Medical devices; immunology and microbiology devices; classification of the West Nile Virus IgM capture Elisa assay. Final rule

The Food and Drug Administration (FDA) is classifying the West Nile Virus IgM Capture Elisa assay into class II (special controls). The agency is taking this action in response to a petition submitted under the Federal Food, Drug, and Cosmetic Act (the act) as amended by the Medical Device Amendments of 1976 (the amendments), the Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997 (FDAMA). The agency is classifying this 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 announcing the availability of a guidance document that will serve as the special control for the device.     

Iron-containing supplements and drugs; label warning statements and unit-dose packaging requirements; removal of regulations for unit-dose packaging requirements for dietary supplements and drugs. Final rule; removal of regulatory provisions in response to court order

The Food and Drug Administration (FDA) is removing, in part, a final rule that required unit-dose packaging for iron-containing dietary supplement and drug products that contain 30 milligrams (mg) or more of iron per dosage unit. FDA is taking this action in response to the Court's ruling in Nutritional Health Alliance v. FDA, in which the Court concluded that the Federal Food, Drug, and Cosmetic Act (the act) does not provide FDA with authority to require manufacturers of iron-containing dietary supplement and drug products to use unit-dose packaging for poison prevention purposes. Today's action takes the ministerial step of removing the unit-dose packaging provisions from title 21 of the Code of Federal Regulations.     

Elimination of sanctions for refusal of vocational rehabilitation services without good cause. Final rule

We are amending our regulations to remove provisions relating to the imposition of benefit sanctions on account of a beneficiary's refusal of rehabilitation services. We are making these changes to reflect the repeal of sections 222(b) and 1615(c) of the Social Security Act (the Act). Prior to their repeal, these sections of the Act authorized the Commissioner of Social Security to impose sanctions against the benefits of a disabled or blind beneficiary who refused, without good cause, to accept rehabilitation services made available by a State vocational rehabilitation (VR) agency. The Ticket to Work and Work Incentives Improvement Act of 1999 repealed these sections of the Act, effective January 1, 2001. We are amending our regulations by removing rules and related provisions that are obsolete as a result of the repeal of these sections of the Act to conform our regulations to the changes in the statute.     

Food labeling: health claims; D-tagatose and dental caries. Final rule

The Food and Drug Administration (FDA) is adopting as a final rule, without change, the provisions of the interim final rule that amended the regulation authorizing a health claim on sugar alcohols and dental caries, i.e., tooth decay, to include the sugar D-tagatose as a substance eligible for the dental caries health claim. FDA is taking this action to complete the rulemaking initiated with the interim final rule.     

Pediculicide drug products for over-the-counter human use; amendment of final monograph. Final rule

The Food and Drug Administration (FDA) is issuing a final rule amending the final monograph (FM) for over-the-counter (OTC) pediculicide drug products to revise labeling for the statement of identity, warnings, directions, and other required statements. Pediculicide drug products are used for the treatment of head, pubic (crab), and body lice. FDA is issuing this final rule as part of its ongoing review of OTC drug products after considering public comment on its proposed regulation and all relevant data and information that have come to the agency's attention.     

Medical devices: classification of the dental sonography device and jaw tracking device. Final rule

The Food and Drug Administration (FDA) is classifying the dental sonography device into class I, when it is used to monitor temporomandibular joint sounds, and into class II, when it is used to interpret temporomandibular joint sounds for the diagnosis of temporomandibular joint disorders and associated orofacial pain. FDA is classifying the jaw tracking device into class I, when it is used to monitor mandibular jaw positions relative to the maxilla, and into class II, when it is used to interpret mandibular jaw positions relative to the maxilla, for the diagnosis of temporomandibular joint disorders and associated orofacial pain. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document that will serve as the special control for this device. FDA is taking this action 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), the Food and Drug Administration Modernization Act of 1997 (FDAMA) and the Medical Device User Fee and Modernization Act of 2002 (MDUFMA).     

公共部门的宽带薪酬:比较与前瞻

本文运用比较研究的方法分析西方的公共部门工资改革和中国的2006年公务员工资改革。就公共部门工资管理最前沿的宽带薪酬而言,目前国内研究缺乏对背后原因的探讨以及横向的比较。本文认为,在受到新公共管理运动的影响下,公共部门宽带薪酬,是当代公共部门人事管理中一项重大创新,但是实施起来还有一定的前置条件。2006年中国公务员工资改革虽然与宽带薪酬的理念不同,但不失为一项务实、有效的改革。而宽带薪酬的理念可在局部地区和部门试行,为今后进一步工资改革积累经验。     

政府架构与运行机制研究:经验与启示

自上世纪80年代以来,西方主要国家进行了一系列卓有成效的政府改革与创新。基于对英国、美国、日本、澳大利亚、新西兰等西方主要国家中央政府机构架构及运行机制的前期研究,本文就政府运行机制及其管理变革的规律性特点及趋势、政府机构设置及管理的趋势、促使政府高效运作的基本保障机制与措施等三个方面进行了分析和总结。     

城市政府业务重组的原理与方法

本文从职能边界、职能内容、权能配置等三个层面界定了城市政府业务重组的基本内涵。在理论分析和业务环境调查研究的基础上,分析了其主要特征,并分析了公民社会、市场环境、部门利益、法律环境和信息技术等影响因素。在此基础上,本文提出了城市政府业务重组的实施方法和步骤。本文认为,不能将业务重组和流程再造混为一谈,流程再造只是业务重组过程中的一个环节。