REGULATIONS.

SEC. 104. [21 U.S.C. 331 note] 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.