January 2008 – Federal Register Recent Federal Regulation Documents

The Office of Personnel Management is issuing proposed regulations to achieve a consistent and effective policy for the use of Social Security Numbers by Federal agencies to combat fraud and identity theft. Federal agencies must reduce the threat of identity theft by eliminating the unnecessary use and collection of Social Security Numbers. This proposed regulation imposes significant restrictions on the use of Social Security Numbers throughout the Federal Government and is consistent with the recommendations made by the President's Identity Theft Task Force.

We propose to adopt a new airworthiness directive (AD) for all McDonnell Douglas airplanes identified above. This proposed AD would require revising the FAA-approved maintenance program to incorporate new airworthiness limitations for fuel tank systems to satisfy Special Federal Aviation Regulation No. 88 requirements. This proposed AD results from a design review of the fuel tank systems. We are proposing this AD to prevent the potential for ignition sources inside fuel tanks caused by latent failures, alterations, repairs, or maintenance actions, which, in combination with flammable fuel vapors, could result in a fuel tank explosion and consequent loss of the airplane.

These special conditions are issued for the Embraer Model EMB- 500 airplane. This airplane will have a novel or unusual design feature(s) associated with aft mounted engine fire protection. 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.

We propose to adopt a new airworthiness directive (AD) for the products listed above. This proposed 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:

We propose to adopt a new airworthiness directive (AD) for the products listed above. This proposed 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:

EPA is proposing to approve the maintenance plan for the San Manuel Area in Pinal and Pima Counties, Arizona, as a revision to the Arizona state implementation plan, and to grant the request submitted by the State to redesignate this area from nonattainment to attainment of the national ambient air quality standards for sulfur dioxide (SO2) for the San Manuel SO2 nonattainment area. EPA is proposing this action in accordance with the Clean Air Act.

The Combat Methamphetamine Epidemic Act of 2005 (CMEA), which was enacted on March 9, 2006, requires DEA to establish an assessment of annual need for the importation and manufacture of ephedrine, pseudoephedrine, and phenylpropanolamine. Because of the new CMEA mandates for importation, import quotas, and production quotas for these chemicals, DEA must revise its registration provisions. The changes made by the CMEA render current DEA regulations inadequate for two reasons. First, although DEA registers bulk manufacturers of the three chemicals in the United States and importers of the bulk chemicals, some of those chemicals are distributed to non-registered companies that process them into prescription drugs. Under the Controlled Substances Act, section 826, production quotas are available only to registered manufacturers. DEA cannot meet the CMEA mandate to establish annual need and import quotas, and then issue individual quotas for each of the chemicals unless all manufacturers manufacturing or procuring the chemicals and manufacturing drug products that contain the chemicals are registered as manufacturers, even if the distribution of the final drug products is not regulated. DEA also must know the quantity of prescription drug products containing the three chemicals being imported. Without this information, DEA would not be able to determine an assessment of annual need for these chemicals. Any person importing prescription drug products containing any of the three chemicals must register although the distribution of these products would not be subject to DEA regulation. Second, persons currently registered to import, distribute, or dispense controlled substances who manufacture drug products using ephedrine, pseudoephedrine, or phenylpropanolamine, are not necessarily registered to do so. This must also be changed so that controlled substance registrants will only receive a waiver from the requirement of separate chemical registration if they engage in the same activity for both lawfully marketed drug products containing List I chemicals and controlled substances (as is already the case for bulk manufacture, imports, and exports.) In this way, any registrant that must obtain a quota to manufacture or procure one or more of the chemicals will be a registered manufacturer, as required by the CSA. Were DEA not to issue this rule, it would have no mechanism to issue production or import quotas for persons handling prescription drug products containing ephedrine, pseudoephedrine, or phenylpropanolamine. If these persons were not required to register, there would be no mechanism by which they would be permitted to apply for production or import quotas. Therefore, these persons would have no means by which to acquire the List I chemicals ephedrine, pseudoephedrine, or phenylpropanolamine necessary for them to conduct business. Accordingly, DEA is proposing to amend its registration regulations to ensure that every location that manufactures or imports one of these chemicals or drug products that contain ephedrine, pseudoephedrine, or phenylpropanolamine is a DEA registered manufacturer or importer. These amendments will make it possible to establish the system of quotas and assessment of annual needs for the manufacturing that Congress mandated for ephedrine, pseudoephedrine, and phenylpropanolamine.

EPA is taking direct final action to approve a revision to the Washoe County portion of the Nevada State Implementation Plan. Submitted by the State of Nevada on May 30, 2007, this plan revision consists of a maintenance plan prepared for the purpose of providing for continued attainment of the 8-hour ozone standard in Washoe County through the year 2014 and thereby satisfying the related requirements under section 110(a)(1) of the Clean Air Act and EPA's phase 1 rule implementing the 8-hour ozone national ambient air quality standard. EPA is taking this action pursuant to those provisions of the Clean Air Act that obligate the Agency to take action on submittals of state implementation plans and plan revisions.

EPA is promulgating new source standards of performance for stationary spark ignition internal combustion engines. EPA is also promulgating national emission standards for hazardous air pollutants for new and reconstructed stationary reciprocating internal combustion engines that either are located at area sources of hazardous air pollutant emissions or that have a site rating of less than or equal to 500 brake horsepower and are located at major sources of hazardous air pollutant emissions.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of supplemental new animal drug applications (NADAs) filed by Fort Dodge Animal Health, Division of Wyeth. The supplemental NADAs provide for revisions to the labeling of two cephapirin sodium products administered by intramammary infusion to lactating cows for the treatment of mastitis.

EPA is taking final action to approve the State Plan submitted by Missouri on May 18, 2007, and revisions submitted on September 6, 2007. The plan addresses the requirements of EPA's Clean Air Mercury Rule (CAMR), promulgated on May 18, 2005, and subsequently revised on June 9, 2006. EPA has determined that the submitted State Plan fully meets the CAMR requirements for Missouri. CAMR requires States to regulate emissions of mercury (Hg) from large coal-fired electric generating units (EGUs). CAMR establishes State budgets for annual EGU Hg emissions and requires States to submit State Plans to ensure that annual EGU Hg emissions will not exceed the applicable State budget. States have the flexibility to choose which control measures to adopt to achieve the budgets, including participating in the EPA-administered CAMR cap-and-trade program. In the State Plan that EPA is approving today, Missouri has met the CAMR requirements by electing to participate in the EPA trading program.

In this document, the Commission adopts rules and provides guidance to efforts to promote the operation and expansion of the low power FM (LPFM) service. The Commission solicited and reviewed comments regarding the status of LPFM service, and found that to promote the service, it was necessary to make rule changes related to ownership and technical issues.

The National Indian Gaming Commission (``NIGC'') announces the extension of the comment period on the proposed rule concerning Classification Standards for Bingo, Lotto, Other Games Similar to Bingo, Pull Tabs and Instant Bingo as Class II Gaming When Played Through an Electronic Medium Using ``Electronic, Computer, or Other Technologic Aids.'' The proposed rule was published in the Federal Register on October 24, 2007 (72 FR 60483). The NIGC is extending the comment period to March 9, 2008.

The National Indian Gaming Commission (``NIGC'') announces the extension of the comment period on the proposed rule concerning Minimum Internal Control Standards for Class II Gaming. The proposed rule was published in the Federal Register on October 24, 2007 (72 FR 60495). The NIGC is extending the comment period to March 9, 2008.

In this document, the Commission adopts new cost recovery methodologies regarding compensation for the provision of Telecommunications Relay Services (TRS) from the Interstate TRS Fund (the Fund). Those cost recovery methodologies will result in fairer, more predictable rates that better reflect the actual costs and market realities of providing TRS. The Commission also: adopts new per-minute compensation rates for the various forms of TRS; clarifies the nature of certain cost categories and extent to which they are compensable from the Fund; reaffirms the role that the TRS Advisory Council is to play in the oversight of TRS; and announces its intent of additional and more comprehensive auditing of TRS providers to ensure Fund integrity.

The U.S. Office of Personnel Management is issuing a proposed rule that would update the 2002 North American Industry Classification System (NAICS) codes currently used in Federal Wage System wage survey industry regulations with the 2007 NAICS revisions published by the Office of Management and Budget.

EPA is approving revisions to the Commonwealth of Pennsylvania State Implementation Plan which were submitted on November 21, 2006 by the Pennsylvania Department of Environmental Protection (PADEP). These revisions modify and clarify the existing regulatory requirements for the control of volatile organic compounds from gasoline dispensing facilities in Allegheny County. The revisions modify the compliance dates and make other minor technical amendments to the efficiency and compliance testing portions of the Stage II regulations in Allegheny County. EPA is approving these revisions to the Commonwealth of Pennsylvania's State Implementation Plan in accordance with the requirements of the Clean Air Act (CAA).

EPA proposes to approve the State Implementation Plan (SIP) revision submitted by the State of Maryland for the purpose of approving revisions and additions to the current Stage II regulations that apply to gasoline dispensing facilities. In the Final Rules section of this Federal Register, EPA is approving the State's SIP submittal as a direct final rule without prior proposal because the Agency views this as a noncontroversial submittal and anticipates no adverse comments. A detailed rationale for the approval is set forth in the direct final rule. If no adverse comments are received in response to this action, no further activity is contemplated. If EPA receives adverse comments, the direct final rule will be withdrawn and all public comments received will be addressed in a subsequent final rule based on this proposed rule. EPA will not institute a second comment period. Any parties interested in commenting on this action should do so at this time.

EPA is taking direct final action to approve revisions to the Kern County Air Pollution Control District (KCAPCD) portion of the California State Implementation Plan (SIP). These revisions concern particulate matter (PM-10) emissions from ambient dust, propellant testing, and rocket testing. We are approving local rules under the Clean Air Act as amended in 1990 (CAA or the Act).

We, the U.S. Fish and Wildlife Service (Service), propose to revise currently designated critical habitat for the Quino checkerspot butterfly (Euphydryas editha quino) under the Endangered Species Act of 1973, as amended (Act). In total, approximately 98,487 acres (ac) (39,857 hectares (ha)) fall within the boundaries of the proposed revised critical habitat designation: 23,494 ac (9,508 ha) are federally owned; 7,756 ac (3,139 ha) are owned by the State of California; 4,359 ac (1,764 ha) are Tribal lands; 7,739 ac (3,132 ha) are owned by city or county governments; and 55,139 ac (22, 314 ha) are privately owned. Of these 98,487 ac (39,857 ha), we are considering excluding 1,684 ac (681 ha) of land within the San Diego County Multiple Species Conservation Plan's City of Chula Vista Subarea Plan, and 37,245 ac (15,073) of non-Federal land within the Western Riverside County Multiple Species Habitat Conservation Plan (MSHCP) area. Areas included in the proposed revision are in Riverside and San Diego Counties, California.

Comments are requested on the proposed Base (1 percent annual- chance) Flood Elevations (BFEs) and proposed BFE modifications for the communities listed in the table below. The purpose of this notice is to seek general information and comment regarding the proposed regulatory flood elevations for the reach described by the downstream and upstream locations in the table below. The BFEs and modified BFEs are a part of the floodplain management measures that the community is required either to adopt or to show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP). In addition, these elevations, once finalized, will be used by insurance agents, and others to calculate appropriate flood insurance premium rates for new buildings and the contents in those buildings.

Comments are requested on the proposed Base (1 percent annual- chance) Flood Elevations (BFEs) and proposed BFE modifications for the communities listed in the table below. The purpose of this notice is to seek general information and comment regarding the proposed regulatory flood elevations for the reach described by the downstream and upstream locations in the table below. The BFEs and modified BFEs are a part of the floodplain management measures that the community is required either to adopt or show evidence of having in effect in order to qualify or remain qualified for participation in the National Flood Insurance Program (NFIP). In addition, these elevations, once finalized, will be used by insurance agents, and others to calculate appropriate flood insurance premium rates for new buildings and the contents in those buildings.

This interim rule lists communities where modification of the Base (1% annual-chance) Flood Elevations (BFEs) is appropriate because of new scientific or technical data. New flood insurance premium rates will be calculated from the modified BFEs for new buildings and their contents.

The Food and Drug Administration (FDA) is proposing to amend its regulations regarding changes to an approved new drug application (NDA), biologics license application (BLA), or medical device premarket approval application (PMA) to codify the agency's longstanding view on when a change to the labeling of an approved drug, biologic, or medical device may be made in advance of the agency's review of such change. FDA is proposing to reaffirm its longstanding position that a supplemental application submitted under those provisions is appropriate to amend the labeling for an approved product only to reflect newly acquired information, as well as to clarify that such a supplemental application may be used to add or strengthen a contraindication, warning, precaution, or adverse reaction only if there is sufficient evidence of a causal association with the drug, biologic, or device. The amendments proposed by this document are intended to reflect the agency's existing practices with respect to supplemental applications submitted to FDA.