Federal agencies are often referred to as "regulatory" agencies, because they are empowered to create and enforce rules/regulations that execute the laws.Federal regulations are always authorized by legislation.

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. Individuals and other entities can be fined, sanctioned, and criminally prosecuted for violating federal regulations. 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 an"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 Web sites 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.

Once a regulation takes effect, it becomes a "final rule" and is printed in the Federal Register, the Code of Federal Regulations (CFR) and usually posted on the Web site of the regulatory agency.

The Code of Federal Regulations (CFR) annual edition is the codification of the general and permanent rules published in the Federal Register by the departments and agencies of the Federal Government. It is divided into 50 titles that represent broad areas subject to Federal regulation. The 50 subject matter titles contain one or more individual volumes, which are updated once each calendar year, on a staggered basis.

The annual update cycle is as follows:

Titles 1-16 are revised as of January 1;  titles 17-27 are revised as of April 1; titles 28-41 are revised as of July 1; and titles 42-50 are revised as of October 1. Each title is divided into chapters, which usually bear the name of the issuing agency. Each chapter is further subdivided into parts that cover specific regulatory areas. Large parts may be subdivided into subparts. All parts are organized in sections, and most citations to the CFR refer to material at the section leve