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Rulemaking Process and Steps to Comment

posted on Wed, Feb 2 2011 2:35 pm by Jill Krueger

Rulemaking Process

When we were kids, Schoolhouse Rock taught many of us how a bill becomes a law. Yet most of our young cartoon-watching minds never learned about the next stage in the process—how a law becomes a regulation.

Because of the important role of regulations in public health, it is essential to understand the rulemaking process. The transformation from bill to law is just the beginning.

It all starts when a federal agency is granted rulemaking authority by Congress. Under the Administrative Procedure Act, a federal agency must follow a specific process for rulemaking. Most states have a similar process. (“Rule” and “regulation” both refer to measures passed by government agencies that have the force and effect of law.)

Rulemaking Process

The rulemaking process begins with a notice of proposed rulemaking in the Federal Register. The notice includes the proposed language for the rule, as well as a preamble that provides background information. The notice usually requests comments from the public. In general, the agency has a duty to consider all comments received, though it may disagree with the comments after considering them.

A regulation only becomes enforceable when it is published as a final rule. Congress may exempt certain regulations from the public comment requirement, for example, in order to address an emergency. Sometimes in these cases, the agency will publish an interim final rule. This means the rule takes effect immediately, but the agency also requests public comment and will publish another final rule in the future, after considering the comments.

Steps for Submitting Comments

The Network for Public Health Law monitors the Federal Register on a daily basis, and highlights proposed rules related to public health in the Network Report.

Commenting on a proposed rule is generally not considered lobbying. However, you should check with your attorney or employer to find out whether any restrictions apply before submitting comments in your professional or personal capacity. Once submitted, comments are generally available to the public for review.

A proposed rule usually includes the deadline for comments to be submitted, a contact person at the agency and ways to submit comments, including via mail, e-mail or the government portal, www.regulations.gov.

Benefits of Notice-and-Comment Rulemaking

Commenting on proposed rules provides the opportunity to:

  • Introduce evidence that may have been overlooked
  • Identify inconsistencies with the law, including violations of the Constitution
  • Describe practical barriers
  • Suggest alternatives
  • Request clarification
  • Point out drafting errors
  • Make policy arguments
  • Offer proposals to improve administration of the program
  • Advocate for adoption of a state or local rule (or argue that the new federal rule should not preempt it)


Notice-and-comment rulemaking may provide an opportunity for you to be more deeply involved in developing public health policies. The contributions of public health practitioners, officials and advocates may result in better regulations, as evidenced by improved health outcomes, greater compliance, lower costs or fewer appeals and legal challenges.

This information was developed by Jill Krueger, senior attorney for the Network for Public Health Law – National Coordinating Center at the Public Health Law Center.

The Network for Public Health Law provides information and technical assistance on issues related to public health. The legal information and assistance provided in this document does not constitute legal advice or legal representation. For legal advice, readers should consult a lawyer in their state.

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