Page:United States Statutes at Large Volume 124.djvu/2668

 124 STAT. 2642 PUBLIC LAW 111–255—OCT. 5, 2010 LEGISLATIVE HISTORY—S. 1674: CONGRESSIONAL RECORD, Vol. 156 (2010): Aug. 5, considered and passed Senate. Sept. 23, considered and passed House. SEC. 4. STUDY AND REPORT. (a) STUDY.—Not later than 36 months after the effective date of this Act, the Comptroller General of the United States shall conduct a study to evaluate the impact of this Act on enrollment of individuals who receive Supplemental Security Income benefits under title XVI of the Social Security Act (referred to in this section as ‘‘SSI beneficiaries’’) in clinical trials for rare diseases or conditions. Such study shall include an analysis of the following: (1) The percentage of enrollees in clinical trials for rare diseases or conditions who were SSI beneficiaries during the 3-year period prior to the effective date of this Act as compared to such percentage during the 3-year period after the effective date of this Act. (2) The range and average amount of compensation pro- vided to SSI beneficiaries who participated in clinical trials for rare diseases or conditions. (3) The overall ability of SSI beneficiaries to participate in clinical trials. (4) Any additional related matters that the Comptroller General determines appropriate. (b) REPORT.—Not later than 12 months after completion of the study conducted under subsection (a), the Comptroller General shall submit to Congress a report containing the results of such study, together with recommendations for such legislation and administrative action as the Comptroller General determines appro- priate. Approved October 5, 2010.