What Is a Notice-and-Comment Rulemaking? The Federal Regulatory Process Explained

Right now, the Fish and Wildlife Service is proposing to rescind the definition of “harm” under the Endangered Species Act, which resulted in more than 242,900 submitted comments. The Forest Service wants to rescind the 2001 Roadless Rule, which generated 223,862 comments. The Council on Environmental Quality is proposing to remove its NEPA regulations, which resulted in 88,806 comments.

Every one of those comments exists because of a single legal requirement: before the federal government can create a binding regulation, it must give the public a chance to weigh in.

This is notice-and-comment rulemaking, the process that turns a policy idea into enforceable law. It is the primary mechanism by which the executive branch governs, and it produces more binding legal requirements each year than Congress does. In 2025, agencies published 1,498 proposed rules and finalized 2,441 rules.

Understanding how this process works is essential for anyone in government affairs, regulatory compliance, or administrative law.

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What Is Notice-and-Comment Rulemaking?

Notice-and-comment rulemaking (also called “informal rulemaking”) is the process federal agencies use to create, amend, or repeal regulations. Required by Section 553 of the Administrative Procedure Act (APA) of 1946, the process has three core steps: the agency publishes a proposed rule in the Federal Register, the public submits written comments during an open comment period, and the agency considers those comments before publishing a final rule that carries the force of law.

Congress established this process as a democratic check on executive branch lawmaking. When Congress passes a statute like the Clean Air Act or the Dodd-Frank Act, it typically delegates broad authority to agencies to fill in the details through regulation. Notice-and-comment ensures the public has input before that authority becomes binding.

The term “informal” is misleading. It doesn’t mean casual, it means the agency isn’t required to hold a formal, trial-like hearing with witnesses and cross-examination. That alternative is called “formal rulemaking” under APA Sections 556–557, but it is rarely used today.

Notice-and-comment applies to most regulations issued by executive branch agencies (e.g., EPA, HHS, DOT, DOL, and others) and many independent agencies (e.g., SEC, FCC, FERC). It does not apply to military or foreign affairs functions, internal agency management rules, interpretive rules, general statements of policy, or rules where the agency finds “good cause” to skip it, such as in emergencies.

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How Does the Rulemaking Process Work?

The process follows six steps, from the initial identification of a problem to a legally enforceable regulation.

Step 1: The Agency Identifies a Need

A rulemaking begins when Congress passes a statute directing or authorizing an agency to regulate, or when an agency identifies a problem within its existing authority. For example, the Clean Air Act directs the Environmental Protection Agency to set National Ambient Air Quality Standards. The FDA Reauthorization Act of 2017 directed the FDA to create a category of over-the-counter hearing aids.

Some agencies publish an Advance Notice of Proposed Rulemaking (ANPRM) at this stage to gather early public input before drafting a proposal. This step is optional but is increasingly common for complex or controversial rules.

Step 2: The Agency Drafts a Proposed Rule

Agency staff are subject matter experts and use their expertise when drafting the proposed regulation. This internal drafting process is not publicly visible and can take anywhere from a few months to several years.

For rules deemed “significant” under Executive Order 12866, the draft must be submitted to the Office of Information and Regulatory Affairs (OIRA), a small office within the White House Office of Management and Budget, for interagency review before publication.

However, OIRA review is more than a formality.

By the time the public eventually sees the proposed rule in the Federal Register, it has often already been shaped by White House input.

Over the last decade, OIRA review has averaged 94 days for proposed rules, though controversial proposals can sit in review for over a year.

Step 3: The Proposed Rule Is Published

The proposed rule (formally called a Notice of Proposed Rulemaking, or NPRM) is published in the Federal Register, the government’s official daily journal. The NPRM includes the proposed regulatory text, the agency’s legal authority for the rule, its reasoning and supporting data, and a deadline for public comments.

The Federal Register publication date starts the clock on the comment period.

Step 4: The Public Comment Period

This is where the public participates. Comment periods typically last 30 to 60 days, though major rules often receive 90 days or more. Anyone can submit a comment — individuals, companies, trade associations, nonprofits, state and local governments, other federal agencies, and members of Congress.

Comments are submitted through Regulations.gov and become part of the permanent public record. While any comments can be submitted, agencies are only legally required to consider “significant” comments and to respond to them in the final rule’s preamble.

The most-commented rulemaking dockets currently tracked by Regulation Roundup illustrate the scale of public participation:

An important nuance: comment counts do not equal influence. Agencies are not required to follow majority opinion. The legal standard is whether the agency gave “reasoned consideration” to the substance of comments, not whether it followed the popular vote. One well-reasoned technical comment from an affected industry or a state environmental agency can carry more weight than 100,000 identical form letters generated by a mass-mail campaign.

This matters for practitioners. If you want to influence a final rule, the quality and specificity of your comment supported by data, cost estimates, or legal analysis is what counts.

Step 5: The Agency Revises and Finalizes the Rule

After the comment period closes, the agency reviews all submissions and revises the rule as appropriate. The final rule must include a “concise general statement of basis and purpose.” However, in practice, this preamble often runs dozens or hundreds of pages with agency responses — point by point — to significant comments.

For significant rules, the final rule goes back through OIRA review before publication. Over the last decade, this second round of OIRA review has averaged 64 days — faster than the proposed rule stage, since the core policy questions have typically been resolved.

The final rule is then published in the Federal Register with an effective date, typically at least 30 days after publication under the Administrative Procedure Act. For “major rules,” defined under the Congressional Review Act as rules that OIRA determines will have an annual economic effect of $100 million or more, significantly increase costs or prices, or have substantial adverse economic impacts, the effective date is generally delayed 60 days after publication or congressional receipt, whichever is later.

Step 6: The Rule Takes Effect

On the effective date, the rule becomes legally enforceable. Regulated parties must comply or face penalties. The rule is then codified by incorporation into the relevant title and section of the Code of Federal Regulations (CFR), which is the government’s compilation of all currently effective regulations.

At this point, the rule can be challenged in federal court, typically under the “arbitrary and capricious” standard of APA Section 706, meaning the court asks whether the agency considered the relevant factors and articulated a satisfactory explanation for its decision.

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How Long Does the Rulemaking Process Take?

There is no standard timeline. A simple, non-controversial rule can move from proposal to final rule in a few months. A major, contested regulation can take years (and sometimes span multiple presidential administrations).

Here is how the phases typically break down:

Case Study: Over-the-Counter Hearing Aids

The FDA’s rule establishing over-the-counter hearing aids illustrates what a full rulemaking lifecycle looks like in practice:

From the congressional mandate to enforceable regulation: five years. From the proposed rule to the effective date of the final rule: roughly one year. Both timelines are typical for a major, economically significant rule.

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What Happens After a Final Rule Is Published?

A final rule is not necessarily the end of the story. There are three main paths after publication.

Judicial Review

Any party “adversely affected” by a rule can challenge it in federal court. Courts review the rulemaking record, which includes the NPRM, public comments, and agency responses, to determine whether the agency acted within its statutory authority and provided reasoned explanations for its decisions.

A critical question in judicial review is whether the agency adequately responded to significant public comments. Failure to address a well-supported objection raised during the comment period is one of the most common grounds for courts to vacate a rule.

This dynamic became even more important after the Supreme Court’s 2024 Loper Bright Enterprises v. Raimondo decision, which overturned the longstanding Chevron doctrine. Courts no longer defer to agencies’ interpretations of ambiguous statutes, making the quality of the rulemaking record and the agency’s responsiveness to public comments a more important factor in litigation.

Congressional Review Act

Congress can overturn a final rule using a joint resolution of disapproval under the Congressional Review Act (CRA). If passed by both chambers and signed by the president (or enacted over a veto), the rule is nullified, and the agency cannot reissue a “substantially similar” rule without new congressional authorization.

The CRA is most potent at the start of a new administration, when the incoming Congress can use an expedited, filibuster-proof procedure to reverse rules finalized in the final months of the previous administration. The 119th Congress has already enacted 22 CRA disapprovals, overturning Biden-era rules on topics ranging from emissions standards to financial regulation.

Executive Action

A new president can direct agencies to reconsider, suspend, or repeal rules finalized by the previous administration. But there is a critical constraint: repeal requires going through the same notice-and-comment process. A president cannot simply delete a regulation by executive order.

This is why the current administration is using notice-and-comment to formally rescind regulations on NEPA, the ESA definition of “harm,” and the Roadless Rule, rather than simply withdrawing them. And those rescissions are themselves attracting hundreds of thousands of public comments.

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When Can Agencies Skip the Comment Period?

Not every federal regulation goes through notice-and-comment. The APA provides several exceptions.

The Good Cause Exception

APA Section 553(b)(B) allows agencies to skip notice-and-comment when they find “good cause” that the standard process would be “impracticable, unnecessary, or contrary to the public interest.” This exception was used heavily during the COVID-19 pandemic, when agencies issued emergency health and economic rules without the standard comment period.

Courts have increasingly scrutinized good cause invocations. Agencies must provide a specific, contemporaneous explanation for why the emergency justified bypassing public input. A general assertion of urgency is not enough.

When agencies invoke good cause, they typically publish an “interim final rule” that takes effect immediately but includes a post-publication comment period. In 2025, OIRA reviewed 41 interim final rules.

Interpretive Rules and Policy Statements

Agencies can issue “interpretive rules” (explaining existing regulations) and “general statements of policy” (announcing enforcement priorities) without notice-and-comment. These documents do not carry the force of law, but they can significantly affect regulated parties by signaling how an agency intends to enforce existing rules.

The distinction between a “legislative rule” (which requires notice-and-comment) and “guidance” (which does not) is one of the most contested boundaries in administrative law. When agencies use guidance documents to effectively create new requirements without going through the rulemaking process, courts and regulated parties push back.

Direct Final Rules

For non-controversial, routine changes, agencies sometimes publish a “direct final rule” that takes effect automatically unless someone files an adverse comment within a specified period. If an adverse comment is received, the agency withdraws the direct final rule and starts the standard notice-and-comment process. This mechanism is commonly used for minor technical corrections and conforming amendments.

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Why Should You Care?

The practical significance of notice-and-comment depends on your role.

Government affairs professionals: The comment period is your window to shape regulation before it becomes law. Missing it means your only recourse is litigation, which is slower, more expensive, and less certain.

Regulatory attorneys: The rulemaking record (i.e., the NPRM, public comments, and agency response in the final rule preamble) is the evidentiary foundation for any subsequent judicial challenge. If your client did not comment during the rulemaking, courts may find they forfeited their right to raise certain objections.

Compliance officers: The gap between a proposed rule and the final rule often contains critical changes. A proposed rule that would have imposed $10 million in annual compliance costs may be scaled back substantially in the final version, but only if affected parties submitted comments explaining why.

Lobbyists: Notice-and-comment is not the only point of influence in the regulatory process. Agencies accept input during the Unified Regulatory Agenda planning process, OIRA meetings with stakeholders, pre-NPRM listening sessions, and congressional oversight. But the formal comment period is the only point at which the agency has a legal obligation to respond to your arguments on the record.

In a system where Congress increasingly delegates broad authority to agencies, notice-and-comment rulemaking is the primary mechanism of democratic accountability for the regulatory state.

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Track the Rulemaking Process on Regulation Roundup

Regulation Roundup tracks every stage of the rulemaking process in one place — from the first appearance on the Unified Regulatory Agenda, through OIRA review, Federal Register publication, public comment periods on Regulations.gov, and final rule publication.

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