Under the Administrative Procedure Act, the key process requirements that must be met are to provide notice to the public and to solicit public input. With exceptions only for emergency situations, all regulations must first be issued as a Notice of Proposed Rulemaking and published in the Federal Register. As part of the process, agencies establish a time period (often 90 days) during which interested citizens may submit comments. When the final regulation is published in the Federal Register, the agency’s response to the comments is included. The final regulation is then incorporated into the Code of Federal Regulations.
The proposed regulatory language is then published in the Federal Register, along with a preamble that discusses the rationale for the overall regulation and its specific provisions and that summarizes the economic analysis. Related reports, including the complete economic analysis, are placed in a docket (and generally on the agency’s website), where they can be reviewed by the general public.
This process is governed by statutory guidelines as well as by agency administrative directives. Under the Administrative Procedure Act (APA, 5 U.S.C. Art. 500 et seq.), agencies are required to provide supporting information and request comment from the public before finalizing the regulation.3 These requirements are rooted in notions of due process and fairness and, if not strictly followed, the courts will rule that the regulation has not been appropriately issued. The APA requirements are summarized in Box 1-2.
Once the agency receives comments, the workgroup may reconvene to review the comments, determine whether additional analysis or public outreach is needed, and develop the final regulation and supporting analyses. The final regulation is then published in the Federal Register after review within the issuing agency as well as by OMB and other agencies. The economic analysis is generally updated to reflect any new information received as well as any changes in the regulatory requirements, and placed in the docket along with other supporting documentation. This documentation includes the comments received by the agency and the agency’s detailed responses. The Federal Register preamble to the regulation generally summarizes the comments received and the agency’s responses, provides information supporting and describing the final regulatory provisions, and sum-