Executive Order 13,422, OMB's good guidance practices, and implications for health rulemaking and guidance.

In early 2007, President Bush issued Executive Order 13,422, extending executive review to significant guidance documents, requiring the designation of a politically-appointed Regulatory Policy Officer (RPO) within each agency, and strengthening the review and consultation role of the Office of Management and Budget's (OMB) Office of Information and Regulatory Affairs (OIRA). Almost simultaneously, the OMB issued its Final Bulletin for Good Guidance Practices (GGP) to address the growing agency practice of using non-binding guidance documents in lieu of rulemaking procedures to direct the conduct of regulated entities. This paper describes the evolution of executive review of rulemaking and guidance, the impetus for the current changes, and the possible implications of the executive order and OMB's Final Bulletin on Good Guidance Practices for the health law arena.