Blood vessels recovered with organs and intended for use in organ transplantation. Final rule

The Food and Drug Administration (FDA) and the Health Resources and Services Administration (HRSA) are amending their regulations to include as part of an organ those blood vessels recovered with the organ that are intended for use in organ transplantation (HRSA regulation); and to exclude such blood vessels from the definition of human cells, tissues, or cellular or tissue-based products (HCT/Ps) (FDA regulation). The purpose of this final rule is to amend the regulations so that blood vessels recovered with organs and intended for use in organ transplantation, and labeled as such, are governed by the regulations pertaining to organs. The regulation of other recovered blood vessels remains unchanged. We (HRSA and FDA) believe that this change will eliminate the burden resulting from an organ procurement organization's efforts to comply with both FDA and HRSA rules with respect to blood vessels (FDA jurisdiction) and organs (HRSA jurisdiction).     

Control of communicable diseases; restrictions on African rodents, prairie dogs, and certain other animals. Interim final rule; supplement and partial reopening of comment period

The Food and Drug Administration (FDA) is reopening the comment period for the interim final rule on the capture, transport, sale, barter, exchange, distribution, and release of African rodents, prairie dogs, and certain other animals, which was published in the Federal Register of November 4, 2003 (68 FR 62353). FDA is taking this action because it is adding new information, primarily in the form of peer-reviewed scientific literature, to the administrative record. FDA is reopening the comment period for 30 days for the sole purpose of inviting public comments on the information being added to the administrative record.     

Medical devices; immunology and microbiology devices; classification of quality control material for cystic fibrosis nucleic acid assays. Final rule

The Food and Drug Administration (FDA) is classifying quality control material for cystic fibrosis nucleic acid assays 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: Quality Control Material for Cystic Fibrosis Nucleic Acid Assays." 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 the guidance document that will serve as the special control for this device.     

Current good manufacturing practice in manufacturing, packaging, labeling, or holding operations for dietary supplements. Final rule

The Food and Drug Administration (FDA) is issuing a final rule regarding current good manufacturing practice (CGMP) for dietary supplements. The final rule establishes the minimum CGMPs necessary for activities related to manufacturing, packaging, labeling, or holding dietary supplements to ensure the quality of the dietary supplement. The final rule is one of many actions related to dietary supplements that we are taking to promote and protect the public health.     

Advisory committee; Risk Communication Advisory Committee; establishment. Final Rule

The Food and Drug Administration (FDA) is announcing the establishment of the Risk Communication Advisory Committee in the Office of Planning, Office of the Commissioner. This document adds the Risk Communication Advisory Committee to the agency's list of standing advisory committees.     

Microbiology devices; reclassification of herpes simplex virus types 1 and 2 serological assays. Final rule

The Food and Drug Administration (FDA) is reclassifying herpes simplex virus (HSV) types 1 and/or 2 (HSV 1 and 2) serological assays from class III (premarket approval) to class II (special controls). FDA had earlier proposed this reclassification on its own initiative based on new information. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a class II special controls guidance entitled "Class II Special Controls Guidance Document: Herpes Simplex Virus Types 1 and 2 Serological Assays."     

论民族地区公民基层政治参与传统特征的引导控制

民族地区传统社会调节体系的非制度政治参与在现阶段民族地区公民基层政治参与中有所表现,它有着较强的历史沿袭性,正面效应与负面效应并存,执政党及政府要通过对民族地区公民基层政治参与合理有效的引导控制,促使其向体现民主法制的自治体系转化。     

突发公共安全事件扩散动力学模型仿真研究

由于自然—社会—经济系统互动随社会发展不断增加,突发公共安全事件更多地呈现出扩散化的形式,产生的影响远大于单一事件的发生。本文以复杂系统理论和复杂网络理论为基础并借鉴灾害链的相关研究,分别针对单一突发公共安全事件、突发公共安全事件链式扩散和突发公共安全事件网络扩散的特征、共性进行探索,建立事件发生和扩散的复杂系统动力学模型,通过突发公共安全事件扩散网络的动力学模型进行仿真实验,进一步探索不同网络结构和影响因素下的突发事件扩散机理。在复杂网络中,不同网络结构、事件爆发阈值、事件间关联度都会对突发事件的扩散产生影响。     

“领导干部作风建设”理论与实践的东西方比较

干部作风建设是党的领导人历来十分重视的议题。改革开放以来,中国社会处于激烈的变化中,传统的社会结构和道德观念开始瓦解,新的观念还没有很好地建立,法制环境也在逐步形成和完善之中。在这样的历史背景下,加强干部作风建设,打造新型组织文化,创立良好的国家治理环境,逐渐成为政府管理工作的重中之重。本文探讨和分析了中西方对干部作风建设的不同研究路径、实践经验和话语体系,提出应该总结国内经验、沟通话语体系、借鉴国际经验,通过制度环境建设与制度体系构建等多重方式建立领导干部作风建设的长效机制,以适应我国改革发展的持续性挑战。