118 STAT. 576 PUBLIC LAW 108–214—APR. 1, 2004 (2) PREMARKET NOTIFICATION.—Section 510(o) of the Fed eral Food, Drug, and Cosmetic Act (21 U.S.C. 360(o)), as added by section 302(b) of Public Law 107–250 (116 Stat. 1616), is amended— (A) in paragraph (1)(B), by striking ‘‘, adulterated’’ and inserting ‘‘or adulterated’’; and (B) in paragraph (2)— (i) in subparagraph (B), by striking ‘‘, adulterated’’ and inserting ‘‘or adulterated’’; and (ii) in subparagraph (E), by striking ‘‘semicritical’’ and inserting ‘‘semi critical’’. (d) MISCELLANEOUS CORRECTIONS.— (1) CERTAIN AMENDMENTS TO SECTION 515.— (A) IN GENERAL.— (i) TECHNICAL CORRECTION.—Section 515(c) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(c)), as amended by sections 209 and 302(c)(2)(A) of Public Law 107–250 (116 Stat. 1613, 1618), is amended by redesignating paragraph (3) (as added by section 209 of such Public Law) as paragraph (4). (ii) MODULAR REVIEW.—Section 515(c)(4)(B) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(c)(4)(B)) is amended by striking ‘‘unless an issue of safety’’ and inserting ‘‘unless a significant issue of safety’’. (B) CONFORMING AMENDMENT.—Section 210 of Public Law 107–250 (116 Stat. 1614) is amended by striking ‘‘, as amended’’ and all that follows through ‘‘by adding’’ and inserting ‘‘is amended in paragraph (3), as redesignated by section 302(c)(2)(A) of this Act, by adding’’. (2) CERTAIN AMENDMENTS TO SECTION 738.— (A) IN GENERAL.—Section 738(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j(a)), as amended by subsection (a), is amended— (i) in the matter preceding paragraph (1)— (I) by striking ‘‘(a) TYPES OF FEES.—Beginning on’’ and inserting the following: ‘‘(a) TYPES OF FEES.— ‘‘(1) IN GENERAL.—Beginning on’’; and (II) by striking ‘‘this section as follows:’’ and inserting ‘‘this section.’’; and (ii) by striking ‘‘(1) PREMARKET APPLICATION,’’ and inserting the following: ‘‘(2) PREMARKET APPLICATION,’’. (B) CONFORMING AMENDMENTS.—Section 738 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379j), as amended by subparagraph (A), is amended— (i) in subsection (d)(1), in the last sentence, by striking ‘‘subsection (a)(1)(A)’’ and inserting ‘‘subsection (a)(2)(A)’’; (ii) in subsection (e)(1), by striking ‘‘subsection (a)(1)(A)(vii)’’ and inserting ‘‘subsection (a)(2)(A)(vii)’’; (iii) in subsection (e)(2)(C)— (I) in each of clauses (i) and (ii), by striking ‘‘subsection (a)(1)(A)(vii)’’ and inserting ‘‘subsection (a)(2)(A)(vii)’’; and 21 USC 360e.
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