December 5, 2005 – Federal Register Recent Federal Regulation Documents

The provisions of the interim rule entitled School Food Safety Inspections published on June 15, 2005, at 70 FR 34627, could not become effective until approval of the associated information collection requirements by the Office of Management and Budget (OMB). Those requirements were cleared by OMB on August 26, 2005 under OMB Control Number 0584-0006. This document announces the effective date of the information collection provisions contained in the originally- published rule.

The Food and Drug Administration (FDA) is announcing a call- for-data for safety and effectiveness information on the following conditions as part of FDA's ongoing review of over-the-counter (OTC) drug products: Bisoctrizole, up to 10 percent, as a sunscreen single active ingredient and in combination with other sunscreen active ingredients; and bemotrizinol, up to 10 percent, as a sunscreen single active ingredient and in combination with other sunscreen active ingredients. FDA reviewed time and extent applications (TEAs) for these conditions and determined that they are eligible for consideration in our OTC drug monograph system. FDA will evaluate the submitted data and information to determine whether these conditions can be generally recognized as safe and effective (GRAS/E) for their proposed OTC use.

FRA is clarifying preamble language and correcting rule text language in FRA's Standards for Development and Use of Processor-Based Signal and Train Control Systems, a final rule published on March 7, 2005 (PTC Rule). First, some language in the section-by-section analysis portion of the preamble to the PTC Rule inadvertently differs from the actual regulatory language, and FRA is noting the unintended variation to avoid confusion. Second, FRA is clarifying language regarding the applicability of new 49 CFR part 236, subpart H (the Processor-Based Standards) to highway-rail grade crossing warning systems (HGCWS). FRA wants to ensure that the rule language conforms with FRA's initial intent that the regulation apply to only certain HGCWS. Therefore, FRA is adding a provision to clarify which HGCWS products may be excluded from the requirements of the PTC Rule. FRA is also adding a provision to clarify that certain HGCWS products excluded from the requirements of the Processor-Based Standards may, at the option of the railroad, be made subject to the Processor-Based Standards. Third, FRA is adding a provision to clarify which HGCWS products shall be included in the software management control plans pursuant to 49 CFR 236.18. Finally, FRA is correcting a minor error in which a provision of the Processor-Based Standards was incorrectly cited.

The Food and Drug Administration (FDA) is announcing a call- for-data for safety and effectiveness information on the following conditions as part of FDA's ongoing review of over-the-counter (OTC) drug products: Climbazole, 0.1 to 0.5 percent and 0.5 to 2.0 percent, as a dandruff control active ingredient in leave-on and rinse-off dosage forms, respectively. FDA has reviewed a time and extent application (TEA) for these conditions and determined that they are eligible for consideration in its OTC drug monograph system. FDA will evaluate the submitted data and information to determine whether these conditions can be generally recognized as safe and effective (GRASE) for their proposed OTC use.

The FAA is adopting a new airworthiness directive (AD) for all EMBRAER Model EMB-120, -120ER, -120FC, -120QC, and -120RT airplanes. This AD requires modifying electrical harnesses located at the left- and right-hand wing roots; and re-routing and modifying the harness of the right-hand outboard flap actuator. This AD results from fuel system reviews conducted by the manufacturer. We are issuing this AD to prevent chafed electrical harnesses, which could result in a potential source of ignition for fuel vapors near a fuel tank and consequent fire or fuel tank explosion.

The FAA is superseding an existing airworthiness directive (AD) that applies to certain EMBRAER Model EMB-135 and Model EMB-145 series airplanes. The existing AD currently requires repetitive inspections of the spring cartridges of the elevator gust lock system to determine if the lock washer projection correctly fits the slots in the cartridge flange, and corrective action if necessary. The existing AD also provides for optional terminating action for the repetitive inspections for certain airplanes. This AD retains the requirements of the existing AD and adds a requirement for final terminating action for all affected airplanes. This AD results from reports of an improperly fitting lock washer causing the clevis of the spring cartridge in the electromechanical elevator gust lock system to become unscrewed. We are issuing this AD to prevent the unscrewing of the spring cartridge clevis from jamming the elevator, which could lead to reduced controllability of the airplane.

The FAA is adopting a new airworthiness directive (AD) for certain Learjet Model 45 airplanes. This AD requires modifying the electrical wire bundle for the alternator on the left-hand engine, inspecting for clearance between wire harnesses and engine tubing for each engine, and corrective actions if necessary. For certain airplanes, this AD also requires replacing the fuses for the hydraulic shutoff valves with fuses having higher amperage. This AD results from a report of a fire in the left-hand engine nacelle. We are issuing this AD to prevent chafing between the wire bundle for the alternator on each engine and the hydraulic lines, which could result in a fire in the engine nacelle.