The Federal Rulemaking Process
The process of creating and enacting federal regulations is generally referred to as the “rulemaking” process. Congress passes a law designed to address a need or problem. The appropriate regulatory agency then creates regulations necessary to implement the law. For example, the Food and Drug Administration creates its regulations under the authority of the Food Drug and Cosmetics Act, the Controlled Substances Act, and other legislation. These acts are known as "enabling legislation," because the legislation enables the regulatory agencies to create the regulations required to administer and enforce the acts.
Regulatory agencies create regulations according to rules and processes defined by another law known as the Administrative Procedure Act (APA), 5 U.S.C. 500 et. seq.
Under the APA, the agencies must publish all proposed new regulations in the Federal Register at least 30 days before they take effect, and they must provide a way for interested parties to comment, offer amendments, or to object to the regulation.
Some regulations require only publication and an opportunity for comments to become effective. Others require publication and one or more formal public hearings. The enabling legislation states which process is to be used in creating the regulations. Regulations requiring hearings can take several months to become final.
New regulations or amendments to existing regulations are known as "proposed rules." Notices of public hearings or requests for comments on proposed rules are published in the Federal Register, on the websites of the regulatory agencies, and in many newspapers and other publications. The notices will include information on how to submit comments or participate in public hearings on the proposed rule.
Regulations.gov may be used to:
Agency websites may also serve as a resource for public comment.