Sec. 5. Implementation and effect
158 words·~1 min read·
/bill/113/s/3004/is/section-5A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
Subject to the provisions of this section, this Act shall take effect on the date of enactment. The Secretary, in consultation with the Secretary of Commerce, shall promulgate such regulations and finalize such guidance as necessary to implement the provisions of section 4. Such regulations or guidance shall take effect 18 months after the date of enactment of this Act. Notwithstanding any provision of section 4, the Secretary may not make a determination on a request for designation by a manufacturer or sponsor under section 4(a) prior to the effective date of the regulations under subsection
(b)or 30 months after the date of enactment of this Act, whichever occurs first, and the Secretary may not designate a medicine under section 4(a) unless the requirement under section 4(a)(2)(D) is met for such medicine as of the effective date of the regulations under subsection
(b)or 30 months after the date of enactment of this Act, whichever occurs first.