5 Colo. Code Regs. § 1005-6-8

Current through Register Vol. 47, No. 24, December 25, 2024

Section 5 CCR 1005-6-8 - License Revocation and Fines

A. It is a violation of these rules and article 57 for any person, corporation, or other entity to operate as a gamete agency, gamete bank, or fertility clinic in Colorado, to match or provide gametes or embryos to recipients in Colorado, without a valid license or in violation of the terms and conditions of a license.

B. The Department may suspend, revoke or not renew the license, in accordance with the procedures set forth in section 24-4-104, C.R.S., of a licensed gamete agency, gamete bank, or fertility clinic that fails to adhere to the terms and conditions of its license and the standards and requirements established by rule pursuant to article 57.

C. The Department may assess a civil penalty of not more than twenty thousand ($20,000) dollars, adjusted annually for inflation, for each day the person, corporation or entity is in violation of article 57 and these rules.

a. The Department may vary the amount of the fine depending on the size of the licensed entity, the potential for harm or injury, the responsibility of the entity, history of noncompliance, economic benefit of the violation, and whether there is a pattern of potential or actual harm or injury.

b. The assessed penalty accrues from the date the Department finds that the person, corporation, or entity is in violation of these rules and article 57.

c. If the violation(s) is a one-time event with a longer time frame of effect (such selling of non-compliant gametes) or an event that cannot be redressed, the Department will assess the appropriate penalties depending on the severity of the violation and whether it is indicative of a pattern of non-compliance on the part of the entity.

d. The Department will assess, enforce, and collect the penalty in accordance with article 4 of Title 24 and credit the money to the general fund.

e. Enforcement and collection of the penalty occurs following the decision reached in accordance with procedures set forth in section 24-4-105, C.R.S. or at the expiration of the appeal period.

D. If the Department revokes or suspends a license, denies an initial license application, or assesses a civil penalty, it will provide the licensee with a notice explaining the basis for the action. The notice will also inform the licensee of its right to appeal and the procedure for appealing the action.

5 CCR 1005-6-8

47 CR 20, October 25, 2024, effective 11/14/2024