Before Notice & Comment

Step 1 Statutory Authorization

Rulemaking must begin with a statute telling the agency to solve some problem or accomplish some goal, and giving it power to make rules. This statutory delegation of authority might come in the statute that creates the agency, or in a later statute giving the agency more responsibility. Other statutes, particularly the Administrative Procedure Act (APA), tell the agency how to use its rulemaking power.

Step 2 Decision to Begin Rulemaking

Sometimes, the statute also tells the agency it must make a rule on a certain subject. Usually, though, the agency has to decide which of many possible problems or goals deserve attention, now, in a rulemaking. Many things may affect its decision, including: Congressional oversight, Presidential directive, a lawsuit, advice from an advisory committee of experts, a petition from a member of the public or a corporation, or the judgment of its own staff. The agency will announce its decision up to12 months in advance in its Regulatory Agenda.

Step 3 Preparing the Proposed Rule

Agencies use different systems for drafting proposed rules, but all involve collecting information and talking informally with groups interested in the issues. If the agency thinks more formal public participation would help, it may publish an Advanced Notice of Proposed Rulemaking. This starts a notice-and-comment process on what the proposed rule should be. A different way to develop the proposed rule is negotiated rulemaking. The agency invites representatives of all interested groups to try to agree on what the rule should be. If they can, and the agency approves it, this becomes the proposed rule.

Step 4 Regulatory Analysis & Review

Many proposed rules have to pass review before going any further. If the proposed rule is “economically significant,” the agency must predict the costs and benefits of the rule, and tell the Office of Information & Regulatory Affairs (OIRA) why it is not proposing cheaper solutions. If the proposed rule requires collecting information from the public, the agency must get OIRA’s permission. Depending on the nature of the proposed rule, the agency may also have to predict its impact on: small businesses; state, local and tribal governments; federalism; and/or just compensation.

Notice & Comment Process

Step 5.1 Notice of Proposed Rulemaking

The notice-and-comment process begins when the agency publishes the proposed rule in the Federal Register. This Notice of Proposed Rulemaking (NPRM) usually : identifies the statute authorizing the rule; prints the text of the proposed rule; describes generally what problems or goals the agency is working on, and why it thinks the proposal is a good solution; identifies important data and other information used in developing the proposed rule; invites everyone to comment on all or part of it; and tells how to submit comments, as well as the date when they are due.

Step 5.2 Opportunity for Public Comment

During the comment process, anyone may submit a comment on any part of the rule. This process is not a vote on whether the proposed rule is good or bad. By law, the agency may not choose the final rule based on whether more commenters favor the rule than oppose it. Instead, it must decide based on: whether the rule makes sense given facts, real world experience, scientific data, and expert opinion; whether it is likely to help with the goals or problems the authorizing statute tells the agency to work on; and whether other solutions would work better. See Steps 7 & 9

Step 5.3 Opportunity for More Process

During the comment period, the agency may also hold public hearings at which people can give their views in person. Sometimes the authorizing statute requires such hearings. Sometimes the agency chooses to hold them to get more information or to help people better understand the proposed rule. After the comment period has closed, the agency may give another period of time for people to submit reply comments (comments that react to what is said in other comments.) Sometimes the authorizing statute requires this; sometimes the agency chooses to do it to get a fuller discussion of the proposed rule.

Step 5.4 Fastrack to Final

When the agency believes a proposed rule concerns only routine or uncontroversial things, it may try direct final rulemaking. It publishes the rule as a direct final rule (rather than a proposed rule) in the Federal Register. It also states that, unless it gets negative comments, the rule will become final shortly after the comment period ends. Basically, this step will then become final publication. See Step 7

Step 5.5 Rulemaking Without Process

The Administrative Procedure Act (APA) allows some rules to become final without going through the notice-and-comment process. They include: interpretive rules, which explain how the agency interprets existing rules or statutes, but don’t set new legal standards; rules setting agency procedure; and rules in circumstances when the notice-and- comment process would be “impracticable, unnecessary, or contrary to the public interest”(often called interim rules or “interim-final rules). Such rules go right to final publication. See Step 7

After Notice & Comment

Step 6 Post-Comment Internal Review

After getting all the comments, the agency must review them carefully. If they contain new data or policy arguments, or good questions or criticisms, it may decide the proposed rule should be changed. It must also be sure to check with any other agency responsible for issues covered by the rule. Statutes often give more than one agency power to work in an area. Coordinating with such agencies always makes sense; sometimes, the statute requires it. Finally, rules that had to pass regulatory review earlier must now return to the Office of Information and Regulatory Affairs (OIRA) for a final review.

Step 7 The Outcome

Depending on what the agency learned from the comments, coordinating with other agencies, and OIRA final review, it may decide to:

STOP the rulemaking, at least for now. It may publish this decision in the Federal Register, or simply do nothing.


CHANGE the proposed rule. If the changes are major, it must begin a second notice-and-comment process so the public can react.


ADOPT the proposed rule as its final rule, either unchanged or without major changes. It must publish the final rule in the Federal Register, along with a statement of basis and purpose. This statement must: state the goals or problems the rule is aimed at, and link these to the authorizing statute; describe the facts and data the agency relies on; respond to major criticisms in the comments; and explain why the agency did not choose other solutions.

Step 8 Congressional Review

Most new final rules must be sent to Congress for review. “Major rules” (ones that are economically significant for OIRA review, see step 4) are usually suspended for 60 days while this occurs. If the House and Senate pass a resolution of disapproval and the President signs it (or if both override a presidential veto), the rule becomes ineffective. Since 1996, when this process started, Congress disapproved on one rule.

Step 9 Possible Judicial Review

A person or corporation who is injured, or threatened with injury, by the rule can often get a court to review it as soon as it takes effect. Usually, the court can consider arguments that the rule:is unconstitutional; is outside the agency’s statutory authority; was made without following the procedures required by the Administrative Procedure Act or some other law; or was “arbitrary, capricious, [or] an abuse of discretion.” If the court agrees, it will usually vacate (set aside) all or part of the rule. Depending on which problem the court found, the agency will have to write a new statement of basis and purpose to better explain its decision, or even start again with a new proposed rule.

Step 10 Interpretation, Enforcement, Reassessment

Publishing a final rule doesn’t end the agency’s job. Those who must obey the rule, as well as agency inspectors and other officials whose job is enforcing it, may need help with the details of complying. Agencies often write compliance assistance materials and technical assistance manuals; sometimes such help is required by statute. Interpretative rules, which contain the agency’s interpretation of its rule and can be adopted without notice and comment, are another form of such guidance. Eventually, the agency may study the rule to decide whether it should be changed, or even repealed. This may be triggered by: a statute that requires such study every few years; a Presidential directive; a petition from the public; or the agency’s sense that circumstances have changed. If the agency decides to amend or repeal the rule, it must use the notice and comment process to make this change. Return to Learn About Rulemaking