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Rulemaking Process

The rulemaking process is designed to achieve consensus within the Department of Health and Human Services (HHS) and across other Federal departments. Once the Notice of Proposed Rulemaking (NPRM) receives approval from the government, the public is given the opportunity to comment on the proposed rule. Public comments are then analyzed and considered in the development of the final rule. This process is important because the final rule has the force of Federal law.

Step 1: Before the NPRM can be published in the Federal Register, it must be reviewed and approved by Federal government officials. Questions and concerns generated from the government officials must be answered and resolved before the NPRM can be released for public comment.

Step 2: The proposed regulation is published in the Federal Register.

Step 3: The publication of the NPRM is followed by a public comment period of 60 days. The purpose of the comment period is to provide the public with an opportunity to raise issues and questions that can be addressed before the regulation is finalized.

Step 4: Comments are then analyzed and summarized, and the proposed rule is revised to incorporate appropriate changes.

Step 5: The final rule is published in the Federal Register and is also available on the AHRQ PSO Web site. The final rule includes a summary of the comments and responses to the comments, including any changes that were made to the proposed regulation as a result of the comments received.

Please visit this Web site to keep apprised of information regarding the NPRM, the final rules, and the status of the process detailed above. To be notified of these developments electronically, please subscribe to PSO E-mail updates at: Patient Safety Organizations E-mail Updates.