COMMUNICATION WITH PEDIATRIC REVIEW COMMITTEE.

SEC. 503. [21 U.S.C. 355a note] COMMUNICATION WITH PEDIATRIC REVIEW COMMITTEE. Not later than 1 year after the date of enactment of this Act, the Secretary of Health and Human Services (referred to in this title as the “Secretary”) shall issue internal standard operating procedures that provide for the review by the internal review committee established under section 505C of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355d) of any significant modifications to initial pediatric study plans, agreed initial pediatric study plans, and written requests under sections 505A and 505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a, 355c). Such internal standard operating procedures shall be made publicly available on the Internet Web site of the Food and Drug Administration.