Sec. 104. REGULATIONS
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/statute-compilations/comps-10691/sec-104A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
## SEC. 104 REGULATIONS **[**[21 U.S.C. 331 note](/us/usc/t21/s331)**]** 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.
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U.S. Code