12 2 STA T .35 25 PUBLIC LA W 11 0– 31 6— AU G .1 4, 200 8LEGIS L AT I V E H IST ORY— H . R. 6432: HO U SE RE P ORTS: No . 1 1 0–8 04 (C o m m.o n En ergya n d Commer c e ) . CONGRESSIONAL RECOR D, Vo l .1 5 4 (2008): Ju ly 30, con si dered and p assed House. Aug. 1, considered and passed Sena t e. clin ic a l tr ial fo ra d r ug t h ati s a p pro ve d under section 50 5 of the F ederal Food ,D rug, and C os m etic A ct or licensed under section 3 5 1 of this Act or a device that is cleared under section 510 (k) of the Federal Food, Drug, and Cosmetic Act or approved under section 515 or 5 2 0(m) of such Act, the follo w ing ele - ments
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and (2) in clauses (i) and (iii) of su b paragraph ( I ),b y striking the term ‘ ‘drugs described in subparagraph (C)’’ each place such term appears and inserting ‘‘applicable clinical trials described in subparagraph (C)’’ . Approved August 1 4 , 200 8 .
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