Medical devices; immunology and microbiology devices; classification of norovirus serological reagents. Final rule

The Food and Drug Administration (FDA) is classifying norovirus serological reagents into class II (special controls). The special control that will apply to these devices is the guidance document entitled ``Class II Special Controls Guidance Document: Norovirus Serological Reagents.' The Agency is classifying these devices into class II (special controls) because special controls, in addition to general controls, will provide a reasonable assurance of safety and effectiveness of these devices and there is sufficient information to establish special controls.     

Administrative simplification: adoption of standards for health care electronic funds transfers (EFTs) and remittance advice. Interim final rule with comment period

This interim final rule with comment period implements parts of section 1104 of the Affordable Care Act which requires the adoption of a standard for electronic funds transfers (EFT). It defines EFT and explains how the adopted standards support and facilitate health care EFT transmissions.     

Current good manufacturing practice in manufacturing, processing, packing, or holding of drugs; revision of certain labeling controls. Final rule

The Food and Drug Administration (FDA) is amending the packaging and labeling control provisions of the current good manufacturing practice (CGMP) regulations for human and veterinary drug products by limiting the application of special control procedures for the use of cut labeling to immediate container labels, individual unit cartons, or multiunit cartons containing immediate containers that are not packaged in individual unit cartons. FDA is also permitting the use of any automated technique, including differentiation by labeling size and shape, that physically prevents incorrect labeling from being processed by labeling and packaging equipment when cut labeling is used. This action is intended to protect consumers from labeling errors more likely to cause adverse health consequences, while eliminating the regulatory burden of applying the rule to labeling unlikely to reach or adversely affect consumers. This action is also intended to permit manufacturers to use a broader range of error prevention and labeling control techniques than permitted by current CGMPs.     

东南亚国家的经济外交与地区安全秩序的重塑

冷战结束后,塑造东亚地区安全秩序的力量来源主要有两个:一是雅尔塔体系的遗产,二是东南亚国家的经济外交。一方面,中国与俄罗斯通过上海合作组织构建了在安全等领域的合作,而美国在美日同盟的基础上强化了其在东亚的单边及多边同盟体系。因此,雅尔塔体系遗产的组织化程度较以往明显提高。另一方面,东南亚诸国通过在东盟"10+"合作框架、亚太经合组织以及亚欧会议等平台实施经济外交,比较成功地把主要大国及区域集团力量牵绊在东亚地区,并藉此影响了冷战后东亚地区的政治、安全秩序。     

PuriTyper~(TM)法医学纯化试剂盒的性能验证

目的验证PuriTyperTM纯化试剂盒各项性能指标和法医学应用价值。方法收集及制备抗凝血液、常见案件检材(唾液、烟头、精液、毛发、指甲、骨骼及组织块)、斑痕样本(血斑、唾液斑、精斑)以及模拟添加抑制剂和模仿自然环境中放置的血斑。采用PuriTyperTM纯化试剂盒提取纯化并进行DNA定量,IdentifilerTM复合扩增试剂盒扩增,产物经ABI 3130遗传分析仪进行检测,Genemapper软件分析结果,对该试剂盒灵敏度、稳定性、重复性、检材适应性进行测试。结果采用该试剂盒提取0.1～40μL血液分别获得0.042～26.45ng/μL的DNA。3种斑痕样本DNA产量平行试验结果稳定。不同类型检材重复检验所获IPC的CT平均值在27.60至28.03之间。常见案件检材所得分型与已知结果均一致。结论 PuriTyperTM纯化试剂盒能够满足法医DNA检验的要求,对法医学实践具有重要的应用价值。     

法医DNA标准物质备选细胞STR等位基因片段长度的定值

目的 研究建立法医DNA标准物质备选细胞基因组STR基因座等位基因片段长度标准定值的方法.方法 利用有机法提取HPF和HSSM细胞基因组DNA并进行STR复合扩增,将产物进行电泳检测.利用Gene Mapper软件分析电泳结果,记录STR基因座等位基因的数值,并对目前我国公安系统应用较为广泛的DNATyperTM15、IdentifilerTM两种试剂盒扩增产物进行相应的DNA片段长度(bp)统计以及定值.结果 HPF为男性个体细胞,HSSM为女性个体细胞.HPF和HSSM细胞DNATyperTM15系统等位基因片段长度范围分别为126.26±0.05～367.53±0.20bp和125.33±0.07～370.08±0.17bp,IdentifilerTM系统等位基因片段长度范围分别为117.22±0.04～340.02±0.08bp和117.21±0.03～323.86±0.09bp.结论 对STR基因座等位基因片段长度进行标准定值,可为法医DNA标准物质提供有效的溯源途径.     

气候政治的俄罗斯因素——俄罗斯参与国际气候合作的立场、问题与前景

长期以来,俄罗斯在国际气候合作中的影响被广泛忽视。俄罗斯曾经是《京都议定书》得以生效的关键性促成力量;未来数年俄罗斯仍将是世界性的能源大国;其累计的高额碳信用额度引起了欧盟和美国的担忧;其拥有的强大的碳隔离能力如若不善加管理,则有可能从碳库转化成碳源,给全球的气候变化带来不可忽视的影响。俄罗斯在国际气候合作中的立场有何变化?受到那些因素的影响?存在哪些问题?在后京都气候框架中又将发挥什么样的作用?通过对近年来俄罗斯气候领域的具体分析,将可以找到这一系列问题的答案。     

两岸三地公共场所禁烟立法的比较与借鉴

吸烟者的吸烟自由与被动吸烟者的生命健康权存在冲突,家庭等私人机制对于出现在非公共场所中相关矛盾可予以妥善处理,但是对于公共场所中发生的相关矛盾则应当诉诸公权力的干预。各国及地区已经普遍地建立公共场所禁烟制度,台湾、香港的相关立法堪为大陆立法借鉴。比较两岸三地立法,公共场所的界定是控烟的关键,管理体制的建立是控烟的重要保障,处罚机制的设计是控烟有效实施的基础。