GOVERNMENT ACCOUNTABILITY OFFICE REPORT.

SEC. 404. GOVERNMENT ACCOUNTABILITY OFFICE REPORT. Not later than January 1, 2011, the Comptroller General of the United States, in consultation with the Secretary of Health and Human Services, shall submit to the Congress a report that addresses the effectiveness of sections 505A and 505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a, 355c) and section 409I of the Public Health Service Act (42 U.S.C. 284m) in ensuring that medicines used by children are tested and properly labeled. Such report shall include—(1) the number and importance of drugs and biological products for children that are being tested as a result of the amendments made by this title and title V and the importance 121 STAT. 876 for children, health care providers, parents, and others of labeling changes made as a result of such testing;(2) the number and importance of drugs and biological products for children that are not being tested for their use notwithstanding the provisions of this title and title V and possible reasons for the lack of testing;(3) the number of drugs and biological products for which testing is being done and labeling changes required, including the date labeling changes are made and which labeling changes required the use of the dispute resolution process established pursuant to the amendments made by this title, together with a description of the outcomes of such process, including a description of the disputes and the recommendations of the Pediatric Advisory Committee;(4) any recommendations for modifications to the programs established under sections 505A and 505B of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355a) and section 409I of the Public Health Service Act (42 U.S.C. 284m) that the Secretary determines to be appropriate, including a detailed rationale for each recommendation; and(5)(A) the efforts made by the Secretary to increase the number of studies conducted in the neonate population; and(B) the results of those efforts, including efforts made to encourage the conduct of appropriate studies in neonates by companies with products that have sufficient safety and other information to make the conduct of the studies ethical and safe.