兰州市地下管线工程档案管理办法
甘肃省兰州市人民政府
兰州市地下管线工程档案管理办法
(2013年1月4日兰州市人民政府第28次常务会议审议通过 2013年2月16日兰州市人民政府令[2013]第4号公布 自2013年4月1日起施行)
第一条 为加强城市地下管线工程档案管理,充分发挥地下管线工程档案在城市规划、建设、管理中的作用,保障地下管线安全,根据《中华人民共和国档案法》、《建设工程质量管理条例》等有关法律法规,结合本市实际,制定本办法。
第二条 本办法适用于本市规划区域内地下管线工程档案的移交、收集和管理。
本办法所称地下管线工程,是指城市新建、扩建、改建的各种地下管线,包括城市供水、排水、热力、燃气、电力、通讯、广播电视、工业等的地下管线及、相关的地下工程。
本办法所称地下管线工程档案,是指在地下管线工程的规划、建设及其管理活动中形成的具有保存价值的文字、图表、声像、电子等各种载体的文件材料。
第三条 市建设行政主管部门是本市地下管线工程档案工作的行政主管部门。
市城建档案管理机构负责全市地下管线工程档案的日常管理工作,并直接负责城关、七里河、西固、安宁四区范围内地下管线工程档案的业务指导、接收、收集、保管与提供利用工作,业务上受市档案管理部门的监督指导。
红古区及永登、皋兰、榆中三县建设行政主管部门负责本县(区)内地下管线工程档案管理工作,业务上受市城建档案管理机构的监督指导。
市规划、公安、交通、城市管理等管理部门应当按照各自职责,协助做好地下管线工程档案有关工作。
第四条 城市地下管线工程档案管理应当遵循集中统一管理的原则,实行统一接收、集中保管、动态管理、资源共享,确保地下管线工程档案的完整、准确、安全和有效利用。
第五条 城市供水、排水、热力、燃气、电力、通讯、广播电视、工业等的地下管线专业管理单位(以下简称地下管线专业管理单位)应当向市城建档案管理机构报送已形成的地下管线档案资料。
第六条 地下管线专业管理单位应当将更改、报废、漏测部分的地下管线工程档案,及时修改补充到本单位的地下管线专业图上,并在修改补充后一个月内将修改补充的地下管线专业图及有关资料向市城建档案管理机构移交。
第七条 建设单位办理地下管线工程施工许可手续时,城建档案管理机构应当将工程竣工后需移交的工程档案内容和要求告知建设单位。
第八条 地下管线工程覆土前,建设单位应当委托具有相应资质的工程测量单位,按照城市地下管线探测相关标准、规程进行竣工测量,形成准确的竣工测量数据文件和管线工程测量图。
第九条 地下管线工程竣工验收前,建设单位应当提请市城建档案管理机构对地下管线工程档案进行专项预验收,并且应当取得市城建档案管理机构核发的《地下管线工程专项验收意见书》。
第十条 建设单位在地下管线工程竣工验收后三个月内,应向市城建档案管理机构移交符合《建设工程文件归档整理规范》要求的下列档案资料:
(一)地下管线工程项目准备阶段文件、监理文件、施工文件、竣工验收文件和竣工图;
(二)地下管线竣工测量成果;
(三)其他应当归档的文件资料。
第十一条 属建设项目配套工程的地下管线工程档案,工程建设单位应当按照本办法第八条、第十条的规定,与建设工程档案一并移交市城建档案管理机构。
第十二条 工程测量单位应当向市城建档案管理机构移交有关地下管线工程的1:500城市地形图和控制成果。
对于工程测量单位移交的城市地形图和控制成果,市城建档案管理机构不得出售、转让。
第十三条 建设单位在申请领取《建设工程规划许可证》前,应当到市城建档案管理机构及有关部门查询施工地段的地下管线工程档案,取得该施工地段地下管线现状资料,并将有关资料提供给施工单位。
施工单位在施工中发现未建档的地下管线时,应当立即通过建设单位向市建设行政主管部门报告。市建设行政主管部门应当及时查明地下管线性质、权属,责令地下管线产权单位补测建档,并向市城建档案管理机构报送补测的管线档案资料。
第十四条 市城建档案管理机构应当运用现代信息技术管理地下管线工程档案,确保其完整性、准确性和系统性。
市城建档案管理机构应当建立城市地下管线信息系统,及时将地下管线专业管理单位移交的地下管线专业图等地下管线工程档案资料和工程测量单位移交的城市地形图和控制成果录入地下管线信息数据库,实行动态管理。
第十五条 市城建档案管理机构应当建立地下管线工程档案资料的使用制度,积极开发地下管线工程档案资源,为政府相关部门履行行政职能和地下管线专业管理单位建设发展提供无偿服务。
第十六条 市城建档案管理机构应当建立、健全科学的内部管理制度,依法做好地下管线工程档案的接收、整理、鉴定、统计和保管工作。
第十七条 市城建档案管理机构应当建立地下管线工程档案资料的保密管理制度,并完善保密防护措施。对需要保密的地下管线工程档案资料,必须严格按照《保密法》有关规定划分知悉范围,实行分级管理。
第十八条 建设单位未移交地下管线工程档案的,由市建设行政主管部门责令改正,处一万元以上十万元以下的罚款;对单位直接负责的主管人员和其他直接责任人员,处单位罚款数额5%以上10%以下的罚款;因建设单位未移交地下管线工程档案,造成施工单位在施工中损坏地下管线的,建设单位依法承担相应的责任。
第十九条 地下管线专业管理单位未移交地下管线工程档案的,由市建设行政主管部门责令改正,处一万元以下的罚款;因地下管线专业管理单位未移交地下管线工程档案,造成施工单位在施工中损坏地下管线的,地下管线专业管理单位依法承担相应的责任。
第二十条 有关单位或者个人违反本办法规定,有下列情形之一的,由县级以上档案管理部门按照《甘肃省档案条例》有关规定予以处罚:
(一)损毁、丢失地下管线工程档案的;
(二)涂改、伪造地下管线工程档案的;
(三)擅自提供、抄录、公布、销毁地下管线工程的;
(四)违反国家规定,赠送、交换、转让、出卖、倒卖地下管线工程档案及其复制件的。
第二十一条 市城建档案管理机构工作人员玩忽职守、循私舞弊的,由其所在单位或者建设行政主管部门给予行政处分;构成犯罪的,由司法机关依法追究其法律责任。
第二十二条 红古区及永登、皋兰、榆中三县的城市地下管线工程档案的管理参照本办法执行。
第二十三条 本办法自2013年4月1日起施行。
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.