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Code · STATUTE-COMPILATIONS · Food and Drug Administration Safety and Innovation Act · Sec. 709

Sec. 709. ADMINISTRATIVE DETENTION

319 words·~1 min read·/statute-compilations/comps-9932/sec-709

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## SEC. 709 ADMINISTRATIVE DETENTION ###
(a)In General **[**[21 U.S.C. 334](/us/usc/t21/s334)**]** Section 304(g) (21 U.S.C. 335a(g)) is amended— ####
(1)in paragraph (1), by inserting “, drug,” after “device”, each place it appears; ####
(2)in paragraph (2)(A), by inserting “, drug,” after “(B), a device”; and ####
(3)in paragraph (2)(B), by inserting “or drug” after “device” each place it appears. ###
(b)Regulations **[**[21 U.S.C. 334 note](/us/usc/t21/s334)**]** ####
(1)In general Not later than 2 years after the date of the enactment of this Act, the Secretary of Health and Human Services shall promulgate regulations in accordance with section 304(i) of the Federal Food, Drug, and Cosmetic Act, as added by paragraph
(2)of this subsection, to implement administrative detention authority with respect to drugs, as authorized by the amendments made by subsection (a). Before promulgating such regulations, the Secretary shall consult with stakeholders, including manufacturers of drugs. ####
(2)In general Section 304 (21 U.S.C. 334) is amended by adding at the end the following: > > ### “(i) Procedures for Promulgating Regulations > > > #### “(1) In general > > In promulgating a regulation implementing this section, the Secretary shall— > > > ##### “(A) > > issue a notice of proposed rulemaking that includes the proposed regulation; > > > ##### “(B) > > provide a period of not less than 60 days for comments on the proposed regulation; and > > > ##### “(C) > > publish the final regulation not less than 30 days before the regulation’s effective date. > > > #### “(2) Restrictions > > Notwithstanding any other provision of Federal law, in implementing this section, the Secretary shall only promulgate regulations as described in paragraph (1).” > . ###
(c)Effective Date **[**[21 U.S.C. 334 note](/us/usc/t21/s334)**]** The amendments made by subsection
(a)shall not take effect until the Secretary has issued a final regulation under subsection (b).
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Sec. 709
ADMINISTRATIVE DETENTION
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