Page:United States Statutes at Large Volume 117.djvu/1961

 117 STAT. 1942

PUBLIC LAW 108–155—DEC. 3, 2003

(A) in the section heading, by striking ‘‘PHARMACOLOGY’’; (B) in subsection (a), by striking ‘‘(42 U.S.C. 217a),’’ and inserting (42 U.S.C. 217a) or other appropriate authority,’’; (C) in subsection (b)— (i) in paragraph (1), by striking ‘‘and in consultation with the Director of the National Institutes of Health’’; and (ii) in paragraph (2), by striking ‘‘and 505A’’ and inserting ‘‘505A, and 505B’’; and (D) by striking ‘‘pharmacology’’ each place it appears and inserting ‘‘therapeutics’’. (3) Section 15(a)(2)(A) of the Best Pharmaceuticals for Children Act (115 Stat. 1419) is amended by striking ‘‘Pharmacology’’. (4) Section 16(1)(C) of the Best Pharmaceuticals for Children Act (21 U.S.C. 355a note; Public Law 107–109) is amended by striking ‘‘Advisory Subcommittee of the Anti-Infective Drugs’’. (5) Section 17(b)(1) of the Best Pharmaceuticals for Children Act (21 U.S.C. 355b(b)(1)) is amended in the second sentence by striking ‘‘Advisory Subcommittee of the Anti-Infective Drugs’’. (6) Paragraphs (8), (9), and (11) of section 409I(c) of the Public Health Service Act (42 U.S.C. 284m(c)) are amended by striking ‘‘Advisory Subcommittee of the Anti-Infective Drugs’’ each place it appears. 21 USC 355c note.

VerDate 11-MAY-2000

10:15 Aug 27, 2004

SEC. 4. EFFECTIVE DATE.

(a) IN GENERAL.—Subject to subsection (b), this Act and the amendments made by this Act take effect on the date of enactment of this Act. (b) APPLICABILITY TO NEW DRUGS AND BIOLOGICAL PRODUCTS.— (1) IN GENERAL.—Subsection (a) of section 505B of the Federal Food, Drug, and Cosmetic Act (as added by section 2) shall apply to an application described in paragraph (1) of that subsection submitted to the Secretary of Health and Human Services on or after April 1, 1999. (2) WAIVERS AND DEFERRALS.— (A) WAIVER OR DEFERRAL GRANTED.—If, with respect to an application submitted to the Secretary of Health and Human Services between April 1, 1999, and the date of enactment of this Act, a waiver or deferral of pediatric assessments was granted under regulations of the Secretary then in effect, the waiver or deferral shall be a waiver or deferral under subsection (a) of section 505B of the Federal Food, Drug, and Cosmetic Act, except that any date specified in such a deferral shall be extended by the number of days that is equal to the number of days between October 17, 2002, and the date of enactment of this Act. (B) WAIVER AND DEFERRAL NOT GRANTED.—If, with respect to an application submitted to the Secretary of Health and Human Services between April 1, 1999, and the date of enactment of this Act, neither a waiver nor deferral of pediatric assessments was granted under regulations of the Secretary then in effect, the person that submitted the application shall be required to submit assessments under subsection (a)(2) of section 505B of the Federal Food, Drug, and Cosmetic Act on the date that is the later of—

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