The government has issued new guidelines for federal agencies that produce "significant guidance documents." The new rules, issued by an executive order and by the Office of Management and Budget, require that guidance documents produced by government agencies be reviewed first by the OMB to ensure that the documents are consistent with applicable law, the president's priorities, and other principles set forth by the administration. The new guidelines will also require that all significant guidance documents be subject to public notice and comment. However, government agencies will not be required to formally respond to these comments, as is the case when regulations are proposed. These changes will be effective 180 days after they are published in the Federal Register.

Many federal agencies have used guidance documents to provide information requested by the regulated community more quickly than could be done through the formal rulemaking process. The new requirements are likely to slow the issuance of such documents. The AAMC believes that senior agency officials, not the OMB, should be responsible for approving significant guidance documents and for establishing approval procedures. According to a comment letter submitted by the association in January 2006, "these officials are accountable for the responsiveness of the agency and best understand the role of guidance in the context of the policies and mission of these agencies." For more information, please visit http://www.whitehouse.gov/omb/memoranda/fy2007/m07-07.pdf
and http://www.whitehouse.gov/omb/inforeg/eo12866/eo12866_amended_01-2007.pdf.