PUBLIC LAW 108–155—DEC. 3, 2003
117 STAT. 1941
‘‘(e) MEETINGS.—Before and during the investigational process for a new drug or biological product, the Secretary shall meet at appropriate times with the sponsor of the new drug or biological product to discuss— ‘‘(1) information that the sponsor submits on plans and timelines for pediatric studies; or ‘‘(2) any planned request by the sponsor for waiver or deferral of pediatric studies. ‘‘(f) SCOPE OF AUTHORITY.—Nothing in this section provides to the Secretary any authority to require a pediatric assessment of any drug or biological product, or any assessment regarding other populations or uses of a drug or biological product, other than the pediatric assessments described in this section. ‘‘(g) ORPHAN DRUGS.—Unless the Secretary requires otherwise by regulation, this section does not apply to any drug for an indication for which orphan designation has been granted under section 526. ‘‘(h) INTEGRATION WITH OTHER PEDIATRIC STUDIES.—The authority under this section shall remain in effect so long as an application subject to this section may be accepted for filing by the Secretary on or before the date specified in section 505A(n).’’. (b) CONFORMING AMENDMENTS.—(1) Section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(b)(1)) is amended in the second sentence— (A) by striking ‘‘and (F)’’ and inserting ‘‘(F)’’; and (B) by striking the period at the end and inserting ‘‘, and (G) any assessments required under section 505B.’’. (2) Section 505A(h) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a(h)) is amended— (A) in the subsection heading, by striking ‘‘REGULATIONS’’ and inserting ‘‘PEDIATRIC RESEARCH REQUIREMENTS’’; and (B) by striking ‘‘pursuant to regulations promulgated by the Secretary’’ and inserting ‘‘by a provision of law (including a regulation) other than this section’’. (3) Section 351(a)(2) of the Public Health Service Act (42 U.S.C. 262(a)(2)) is amended— (A) by redesignating subparagraph (B) as subparagraph (C); and (B) by inserting after subparagraph (A) the following: ‘‘(B) PEDIATRIC STUDIES.—A person that submits an application for a license under this paragraph shall submit to the Secretary as part of the application any assessments required under section 505B of the Federal Food, Drug, and Cosmetic Act.’’. SEC. 3. TECHNICAL AND CONFORMING AMENDMENTS.
(a) ABBREVIATED NEW DRUG APPLICATION.—Section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) is amended in subparagraphs (A) and (B) of subsection (b)(2) and subparagraphs (A) and (B) of subsection (c)(2) by striking ‘‘505(j)(4)(B)’’ and inserting ‘‘505(j)(5)(B)’’. (b) PEDIATRIC ADVISORY COMMITTEE.—(1) Section 505A(i)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a(i)(2)) is amended by striking ‘‘Advisory Subcommittee of the Anti-Infective Drugs’’ each place it appears. (2) Section 14 of the Best Pharmaceuticals for Children Act (42 U.S.C. 284m note; Public Law 107–109) is amended—
VerDate 11-MAY-2000
10:15 Aug 27, 2004
Jkt 019194
PO 00000
Frm 00893
Fmt 6580
Sfmt 6581
D:\STATUTES\2003\19194PT2.001
APPS10
PsN: 19194PT2
�
