April 20, 2005 – Federal Register Recent Federal Regulation Documents
Results 101 - 150 of 159
Prospective Grant of Exclusive License: Human Anesthetic Formulation Based Upon Cyclodextrin Carriers
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 license worldwide to practice the invention embodied in U.S. Patent No. 6,407,079, entitled ``Pharmaceutical compositions containing drugs which are instable or sparingly soluble in water and methods for their preparation,'' to Jurox Pty Ltd., having a place of business in Rutherford, Australia. The field of use may be limited to the development of injectable anesthetic formulations containing Alfaxalone-hydroxypropyl-beta cyclodextrin complex for use in humans. The United States of America has an interest in the patent rights of this invention.
Government-Owned Inventions; Availability for Licensing
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.
Government-Owned Inventions; Availability for Licensing
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.
Model Milestones For NRC Adjudicatory Proceedings
The Nuclear Regulatory Commission (NRC) is amending its regulations to adopt model milestones for the conduct of NRC adjudicatory proceedings, to require a presiding officer to refer to the model milestones as a starting point for establishing a hearing schedule in an adjudicatory proceeding, and to manage the case in accordance with that schedule.
Employment of Relatives
The Office of Personnel Management (OPM) is issuing final regulations on a plain language rewrite of its regulations regarding the employment of relatives as part of a broader review of OPM's regulations. The purpose of the revision is to make the regulations more readable.
Member Business Loans
NCUA proposes to revise its member business loans (MBL) rule to clarify the minimum capital requirements a federally insured corporate credit union (Corporate CU) must meet to make unsecured MBLs to its members other than member credit unions and corporate credit union service organizations (Corporate CUSOs). NCUA also proposes to revise the definition of ``construction or development loan'' to include loans for renovating or developing property owned by a borrower for income-producing purposes and the definition of ``net worth'' to be more consistent with how that phrase is defined in the Federal Credit Union Act (Act) and NCUA's prompt corrective action regulation (PCA). Additionally, NCUA is soliciting comments on how best to amend the MBL rule to enable credit unions to participate more fully in government guaranteed loan programs.
Public Notice for a Change in Use of Aeronautical Property at Louisville International Airport, Louisville, KY
Under the provisions of 49 U.S.C. 47153(c), the Federal Aviation Administration is requesting public comment on the Louisville Regional Airport Authority's request to change a portion (3.49 acres) of airport property from aeronautical use to non-aeronautical use. The property is to be sold to Huber's Inc., d/b/a Budget Truck and Car Rental (``Budget'') for commercial development. The 3.49 acres is located in the Highland Park neighborhood, north of the Intrastate 264, and is located one block on the west side of Crittenden Drive between East Adair and Wawa Avenues.
Noise Exposure Map Notice for Flagstaff Airport, Flagstaff, AZ
The Federal Aviation Administration (FAA) announces its determination that the noise exposure maps submitted by the City of Flagstaff for Flagstaff Pulliam Airport under the provisions of 49 U.S.C. 47501 et seq. (Aviation Safety and Noise Abatement Act) and 14 CFR part 150 are in compliance with applicable requirements.
Receipt of Noise Compatibility Program Update/Revised Five-Year Forecast Condition NEM and Request for Review for Lehigh Valley International Airport, Allentown, PA
The Federal Aviation Administration (FAA) announces that it is reviewing a revised noise compatibility program and revised five-year forecast condition NEM submitted by the Lehigh-Northampton Airport Authority for Lehigh Valley International Airport under the provisions of Title I of the Aviation Safety and Noise Abatement Act of 1979 (Pub. L. 96-193) and 14 CFR part 150. This program was submitted subsequent to a determination by the FAA that the associated updated noise exposure maps submitted under 14 CFR part 150 for Lehigh Valley International Airport were in compliance with applicable requirements effective May 14, 2004. The proposed noise compatibility program update and revised five-year forecast condition NEM will be approved or disapproved on or before October 9, 2005.
Notice
The Federal Aviation Administration (FAA) announces its determination that the noise exposure maps submitted by Metropolitan Nashville Airport Authority for Nashville International Airport under the provisions of 49 U.S.C. 47501 et seq. (Aviation Safety and Noise Abatement Act) and 14 CFR part 150 are in compliance with applicable requirements.
Petitions for Exemption; Summary of Petitions Received
Pursuant to FAA's rulemaking provisions governing the application, processing, and disposition of petitions for exemption part 11 of Title 14, Code of Federal Regulations (14 CFR), this notice contains a summary of certain petitions seeking relief from specified requirements of 14 CFR, dispositions of certain petitions previously received, and corrections. 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 any petition or its final disposition.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Adverse Experience Reporting for Licensed Biological Products; and General Records
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.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; New Animal Drugs For Investigational Use
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 (the PRA).
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Study of Health Claims on Food Packages
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.
Draft “Guidance for Industry: Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection;” Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Guidance for Industry: Assessing Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection,'' dated April 2005. The draft guidance document provides revisions to the previously published recommendations for assessing donor suitability and product safety when donors are diagnosed with or suspected of West Nile Virus (WNV) infections based on symptoms and laboratory tests. This draft guidance proposes revised deferral periods for such donors, and updates information on product retrieval and quarantine. When finalized, this guidance will supersede ``Guidance for Industry: Revised Recommendations for the Assessment of Donor Suitability and Blood and Blood Product Safety in Cases of Known or Suspected West Nile Virus Infection,'' dated May 2003.
Endangered Species; Permits No. 1501 and 1506
Notice is hereby given that two applicants have been issued a permit to take endangered and threatened sea turtles for purposes of scientific research.
Taking of Marine Mammals Incidental to Commercial Fishing Operations; Atlantic Large Whale Take Reduction Plan (ALWTRP)
The Assistant Administrator for Fisheries (AA), NOAA, announces temporary restrictions consistent with the requirements of the ALWTRP's implementing regulations. These regulations apply to lobster trap/pot and anchored gillnet fishermen in an area totaling approximately 1,052 square nautical miles (nm\2\) (3,608 km\2\) in April and 1,235 nm\2\ (4,236 km\2\) in May, southeast of Chatham, MA, for 15 days. The purpose of this action is to provide protection to an aggregation of northern right whales (right whales).
Change in Off-Highway Vehicle (OHV) Designations; Closure of Public Lands to Recreational Target Shooting; and Implementation of Supplementary Rules Regarding Operation of Motorized Vehicles and Bicycles
This notice implements five decisions from the Gold Belt Travel Management Plan, approved August 18, 2004. The following decisions are effective immediately on certain public lands in El Paso, Fremont, Park, and Teller Counties, Colorado. (1) A change in the OHV designation for the Penrose Commons area (3,200 acres) from ``open'' to OHV use to OHV use ``limited to designated roads and trails''. (2) A change in the OHV designation for the Deer Haven area (4,900 acres) from ``closed'' to OHV use to OHV use ``limited to designated roads and trails''. (3) The closure of approximately 11,000 acres of public lands to recreational target shooting. Licensed hunters in legitimate pursuit of game during the proper season with appropriate firearms, as defined by the Colorado Division of Wildlife, are exempt from this closure. (4) A supplementary rule limiting motorized vehicle travel for parking, camping, and retrieving game to a maximum of 100 feet from designated roads and trails in the Gold Belt Travel Management Plan area (138,600 acres). (5) A supplementary rule restricting mountain bikes to designated roads and trails in the Gold Belt Travel Management Plan area (138,600 acres). The purpose of the change in designation, closure and supplementary rules is to prevent damage to public lands and resources, reduce user conflicts, protect public safety, and reduce vandalism to public and private property. The closure is made under the authority of 43 CFR 8364.1 and the supplementary rules are made under the authority of 43 CFR 8365.1-6.
Petition To Modify an Exemption of a Previously Approved Antitheft Device; General Motors Corporation
On May 15, 1995, this agency granted in full General Motors Corporation's (GM) petition for exemption from the parts-marking requirements of the vehicle theft prevention standard for the Chevrolet Lumina and Monte Carlo vehicle line (see 60 FR 25938). On March 29, 1999, the agency granted in full GM's petition for modification of the previously approved antitheft device for the Chevrolet Lumina and Monte Carlo vehicle line. This notice (see 60 FR 25938) acknowledged GM's notification that the nameplate for its Chevrolet Lumina/Monte Carlo line would be changed to the Chevrolet Impala/Monte Carlo line beginning with model year (MY) 2000. This notice also grants in full GM's second petition to modify the exemption of the previously approved antitheft device for that line. NHTSA is granting GM's petition to modify the exemption because it has determined, based on substantial evidence, that the modified antitheft device described in GM's petition to be placed on the vehicle line as standard equipment, is likely to be as effective in reducing and deterring motor vehicle theft as compliance with the parts-marking requirements.
Federal Motor Vehicle Theft Prevention Standard; Final Listing of Model Year 2006 High-Theft Vehicle Lines
This final rule announces NHTSA's determination for model year (MY) 2006 high-theft vehicle lines that are subject to the parts- marking requirements of the Federal motor vehicle theft prevention standard, and high-theft MY 2006 lines that are exempted from the parts-marking requirements because the vehicles are equipped with antitheft devices determined to meet certain statutory criteria pursuant to the statute relating to motor vehicle theft prevention.
Final Nationwide Programmatic Section 4(f) Evaluation and Determination for Federal-Aid Transportation Projects That Have a Net Benefit to a Section 4(f) Property
The FHWA is issuing this approved final nationwide programmatic Section 4(f) evaluation (programmatic evaluation) for use in certain Federal (Federal-aid or Federal Lands Highway) transportation improvement projects where the use of publicly owned property from a Section 4(f) park, recreation area, or wildlife and waterfowl refuge or property from a historic site results in a net benefit to the Section 4(f) property. The application of this programmatic evaluation is intended to promote environmental stewardship by encouraging the development of measures that enhance Section 4(f) properties and to streamline the Section 4(f) process by reducing the time it takes to prepare, review and circulate a draft and final individual Section 4(f) Evaluation (individual evaluation) that documents compliance with Section 4(f) requirements. This programmatic evaluation provides a procedural option for demonstrating compliance with the statutory requirements of Section 4(f) and is an addition to the existing nationwide programmatic evaluations, all of which remain in effect. This programmatic evaluation can be applied to specific project situations that fit the criteria contained in the Applicability section. To fully realize the streamlining benefits of this programmatic evaluation, the FHWA and the Applicant (defined later) are encouraged to initiate coordination with the official(s) with jurisdiction (defined later) over a Section 4(f) property as early as possible and practicable to facilitate the assessment of benefits and harm to a Section 4(f) property.
Revisions to the Territory of Guam State Implementation Plan, Update to Materials Incorporated by Reference
EPA is updating the materials submitted by the Territory of Guam that are incorporated by reference (IBR) into the Territory of Guam State Implementation Plan (SIP). The regulations affected by this update have been previously submitted by the territorial agency and approved by EPA. This update affects the SIP materials that are available for public inspection at the Office of the Federal Register (OFR), Office of Air and Radiation Docket and Information, and the Regional Office.
Issuance of an Experimental Use Permit
EPA has granted an experimental use permit (EUP) to the following pesticide applicant. An EUP permits use of a pesticide for experimental or research purposes only in accordance with the limitations in the permit.
Certain New Chemicals; Receipt and Status Information
Section 5 of the Toxic Substances Control Act (TSCA) requires any person who intends to manufacture (defined by statute to include import) a new chemical (i.e., a chemical not on the TSCA Inventory) to notify EPA and comply with the statutory provisions pertaining to the manufacture of new chemicals. Under sections 5(d)(2) and 5(d)(3) of TSC, EPA is required to publish a notice of receipt of a premanufacture notice (PMN) or an application for a test marketing exemption (TME), and to publish periodic status reports on the chemicals under review and the receipt of notices of commencement to manufacture those chemicals. This status report, which covers the period from March 28, 2005 to April 4, 2005, consists of the PMNs pending or expired, and the notices of commencement to manufacture a new chemical that the Agency has received under TSCA section 5 during this time period.
Notice of Request for Proposals for Projects To Be Funded from the Water Quality Cooperative Agreement Allocation (CFDA 66.463-Water Quality Cooperative Agreements); Correction
EPA Region 6 published in the Federal Register of March 30, 2005, a notice soliciting proposals funded from the Regional Water Quality Cooperative Agreement allocation. This document is being issued to add and clarify several requirements that must be included in competitive funding announcements according to EPA Order 5700.7, Environmental Results under EPA Assistance Agreements. Additionally, a clarification on how past performance will be evaluated is included. Due to this correction notice, the deadline for submittal of all proposals is May 31, 2005.
Service Rules and Procedures To Govern the Use of Aeronautical Mobile Satellite Service Earth Stations in Frequency Bands Allocated to the Fixed Satellite Service
The Federal Communications Commission (FCC) proposes and seeks comment on a regulatory framework for licensing the operation of Aeronautical Mobile Satellite Service (AMSS) systems to communicate with fixed-satellite service (FSS) networks in the Ku-Band frequencies. Aircraft Earth stations (AES) in the AMSS can be used to provide broadband telecommunications services on passenger, government, and executive/private aircraft. This Notice of Proposed Rulemaking (NPRM) also seeks comments on licensing methods for AES terminals that will minimize the burdens upon applicants and licensees, while maintaining operational limitations necessary to avoid harmful interference.
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