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Regulatory Process

The Regulatory Timeline

Rulemaking is the policy-making process for Executive and Independent agencies of the Federal government. Agencies use this process to develop and issue Rules (Rules are also referred to as “regulations”).

The process is governed by the Administrative Procedure Act (APA) (5 U.S.C. Chapter 5) and can lead to a new Rule, an amendment to an existing Rule, or the repeal of an existing Rule. Executive Orders 12866, 13563, and 13579 also establish principles and guidance for the rulemaking process.

The interactive diagram below provides a general overview of the rulemaking process. To learn more about the rulemaking process and view related frequently asked questions, visit .

Prerule Stage

Origins of a rule

An agency cannot issue a Rule unless granted authority to do so by law.

Alternative actions

Before the rulemaking process, an agency evaluates possible alternative solutions to a rulemaking and determines whether the benefits of the Rule justify its costs.

Agencies use economic analyses (sometimes referred to as benefit-cost analyses, regulatory impact analyses, or regulatory evaluations), when applicable to determine the best alternative solutions.

In many instances, agencies publish an Advanced Notice of Proposed Rulemaking to solicit public comments to determine if they should initiate a rulemaking. Such actions occur prior to the Proposed Rule stage, and are published in the Federal Register (FR) and made publicly available in print and on-line at .

Proposed Rule Stage

Notice of Proposed Rulemaking

After an agency researches the issues and determines whether a new Rule is necessary, it often proposes a regulation, also known as a Notice of Proposed Rulemaking (NPRM). Typically these proposals are published in the Federal Register (FR) and made publicly available in print and on-line at so that they are readily accessible to the public.

Public comment period

During this phase of the rulemaking process, agencies accept public comments via Some agencies also accept comments by mail, fax, or email. In a typical case, an agency will allow 60 days for public comment. However, in some cases they provide either shorter or longer comment periods. An agency may receive no comments or as many as thousands of comments or more.

Some public comments contain one-sentence or one-paragraph comments, while others contain thousands of pages with detailed analysis, with supporting documents submitted as attachments.


The rulemaking docket (known on as a Docket Folder) contains all of an agency’s relevant rulemaking materials (e.g., NPRM, hearing Notices, extensions of comment period, and Final Rule), supporting documents (e.g., economic and environmental analyses), studies and other references, all public comments, and other relevant documents.

The public dockets for agency rulemakings can be found at You can access any electronic docket on this site by searching with a unique identifier such as the docket number or ID, Regulation Identifier Number (RIN), or even a keyword. Agencies include the docket number or ID on most Federal Register documents, and when applicable a RIN is included. RINs are also used in the Unified Agenda to identify agencies’ rulemakings.

Final Rule Stage

Post-comment period

After the comment period closes, the agency reviews all comments received and conducts a comment analysis. Then agencies decide whether to proceed with the rulemaking process or issue a new or modified proposal. In some cases they withdraw the proposal.

Preparing a Final Rule

Any Final Rule must include preamble and Rule text. The preamble includes a response to the significant, relevant issues raised in public comments and a statement providing the basis and the purpose of the Rule. Typically, agencies respond to all public comments in the preamble of the Final Rule or a withdrawn proposal.

Published Final Rule

The Final Rule is published in the Federal Register (FR) and made publicly available in print and on-line at . No Final Rule becomes effective in less than 30 days of its publication in the FR, unless it grants an exemption, relieves a restriction, or for “good cause,” which includes such things as emergencies. A copy of any published Final Rule can be found on this site in the rulemaking docket, along with the relevant regulatory materials (e.g., Supporting and Related Materials, Public Submissions).

Long-Term Action

Some of the rulemakings listed in the Unified Agenda are designated as Long-Term actions indicating regulatory development is pending. Such rulemakings are not expected to result in either additional regulatory actions over the subsequent 12 months or after a specified month and year.

Completed Actions

A rulemaking designated as a Completed action is the result of a regulatory action, which has been withdrawn by an agency since the publication of the preceding edition of the Regulatory Agenda. Additionally, a Completed action indicates that it is no longer being considered by the agency.

The regulatory process described here includes content from the following: The Informal Rulemaking Process and the Map of the Regulatory Process .