高等级病原微生物实验室建设审查办法

（2011年6月24日科学技术部令第15号公布  自2011年8月1日起施行）

第一章　总则

第一条　为规范三级、四级病原微生物实验室（以下简称高等级病原微生物实验室）建设审查，根据《病原微生物实验室生物安全管理条例》（国务院第424号令）的有关规定，制定本办法。

第二条　新建、改建、扩建高等级病原微生物实验室或者生产、进口移动式高等级病原微生物实验室（以下简称建设实验室）应当报科学技术部审查同意。

第二章　申请

　第三条　向科学技术部申请建设实验室，应当符合下列条件：

（一）已纳入国家生物安全实验室体系规划；

（二）对于开展相关实验活动确属必要；

（三）具有从事相关实验活动的职能和工作基础；

（四）具有规范的运行管理制度；

（五）具有相应的设施设备和专业人才队伍；

（六）法律法规规定的其他条件。

第四条　申请单位应当经其所在地的省级人民政府或按照业务隶属关系经国务院有关部门（以下简称申请单位主管部门）向科学技术部提交《高等级病原微生物实验室建设审查申请书》（格式见附件）。

第五条　申请单位主管部门收到申请资料后，应当在5个工作日内完成形式审查。申请材料不齐全或不符合规定形式的，应当在5个工作日内通知申请单位补正；申请材料齐全并符合规定形式的，申请单位主管部门应当在10个工作日内将全部申请材料报科学技术部。

第三章　审查

第六条　科学技术部设立高等级病原微生物实验室生物安全审查委员会（以下简称委员会）。委员会由从事实验室管理及相关领域科研工作的专家组成，任期5年。

委员会的主要职责是：根据科学技术部委托对有关实验室建设申请进行审查并提出审查建议；根据实际需求，提出建设实验室审查方式建议；对高等级病原微生物实验室发展提供咨询意见。

第七条　科学技术部将从委员会中抽取专家组成专家组对受理的申请进行审查。专家组一般不少于9人。

第八条　科学技术部将组织专家组采取会议或现场审查的方式进行审查。基本程序包括：

（一）资料审核；

（二）申请单位陈述；

（三）专家提问；

（四）专家组讨论形成审查建议。

第九条　专家组成员应遵守诚信和回避制度，客观、公正地开展工作。

第十条　科学技术部根据专家组审查建议，经部务会研究形成审查意见。

第十一条　科学技术部自收到申请单位主管部门报来的申请材料之日起10个工作日内作出审查意见，以书面形式送达申请单位主管部门。审查结论分为同意或不同意两种。在10个工作日内不能作出审查意见的，经科学技术部负责人批准可以延长10个工作日。

专家评审时间不计入前款规定的期限内。

第十二条　申请单位对科学技术部审查意见有异议的，可自收到通知之日起15个工作日内经其主管部门以书面形式向科学技术部申请复核。

对于理由充分的复核申请，科学技术部将组织专家进行复核审查。

第十三条　实验室建设申请单位在实验室建设审查过程中存在弄虚作假等行为的，科学技术部将终止对其申请的审查或撤销已作出的审查意见，书面通知其主管部门，并根据情节轻重决定在1-3年内不再受理其申请。

第四章　附则

第十四条　实验室建设申请与审查过程中涉及国家秘密的，应严格按照有关保密规定执行。

第十五条　实验室建设申请与审查工作不收取任何费用。

第十六条　本办法自2011年8月1日起施行。

第十七条　本办法由科学技术部负责解释。

附件：高等级病原微生物实验室建设审查申请书

附件：高等级病原微生物实验室建设审查申请书

    （格式文本）

    拟建实验室名称：____________________________________________

    拟建设实验室级别和类型：____________________________________

    申请单位名称（盖章）：______________________________________

    申请单位负责人签字：________________________________________

    申请单位主管部门（省级人民政府或国务院部门）

    （盖章）：__________________________________________________

  年  月  日

中华人民共和国科学技术部制

    填写说明

1. 申请书一式13份，附电子版（可从科学技术部网站下载）。

2. 申请书应当使用A4规格纸张打印（中文使用微软雅黑4号字，英文使用12号字）。

3. 申报的各项内容应当完整、清楚。

4. 申请资料的复印件应当足够清楚并与原件一致。

┌───────────────────────────┐

│一、申请单位职能范畴及基本情况                                          │

│（一）申请单位职能（应附证明材料）                                      │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

├────────────────────────────────────┤

│（二）申请单位基本情况（单位性质，隶属关系，历史沿革，科研人员情况，取得│

│重大科研成果等）                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

├────────────────────────────────────┤

│二、必要性分析                                                          │

│（一）国家生物安全实验室体系规划审批情况（附国务院投资主管部门的批准文件│

│等证明资料）                                                            │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

├────────────────────────────────────┤

│（二）实验室建设的必要性（主要说明实验室用途，包括科研或承担任务的意义、│

│来源、主要内容、实施年限以及实验室在其中发挥的作用，并附相关证明资料，如│

│国家或省级疾（疫）病预防控制机构开具的承担高致病性病原微生物疾病预防控制│

│或动物疫病预防控制任务的证明，国家质检总局或省级检验检疫部门开具的承担高│

│致病性病原微生物及动植物检验检疫任务的证明，国务院或省级人民政府有关行政│

│主管部门开具的承担国家高致病性菌（毒）种保藏任务的证明，被指定为高致病性│

│病原微生物国家参考实验室的证明，国务院或省级人民政府科技行政主管部门出具│

│的承担国家或省部级涉及高致病性病原微生物研究工作的证明等。）            │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

├────────────────────────────────────┤

│三、可行性分析                                                          │

│（一）前期工作基础（主要说明与高致病性病原微生物相关的工作业绩，包括已完│

│成和正在执行的由国家或省部委赋予的任务情况，附证明文件）                │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

├────────────────────────────────────┤

│（二）与拟建设实验室和拟从事实验活动相配套的设施设备（主要是安全和防护措│

│施等，附清单）                                                          │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

├────────────────────────────────────┤

│（三）与拟建设实验室和拟从事实验活动相配套的人才队伍（包括从事管理、实验│

│操作、 技术保障、安全保卫等的人员配备，附至少有6名具有在与拟建设实验室相│

│同生物安全防护水平实验室工作经历和工作资质的证明文件）                  │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

├────────────────────────────────────┤

│（四）运行管理制度及长期稳定运行的经费保障（附证明文件）                │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

├────────────────────────────────────┤

│四、实验室建设的基本构想                                                │

│（一）建设实验室级别和类型                                              │

│1.级    别：□BSL-3     □BSL-4    □ABSL-3    □ABSL-4                 │

│2.类    型：□固定      □移动                                          │

│3.建设方式：□新建      □改建    □扩建                                │

│4.设施来源：□自行建造  □引进（注明从何处引进）                        │

├────────────────────────────────────┤

│（二）建设地点                                                          │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

├────────────────────────────────────┤

│（三）建设规模（详细介绍平面布局、功能单元及配套设施，并附工艺平面图）  │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

├────────────────────────────────────┤

│（四）时间进度                                                          │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

├────────────────────────────────────┤

│（五）建设经费与筹资方式                                                │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

├────────────────────────────────────┤

│五、实验室建成后的管理安排                                              │

│（一）组织机构                                                          │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

├────────────────────────────────────┤

│（二）管理模式                                                          │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

├────────────────────────────────────┤

│（三）运行机制                                                          │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

├────────────────────────────────────┤

│六、风险评估及对策                                                      │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

├────────────────────────────────────┤

│七、审核意见                                                            │

├────────────────────────────────────┤

│申请单位意见（配套经费、实验条件和后勤保障承诺）                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                              法定代表人签字：          │

│                                                  单位盖章：            │

│                                                                        │

│                                                年    月    日          │

├────────────────────────────────────┤

│主管部门意见（该主管部门指省级人民政府或国务院部门）                    │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                                        │

│                                                负责人签字：            │

│                                                 单位盖章：             │

│                                                                        │

│                                                年    月    日          │

└────────────────────────────────────┘