Rules are government statements that either:
- Explain law or policy, or
- Describe an agency's organization or procedures.
HHS issues and enforces rules on a broad range of topics. For example, HHS rules help ensure that:
- The foods we consume are safe.
- Private health information remains confidential.
- Child care centers, hospitals, and other institutions we trust to care for our loved ones operate at high standards.
How does an agency identify the need for a rule?
There are many reasons why an agency decides to begin the rulemaking process. These include:
- Legal (or Statutory) mandate. Congress may specifically require a rule or at least the initiation of the rulemaking process, sometimes with a deadline.
- Agency identification of a problem or potential reform. An agency may decide to either propose a new regulation or modify an existing regulation through a process called “retrospective review.” It does this for a variety of reasons, including:
- Exploring agency reforms that could produce savings or reduce burdens on the public.
- Getting requests for interpretations or exemptions.
- Identifying changes in technology that can improve the agency’s practices.
- Identifying a problem because of an Inspector General report or other agency oversight.
- Having difficulty enforcing existing rules.
- Petition for rulemaking. HHS agencies often hear directly from regulated groups and other stakeholders regarding rules that they would like the Department to change. The public may ask or petition an agency to issue, modify, or withdraw a rule. The Department reviews these petitions to decide whether to take action.
- Advisory Committee, Government Accountability Office, or similar recommendations. Suggestions for rules may come from federal advisory committees, the HHS Office of the Inspector General, the Government Accountability Office, special commissions, or other bodies asked by Congress or the President to make recommendations on particular issues.
Glossary of Rulemaking Terms
The Administrative Procedure Act (APA) outlines the basic requirements that federal agencies must follow when creating rules. Its basic purposes are (1) to help inform the public about agencies’ organization, procedure, and rules; (2) to provide the public with a chance to participate in the rulemaking process; (3) to establish uniform standards for rulemaking across various agencies; and (4) to outline the process for courts to review regulations.
An ANPRM generally describes the regulatory action an agency is considering, explains the underlying issues, and asks for public input on specific questions. Agencies frequently use an ANPRM when it is desirable or advisable to obtain a broad spectrum of public comments early in a regulatory action. Use of an ANPRM is optional.
Is the official printed book that organizes all the permanent rules made by federal agencies. The eCFR is an online version that’s updated regularly, but it’s not considered the official legal version.
A comment period is the range of time the public has to submit input before an agency makes a final decision on a proposed rule. Federal agencies typically invite public comments on RFIs, ANPRMs, NPRMs, Direct Final Rules, and Interim Final Rules. In most cases, the comment period is 60 days.
A Direct Final Rule is used when an agency believes that a rule is not controversial and is unlikely to receive negative comments. An agency publishes an NPRM and a Direct Final Rule in the Federal Register at the same time, with a statement that the rule will be effective as a final rule as of a particular date unless the agency receives a negative comment. If someone files a negative comment, then the Department will review all comments before moving to the next rulemaking stage. The DirectDirect Final Rule will be withdrawn.
The Federal Register is the official publication for the U.S. government. An agency must publish any major change in its policies that will affect citizens in the Federal Register. The Federal Register publishes daily Monday – Friday, except on holidays.
A Final Rule is a regulation that has completed the notice and public comment process and includes the language that formally changes the CFR. The Federal Register publishes final rules in official form, and in addition to the CFR-changing regulatory text, they generally have a preamble that explains the basis for the rule, responds to comments received, and contains a variety of analyses of the rule’s potential impacts. Economically significant final rules (that is, they are estimated to have an impact of $100 million or more) generally take effect 60 days after publication; after which, they have the force of law. Final rules with an impact of less than $100 million are generally effective 30 days after publication.
An Interim Final Rule is a rule that an agency adopts without prior public input that is effective immediately but then invites comment after publication. An agency uses this type of rule when it has a good reason for not following the usual rulemaking process, such as in time-sensitive or emergency situations.
An NPRM tells the public that the agency is proposing a new rule or a revision to an existing rule and provides the public with a timeframe to comment. The NPRM includes a “preamble,” which explains the need and authority for the proposed rule and the issues involved.
Similar to an NPRM, agencies may use an RFI when they want public input on how to implement laws passed by Congress, whether the agency should issue a new rule, or if there is a need to change existing policy. Comments also help agencies decide what action to take if it moves forward.
