September 2006 – Federal Register Recent Federal Regulation Documents

This document corrects technical errors that appeared in the July 31, 2006 Federal Register, entitled ``Medicare Program; Prospective Payment System and Consolidated Billing for Skilled Nursing FacilitiesUpdateNotice.'' Effective Date: This correction is effective October 1, 2006.

The Food and Drug Administration (FDA) has determined the regulatory review period for PLENAXIS and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent that claims that human drug product.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pfizer, Inc. The supplemental NADA provides for the addition of a pathogen to the indication for use of tulathromycin in cattle, by injection, for the treatment of respiratory disease.

The Food and Drug Administration (FDA) has determined the regulatory review period for LYRICA (new drug application (NDA) 21-723) and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product.

The FAA is adopting a new airworthiness directive (AD) for certain Lycoming Engines (L)O-360, (L)IO-360, AEIO-360, O-540, IO-540, AEIO-540, (L)TIO-540, IO-580, and IO-720 series reciprocating engines. This AD requires replacing certain crankshafts. This AD results from reports of 23 confirmed failures of similar crankshafts in Lycoming Engines 360 and 540 series reciprocating engines. We are issuing this AD to prevent failure of the crankshaft, which will result in total engine power loss, in-flight engine failure, and possible loss of the aircraft.

This regulation establishes tolerances for residues of flufenoxuron in or on apple, grape, pear, orange, and livestock commodities. 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).

These special conditions are issued for Boeing Model 767-300 series airplanes. These airplanes, modified by TIMCO Aviation Services, Inc. (TIMCO), will have a novel or unusual design feature associated with a forward lower lobe crew rest module (CRM). The applicable airworthiness regulations do not contain adequate or appropriate safety standards for this design feature. These special conditions contain the additional safety standards that the Administrator considers necessary to establish a level of safety equivalent to that established by the existing airworthiness standards.

The Occupational Safety and Health Review Commission (OSHRC) is amending its regulations implementing the Privacy Act of 1974, 5 U.S.C. 552a. The Privacy Act has been amended multiple times since OSHRC first promulgated its regulations in 1979. The amendments to OSHRC's regulations at 29 CFR Part 2400 will assist the agency in complying with the requirements of the Privacy Act.

This notice announces the initial filing of a pesticide petition proposing the establishment of regulations for residues of the herbicide pyroxsulam on wheat, hay, and straw.

NMFS proposes a rule to implement Amendment 16-4 to the Pacific Coast Groundfish Fishery Management Plan (FMP) and to set the 2007-2008 harvest specifications and management measures for groundfish taken in the U.S. exclusive economic zone (EEZ) off the coasts of Washington, Oregon, and California. Amendment 16-4 would modify the FMP to implement revised rebuilding plans for seven overfished species: bocaccio, canary rockfish, cowcod, darkblotched rockfish, Pacific ocean perch (POP), widow rockfish, and yelloweye rockfish. Groundfish harvest specifications and management measures for 2007-2008 are intended to: achieve but not exceed optimum yields (OYs); prevent overfishing; rebuild overfished species; reduce and minimize the bycatch and discard of overfished and depleted stocks; provide harvest opportunity for the recreational and commercial fishing sectors; and, within the commercial fisheries, achieve harvest guidelines and limited entry and open access allocations as closely as possible. Together, Amendment 16-4 and the 2007-2008 harvest specifications and management measures are intended to rebuild overfished stocks as soon as possible, taking into account the status and biology of the stocks, the needs of fishing communities, and the interaction of the overfished stocks within the marine environment. In addition to the management measures implemented for directed and incidental groundfish fisheries, this proposed rule would implement a new Yelloweye Rockfish Conservation Area off Washington State, which will be closed to commercial salmon troll fishing.

The Defense Science Board Task Force on Directed Energy will meet in closed session on September 28, 2006, at the Institute for Defense Analysis, 1801 N. Beauregard Street, Alexandria, VA. The task force will review directed energy weapon systems and technology applications. The mission of the Defense Science Board is to advise the Secretary of Defense and the Under Secretary of Defense for Acquisition, Technology & Logistics on scientific and technical matters as they affect the perceived needs of the Department of Defense. At these meetings, the Defense Science Board Task Force will: Review all surface, sub-surface, air and space DE programs in The Department and other organizations; examine recent supporting technology advancements and their applications with respect to supporting military DE weapon system developments; as well as make recommendations on potential strategic advantage DE weapons can provide with regards to the delivery of precision effects, decreased collateral damage, limiting unintended effects, and decreasing post combat reconstitution costs and efforts. In accordance with Section 10(d) of the Federal Advisory Committee Act, Pub L. 92-463, as amended (5 U.S.C. App. II), it has been determined that these Defense Science Board Task Force meetings concern matters listed in 5 U.S.C. 552b(c)(1) and that, accordingly, the meeting will be closed to the public.

The Defense Science Board Task Force on Biometrics will meet in closed session on September 28-29, 2006, at Science Applications International Corporation (SAIC), 4001 N. Fairfax Drive, Arlington, VA. This meeting will define the role of biometrics technologies and capabilities within DoD's Space. It will also recommend best organizational fit within DoD to implement the biometric and identify dominance missions. The briefings will contain proprietary material from the private business sector. The mission of the Defense Science Board is to advise the Secretary of Defense and the Under Secretary of Defense for Acquisition, Technology & Logistics on scientific and technical matters as they affect the perceived needs of the Department of Defense. At this meeting, the Defense Science Board Task Force will: Identify the biometric mission space metrics across the major applications (e.g. physical and logical access, intelligence, data sharing, Homeland Defense, force protection/counter terrorism, privacy protection, administrative and business practices-pay, human resource, medical, digital signature, etc.). Additionally the task force will develop a methodology to address needed taxonomy and policy development activities within the Department of Defense and identify the activities required for effective operational support and organizations structure to support these activities. In accordance with Section 10(d) of the Federal Advisory Committee Act, Pub. L. No. 92-463, as amended (5 U.S.C. App. II), it has been determined that these Defense Science Board Task Force meetings concern matters listed in 5 U.S.C. 552b(c)(4) and that, accordingly, the meetings will be closed to the public.

This Notice is published in accordance with Section 10(a)(2) of the Federal Advisory Committee Act (P.L. 92-463). The topic of the meeting on October 17-19, 2006 are to review new start and continuing research and development projects requesting Strategic Environmental Research and Development Program funds in excess of $1M. This meeting is open to the public . Any interested person may attend, appear before, or file statements with the Scientific Advisory Board at the time and in the manner permitted by the Board.

Pursuant to 10 U.S.C. 2869(d)(1) the Department of the Army (Army) is providing notice of its intent to convey the ``Drum Stick'' parcel of the former Fort Ord, located in Monterey County, CA in return for the ``Stillwell Kidney'' parcel owned by the City of Seaside. Fort Ord was selected for closure by the Base Realignment and Closure Commission in 1991. The Drum Stick parcel is an undeveloped, densely- vegetated 11.28-acre property adjacent to California State Route 1 on the former Fort Ord. the Stillwell Kidney parcel currently contains approximately 400 abandoned housing units. Under 10 U.S.C. 2869, the Army is authorized to enter into an agreement to convey real property, including any improvements thereon, located on a military installation that is closed or realigned under a Base Realignment and Closure (BRAC) Act to any person who agrees to convey to the Army real property of at least equal value. The Army has concluded that the Stillwell Kidney parcel has a fair market value that is at least equal to that of the Drum Stick parcel.

NMFS issues a final rule implementing the Bering Sea and Aleutian Islands (BSAI) Catcher Processor Capacity Reduction Program (Reduction Program) for the longline catcher processor subsector of the BSAI non-pollock groundfish fishery (Reduction Fishery), in compliance with the FY 2005 Appropriations Act. This program is voluntary and permit holders of the Reduction Fishery (Subsector Members) are eligible to participate. Subsector Members must sign and abide by the Capacity Reduction Agreement (Reduction Agreement) and, if their offers are selected, a Fishing Capacity Reduction Contract (Reduction Contract) with the U.S. Government. These key components of the Capacity Reduction Plan (Reduction Plan) were prepared by the Freezer Longline Conservation Cooperative (FLCC) and are implemented by the final regulations. The aggregate of all Reduction Agreements and those Reduction Contracts signed by Subsector Members whose offers were accepted by \2/3\ votes of the Subsector Members, will together with the FLCC's supporting documents and rationale that these offers represent the expenditure of the least money for the greatest capacity reduction, constitute the Reduction Plan to be submitted to the Secretary of Commerce for approval. Subsector Members participating in the Reduction Program will receive up to $36 million in exchange for relinquishing valid non-interim Federal License Limitation Program BSAI groundfish licenses endorsed for catcher processor fishing activity, Catcher/Processor (C/P), Pacific cod, and hook and line gear, as well as any present or future claims of eligibility for any fishing privilege based on such permit (the Groundfish Reduction Permit) and additionally, any future fishing privilege of the vessel named on the permit. Individual fishing quota (IFQ) quota shares would be excluded from relinquishment. Following submission of the Reduction Plan and approval by the Secretary, NMFS will conduct an industry referendum to determine the industry's willingness to repay a fishing capacity reduction loan to effect the Reduction Plan. A \2/3\ majority vote in favor would bind all parties and complete the reduction process. NMFS will issue a 30-year loan to be repaid by those harvesters remaining in the Reduction Fishery. The intent of this final rule is to permanently reduce harvesting capacity in the Reduction Fishery. This should result in increased harvesting productivity for post-reduction Subsector Members and help with conservation and management of the Reduction Fishery.

The Department proposed to revise the forms used by labor organizations to file the annual financial reports required by the Labor-Management Reporting and Disclosure Act (``LMRDA'' or ``Act''), 29 U.S.C. 431(b). Under the proposal, specified labor organizations would file annual reports about particular trusts to which they contributed money or otherwise provided financial assistance (Form T- 1). This document sets forth the Department's review of and response to comments on the proposal; this review was undertaken by the Department after the decision by the United States Court of Appeals for the District of Columbia Circuit in American Federation of Labor and Congress of Industrial Organizations v. Chao, 409 F.3d 377 (2005). Under this rule, the Department will require that a labor organization (``union'') with total annual receipts of $250,000 or more file a Form T-1 for each trust provided that the trust is of the type defined by section 3(l) of the LMRDA (defining ``trust in which a labor organization is interested'') and a number of conditions are met: The union's financial contribution to the trust was $10,000 or more during the year; the trust had $250,000 or more in annual receipts; and the union, acting either alone or with other unions, selects a majority of the members of the trust's governing board or the union's contribution to the trust, made independently or in combination with other unions, represents greater than 50% of the trust's revenue in the one-year reporting period. The Department will provide four exceptions to the Form T-1 requirements, and unions will not, therefore, be required to file a Form T-1 for: A Political Action Committee fund, if publicly available reports on the fund are filed with federal or state agencies; a political organization for which reports are filed with the Internal Revenue Service under 26 U.S.C. 527; an employee benefit plan filing a complete and timely report under the Employee Retirement Income Security Act (``ERISA''); and a trust or trust fund for which an independent audit has been conducted, in accordance with the standard set forth in this final rule, if the audit is made publicly available. Under this exception the labor organization must submit the first page of the Form T-1 and a copy of the audit.

This action establishes Class E airspace at Butler, GA. Area Navigation (RNAV) Global Positioning System (GPS) and Nondirectional Radio Beacon (NDB) Standard Instrument Approach Procedures (SIAP) Runway (RWY) 18 and RWY 36 have been developed for Butler Municipal Airport. As a result, controlled airspace extending upward from 700 feet Above Ground Level (AGL) is needed to contain the SIAPs and for Instrument Flight Rules (IFR) operations at Butler Municipal Airport. The operating status of the airport will change from Visual Flight Rules (VFR) to include IFR operations concurrent with the publication of the SIAP.