Advocacy Advisor

Examining the federal rule-making process

How to navigate the Federal Register and participate in shaping health care regulations
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The public rule-making process is the method through which federal rules and procedures are established. Typically, when Congress passes a law to create an agency, it grants that agency general authority to regulate certain activities. Congress also may pass a law that more specifically directs an agency to accomplish certain goals.

An agency must not take action that goes beyond its authority or violates the Constitution. Agencies must follow an open, public process when they issue regulations, according to the Administrative Procedure Act.

The proposed rule, or Notice of Proposed Rulemaking, is the official document that announces and explains an agency’s plan to address a problem or accomplish a goal. All proposed rules must be published in the Federal Register to notify the public and to give them an opportunity to submit comments. Comment periods range from 30 to 60 days but, for complex rules, agencies may provide for longer time periods. The proposed rule and the public comments form the basis of the final rule.

The notice and comment process enables anyone to submit a comment on any part of the proposed rule. However, this process is not like a vote. The agency must base its reasoning and conclusions on the rule-making record, consisting of the comments, scientific data, expert opinions and facts accumulated during the rule-making process.

To move forward with a final rule, the agency must conclude that its proposed solution will help accomplish the goals identified. It must also consider whether alternate solutions would be more effective or cost less. If the rule-making record contains persuasive new data or policy arguments, or poses difficult questions or criticisms, the agency may decide to terminate the rule-making, or decide to continue the rule-making but change aspects of the rule. If the changes are major, the agency may publish a supplemental proposed rule. If the changes are minor or a logical outgrowth of the issues in the proposed rule, the agency may proceed with a final rule.

Find a description of the process here.


Jonathan Flannery, MHSA, CHFM, FASHE, FACHE, ASHE senior associate director of advocacy

 

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