REGULATIONS.

SEC. 104. REGULATIONS. In promulgating any regulations to implement this title (and the amendments made by this title), the Secretary of Health and Human Services shall—(1) issue a notice of proposed rulemaking that includes the proposed regulation;(2) provide a period of not less than 60 calendar days for comments on the proposed regulation; and(3) publish the final regulation not more than 18 months following publication of the proposed rule and not less than 30 calendar days before the effective date of such final regulation.