February 21, 2008 – Federal Register Recent Federal Regulation Documents

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NRC Regulatory Issue Summary 2007-26, Implementation of Certification of Compliance Amendments to Previously Loaded Spent Fuel Storage Casks (RIS 2007-26)
Document Number: E8-3213
Type: Notice
Date: 2008-02-21
Agency: Nuclear Regulatory Commission, Agencies and Commissions
The Nuclear Regulatory Commission (NRC) will host a meeting with the public to receive comments on NRC Regulatory Issue Summary 2007-26, Implementation of Certification of Compliance Amendments to Previously Loaded Spent Fuel Storage Casks (RIS 2007-26). Purpose: To serve as a forum for members of the public to provide oral comments on RIS 2007-26 published for comment in the Federal Register on January 14, 2008 (73 FR 2281).
Privacy Act of 1974; System of Records
Document Number: E8-3210
Type: Notice
Date: 2008-02-21
Agency: Office of the Secretary, Department of Defense
The Office of the Inspector General (OIG) is altering a system of records to its existing inventory of record systems subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended.
Privacy Act of 1974; System of Records
Document Number: E8-3209
Type: Notice
Date: 2008-02-21
Agency: Department of Defense, Department of the Air Force, Air Force Department
The Department of the Air Force proposes to add a system of records notice to its inventory of records systems subject to the Privacy Act of 1974 (5 U.S.C. 552a), as amended.
Petition for Exemption; Summary of Petition Received
Document Number: E8-3208
Type: Notice
Date: 2008-02-21
Agency: Federal Aviation Administration, Department of Transportation
This notice contains a summary of a petition seeking relief from specified requirements of 14 CFR. The purpose of this notice is to improve the public's awareness of, and participation in, this aspect of FAA's regulatory activities. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of the petition or its final disposition.
In the Matter of: Certain DVD Players and Recorders and Certain Products Containing Same; Notice of Commission Issuance of a Limited Exclusion Order Against the Infringing Products of Respondents Found in Default; Termination of Investigation
Document Number: E8-3205
Type: Notice
Date: 2008-02-21
Agency: International Trade Commission, Agencies and Commissions
Notice is hereby given that the U.S. International Trade Commission has issued a limited exclusion order against the infringing products of Dongguan GVG Digital Products Ltd. and GVG Digital Technology Holdings Ltd. (collectively, the ``GVG respondents''), who were previously found in default, and has terminated the above- captioned investigation under section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337 (``section 337'').
Formations of, Acquisitions by, and Mergers of Bank Holding Companies
Document Number: E8-3202
Type: Notice
Date: 2008-02-21
Agency: Federal Reserve System, Agencies and Commissions
Oil and Gas and Sulphur Operations in the Outer Continental Shelf-Pipelines and Pipeline Rights-of-Way; Reopening Public Comment Period
Document Number: E8-3201
Type: Proposed Rule
Date: 2008-02-21
Agency: Department of the Interior, Minerals Management Service
This action reopens the period for submitting comments on the proposed rule published on October 3, 2007. That proposed rule requested comments on the revisions to Outer Continental Shelf pipeline and pipeline rights-of-way regulations. The comment period has been reopened to March 17, 2008. The MMS will hold a public meeting to discuss the proposed rule in the Gulf of Mexico Regional Office on February 22, 2008.
Environmental Assessment: Milwaukee County, WI
Document Number: E8-3196
Type: Notice
Date: 2008-02-21
Agency: Federal Highway Administration, Department of Transportation
The FHWA is issuing this notice to advise the public that an Environmental Assessment will be prepared for a proposed interchange project in Milwaukee County, Wisconsin by the Wisconsin Department of Transportation (WisDOT).
Environmental Impact Statement: Albuquerque, NM
Document Number: E8-3195
Type: Notice
Date: 2008-02-21
Agency: Federal Highway Administration, Department of Transportation
The FHWA is issuing this notice to advise the public and other agencies that an environmental impact statement will be prepared for a proposed transportation project in Albuquerque, NM.
Dixie National Forest, UT; Tropic to Hatch 138kV Transmission Line Project
Document Number: E8-3194
Type: Notice
Date: 2008-02-21
Agency: Department of Agriculture, Forest Service
The Forest Supervisor of the Dixie National Forest gives notice of intent to prepare an Environmental Impact Statement to address potential effects of a proposed project by Garkane Energy Cooperative (Garkane) to construct, operate and maintain a 138 kilovolt (kV) electric transmission line requiring a Special Use Authorization, Grant of Right-of-Way, and/or Special Use Permit for a Right-of-Way. The proposed project will include the construction of a 138kV transmission line, associated substations, access roads and the removal and reclamation of a portion of the existing transmission line. The proposed action would cross lands administered by the Forest Service, Bureau of Land Management, State and private. If approved, the proposed project would require amending the Grand Staircase-Escalante National Monument Management Plan to allow a utility right-of-way in the primitive management zone adjacent to an existing utility right-of-way. Dependant upon the final location of the transmission line alignment, the Dixie National Forest Plan may need amending to adjust or modify the scenic integrity objectives. The Dixie National Forest will serve as the lead agency. The National Park Service and the Bureau of Land Management Kanab Field Office and Grand Staircase-Escalante National Monument will participate as cooperating agencies, and each agency will issue separate decisions based on the analysis. The Utah State Institutional Trust Lands have been invited as a cooperating agency.
Notice of Settlement Agreement Under the Comprehensive Environmental Response, Compensation and Liability Act
Document Number: E8-3193
Type: Notice
Date: 2008-02-21
Agency: Department of Defense, Department of the Air Force, Air Force Department
Pursuant to Section 122(i) of the Comprehensive Environmental Response, Compensation and Liability Act (``CERCLA'') of 1980, as amended, 42 U.S.C. 9622(i), notice is hereby given that the Department of the Air Force and Raytheon Company (``Raytheon'') entered into a proposed Settlement Agreement and Administrative Order on Consent (``SA-AOC'') to resolve their respective claims for CERCLA response costs relating to environmental response actions at Air Force Plant 44 located in Tucson, Arizona, which is part of the Tucson International Airport Area Superfund Site. The SA-AOC resolves the Air Force's claims under CERCLA Sections 106 and 107, 42 U.S.C. 9606 and 9607, in connection with Plant 44. Under the SA-AOC, Raytheon will pay up to $300,000 per year and up to $20 million in total to reimburse the Air Force for its past and future costs. The SA-AOC also resolves Raytheon's claims against the United States for CERCLA response costs incurred by the company at Plant 44. Under the SA-AOC, the United States, on behalf of the Air Force, will reimburse Raytheon for future CERCLA response costs incurred by the company that exceed $300,000 per year or $20 million in total.
Airworthiness Directives; Rolls-Royce plc RB211 Series Turbofan Engines
Document Number: E8-3192
Type: Proposed Rule
Date: 2008-02-21
Agency: Federal Aviation Administration, Department of Transportation
We propose to adopt a new airworthiness directive (AD) for the products listed above. This proposed AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as:
Airworthiness Directives; Embraer Model EMB-135BJ Airplanes
Document Number: E8-3191
Type: Proposed Rule
Date: 2008-02-21
Agency: Federal Aviation Administration, Department of Transportation
We propose to adopt a new airworthiness directive (AD) for the products listed above. This proposed AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as:
Airworthiness Directives; Empresa Brasileira de Aeronautica S.A. (EMBRAER) Model EMB-135ER, -135KE, -135KL, and -135LR Airplanes, and Model EMB-145, -145ER, -145MR, -145LR, -145XR, -145MP, and -145EP Airplanes
Document Number: E8-3190
Type: Proposed Rule
Date: 2008-02-21
Agency: Federal Aviation Administration, Department of Transportation
We propose to adopt a new airworthiness directive (AD) for the products listed above. This proposed AD results from mandatory continuing airworthiness information (MCAI) originated by an aviation authority of another country to identify and correct an unsafe condition on an aviation product. The MCAI describes the unsafe condition as:
International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex on Residue on Ignition/Sulphated Ash General Chapter; Availability
Document Number: E8-3187
Type: Notice
Date: 2008-02-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 1: Residue on Ignition/Sulphated Ash General Chapter.'' 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 guidance provides the results of the ICH Q4B evaluation of the Residue on Ignition/Sulphated Ash General Chapter harmonized text from each of the three pharmacopeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The guidance conveys recognition of the three pharmacopeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The guidance is intended to recognize the interchangeability among these texts from the local regional pharmacopeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance on the Q4B process entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions.''
International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the International Conference on Harmonisation Regions; Availability
Document Number: E8-3186
Type: Notice
Date: 2008-02-21
Agency: Food and Drug Administration, Department of Health and Human Services
The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions.'' 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 guidance describes a process for the evaluation and recommendation by the ICH Q4B Expert Working Group (EWG) of selected pharmacopeial texts to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH regions. Following favorable evaluations, ICH will issue topic- specific annexes with information about these texts and their implementation (the Q4B Outcomes). Implementation of the Q4B annexes is intended to avoid redundant testing by industry in favor of a common testing strategy in each ICH regulatory region.
Astronomy and Astrophysics Advisory Committee #13883; Notice of Meeting
Document Number: E8-3185
Type: Notice
Date: 2008-02-21
Agency: National Science Foundation, Agencies and Commissions
Importer of Controlled Substances; Notice of Registration
Document Number: E8-3184
Type: Notice
Date: 2008-02-21
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances; Notice of Registration
Document Number: E8-3183
Type: Notice
Date: 2008-02-21
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances; Notice of Application
Document Number: E8-3182
Type: Notice
Date: 2008-02-21
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances; Notice of Registration
Document Number: E8-3181
Type: Notice
Date: 2008-02-21
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances; Notice of Registration
Document Number: E8-3180
Type: Notice
Date: 2008-02-21
Agency: Drug Enforcement Administration, Department of Justice
Manufacturer of Controlled Substances; Notice of Registration
Document Number: E8-3179
Type: Notice
Date: 2008-02-21
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances; Notice of Application
Document Number: E8-3178
Type: Notice
Date: 2008-02-21
Agency: Drug Enforcement Administration, Department of Justice
Manufacturer of Controlled Substances; Notice of Application
Document Number: E8-3177
Type: Notice
Date: 2008-02-21
Agency: Drug Enforcement Administration, Department of Justice
Manufacturer of Controlled Substances; Notice of Application
Document Number: E8-3176
Type: Notice
Date: 2008-02-21
Agency: Drug Enforcement Administration, Department of Justice
Manufacturer of Controlled Substances; Notice of Application
Document Number: E8-3175
Type: Notice
Date: 2008-02-21
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances; Notice of Registration
Document Number: E8-3174
Type: Notice
Date: 2008-02-21
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances; Notice of Registration
Document Number: E8-3173
Type: Notice
Date: 2008-02-21
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances; Notice of Registration
Document Number: E8-3172
Type: Notice
Date: 2008-02-21
Agency: Drug Enforcement Administration, Department of Justice
Importer of Controlled Substances; Notice of Registration
Document Number: E8-3171
Type: Notice
Date: 2008-02-21
Agency: Drug Enforcement Administration, Department of Justice
Submission for OMB Review; Comment Request
Document Number: E8-3170
Type: Notice
Date: 2008-02-21
Agency: Department of Agriculture
Submission for OMB Review; Comment Request
Document Number: E8-3169
Type: Notice
Date: 2008-02-21
Agency: Department of Agriculture
Submission for OMB Review; Comment Request
Document Number: E8-3168
Type: Notice
Date: 2008-02-21
Agency: Department of Agriculture
Submission for OMB Review; Comment Request; Process Evaluation of the Global Health Research Initiative Program for New Foreign Investigators (GRIP)
Document Number: E8-3166
Type: Notice
Date: 2008-02-21
Agency: Department of Health and Human Services, National Institutes of Health
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Fogarty International Center (FIC), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on November 30, 2007, and allowed 60 days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: Process evaluation of the Global Health Research Initiative Program for New Foreign Investigators (GRIP). Type of Information Collection Request: NEW. Need and Use of Information Collection: This study will assess the outputs of the Global Health Research Initiative Program for New Foreign Investigators (GRIP) to date, assess the program's alignment with new strategic goals of the FIC, and identify potential directions for program enhancement. The primary objectives of the study are to determine if GRIP awards (1) promote productive re-entry of NIH-trained foreign investigators into their home countries, (2) increase the research capacity of the international scientists and institutions, and (3) stimulate research on a wide variety of high priority health-related issues. The findings will provide valuable information concerning: (1) Specific research advances attributable to GRIP support; (2) specific capacity and career enhancing advances that are attributable to GRIP; (3) policy implications for GRIP at the program level based on survey responses, such as successes and challenges of the program's implementation, the GRIP support mechanism, etc. Frequency of Response: Once. Affected Public: None. Type of Respondents: Foreign researchers. The annual reporting burden is as follows: Estimated Number of Respondents: 101; Estimated Number of Responses Per Respondent: 1; Average Burden Hours Per Response: 0.50; and Estimated Total Annual Burden Hours Requested: 50.5. The annualized cost to respondents is estimated at: $656.50. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. Table 1 and Table 2 respectively present data concerning the burden hours and cost burdens for this data collection.
Prospective Grant of an Exclusive License: Development and Commercialization of Therapeutic Products for Breast Cancer
Document Number: E8-3165
Type: Notice
Date: 2008-02-21
Agency: Department of Health and Human Services, National Institutes of Health
This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), announces that the Department of Health and Human Services is contemplating the grant of an exclusive license to practice the inventions embodied in U.S. Patent Application No. 09/693,600 filed October 20, 2000 entitled ``Method and Composition for Enhancing Immune Response'' [E-037-2001/1-US-01]; Japanese Patent Application No. 2002- 555834 filed October 22, 2001 entitled ``Method and Composition for Enhancing Immune Response'' [E-037-2001/1-JP-03]; and European Patent Application No. 01989341.1 filed October 22, 2001 entitled ``Method and Composition for Enhancing Immune Response'' [E-037-2001/1-EP-04]; to ODC Therapy, Inc. The prospective exclusive license territory may be worldwide and the field of use may be limited to therapeutic applications for breast cancer patients expressing high levels of serum or plasma IgE.
Government-Owned Inventions; Availability for Licensing
Document Number: E8-3164
Type: Notice
Date: 2008-02-21
Agency: Department of Health and Human Services, National Institutes of Health
The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.
Prospective Grant of Exclusive License: Regulatory Approved Clinical Diagnostics for Anti-HPV16 L1 Serum Antibody Detection in HPV Vaccine Recipients
Document Number: E8-3162
Type: Notice
Date: 2008-02-21
Agency: Department of Health and Human Services, National Institutes of Health
This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive worldwide license to practice the invention embodied in HHS Ref. No. E-253-1993/0 and certain foreign rights under HHS Ref. No. E-166-1992 including U.S. Patent 5,437,951, U.S. Patent 5,985,610, U.S. Patent 5,871,998, U.S. Patent 5,716,620, U.S. Patent 5,744,142, U.S. Patent 5,756,284, U.S. Patent 5,709,996, U.S. Patent Application 09/ 316,487, U.S. Patent Application 10/371,846, International Patent Application PCT/US93/08342, European Patent Application 93921353.4, European Patent Application 040104531.1, European Patent Application 040783235, Australian Patent 683220, Australian Patent Application 2004203609, Canadian Patent No. 2,143,845, Japanese Patent Applications 1994-507481, Japanese Patent Applications 2001-101791 and continuation and divisional patents and patent applications thereof, entitled ``Self-Assembling Recombinant Papillomavirus HPV16 Capsid Proteins,'' to Biotrin International, Ltd., a limited liability company formed under the laws of the European Union and the Republic of Ireland. The United States of America is the assignee of the patent rights of the above inventions. The contemplated exclusive license may be granted in the field of regulatory approved clinical diagnostics for serum anti-HPV16 L1 antibody detection in HPV vaccine recipients.
Proposed Information Collection; Comment Request; Award for Excellence in Economic Development
Document Number: E8-3159
Type: Notice
Date: 2008-02-21
Agency: Department of Commerce, Economic Development Administration
The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995.
Submission for OMB Review; Comment Request
Document Number: E8-3158
Type: Notice
Date: 2008-02-21
Agency: Department of Commerce
Notice of Public Information Collection(s) Being Submitted for Review to the Office of Management and Budget
Document Number: E8-3157
Type: Notice
Date: 2008-02-21
Agency: Federal Communications Commission, Agencies and Commissions
The Federal Communications Commission, as part of its continuing effort to reduce paperwork burden invites the general public and other Federal agencies to take this opportunity to comment on the following information collection(s), as required by the Paperwork Reduction Act (PRA) of 1995, 44 U.S.C. 3501-3520. An agency may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act (PRA) that does not display a valid control number. Comments are requested concerning (a) whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's burden estimate; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology.
Voluntary Protection Program Application Information; Extension of the Office of Management and Budget's (OMB) Approval of Information Collection (Paperwork) Requirements
Document Number: E8-3153
Type: Notice
Date: 2008-02-21
Agency: Department of Labor, Occupational Safety and Health Administration
OSHA solicits public comment concerning its proposal to extend OMB approval of the information collection requirements contained in the Voluntary Protection Programs.
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