Medicare and Medicaid programs; fire safety requirements for certain health care facilities. Final rule

This final rule amends the fire safety standards for hospitals, long-term care facilities, intermediate care facilities for the mentally retarded, ambulatory surgery centers, hospices that provide inpatient services, religious nonmedical health care institutions, critical access hospitals, and Programs of All-Inclusive Care for the Elderly facilities. Further, this final rule adopts the 2000 edition of the Life Safety Code and eliminates references in our regulations to all earlier editions.     

International Conference on Harmonisation; guidance on electronic common technical document specification; availability. Notice

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "M2 eCTD: Electronic Common Technical Document Specification." 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 defines the means for industry-to-agency transfer of regulatory information that will facilitate the creation, review, life cycle management, and archiving of the electronic submission. The guidance is intended to assist industry in transferring electronically their marketing applications for human drug and biological products to a regulatory authority.     

Health insurance reform: security standards. Final rule

This final rule adopts standards for the security of electronic protected health information to be implemented by health plans, health care clearinghouses, and certain health care providers. The use of the security standards will improve the Medicare and Medicaid programs, and other Federal health programs and private health programs, and the effectiveness and efficiency of the health care industry in general by establishing a level of protection for certain electronic health information. This final rule implements some of the requirements of the Administrative Simplification subtitle of the Health Insurance Portability and Accountability Act of 1996 (HIPAA).     

International Conference on Harmonisation; guidance on Q1A stability testing of new drug substances and products; availability. Notice

The Food and Drug Administration (FDA) is announcing the availability of a revised guidance entitled "Q1A(R) Stability Testing of New Drug Substances and Products." The revised 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 sets forth recommendations on the information to be submitted in the stability data package for a new drug substance or drug product for a registration application within the three regions of the European Union (EU), Japan, and the United States. The purpose of there vision is to add information to certain sections and to provide clarification to other sections of the guidance.     

International Conference on Harmonisation; guidance on S7A safety pharmacology studies for human pharmaceuticals; availability. Notice

The Food and Drug Administration (FDA) is announcing the availability of a guidance entitled "S7A Safety Pharmacology Studies for Human Pharmaceuticals." 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 a definition, general principles, and recommendations for the nonclinical safety pharmacology studies. The guidance is intended to help protect clinical trial participants and patients receiving marketed products from potential adverse effects of pharmaceuticals, while avoiding unnecessary use of animals and other resources.     

美国议员筹款忙

去年秋季,我的一个多年的老友竞选国会众议员,并且当选了.他是一个不错的人--聪明、关心别人、品行端正.在当选几天之后,我打电话向他祝贺.我们只简短地谈到第111届国会所面临的重大事项,包括经济问题、伊朗和阿富汗的前景,但是他很快就将话题转到了另一个主题:筹款事宜.     

紧抓奥运契机做好供热保障

北京城市供热作为城市建设发展的支撑和城市运行的载体，在七年的奥运筹办期间，充分利用奥运给予行业发展的历史契机，科学发展，圆满实现了奥运供热保障的目标。     

与大部门共生的独立机构——以贸促机构为例

本文以西方发达国家(地区)贸易促进机构为具体案例,说明在西方行政管理体制改革的过程中,负责执行政府政策或法律、负责监管的独立机构所体现出来的公共治理结构中的多元化、社会化和市场化的趋势。这些独立机构和负责决策的大部门相互分工,相辅相成,共同构成政府公共管理和服务的主体。此外,本文提出在完善我国大部制的过程中,有必要不遗余力地推进独立机构的建设,并且通过对我国贸促机构的分析,提出可以以贸促机构作为我国建立独立机构的试点。     

Improving Human Rights Protection Through Development in Scientific Way Address at the Opening Ceremony of the Third Beijing Forum on Human Rights

Distinguished guests, experts and scholars, ladies and gentlemen:In the golden October when people are enjoying clean and fresh air, the China Society for Human Rights Studies unveiled its Third Beijing Forum on Human Rights.     

关于境内机构捐赠外汇管理有关问题的通知

For the purpose of realizing the adminiswation of donations in foreign exchange and facilitating the receipt and payment of donations in foreign exchange,and pursuant to the Regulations of the People's Republic of China on Foreign Exchange Administration and other relevant laws and regulations, the relevant issues concerning administration of donations in foreign exchange by domestic institutions are hereby promulgated: