Notice of Rulemaking- FDA Approval of Stiripentol December 14, 2018November 6, 2018 The Department of Health Care Policy and Financing - Medical Services will be holding a rulemaking hearing on Friday, December 14th, 2018, 9:00 am on rules regarding FDA Approval of Stiripentol. The hearing will be held at: 303 East 17th Avenue, 11th Floor, Denver CO 80203. The purpose of this rulemaking is: Stiripentol, a drug used to treat an epileptic condition known as Dravet Syndrome, is now FDA approved. Due to the recent FDA approval of Stiripentol, its reference under 10 C.C.R. 2505-10, Section 8.800.4.C.5.a, as a non-FDA approved drug will be deleted. The Department currently covers Stiripentol and will continue covering Stiripentol. This rule change is simply a technical clean-up to remove its designation as a non-FDA approved drug. If you believe there will be a significant negative impact on small business, job creation or economic competitiveness, you may request that the Department of Regulatory Agencies require the rulemaking agency to prepare a cost-benefit analysis of a proposed rule or amendment. This request must be made to the Department of Regulatory Agencies by Thursday, November 15th, 2018. You may also submit comments directly to the rulemaking agency for the agency's consideration during the upcoming rulemaking hearing. |