distributors of NOAA Electronic Navigational Charts/NOAA Hydrographic Products
The National Oceanic and Atmospheric Administration (NOAA) is promulgating certification requirements with standards for applicants who want to redistribute NOAA Electronic Navigational Charts (NOAA ENCs[supreg]) as official data. Two types of certification are offered. The first type, ``Certified NOAA ENC Distributor'' (CED), covers NOAA ENC downloading, exact copying, and redistribution of those copies. The second type, ``Certified NOAA ENC Value Added Distributor'' (CEVAD), permits reformatting official NOAA ENCs into a System Electronic Navigational Chart (SENC) using type-approved software, and distribution of that SENC. NOAA intends by this action to assure that, though redistributed, quality official NOAA ENC data is offered to the public in support of safe navigation on U.S. waters.
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