November 14, 2005 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is proposing to amend the classification regulations for condoms and condoms with spermicidal lubricant containing nonoxynol-9 (condoms with spermicidal lubricant) to designate a special control for natural rubber latex (latex) condoms with and without spermicidal lubricant. FDA is proposing the draft guidance document entitled ``Class II Special Controls Guidance Document: Labeling for Male Condoms Made of Natural Rubber Latex,'' as the special control that the agency believes will help provide a reasonable assurance of the safety and effectiveness of the devices. Elsewhere in this issue of the Federal Register, FDA is announcing a notice of availability of the draft special controls guidance document for public comment.

The U.S. Small Business Administration (SBA) is temporarily amending the size eligibility criteria for loan assistance provided under the ``Gulf Opportunity Pilot Loan Program,'' a one-year pilot under the 7(a) Business Loan Program. The pilot program makes available on an expedited basis 7(a) loans to small businesses located in, locating to, or relocating in disaster areas declared by the President as a result of Hurricanes Katrina and Rita and any contiguous parishes or counties. This interim final rule makes financial assistance under the pilot program available to businesses that are considered small for the purpose of SBA's 7(a) Business Loan Program and businesses considered small for the purpose of SBA's Certified Development Company Program. SBA prepared this rule as an interim final rule because its immediate implementation will facilitate the reconstruction and economic recovery of the Gulf Coast.

On August 11, 2005, the Economic Development Administration (``EDA'') published an interim final rule in the Federal Register. On September 30, 2005, EDA published a final rule in the Federal Register delaying the effective date of certain provisions of the interim final rule from October 1, 2005 until November 14, 2005. The September 30, 2005 final rule also extended the deadline for submitting public comments on the interim final rule from October 11, 2005 until November 14, 2005. This final rule further delays the effective date of certain provisions of the interim final rule from November 14, 2005 until January 31, 2006. This delay in effective date is necessary to provide additional time for EDA to consider comments received concerning certain provisions of the interim final rule, as well for EDA to address matters pertaining to the effective implementation of the interim final rule. Capitalized terms used but not otherwise defined in this final rule have the meanings ascribed to them in the interim final rule.

The Office of Personnel Management is issuing a final rule to remove Adams County, CO, from the Adams-Denver, CO, Federal Wage System nonappropriated fund (NAF) wage area, redefine Arapahoe County, CO, from the area of application to the survey area, and change the Adams- Denver wage area's name to Arapahoe-Denver. These changes are necessary because the closure of Fitzsimons Army Medical Center in Adams County left the Adams-Denver survey area without a host activity to conduct local NAF wage surveys.

These special conditions are issued for Cessna Model 650 airplanes modified by Elliott Aviation Technical Product Development, Inc. These modified airplanes will have a novel or unusual design feature when compared to the state of technology envisioned in the airworthiness standards for transport category airplanes. The modification incorporates the installation of electronic flight display systems manufactured by Universal Avionics Systems Corporation. The electronic flight display systems perform critical functions. The applicable airworthiness regulations do not contain adequate or appropriate safety standards for the protection of these systems from the effects of high-intensity radiated fields (HIRF). 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 Civilian Agency Acquisition Council and the Defense Acquisition Regulations Council are issuing amendments to the Federal Acquisition Regulation (FAR) to correct references included in FAC 2005-06, FAR cases 2004-018, Information Technology Security (Item I), and 2004-006, Accounting for Unallowable Costs (Item IX), which were published in the Federal Register at 70 FR 57449 and 57463, September 30, 2005.

The Coast Guard is proposing to establish a permanent regulated navigation area on the Chicago Sanitary and Ship Canal on the Illinois Waterway near Romeoville, IL. This permanent regulated navigation area will place navigational and operational restrictions on all vessels transiting through the demonstration electrical dispersal barrier located on the Chicago Sanitary and Ship Canal. This regulated navigation area is necessary to protect vessels and their crews from harm as a result of electrical discharges emitting from the electrical dispersal barrier as vessels transit over it.

The Office of Government Ethics is issuing an interim rule amendment that permits Government employees to participate in certain particular matters of general applicability affecting mutual funds and unit investment trusts, notwithstanding the employees' disqualifying financial interest under 18 U.S.C. 208(a) arising from the ownership of mutual funds or unit investment trusts.

EPA is proposing to make determinations that the Greene County and Jackson County ozone nonattainment areas have attained the 8-hour ozone National Ambient Air Quality Standard (NAAQS). These proposed determinations are based on three years of complete, quality-assured ambient air quality monitoring data for the 2002-2004 seasons that demonstrate that the 8-hour ozone NAAQS has been attained in the areas. EPA is proposing to approve requests from the State of Indiana to redesignate the Greene County and Jackson County areas to attainment of the 8-hour ozone NAAQS. These requests were submitted by the Indiana Department of Environmental Management (IDEM) on July 15, 2005 and supplemented on September 6, 2005, September 7, 2005, October 6, 2005, and October 20, 2005. In proposing to approve these requests, EPA is also proposing to approve the State's plans for maintaining the 8-hour ozone NAAQS through 2015 in these areas as a revision to the Indiana State Implementation Plan (SIP). EPA is also proposing to find adequate and approve the State's 2015 Motor Vehicle Emission Budgets (MVEBs) for these areas. In the final rules section of this Federal Register, EPA is approving the SIP revisions as a direct final rule without prior proposal, because EPA views these actions as noncontroversial and anticipates no adverse comments. A detailed rationale for the approvals is set forth in the direct final rule. If we do not receive any adverse comments in response to these direct final and proposed rules, we do not contemplate taking any further action in relation to these proposed rule. If EPA receives adverse comments with respect to an area addressed by these rules, we will publish a timely withdrawal of the action affecting that area, informing the public that the rule will not take effect with respect to that area. EPA will respond to the 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 on this action should do so at this time.

On November 5, 2001, we published a direct final rule and concurrent notice of proposed rulemaking to revise the requirements on variability in the composition of additives certified EPA's Gasoline Deposit Control Program. We received adverse comments on two of the amendments contained in the direct final rule and proposed rule. Consequently, we issued a partial withdrawal notice on January 24, 2002, to withdraw the amendments that received adverse comments. This action addresses the public comments received on the withdrawn amendments. We found the adverse comments on the withdrawn amendments unpersuasive. However, we agreed with one commenter's suggestion that additional clarifying language would be useful in one of the subject amendments to prevent any potential for misinterpretation. Consequently, today's action implements the previously withdrawn amendments with the addition of clarifying language. The changes to the regulatory requirements made by this action address additive manufacturer concerns that compliance with the previous requirements would be burdensome and difficult, while maintaining the emissions control benefits of the gasoline deposit control program.

The FAA is adopting a new airworthiness directive (AD) for certain Bombardier Model CL-600-2B19 (Regional Jet Series 100 & 440) airplanes. This AD requires revising the Airworthiness Limitations section of the Instructions for Continued Airworthiness of the Canadair Regional Jet Maintenance Requirements Manual by incorporating new procedures for repetitive detailed and special detailed inspections for cracking of the aft pressure bulkhead. This AD results from a fatigue test, which revealed cracking of the aft pressure bulkhead; subsequent in-service reports show that fatigue cracking has been found on other airplanes. We are issuing this AD to detect and correct cracking in the aft pressure bulkhead, which could result in reduced structural integrity and rapid decompression of the airplane.

The FAA is adopting a new airworthiness directive (AD) for certain Learjet Model 23, 24, 24A, 24B, 24B-A, 24C, 24D, 24D-A, 24E, 24F, 24F-A, 25, 25A, 25B, 25C, 25D, and 25F airplanes. This AD requires replacement of the spherical accumulator for the main hydraulic system with a new cylindrical accumulator. For certain airplanes, this AD also requires modification of the accumulator pressure gauge. This AD results from reports of the failure of two thrust reverser accumulators (which are similar to the main hydraulic system's spherical accumulator) and fatigue cracks found on four thrust reverser accumulators. We are issuing this AD to prevent failure of the spherical accumulator for the main hydraulic system, due to fatigue cracking on the threads, which could result in the loss of hydraulic power, damage to the surrounding airplane structure, and loss of airplane control. The failure of the accumulator could also result in injury to any persons in the surrounding area. The loss of hydraulic fluid could also leak onto a potential source of ignition and result in a consequent fire.

The FAA is adopting a new airworthiness directive (AD) for certain Saab Model SAAB 2000 airplanes. This AD requires modifying the manual feather-and-unfeather system for the propellers to make the design of the system more robust. This AD results from reports of in- flight engine shutdown caused by uncommanded operation of the feather pump of the propeller. We are issuing this AD to prevent uncommanded feathering of the propeller, which could result in the shutdown of an engine during flight and consequent reduced controllability of the airplane.

The FAA is superseding an existing airworthiness directive (AD), which applies to all Airbus Model A300 B4-600 and A300 B4-600R series airplanes, and all Model A300 F4-605R airplanes. That AD currently requires repetitive inspections to detect cracks of certain attachment holes, installation of new fasteners, follow-on inspections or repair if necessary, and modification of the angle fittings of fuselage frame FR47. This new AD revises certain inspection thresholds and intervals. This new AD also adds inspections to detect cracks of additional attachment holes. This AD results from reports of cracks found before the inspection thresholds in the existing AD and cracks found in nearby areas not inspected by the existing AD. We are issuing this AD to prevent fatigue cracking of the forward fitting of fuselage frame FR47, which could result in reduced structural integrity of the frame.

The FAA is adopting a new airworthiness directive (AD) for all Airbus Model A330-200 and A330-300 series airplanes; and Model A340-200 and A340-300 series airplanes. This AD requires an accelerated schedule of repetitive testing of the elevator servo control loops, and corrective actions if necessary. This AD results from reports of failed elevator servo controls due to broken guides. We are issuing this AD to ensure proper functioning of the elevator servo controls. Failure of the elevator servo controls during certain phases of takeoff could result in an unannounced loss of elevator control and consequent reduced controllability of the airplane.