The Centers for Medicare and Medicaid Services (CMS) has been assigned the responsibility for overseeing the Sunshine Act, including issuance of the regulations. The Sunshine Act was scheduled to go into effect January 1, 2012. In late December 2011, the CMS released proposed regulations. The most immediate impact of the proposed regulations was to delay the commencement of the reporting period to a date later in 2012. In May 2012, the CMS published an announcement on their website stating that they (1) will not require data collection by applicable manufacturers before January 1, 2013, and (2) intend to release final regulations as planned later in 2012. Shire will update this site in the future as additional information becomes available. Shire has interpreted the law to the best of our ability, but this interpretation is subject to change as the final regulations provide detail and clarity on various aspects of compliance with the Sunshine Act.