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ENFORCEMENT DECREE OF THE ACT ON THE ACQUISITION, MANAGEMENT, AND UTILIZATION OF BIOLOGICAL RESEARCH RESOURCES

Presidential Decree No. 21808, Nov. 5, 2009

Amended by Presidential Decree No. 24423, Mar. 23, 2013

Presidential Decree No. 28210, Jul. 26, 2017

 Article 1 (Purpose)
The purpose of this Decree is to prescribe matters delegated by the Act on the Acquisition, Management, and Utilization of Biological Research Resources and matters necessary for the enforcement thereof.
 Article 2 (Master Plans and Implementation Plans)
(1) The Minister of Science and ICT shall formulate a master plan for the management of biological research resources (hereinafter referred to as "master plan") under Article 7 (1) of the Act on the Acquisition, Management, and Utilization of Biological Research Resources (hereinafter referred to as the "Act") in the year immediately preceding the commencement year of the master plan. <Amended by Presidential Decree No. 24423, Mar. 23, 2013; Presidential Decree No. 28210, Jul. 26, 2017>
(2) Following consultations with the heads of related central administrative agencies, the Minister of Science and ICT may prepare a plan specific to the field under his/her jurisdiction under Article 7 (3) of the Act and common guidelines for the formulation of annual implementation plans under Article 7 (5) of the Act and notify the heads of related central administrative agencies thereof. <Amended by Presidential Decree No. 24423, Mar. 23, 2013; Presidential Decree No. 28210, Jul. 26, 2017>
(3) The head of each related central administrative agency shall notify the Minister of Science and ICT of a plan specific to the field under his/her jurisdiction under Article 7 (3) of the Act by no later than September 30 of the year immediately preceding the commencement year of the relevant master plan. <Amended by Presidential Decree No. 24423, Mar. 23, 2013; Presidential Decree No. 28210, Jul. 26, 2017>
(4) If necessary for the efficient promotion of the master plan, the Minister of Science and ICT may request the heads of related central administrative agencies to submit implementation plans for the relevant year and the data related to the performance record of the implementation plans of the previous year. <Amended by Presidential Decree No. 24423, Mar. 23, 2013; Presidential Decree No. 28210, Jul. 26, 2017>
 Article 3 (Standards for Designation of Biological Resource Centers)
(1) The minimum standards for the designation of a biological resource center in which biological research resources can be deposited, registered and preserved (hereinafter referred to as "biological resource center") under Article 8 (1) of the Act shall be as follows:
1. It shall have facilities and equipment capable of receiving deposits and registrations of at least 100 items of biological research resources and of preserving and managing them for a long period;
2. It shall secure the following personnel of at least a fifth of the whole human resources (one person, if the total number of human resources is less than five):
(a) Persons with a master’s or higher degree in the field of biology under the national standard classification system for science and technology under Article 27 of the Framework Act on Science and Technology;
(b) Persons with a bachelor’s degree in the field of biology under the national standard classification system for science and technology under Article 27 of the Framework Act on Science and Technology, who have worked in the related fields including research institutes for at least three years;
3. It shall possess computation equipment, backup facilities and security facilities for the operation of an information system for biological research resources, and shall secure at least one person in charge of data processing.
(2) The head of a related central administrative agency may, if necessary, prescribe additional standards for designation by Ordinance of the relevant Ministry other than designation standards referred to in paragraph (1), reflecting the characteristics of biological research resources under his/her jurisdiction.
(3) The head of a related central administrative agency may, taking into consideration the expertise of the human resources, facilities, etc., designate a person deemed suitable to perform the duties of a biological resource center under Article 8 (2) of the Act as a biological resource center from among persons fulfilling designation standards referred to in paragraphs (1) and (2).
 Article 4 (Procedures for Designation of Biological Resource Centers)
(1) A person who intends to be designated as a biological resource center shall file an application for designation including the following matters with the head of the related central administrative agency:
1. Current state of possession of biological research resources;
2. Current state of possession of facilities, equipment and human resources;
3. Outcomes of projects related to biological research resources and plans therefor;
4. Other matters prescribed and publicly notified by the head of the related central administrative agency for verifying the competence in performance of duties prescribed in the subparagraphs of Article 8 (2) of the Act.
(2) The head of a related central administrative agency shall determine whether to make a designation, within 30 days from the receipt of the application under paragraph (1): Provided, That where any extenuating circumstances exist, the time limit may be extended only once for a fixed period not exceeding 30 days, and in such cases, he/she shall notify the applicant of the reason therefor in writing (including electronic documents).
(3) Upon designating a biological resource center, the head of a related central administrative agency shall issue a certificate of designation to a designated institution and publish the following matters in the Official Gazette:
1. Name and address of a designated institution;
2. Date of designation;
3. Current state of resources being preserved by a designated institution.
(4) Matters necessary for designation procedures for a biological resource center other than those prescribed in paragraphs (1) through (3) shall be prescribed by Ministerial Ordinance of the relevant central administrative agency.
 Article 5 (Methods of Deposit and Registration)
(1) A person who intends to deposit and register biological research resources under Article 9 (1) of the Act shall file an application after preparing the conditions of the biological research resources suitable therefor.
(2) Where the outcomes of the examination of the application for deposit and registration under paragraph (1) turn out to be appropriate, the biological resource center shall issue a certificate of deposit to the applicant, and where they turn out to be inappropriate, it shall reject the receipt of the deposit or notify the applicant to make a supplementation.
(3) "Grounds prescribed by Presidential Decree" in the proviso to Article 9 (2) of the Act means the following:
1. Where it is difficult to prevent the leakage of personal information because the biological research resources are originated from the human body;
2. Where the biological research resources may cause harm to public health, the ecosystem, etc.;
3. Where biological research resources are designated by any other Act as those requiring special protection;
4. Where it is necessary to restrict the disclosure for a limited time period for patent application;
5. Where the quality of biological research resources intended for deposit and registration is not appropriate for preservation and management.
(4) Matters necessary for the deposit and registration of biological research resources other than those prescribed in paragraphs (1) through (3) shall be prescribed by Ministerial Ordinance of the relevant central administrative agency.
 Article 6 (Standards, etc. for Designation of Competent Authority)
(1) The head of a related central administrative agency may designate an entity suitable for performing duties prescribed in the subparagraphs of Article 10 (1) of the Act as a competent authority from among entities satisfying the following criteria:
1. It shall fulfill standards for designation of a biological resource center prescribed in Article 3;
2. It shall secure an exclusive organization capable of performing the duties prescribed in Article 10 (1) of the Act and at least three personnel exclusively therefor;
3. It shall have an information system for exchange of information among biological resource centers;
4. It shall formulate a management plan and a project plan of biological resource centers.
(2) Upon designating a competent authority under paragraph (1) (hereinafter referred to as “competent authority”), the head of a related central administrative agency shall issue a certificate of the designation of a competent authority to the relevant institution and publish the designation in the Official Gazette.
(3) In order to operate competent authorities in an efficient manner, including through technical cooperation, exchange of information, and linkage for the management of biological resource centers, competent authorities may organize a consultative council of competent authorities.
(4) The Minister of Science and ICT may subsidize part or all of expenses incurred in operating the consultative council of competent authorities referred to in paragraph (3). <Amended by Presidential Decree No. 24423, Mar. 23, 2013; Presidential Decree No. 28210, Jul. 26, 2017>
(5) Matters necessary for the designation and operation of competent authorities, other than those prescribed in paragraphs (1) through (4), shall be prescribed by Ministerial Ordinance of the relevant central administrative agency.
 Article 7 (Standards for Designation of Information Centers of Biological Research Resources)
(1) An entity which intends to be designated as an information center of biological research resources under Article 10 (2) of the Act (hereinafter referred to as "information center of biological research resources") shall fulfil the following minimum standards:
1. It shall be equipped with a computer room having computer servers, network facilities, backup facilities, and security facilities;
2. It shall secure the following personnel of at least a tenth of the whole human resources (one person, if the total number of human resources is less than 10):
(a) Persons with a master’s or higher degree in the field of computer science or biology under the national standard classification system for science and technology under Article 27 of the Framework Act on Science and Technology;
(b) Persons with a bachelor’s degree in the field of computer science or biology under the national standard classification system for science and technology under Article 27 of the Framework Act on Science and Technology, who have worked in the related fields including research institutes for at least three years.
(2) The head of a related central administrative agency may, if necessary, prescribe additional standards for designation by Ordinance of the relevant Ministry other than designation standards referred to in paragraph (1), reflecting the characteristics of biological research resources under his/her jurisdiction, if necessary.
(3) The head of a related central administrative agency may, taking into consideration the human resources, facilities, outcomes of related projects and other expertise of an entity, designate an entity deemed suitable to perform the duties of an information center of biological research resources as an information center of biological research resources from among entities fulfilling designation standards referred to in paragraphs (1) and (2).
 Article 8 (Procedures for Designation of Information Center of Biological Research Resources)
(1) An entity which intends to be designated as an information center of biological research resources shall file an application for the designation including the following matters with the head of the related central administrative agency:
1. Current state of possession of facilities and human resources;
2. Current state of construction of an information system;
3. Outcomes of projects related to the management of information on biological research resources, and plans therefor;
4. Other matters prescribed and publicly notified by the head of the related central administrative agency for verifying the competence in performance of duties prescribed in the subparagraphs of Article 10 (2) of the Act.
(2) The head of a related central administrative agency shall determine whether to make the designation, within 30 days from the receipt of the application under paragraph (1): Provided, That where any extenuating circumstances exist, the time limit may be extended only once for a fixed period not exceeding 30 days, and in such cases, he/she shall notify the applicant of the reason therefor in writing (including electronic documents).
(3) Upon designating an information center of biological research resources, the head of a related central administrative agency shall issue a certificate of designation to a designated institution and publish the following matters in the Official Gazette:
1. Name and address of a designated institution;
2. Date of designation;
3. Current state of resources being preserved by a designated institution.
(4) Matters necessary for designation, other than those prescribed in paragraphs (1) through (3), shall be prescribed by Ministerial Ordinance of the relevant central administrative agency.
 Article 9 (Standards, etc. for Designation of the National Information Center of Biological Research Resources)
(1) The Minister of Science and ICT may designate an entity deemed appropriate for performing the duties prescribed in the subparagraphs of Article 11 (2) of the Act as the National Information Center of Biological Research Resources under Article 11 (1) of the Act (hereinafter referred to as the "National Information Center of Biological Research Resources") from among entities satisfying the following criteria: <Amended by Presidential Decree No. 24423, Mar. 23, 2013; Presidential Decree No. 28210, Jul. 26, 2017>
1. It shall fulfill standards for designation of an information center of biological research resources prescribed in Article 7;
2. It shall have continuously performed duties related to the information on biological research resources for the recent three years.
(2) Upon designating the National Information Center of Biological Research Resources, the Minister of Science and ICT shall issue a certificate of the designation to a designated institution and publish the designation in the Official Gazette. <Amended by Presidential Decree No. 24423, Mar. 23, 2013; Presidential Decree No. 28210, Jul. 26, 2017>
(3) Matters necessary for procedures, etc. for designation of National Information Center of Biological Research Resources, other than those prescribed in paragraphs (1) and (2), shall be prescribed by Ordinance of the Minister of Science and ICT. <Amended by Presidential Decree No. 24423, Mar. 23, 2013; Presidential Decree No. 28210, Jul. 26, 2017>
 Article 10 (Cancellation, etc. of Designation)
(1) Standards for cancellation of designation, etc. under Article 12 of the Act, shall be as specified in the attached Table.
(2) Where designation is cancelled in accordance with standards for disposition specified in the attached Table, the relevant biological resource center, competent authority, information center of biological research resources or the National Information Center of Biological Research Resources shall return the certificate of designation respectively to the head of the related central administrative agency or the Minister of Science and ICT. <Amended by Presidential Decree No. 24423, Mar. 23, 2013; Presidential Decree No. 28210, Jul. 26, 2017>
(3) The head of the related central administrative agency or the Minister of Science and ICT shall respectively publish the name of the biological resource center, competent authority, information center of biological research resources or the National Information Center of Biological Research Resources against which the designation is cancelled and a reason for the cancellation in the Official Gazette. <Amended by Presidential Decree No. 24423, Mar. 23, 2013; Presidential Decree No. 28210, Jul. 26, 2017>
 Article 11 (Preservation and Management of Biological Research Resources Following Cancellation of Designation and Suspension of Project)
(1) Biological research resources deposited and registered after a designation is made, among those preserved and managed by a biological resource center, competent authority, information center of biological research resources or the National Information Center of Biological Research Resources, the designation of which has been cancelled or the project of which has been suspended under Article 12 of the Act, shall be managed by institutions classified as follows: <Amended by Presidential Decree No. 24423, Mar. 23, 2013; Presidential Decree No. 28210, Jul. 26, 2017>
1. If an institution, the designation of which is cancelled or the project of which is suspended, is a biological resource center, competent authority, or information center of biological research resources: An institution to be designated by the related central administrative agency;
2. If an institution, the designation of which is cancelled or the project of which is suspended, is the National Information Center of Biological Research Resources: An institution to be designated by the Minister of Science and ICT.
(2) An institution that takes over the management authority under paragraph (1) shall consult in advance respectively with the biological resource center, competent authority, information center of biological research resources or the National Information Center of Biological Research Resources, the designation of which has been canceled or the project of which has been suspended, on procedures for preservation and management.
 Article 12 (Disclosure of Information on Biological Research Resources)
(1) In order to facilitate the distribution of information on biological research resources under Article 18 (1) of the Act, the head of a related central administrative agency shall establish a database of information on biological research resources and extensively disclose it so that it can be utilized by related research institutes, industry, academia, etc.
(2) The Minister of Science and ICT shall ensure that information on biological research resources shall be provided in an integrated manner in linkage with the database referred to in paragraph (1). <Amended by Presidential Decree No. 24423, Mar. 23, 2013; Presidential Decree No. 28210, Jul. 26, 2017>
(3) For the purpose of Article 18 (2) of the Act, the Minister of Science and ICT shall implement the standardization work of information on biological research resources. <Amended by Presidential Decree No. 24423, Mar. 23, 2013; Presidential Decree No. 28210, Jul. 26, 2017>
(4) The head of a related central administrative agency may entrust a competent authority with the establishment of a database of information referred to in paragraph (1) and the disclosure thereof.
 Article 13 (Statistical Research and Issuance of Statistical Publications)
(1) Forms and method of research necessary for the issuance of statistical publications related to biological research resources under Article 19 of the Act and other necessary matters under Article 19 of the Act shall be prescribed by the Minister of Science and ICT following consultations with the heads of related central administrative agencies and the Commissioner of the Statistics Korea. <Amended by Presidential Decree No. 24423, Mar. 23, 2013; Presidential Decree No. 28210, Jul. 26, 2017>
(2) Subjects of statistical research for preparation of the statistical publications related to biological research resources shall be as follows: <Amended by Presidential Decree No. 24423, Mar. 23, 2013; Presidential Decree No. 28210, Jul. 26, 2017>
1. Matters concerning the current status of possession of biological research resources;
2. Matters concerning institutions in possession of biological research resources;
3. Matters concerning human resources and equipment of institutions in possession of biological research resources;
4. Matters concerning the international trend related to biological research resources;
5. Matters concerning policies and systems related to biological research resources;
6. Other matters necessary for the preparation of statistical publications, which are prescribed by the Minister of Science and ICT.
 Article 14 (Entrustment of Duties)
The Minister of Science and ICT shall entrust the National Information Center of Biological Research Resources with the following affairs pursuant to Article 21 (2) of the Act: <Amended by Presidential Decree No. 24423, Mar. 23, 2013; Presidential Decree No. 28210, Jul. 26, 2017>
1. Overall management of information on biological research resources under Article 5 (2) of the Act;
2. Standardization for distribution of information on biological research resources under Article 18 (2) of the Act;
3. Issuance of statistical publications under Article 19 of the Act.
ADDENDUM
This Decree shall enter into force on November 9, 2009.
ADDENDA <Presidential Decree No. 24423, Mar. 23, 2013>
Article 1 (Enforcement Date)
This Decree shall enter into force on the date of its promulgation. (Proviso Omitted.)
Articles 2 through 7 Omitted.
ADDENDA <Presidential Decree No. 28210, Jul. 26, 2017>
Article 1 (Enforcement Date)
This Decree shall enter into force on the date of its promulgation.
Articles 2 through 6 Omitted.