January 2011 โ Federal Register Recent Federal Regulation Documents
Results 801 - 850 of 2,419
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry and Food and Drug Administration Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information request regarding the Guidance for Industry and FDA Staff; Section 905(j) Reports: Demonstrating Substantial Equivalence for Tobacco Products.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Prescription Drug Advertisements
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
Generic Drug User Fee; Notice of Public Meeting; Reopening of the Comment Period
The Food and Drug Administration (FDA) is reopening until February 23, 2011, the comment period for the notice of public meeting entitled Generic Drug User Fee; Public Meeting; Request for Comments, published in the Federal Register of August 9, 2010 (75 FR 47820). In that notice, FDA announced a public meeting that took place on September 17, 2010, to gather stakeholder input on the development of a generic drug user fee program. FDA is reopening the comment period to permit public consideration of late-received comments and to provide an opportunity for all interested parties to provide information and share views on the matter.
Proposed Information Collection (Veterans Benefits Administration (VBA) Voice of the Veteran (VOV) Pilot Surveys) Activity: Comment Request
The Veterans Benefits Administration (VBA), Department of Veterans Affairs (VA), is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act (PRA) of 1995, Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed new collection, and allow 60 days for public comment in response to the notice. This notice solicits comments information needed to determine beneficiary satisfaction with benefit application and servicing processes for the VBA Compensation and Pension (C&P) Service, Education (EDU) Service, Vocational Rehabilitation and Employment (VR&E) Service and Loan Guaranty (LGY) Service.
Committee on Equal Opportunity in Science and Engineering Solicitation of Recommendations for Membership
The National Science Foundation (NSF) solicits recommendations for membership on the Committee on Equal Opportunities in Science and Engineering (CEOSE) (1173). Recommendations should consist of the name of the recommended individual, the individual's curriculum vita, and an expression of the recommended individual's interest, and include the following contact information: recommended individual's address, telephone number, FAX number, and e-mail address. Self recommendations are accepted.
Putnam-Cumberland, TN-Improve Power Supply
This notice is provided in accordance with the Council on Environmental Quality's regulations (40 CFR Parts 1500-1508) and the Tennessee Valley Authority's (TVA) procedures for implementing the National Environmental Policy Act (NEPA). TVA will prepare an environmental assessment (EA) or an environmental impact statement (EIS) to address the potential environmental effects of proposed electrical power supply improvements in the Putnam and Cumberland region of east-central Tennessee. The purpose of the proposed project is to ensure the reliable transmission of electric power to meet increasing power demands in the project area. In its environmental review, TVA will evaluate the potential environmental impacts of the construction, operation, and maintenance of proposed new and upgraded power transmission facilities. TVA will develop and evaluate various alternatives, including the No Action Alternative, in the environmental review. Public comments are invited concerning both the scope of the review and environmental issues that should be addressed.
Farm and Ranch Lands Protection Program
This final rule amends the Natural Resources Conservation Service (NRCS) regulations for implementation of the Farm and Ranch Lands Protection Program (FRPP). This action is necessary to address the comments received on the interim final rule as published and to publish changes to the entity certification requirements. This document provides a 30 day public comment period on the entity certification requirements.
Rules of Practice
Section 916 of the Dodd-Frank Wall Street Reform and Consumer Protection Act (``Dodd-Frank Act'') \1\ amended Section 19(b) of the Securities Exchange Act of 1934 (``Exchange Act''),\2\ which governs the handling of proposed rule changes submitted by self-regulatory organizations (``SROs''). Among other things, the Dodd-Frank Act's amendments to Section 19 of the Exchange Act require the Securities and Exchange Commission (``Commission'') to promulgate rules setting forth the procedural requirements of proceedings to determine whether a proposed rule change should be disapproved. In satisfaction of this requirement, the Commission is adopting new Rules of Practice to formalize the process it will use when conducting proceedings to determine whether an SRO's proposed rule change should be disapproved under Section 19(b)(2) of the Exchange Act. The new rules are intended to add transparency to the Commission's conduct of those proceedings and address the process the Commission will follow to institute proceedings and provide notice of the grounds for disapproval under consideration as well as provide interested parties with an opportunity to submit written materials to the Commission. In addition, the Commission is making conforming changes to Rule 19b-4 under the Exchange Act in recognition of the new Rules of Practice. Further, pursuant to Section 107 of the Sarbanes-Oxley Act of 2002 (``Sarbanes- Oxley Act''), the provisions of paragraphs (1) through (3) of Section 19(b) of the Exchange Act govern the proposed rules of the Public Company Accounting Oversight Board (``PCAOB'').\3\ The Commission is amending Regulation P to add a rule providing that these new Rules of Practice also formalize the process the Commission will use when conducting proceedings to determine whether a PCAOB proposed rule should be disapproved.
Notice of Opportunity for Public Comment on Surplus Property Release at Brunswick-Golden Isles Airport, Brunswick, GA
Under the provisions of Title 49, U.S.C. Section 47153(c), notice is being given that the FAA is considering a request from the Glynn county Airport Commission to waive the requirement that a 16.84- acre parcel of surplus property, located on Glynn County Airport owned and operated land adjacent to, but separated by a public roadway, Brunswick-Golden Isles Airport, be used for aeronautical purposes.
Airworthiness Directives; PIAGGIO AERO INDUSTRIES S.p.A Model PIAGGIO P-180 Airplanes
We are adopting a new airworthiness directive (AD) for the products listed above. This emergency AD was sent previously to all known U.S. owners and operators of these airplanes. This AD supersedes Emergency AD 2011-01-51, requires an immediate functional test of the fuselage drain holes, and requires sending a report of the results to the FAA. This AD also allows, with noted exceptions, for the return/ position of the airplane to a home base, hangar, maintenance facility, etc. This AD was prompted by reports of water accumulation in the belly of the fuselage that froze and caused the flight controls to jam. We are issuing this AD to prevent water or fluid from accumulating in the belly of the fuselage and freezing when the aircraft reaches and holds altitudes where the temperature is below the freezing point. This condition could cause the flight controls to jam with consequent loss of control.
Information Technology (IT) Security
NASA is revising the NASA FAR Supplement (NFS) to update requirements related to Information Technology Security, consistent with Federal policies for the security of unclassified information and information systems. The rule imposes no new requirements. Its purpose is to more clearly define applicability, update procedural processes, eliminate the requirement for contractor personnel to meet the NASA System Security Certification Program, and provide a Web site link within a contract clause to a library where contractors can find all underlying regulations and referenced documents.
Notice of Funding Opportunity and Solicitation for Grant Application (SGA) for Trade Adjustment Assistance Community College and Career Training Grants Program
Through this notice, the Department of Labor's Employment and Training Administration (ETA) announces the availability of approximately $500 million in grant funds authorized in the Health Care and Education Reconciliation Act of 2010 (Reconciliation Act) from the Trade Adjustment Assistance Community College and Career Training Grants funding source to provide community colleges and other eligible institutions of higher education with funds to expand and improve their ability to deliver education and career training programs that can be completed in two years or less, are suited for workers who are eligible for training under the Trade Adjustment Assistance for Workers program, and prepare program participants for employment in high-wage, high- skill occupations. ETA intends to fund grants ranging from $2.5 million to $5 million for individual applicants and from $2.5 million to $20 million for consortium applicants with this SGA. The complete SGA and any subsequent SGA amendments, in connection with the Workforce Investment Act and Health Care and Education Reconciliation Act of 2010 (Reconciliation Act) is described in further detail on ETA's Web site at https://www.doleta.gov or on https:// www.grants.gov. The Web sites provide application information, eligibility requirements, review and selection procedures and other program requirements governing this solicitation.
National Science Foundation Rules of Practice and Statutory Conflict-of-Interest Exemptions
The National Science Foundation (NSF) is amending its regulations to remove the provisions concerning statutory conflict-of- interest exemptions.
Willapa National Wildlife Refuge, Pacific County, WA
We, the U.S. Fish and Wildlife Service (Service), announce the availability of our draft comprehensive conservation plan and draft environmental impact statement (Draft CCP/EIS) for the Willapa National Wildlife Refuge (refuge) for public review and comment. In the Draft CCP/EIS, we described our alternatives, including our preferred alternative, for managing the refuge for 15 years following approval of the final CCP.
Notice of Intent To Prepare a Draft Environmental Impact Statement (DEIS) for Housing Approximately 1,750 Low-Security, Adult Male Inmates, That Are Predominantly Criminal Aliens at a Privately-Owned and Operated Institution in Either Hinton, OK; McRae, GA; Baldwin, MI; or Scott County, MS
Pursuant to Section 102(2)(c) of the National Environmental Policy Act (NEPA) of 1969, as implemented by the Council on Environmental Quality Regulations (40 Code of Federal Regulations [CFR] Parts 1500-1508), the Federal Bureau of Prisons (BOP) intends to prepare a Draft Environmental Impact Statement (DEIS) and conduct Public Scoping Meetings for the proposed housing of inmates under the Criminal Alien Requirement 12 (CAR 12) solicitation, at a facility located in either Hinton, Oklahoma; McRae, Georgia; Baldwin, Michigan; or Scott County, Mississippi.
2010-2011 Refuge-Specific Hunting and Sport Fishing Regulations
The Fish and Wildlife Service adds one refuge to the list of areas open for hunting and/or sport fishing and increases the activities available at seven other refuges, along with pertinent refuge-specific regulations on other refuges that pertain to migratory game bird hunting, upland game hunting, big game hunting, and sport fishing for the 2010-2011 season.
Foreign Trade Regulations (FTR): Mandatory Automated Export System Filing for All Shipments Requiring Shipper's Export Declaration Information: Proposed Substantive Changes and Corrections
The U.S. Census Bureau (Census Bureau) proposes to amend its regulations to reflect new export reporting requirements. Specifically, the Census Bureau is proposing to require mandatory filing of export information through the Automated Export System (AES) or through AESDirect for all shipments of used self-propelled vehicles, temporary exports and household goods. The Census Bureau is also proposing to modify the postdeparture filing program by changing the filing time frame from ten (10) calendar days to five (5) calendar days and only allowing postdeparture reporting for approved commodities. In addition to the new export reporting requirements and the modifications to the postdeparture filing program, the proposed rule would make remedial changes to the FTR to improve clarity and to correct errors. These changes are discussed in detail in the SUPPLEMENTARY INFORMATION section.
Auction of FM Broadcast Construction Permits Rescheduled for April 27, 2011; Notice and Filing Requirements, Minimum Opening Bids, Upfront Payments, and Other Procedures for Auction 91
This document announces the procedures and minimum opening bids for the upcoming auction of certain FM Broadcast construction permits. This document is intended to familiarize prospective bidders with the procedures and minimum opening bids for the auction. This auction, which is designated as Auction 91, is now scheduled to start on April 27, 2011.
Agency Information Collection Activities; Proposed Collection; Comment Request; Orphan Drugs; Common European Medicines Agency/Food and Drug Administration Application Form for Orphan Medicinal Product Designation (Form FDA 3671)
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the procedures by which sponsors of orphan drugs may request eligibility for the incentives by implementing a program as outlined in the Orphan Drug Act and the joint adoption by FDA and the European Medicines Agency (EMA) of the Common EMA/FDA Application Form for Orphan Medicinal Product Designation (form FDA 3671).
Fifty-Third Meeting: RTCA Special Committee 186: Automatic Dependent Surveillance-Broadcast (ADS-B)
The FAA is issuing this notice to advise the public of a meeting of RTCA Special Committee 186: Automatic Dependent SurveillanceBroadcast (ADS-B).
Fourth Meeting: RTCA Special Committee 224: Airport Security Access Control Systems
The FAA is issuing this notice to advise the public of a meeting of RTCA Special Committee 224: Airport Security Access Control Systems.
Second Meeting RTCA NextGen Advisory Committee (NAC)
The FAA is issuing this notice to advise the public of a meeting of RTCA NextGen Advisory Committee (NAC).
Advisory Council on Blood Stem Cell Transplantation; Notice of Meeting
The ACBSCT will be conducting a conference call to discuss: (1) Final language of recommendations from November 15, 2010, Council meeting; and (2) Interim Report to Congress.
Approval of One-Year Extension for Attaining the 1997 8-Hour Ozone Standard for the Delaware, Maryland, and Pennsylvania Portions of the Philadelphia-Wilmington-Atlantic City Moderate Nonattainment Area
EPA is extending the attainment date from June 15, 2010 to June 15, 2011 for the Delaware, Maryland, and Pennsylvania portions of the Philadelphia-Wilmington-Atlantic City nonattainment area (Philadelphia Area), which is classified as moderate for the 1997 8- hour ozone national ambient air quality standard (NAAQS). This extension is based in part on air quality data recorded during the 2009 ozone season. Specifically, the Philadelphia Area's 4th highest daily 8-hour monitored ozone value during the 2009 ozone season is 0.084 parts per million (ppm) or less. Accordingly, EPA is revising the tables concerning the 8-hour ozone attainment dates for the Philadelphia Area in the States of Delaware and Maryland, and the Commonwealth of Pennsylvania (the States). EPA is approving the extension of the attainment date for the Delaware, Maryland, and Pennsylvania portions of the Philadelphia Area in accordance with the requirements of the Clean Air Act (CAA). EPA is approving the extension of the attainment date for the New Jersey portion of the Philadelphia Area in a separate rulemaking in this Federal Register.
Approval and Promulgation of One-Year Extension for Attaining the 1997 8-Hour Ozone Standard for the New Jersey Portion of the Philadelphia-Wilmington-Atlantic City Moderate Nonattainment Area
EPA is approving an extension from June 15, 2010 to June 15, 2011 of the applicable attainment date for the New Jersey portion of the Philadelphia-Wilmington-Atlantic City 1997 8-hour ozone nonattainment area (Philadelphia Area), which is classified as moderate nonattainment for the 1997 8-hour ozone national ambient air quality standard (NAAQS). This extension is based in part on complete, quality- assured air quality data recorded during the 2009 ozone season. In accordance with requirements for a 1-year extension, the Philadelphia Area's 4th highest daily 8-hour monitored ozone value during the 2009 ozone season at each monitor in the area is less than 0.084 parts per million (ppm). EPA is revising the table with regard to the 8-hour ozone attainment date for the New Jersey portion of the Philadelphia Area.
Agency Information Collection Activities; Submission to OMB for Review and Approval; Willingness To Pay Survey for ยง 316(b) Existing Facilities Cooling Water Intake Structures (New)
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 for a new collection. The ICR, which is abstracted below, describes the nature of the information collection and its estimated burden and cost.
Proposed Administrative Settlement Agreement Under Section 122(h) of the Comprehensive Environmental Response, Compensation, and Liability Act for the D'Imperio Property Superfund Site, Located in Hamilton Township, Atlantic County, NJ
The United States Environmental Protection Agency (``EPA'') is proposing to enter into an administrative settlement agreement (``Settlement Agreement'') with Air Products and Chemicals, Inc., Alco Industries, Inc., Bayer CropScience Inc., Colonial Heights Packaging, Inc., Continental Holdings, Inc., Croda Inks Corporation, Henkel Corporation, Kimberly-Clark Tissue Company, Sonoco Products Company, Stepan Company, Union Carbide Corporation, USG Corporation, and United States Steel Corporation (``Respondents'') pursuant to Section 122(h) of the Comprehensive Environmental Response, Compensation, and Liability Act (``CERCLA''), 42 U.S.C. 9622(h). The Settlement Agreement provides for Respondents' payment of certain costs incurred and to be incurred at the D'Imperio Property Superfund Site, located in Hamilton Township, Atlantic County, New Jersey (``Site''). In accordance with Section 122(i) of CERCLA, 42 U.S.C. 9622(i), this notice is being published to inform the public of the proposed Settlement Agreement and of the opportunity to comment. For thirty (30) days following the date of publication of this notice, EPA will receive written comments relating to the proposed Settlement Agreement. EPA will consider all comments received and may modify or withdraw its consent to the settlement if comments received disclose facts or considerations that indicate that the proposed settlement is inappropriate, improper or inadequate. EPA's response to any comments received will be available for public inspection at EPA Region 2, 290 Broadway, 17th floor New York, New York 10007-1866.
Mid-Atlantic Fishery Management Council; Public Meetings
The Mid-Atlantic Fishery Management Council (Council) and its Squid, Mackerel, Butterfish Committee with Advisors, its Surfclam/Ocean Quahog/Tilefish Committee, its Ecosystem/Ocean Planning Committee, its Research Set-Aside (RSA) Committee and its, Executive Committee will hold public meetings.
Pacific Fishery Management Council; Public Meeting
The Pacific Fishery Management Council's (Pacific Council) Tule Chinook Workgroup (TCW) will hold a meeting to review initial work products and revise future work plans relative to developing an abundance-based harvest management approach for Columbia River natural tule Chinook. This meeting of the TCW is open to the public.
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