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Oklahoma Administrative Code (Last Updated: March 11, 2021) |
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TITLE 310. Oklahoma State Department of Health |
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Chapter 681. Medical Marijuana Regulations |
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Subchapter 4. Research Facilities and Education Facilities |
SECTION 310:681-4-3. Applications
Latest version.
- (a) Application fee. An applicant for a research facility or education facility license, or renewal thereof, shall submit to the Department a completed application on a form and in a manner prescribed by the Department, along with the application fee as established in 63 O.S. § 420 et seq. and the Oklahoma Medical Marijuana and Patient Protection Act, 63 O.S. § 427.1 et seq.(b) Submission. The application shall be on the Department prescribed form and shall include the following information about the establishment:(1) Name of the establishment;(2) Physical address of the establishment, including the county in which any licensed premises will be located;(3) GPS coordinates of the establishment;(4) Phone number and email of the establishment; and(5) Hours of operation for any licensed premises.(c) Individual applicant. The application for a research facility or education facility license made by an individual on his or her own behalf shall be on the Department prescribed form and shall include at a minimum:(1) The applicant's first name, middle name, last name, and suffix if applicable;(2) The applicant's residence address and valid mailing address;(3) The applicant's date of birth;(4) The applicant's telephone number and email address;(5) Indication of the type of research to be conducted;(6) Indication of any public money involved in the research and/or curriculum, if applicable;(7) An attestation that the information provided by the applicant is true and correct;(8) An attestation that any licensed premises shall not be located on tribal lands;(9) An attestation that the research project does not involve biomedical or clinical research subject to federal regulations and institutional oversight, which is exempt from Department regulations, and that research facility and education facility licenses granted by the Department are only issued for the research and/or curriculum described and approved in the application;(10) An attestation that the use of any public funds or involvement of any public institution for research purposes must be disclosed at the time of application and that additional information and documentation regarding the research and/or curriculum may be required to be submitted during and after the application submission;(11) An attestation that the applicant adheres to 45 CFR § 46 (Protection of Human Subjects under United States Law) regulations; and(12) A statement signed by the applicant pledging not to divert marijuana to any individual or entity that is not lawfully entitled to possess marijuana.(d) Application on behalf of an entity. In addition to requirements of Subsection (c), an application for a research facility or education facility license made by an individual on behalf of an entity shall include:(1) An attestation that applicant is authorized to make application on behalf of the entity;(2) Full name of organization;(3) Trade name, if applicable;(4) Type of business organization;(5) Mailing address;(6) Telephone number and email address;(7) The name, residence address, and date of birth of each owner, if applicable; and(8) The name and residence address of each principal investigator or principal officer, if applicable.(e) Supporting documentation for research facility applicants. Each application for a research facility shall be accompanied by the following documentation:(1) A certificate of compliance on a form prescribed or otherwise authorized by the Department that is issued by the political subdivision where the licensed premises is to be located certifying compliance with the categories listed in 63 O.S. § 426.1(E);(2) If applicable, a list of all owners and principal officers of the applicant and supporting documentation, including, but not limited to: certificate of incorporation, bylaws, articles of organization, operating agreement, certificate of limited partnership, resolution of a board of directors, or other similar documents;(3) If applicable, documents establishing the applicant; and the members, managers, and board members; and seventy-five percent (75%) of the applicant's ownership interests are Oklahoma residents as required in accordance with OAC 310:681-1-6. This requirement shall not apply to research facility applicants that are public institutions or Oklahoma non-profit entities registered with the Oklahoma Secretary of State.(4) The applicant shall submit a full description of the research including the following:(A) Defined protocol;(B) Clearly articulated goals;(C) Defined methods and outputs;(D) Defined start and end date; and(E) Funding source(s)(5) Any further documentation or information the Department determines is necessary to ensure the applicant is qualified under Oklahoma law and these Rules to obtain a research facility license.(f) Supporting documentation for education facility applicants. Each application for an education facility license shall be accompanied by the following documentation:(1) A certificate of compliance on a form prescribed or otherwise authorized by the Department that is issued by the political subdivision where the licensed premises is to be located certifying compliance with the categories listed in 63 O.S. § 427(E);(2) An application for an education facility must include non-profit registration with the Oklahoma Secretary of State;(3) If research is being conducted the applicant shall submit a full description of the research including the following:(A) Defined protocol;(B) Clearly articulated goals;(C) Defined methods and outputs;(D) Defined start and end date; and(E) Funding source(s)(4) If applicable, the education facility applicant must submit the curriculum and/or a description of the curricula that will be used; and(5) Any further documentation or information the Department determines is necessary to ensure the applicant is qualified under Oklahoma law and these Rules to obtain an education facility license.(g) Supporting documentation for public research or education.(1) Research facility and education facility licensees may contract to perform research and/or education in conjunction with a public higher education research institution. If the research will be conducted with a public institution or public money, the Department shall review the research project and/or curriculum of the applicant to determine if it meets additional requirements in accordance with the Oklahoma Medical Marijuana and Patient Protection Act, 63 O.S. § 427.1 et seq. The applicant shall supply all relevant information and documentation to establish that the research or education meets these additional requirements. The Department shall review the research or education project to assess:(A) The quality, study design, value, or impact of the project;(B) Whether the applicant has the appropriate personnel, expertise, facilities, infrastructure, funding, and human, animal, or other approvals in place to successfully conduct the project; and(C) Whether the amount of marijuana to be grown by the applicant is consistent with the scope and goals of the project.(2) To assess these criteria, research facility and education facility applications for research or education involving public institutions or public money shall include:(A) A description of how public institutions and public funds will be utilized in the research or education;(B) A full description of the research project to include:(i) Abstract;(ii) Study problem or curriculum;(iii) Rationale, including identification of the need, gaps, benefits, advance best practices, public policy or safety(iv) Literature review, including a bibliography of all referenced materials;(v) Study or curriculum objectives;(vi) Research method; and(vii) Ethical considerations.(C) An overview of the amount of marijuana to be purchased, grown, or cultivated, and an explanation for the amount to be purchased or grown;(D) Contract(s) and agreement(s) with public institutions involved in the research and sources of public funds supporting the research;(E) Documentation of applicant's ability to successfully implement the research project and/or curriculum to include:(i) Curriculum vitae or resumes for all principal investigators and co-principal investigators;(ii) Organizational chart; and(iii) Description of the funding source(s).(F) Any further documentation or information the Department determines is necessary to ensure the applicant is qualified under Oklahoma law and these Rules.(h) Incomplete application. Failure to submit a complete application with all required information and documentation shall result in a rejection of the application. The Department shall notify the applicant via email through the electronic application account of the reasons for the rejection.(i) Review process. Research facility and education facility license approval shall be assessed by a procedural review process as determined by the Department.(j) Application denial. If the Department determines that the research or education project does not meet the requirements of state law or these Rules, the application shall be denied.