March 10, 2005 – Federal Register Recent Federal Regulation Documents

The Department of Commerce (the ``Department'') is conducting administrative reviews of the antidumping duty orders on heavy forged hand tools, finished or unfinished, with or without handles, from the People's Republic of China. These reviews cover imports of subject merchandise from four manufacturers/exporters. We preliminarily find that certain manufacturers/exporters sold subject merchandise at less than normal value during the POR. If these preliminary results are adopted in our final results of review, we will instruct U.S. Customs and Border Protection (``Customs'') to assess antidumping duties on all appropriate entries. We invite interested parties to comment on these preliminary review results. We will issue the final review results no later than 120 days from the date of publication of this notice.

The New England Fishery Management Council (Council) is scheduling a public meeting of its Habitat/MPA/Ecosystem Oversight Committee in March, 2005 to consider actions affecting New England fisheries in the exclusive economic zone (EEZ). Recommendations from this group will be brought to the full Council for formal consideration and action, if appropriate.

The Department of Homeland Security (DHS) is correcting a notice that was published in the Federal Register on March 7, 2005, at 70 FR 11017 which announced the holding of a meeting for the purposes of receiving reports and briefings, and member deliberations. In the ADDRESSES section to the notice, DHS inadvertently omitted the identification of the appropriate DHS docket number associated with the notice. DHS would like to announce that the DHS docket number for submitting comments via to this notice is DHS-2005-0019. Directions for submitting comments using this method are outlined within 70 FR 11017.

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled ``Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle'' dated January 2005. The draft guidance document serves as the special control to support the reclassification from class III to class II of the automated blood cell separator device operating on a centrifugal or filtration separation principle intended for the routine collection of blood and blood components. This draft guidance document describes a means by which the automated blood cell separator device operating by centrifugal or filtration separation principle may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule to reclassify these device types into class II (special controls).

The Food and Drug Administration (FDA) is classifying drug metabolizing enzyme (DME) genotyping test systems into class II (special controls). The special control that will apply to the device is the guidance document entitled ``Class II Special Controls Guidance Document: Drug Metabolizing Enzyme Genotyping System.'' The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a guidance document that is the special control for this device.

The Food and Drug Administration (FDA) is classifying instrumentation for clinical multiplex test systems into class II (special controls). The special control that will apply to the device is the guidance document entitled ``Class II Special Controls Guidance Document: Instrumentation for Clinical Multiplex Test Systems.'' The agency is classifying the device into class II (special controls) in order to provide a reasonable assurance of safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a guidance document that is the special control for this device.

The Food and Drug Administration (FDA) is proposing to reclassify from class III to class II (special controls) the automated blood cell separator device operating on a centrifugal separation principle and intended for the routine collection of blood and blood components. This proposed rule would also modify the special control for the device with the same intended use but operating on a filtration separation principle. The reclassification is being proposed on FDA's own initiative under procedures set forth in FDA regulations and based on information provided to FDA. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the act), as amended by the Medical Device Amendments of 1976 (the 1976 amendments), the Safe Medical Devices Act of 1990 (the SMDA), and the Food and Drug Administration Modernization Act of 1997 (FDAMA). The agency proposes this reclassification because special controls, in addition to general controls, are capable of providing reasonable assurance of the safety and effectiveness of the device. Elsewhere in this issue of the Federal Register, FDA is publishing a notice of availability of a draft guidance document entitled ``Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle,'' which will serve as the special control if this proposal becomes final.

We have received applications from two motorcycle manufacturers (Bajaj and Piaggio) for temporary exemptions from a provision in the Federal motor vehicle safety standard on motorcycle controls and displays specifying that a motorcycle rear brake, if provided, must be controlled by a right foot control. The manufacturers ask that we permit the left handlebar as an alternative location for the rear brake control. Each manufacturer states its belief that ``compliance with the standard would prevent the manufacturer from selling a motor vehicle with an overall level of safety at least equal to the overall safety level of nonexempt vehicles.'' We are publishing this notice of receipt of the applications in accordance with our regulations on the subject, and ask for public comment on each application. This publication does not mean that we have made a judgment yet about the merits of the applications.

Pursuant to FAA's rulemaking provisions governing the application, processing, and disposition of petitions for exemption part 11 of Title 14, Code of Federal Regulations (14 CFR), this notice contains a summary of certain petitions seeking relief from specified requirements of 14 CFR, dispositions of certain petitions previously received, and corrections. The purpose of this notice is to improve the public's awareness of, and participation in, this aspect of FAA's regulatory activities. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of any petition or its final disposition.

These special conditions are issued for the Cessna Aircraft Company, Model 172R and 172S airplanes. These airplanes, as modified by Cessna Aircraft Company, will have a novel or unusual design feature(s) associated with the installation of a Garmin G1000 electronic flight instrument system (EFIS) and the protection of this system from the effects of high intensity radiated field (HIRF) environments. 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.

This proposed rule would establish the second and third trimester season quotas for large coastal sharks (LCS), small coastal sharks (SCS), pelagic, blue, and porbeagle sharks based on over- or underharvests from the 2004 second semi-annual season. In addition, this rule proposes the opening and closing dates for the LCS fishery based on adjustments to the trimester quotas. This action could affect all commercial fishermen in the Atlantic commercial shark fishery.

The Advisory Council on Historic Preservation has approved an exemption that would relieve Federal agencies from the requirement of taking into account the effects of their undertakings on the Interstate Highway System, except with regard to certain individual elements or structures that are part of the system. The proposed exemption was published in the Federal Register on December 29, 2004 with a 30 day period for public comment. Minor revisions were made in response to these comments.

The Bureau of Industry and Security (BIS) publishes this notice to announce that the agency will hold a meeting on March 28, 2005 for organizations interested in exporting ``tools of trade'' items for humanitarian work in Sudan under a License Exception, as provided under the rule BIS published in the Federal Register on February 18, 2005. U.S. Government officials will provide information at this meeting on the use of this License Exception for Sudan. This meeting is open to the public.

This notice sets forth the dates of April 7, 2005 and October 6, 2005 of the Gettysburg National Military Park Advisory Commission.