July 11, 2006 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) has determined the regulatory review period for MULTIHANCE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent that claims that human drug product.

The National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), in collaboration with the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), organized an independent, scientific peer review meeting on May 23, 2006, to evaluate the validation status of the in vitro 3T3 and normal human keratinocyte (NHK) neutral red uptake (NRU) basal cytotoxicity test methods. These two in vitro cytotoxicity test methods are proposed as adjuncts (for the purpose of determining the starting dose) to in vivo acute oral toxicity tests. The peer review report from this meeting, entitled Peer Review Panel Evaluation of the Use of In Vitro Basal Cytotoxicity Test Methods for Estimating Starting Doses for Acute Oral Systemic Toxicity Testing, is now available. The report contains (1) a summary of the peer review evaluation and (2) the peer review panel's (Panel) conclusions on the draft ICCVAM test method recommendations regarding the proposed usefulness, limitations, and validation status of the 3T3 and NHK cytotoxicity test methods. The NICEATM invites public comment on the Panel's conclusions on the draft ICCVAM test method recommendations. Copies of the Panel report may be obtained on the ICCVAM/NICEATM Web site at https://iccvam.niehs.nih.gov, or by contacting NICEATM at the address given below.

In accordance with the National Environmental Policy Act (NEPA) of 1969 and the Federal Land Policy and Management Act (FLPMA) of 1976, the BLM has prepared a Draft Environmental Impact Statement (DEIS) to analyze and undertake the Eastside Township Fuels and Vegetation Project, and by this notice is announcing the opening of the comment period.

Background

The IC Clearance Official, Regulatory Information Management Services, Office of Management invites comments on the submission for OMB review as required by the Paperwork Reduction Act of 1995.

The U.S. Fish and Wildlife Service announces that the Final Comprehensive Conservation Plan (CCP) and Environmental Impact Statement (EIS) is available for Upper Mississippi River National Wildlife and Fish Refuge. The Final CCP/EIS was prepared pursuant to the National Wildlife Refuge System Administration Act of 1966, as amended by the National Wildlife Refuge System Improvement Act of 1997, and the National Environmental Policy Act of 1969. Goals and objectives in the CCP describe how the agency intends to manage the refuge over the next 15 years.

The FAA proposes to supersede Airworthiness Directive (AD) 2004-11-04, which applies to all CTRM Aviation Sdn. Bhd. (Formerly Eagle Aircraft (Malaysia) Sdn. Bhd.) Model Eagle 150B airplanes. AD 2004-11-04 currently requires you to inspect certain canard inboard flap hinge support brackets (initially before further flight and repetitively before the first flight of each day) and perform any necessary follow-up action. This proposed AD results from mandatory continuing airworthiness information (MCAI) issued by the airworthiness authority for Malaysia to require the installation of improved design inboard flap hinge brackets as terminating action for the repetitive inspections. Consequently, this proposed AD would initially retain the requirement that you inspect certain canard inboard flap hinge support brackets (initially before further flight and repetitively before the first flight of each day) and then require that you replace the parts with new design inboard flap hinge brackets as terminating action for the repetitive inspections or if cracks are found. We are issuing this proposed AD to detect and correct cracks in the canard inboard flap hinge support brackets, which could result in loss of retention of controls and consequently, loss of airplane control.

The FAA proposes to supersede an existing airworthiness directive (AD) for Rolls Royce plc (RR) RB211-524 series turbofan engines with certain part number (P/N) intermediate pressure compressor (IPC) stage 5 disks installed. That AD currently requires new reduced IPC stage 5 disk cyclic limits. This proposed AD would require the same reduced IPC stage 5 disk cyclic limits, the requirement to remove from service affected disks that already exceed the new reduced cyclic limit, and to remove from service other affected disks before exceeding their cyclic limits using a drawdown schedule. This proposed AD also would exempt disks reworked to RR Service Bulletin (SB) RB.211-72-E182, Revision 1, dated July 30, 2004, and would allow an on-wing eddy current inspection (ECI) on RB211-524G and RB211-524H series engines. This proposed AD results from the manufacturer issuing a revised Alert Service Bulletin (ASB) to remove certain disks from applicability, and to allow an on-wing ECI on RB211-524G and RB211-524H series engines. We are proposing this AD to prevent failure of the IPC stage 5 disk, which could result in uncontained engine failure and possible damage to the airplane.

Notice is hereby given that the comment period on proposed changes in the regulatory periods when minimum grade, size, quality, and maturity requirements apply to southeastern California grapes under Marketing Order No. 925 (order), and to imported grapes under the table grape import regulation is reopened and extended.

The Director of the Minerals Management Service (MMS) is requesting nominations for three public representatives to serve on the Department's Royalty Policy Committee (RPC). These nominations may originate from state and local governments, universities, organizations, or individuals; they may include self-nominations.

The Coast Guard proposes to temporarily change the drawbridge operating regulations governing the operation of the General Edwards SR1A Bridge, at mile 1.7, across the Saugus River between Lynn and Revere, Massachusetts. This change to the drawbridge operation regulations would allow the bridge to remain in the closed position from November 1, 2006 through April 30, 2007. This action is necessary to facilitate structural maintenance at the bridge.

The Commander, First Coast Guard District, has issued a temporary deviation from the regulation governing the operation of the Loop Parkway Bridge, across Long Creek at mile 0.7, at Jones Beach, New York. This deviation will test a change to the drawbridge operation schedule to determine whether a permanent change to the schedule is needed. This deviation will allow the bridge to open on signal for all marine traffic, Monday through Friday twice an hour at twenty and fifty minutes after the hour, from 6:20 a.m. to 7:20 p.m., except that, between 9:50 a.m. and 3:20 p.m., the bridge shall open on signal for all commercial vessels. On Saturday, Sunday, and Federal Holidays, the bridge shall open on signal once an hour, at twenty minutes after the hour, between 7:20 a.m. and 8:20 p.m., except that, the bridge shall open on signal for all commercial vessels. At all other times the bridge shall open on signal for all vessel traffic.