2008 – Federal Register Recent Federal Regulation Documents

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 Phibro Animal Health. The supplemental NADA provides for use of oxytetracycline dihydrate in Type C medicated feeds for the control of mortality in freshwater-reared salmonids due to coldwater disease and for the control of mortality in freshwater-reared Oncorhynchus mykiss due to columnaris disease.

The Coast Guard is revising the dates and is reinstating a temporary regulated navigation area and safety zone on the Chicago Sanitary and Ship Canal near Romeoville, IL. This regulated navigation area and safety zone places navigational and operational restrictions on all vessels transiting through the electrical dispersal barrier IIA.

NMFS announces that the 2008 summer flounder commercial quota allocated to the Commonwealth of Massachusetts has been harvested. Vessels issued a commercial Federal fisheries permit for the summer flounder fishery may not land summer flounder in Massachusetts for the remainder of calendar year 2008, unless additional quota becomes available through a transfer from another state. Regulations governing the summer flounder fishery require publication of this notification to advise Massachusetts that the quota has been harvested and to advise vessel permit holders and dealer permit holders that no commercial quota is available for landing summer flounder in Massachusetts.

These proposed regulations provide guidance concerning substantiation and reporting requirements for cash and noncash charitable contributions under section 170 of the Internal Revenue Code (Code). The regulations reflect the enactment of provisions of the American Jobs Creation Act of 2004 and the Pension Protection Act of 2006. The regulations provide guidance to individuals, partnerships, and corporations that make charitable contributions, and will affect any donor claiming a deduction for a charitable contribution after the date these regulations are published as final regulations in the Federal Register.

The FAA is superseding emergency Airworthiness Directive (AD) 2008-13-51, which currently applies to all owners/operators of Eclipse Aviation Corporation (Eclipse) Model EA500 airplanes that received the emergency AD by letter issued June 12, 2008. Emergency AD 2008-13-51 requires owner/operators to insert temporary revisions into the emergency and normal procedures sections of the airplane flight manual (AFM), do a pilot evaluation of the throttles with replacement as necessary, and report the evaluation results to the FAA. Emergency AD 2008-13-51 was the result of the throttle position exceeding its maximum range. Since issuing that AD, Eclipse developed an FAA-approved test procedure and issued Eclipse Aviation Alert Service Bulletin SB 500-76-001, REV B, dated July 22, 2008. The service bulletin provides a standardized procedure for testing and modifying (as applicable) the throttle lever with replacement as necessary. We are issuing this AD to mandate the actions in this service bulletin to be done by a person authorized to perform maintenance and reduce the likelihood of the throttle position signal exceeding its maximum range, which could cause loss of left and right engine control. This condition could result in the inability to maintain desired airspeed and/or altitude with consequent loss of control.

EPA is proposing to approve State Implementation Plan (SIP) revisions submitted by the State of Colorado on August 1, 2007. These revisions establish affirmative defense provisions for source owners and operators for excess emissions during periods of malfunction. The affirmative defense provisions are contained in the State of Colorado's Common Provisions regulation. The intended effect of this action is to approve only those portions of Colorado's Common Provisions regulation submitted on August 1, 2007 that relate to the affirmative defense for malfunctions. This action is being taken under section 110 of the Clean Air Act. In the ``Rules and Regulations'' section of this Federal Register, EPA is approving the State's SIP revision as a direct final rule without prior proposal because the Agency views this as a non- controversial SIP revision and anticipates no adverse comments. A detailed rationale for the approval is set forth in the preamble to the direct final rule. If EPA receives no adverse comments, EPA will not take further action on this proposed rule. If EPA receives adverse comments, EPA will withdraw the direct final rule and it will not take effect. EPA will address all public comments in a subsequent final rule based on this proposed rule. EPA will not institute a second comment period on this action. Any parties interested in commenting must do so at this time. Please note that if EPA receives adverse comment on an amendment, paragraph, or section of this rule and if that provision may be severed from the remainder of the rule, EPA may adopt as final those provisions of the rule that are not the subject of an adverse comment.

On November 10, 2003, EPA promulgated national emission standards for hazardous air pollutants (NESHAP) for miscellaneous organic chemical manufacturing. The rule is referred to as the miscellaneous organic NESHAP or the MON. The MON incorporates by reference the wastewater tank requirements in the National Emission Standards for Organic Hazardous Air Pollutants From the Synthetic Organic Chemical Manufacturing Industry for Process Vents, Storage Vessels, Transfer Operations, and Wastewater, which EPA promulgated on April 24, 1994, and which is referred to as the hazardous organic NESHAP or the HON. In this action EPA proposes to amend the HON, and thereby, the MON, by adding an equivalent means of emission limitation for wastewater tanks. This action also clarifies and corrects technical inconsistencies that have been discovered in the MON.

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 Phibro Animal Health. The supplemental NADA provides for label revisions associated with a previous change of sponsorship and other minor changes for amprolium concentrate solution to make medicated drinking water for chickens and turkeys for the treatment of coccidiosis. The product approval is being codified for the first time.

The Commander, First Coast Guard District, has issued a temporary deviation from the regulation governing the operation of the NJTRO Lower Hack Bridge across the Hackensack River, mile 3.4, at Jersey City, New Jersey. Under this temporary deviation, the NJTRO Lower Hack Bridge may remain in the closed position for 42 days to facilitate bridge lift cable maintenance. Vessels that can pass under the draw without a bridge opening may do so at all times. This deviation is necessary to facilitate necessary bridge maintenance.

The Coast Guard is establishing a temporary safety zone on the Atlantic Ocean offshore from Fort Lauderdale, Florida for the 2008 Personal Watercraft Challenge. This temporary safety zone is intended to restrict vessels from entering waters within the zone unless specifically authorized by the Captain of the Port Miami, Florida, or a designated representative. This rule is necessary to provide for the safety of life on the navigable waters of the United States and protect participants, spectators, and mariner traffic from potential hazards associated with the event.

This document contains corrections to the final regulations (Docket No. RM06-23-000) which were published in the Federal Register of Wednesday, November 14, 2007. The final rule document amended regulations for gaining access to critical energy infrastructure information (CEII).

The Securities and Exchange Commission is publishing for comment this proposed guidance to boards of directors of registered investment companies to assist them in fulfilling their fiduciary responsibilities with respect to overseeing the trading of investment company portfolio securities. The guidance focuses on the role of an investment company board in overseeing the best execution obligations of the investment adviser hired to invest in securities and other instruments on the investment company's behalf. In this respect, we address the conflicts of interest that may exist when an investment adviser uses an investment company's brokerage commissions to purchase services other than execution, such as the purchase of brokerage and research services through client commission arrangements. The Commission also is requesting comment on whether to propose that advisers be subject to new disclosure requirements concerning the use of client commission arrangements to investment company shareholders and other investment advisory clients.

The Nuclear Regulatory Commission (NRC) is proposing to amend its regulations that govern medical use of byproduct material related to reporting and notifications of medical events (MEs) to clarify requirements for permanent implant brachytherapy. The proposed amendments would change the criteria for defining an ME for permanent implant brachytherapy from dose-based to activity-based; add a requirement to report, as an ME, any administration requiring a written directive (WD) if a WD was not prepared; clarify requirements for WDs for permanent implant brachytherapy; and make certain administrative and clarification changes. These amendments regarding permanent implant brachytherapy are being proposed in response to several incidents involving therapeutic use of byproduct material. The proposed changes are based in part on recommendations from NRC's Advisory Committee on the Medical Use of Isotopes (ACMUI) and the NRC's Medical Radiation Safety Team. This proposed rule would affect all medical licensees that perform procedures using byproduct material that require completion of a WD.

We propose to adopt a superseding airworthiness directive (AD) for the specified Agusta S.p.A. (Agusta) model helicopters. This proposed AD results from a revised mandatory continuing airworthiness information (MCAI) originated by an aviation authority to identify and correct an unsafe condition on an aviation product. The aviation authority of Italy, with which we have a bilateral agreement, reports that the previous MCAI should not apply to newly redesigned and improved tail rotor blades. This action proposes the same inspection requirements as the current AD but would limit the applicability to only three part-numbered tail rotor blades. The proposed AD would require actions that are intended to prevent fatigue failure of a tail rotor blade (blade), loss of a tail rotor, and subsequent loss of control of the helicopter.

This document contains a correction to final regulations (TD 9415), that were published in the Federal Register on Monday, July 14, 2008 (73 FR 40171). The final regulations relates to income that is associated with a residual interest in a Real Estate Mortgage Investment Conduit (REMIC) and that is allocated through certain entities to foreign persons who have invested in those entities.

NASA proposes to revise the NASA FAR Supplement (NFS) to update procedures for compliance with Federal Acquisition Regulation (FAR) Subpart 4.13, Personal Identity Verification of Contractor Personnel. FAR 4.13 requires that agencies include their implementing guidance of FIPS 201 and OMB guidance M-05-24 in solicitations and contracts that require the contractor to have routine physical access to Federally-controlled facilities and/or access to Federally- controlled information systems. NASA further proposes to designate The Assistant Administrator, Office of Security and Program Protection as the official with overall responsibility for verifying contractor employee personal identity.

This regulation establishes tolerances for residues of dodine in or on bananas and peanuts. Agriphar S.A. c/o Ceres International LLC requested these tolerances under the Federal Food, Drug, and Cosmetic Act (FFDCA).

We, the U.S. Fish and Wildlife Service (Service), propose to revise the currently designated critical habitat for Cirsium loncholepis (La Graciosa thistle) pursuant to the Endangered Species Act of 1973, as amended (Act). In total, approximately 38,447 acres (ac) (15,559 hectares (ha)) fall within the boundaries of this proposed revised critical habitat designation. The proposed revision is to critical habitat located in San Luis Obispo and Santa Barbara Counties, California.

This action establishes Class E airspace at Lexington, OK. New Area Navigation (RNAV) Global Positioning System (GPS) Standard Instrument Approach Procedures (SIAPs) at Muldrow Army Heliport make this action necessary. This action will enhance the safety and management of Instrument Flight Rules (JFR) aircraft operations at Muldrow Army Heliport, Lexington, OK.

This action amends Class D and Class E airspace at Altus Air Force Base (AFB), Altus OK. Additional controlled airspace is necessary to accommodate aircraft using Standard Instrument Approach Procedures (SIAPs). This action is necessary for the safety and management of Instrument Flight Rules (IFR) operations at Altus AFB, OK.

This document adopts as a final rule, with some changes, interim amendments to title 19 of the Code of Federal Regulations (``CFR'') which were published in the Federal Register on June 29, 2007, as CBP Dec. 07-51 to implement the preferential tariff treatment and other customs-related provisions of the United States-Morocco Free Trade Agreement signed by the United States and the Kingdom of Morocco.

NMFS announces the closure of the Nantucket Lightship Scallop Access Area (NLCA) to scallop vessels until June 15, 2010. This closure is based on a determination by the Northeast Regional Administrator (RA) that scallop vessels will have caught the yellowtail flounder (yellowtail) total allowable catch (TAC) for the NLCA on August 3, 2008. Effective 0001 hours, August 4, 2008, vessels may not fish for scallops in the NLCA. Vessels on a NLCA scallop trip at the time of this announcement must leave the NLCA prior to 0001 hour, August 4, 2008. This action is being taken to prevent the scallop fleet from exceeding the yellowtail TAC allocated to the NLCA for the 2008 scallop fishing year in accordance with the regulations implementing the Atlantic Sea Scallop Fishery Management Plan (FMP), Northeast (NE) Multispecies FMP and the Magnuson-Stevens Fishery Conservation and Management Act.

The General Services Administration (GSA) is proposing to amend the General Services Acquisition Regulation (GSAR) to revise language that provides requirements for bonds and insurance.

The Commission requests comments on a channel substitution proposed by Twin Cities Public Television, Inc. (``Twin Cities''), the licensee of KTCI-TV, analog channel *16, and permittee of post- transition DTV channel *26, St. Paul, Minnesota. Twin Cities requests the substitution of DTV channel *38 for its post-transition DTV channel *26.

The Commission requests comments on a channel substitution proposed by Hearst-Argyle Television, Inc. (``KMBC''), the licensee of KMBC-DT, pre-transition digital channel 7, and permittee of KMBC-DT, post-transition digital channel 9, Kansas City, Missouri. KMBC requests the substitution of channel 29 for post-transition digital channel 9 at Kansas City.