N.Y. Comp. Codes R. & Regs. tit. 9 § 132.12

Current through Register Vol. 46, No. 43, October 23, 2024

Section 132.12 - Conditions for License Suspension or Revocation

(a) Each of the following, in and of itself, may be used to suspend or revoke a research license:

(1) The research project is:

(i) not operational within the time projected in the application or the time otherwise approved by the Board;

(ii) denied pursuant to any of the provisions in section 132.3(d) of this Part; or

(iii) not registered with the Office in association with the research license.

(2) Information provided by the research licensee was deceptive, misleading, inconsistent with the facts, false or fraudulent, or deceives or creates a misleading impression, whether directly, or by omission or ambiguity, including lack of disclosure or insufficient disclosure.

(3) The research licensee has failed to comply with any requirement of this Part or any applicable law or regulation.

(4) There has been a lack of responsible operation of the research licensee, as shown by, but not limited to, a failure to maintain research project:

(i) quality;

(ii) study design;

(iii) value and impact;

(iv) appropriate personnel;

(v) expertise;

(vi) facilities and infrastructure;

(vii) funding;

(viii) human, animal, or appropriate approvals, such as IRB or IACUC, in place to successfully conduct the research project;

(ix) inconsistency with the amount of investigational products approved to be grown or purchased for the research project's scope and goals; or

(x) other incompetent or negligent operation as determined by the Board.

(5) The financial management of the research licensee has resulted in the filing of a petition for a Court Appointee related to the financial solvency of the research site or affiliated organization.

(6) A research licensee fails to satisfy the security requirements of this Part, as applicable.

(7) The principal investigator or key personnel on the research project has a history of criminal conduct as evidenced by any criminal proceedings that resulted in conviction, guilty plea, plea of nolo contendere, or admission to sufficient facts in New York State.

(8) The principal investigator or key personnel on the research project has committed, permitted, aided or abetted, or conspired to commit any illegal practice(s) in the operation of any research site including, but not limited to, engaging in the diversion investigational products.

(9) The research licensee has failed to cooperate or give information to a law enforcement official acting within his or her lawful jurisdiction related to any matter arising out of conduct at any research site.

(10) The conduct or practices of the research licensee have materially diverged from the research, and the research licensee's approved research project violates what is set forth in any applicable regulation, or the rules promulgated thereto, or presents a risk to public health and safety.

(11) The research licensee approved to cultivate cannabis grew over a canopy size as approved in their research project(s).

(b) Each of the following, in and of itself, may be used to deny, suspend or revoke the registration of a research project:

(1) the research project does not meet the requirements of Cannabis Law;

(2) the proposed research is or may become a danger to public health or safety;

(3) the proposed research poses a health or safety risk to the human subjects;

(4) the research licensee has received a denial from an IRB or IACUC, if applicable;

(5) the research licensee failed to be registered with the U.S. Department of Agriculture for a research project involving animals, if applicable;

(6) the research licensee has not provided:

(i) sufficient justification for the scientific value or validity of the proposed research project;

(ii) justification for the canopy sizes for the research study;

(iii) valid justification for the use or disposal of the research licensee's excess cultivated cannabis plant(s) for the research study;

(7) the research licensee becomes unqualified to conduct the proposed research project;

(8) the research protocol, funding, or other resources become insufficient to perform the proposed research project;

(9) any information provided is false, misleading, or inconsistent with the facts presented;

(10) the research licensee failed to supply information and/or documents requested by the Office within the deadline imposed by the Office;

(11) research licensee does not meet the requirements for the research project as set forth by this Part; or

(12) any other reason as determined by the Board.

(c) The following shall authorize the Office to enforce and impose fees and fines for violations pursuant to Part 133 of this Title against the affiliated organization as described in section 132.3(a)(7) of this Part if it is discovered that the affiliated organization behaved in the following manner regarding a cannabis research license's registered research project:

(1) the proposed research is or may become a danger to public health or safety as a direct result of the affiliated organization's behavior;

(2) the proposed research became a health or safety risk to the human subjects as a direct result of the affiliated organization's behavior;

(3) information provided by the affiliated organization was deceptive, misleading, inconsistent with the facts, false or fraudulent, or deceives or creates a misleading impression, whether directly, or by omission or ambiguity, including lack of disclosure or insufficient disclosure; or

(4) the affiliated organization's actions have directly caused the research licensee to violate any requirement of this Part or any applicable law or regulation.

(d) Failure by the research licensee to comply with any requirements in this Part may result in suspension, revocation, and or a civil penalty in accordance with all applicable rules and regulations of the Office and pursuant to section 133 of the Cannabis Law.

N.Y. Comp. Codes R. & Regs. Tit. 9 § 132.12

Adopted New York State Register August 9, 2023/Volume XLV, Issue 32, eff. 8/9/2023