铁道部关于公布《铁路行车公寓管理规则》的通知
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铁道部关于公布《铁路行车公寓管理规则》的通知
铁道部
铁道部关于公布《铁路行车公寓管理规则》的通知
各铁路局：
现公布《铁路行车公寓管理规则》，请认真组织落实。原《铁路乘务员公寓管理办法》（铁劳〔1995〕28号）同时废止。
第一章 总则
第一条 为加强行车公寓的管理和建设，更好地为铁路运输服务，特制定本规则。
第二条 铁路行车公寓（以下简称公寓）是专为执行铁路运输任务的行车乘务人员提供食宿等服务的生产性设施，是铁路运输生产的重要组成部分。
第三条 公寓要始终坚持为运输安全生产、为乘务人员服务的宗旨，不断完善设施设备，提高服务质量和管理水平，努力为乘务人员创造和提供安静、舒适、清洁、方便的食宿条件，使乘务人员精力充沛地投入运输安全生产中。
第二章 组织领导
第四条 铁路局对公寓实行专业化管理，制定公寓管理的规章制度和办法，实施监督、协调、检查、指导。
第五条 跨局公寓的设立和撤销由铁道部批准；局管内公寓的设立和撤销由铁路局批准，并报部备案。
第六条 各级领导要把公寓工作作为行车安全和运输生产的一项重要任务来抓，经常深入公寓调查了解情况，及时研究解决存在的问题。
第三章 接待范围
第七条 按图定交路执行运输任务的机车乘务员（含指导司机）、客运乘务员（含乘警、检车员）、运转车长等行车乘务人员。
第八条 在满足图定交路的行车乘务人员食宿的情况下，可接待机械保温车乘务员、出入厂架修过路的机车乘务员以及其它执行行车任务的有关人员。
第四章 设施设备
第九条 公寓应具备完善、配套的设施设备，满足运输生产和乘务人员食、宿、浴、娱的需要，实现公寓标准化（铁路行车公寓设备备品配置标准详见附件）。
第十条 要根据运输任务的变化，及时调整公寓的配置和规模，以满足运输需要。新建、扩建公寓用房和建筑的设计标准要严格执行《铁路房屋建筑设计标准》（ＴＢ10011－98），并根据地区需要安装空调和采暖设施，采暖与空调的设置应符合《铁路房屋暖通空调设计标准》（ＴＢ10056－98）的规定。公寓主管部门要参与新建、扩建公寓的设计审查。
第十一条 加强空调、锅炉、洗涤、炊事等机械设备的维修保养，保证正常运作，保养状态良好。
第十二条 公寓环境要绿化、美化，实现庭院化。
第五章 管理工作
第十三条 搞好公寓职工技术、业务培训，不断提高职工队伍素质。
第十四条 建立健全公寓管理各项规章制度、工作标准、管理办法，做到管理有规定，作业有程序，工作有标准，质量有考核，实行标准化管理。继续开展标准化公寓创建活动。
第十五条 推行现代化管理，运用方针目标管理、全面质量管理等科学管理方法，不断提高公寓现代化管理水平。
第十六条 加强财务和财产管理，保证公寓费用的合理使用，搞好成本控制。
第十七条 逐步推行公寓内部清算制度，严格执行《铁路跨局乘务员公寓内部清算暂行办法》（铁财函〔1995〕341号）。
第六章 工作质量
第十八条 服务质量
1．工作人员要按规定持证上岗，做到着装整洁，态度和蔼，仪容文雅，服务周到，文明礼貌。
2．工作人员熟知本岗位作业标准和作业程序，严格执行作业程序和岗位责任制，做到上标准岗、干标准活。
3．设备、备品、卧具保持完整无缺，清洁卫生，摆放有序。
4．公寓实行昼夜服务，不间断供应饭菜、开水、热水，开放浴室，保持室内温度适宜。学习室、电视室、文娱室、阅览室接时开放，管理有序。
第十九条 饭菜供应质量
1．根据乘务员的需要，结合季节和地区特点，经常调剂饭菜花样品种，以单炒菜为主，实行营养配餐，做到品种多、质量高，并有方便携带食品。
2．食品加工符合操作规程和烹饪工艺，饭菜成品达到色、香、味、型俱佳。
3．加强成本核算制度，降低成本，做到价格合理，收支平衡，经济结果公开。
第二十条 卫生工作
1．严格执行《食品卫生法》，认真落实《公共场所卫生管理条例》、《食品加工、销售、饮食业卫生五四制》，杜绝食物中毒。接受辖区内卫生防疫部门的监督检查。
2．炊具、灶具、工作案台以及炊事机械设备及时清洗清扫，餐饮用具及时消毒，保持清洁卫生。
3．室内外保持清洁卫生，做到窗明几净，无灰尘、无垃圾、无积水、无异味。
4．卧具实行一人一换制度。
第二十一条 安全叫班
1．值（叫）班工作人员熟悉接待范围、列车车次，交路及房间、床位运用情况；值班室应有不同方向、不同性质的入寓登记簿。
2．值班员准确接受派班计划，作好记录，并及时输入微机叫班机，遇有特殊情况应及时主动与派班单位联系，机务派班室、车务乘务室（无派班和乘务室的由本地区车站）应及时准确地将派班计划通知公寓值班室，实行一车次一通知。
3．值班员根据派班计划，实行一派一叫，严格执行一叫、二签、三催、四复查的叫班制度，确保叫班准确无误，并做到叫班录音清楚，语言规范，登记齐全、准确。
4．严格值（叫）班对口交接，做到交接清楚、记录准确、互相签字。
第七章 住寓管理
第二十二条 住寓人员凭乘务报单或有效证件办理住寓手续，按值班员的安排住宿，不得擅自更换房间、床位。
第二十三条 公寓要保持肃静，不准在公寓有喧哗、打闹、吵架、饮酒、随地吐痰、乱扔脏物等不文明行为；不准私带客人进寓和留宿；不准在住宿房间从事娱乐活动；不准将易燃、易爆、有污浊异味等物品带入公寓；严禁在公寓进行赌博、吸毒等违法行为。
第二十四条 住寓人员要爱护公寓的设备备品，如有损坏，照价赔偿。
第八章 共管共建
第二十五条 公寓要成立由公寓、驻寓单位、房建、水电、公安、卫生防疫及与公寓工作有直接联系的单位共同组成的共管共建委员会。共管共建委员会要制定工作制度，定期召开会议，总结工作，沟通情况，及时解决存在的问题，不断改进公寓工作。
第二十六条 各单位、各部门要各负其责，共同努力，切实把公寓建成两个文明阵地。
各驻寓单位应派得力干部驻寓，教育乘务员遵守公寓各项规章制度，组织乘务员学习政治、技术、业务知识，严格执行乘务员出乘前休息制度。
房建、水电部门要定期对公寓设施设备进行检查，发现故障及时抢修，保证设备处于完好状态。
计划、财务部门要把新建、扩建公寓，公寓空调、锅炉等大型设施设备维修及时纳入计划，保证公寓正常的经费开支。
公安部门要主动配合公寓整顿治安秩序，定期检查消防、防火、防盗工作，保证公寓秩序良好。
工会、共青团组织要在公寓开展“建家”活动，指导帮助公寓搞好群众性文化娱乐活动，建立图书点。
第九章 附则
第二十七条 各铁路局根据本规则制定相应的管理细则。
第二十八条 本规则自发布之日起执行。
第二十九条 本规则由铁道部运输局负责解释。
附件：铁路行车公寓设备备品配置标准
1．房间设备、备品
1．1住宿房间
1．1．1机车乘务员、运转车长的住宿房间设2－3张单人床，客运乘务员的住宿房间设3－4张单人床。
1．1．2按床位配备：床垫、被褥、床单、枕巾、枕芯、被罩、拖鞋；按地区需要配备：毛毯、毛巾被、蚊帐、凉席、枕席；各房间应配备桌、椅（机车乘务员房间可配沙发、茶几）、热水瓶、烟灰缸、脸盆、墙壁挂衣板、窗帘及更衣柜，根据地区需要配备电扇。
1．2值班室
设工作台、靠背椅、微机联网口叫班机、录音专用电话、钟表、应急照明灯具、手电等。
1．3电视室、学习室、文娱室、阅览室
1．3．1配备彩电、棋类桌、阅览桌、书报架、图书柜及椅子，有条件的可设乒乓球台或台球台。
1．3．2公寓应有报纸、图书、杂志。
1．4根据地区需要配备空调、取暖设备。
2．食堂
2．1厨房
2．1根据需要配备炉灶、工作台、冰柜、烤箱（柜）、保鲜柜、蒸箱、消毒箱（柜）及必备的炊事机械。
2．1．2应设有排水、排气、排烟、防暑、防蝇、防寒设施设备。
2．1．3有生熟分开加工的设施设备，有洗菜、洗餐具的洗刷消毒池，洗手池和管道疏通设备。
2．1．4对少数民族应设专用炊餐灶具。
2．1．5有存放成品、半成品的货架、盆、筐等容器和纱帘、纱罩等用具。配备够用的衡器。
2．2餐厅
2．2．1餐厅应配够用的餐桌椅（凳），有洗手池和开水桶。
2．2．2设有通风、降温、防寒、防蝇等设施。
2．3食堂仓库
2．3．1主、副食库分开设置。有良好的通风、采光、防潮、防鼠、防虫设施。
2．3．2副食库有加盖的缸、桶、盆、货架，有完整准确的大、小衡器。
3．浴室
3．1洗浴间应有够用的淋浴喷头，有良好的通风、排气、排水、照明设施，蒸汽管路有防烫装置。
3．2更衣间配够用的更衣箱、座椅，有穿衣镜。
4．厕所
4．1设水冲式大、小便池，有洗手池。
4．2厕所与盥洗室分设。
5．盥洗室
5．1应设冷、热水管，有照面镜、洗脸池、洗墩布池和污物箱。
5．2每层楼设开水炉（器）。
6．洗涤、烘干室
6．1配有保证卧具一人一换的洗涤烘干设施及相应容量的设备。
6．2洗涤室配卧具整理台、缝纫机及存放架。
7．环境
7．1院内要有绿地面积，道路硬化，设有集中垃圾箱。
7．2院内房舍间要有连廊或走廊。
7．3院内通道有适用的照明设备。
7．4公共场所设有痰盂和垃圾桶。
8．财务室、各仓库有防盗设施。
9．按规定配备消防、安全设施。
10．地面平整，盥洗室、厕所、浴室、厨房地面防滑。
Special Review and Approval Procedure for Drug Registration of the State Food and Drug Administration
Commissioner of SFDA
Special Review and Approval Procedure for Drug Registration of the State Food and Drug Administration
(SFDA Decree No. 21)
The Special Review and Approval Procedure for Drug Registration of the State Food and Drug Administration, adopted at the executive meeting of the State Food and Drug Administration (SFDA) on November 18, 2005, is hereby promulgated and shall go into effect as of the date of promulgation.
Shao Mingli
Commissioner of SFDA
November 18, 2005
Special Review and Approval Procedure for Drug Registration of the State Food and
Drug Administration
Chapter 1 General Provisions
Article 1 This Procedure is formulated for the purpose of effective prevention, timely control and elimination of the hazards of public health emergencies to ensure the health and safety of the public in accordance with the Drug Administration Law of the People’s Republic of China, Law of the People’s Republic of China on the Prevention and Treatment of Infectious Diseases, Regulations for Implementation of the Drug Administration Law of the People’s Republic of China, Regulations on Preparedness for and Response to Emergent Public Health Hazards, and other relevant laws and regulations.
Article 2 The special review and approval procedure for drug registration refers to the procedure and requirements of the State Food and Drug Administration to carry out special review and approval of drugs for handling public heath emergencies under the principle of unified leadership, early involvement, expeditiousness and efficiency, and scientific review and approval, in an effort to approve drugs for the prevention and treatment of public health emergencies as soon as possible under the threat or after the occurrence of public heath emergencies.
Article 3 The State Food and Drug Administration may, according to law, decide to follow the Procedure to conduct special review and approval of drugs for public health emergencies in any of the following circumstances:
(1) Where the President of the People’s Republic of China declares a state of emergency or the State Council decides that certain areas within a province, autonomous region or municipality directly under the Central Government are in a state of emergency;
(2) Where the contingency program for public health emergencies is initiated according to law;
(3) Where the drug reserve department or the health administrative department of the State Council proposes a special review and approval for drugs having existing national drug standard;
(4) Other circumstances applicable to special review and approval.
Article 4 The State Food and Drug Administration is responsible for the review and approval of clinical trials, production and importation of drugs for the prevention and treatment of public health emergencies.
The (food and) drug regulatory department of a province, autonomous region, or municipality directly under the Central Government shall, upon entrustment of the State Food and Drug Administration, be responsible for on-site inspection and sampling of the pilot products of the drugs for the prevention and treatment of public health emergencies.
Chapter 2 Application Acceptance and On-site Inspection
Article 5 Where the special review and approval procedure for drug registration is initiated, the State Food and Drug Administration is responsible for the acceptance of registration applications for drugs for public health emergencies.
Where a drug or a preventive biological product for public health emergencies has not been marketed in China, the applicant shall, before submission of the registration application, provide the State Food and Drug Administration with relevant research and development information.
Article 6 The applicant shall submit a registration application with relevant technical dossier to the State Food and Drug Administration according to the relevant provisions and requirements on administration of drug registration.
The registration application for drug for public health emergencies may be submitted in electronic form.
Article 7 Before submitting an application for registration, the applicant may provide a feasibility assessment application with general information and relevant explanations. The State Food and Drug Administration shall only comment on the scientific rationality and feasibility of the drug project, and respond within 24 hours.
The response to a feasibility assessment application shall be neither deemed as the review and approval opinion nor legally binding on the review and approval result of a registration application.
Article 8 The State Food and Drug Administration shall organize an expert group to evaluate and review the registration application for drug for the prevention and treatment of public health emergencies, make a decision within 24 hours on whether or not to accept the application, and notify the applicant.
Article 9 Where a registration application is accepted, the State Food and Drug Administration shall organize technical review of submitted dossier within 24 hours and at the same time notify the (food and) drug regulatory department of the province, autonomous region or municipality directly under the Central Government where the applicant is located to conduct an on-site inspection on drug research and development conditions, and organize sampling and testing of pilot products.
The (food and) drug regulatory department of the province, autonomous region, or municipality directly under the Central Government shall, within five days, submit the on-site inspection result and relevant opinion to the State Food and Drug Administration.
Article 10 The (food and) drug regulatory department of the province, autonomous region, or municipality directly under the Central Government shall organize staff from the departments of drug registration, drug safety and inspection, etc. to participate in the on-site inspection.
The National Institute for the Control of Pharmaceutical and Biological Products shall be notified to send staff to participate in the on-site inspection and sampling of preventive biological products.
Article 11 For drugs that have existing national standards for the prevention and treatment of public health emergencies, the State Food and Drug Administration may directly review and approve the drug in accordance with the relevant provisions in Chapter 6 of the Procedure when it deems there is no need for a clinical trial in accordance with law.
Article 12 With respect to the registration application for a specific vaccine, where only the original virus strain used in the manufacturing is changed while the manufacturing processes or quality specifications are maintained, the State Food and Drug Administration shall make a decision on whether or not to grant the approval within three days after verifying the changed strain used in the manufacturing.
Chapter 3 Testing for Registration
Article 13 After receiving the samples taken by the (food and) drug regulatory department of a province, autonomous region, or municipality directly under the Central Government, the drug testing institution shall immediately organize verification of specifications and laboratory testing on the samples.
The drug testing institution shall complete the testing within the time frame for the drug being applied.
Article 14 For a drug applied first time for marketing, the State Food and Drug Administration may, when necessary, make early involvement by appointing the National Institute for the Control of Pharmaceutical and Biological Products to communicate with the applicant prior to testing for registration so as to timely resolve technical problems which may arise in the process of quality specifications verification and laboratory testing.
With respect to preventive biological products used to prevent and control the epidemic of serious infectious diseases, the State Food and Drug Administration may, depending on the situation, allow the testing for registration and the manufacturer’s self-testing to be performed in parallel.
Article 15 After completion of the specifications verification and laboratory testing on a drug, the drug testing institution shall, within two days, issue its verification opinion and submit it along with the drug test report to the State Food and Drug Administration.
Chapter 4 Technical Review
Article 16 The State Food and Drug Administration shall, within 15 days after acceptance of the registration application for drug for the prevention and treatment in public health emergencies, complete the first round of technical review.
Article 17 Where the State Food and Drug Administration considers that additional data are needed, it shall immediately inform the applicant of the content and timeline.
Where the applicant submits the supplementary data within the specified timeline, the State Food and Drug Administration shall complete the technical review within three days, or, depending on the situations, organize another review meeting within five days, and then complete the review report within two days.
Chapter 5 Clinical Trial
Article 18 Where the technical review is completed, the State Food and Drug Administration shall, within three days, complete the administrative examination, make a decision and inform the applicant.
Where the State Food and Drug Administration decides to approve a clinical trial, it shall issue a Drug Clinical Trial Approval. Where it decides not to approve, it shall issue a Disapproval Notice with reasons.
Article 19 Where an applicant obtains a clinical trial approval, it shall conduct the trial strictly following the relevant requirements in the approval document, and comply with the Good Clinical Practice.
Article 20 Drug clinical trials shall be conducted in institutions legally certified for drug clinical trials. If a clinical trial has to be conducted by an institution not yet certified, a special approval by the State Food and Drug Administration should be obtained.
The application for a clinical trial conducted by an institution not yet certified for drug clinical trials may be submitted along with the application for drug registration.
Article 21 The investigator responsible for a drug clinical trial shall, in accordance with the relevant provisions, timely report adverse events occurred in the process of the clinical trial to the State Food and Drug Administration. If no adverse event occurs, the investigator shall collect relevant information and report to the State Food and Drug Administration monthly.
Article 22 The State Food and Drug Administration shall, in accordance with law, supervise and inspect the clinical trials of drugs for public health emergencies.
Chapter 6 Review, Approval and Monitoring of Drug Production
Article 23 The applicant shall, after completion of the drug clinical trials, submit the relevant data to the State Food and Drug Administration in accordance with the Provisions for Drug Registration.
Article 24 The State Food and Drug Administration shall, within 24 hours after receiving data submitted by the applicant, organize technical review, and at the same time notify the (food and) drug regulatory department of the province, autonomous region, or municipality directly under the Central Government where the applicant is located to conduct the on-site inspection on the drug manufacturing conditions, and organize the sampling and testing of pilot products.
The (food and) drug regulatory department of the province, autonomous region, or municipality directly under the Central Government shall, within five days, submit the result and opinion of the on-site inspection to the State Food and Drug Administration.
Article 25 Any newly-established drug manufacturer or manufacturer with newly-built manufacturing workshops or newly-added dosage forms for production may apply to the State Food and Drug Administration for a certificate of the Good Manufacturing Practice along with the application for drug registration. The State Food and Drug Administration shall, when conducting the drug registration review, immediately carry out an inspection on the Good Manufacturing Practice certification.
Article 26 The drug testing institution shall, after receiving the samples of three batches taken by the (food and) drug regulatory department of the province, autonomous region, or municipality directly under the Central Government, immediately arrange the testing.
Upon completion of testing, the drug testing institution shall, within two days, complete the test report and submit it to the State Food and Drug Administration.
Article 27 The State Food and Drug Administration shall carry out technical review in accordance with Chapter 4 of the Procedure, and shall, within three days after the completion of the technical review, complete the administrative examination, make a decision and inform the applicant.
Where the State Food and Drug Administration decides to approve the drug, it shall issue the Letter of Approval for Drug Registration, and may grant an approval number for the drug at the same time if the applicant has appropriate manufacturing conditions; if it decides to disapprove the manufacturing, it shall issue a Disapproval Notice with reasons.
Article 28 Where a drug manufacturer or distributor, or a medical and health institution finds any new or serious adverse drug reaction or cluster adverse reaction relating to a specially approved drug for public health emergencies, it shall immediately report the case to the local (food and) drug regulatory department of the province, autonomous region, or municipality directly under the Central Government, the health administrative department at the provincial level and the professional institution for adverse drug reactions monitoring.
The professional institution for adverse drug reactions monitoring shall regard drugs specially approved for public health emergencies as critically monitored products, analyze the collected case reports in accordance with the relevant provisions and timely report to the (food and) drug regulatory department of the province, autonomous region, or municipality directly under the Central Government and the State Food and Drug Administration.
The State Food and Drug Administration shall reinforce the reevaluation of approved drugs for public health emergencies after they are marketed.
Chapter 7 Supplementary Provisions
Article 29 The measures for special review and approval of the medical devices for public health emergencies shall be separately formulated by the State Food and Drug Administration with reference to the relevant provisions of the Procedure.
Article 30 The Procedure shall go into effect as of the date of promulgation.
体育总局、教育部关于禁止在中小学开展万智牌活动的通知
体育总局 教育部
体育总局、教育部关于禁止在中小学开展万智牌活动的通知
体育总局 教育部
万智牌是近年来在国际上新流行的一种智力体育项目。目前，国家体育总局在北京、上海、南京、成都、大连等地区进行试验工作，取得了一定的经验，同进也发现了一些问题。为保证这一新项目在试验阶段能够有序、规范发展，特作以下规定：
一、为保障青少年学生正常学习和身心健康发展，禁止中小学开展万智牌活动。
二、各级各类学校均不得组织任何形式的万智牌比赛活动。
三、万智牌试验工作要在国家体育总局规划下有序地进行。未经国家体育总局批准，各地不得擅自开展万智牌试验工作。
四、严格按照我国颁布的有关法规管理万智牌比赛活动。未经国家体育总局批准，各地均不得组织万智牌比赛活动。
2000年7月26日
