辽阳市城乡生活困难居民应急救助办法
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辽阳市城乡生活困难居民应急救助办法
辽阳市城乡生活困难居民应急救助办法
辽阳市人民政府令第110号
《辽阳市城乡生活困难居民应急救助办法》业经2009年10月28日辽阳市第十四届人民政府第26次常务会议审议通过，现予发布实施。
市长 唐志国
二〇〇九年十一月二十三日
辽阳市城乡生活困难居民应急救助办法
第一条 为建立健全城乡社会救助体系，使我市城乡突发性生活困难居民得到及时救助，根据有关法规、规章规定，制定本办法。
第二条 在我市行政区域内对城乡突发性生活困难居民实施应急救助的,适用本办法。
第三条 本办法所称应急救助，是指市、县（市）区政府对因突发性特殊事件造成临时性生活重大困难的城乡居民，给予临时性救助的社会福利制度。
第四条 政府救助的重点是发生突发性特殊困难后，靠自身力量和互助仍不能在短期内恢复和维持最低生活水平的居民。
第五条 应急救助实行属地管理、分级负责、适度救助、公开、公平、公正，以自救、互助和政府救助相结合的原则。
第六条 市、县（市）区政府民政部门是本行政区域内的城乡生活困难居民应急救助的主管部门，负责应急救助的监督管理工作，同级财政部门负责应急救助资金的筹集工作。
第七条 户籍在我市并在我市行政区域内居住的城乡居民或者户籍在外埠在我市居住超过6个月的人员，具备以下条件之一的，可以申请应急救助：
（一）家庭遇到突发性灾害或者其他特殊困难，影响到基本生活的；
（二）患重大疾病而造成家庭生活困难，或者因其他特殊性困难导致实际生活水平降至当地最低生活保障标准以下，且生活一时难以维持的。
在特定时期，政府可以指定对某些特殊困难群体给予应急救助。
第八条 应急救助的数额应当根据享受救助居民遭受突发性灾难影响基本生活的程度，与当地最低生活保障标准相适应。
第九条 应急救助采取以现金和物品救助相结合的方式。对同一家庭应急救助的间隔时间不得少于6个月。一次性救助款物合计金额每户一般不超过5000元。
第十条 城乡生活困难居民申请应急救助的，以家庭为单位向居住地的社区（村）提出书面申请。由于某种原因造成人户分离，在暂住地居住1年以下的，携暂住地的社区（村）出具的暂住证明，向户籍所在地的社区（村）提出申请。在暂住地居住1年以上的，携户籍所在地的社区（村）出具的户籍证明，向暂住地的社区（村）提出申请。外来务工人员遇重大突发性灾难后，用工单位无力解决的，由用工单位向务工所在地县（市）区民政部门提出申请。
第十一条 社区（村）收到应急救助申请后，应当核实其家庭生活状况，对符合应急救助条件的，填写《辽阳市城乡困难居民应急救助审批表》，经街道办事处（乡镇政府）审核报县（市）区民政部门审批。
县（市）区民政部门应当于受理申请后7个工作日内，办结审批手续。对符合应急救助条件的，予以批准。对不予批准的，应当书面说明理由。
市民政部门对符合应急救助条件的人员，根据情况给予救助。
第十二条 申请人申请应急救助时，应提供下列材料：
（一）书面申请书；
（二）户籍证明、本人身份证（暂住证）；
（三）严重损失或者重大疾病以及其他特殊性困难证明；
（四）其他有关证明。
第十三条 应急救助申请批准后，由社区（村）进行公示，无异议的，由市、县（市）区民政部门直接将应急救助款物发给申请人。
第十四条 应急救助所需资金纳入市、县（市）区政府财政预算，市、县（市）区政府每年各自从本级财政资金中安排50万元，用于各级城乡困难居民临时救助。
第十五条 财政部门和民政部门应当将应急救助资金列入社会保障资金专户，专款专用。市、县（市）区民政部门应当于每年11月底前向同级财政部门报送下一年度应急救助资金预算和当年应急救助资金的使用情况。
第十六条 市民政、财政部门应当定期对县（市）区应急救助款物管理、使用情况进行监督检查。对在应急救助实施过程中违反规定的工作人员，应当依法依纪追究责任。
第十七条 本办法第七条、第九条、第十条中涉及居住期限的，均以公安部门发给的暂住证为准。
第十八条 本办法自发布之日起施行。辽阳市民政局、辽阳市财政局2005年7月1日发布的《辽阳市城乡生活困难居民应急救助办法》（辽市民发[2005]60号）同时废止。
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Special Review and Approval Procedure for Drug Registration of the State Food and Drug Administration
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.
2007年化肥关税配额进口总量、分配原则和申请程序
商务部公告2006年第79号 2007年化肥关税配额进口总量、分配原则和申请程序
根据《中华人民共和国货物进出口管理条例》和我国加入世界贸易组织的有关承诺，现公布2007年化肥关税配额进口总量、分配原则和申请程序。凡符合条件的化肥进口单位均可通过商务部授权的重要工业品进口管理机构提出申请或直接向商务部提出申请。申请期为2006年10月10日至11月10日。
附件：2007年化肥关税配额进口总量、分配原则和申请程序
二○○六年十月十日
附件：
2007年化肥关税配额进口总量、分配原则和申请程序
2007年实行关税配额管理的化肥品种为：尿素（税号：31021000）、磷酸二铵（税号：31053000）和复合肥（税号：31052000）。关税配额内税率为4％，关税配额外税率为50％。
一、关税配额总量
2007年可分配的化肥关税配额总量分别为：尿素330万吨，磷酸二铵690万吨，复合肥345万吨。
二、分配依据
（一）申请单位以往的进口实绩；
（二）申请单位的生产能力、经营规模、销售状况；
（三）以往分配的配额是否得到充分使用；
（四）申请配额的数量情况；
（五）新的进口经营者的申请情况；
（六）其他需要考虑的因素。
三、国营贸易关税配额
2007年化肥国营贸易配额数量分别为：尿素297万吨，磷酸二铵449万吨，复合肥224万吨。
申请化肥国营贸易配额的单位为：有进口基数和实绩的农业生产资料公司；有进口基数和实绩的农业三站（土肥站、种子站、农技站）；有进口基数和实绩的化肥生产企业；符合条件的新的进口申请者。
四、非国营贸易关税配额
2007年化肥非国营贸易进口关税配额数量分别为：尿素33万吨，磷酸二铵241万吨，复合肥121万吨。
申请化肥非国营贸易配额的单位为：有进口基数和进口实绩的边境小额贸易企业；有进口基数和进口实绩的外商投资企业；有进口基数和进口实绩的经济特区化肥进口企业；符合条件的新的进口申请者。
五、申请关税配额须报送的材料
申请化肥关税配额的单位须报送下列材料：
（一）申请单位的基本情况：工商营业执照副本复印件、注册资本、生产能力、经营规模、销售收入、税金总额等；
（二）近三年（2004－2006年）配额分配数量，包括分品种数量，并附送原进口配额管理机构分配文件的复印件；
（三）近三年（2004－2006年）化肥进口实绩，包括分品种进口实绩（进口实绩以海关报关统计为准）；
（四）2007年申请的化肥关税配额的品种和数量；
（五）申请国营贸易或者非国营贸易（两者不能同时申请）。
六、申请程序
进口申请单位应将申请材料统一送交商务部授权的重要工业品进口管理机构，由其统一转报商务部。中央企业直接报送商务部。
