Page:United States Statutes at Large Volume 115 Part 2.djvu/431

 PUBLIC LAW 107-109-^AN. 4, 2002 115 STAT. 1415 "(2) on or before October 1, 2007, an application for the drug is accepted for filing under section 505(b); and "(3) all requirements of this section are met.". SEC. 9. DISSEMINATION OF PEDIATRIC INFORMATION. Section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) (as amended by section 5(b)(2)) is amended by adding at the end the following: " (m) DISSEMINATION OF PEDIATRIC INFORMATION.— "(1) IN GENERAL.—Not later than 180 days after the date DeadHne. of submission of a report on a pediatric study under this section, the Commissioner shall make available to the public a summary of the medical and clinical pharmacology reviews of pediatric studies conducted for the supplement, including by publication in the Federal Register. "(2) EFFECT OF SUBSECTION. — Nothing in this subsection alters or amends section 301(j) of this Act or section 552 of title 5 or section 1905 of title 18, United States Code.". SEC. 10. CLARIFICATION OF INTERACTION OF PEDIATRIC EXCLU- SIVITY UNDER SECTION 505A OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT AND 180-DAY EXCLUSIVITY AWARDED TO AN APPLICANT FOR APPROVAL OF A DRUG UNDER SECTION 505(j) OF THAT ACT. Section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) (as amended by section 9) is amended by adding at the end the following: "(n) CLARIFICATION OF INTERACTION OF MARKET EXCLUSIVITY UNDER THIS SECTION AND MARKET EXCLUSIVITY AWARDED TO AN APPLICANT FOR APPROVAL OF A DRUG UNDER SECTION 505(j).— If a 180-day period under section 505(j)(5)(B)(iv) overlaps with a 6-month exclusivity period under this section, so that the applicant for approval of a drug under section 505(j) entitled to the 180-day period under that section loses a portion of the 180- day period to which the applicant is entitled for the drug, the 180-day period shall be extended from— "(1) the date on which the 180-day period would have expired by the number of days of the overlap, if the 180- day period would, but for the application of this subsection, expire after the 6-month exclusivity period; or "(2) the date on which the 6-month exclusivity period expires, by the number of days of the overlap if the 180- day period would, but for the application of this subsection, expire during the six-month exclusivity period.". SEC. 11. PROMPT APPROVAL OF DRUGS UNDER SECTION 505(j) WHEN PEDIATRIC INFORMATION IS ADDED TO LABELING. (a) IN GENERAL. —Section 505A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) (as amended by section 10) is amended by adding at the end the following: "(o) PROMPT APPROVAL OF DRUGS UNDER SECTION 505(j) WHEN PEDL\TRIC INFORMATION IS ADDED TO LABELING.— "(1) GENERAL RULE.— ^A drug for which an application has been submitted or approved under section 505(j) shall not be considered ineligible for approval under that section or misbranded under section 502 on the basis that the labeling of the drug omits a pediatric indication or any other aspect of labeling pertaining to pediatric use when the omitted indication

�