Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Performance Standard for Diagnostic X-Ray Systems and Their Major Components
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Performance Standard for Diagnostic X-Ray Systems and Their Major Components'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Determination That ZYVOX (Linezolid) Tablets, 400 Milligrams, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that ZYVOX (linezolid) tablets, 400 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for linezolid tablets, 400 mg.
International Conference on Harmonisation; Guidance on Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process.'' The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The purpose of the guidance is to provide principles for assessing the comparability of biotechnological/biological products before and after changes are made in the manufacturing process for the drug substance or drug product. The guidance is intended to assist in the collection of relevant technical information that serves as evidence that the manufacturing process changes will not have an adverse impact on the quality, safety, and efficacy of the drug product.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Medical Device Labeling Regulations
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Medical Device Labeling Regulations'' 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
The EIA is soliciting comments on: A revised Form EIA-1605, ``Voluntary Reporting of Greenhouse Gases'' and instructions; A three year extension of Office of Management and Budget (OMB) approval in order for EIA to implement the revised Form EIA-1605; and The discontinuation of the Form EIA-1605EZ.
Tariff Treatment Related to Disassembly Operations Under the North American Free Trade Agreement
This document adopts as a final rule, with some changes, proposed amendments to the Customs and Border Protection (``CBP'') Regulations concerning the North American Free Trade Agreement (``the NAFTA''). The regulatory changes interpret the term ``production'' to include disassembly and clarify that components recovered from the disassembly of used goods in a NAFTA country are entitled to NAFTA originating status when imported into the United States provided that the recovered components satisfy the applicable NAFTA rule of origin requirements.
On June 30, 2005, the Board served a decision to update its computation of the railroad industry's cost-of-capital for 2004. The composite after-tax cost-of-capital rate for 2004 is found to be 10.1%, based on a current cost-of-debt of 5.25%; a cost of common equity capital of 13.16%; and a capital structure mix comprised of 38.5% debt and 61.5% common equity. The cost-of-capital finding made in this proceeding will be used in a variety of Board proceedings.
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 will be submitting 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. The clearance currently expires on September 30, 2005. 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; and ways to enhance the quality, utility, and clarity of the information to be collected.
Raw In-Shell Pistachios From Iran
The Commission hereby gives notice of the scheduling of a full review pursuant to section 751(c)(5) of the Tariff Act of 1930 (19 U.S.C. 1675(c)(5)) (the Act) to determine whether revocation of the antidumping duty order on raw in-shell pistachios from Iran would be likely to lead to continuation or recurrence of material injury within a reasonably foreseeable time. For further information concerning the conduct of this review and rules of general application, consult the Commission's Rules of Practice and Procedure, part 201, subparts A through E (19 CFR part 201), and part 207, subparts A, D, E, and F (19 CFR part 207).
Extension of Comment Period on Interim Environmental Guidelines
The Millennium Challenge Corporation (MCC) is extending until July 15, 2005, the period for interested persons to submit comments on the March 4, 2005 Notice of Interim Environmental Guidelines For Public Comment (Federal Register, Vol. 70, No. 42, pp. 10690-10693). In the March 4, 2005 Notice, MCC published the full text of its interim Environmental Guidelines and asked for public comments over a 90 day period. This period is being extended through July 15, 2005.
Marten Creek Timber Sales and Associated Activities Kootenai National Forest, Sanders County, MT
The USDA, Forest Service, will prepare an Environmental Impact Statement (EIS) to disclose the environmental effects of timber harvest, prescribed fire, and watershed rehabilitation in the Marten Creek project area on the Cabinet Ranger District of the Kootenai National Forest. The Marten Creek project area is located approximately 7 air miles northwest of Trout Creek, Montana, near the community of Trout Creek, Montana. Scoping Comment Date: Comments concerning the scope of the analysis should be postmarked or received by September 2, 2005.
Notice of Public Meeting, Alaska Resource Advisory Council
In accordance with the Federal Land Policy and Management Act (FLPMA) and the Federal Advisory Committee Act of 1972 (FACA), the U.S. Department of the Interior, Bureau of Land Management (BLM) Alaska Resource Advisory Council will meet as indicated below.
List of Approved Spent Fuel Storage Casks: VSC-24 Revision
The Nuclear Regulatory Commission (NRC) is amending its regulations revising the BNG Fuel Solutions Corporation Ventilated Storage Cask (VSC-24) System listing within the ``List of approved spent fuel storage casks'' to include Amendment No. 5 to Certificate of Compliance Number (CoC No.) 1007. Amendment No. 5 will change the certificate holder's name from Pacific Sierra Nuclear Associates to BNG Fuel Solutions Corporation. No changes were required to be made to the VSC-24 Final Safety Analysis Report nor its Technical Specifications.
List of Approved Spent Fuel Storage Casks: VSC-24 Revision
The Nuclear Regulatory Commission (NRC) is proposing to amend its regulations revising the BNG Fuel Solutions Corporation Ventilated Storage Cask (VSC-24) System listing within the ``List of approved spent fuel storage casks'' to include Amendment No. 5 to Certificate of Compliance Number (CoC No.) 1007. Amendment No. 5 would change the certificate holder's name from Pacific Sierra Nuclear Associates to BNG Fuel Solutions Corporation. No changes were required to be made to the VSC-24 Final Safety Analysis Report nor its Technical Specifications.
Notice of Availability of an Environmental Assessment (EA) and Finding of No Significant Impact/Record of Decision (FONSI/ROD) Executed by the Federal Aviation Administration (FAA) for the Evaluation of Environmental Impacts Associated With a Proposed Extension of Runway 10R/28L for the Capital City Airport Located in Lansing, MI
The FAA is making available an EA and FONSI/ROD for the evaluation of environmental impacts associated with a proposed extension to runway 10R/28L executed by the FAA, for the Capital City Airport located in Lansing, Michigan. Point of Contact: Mr. Brad Davidson, Environmental Protection Specialist, FAA Great Lakes Region, Detroit Airports District Office, 11677 South Wayne Road, Suite 107, Romulus, MI 48174 (734) 229-2900.
Notice of Proposed Information Collection.
In compliance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.), the FAA invites public comment on one new public information collection which will be submitted to OMB for approval.
Special Conditions: Gulfstream Aerospace Limited Partnership (GALP) Model G150 Airplane; Windshield Coating in Lieu of Wipers
This notice proposes special conditions for the Gulfstream Aerospace Limited Partnership (GALP) Model G150 airplane. This airplane will have a novel or unusual design feature associated with use of a hydrophobic coating, rather than windshield wipers, as the means to maintain a clear portion of the windshield during precipitation conditions, as required by the airworthiness standards for transport category airplanes. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These proposed special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.
Special Conditions; Diamond Aircraft Industries, EFIS and Full Authority Digital Engine Control (FADEC) on the Diamond DA-42; Protection of Systems for High Intensity Radiated Fields (HIRF)
These special conditions are issued to Diamond Aircraft Industries GmbH, N.A. Otto-Strasse 5, A-2700 Wiener Neistadt, Austria; telephone: 43 2622 26 700; facsimile: 43 2622 26 780, as part of the FAA Type Validation of the Diamond Aircraft Industries Model DA-42. This airplane will have novel and unusual design features when compared to the state of technology envisaged in the applicable airworthiness standards. These novel and unusual design features include the installation of a Garmin Model G-1000 electronic flight instrument system (EFIS) display, and digital engine controls. The applicable regulations do not contain adequate or appropriate airworthiness standards for the protection of these systems from the effects of high intensity radiated fields (HIRF). These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to the airworthiness standards applicable to these airplanes.
Security Zone; Georgetown Channel, Potomac River, Washington, DC
The Coast Guard is establishing a temporary security zone on the waters of the upper Potomac River. This action is necessary to provide for the security of a large number of visitors to the annual July 4th celebration on the National Mall in Washington, DC. The security zone will allow for control of a designated area of the river and safeguard spectators and high-ranking officials.
Federal Motor Vehicle Safety Standards; Hydraulic and Electric Brake Systems
This document amends the Federal motor vehicle safety standard on hydraulic and electric brake systems to extend the current minimum performance requirements and associated test procedures for parking brake systems to all multipurpose passenger vehicles (MPVs), buses and trucks with gross vehicle weight ratings (GVWR) greater than 10,000 pounds (4,536 kilograms) equipped with hydraulic or electric brake systems. Currently, the only vehicles with GVWRs greater than 10,000 pounds to which the standard's parking brake requirements apply are school buses. The agency concludes that it is in the interest of safety to require all MPVs, buses and trucks with GVWRs over 10,000 pounds to have parking brakes that meet the performance requirements currently applicable to heavy school buses.
Special Conditions; Raytheon Model King Air H-90 (T-44A) Protection of Systems for High Intensity Radiated Fields (HIRF)
These special conditions are issued to ARINC Inc., 1632 S. Murray Blvd., Colorado Springs, CO 80916 for a Supplemental Type Certificate for the Raytheon Model King Air H-90 (T-44A) airplane. These airplanes will have novel and unusual design features when compared to the state of technology envisaged in the applicable airworthiness standards. The novel and unusual design features include the installation of the Rockwell Collins Pro Line 21 Avionics System. This system includes Electronic Flight Instrument Systems (EFIS), electronic displays, digital Air Data Computers (ADC), and supporting equipment. The applicable regulations do not contain adequate or appropriate airworthiness standards for the protection of these systems from the effects of high intensity radiated fields (HIRF). These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to the airworthiness standards applicable to these airplanes.
Locomotive Event Recorders
FRA is issuing revisions to the regulations governing locomotive event recorders to improve the crashworthiness of railroad locomotive event recorders and to enhance the quality of information available for post-accident investigations. FRA is amending its existing regulations in four major ways: By requiring that a new locomotive have an event recorder with a ``hardened'' memory module, proven by a requirement that the memory module preserve stored data throughout a sequence of prescribed tests; by requiring that this event recorder on a new locomotive collect certain additional types of information; by simplifying standards for inspecting, testing, and maintaining all event recorders; and by requiring the phasing out, over a four-year period, of event recorders on existing locomotives that use magnetic tape as a data storage medium and their replacement with event recorders with a certified survivable version of its previous event recorder. FRA is also revising the definitions contained in the existing regulation to remove the letter designations so that the defined terms are simply presented in alphabetical order.
Qualification of Drivers; Exemption Applications; Vision
This notice publishes the FMCSA decision to renew the exemption from the vision requirement in the Federal Motor Carrier Safety Regulations for Mr. Thomas E. Howard. The FMCSA has statutory authority to exempt individuals from vision standards if the exemptions granted will not compromise safety. The agency has concluded that granting this exemption will provide a level of safety that will be equivalent to, or greater than, the level of safety maintained without the exemption for this commercial motor vehicle (CMV) driver.
Federal Motor Vehicle Safety Standards; Child Restraint Systems
Federal Motor Vehicle Safety Standard (FMVSS) No. 213, ``Child restraint systems,'' requires that the webbing of child restraints must not lose more than a specified percentage of its original breaking strength as a result of being exposed to certain adverse conditions. The standard currently does not specify a minimum breaking strength for the unexposed webbing. This document proposes such a minimum, as well as a minimum breaking strength requirement for the exposed webbing. It also makes clearer in the text of FMVSS No. 213 that the heavier of two weights specified in the standard is used to abrade the webbing used to attach child restraint systems to the child restraint anchorages located in a vehicle.
Policy Statement on Creditworthiness for Interstate Natural Gas Pipelines and Order Withdrawing Rulemaking Proceeding
On February 2, 2004, the Federal Energy Regulatory Commission (Commission) issued a notice of proposed rulemaking (NOPR) proposing to amend its open access regulations governing capacity release and standards for business practices and electronic communications with interstate natural gas pipelines. The NOPR proposed to incorporate by reference ten creditworthiness standards promulgated by the Wholesale Gas Quadrant of the North American Energy Standards Board (NAESB) and adopt additional regulations related to the creditworthiness of shippers on interstate natural gas pipelines. The Commission adopted the NAESB creditworthiness standards in Docket No. RM96-1-026 (70 FR 28204), and is now issuing a policy statement on creditworthiness. Therefore, the proposed rulemaking in Docket No. RM04-4-000 is withdrawn.
The Antitrust Modernization Commission will hold a public meeting on July 28, 2005. The purpose of the meeting is for the Antitrust Modernization Commission to consider and vote on plans (including proposed requests for public comment and public hearings) for studying certain issues selected by the Commission in its January 13 and March 24, 2005, meetings.
Notice of Public Hearings
The Antitrust Modernization Commission will hold public hearings on July 28, 2005. The topics of the hearings are the Robinson- Patman Act and certain civil remedies issues.
Standardization of Generator Interconnection Agreements and Procedures
The Federal Energy Regulatory Commission (Commission) affirms, with certain clarifications, the fundamental determinations in Order No. 2003-B.
Notice of Public Meeting: Northeast California Resource Advisory Council
In accordance with the Federal Land Policy and Management Act of 1976 (FLPMA), and the Federal Advisory Committee Act of 1972 (FACA), the U.S. Department of the Interior, Bureau of Land Management (BLM) Northeast California Resource Advisory Council will meet as indicated below.
U.S. Treasury Securities-State and Local Government Series
The Department of the Treasury (Treasury) is issuing this final rule to revise the regulations governing State and Local Government Series (SLGS) securities. SLGS securities are non-marketable Treasury securities that are only available for purchase by issuers of tax-exempt securities. The changes in the final rule prohibit issuers of tax-exempt securities from engaging in certain practices that in effect use the SLGS program as a cost-free option. The final rule also makes other changes that are designed to improve the administration of the SLGS program.
Demand Deposit Securities of the State and Local Government Series (SLGS); Average Marginal Tax Rate and Treasury Administrative Cost
This notice is being published to provide the information necessary to apply the interest rate formula for Demand Deposit certificates of indebtednessState and Local Government Series (SLGS) (31 CFR Part 344, Subpart C). The factor necessary to convert the interest rate to a tax-exempt equivalent (1the estimated average marginal tax rate of purchasers of tax-exempt bonds) is 1-.21 or .79. The current Treasury administrative cost is five basis points. Treasury is amending this rate and designating the new Treasury administrative cost, as of the effective date of this notice, as one basis point. The final rule, amending the regulations governing SLGS securities, which appears elsewhere in this issue of the Federal Register, makes provision for the simultaneous publication of this notice (31 CFR 344.7).
Senior Executive Service; Performance Review Board; Members
Section 4314(c) of Title 5, U.S.C. (as amended by the Civil Service Reform Act of 1978) requires each agency to establish, in accordance with regulations prescribed by the Office of Personnel Management, one or more Performance Review Boards (PRB) to review, evaluate and make a final recommendation on performance appraisals assigned to individual members of the agency's Senior Executive Service. The PRB established for the National Capital Planning Commission also makes recommendations to the agency head regarding SES performance awards, rank awards and bonuses. Section 4314(c)(4) requires that notice of appointment of Performance Review Board members be published in the Federal Register. The following persons have been appointed to serve as members of the Performance Review Board for the National Capital Planning Commission: Kent E. Baum, Jill Crumpacker, Patricia E. Gallagher and Rosita Parkes from June 24, 2005 to June 24, 2007.
Board of Veterans' Appeals: Clarification of a Notice of Disagreement
The Department of Veterans Affairs (VA) proposes to amend its regulations governing appeals to the Board of Veterans' Appeals (Board) to clarify the actions an agency of original jurisdiction must take to determine whether a written communication from a claimant that is ambiguous in its purpose is intended to be a Notice of Disagreement with an adverse claims decision.
Candidate Solicitation at State, District, and Local Party Fundraising Events
The Federal Election Commission is publishing a revised Explanation and Justification for its rule regarding appearances by Federal officeholders and candidates at State, district, and local party fundraising events under the Federal Election Campaign Act of 1971, as amended (``FECA''). The rule, which is not being amended, contains an exemption permitting Federal officeholders and candidates to speak at State, district, and local party fundraising events ``without restriction or regulation.'' These revisions to the Explanation and Justification conform to the decision of the U.S. District Court for the District of Columbia in Shays v. FEC. Further information is provided in the supplementary information that follows.
Expected Non-Market Economy Wages: Request for Comment on Calculation Methodology
The Department of Commerce (``Department'') has a long- standing practice of calculating expected non-market economy (``NME'') wages for use as surrogate values in antidumping proceedings involving NME countries. These expected NME wages are calculated annually in accordance with Sec. 351.408(c)(3) of the Department's regulations. This notice describes the Department's methodology for the calculation of expected NME wages and provides the public with an opportunity to comment on this methodology in response to comments that have been submitted in several NME proceedings. For purposes of public comment, the Department has also calculated expected NME wages using currently available data for 2003 and the methodology described herein. This is a sample calculation based on 2003 data, and is subject to data updates and revisions.
Capitalization of Tangible Assets; Correction
This document contains technical corrections to the Illustrations in CAS 9904.404, ``Capitalization of Tangible Assets.'' An amendment to this Standard was published on February 13, 1996 (61 FR 5520). However, while the contractor's minimum cost criteria for capitalization was increased from $1,500 to $5,000 in the body of the Standard, this change was not reflected in the Illustrations part of the Standard. This technical correction brings the figures in the relevant Illustrations into line with the $5,000 minimum cost criteria for capitalization currently incorporated in the body of the Standard.
Airworthiness Directives; Boeing Model 727 Airplanes, Equipped With an Auxiliary Fuel Tank Having a Fuel Pump Installed
The FAA is adopting a new airworthiness directive (AD) for Boeing Model 727 airplanes equipped with an auxiliary fuel tank having a fuel pump installed. This AD requires revising the airplane flight manual to include limitations on operating the fuel pumps for the auxiliary fuel tank. This AD is prompted by a design review of the fuel pump installation, which revealed a potential unsafe condition related to the auxiliary fuel tank(s). We are issuing this AD to prevent dry operation of the fuel pumps for the auxiliary fuel tank, which could create a potential ignition source inside the auxiliary fuel tank that could result in a fire or explosion of the auxiliary fuel tank.
Diesel Particulate Matter Exposure of Underground Metal and Nonmetal Miners
This document contains corrections to the preamble and rule text of the final rule that was published in the Federal Register on Monday, June 6, 2005 (70 FR 32868). The rule relates to diesel particulate matter exposure of underground metal and nonmetal miners.