On August 22, 2011, HHS released its “Plan for Retrospective Review of Existing Rules.”  The plan was developed in compliance with Executive Order 13563, which directed agencies to design cost effective, evidence-based regulations that are compatible with economic growth, job creation, and competitiveness, and which rely on the best, most innovative, and least burdensome tools to achieve regulatory ends. HHS’s plan identifies a preliminary list of regulations that are appropriate candidates for review over the next two years and establishes an ongoing process of retrospective review of existing regulations to determine whether any should be streamlined, expanded, or repealed (which could necessitate new rulemaking). For instance, based on a retrospective review of current regulations, CMS plans to issue a proposed rule in September 2011 that would revise obsolete or burdensome hospital conditions of participation requirementsl the Administration estimates the changes may save up to $3 billion over five years. HHS also highlights Medicare regulatory reviews involving: quality reporting, Medicare appeals, and Medicare payment policy revisions designed to reduce documentation burdens and clarify requirements.  The listing for Food and Drug Administration (FDA) regulatory review items includes revisions to the FDA's bar code rule, good manufacturing practice regulations for drugs, and medical device adverse event report requirements.