International Conference on Harmonisation; guidance on good manufacturing practice for active pharmaceutical ingredients; availability. Notice

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q7A Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients." The guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The guidance describes current good manufacturing practice (CGMP) for manufacturing of active pharmaceutical ingredients (APIs). The guidance is intended to help ensure that all APIs meet the standards for quality and purity they purport or are represented to possess.     

Additional criteria and procedures for classifying over-the-counter drugs as generally recognized as safe and effective and not misbranded. Final rule

The Food and Drug Administration (FDA) is issuing a final rule establishing additional criteria and procedures by which over-the- counter (OTC) conditions may become eligible for consideration in the OTC drug monograph system. The criteria and procedures address how OTC drugs initially marketed in the United States after the OTC drug review began in 1972, and OTC drugs without any U.S. marketing experience, can meet the statutory definition of marketing to a "material extent" and "for a material time" and become eligible. If found eligible, the condition would be evaluated for general recognition of safety and effectiveness in accordance with FDA's OTC drug monograph regulations. FDA is also changing the current OTC drug monograph procedures to streamline the process and provide additional information in the review.     

Registration and reregistration application fees. Confirmation of final rule,remanded for further notice and comment,and response to comments

DEA is publishing a final rule regarding the registration and reregistration fees charged to controlled substances registrants. DEA is required to charge reasonable fees relating to the registration and control of the manufacture, distribution, and dispensing of controlled substances. To address this mandate, on March 22, 1993 DEA published a final rule in the Federal Register, establishing registration fees for controlled substances registrants (58 FR 15272). Following publication of the final rule, the American Medical Association (AMA) and others filed a complaint in the United States District Court for the District of Columbia objecting to the new fees. The district court issued its final order granting the government's motion for summary judgment and disposing of all claims. The AMA appealed. The United States Court of Appeals for the District of Columbia Circuit found DEA's rulemaking to be inadequate. The appeals court remanded, without vacating, the rule to DEA, requiring the agency to provide an opportunity for meaningful notice and comment on the fee-funded components of the Diversion Control Program. DEA responded to the remand requirement through a document published in the Federal Register on December 30, 1996 (61 FR 68624). This Final Rule supplements the December 30, 1996 Federal Register document and with that document, constitutes the final rule on the Drug Diversion Control Fee Account.     

Medical devices; ear, nose and throat devices; reclassification of the endolymphatic shunt tube with valve. Final rule

The Food and Drug Administration (FDA) is reclassifying the endolymphatic shunt tube with valve from class III (premarket approval) into class II (special controls). The device is intended to be implanted in the inner ear to relieve the symptoms of vertigo and hearing loss due to endolymphatic hydrops (increase in endolymphatic fluid) of Meniere's disease. FDA is also identifying the guidance document entitled "Class II Special Controls Guidance Document: Endolymphatic Shunt Tube With Valve; Guidance for Industry and FDA" (the guidance) as the special control that the agency believes will reasonably ensure the safety and effectiveness of the device. This reclassification is based on new information submitted in are classification petition by E. Benson Hood Laboratories, Inc. (Hood Laboratories). 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 Safe Medical Devices Act of 1990, and the Food and Drug Administration Modernization Act of 1997. Elsewhere in this issue of the Federal Register, FDA is publishing a notice announcing the guidance.     

新奥尔良飓风灾难应对失当的成因剖析

举世瞩目的新奥尔良飓风灾难及随后问题百出的救援过程,折射出公共管理和城市管理过程中仍存在许多值得政府管理工作者高度重视的问题。本文从城市管理、危机管理和公共管理的角度对导致这次灾难加深加重的原因进行剖析,特别探讨了城市规划失误、财政专项资金挪用、危机预警意识薄弱、行政效率低下、忽视弱势群体以及政府间关系协调失当等原因。最后,本文强调了新奥尔良飓风灾难这一典型案例对中国的城市管理和危机管理的借鉴意义。     

公民社会的兴起对政策制定的影响

改革开放以来,随着国家与社会关系的调整和社会主义市场经济体制的建立,中国公民社会开始兴起。公民越来越多地借助于各种民间组织进入公共政策制定过程,影响政府的政策导向。公民社会的兴起提升了公民的参与意识,扩大了公民参与政策的范围,促进了政府政策制定模式转换和多元互动政策主体的出现。同时,公民社会的兴起也加剧了政策制定过程中的利益博弈,给政府的政策合意带来困难。     

危机预警中的政府信息管理与调控——基于人口安全预警系统的研究

对预警信息的科学调控能够有效提升危机预警工作质量。本文以人口安全预警系统为例,建构了预警系统参与要素协作模型和预警临界值选择模型。在此基础上,从信息要素与信息流角度分析了预警系统的整体构成、要素协作机制与信号表达机制,并进而反思了危机预警中的政府信息管理角色和信息调控模式,提出了提升预警预测精度和时间效率的途径与方法。     

从“后起飞跃”到“新阶段”发展——陕西经济发展30年回眸及战略创新研究

改革开放以来,是陕西经济发展历史上最好的时期,同时经历了一个"后起飞跃"过程,到本世纪初开始进入一个"新阶段"。支撑"飞跃"的主要增长点是投资拉动、产业结构有所优化、特色优势产业成长、劳务产业兴起和陕北高速增长板块崛起,另一方面形成诸多深层矛盾和障碍因素。基于对正反经验的总结,应创新发展理念,促进增长要素优化转变,打造"三引擎"动力模式,在提升主体活力中推动民众创业,构建城乡一体化发展格局,提高人民物质文化水平等,确保"新阶段"健康持续推进。     

公共管理类创新人才培养与社会需求的和谐发展路径

创新型国家的建立离不开创新型公共管理人才的支持。我国高校的公共管理类人才培养体制近年来成长迅速,但仍处于探索阶段,与社会需求有一个动态渐进的和谐过程。本文在问卷调查的基础上,从社会需求主体的吸纳意愿、供给主体的从业发展意愿等角度分析了公共管理类人才的培养现状及社会适应性问题,并从社会人才需求和高校人才培养等角度,对高校人才培养和社会人才需求不和谐现象的原因进行了分析,提出了能够与社会需求和谐发展的公共管理类创新人才的培养路径。