Required warnings for cigarette packages and advertisements. Final rule

The Food and Drug Administration (FDA) is amending its regulations to add a new requirement for the display of health warnings on cigarette packages and in cigarette advertisements. This rule implements a provision of the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) that requires FDA to issue regulations requiring color graphics, depicting the negative health consequences of smoking, to accompany the nine new textual warning statements required under the Tobacco Control Act. The Tobacco Control Act amends the Federal Cigarette Labeling and Advertising Act (FCLAA) to require each cigarette package and advertisement to bear one of nine new textual warning statements. This final rule specifies the color graphic images that must accompany each of the nine new textual warning statements.     

Medical Devices; general and plastic surgery devices; classification of contact cooling system for aesthetic use. Final rule

The Food and Drug Administration (FDA) is classifying the contact cooling system for aesthetic use into class II (special controls). The special control that will apply to the device is the guidance document entitled "Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Contact Cooling System for Aesthetic Use." The Agency is classifying the device into class II (special controls) in order to provide 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 this device type.     

Medical devices; reclassification of the topical oxygen chamber for extremities. Final rule

The Food and Drug Administration (FDA) is reclassifying the topical oxygen chamber for extremities (TOCE) from class III to class II. This device is intended to surround a patient's limb and apply humidified oxygen topically at a pressure slightly greater than atmospheric pressure to aid healing of chronic skin ulcers, such as bedsores. This reclassification is on the Secretary of Health and Human Services's own initiative based on new information. This action is being taken under the Federal Food, Drug, and Cosmetic Act (the FD&C 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). Elsewhere in this issue of the Federal Register, FDA is announcing the availability of the guidance document entitled ``Class II Special Controls Guidance Document: Topical Oxygen Chamber for Extremities,' which will serve as the special control for this device.     

Medical devices; general and plastic surgery devices; classification of the low level laser system for aesthetic use. Final rule

The Food and Drug Administration (FDA) is classifying the low level laser system for aesthetic use into class II (special controls). The special control(s) that will apply to the device is entitled ``Class II Special Controls Guidance Document: Low Level Laser System for Aesthetic Use.' 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 announcing the availability of a guidance document that will serve as the special control for this device type.     

Implementation of the Methamphetamine Production Prevention Act of 2008. Final rule

In October 2008, the President signed the Methamphetamine Production Prevention Act of 2008 (MPPA), which clarifies the information entry and signature requirements for electronic logbook systems permitted for the retail sale of scheduled listed chemical products. On March 23, 2010, DEA published a Notice of Proposed Rulemaking to implement the provisions of the MPPA and make its regulations consistent with the new requirements. This action finalizes without change the Notice of Proposed Rulemaking published on March 23, 2010. The Final Rule will make it easier for regulated sellers to maintain electronic logbooks by allowing greater flexibility as to how information may be captured.     

Schedules of controlled substances: placement of ezogabine into Schedule V. Final rule

With the issuance of this final rule, the Administrator of the Drug Enforcement Administration (DEA) places the substance ezogabine, including its salts, isomers, and salts of isomers whenever the existence of such salts, isomers, and salts of isomers is possible, into Schedule V of the Controlled Substances Act (CSA). This action is pursuant to the CSA which requires that such actions be made on the record after opportunity for a hearing through formal rulemaking.     

Advisory committee; Medical Imaging Drugs Advisory Committee; re-establishment

The Food and Drug Administration (FDA) is announcing the re-establishment of the Medical Imaging Drugs Advisory Committee in FDA's Center for Drug Evaluation and Research. This rule amends the current language for the Medical Imaging Drugs Advisory Committee in the Agency's list of standing advisory committees in FDA's regulations.     

运用电子政务推进市县政府集中办公

在能源日益匮乏的今天,建设节约型机关、降低能源消耗、提高政府工作效率,已经成为政府部门亟待解决的问题。电子政务在政府办公自动化、公民服务电子化、行政决策电子化等方面有助于节约政府开支,推进节约型机关建设;而市县政府集中办公可以通过精简和优化机构和人员、缩减财政开支、提升公共服务质量等推进节约型机关建设。因此,发展电子政务和推进市县集中办公是地方政府改革和建设节约型机关的重要方向和途径。     

比较视角下的效能建设:绩效改进、创新与服务型政府

基于省际比较和国际比较的视角,本文对效能建设这一具有中国特色的政府创新活动进行了初步的理论研究。本文选取福建省等6个省(自治区)的效能建设实践进行文本分析和相似度分析,提取效能建设的共性特征,并将之与中国地方政府创新奖的获奖案例和发达国家行政改革实践进行比较,识别效能建设的核心要素。本文认为,效能建设的本质是一项政府绩效改进活动,其核心是政府采用和实施的一系列创新组合,其旨归与服务型政府构建一脉相承。本文的多案例研究和理论框架为推进效能建设的学术研究提供了初步基础,并对未来研究方向进行了探讨。     

财政与我国金融稳定关系初探

金融稳定的公共产品特性和金融危机的负外部性决定了财政应当在维护金融稳定中担当重要角色。我国财政部门在推进金融体制改革和化解金融风险方面发挥了积极作用,但也存在着职责界定不清、缺乏制度化安排以及职能缺位等问题。为适应金融危机后建立健全系统性金融风险防范预警体系和处置机制的现实需要,有必要进一步充分发挥财政部门的作用,包括建立和完善跨部门的金融稳定协调机制、强健国家财政、实行跨境资本流动税收调节机制以及建立金融稳定准备金等。