; and and inserting ; ; and (2) by striking paragraph (11) and inserting the following: (11) an assessment of the impact of the amendments to such section 505B made by the RACE for Children Act on pediatric labeling of drugs and pediatric labeling of molecularly targeted drugs for the treatment of cancer; (12) an assessment of the efforts of the Secretary to implement the plan developed under section 505C–1 of the Federal Food, Drug, and Cosmetic Act, regarding earlier submission of pediatric studies under sections 505A and 505B, including— (A) the average length of time after the approval of an application under section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act ( 21 U.S.C. 355(b)(1) ) before studies conducted pursuant to such sections 505A or 505B are completed, submitted, and incorporated into labeling; (B) the average length of time after the receipt of a proposed pediatric study request before the Secretary responds to such request; (C) the average length of time after the submission of a proposed pediatric study request before the Secretary issues a written request for such studies; (D) the number of written requests issued for each investigational new drug prior to the submission of an application under section 505(b)(1) of the Federal Food, Drug, and Cosmetic Act; and (E) the average number, and range of numbers, of amendments to written requests issued; (13) a list of sponsors of applications or holders of approved applications who received exclusivity under such section 505A after receiving a letter issued under such section 505B(d)(1) and before the studies referred to in such letter were completed and submitted