International Conference on Harmonisation; Guidance on E15 Pharmacogenomics Definitions and Sample Coding; Availability. Notice

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "E15 Definitions for Genomic Biomarkers, Pharmacogenomics, Pharmacogenetics, Genomic Data and Sample Coding Categories." 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 contains definitions of key terms in the discipline of pharmacogenomics and pharmacogenetics, namely genomic biomarkers, pharmacogenomics, pharmacogenetics, and genomic data and sample coding categories. In the effort to develop harmonized approaches to drug regulation, it is important to ensure that consistent definitions of terminology are being applied across all constituents of the ICH. The guidance is intended to facilitate the integration of the discipline of pharmacogenomics and pharmacogenetics into global drug development and approval processes.     

International Conference on Harmonisation; Guidance on Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex on Residue on Ignition/Sulphated Ash General Chapter; Availability. Notice

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 1: Residue on Ignition/Sulphated Ash General Chapter.' 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 provides the results of the ICH Q4B evaluation of the Residue on Ignition/Sulphated Ash General Chapter harmonized text from each of the three pharmacopeias (United States, European, and Japanese) represented by the Pharmacopoeial Discussion Group (PDG). The guidance conveys recognition of the three pharmacopeial methods by the three ICH regulatory regions and provides specific information regarding the recognition. The guidance is intended to recognize the interchangeability among these texts from the local regional pharmacopeias, thus avoiding redundant testing in favor of a common testing strategy in each regulatory region. Elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance on the Q4B process entitled "Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions."     

Control of a chemical precursor used in the illicit manufacture of fentanyl as a List I chemical. Final rule

The Drug Enforcement Administration (DEA) is finalizing the Interim Rule with Request for Comment published in the Federal Register on April 23, 2007. The Interim Rule controlled the chemical N-phenethyl-4- piperidone (NPP) as a List I chemical under the Controlled Substances Act. Clandestine laboratories are using this chemical to illicitly manufacture the schedule II controlled substance fentanyl. No comments to the Interim Rule were received. This Final Rule finalizes the regulations without change.     

Supplemental applications proposing labeling changes for approved drugs, biologics, and medical devices. Final rule

The Food and Drug Administration (FDA) is amending its regulations regarding changes to an approved new drug application (NDA), biologics license application (BLA), or medical device premarket approval application (PMA). This final rule provides that a supplemental application submitted under certain FDA regulations is appropriate to amend the labeling for an approved product to reflect newly acquired information and to add or strengthen a contraindication, warning, precaution, or adverse reaction if there is sufficient evidence of a causal association with the drug, biologic, or device, as defined in other FDA regulations and guidance documents.     

Updating OSHA standards based on national consensus standards. final rule; confirmation of effective date

OSHA is confirming the effective date of its direct final rule that revises a number of standards for general industry that refer to national consensus standards. The direct final rule states that it would become effective on March 13, 2008 unless OSHA receives significant adverse comment on these revisions by January 14, 2008. OSHA received no adverse comments by that date and, therefore, is confirming that the rule will become effective on March 13, 2008.     

构建第三方参与的海内外侨胞信任机制

新时期侨务工作以三个大有作为为战略契机,致力于凝聚侨心、汇集侨智、发挥侨力、维护侨益。随着新生代华侨华人群体的不断壮大,在凝聚侨心的工作中,除了重视中华传统文化的纽带作用外,还应重视海内外侨胞信任机制的建设。在凝聚侨心目标下,本文通过两利益主体参与和第三方利益主体参与的博弈理论分析以及MATLAB 7.0模拟第三方参与下的多利益主体分析得出结论:第三方参与模式是海内外侨胞信任机制构建的关键所在。     

社会保障成本转嫁及其自我强化机制

在我国经济体制转轨过程中,社会保障一直承担着国有企业改革的成本转嫁。近年来,某些重大公共工程和公共政策,诸如三峡工程、南水北调工程等,也向社会保障进行成本转嫁,加重了社会保障的负担。本文认为,为了防止把社会保障变成转嫁成本的公地,应建立社会保障评估制度,对重大工程和公共政策实行事先的社会保障评估。     

关于政府信任的思考与分析

目前,政府信任是西方学术界所关注的热点问题之一,它已经成为政府改革处方的基础,而国内学者对此关注和探讨的还不多。一个理性的政府应该选择与公众建立良好的政治互动关系。就政府信任的产生而言,政府信任高低与否的根本原因在于公众对政府的认知与公共期望之间的偏离程度大小;就政府信任的效能而言,政府信任具有重要的政治价值。     

细节决定成败——新时代对公安民警人文素质培养的诉求

本文从公安工作的细节决定 公安工作的成败着眼,引出公安民警 人文素质的高低决定其公正执法和服 务群众的质量之命题,进而从多角度、 多侧面论证了加强公安民警人文素质 培养的时代要求及现实意义。