December 22, 2008 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is proposing to classify into class II (special controls) the tissue expander, as a device intended for temporary (less than 6 months) subdermal implantation to stretch the skin for surgical applications, specifically to develop surgical flaps and additional tissue coverage. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the draft guidance that FDA intends will serve as the special control if FDA classifies this device type into class II.

The Commission is adding Express Mail and Priority Mail Contract 2 to the Competitive Product List. This action is consistent with changes in a recent law governing postal operations and a recent Postal Service request. Republication of the lists of market dominant and competitive products is also consistent with new requirements in the law.

The Bureau of Industry and Security (BIS) is publishing this final rule to amend the Chemical Weapons Convention Regulations (CWCR) by updating the address for submitting declarations, reports, and advance notifications under the CWCR and for submitting chemical determination requests, and requests to obtain the forms needed to complete the declarations and reports. This final rule also updates the telephone and facsimile numbers for contacting, or providing information to, BIS's Treaty Compliance Division (TCD), which administers the requirements contained in the CWCR. In addition, this rule updates the e-mail addresses in the CWCR for submitting chemical determination requests or requests for BIS to provide written interpretations of CWCR requirements. These changes are being implemented by BIS to reflect the recent relocation of TCD. This rule also updates the list of countries that currently are States Parties to the CWC by adding ``Congo (Republic of the),'' ``Guinea-Bissau,'' and ``Lebanon,'' which recently became States Parties. Finally, this rule revises a number of references in the CWCR to the Export Administration Regulations (EAR) to indicate the correct legal citation for the EAR.

The Environmental Protection Agency (EPA) is proposing to approve a revision to New Jersey's State Implementation Plan (SIP) submitted on November 3, 2008. The proposed SIP revision includes a regulation that allows for continuation of New Jersey's statewide nitrogen oxides (NOX) budget and NOX allowance trading program beyond the year 2008. New Jersey's program began in 2003 for large electric generating units and industrial sources. The intended effect of this proposed SIP revision is to allow the continuation of the State's program to reduce emissions of NOX in order to help attain the national ambient air quality standard for ozone. EPA is proposing this action pursuant to section 110 of the Clean Air Act.

The Commission is adding Parcel Select & Parcel Return Service Contract 1 to the Competitive Product List. This action is consistent with changes in a recent law governing postal operations and a recent Postal Service request. Republication of the lists of market dominant and competitive products is also consistent with new requirements in the law.

This action summarizes the results under the criteria contained in section 610 of the Regulatory Flexibility Act (RFA), of an Agricultural Marketing Service (AMS) review of Marketing Order No. 927, regulating the handling of pears grown in Oregon and Washington. AMS has determined that the marketing order should be continued.

This document contains proposed regulations under section 6707 of the Internal Revenue Code (Code), which provide the rules relating to the assessment of penalties against material advisors who fail to timely file a true and complete return required under section 6111(a). The regulations implement the amendments to section 6707 by the American Jobs Creation Act and promote material advisors' compliance with the regulations under section 6111. These regulations affect material advisors responsible for disclosing reportable transactions under section 6111.

This proposed rule would implement a statutorily established program to make HUD-held single family homes and mortgage assets available for sale to units of general local government, states, Indian tribes, nonprofit organizations, and for-profit entities (collectively, purchasers) to provide homeownership opportunities and to promote neighborhood revitalization. Revitalization areas would be identified through application of specified economic and housing criteria. The purchasers would then make available the assets in accordance with a HUD-approved plan to encourage homeownership and revitalize the area.

The FDIC is amending our regulations to increase risk-based assessment rates effective for the first quarter 2009 assessment period. This is in accordance with the Restoration plan for the DIF published on October 16, 2008, in the Federal Register.

EPA is approving a State Implementation Plan (SIP) revision submitted by theCommonwealth of Virginia. This SIP revision fulfills Virginia's reasonably available control technology (RACT) requirements under the Clean Air Act (CAA or the Act) with respect to the 8-hour ozone national ambient air quality standard (NAAQS) in Stafford County. Virginia has fulfilled these requirements by submitting a certification that 1-hour ozone NAAQS RACT controls for sources in the Commonwealth subject to control technology guidelines (CTGs) and for a single major source not subject to any CTG, continue to represent RACT under the 8- hour NAAQS, and submitting a negative declaration demonstrating that no facilities exist in Stafford County that are subject to certain enumerated CTGs that have not been adopted by Virginia.

Numerous EPA air emissions standards require specific work practices for equipment leak detection and repair. On April 6, 2006, we proposed a voluntary alternative work practice for leak detection and repair using a newly developed technology, optical gas imaging. The alternative work practice is an alternative to the current leak detection and repair work practice, which is not being revised. The proposed alternative has been amended in this final rule to add a requirement to perform monitoring once per year using the current Method 21 leak detection instrument. This action revises the General Provisions to incorporate the final alternative work practice.

This action corrects an error in the airspace description contained in a Final Rule that was published in the Federal Register on Monday, November 10, 2008 (73 FR 66515). Airspace Docket No. 08-AAL-1.

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:

This action revises Class E airspace at Toksook Bay, AK to provide adequate controlled airspace to contain aircraft executing Standard Instrument Approach Procedures (SIAPs). One SIAP is being amended for the Toksook Bay Airport. Additionally, one textual Obstacle Departure Procedure (ODP) is being amended. This action revises existing Class E airspace upward from 700 feet (ft.) and 1,200 ft. above the surface at Toksook Bay Airport, Toksook Bay, AK.

EPA is making an interim final determination to extend the stay of certain requirements in the standards of performance for petroleum refineries.

On June 24, 2008, EPA promulgated amendments to the Standards of Performance for Petroleum Refineries and new standards for process units constructed, reconstructed, or modified after May 14, 2007. EPA received three petitions for reconsideration of the final rule. On September 26, 2008, EPA granted reconsideration and issued a stay for the issues raised in the petitions regarding process heaters and flares. In this action, EPA is addressing those specific issues by proposing amendments to certain provisions for process heaters and flares. EPA is also proposing various technical corrections in this action that were raised in the petitions for reconsideration. EPA will take action on other issues raised by Petitioners in future notices.

The FAA is superseding an existing airworthiness directive (AD) for certain GE CT7-8A turboshaft engines. That AD currently requires initial and repetitive inspections of the electrical chip detectors for the No. 3 bearing. This AD requires removing from service certain GE CT7-8A turboshaft engines within 6,200 cycles-since-new. This AD results from investigation for the root causes of two failures of the No. 3 bearing. We are issuing this AD to prevent failure of the No. 3 bearing due to contamination by aluminum oxide, which could result in a possible in-flight shutdown of the engines and loss of control or forced landing of the aircraft.