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Administrative Law

University of Michigan Law School

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Guidance documents

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Regulatory Beneficiaries And Informal Agency Policymaking, Nina A. Mendelson Jan 2007

Regulatory Beneficiaries And Informal Agency Policymaking, Nina A. Mendelson

Articles

Administrative agencies frequently use guidance documents to set policy broadly and prospectively in areas ranging from Department of Education Title IX enforcement to Food and Drug Administration regulation of direct-to-consumer pharmaceutical advertising. In form, these guidances often closely resemble the policies agencies issue in ordinary notice-and-comment rulemaking. However, guidances are generally developed with little public participation and are often immune from judicial review. Nonetheless, guidances can prompt significant changes in behavior from those the agencies regulate. A number of commentators have guardedly defended the current state of affairs. Though guidances lack some important procedural safeguards, they can help agencies supervise …


Guidance Documents And Regulatory Beneficiaries, Nina A. Mendelson Jan 2006

Guidance Documents And Regulatory Beneficiaries, Nina A. Mendelson

Articles

Federal agencies rely heavily on guidance documents, and their volume is massive. The Environmental Protection Agency and the Occupational Safety and Health Administration recently catalogued over 2000 and 1600 such documents, respectively, issued between 1996 and 1999. These documents can range from routine matters, such as how employees should maintain correspondence files, to broad policies on program standards, implementation, and enforcement. Documents in the latter category include Education Department policies on Title IX implementation, Environmental Protection Agency policies on hazardous waste cleanup, the Food and Drug Administration's policies on food safety and broadcast advertising of pharmaceuticals, and many more.Although these …