PUBLIC LAW 110–85—SEPT. 27, 2007
121 STAT. 881
dkrause on GSDDPC44 with PUBLAW
‘‘(C) the types of studies conducted under such sections, including trial design, the number of pediatric patients studied, and the number of centers and countries involved; ‘‘(D) the number of pediatric formulations developed and the number of pediatric formulations not developed and the reasons such formulations were not developed; ‘‘(E) the labeling changes made as a result of studies conducted under such sections; ‘‘(F) an annual summary of labeling changes made as a result of studies conducted under such sections for distribution pursuant to subsection (k)(2); and ‘‘(G) information regarding reports submitted on or after the date of the enactment of the Best Pharmaceuticals for Children Act of 2007. ‘‘(g) LIMITATIONS.—Notwithstanding subsection (c)(2), a drug to which the six-month period under subsection (b) or (c) has already been applied— ‘‘(1) may receive an additional six-month period under subsection (c)(1)(A)(i)(II) for a supplemental application if all other requirements under this section are satisfied, except that such drug may not receive any additional such period under subsection (c)(1)(B); and ‘‘(2) may not receive any additional such period under subsection (c)(1)(A)(ii). ‘‘(h) RELATIONSHIP TO PEDIATRIC RESEARCH REQUIREMENTS.— Notwithstanding any other provision of law, if any pediatric study is required by a provision of law (including a regulation) other than this section and such study meets the completeness, timeliness, and other requirements of this section, such study shall be deemed to satisfy the requirement for market exclusivity pursuant to this section. ‘‘(i) LABELING CHANGES.— ‘‘(1) PRIORITY STATUS FOR PEDIATRIC APPLICATIONS AND SUPPLEMENTS.—Any application or supplement to an application under section 505 proposing a labeling change as a result of any pediatric study conducted pursuant to this section— ‘‘(A) shall be considered to be a priority application or supplement; and ‘‘(B) shall be subject to the performance goals established by the Commissioner for priority drugs. ‘‘(2) DISPUTE RESOLUTION.— ‘‘(A) REQUEST FOR LABELING CHANGE AND FAILURE TO AGREE.—If, on or after the date of the enactment of the Best Pharmaceuticals for Children Act of 2007, the Commissioner determines that the sponsor and the Commissioner have been unable to reach agreement on appropriate changes to the labeling for the drug that is the subject of the application, not later than 180 days after the date of submission of the application— ‘‘(i) the Commissioner shall request that the sponsor of the application make any labeling change that the Commissioner determines to be appropriate; and ‘‘(ii) if the sponsor of the application does not agree within 30 days after the Commissioner’s request to
VerDate Aug 31 2005
13:52 Jan 23, 2009
Jkt 059194
PO 00001
Frm 00879
Fmt 6580
Sfmt 6581
Deadline.
Deadline.
M:\STATUTES\2007\59194PT1.001
APPS10
PsN: 59194PT1
�
