January 26, 2005 – Federal Register Recent Federal Regulation Documents

The U.S. Environmental Protection Agency is proposing to enter into a de minimis settlement pursuant to section 122(g)(4) of the Comprehensive Environmental Response, Compensation and Liability Act of 1980, as amended (``CERCLA''), 42 U.S.C. 9622(g)(4). This proposed settlement is intended to resolve the liability of Technitrol, Inc. (``Settling party'') under CERCLA for response costs incurred and to be incurred at the Malvern TCE Superfund Site, East Whiteland and Charlestown Townships, Chester County, Pennsylvania.

This regulation establishes a tolerance for residues of 4- bromo-2-(4-chlorophenyl)-1-(ethoxymethyl)-5-(trifluoromethyl) -1H- pyrrole-3-carbonitrile in or on all foods except fruiting vegetables. BASF Corporation requested this tolerance under the Federal Food, Drug, and Cosmetic Act (FFDCA), as amended by the Food Quality Protection Act of 1996 (FQPA).

The Copyright Office of the Library of Congress is requesting comment as to whether the 2005 cable statutory license rate adjustment proceeding should take place under the auspices of the Copyright Arbitration Royalty Panel (``CARP'') system or the new Copyright Royalty Judge (``CRJ'') system.

The Copyright Office seeks to examine the issues raised by ``orphan works,'' i.e., copyrighted works whose owners are difficult or even impossible to locate. Concerns have been raised that the uncertainty surrounding ownership of such works might needlessly discourage subsequent creators and users from incorporating such works in new creative efforts or making such works available to the public. This notice requests written comments from all interested parties. Specifically, the Office is seeking comments on whether there are compelling concerns raised by orphan works that merit a legislative, regulatory or other solution, and what type of solution could effectively address these concerns without conflicting with the legitimate interests of authors and right holders.

The Department of Transportation is soliciting proposals from communities or consortia of communities interested in receiving a grant under the Small Community Air Service Development Program. The full text of the Department's order is attached to this document.

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.

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.

This notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), announces that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive license to practice the inventions embodied in U.S. Patent No. 6,083,503, entitled ``Interleukin-2 stimulated T lymphocyte cell death for the treatment of autoimmune diseases, allergic responses, and graft rejection'' (DHHS Reference E-137-1991/0-US-03); U.S. Patent No. 5,989,546 entitled ``Interleukin-2 stimulated T lymphocyte cell death for the treatment of allergic responses'' (DHHS Reference E-137-1991/0- US-04); U.S. Patent No. 5,935,575, entitled ``Interleukin-4 stimulated T lymphocyte cell death for the treatment of allergic disorders'' (DHHS Reference E-151-1992/0-US-11); U.S. Patent Application No. 08/431,644 filed May 2, 1995 entitled ``Modified Myelin Basic Protein Molecules'' (DHHS Reference E-033-1996/0-US-01); and U.S. Patent Application No. 08/482,114 filed June 7, 1995 entitled ``Modified Proteolipid Protein Molecules'' (DHHS Reference E- 128-1996/1-US-01); to Apogenix Biotechnology AG, having a place of business in Heidelberg, Germany. The patent rights in these inventions have been assigned to the United States of America. The prospective exclusive license territory will be worldwide and the field of use may be limited to therapeutics for the treatment of Multiple Sclerosis.

The FAA hereby provides notice of intent to release certain airport properties (approximately 28.43 acres) at the Keystone Airpark, Starke, FL from the conditions, reservations, and restrictions as contained in a Quitclaim Deed agreement between the FAA and the Town of Keystone Heights, dated August 21, 1947. The release of property will allow the Keystone Airpark Authority to dispose of the property for other than aeronautical purposes. The property is located in the southwest corner of the airport west of State Road 100 in proximity to the approach of Runway 4. The parcel is currently designated as non- aeronautical use. The property will be disposed of for the purpose of conveying title to the United States Department of the Interior for the protection of the Florida National Scenic Trail. The fair market value of the property has been determined by appraisal to be $410,000. The airport will receive fair market value for the property, which will be subsequently reinvested in another eligible airport improvements project. Documents reflecting the Sponsor's request are available, by appointment only, for inspection at the Airpark Clerk's office and the FAA Airports District Office.

Pursuant to the Consolidated Appropriations Act, 2005, the National Telecommunications and Information Administration (NTIA), U.S. Department of Commerce, announces the solicitation of applications for planning and construction grants for public telecommunications facilities under the Public Telecommunications Facilities Program (PTFP). The PTFP assists, through matching grants, in the planning and construction of public telecommunications facilities in order to: (1) Extend delivery of services to as many citizens as possible by the most cost-effective means, including use of broadcast and non-broadcast technologies; (2) increase public telecommunications services and facilities available to, operated by, and controlled by minorities and women; (3) strengthen the capability of existing public television and radio stations to provide public telecommunications services to the public.

TSA invites public comment on a new information collection requirement abstracted below that will be submitted to OMB for approval in compliance with the Paperwork Reduction Act.

Under 49 U.S.C. 11327, the Board finds that a settlement agreement that was entered into by Norfolk Southern Corporation and Norfolk Southern Railway Company (collectively, NS) and Wheeling & Lake Erie Railway Company (W&LE), when implemented, will satisfy certain conditions imposed in CSX Corp. et al.ControlConrail Inc. et al., 3 S.T.B. 196 (1998). Under 49 U.S.C. 10502 the Board grants the exemption authority sought by NS and W&LE pursuant to the settlement agreement. The Settlement Agreement includes 7 elements. Element 1 provides that W&LE will be granted overhead trackage rights, limited to one train per day per direction, between Bellevue (Yeomans), OH, at Milepost (MP) T-54.7 and Toledo (Manhattan Jct.), OH, at MP CS- 1.30. Element 1 also provides that W&LE will be granted back- up haulage rights for overflow traffic. In STB Finance Docket No. 33388 (Sub-No. 96), the Board has granted an exemption under 49 U.S.C. 10502 for the Bellevue-Toledo trackage rights, which were originally sought in a responsive application in a rail consolidation proceeding, subject to the labor protective conditions set forth in Norfolk and Western Ry. Co.Trackage RightsBN, 354 I.C.C. 605, 610-15 (1978), as modified in Mendocino Coast Ry., Inc.Lease and Operate, 360 I.C.C. 653, 664 (1980). Element 2 provides that W&LE will purchase the Toledo Pivot Bridge, which is also known as the Maumee River Bridge (this is a railroad swing bridge that spans the Maumee River in Toledo, OH). In STB Finance Docket No. 33388 (Sub-No. 99), the Board has granted a 49 U.S.C. 10502 petition for exemption of the Toledo Pivot Bridge purchase transaction. Any employee affected by the Toledo Pivot Bridge purchase exempted in STB Finance Docket No. 33388 (Sub-No. 99) will be protected as required by section 10902(d), subject to the standards and procedures established in Wisconsin Central Ltd.Acquisition Exem. Union Pac. RR, 2 S.T.B. 218 (1997), aff'd in relevant part sub nom. Association of American Railroads v. STB, 162 F.3d 101 (D.C. Cir. 1998). Element 3 provides for a 10-year extension of W&LE's lease of NS's Huron Dock on Lake Erie. In STB Finance Docket No. 32516 (Sub- No. 1), the Board has accepted a 49 CFR 1180.2(d)(4) notice of exemption respecting the Huron Dock lease extension. Any employee affected by the Huron Dock lease extension exempted in STB Finance Docket No. 32516 (Sub-No. 1) will be protected by the labor protective conditions set forth in Mendocino Coast Ry., Inc.Lease and Operate, 354 I.C.C. 732 (1978), as modified in Mendocino Coast Ry., Inc.Lease and Operate, 360 I.C.C. 653 (1980). Element 4 provides for a 10-year extension of W&LE's Bellevue-Huron Dock overhead trackage rights, by which W&LE accesses Huron Dock. These trackage rights run over the NS line between approximately MP B242 at Bellevue, OH, and approximately MP B229 at Berlin Heights, OH, and between approximately MP B232 at Shinrock, OH (on the Bellevue-Berlin Heights segment), and approximately MP HU12.2 at the Huron Dock connection in Huron, OH. In STB Finance Docket No. 32525 (Sub-No. 1), the Board has accepted a 49 CFR 1180.2(d)(4) notice of exemption respecting the Bellevue-Huron Dock trackage rights extension. Any employee affected by the trackage rights exempted in STB Finance Docket No. 32525 (Sub-No. 1) will be protected by the labor protective conditions set forth in Norfolk and Western Ry. Co. Trackage RightsBN, 354 I.C.C. 605, 610-15 (1978), as modified in Mendocino Coast Ry., Inc.Lease and Operate, 360 I.C.C. 653, 664 (1980). Element 5 provides that W&LE will be granted overhead trackage rights in the Cleveland, OH area between Berea, OH (at MP CD- 194.2), and the Knob, OH (at MP GZ-488.13). In STB Finance Docket No. 33388 (Sub-No. 97), the Board has accepted a 49 CFR 1180.2(d)(7) notice of exemption for the Berea-Knob trackage rights. Any employee affected by the trackage rights exempted in STB Finance Docket No. 33388 (Sub- No. 97) will be protected by the labor protective conditions set forth in Norfolk and Western Ry. Co.Trackage RightsBN, 354 I.C.C. 605, 610-15 (1978), as modified in Mendocino Coast Ry., Inc.Lease and Operate, 360 I.C.C. 653, 664 (1980). Element 6 provides that NS will be granted overhead trackage rights between Clairton, PA (at MP 5.2), and Bellevue, OH (at MP H53.7), with certain rights of ingress and egress at Mingo Jct., OH, Jewett, OH, Bowerston, OH, and Orrville, OH. In STB Finance Docket No. 33388 (Sub-No. 98), the Board has accepted a 49 CFR 1180.2(d)(7) notice of exemption for the Clairton-Bellevue trackage rights. Any employee affected by the trackage rights exempted in STB Finance Docket No. 33388 (Sub-No. 98) will be protected by the labor protective conditions set forth in Norfolk and Western Ry. Co.Trackage RightsBN, 354 I.C.C. 605, 610-15 (1978), as modified in Mendocino Coast Ry., Inc. Lease and Operate, 360 I.C.C. 653, 664 (1980). Element 7 provides that, to allow NS to access a new trailer parking facility in the Maple Heights area (Maple Heights is located a few miles southeast of Cleveland), NS will be granted the right to create and use a second road at-grade crossing over W&LE's Cleveland Subdivision line at MP 8.67 under the same terms and conditions that govern NS's use of the existing road at-grade crossing over the W&LE line at MP 9.03. Element 7 further provides for NS and W&LE to negotiate a broader agreement regarding operations in the Maple Heights area. NS and W&LE are currently evaluating two options, both of which involve the lease, by NS, of freight rights on the Randall Secondary.

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 Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Nonclinical Safety Evaluation of Drug Combinations.'' The guidance provides recommendations on nonclinical approaches to support the clinical study and approval of fixed-dose combination products (FDCs), copackaged products, and adjunctive therapies.