High Grade Pathogens Laboratory Review

Original Language Title: 高等级病原微生物实验室建设审查办法

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Read the untranslated law here: http://www.chinalaw.gov.cn/article/fgkd/xfg/gwybmgz/201109/20110900349569.shtml

High grade pathogens laboratory review

    (Released June 24, 2011 Ministry of science and technology, the 15th since as of August 1, 2011) Chapter I General provisions

    First to standardize the three-level and four-level pathogens laboratory (hereinafter referred to as high-grade laboratory of pathogenic microorganism) construction review, in accordance with the pathogenic microbiological laboratory biosafety management regulation (State Council order No. 424) relevant provisions of these measures.

    New construction, renovation or expansion of high grade II pathogens laboratory or production, imported high grade pathogens laboratory (hereinafter referred to as the construction laboratory) should be reported to the examination and approval of the Ministry of science and technology.

    Chapter II application

Construction of the third applying to the Ministry of science and technology laboratory, shall comply with the following conditions:

(A) have been incorporated into the national bio-safety laboratory system planning;

(B) for a related experimental activity is considered to be necessary;

(Iii) has engaged in related activities functions and activities of the Foundation;

(D) has a standardized operation and management system;

(E) have appropriate facilities and equipment, and professional personnel;

    (Vi) other conditions stipulated by laws and regulations.

    Seat of the fourth applicant shall be subject to the provincial people's Government or by business affiliations by the relevant departments of the State Council (hereinafter referred to as the applicant authority) submitted to the Ministry of science and technology of the high-grade laboratory of pathogenic microorganism application for review (see annex). Fifth Administrative Department of applications upon receipt of the application, shall, within 5 business days of completion of the formal examination.

    Application materials are incomplete or do not meet the requirements, you should notify the applicant within 5 working days correction; application materials are complete and in conformity with the provisions of, the applicant authority shall, within 10 working days will be reported to the Ministry of science and technology of all application materials.

    Chapter III examines Sixth Ministry of science and technology to set up high level pathogens laboratory biosafety Review Committee (hereinafter referred to as the Committee).

Committee consists of experts of laboratory management and related fields of scientific research, for a period of 5 years.

    The Committee's main functions are: according to the Ministry of science and technology related to entrusted to laboratory construction application reviews and review recommendations according to practical needs, proposed the construction of a lab review recommendations pathogenic microbiology laboratories provide advice for the development of high level. Seventh group of experts drawn from the Committee by the Department of science and technology experts to the admissibility of the application for review.

    Expert Group of normally no less than 9 people. Eighth scientific and Technical Department of the Organization of expert group meetings or review of the approach to the review of the site.

Basic procedures include:

(A) data review;

(B) the applicant's statement;

(C) experts questions;

    (D) Expert Panel formed to review proposals.

    Nineth Panel members should comply with the integrity and avoidance system, work objectively and impartially.

    Tenth Ministry of science and technology according to the review by the expert group recommends that upon by ministerial Affairs will study the review opinion. 11th Ministry of science and technology Administrative Department of the receipt of the application the application materials to make review comments within 10 working days from the date of order in writing served on the applicant authorities. Findings agree or disagree is divided into two kinds.

Cannot make review comments within 10 working days, approved by the head of the Ministry of science and technology can be extended by 10 working days.

    Expert review times are not included in the provisions of the preceding paragraph within the period.

12th the applicant disagrees with the opinions of the Department of science and technology, within 15 working days from the date of receipt of the notification by the competent authority in writing to the Ministry of science and technology application for review.

    Full review for reason, Department of science and technology organizations to review expert review.

    13th laboratory construction to the application unit of laboratory construction in the process of reviewing existing acts such as fraud, Department of science and technology will terminate the application for review or withdraw comments that have been made, written notification to the competent authorities, within 1-3 years, and depending on the seriousness of the decision not to proceed with the application.

    The fourth chapter by-laws

    14th laboratory construction to the application and review process involving State secrets, should be strictly in accordance with the relevant confidentiality provisions.

    15th laboratory construction to the application and review process does not charge any fees.

    16th article of the rules take effect on August 1, 2011.

    17th explain these measures by the Ministry of science and technology.

Attachment: application for high grade pathogens laboratory review Annex: application for high grade pathogens laboratory review

(Rich text)

拟建实验室名称:____________________________________________

Proposed to build a laboratory level and type: ____________________________________

申请单位名称(盖章):______________________________________

申请单位负责人签字:________________________________________

The applicant authorities (provincial-level people's Governments or departments of the State Council)

(盖章):__________________________________________________

Year month day

People's Republic of China Ministry of science and technology

    Fill in the description

    1.13 copies of applications, electronic version (can be downloaded from the Web site of the Department of science and technology).

    2. the application shall use A4 size paper printed (using Verdana, 4th Chinese characters, English, 12th).

    3. the various elements of declarations shall be complete and clear.

4. a copy of the application shall be sufficiently clear and consistent with the original.
┌────────────────────────────────────┐
│, Applicant disciplines and basic information │
│ (A) units to apply for function (attached documents) │
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│ (B) units to apply for basic information (unit, reporting relationship, history, researchers obtained │
│重大科研成果等)                                                        │
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│二、必要性分析                                                          │
│ (A) national bio-safety laboratory system of planning examination and approval (approval documents of the investment Department under the State Council │
│等证明资料)                                                            │
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│ (B) the necessity of construction of laboratory (mainly laboratory uses, including research or take on the role of significance, │
│ Sources, main content, age, and the role played by the lab, together with relevant supporting information, such as the │
│ National or provincial disease (epidemic) issued by the disease prevention and control institutions bear the highly pathogenic microbial disease control and prevention, │
│ Or proof of animal epidemic disease prevention and control, issued by the national or provincial general administration of quality supervision, inspection and quarantine departments assume high │
│ Pathogenic micro-organisms and animal and plant inspection and quarantine task proved, the State Council or provincial administrative │
│ Certificate issued by the competent authorities of State highly pathogenic bacteria (HIV) types of preservation task proved, are designated as highly pathogenic │
│ Proof of the national reference laboratory of pathogenic microorganism, issued by the competent administrative Department of the State Council or provincial science and technology │ │ State or provincial level relating to highly pathogenic microorganism research certificates.
)            │
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│三、可行性分析                                                          │
│ (A) early work (mainly explains the performance associated with highly pathogenic microorganisms, including completed │
│ Is being executed by the State or provincial Ministry mandate, supporting documents) │
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├────────────────────────────────────┤
│ (Ii) proposed to build a laboratory and experimental activities in support of the proposed facilities (mainly security and protective measures │
│施等,附清单)                                                          │
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│ (C) proposed to build a laboratory and experimental activities in support of the proposed personnel (including management, experimental │
│ Operation, technical support, safety and security of staff, with at least 6 and proposed to build a laboratory │
│ Biosafety level laboratory experience and qualification supporting documents) │
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│ (D) operation management system and ensure funding for long-term stable operation (attached document) │
│                                                                        │
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├────────────────────────────────────┤
│四、实验室建设的基本构想                                                │
│(一)建设实验室级别和类型                                              │
│ 1. level:-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. facility source:-to build-the introduction of (specify where to introduce) │
├────────────────────────────────────┤
│(二)建设地点                                                          │
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├────────────────────────────────────┤
│ (C) capacity (detailed layout, function units and facilities, and technology plans) │
│                                                                        │
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├────────────────────────────────────┤
│(四)时间进度                                                          │
│                                                                        │
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├────────────────────────────────────┤ │(五)建设经费与筹资方式                                                │
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├────────────────────────────────────┤
│五、实验室建成后的管理安排                                              │
│(一)组织机构                                                          │
│                                                                        │
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├────────────────────────────────────┤
│(二)管理模式                                                          │
│                                                                        │
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├────────────────────────────────────┤
│(三)运行机制                                                          │
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├────────────────────────────────────┤
│六、风险评估及对策                                                      │
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├────────────────────────────────────┤
│七、审核意见                                                            │
├────────────────────────────────────┤
│ Applications unit (matching funds, the experimental conditions and logistical commitment) │
│                                                                        │
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│                                              法定代表人签字:          │
│                                                  单位盖章:            │
│                                                                        │
│                                                年    月    日          │
├────────────────────────────────────┤
│ Department (the Department refers to the provincial people's Government, or the State Council Department) │
│                                                                        │
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│                                                负责人签字:            │
│                                                 单位盖章:             │
│                                                                        │
│                                                年    月    日          │ └────────────────────────────────────┘