Entries for Monday, August 03, 2009
The Federal Register is published every day of the week, excluding weekends and holidays. The Register contains an assortment of notices, proposed rules, final rules, requests for information and presidential documents.
You'll find today's entries listed below by agency, with the locations mentioned located on a map for you. You may also navigate to any date by clicking on the calendar icon below to display calendars for recent months as well as a search box.
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Consumer Product Safety Commission 10 entries
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A&A Global Industries, Inc., Provisional Acceptance of a Settlement Agreement and Order
- Type
- Notice
- Length
- 2 pages
It is the policy of the Commission to publish settlements which it provisionally accepts under the Consumer Product Safety Act in the Federal Register in accordance with the terms of 16 CFR 1118.20(e). Published below is a provisionally-accepted Settlement Agreement with A&A Global Industries, Inc., containing a civil penalty of $40,000.00.
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Cardinal Distributing Company, Inc., Provisional Acceptance of a Settlement Agreement and Order
- Type
- Notice
- Length
- 2 pages
It is the policy of the Commission to publish settlements which it provisionally accepts under the Consumer Product Safety Act in the Federal Register in accordance with the terms of 16 CFR 1118.20(e). Published below is a provisionally accepted Settlement Agreement with Cardinal Distributing Company, Inc., containing a civil penalty of $100,000.00.
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Dollar General Corporation, Provisional Acceptance of a Settlement Agreement and Order
- Type
- Notice
- Length
- 3 pages
It is the policy of the Commission to publish settlements which it provisionally accepts under the Consumer Product Safety Act in the Federal Register in accordance with the terms of 16 CFR 1118.20(e). Published below is a provisionally-accepted Settlement Agreement with Dollar General Corporation, containing a civil penalty of $100,000.00.
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Downeast Concepts, Inc., Provisional Acceptance of a Settlement Agreement and Order
- Type
- Notice
- Length
- 2 pages
It is the policy of the Commission to publish settlements which it provisionally accepts under the Consumer Product Safety Act in the Federal Register in accordance with the terms of 16 CFR 1118.20(e). Published below is a provisionally-accepted Settlement Agreement with Downeast Concepts, Inc., containing a civil penalty of $30,000.00.
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Family Dollar Stores, Inc., Provisional Acceptance of a Settlement Agreement and Order
- Type
- Notice
- Length
- 2 pages
It is the policy of the Commission to publish settlements which it provisionally accepts under the Consumer Product Safety Act in the Federal Register in accordance with the terms of 16 CFR 1118.20(e). Published below is a provisionally-accepted Settlement Agreement with Family Dollar Stores, Inc., containing a civil penalty of $75,000.00.
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First Learning Company Limited, Provisional Acceptance of a Settlement Agreement and Order
- Type
- Notice
- Length
- 3 pages
It is the policy of the Commission to publish settlements which it provisionally accepts under the Consumer Product Safety Act in the Federal Register in accordance with the terms of 16 CFR 1118.20(e). Published below is a provisionally-accepted Settlement Agreement with First Learning Company Limited, containing a civil penalty of $50,000.00.
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Haier America Trading, LLC, Provisional Acceptance of a Settlement Agreement and Order
- Type
- Notice
- Length
- 3 pages
It is the policy of the Commission to publish settlements which it provisionally accepts under the Consumer Product Safety Act in the Federal Register in accordance with the terms of 16 CFR 1118.20(e). Published below is a provisionally accepted Settlement Agreement with Haier America Trading, LLC, containing a civil penalty of $587,500.00.
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Hobby Lobby Stores, Inc., Provisional Acceptance of a Settlement Agreement and Order
- Type
- Notice
- Length
- 2 pages
It is the policy of the Commission to publish settlements which it provisionally accepts under the Consumer Product Safety Act in the Federal Register in accordance with the terms of 16 CFR 1118.20(e). Published below is a provisionally-accepted Settlement Agreement with Hobby Lobby Stores, Inc., containing a civil penalty of $50,000.00.
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Michaels Stores, Inc., Provisional Acceptance of a Settlement Agreement and Order
- Type
- Notice
- Length
- 3 pages
It is the policy of the Commission to publish settlements which it provisionally accepts under the Consumer Product Safety Act in the Federal Register in accordance with the terms of 16 CFR 1118.20(e). Published below is a provisionally-accepted Settlement Agreement with Michaels Stores, Inc., containing a civil penalty of $45,000.00.
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Raymond Geddes & Co., Provisional Acceptance of a Settlement Agreement and Order
- Type
- Notice
- Length
- 3 pages
It is the policy of the Commission to publish settlements which it provisionally accepts under the Consumer Product Safety Act in the Federal Register in accordance with the terms of 16 CFR 1118.20(e). Published below is a provisionally-accepted Settlement Agreement with Raymond Geddes & Co., containing a civil penalty of $40,000.00.
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A&A Global Industries, Inc., Provisional Acceptance of a Settlement Agreement and Order
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Department of Commerce 15 entries
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Foreign-Trade Zone 82, Application for Subzone Authority, ThyssenKrupp Steel and Stainless USA, LLC, Notice of Public Hearing and Reopening of Comment Period
- Type
- Notice
- Length
- 1 page
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Submission for OMB Review; Comment Request
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- Notice
- Length
- 1 page
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Submission for OMB Review; Comment Request
- Type
- Notice
- Length
- 2 pages
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Bureau of Industry and Security 1 entry
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Action Affecting Export Privileges; Micei International; In the Matter of: Micei International, R...
- Type
- Notice
- Length
- 1 page
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Action Affecting Export Privileges; Micei International; In the Matter of: Micei International, R...
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International Trade Administration 5 entries
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Antidumping or Countervailing Duty Order, Finding, or Suspended Investigation; Advance Notificati...
- Type
- Notice
- Length
- 1 page
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Antidumping or Countervailing Duty Order, Finding, or Suspended Investigation; Opportunity To Req...
- Type
- Notice
- Length
- 3 pages
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Certain Tow Behind Lawn Groomers and Certain Parts Thereof from the People's Republic of China: A...
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- Notice
- Length
- 3 pages
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Certain Tow-Behind Lawn Groomers and Certain Parts Thereof From the People's Republic of China: C...
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- Notice
- Length
- 3 pages
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Initiation of Five-year (“Sunsetâ€) Review
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- Notice
- Length
- 2 pages
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Antidumping or Countervailing Duty Order, Finding, or Suspended Investigation; Advance Notificati...
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United States Patent and Trademark Office 1 entry
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Submission for OMB Review; Comment Request
- Type
- Notice
- Length
- 2 pages
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Submission for OMB Review; Comment Request
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National Oceanic and Atmospheric Administration 5 entries
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Availability of Seats for the Florida Keys National Marine Sanctuary Advisory Council
- Type
- Notice
- Length
- 1 page
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Fisheries of the South Atlantic; South Atlantic Fishery Management Council; Public Meeting
- Type
- Notice
- Length
- 1 page
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Fisheries of the South Atlantic; South Atlantic Fishery Management Council; Public Meeting
- Type
- Notice
- Length
- 1 page
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Gulf of Mexico Fishery Management Council; Public Meeting
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- Notice
- Length
- 2 pages
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Pacific Fishery Management Council; Public Meetings
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- Notice
- Length
- 2 pages
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Availability of Seats for the Florida Keys National Marine Sanctuary Advisory Council
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Foreign-Trade Zone 82, Application for Subzone Authority, ThyssenKrupp Steel and Stainless USA, LLC, Notice of Public Hearing and Reopening of Comment Period
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Department of Transportation 8 entries
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Activation of Ice Protection
- Type
- Rule
- Length
- 13 pages
The Federal Aviation Administration amends the airworthiness standards applicable to transport category airplanes certificated for flight in icing conditions. The rule requires a means to ensure timely activation of the airframe ice protection system. This rule is the result of information gathered from a review of icing accidents and incidents, and will improve the level of safety for new airplane designs for operations in icing conditions.
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Airworthiness Directives; Bell Helicopter Textron Canada Model 427 Helicopters
- Type
- Rule
- Length
- 2 pages
We are adopting a new airworthiness directive (AD) for Bell Helicopter Textron Canada (BHTC) Model 427 helicopters. This AD results from mandatory continuing airworthiness information (MCAI) originated by the aviation authority of Canada to identify and correct an unsafe condition on an aviation product. Transport Canada, the aviation authority of Canada, with which we have a bilateral agreement, states that it has been determined that the existing hardware connecting the vertical fin to the tail rotor gearbox needs to be upgraded to prevent the vertical fin from becoming loose.
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Airworthiness Directives; Eurocopter France Model AS 332 C, L, L1, and L2; AS 350 B3; AS 355 F, F1, F2, and N; SA 365 N and N1; AS 365 N2 and N3; SA 366 G1; EC 130 B4; and EC 155B and B1 Helicopters
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- Proposed Rule
- Length
- 3 pages
We propose to adopt a new airworthiness directive (AD) for the specified model helicopters. This proposed AD results from mandatory continuing airworthiness information (MCAI) originated by the European Aviation Safety Agency (EASA), which is the Technical Agent for the Member States of the European Community. The MCAI states that the AD is issued following a manufacturing nonconformity found on one batch of the servo-control caps. With a defective servo-control, rotation of the distributor might not be stopped mechanically since only friction of inner seals holds the distributor sleeve in its position. The proposed
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Petition for Waiver of Compliance
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- Notice
- Length
- 1 page
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Petition for Waiver of Compliance
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- Notice
- Length
- 2 pages
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Petition for Waiver of Compliance
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- Notice
- Length
- 1 page
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Petition for Waiver of Compliance
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- Notice
- Length
- 2 pages
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Qualification of Drivers; Exemption Applications; Diabetes
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- Notice
- Length
- 2 pages
FMCSA announces its decision to exempt twenty-one individuals from its rule prohibiting persons with insulin-treated diabetes mellitus (ITDM) from operating commercial motor vehicles (CMVs) in interstate commerce. The exemptions will enable these individuals to operate CMVs in interstate commerce.
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Activation of Ice Protection
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United States Postal Service 1 entry
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Advertisements for Animals and Sharp Instruments for Use in Animal Fighting Ventures Are Nonmailable
- Type
- Proposed Rule
- Length
- 2 pages
The Postal Service proposes to revise our mailing standards pertaining to animal fighting ventures. We intend to harmonize our standards with section 26 (7 U.S.C. 2156) of the Animal Welfare Act as amended by the Food, Conservation, and Energy Act of 2008.
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Advertisements for Animals and Sharp Instruments for Use in Animal Fighting Ventures Are Nonmailable
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Nuclear Regulatory Commission 6 entries
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Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB) Review; Comment Request
- Type
- Notice
- Length
- 1 page
The NRC has recently submitted to OMB for review the following proposal for the collection of information under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). The NRC hereby informs potential respondents that an agency may not conduct or sponsor, and that a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The NRC published a Federal Register Notice with a 60-day comment period on this information collection on April 8, 2009.
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Establishment of Atomic Safety and Licensing Board;
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- Notice
- Length
- 1 page
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Fitness for Duty Programs
- Type
- Rule
- Length
- 3 pages
This document corrects a final rule appearing in the Federal Register on March 31, 2008 (73 FR 16965), that amended the Nuclear Regulatory Commission's (NRC's) regulations that govern fitness for duty programs. This document is necessary to correct erroneous language in the preamble and codified language of the final rule. These corrections include fixing typographical errors and cross-references, revising language in the preamble to clarify unintended discrepancies with the codified rule text, and making non-substantive changes to the rule text that do not modify any requirements in the final rule.
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Florida Power & Light Company; Notice of Receipt and Availability of Application for a Combined License
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- Notice
- Length
- 1 page
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In the Matter of: Entergy Nuclear Operations, Inc.; Entergy Nuclear Generation Co. (Pilgrim Nuclear Power Station); Entergy Nuclear Indian Point 2, LLC (Indian Point Nuclear Generating Unit Nos. 1 and 2) and 72-51 Entergy Nuclear Indian Point 3, LLC (Indian Point Nuclear Generating Unit No. 3), Entergy Nuclear FitzPatrick, LLC (James A. FitzPatrick Nuclear Power Plant), Entergy Nuclear Vermont Yankee, LLC; (Vermont Yankee Nuclear Power Station), Entergy Nuclear Palisades, LLC (Palisades Nuclear Plant) (Big Rock Point); Order Extending the Effectiveness of the Approval of the Indirect Transfer of Facility Operating Licenses
- Type
- Notice
- Length
- 2 pages
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Limiting the Quantity of Byproduct Material in a Generally Licensed Device
- Type
- Proposed Rule
- Length
- 10 pages
The U.S. Nuclear Regulatory Commission (NRC) is proposing to amend its regulations to limit the quantity of byproduct material contained in a generally licensed device to below one-tenth (1/10) of the International Atomic Energy Agency (IAEA) Category 3 thresholds. As a result of this amendment, individuals possessing devices with byproduct material meeting or exceeding these thresholds would be required to apply for and obtain a specific license. The NRC is also proposing to further clarify the requirements that apply when a device authorized to be used under the general license is instead held under a specific license. The proposed amendments would also modify the Compatibility Categories contained in the current regulations.
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Agency Information Collection Activities: Submission for the Office of Management and Budget (OMB) Review; Comment Request
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Environmental Protection Agency 6 entries
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Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment Request; Consolidated Emissions Reporting Rule (Renewal); EPA ICR No. 0916.13, OMB Control No. 2060-0088
- Type
- Notice
- Length
- 2 pages
In compliance with the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.), this document announces that an Information Collection Request (ICR) has been forwarded to the Office of Management and Budget (OMB) for review and approval. This is a request to renew an existing approved collection. The ICR, which is abstracted below, describes the nature of the information collection and its estimated burden and cost.
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Approval and Promulgation of State Air Quality Plans For Designated Facilities and Pollutants, West Virginia; Control of Emissions From Commercial and Industrial Solid Waste Incinerator Units, Plan Revision
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- Rule
- Length
- 3 pages
EPA is taking direct final action to approve a revision to the West Virginia (WV) commercial and industrial solid waste incinerator (CISWI) 111(d)/129 plan (the ``plan''). The revision contains a modified WV Department of Environmental Protection, Division of Air Quality (DAQ) rule that streamlines and consolidates the state's regulatory structure (WV45CSR6, 18 and 24) for incinerator units and incorporates applicable Clean Air Act (CAA), section 129, requirements into one rule, WV45CSR18. This approval action relates only to CISWI units. The streamlining of the state's regulatory structure of its incinerator rules is not an EPA requirement.
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Approval and Promulgation of State Air Quality Plans for Designated Facilities and Pollutants, West Virginia; Control of Emissions From Hospital/Medical/Infectious Waste Incinerator Units, Plan Revision
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- Rule
- Length
- 3 pages
EPA is taking direct final action to approve a revision to the West Virginia (WV) hospital/medical/infectious waste incinerator (HMIWI) 111(d)/129 plan (the ``plan''). The revision contains a modified WV Department of Environmental Protection, Division of Air Quality (DAQ) rule that streamlines the State's regulatory structure (WV45CSR6, 18, and 24) for incinerator units and incorporates applicable Clean Air Act (CAA), section 129, requirements into one rule, WV45CSR18. This approval action relates only to HMIWI units. The streamlining of the State's regulatory structure of its incinerator rules is not an EPA requirement.
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Approval and Promulgation of State Air Quality Plans for Designated Facilities and Pollutants; West Virginia; Control of Emissions From Existing Commercial and Industrial Incineration (CISWI) Units, Plan Revision
- Type
- Proposed Rule
- Length
- 2 pages
EPA proposes to approve a revision to the West Virginia (WV) commercial and industrial solid waste incinerator (CISWI) 111(d)/129 plan (the ``plan''). The revision contains a modified WV Department of Environmental Protection, Division of Air Quality (DAQ) rule, WV45CSR18, that streamlines the state's regulatory structure for incinerator units into one rule which incorporates Clean Air Act (CAA), section 129 requirements. This approval action relates only to CISWI units. In the Final Rules section of this Federal Register, EPA is approving the State of West Virginia's CISWI plan revision submittal as a direct final rule without prior proposal because the Agency views this as a noncontroversial action and anticipate no adverse comments. A detailed rationale for the approval is set forth in the direct final rule. If no adverse comments are received in response to this action, no further activity is contemplated. If EPA receives adverse comments, the direct final rule will be withdrawn and all public comments
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Approval and Promulgation of State Air Quality Plans for Designated Facilities and Pollutants; West Virginia; Control of Emissions From Existing Hospital/Medical/Infectious Waste Incinerator Units, Plan Revision
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- Proposed Rule
- Length
- 2 pages
EPA proposes to approve a revision to the West Virginia (WV) hospital/medical/infectious waste incinerator (HMIWI) 111(d)/129 plan (the ``plan''). The revision contains a modified WV Department of Environmental Protection, Division of Air Quality (DAQ) rule, WV45CSR18, that streamlines and consolidates the state's regulatory structure for incinerator units into one rule which incorporates Clean Air Act (CAA), section 129, requirements. This approval action relates only to HMIWI units. In the Final Rules section of this Federal Register, EPA is approving the State of West Virginia's HMIWI plan revision submittal as a direct final rule without prior proposal because the Agency views this as a noncontroversial action and anticipates no adverse comments. A detailed rationale for the approval is set forth in the direct final rule. If no adverse comments are received in response to this action, no further activity is contemplated. If EPA receives adverse comments, the direct final rule
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Expedited Approval of Alternative Test Procedures for the Analysis of Contaminants Under the Safe Drinking Water Act; Analysis and Sampling Procedures
- Type
- Rule
- Length
- 11 pages
This action announces the Environmental Protection Agency's (EPA's) approval of alternative testing methods for use in measuring the levels of contaminants in drinking water and determining compliance with national primary drinking water regulations. The Safe Drinking Water Act (SDWA) authorizes EPA to approve the use of alternative testing methods through publication in the Federal Register. EPA is using this streamlined authority to make six additional methods available for analyzing drinking water samples required by regulation. This expedited approach provides public water systems, laboratories, and primacy agencies with more timely access to new measurement techniques and greater flexibility in the selection of analytical methods, thereby reducing monitoring costs while maintaining public health protection.
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Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment Request; Consolidated Emissions Reporting Rule (Renewal); EPA ICR No. 0916.13, OMB Control No. 2060-0088
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United States Commission on Civil Rights 1 entry
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Agenda and Notice of Public Meeting of the New Hampshire Advisory Committee
- Type
- Notice
- Length
- 1 page
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Agenda and Notice of Public Meeting of the New Hampshire Advisory Committee
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Department of State 1 entry
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Amendment to the International Traffic in Arms Regulations: Congressional Certification Regarding South Korea
- Type
- Rule
- Length
- 3 pages
The Department of State is amending the International Traffic in Arms Regulations (ITAR) regarding Congressional certification for the Republic of Korea (also referred to as South Korea). South Korea is now in the same category as the countries in the North Atlantic Treaty Organization (NATO), Japan, Australia, and New Zealand concerning certification to Congress, requiring such certification prior to granting any license for export of major defense equipment sold under a contract in the amount of $25,000,000 or more, or for defense articles or defense services sold under a contract in the amount of $100,000,000 or more, provided the transfer does not include any other countries. The ITAR is being amended at numerous sections to reflect these statutory changes and to update two provisions.
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Amendment to the International Traffic in Arms Regulations: Congressional Certification Regarding South Korea
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Department of Health and Human Services 15 entries
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Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2010
- Type
- Notice
- Length
- 6 pages
The Food and Drug Administration (FDA) is announcing the rates and payment procedures for fiscal year (FY) 2010 animal drug user fees. The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Animal Drug User Fee Act of 2003 (ADUFA) and the Animal Drug User Fee Amendments of 2008 (ADUFA II), authorizes FDA to collect user fees for certain animal drug applications and supplements, on certain animal drug products, on certain establishments where such products are made, and on certain sponsors of such animal drug applications and/or investigational animal drug submissions. This notice establishes the fee rates for FY 2010.
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Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2010
- Type
- Notice
- Length
- 4 pages
The Food and Drug Administration (FDA) is announcing the rates and payment procedures for fiscal year (FY) 2010 generic new animal drug user fees. The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Animal Generic Drug User Fee Act of 2008 (AGDUFA), authorizes FDA to collect user fees for certain abbreviated applications for generic new animal drugs, on certain generic new animal drug products, and on certain sponsors of such abbreviated applications for generic new animal drugs and/or investigational submissions for generic new animal drugs. This notice establishes the fee rates for FY 2010.
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Draft Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Leafy Greens; Availability
- Type
- Notice
- Length
- 2 pages
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Leafy Greens.'' This draft guidance is intended to cover the entire leafy greens supply chain, both domestic firms and foreign firms exporting leafy greens products into the United States, to enhance the safety of leafy greens by recommending practices to minimize microbial food safety hazards and to prevent microbial contamination. This draft guidance, when finalized, will supplement existing FDA guidances, including the 1998 ``Guidance to Industry: Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables,'' which applies to fresh produce commodities, and the 2008 ``Guidance to Industry: Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables,'' which applies to fresh-cut produce.
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Draft Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Melons; Availability
- Type
- Notice
- Length
- 2 pages
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Melons.'' This draft guidance is intended to cover the entire melon supply chain, both domestic firms and foreign firms exporting melons into the United States, to enhance the safety of melons by recommending practices to minimize microbial food safety hazards and to prevent microbial contamination. This draft guidance, when finalized, will supplement existing FDA guidances, including the 1998 ``Guidance to Industry: Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables,'' which applies to fresh produce commodities, and the 2008 ``Guidance to Industry: Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables,'' which applies to fresh-cut produce.
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Draft Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Tomatoes; Availability
- Type
- Notice
- Length
- 2 pages
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Tomatoes.'' This guidance is intended to cover the entire tomato supply chain, both domestic firms and foreign firms exporting tomatoes into the United States, to enhance the safety of tomatoes by recommending practices to minimize microbial food safety hazards and to prevent microbial contamination. This draft guidance, when finalized, will supplement existing FDA guidances, including the 1998 ``Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards for Fresh Fruits and Vegetables,'' which applies to fresh produce commodities, and the 2008 ``Guidance for Industry: Guide to Minimize Microbial Food Safety Hazards of Fresh-cut Fruits and Vegetables,'' which applies to fresh- cut produce.
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Government-Owned Inventions; Availability for Licensing
- Type
- Notice
- Length
- 3 pages
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.
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Government-Owned Inventions; Availability for Licensing
- Type
- Notice
- Length
- 3 pages
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.
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Medical Device User Fee Rates for Fiscal Year 2010
- Type
- Notice
- Length
- 6 pages
The Food and Drug Administration (FDA) is announcing the fee rates and payment procedures for medical device user fees for fiscal year (FY) 2010. The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device User Fee and Modernization Act of 2002 (MDUFMA), the Medical Device User Fee Stabilization Act of 2005 (MDUFSA), and the Medical Device User Fee Amendments of 2007 (title II of the Food and Drug Administration Amendments Act of 2007 (FDAAA)), authorizes FDA to collect user fees for certain medical device submissions, and annual fees both for certain periodic reports and for certain establishments subject to registration. The FY 2010 fee rates are provided in this document. These fees apply from October 1, 2009, through September 30, 2010. To avoid delay in the review of your application, you should pay the fee before or at the time you submit your application to FDA. The fee you must pay is the fee that is in effect on the later of the date that your application is received by FDA or the date your fee payment is received. If you want to pay a reduced small business fee, you must qualify as a small business before you make your submission to FDA; if you do not qualify as a small business before you make your submission to FDA, you will have to pay the higher standard fee. This document provides information on how the fees for FY 2010 were determined, the payment procedures you should follow, and how you may qualify for reduced small business fees.
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National Cancer Institute; Notice of Meeting
- Type
- Notice
- Length
- 1 page
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National Institute of Biomedical Imaging and Bioengineering; Notice of Meeting
- Type
- Notice
- Length
- 1 page
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New Animal Drugs; Nitrofurazone Ointment
- Type
- Rule
- Length
- 2 pages
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original abbreviated new animal drug application (ANADA) filed by First Priority, Inc. The ANADA provides for use of nitrofurazone ointment on horses for prevention or treatment of superficial bacterial infections.
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Notice of Meeting; Moving Into the Future-New Dimensions and Strategies for Women's Health Research for the National Institutes of Health
- Type
- Notice
- Length
- 2 pages
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Prescription Drug User Fee Rates for Fiscal Year 2010
- Type
- Notice
- Length
- 6 pages
The Food and Drug Administration (FDA) is announcing the rates for prescription drug user fees for fiscal year (FY) 2010. The Federal Food, Drug, and Cosmetic Act (the act), as amended by the Prescription Drug User Fee Amendments of 2007 (Title 1 of the Food and Drug Administration Amendments Act of 2007 (FDAAA)) (PDUFA IV), authorizes FDA to collect user fees for certain applications for approval of drug and biological products, on establishments where the products are made, and on such products. Base revenue amounts to be generated from PDUFA fees were established by PDUFA IV, with provisions for certain adjustments. Fee revenue amounts for applications, establishments, and products are to be established each year by FDA so that one-third of the PDUFA fee revenues FDA collects each year will be generated from each of these categories. This notice establishes fee rates for FY 2010 for application fees for an application requiring clinical data ($1,405,500), for an application not requiring clinical data or a supplement requiring clinical data ($702,750), for establishment fees ($457,200), and for product fees ($77,720). These fees are effective on October 1, 2009, and will remain in effect through September 30, 2010. For applications and supplements that are submitted on or after October 1, 2009, the new fee schedule must be used. Invoices for establishment and product fees for FY 2010 will be issued in August 2009, using the new fee schedule.
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Privacy Act of 1974; Report of Altered Systems of Records
- Type
- Notice
- Length
- 7 pages
In accordance with the requirements of the Privacy Act of 1974, the Health Resources and Services Administration (HRSA) is proposing to alter four existing systems of records (SORs) for the reasons indicated below:
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Seafood Hazard Analysis and Critical Control Points Alliance for Education and Training (U18)
- Type
- Notice
- Length
- 2 pages
The Food and Drug Administration (FDA) is announcing its intention to receive and consider a single source application for the award of a cooperative agreement in fiscal year 2009 (FY09) to the University of Florida for the support of the Seafood Hazard Analysis and Critical Control Points (HACCP) Alliance for Education and Training. The goal of the Seafood HACCP Alliance for Education and Training is to provide partial support, periodic clerical assistance, and personnel travel to national and international events and committee meetings.
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Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2010
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Department of Homeland Security 6 entries
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Arkansas; Amendment No. 2 to Notice of a Major Disaster Declaration
- Type
- Notice
- Length
- 1 page
This notice amends the notice of a major disaster declaration for the State of Arkansas (FEMA-1845-DR), dated June 16, 2009, and related determinations.
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Illinois; Amendment No. 1 to Notice of a Major Disaster Declaration
- Type
- Notice
- Length
- 1 page
This notice amends the notice of a major disaster declaration for the State of Illinois (FEMA-1850-DR), dated July 2, 2009, and related determinations.
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Kansas; Amendment No. 1 to Notice of a Major Disaster Declaration
- Type
- Notice
- Length
- 1 page
This notice amends the notice of a major disaster declaration for the State of Kansas (FEMA-1848-DR), dated June 24, 2009, and related determinations.
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Proposed Flood Elevation Determinations
- Type
- Proposed Rule
- Length
- 3 pages
Comments are requested on the proposed Base (1% annual-chance) Flood Elevations (BFEs) and proposed BFE modifications for the communities listed in the table below. The purpose of this notice is to seek general information and comment regarding the proposed regulatory flood elevations for the reach described by the downstream and upstream locations in the table below. The BFEs and modified BFEs are a part of the floodplain management measures that the community is required either to adopt or show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP). In addition, these elevations, once finalized, will be used by insurance agents, and others to calculate appropriate flood insurance premium rates for new buildings and the contents in those buildings.
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Suspension of Community Eligibility
- Type
- Rule
- Length
- 5 pages
This rule identifies communities, where the sale of flood insurance has been authorized under the National Flood Insurance Program (NFIP), that are scheduled for suspension on the effective dates listed within this rule because of noncompliance with the floodplain management requirements of the program. If the Federal Emergency Management Agency (FEMA) receives documentation that the community has adopted the required floodplain management measures prior to the effective suspension date given in this rule, the suspension will not occur and a notice of this will be provided by publication in the Federal Register on a subsequent date.
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Tennessee; Major Disaster and Related Determinations
- Type
- Notice
- Length
- 1 page
This is a notice of the Presidential declaration of a major disaster for the State of Tennessee (FEMA-1851-DR), dated July 13, 2009, and related determinations.
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Arkansas; Amendment No. 2 to Notice of a Major Disaster Declaration
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United States International Trade Commission 1 entry
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Barbed Wire and Barbless Wire Strand From Argentina
- Type
- Notice
- Length
- 4 pages
The Commission hereby gives notice that it has instituted a review pursuant to section 751(c) of the Tariff Act of 1930 (19 U.S.C. 1675(c)) (the Act) to determine whether revocation of the antidumping duty order on barbed wire and barbless wire strand from Argentina would be likely to lead to continuation or recurrence of material injury. Pursuant to section 751(c)(2) of the Act, interested parties are requested to respond to this notice by submitting the information specified below to the Commission; \1\ to be assured of consideration, the deadline for responses is September 2, 2009. Comments on the adequacy of responses may be filed with the Commission by October 19, 2009. 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), as most recently amended at 74 FR 2847 (January 16, 2009).
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Barbed Wire and Barbless Wire Strand From Argentina
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Department of Justice 9 entries
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Civil Division; Agency Information Collection Activities: Revision of a Currently Approved Collection
- Type
- Notice
- Length
- 1 page
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Notice of Lodging of Amendment to Consent Decrees Under the Clean Water Act
- Type
- Notice
- Length
- 2 pages
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Notice of Lodging of Consent Decree Under the Clean Air Act
- Type
- Notice
- Length
- 1 page
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Notice of Lodging of Consent Decree Under the Comprehensive Environmental Response, Compensation, and Liability Act
- Type
- Notice
- Length
- 1 page
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Notice Pursuant to the National Cooperative Research and Production Act of 1993-Cooperative Research Group on Clean Diesel V
- Type
- Notice
- Length
- 1 page
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Notice Pursuant to the National Cooperative Research and Production Act of 1993-Cooperative Research Group on High Efficiency Dilute Gasoline Engine II
- Type
- Notice
- Length
- 1 page
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Notice Pursuant to the National Cooperative Research and Production Act of 1993-Institute of Electrical and Electronic Engineers
- Type
- Notice
- Length
- 1 page
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Notice Pursuant to the National Cooperative Research and Production Act of 1993-Interchangeable Virtual Instruments Foundation, Inc.
- Type
- Notice
- Length
- 2 pages
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Notice Pursuant to the National Cooperative Research and Production Act of 1993-PXI Systems Alliance, Inc.
- Type
- Notice
- Length
- 1 page
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Civil Division; Agency Information Collection Activities: Revision of a Currently Approved Collection
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Department of Energy 1 entry
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Combined Notice of Filings No. 1
- Type
- Notice
- Length
- 1 page
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Combined Notice of Filings No. 1
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Department of the Treasury 3 entries
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Departmental Offices; Privacy Act of 1974, as Amended
- Type
- Notice
- Length
- 3 pages
Pursuant to the provisions of the Privacy Act of 1974 (5 U.S.C. 552a), the U.S. Department of the Treasury (``Treasury'' or the ``Department'') is giving notice that it proposes to establish a new system of records necessary to administer the Home Affordable Modification Program and related homeownership preservation programs (``HAMP'').
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Notice and Request for Comments
- Type
- Notice
- Length
- 3 pages
The U.S. Department of the Treasury, 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)). Currently, the Community Development Financial Institutions Fund (the Fund) is soliciting comments concerning the ``New Markets Tax Credit (NMTC) Program--Allocation Application'' (hereafter, the Application).
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Senior Executive Service; Social Inspector General for the Troubled Asset Relief Program; Performance Review Board
- Type
- Notice
- Length
- 1 page
Pursuant to 5 U.S.C. 4314(c)(4), this notice announces the appointment of members of the Special Inspector General for the Troubled Asset Relief Program Performance Review Board (PRB). The purpose of this Board is to review and make recommendations concerning proposed performance appraisals, ratings, bonuses and other appropriate personnel actions for incumbents of SES positions in SIGTARP. The Board will perform PRB functions for other bureau positions if requested.
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Departmental Offices; Privacy Act of 1974, as Amended
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Department of Defense 13 entries
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Federal Acquisition Regulation; Submission for OMB Review; Change Order Accounting
- Type
- Notice
- Length
- 2 pages
Under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Federal Acquisition Regulation (FAR) Secretariat will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension of a currently approved information collection requirement concerning change order accounting. A request for public comments was published in the Federal Register at 74 FR 18718, April 24, 2009. No comments were received.
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Federal Acquisition Regulation; Submission for OMB Review; Debarment and Suspension
- Type
- Notice
- Length
- 1 page
Under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35), the Federal Acquisition Regulation (FAR) Secretariat will be submitting to the Office of Management and Budget (OMB) a request to review and approve an extension of a currently approved information collection requirement concerning [subject]. A request for public comments was published in the Federal Register at 74 FR 18716 on April 24, 2009. No comments were received.
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Notice of Availability of Government-Owned Inventions; Available for Licensing
- Type
- Notice
- Length
- 1 page
The inventions listed below are assigned to the United States Government as represented by the Secretary of the Navy and are available for domestic and foreign licensing by the Department of the Navy.
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Notice of Intent To Grant Exclusive Patent License; Southern Indiana Innovators, LLC
- Type
- Notice
- Length
- 2 pages
The invention listed below is assigned to the United States Government as represented by the Secretary of the Navy. The Department of the Navy hereby gives notice of its intent to grant to Southern Indiana Innovators, LLC, a revocable, nonassignable, exclusive license to practice in the United States, the Government-owned invention described below:
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Proposed Collection; Comment Request
- Type
- Notice
- Length
- 2 pages
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Proposed Collection; Comment Request
- Type
- Notice
- Length
- 2 pages
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Proposed Collection; Comment Request
- Type
- Notice
- Length
- 2 pages
In compliance with section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Office of Admissions announces the proposed extension of a public information collection and seeks public comment on provisions thereof. 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 information collection; (c) ways to enhance the quality, unity, and clarity of the information to be collected; (d) ways to minimize the burden of the information collection on respondents, including the use of automated collection techniques or other forms of information technology.
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Proposed Collection; Comment Request
- Type
- Notice
- Length
- 1 page
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Proposed Collection; Comment Request
- Type
- Notice
- Length
- 2 pages
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Submission for OMB Review; Comment Request
- Type
- Notice
- Length
- 1 page
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Submission for OMB Review; Comment Request
- Type
- Notice
- Length
- 1 page
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Submission for OMB Review; Comment Request
- Type
- Notice
- Length
- 2 pages
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Submission for OMB Review; Comment Request
- Type
- Notice
- Length
- 1 page
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Federal Acquisition Regulation; Submission for OMB Review; Change Order Accounting
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Federal Reserve System 1 entry
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Formations of, Acquisitions by, and Mergers of Bank Holding Companies
- Type
- Notice
- Length
- 1 page
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Formations of, Acquisitions by, and Mergers of Bank Holding Companies
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Department of Agriculture 5 entries
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Grapes Grown in a Designated Area of Southeastern California and Imported Table Grapes; Relaxation of Handling Requirements
- Type
- Rule
- Length
- 2 pages
The Department of Agriculture (USDA) is adopting, as a final rule, without change, an interim final rule that relaxed the handling requirements prescribed under the California table grape marketing order (order) and the table grape import regulation. The interim final rule relaxed the minimum bunch size requirement for the 2009 season for grapes packed in containers holding 2 pounds net weight or less. Under the relaxation, up to 20 percent of the weight of such containers may consist of single clusters weighing less than one quarter pound, but with at least five berries each. The interim final rule was necessary to provide California desert grape handlers and importers the flexibility to respond to a marketing opportunity on a test basis for one season to meet consumer needs.
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Olives Grown in California; Increased Assessment Rate
- Type
- Rule
- Length
- 3 pages
The Department of Agriculture (USDA) is adopting, as a final rule, without change, an interim final rule that changed the assessment rate established under the marketing order (order) for olives grown in California for the 2009 and subsequent fiscal years. The interim final rule increased the assessment rate from $15.60 to $28.63 per assessable ton of olives handled. The interim final rule was necessary to provide adequate operating funds for the California Olive Committee (committee), which administers the order locally.
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Tri-State Generation and Transmission Association, Inc., Notice of Intent To Hold Public Scoping Meetings and Prepare an Environmental Assessment
- Type
- Notice
- Length
- 2 pages
The Rural Utilities Service (RUS) intends to hold public scoping meetings and prepare an Environmental Assessment (EA) to meet its responsibilities under the National Environmental Policy Act (NEPA) and 7 CFR part 1794 in connection with potential impacts related to a proposed project in Colorado by Tri-State Generation and Transmission Association, Inc. (Tri-State) and Public Service Company of Colorado (Public Service), an Xcel Energy Operating Company. The proposed San Luis Valley-Calumet-Comanche Transmission Project (proposed action) consists of the following: a proposed 230/345-kilovolt (kV) Calumet Substation to be located approximately 6 miles north of the existing Walsenburg Substation in Huerfano County; a proposed double-circuit 230-kV transmission line between the existing San Luis Valley Substation in Alamosa County and the Calumet Substation; a proposed single-circuit 230-kV transmission line between the Calumet Substation and the Walsenburg Substation; and a proposed double-circuit 345-kV transmission line connecting the Calumet Substation to the existing Comanche Substation in Pueblo County. Tri-State is requesting that RUS provide financial assistance for the proposed action.
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Cooperative State Research, Education, and Extension Service 1 entry
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Notice of Funding Availability for the Healthy Urban Food Enterprise Development Center Request f...
- Type
- Notice
- Length
- 1 page
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Notice of Funding Availability for the Healthy Urban Food Enterprise Development Center Request f...
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Animal and Plant Health Inspection Service 1 entry
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National Poultry Improvement Plan and Auxiliary Provisions; Technical Amendment
- Type
- Rule
- Length
- 1 page
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National Poultry Improvement Plan and Auxiliary Provisions; Technical Amendment
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Grapes Grown in a Designated Area of Southeastern California and Imported Table Grapes; Relaxation of Handling Requirements
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Department of the Interior 3 entries
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MMS Information Collection Activity: 1010-0128, Subpart O, Well Control and Production Safety Training, Extension of a Collection; Submitted for Office of Management and Budget (OMB) Review; Comment Request
- Type
- Notice
- Length
- 2 pages
To comply with the Paperwork Reduction Act of 1995 (PRA), we are notifying the public that we have submitted to OMB an information collection request (ICR) to renew approval of the paperwork requirements in the regulations under 30 CFR 250, Subpart O, Well Control and Production Safety Training, and related documents. This notice also provides the public a second opportunity to comment on the paperwork burden of these regulatory requirements.
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Notice of Intent (NOI) To Prepare an Environmental Impact Statement for the LaBarge Platform Project, Sublette County and Lincoln County, WY
- Type
- Notice
- Length
- 2 pages
The Bureau of Land Management (BLM) Field Office, Pinedale, WY, intends to prepare an Environmental Impact Statement (EIS) and to solicit public comments pursuant to section 102(2)(C) of the National Environmental Policy Act (NEPA) of 1969 and in response to a proposal filed by EOG Resources, Inc. (EOG) regarding issues and resource information for the proposed LaBarge Platform Project, Sublette County and Lincoln County, Wyoming. The project is primarily a natural gas exploration and development project.
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Notice of Inventory Completion: St. Lawrence University, Department of Anthropology, Canton, NY; Correction
- Type
- Notice
- Length
- 2 pages
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MMS Information Collection Activity: 1010-0128, Subpart O, Well Control and Production Safety Training, Extension of a Collection; Submitted for Office of Management and Budget (OMB) Review; Comment Request
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Department of Labor 2 entries
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Notification of Employee Rights Under Federal Labor Laws
- Type
- Proposed Rule
- Length
- 14 pages
This Notice of Proposed Rulemaking (NPRM) proposes a regulation to implement Executive Order 13496, which was signed by President Barack Obama on January 30, 2009. Executive Order 13496 (``the Executive Order,'' ``the Order,'' or ``EO 13496'') requires nonexempt Federal departments and agencies to include within their Government contracts specific provisions requiring that contractors and subcontractors with whom they do business post notices informing their employees of their rights as employees under Federal labor laws. The Executive Order requires the Secretary (``Secretary'') of the Department of Labor (``Department'') to initiate a rulemaking to prescribe the size, form, and content of the notice that must be posted by a contractor under paragraph 1 of the contract clause described in section 2 of the Order. Under the Executive Order, Federal Government contracting departments and agencies must include the required contract provisions in every Government contract, except for collective bargaining agreements and contracts for purchases under the Simplified Acquisition Threshold, and except in those cases in which the Secretary exempts a contracting department or agency with respect to particular contracts or subcontracts or class of contracts or subcontracts pursuant to section 4 of the Order. As required by the Executive Order, this proposed rule establishes the content of the notice required by the Executive Order's contract clause, and implements other provisions of the Executive Order, including provisions regarding sanctions, penalties, and remedies that may be imposed if the contractor or subcontractor fails to comply with its obligations under the Order and the implementing regulations.
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Office of Workers' Compensation Programs; Proposed Extension of the Approval of Information Collection Requirements
- Type
- Notice
- Length
- 2 pages
The Department of Labor, as part of its continuing effort to reduce paperwork and respondent burden, conducts a preclearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) [44 U.S.C. 3506(c)(2)(A)]. This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the Employment Standards Administration is soliciting comments concerning its proposal to extend the Office of Management and Budget (OMB) approval of the Information Collection: Claim for Medical Reimbursement (Form OWCP-915). A copy of the proposed information collection request can be obtained by contacting the office listed
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Notification of Employee Rights Under Federal Labor Laws
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Securities and Exchange Commission 1 entry
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Federal Communications Commission 3 entries
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Television Broadcasting Services; Boise, ID
- Type
- Proposed Rule
- Length
- 2 pages
The Commission has before it a petition for rulemaking filed by Fisher Broadcasting--Idaho TV, L.L.C. (``Fisher''), the licensee of KBCI-DT, digital channel 28, Boise, Idaho. Fisher requests the substitution of digital channel 9 for digital channel 28 at Boise.
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Television Broadcasting Services; Fort Worth, TX
- Type
- Proposed Rule
- Length
- 2 pages
The Commission has before it a petition for rulemaking filed by CBS Stations Group of Texas, L.P. (``CBS Stations Group'') and Television Station KTXA, L.P. (``KTXA L.P.'') (collectively, ``Joint Petitioners''), the respective licensees of Fort Worth, Texas stations KTVT(TV), channel 11, and KTXA(TV), channel 19. The Joint Petitioners request the substitution of DTV channel 19 for KTVT(TV)'s assigned DTV channel 11 at Fort Worth and the substitution of DTV channel 29 for KTXA(TV)'s assigned DTV channel 19 at Fort Worth.
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Television Broadcasting Services; Hutchinson and Wichita, KS
- Type
- Proposed Rule
- Length
- 1 page
The Commission has before it a petition for rulemaking filed by Sunflower Broadcasting, Inc. (``Sunflower''), the licensee of stations KWCH-DT, Hutchinson, Kansas, DTV channel 12, and KSCW-DT, Wichita, Kansas, DTV channel 19. Sunflower requests the substitution of DTV channel 19 for KWCH-DT's assigned DTV channel 12 at Hutchinson and the substitution of DTV channel 12 for KSCW-DT's assigned DTV channel 19 at Wichita.
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Television Broadcasting Services; Boise, ID
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Other Entries 3 entries
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Implementation of Privacy Act of 1974
- Type
- Proposed Rule
- Length
- 4 pages
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Notice of Issuance of Statement of Federal Financial Accounting Standards (SFFAS) 34, “The Hier...
- Type
- Notice
- Length
- 2 pages
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Rule Implementing the Freedom of Information Act
- Type
- Proposed Rule
- Length
- 6 pages
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Implementation of Privacy Act of 1974
