March 2010 – Federal Register Recent Federal Regulation Documents

This Notice of Proposed Rulemaking proposes the amendment of the list of Exempted Prescription Products cited in the Code of Federal Regulations. This action is in response to DEA's review of new applications for exemption. DEA has received one new application for exemption for River Edge Pharmaceutical's Servira[supreg]. Having reviewed this application and relevant information, DEA finds that this preparation has no significant potential for abuse. Therefore, DEA hereby proposes that this product be added to the list of Exempted Prescription Products and exempted from the application of certain provisions of the Controlled Substances Act (CSA).

The Food and Drug Administration (FDA) is proposing to amend its regulations concerning direct-to-consumer (DTC) advertisements of prescription drugs. Specifically, the proposed rule would implement a new requirement of the Federal Food, Drug, and Cosmetic Act (the act), added by the Food and Drug Administration Amendments Act of 2007 (FDAAA), that the major statement in DTC television or radio advertisements (or ads) relating to the side effects and contraindications of an advertised prescription drug intended for use by humans be presented in a clear, conspicuous, and neutral manner. FDA is also proposing, as directed by FDAAA, standards that the agency would consider in determining whether the major statement in these advertisements is presented in the manner required by FDAAA.

The Copyright Office is seeking comments regarding the application of Title 17 to the termination of certain grants of transfers or licenses of copyright, specifically those for which execution of the grant occurred prior to January 1, 1978 and creation of the work occurred on or after January 1, 1978. The Copyright Office is seeking comments at this time because the deadlines for serving notices of termination for 1978 grants will begin to expire in 2011 and some stakeholders have raised questions with the Office and some Congressional Offices.

The Food and Drug Administration (FDA or the agency) is announcing an advance notice of proposed rulemaking (ANPRM) to solicit comments from the public regarding potential changes to its current regulation relating to veterinary feed directive (VFD) drugs. FDA's VFD regulation, which became effective on January 8, 2001, established requirements relating to the distribution and use of VFD drugs and animal feeds containing such drugs. FDA is undertaking a review of these requirements in an effort to identify possible changes to improve efficiency. Therefore, the agency is requesting public comment on all aspects of the VFD regulation, particularly suggestions relating to improving efficiency. This information may be used to help draft a proposed rule in the near future.

This rule modifies provisions contained in the existing Regulated Navigation Area (RNA) that were originally implemented to

We are revising an earlier NPRM for the products listed above. This action revises the earlier NPRM by expanding the scope. This 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: Several cases of corrosion and damage on the Down Drive Shafts (DDS), between the Down Drive Gear Box (DDGB) and the Input Gear Box (IPGB), on all 10 Flap Tracks (5 per wing), have been reported by AIRBUS Long Range Operators. Investigations have revealed that corrosion and wear due to absence of grease in the spline interfaces could cause [DDS] disconnection which could result in a free movable flap surface, potentially leading to aircraft asymmetry or even flap detachment.

This action proposes to remove Class E airspace at Brunswick, ME, as the airport has closed and the associated Standard Instrument Approach Procedures (SIAPs) removed, and to establish Class E airspace at Wiscasset, ME, to accommodate the SIAPs developed for the airport. This action enhances the safety and airspace management of Instrument Flight Rules (IFR) operations at Wiscasset Airport, Wiscasset, ME.

The Environmental Protection Agency (EPA) proposes to approve a revision to the Texas State Implementation Plan (SIP). The revision adds additional requirements to control volatile organic compound (VOC) emissions from storage tanks, transport vessels and marine vessels in the Houston/Galveston/Brazoria (HGB) 1997 8-hour ozone nonattainment area, which consists of Brazoria, Chambers, Fort Bend, Galveston, Harris, Liberty, Montgomery and Waller counties. Specifically, this revision subjects owners or operators of VOC storage tanks, transport vessels, and marine vessels located in the HGB 1997 8-hour ozone nonattainment area to more stringent control, monitoring, and recordkeeping requirements. EPA proposes to approve the SIP revision because it will help lower ozone levels in the HGB area by reducing VOC emissions. EPA proposes to approve the revision pursuant to section 110 and part D of the Clean Air Act (CAA).

The Commission is amending its regulations, in order to clarify them in response to Order Nos. 717 and 717- A, governing the Standards of Conduct for transmission providers. These amendments are required in order to make clear to prospective applicants for an Alaska natural gas transportation project which Standards of Conduct are applicable to conducting open seasons for Alaska natural gas transportation projects. This clarification will benefit both prospective applicants and prospective shippers of an Alaska natural gas transportation project by eliminating any uncertainties those parties may have pertaining to the standards of conduct governing open seasons for such a project.

Pursuant to section 215 of the Federal Power Act, the Commission proposes to remand the proposed revised Time Error Correction Reliability Standard developed by the North American Electric Reliability Corporation (NERC) in order for NERC to develop several modifications to the proposed Reliability Standard. The proposed action ensures that any modifications to Reliability Standards will be just, reasonable, not unduly discriminatory or preferential, and in the public interest.

The National Credit Union Administration (NCUA) is issuing a proposed rulemaking covering several related subjects. The proposal documents and clarifies the fiduciary duties and responsibilities of Federal credit union directors. The proposal adds new provisions establishing the procedures for insured credit unions merging into banks. The proposal also amends some of the existing regulatory procedures applicable to insured credit union mergers with other credit unions and conversions to banks.

We are adopting a new airworthiness directive (AD) for certain Model 757 airplanes. This AD requires inspecting to verify the part number of the low-pressure flex-hoses of the flightcrew and supernumerary oxygen system installed under the oxygen mask stowage box at a flightcrew and supernumerary oxygen mask location, and replacing with a new non-conductive low-pressure flex-hose of the oxygen system if necessary. This AD results from reports of a low-pressure flex-hose of a flightcrew oxygen system that burned through due to inadvertent electrical current from a short circuit in an adjacent audio select panel. We are issuing this AD to prevent inadvertent electrical current, which can cause the low-pressure flex-hose of a flightcrew or supernumerary oxygen system to melt or burn, resulting in oxygen system leakage and smoke or fire.

We are adopting a new airworthiness directive (AD) for the products listed above. This AD results from mandatory continuing airworthiness information (MCAI) issued 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:

EPA is proposing to approve revisions to the San Joaquin Valley Unified Air Pollution Control District (SJVUAPCD) portion of the California State Implementation Plan (SIP). These revisions concern volatile organic compound (VOC) emissions from refinery vacuum producing systems and process unit turnaround. We are approving local rules that regulate these emission sources under the Clean Air Act as amended in 1990 (CAA or the Act). We are taking comments on this proposal and plan to follow with a final action.

NMFS issues this proposed rule to implement the Comprehensive Ecosystem-Based Amendment 1 (CE-BA1) to the following South Atlantic fishery management plans (FMPs): The FMP for Coral, Coral reefs, and Live/Hard Bottom Habitats of the South Atlantic Region (Coral FMP); the FMP for the Dolphin and Wahoo Fishery off the Atlantic States (Dolphin and Wahoo FMP); the FMP for Golden Crab of the South Atlantic Region (Golden Crab FMP); the FMP for the Shrimp Fishery of the South Atlantic Region (Shrimp FMP); and the FMP for the Snapper-Grouper Fishery of the South Atlantic Region (Snapper-Grouper FMP), as prepared and submitted by the South Atlantic Fishery Management Council (Council); as well as the FMP for Coastal Migratory Pelagic (CMP) Resources (CMP FMP); and the FMP for the Spiny Lobster Fishery of the Gulf of Mexico and South Atlantic (Spiny Lobster FMP), as prepared and submitted by the South Atlantic and Gulf of Mexico Fishery Management Councils. This proposed rule would establish Deepwater Coral Habitat Areas of Particular Concern (Deepwater Coral HAPCs) off the coast of the southern Atlantic States in which the use of specified fishing gear and methods and the possession of coral would be prohibited. Within the Deepwater Coral HAPCs, fishing zones would be created that would allow continued fishing on the historical grounds for golden crab and deepwater shrimp. In addition, CE-BA1 would update existing Essential Fish Habitat (EFH) information in the area off the southern Atlantic States, thus,

NMFS is prohibiting directed fishing for Atka mackerel in the Central Aleutian District of the Bering Sea and Aleutian Islands management area (BSAI) by vessels participating in the Amendment 80 limited access fishery. This action is necessary to prevent exceeding the 2010 A season allocation of Atka mackerel in this area allocated to vessels participating in the Amendment 80 limited access fishery.

Indian Affairs will conduct consultation meetings with Indian tribes to obtain oral and written comments concerning draft regulations to implement the Buy Indian Act. See the SUPPLEMENTARY INFORMATION section of this notice for details.

We, the Department of Commerce, issue a final rule to bring the Commerce Acquisition Regulation in alignment with the Federal Acquisition Regulation (FAR) and to streamline DOC's internal policy and guidance.

Sunset of the exempted or prohibited use of substances under the National Organic Program (NOP) is required by the Organic Foods Production Act of 1990 (OFPA). The exemptions and prohibitions granted under the OFPA are required to be reviewed every 5 years by the National Organic Standards Board (NOSB). The Secretary of Agriculture has authority under the OFPA to renew such exemptions and prohibitions. If they are not reviewed by the NOSB and renewed by the Secretary within 5 years of their inclusion on the National List, their authorized use or prohibition expires. This advance notice of proposed rulemaking (ANPR) announces the sunset of 37 exempted substances added to the National List for use in organic handling on June 27, 2007; the sunset of 183 continued exemptions (use) and prohibitions of substances used in organic production and handling added to the list on October 21, 2007; the sunset of 2 exemptions of one substance for continued use in organic crop and livestock production added to the national list on December 11, 2007; and the sunset of 10 exempted substances for use in organic livestock production added to the national list on December 13, 2007. This ANPR establishes June 27, 2012, October 21, 2012, December 11, 2012, and December 13, 2012, as the respective dates by which the sunset review and renewal process must be concluded. The NOP may try to conclude the sunset and renewal process for the 232 combined exempted and prohibited substances used in organic production and handling added to the National List in 2007 by the earliest respective date of June 27, 2012. This ANPR also begins the public comment process on whether the identified existing exemptions and prohibitions should be continued. Finally, this ANPR discusses how the NOP will manage the sunset review and renewal process.

This document contains corrections to the final rule governing the Forest Service's Special Use Program that was published in the Federal Register on December 24, 2009 (74 FR 68379). These corrections add phrases which were inadvertently omitted from the final rule and which are necessary to reflect properly the Forest Service's authority to revoke or suspend special use authorizations under the Federal Land Policy and Management Act.

Under the Clean Air Act Section 211(o), as amended by the Energy Independence and Security Act of 2007 (EISA), the Environmental Protection Agency is required to promulgate regulations implementing changes to the Renewable Fuel Standard program. The revised statutory requirements specify the volumes of cellulosic biofuel, biomass-based diesel, advanced biofuel, and total renewable fuel that must be used in transportation fuel. This action finalizes the regulations that implement the requirements of EISA, including the cellulosic, biomass- based diesel, advanced biofuel, and renewable fuel standards that will apply to all gasoline and diesel produced or imported in 2010. The final regulations make a number of changes to the current Renewable Fuel Standard program while retaining many elements of the compliance and trading system already in place. This final rule also implements the revised statutory definitions and criteria, most notably the new greenhouse gas emission thresholds for renewable fuels and new limits on renewable biomass feedstocks. This rulemaking marks the first time that greenhouse gas emission performance is being applied in a regulatory context for a nationwide program. As mandated by the statute, our greenhouse gas emission assessments consider the full lifecycle emission impacts of fuel production from both direct and indirect emissions, including significant emissions from land use changes. In carrying out our lifecycle analysis we have taken steps to ensure that the lifecycle estimates are based on the latest and most up-to-date science. The lifecycle greenhouse gas assessments reflected in this rulemaking represent significant improvements in analysis based on information and data received since the proposal. However, we also recognize that lifecycle GHG assessment of biofuels is an evolving discipline and will continue to revisit our lifecycle analyses in the future as new information becomes available. EPA plans to ask the National Academy of Sciences for assistance as we move forward. Based on current analyses we have determined that ethanol from corn starch will be able to comply with the required greenhouse gas (GHG) threshold for renewable fuel. Similarly, biodiesel can be produced to comply with the 50% threshold for biomass-based diesel, sugarcane with the 50% threshold for advanced biofuel and multiple cellulosic-based fuels with their 60% threshold. Additional fuel pathways have also been determined to comply with their thresholds. The assessment for this rulemaking also indicates the increased use of renewable fuels will have important environmental, energy and economic impacts for our Nation.

This action proposes to establish Class E airspace for the Lucin VHF Omni-Directional Radio Range Tactical Air Navigational Aid (VORTAC), Lucin, UT, to facilitate vectoring of Instrument Flight Rules (IFR) traffic from en route airspace to Salt Lake City, UT. This action would enhance the safety and management of IFR operations for the Salt Lake City, UT area.

This action proposes to amend Class E Airspace at Mount Airy, NC, to accommodate the additional airspace needed for the Standard Instrument Approach Procedures (SIAPs) developed for Mount Airy-Surry County Airport. This action enhances the safety and airspace management of Instrument Flight Rules (IFR) operations at the airport.

NMFS is reopening directed fishing for pollock in Statistical Area 630 of the Gulf of Alaska (GOA) for 72 hours. This action is necessary to fully use the B season allowance of the 2010 total allowable catch (TAC) of pollock in Statistical Area 630 of the GOA.

HUD published a document in the Federal Register on March 19, 2010, announcing a meeting of the Native American Housing Assistance & Self-Determination Negotiated Rulemaking Committee. The document contained an incorrect telephone number for the location where the meeting is to take place. The location,