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FDA Rules and Regulations

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As required by law, the Food and Drug Administration  publishes regulations in the Federal Register, the federal government's official publication for notifying the public of many kinds of agency actions.  Federal regulations are either required or authorized by statute.  Some, such as FDA’s egg safety regulations, address a specific problem or known health hazard, while others, like citizen petition regulations, are administrative or procedural.  The rulemaking procedures that we follow come from U.S. law, Executive Orders (EO’s) and memoranda issued by the President, and FDA’s own regulations.   You can find more information about rules and rulemaking at the Reginfo.gov site's Frequently Asked Questions page.

Notice and Comment Rulemaking

The process that we use most often to issue rules is usually called “notice and comment rulemaking”.  The first public step in the notice and comment rulemaking process is for us to issue a proposed rule (also called a “notice of proposed rulemaking” or “NPRM”).  The proposed rule explains what we intend to require or intend to do, as well as our basis (e.g., scientific and policy reasons) and asks for public comment.  Comments are generally submitted via the Federal Government’s electronic docket site, available at Regulations.gov

If we need more information or have not decided on the details of a regulatory path, sometimes we issue a request for comments or an advance notice of proposed rulemaking (ANPRM).  These kinds of Federal Register notices ask for public comment on broad issues or questions and seek data or other information.  We use the information provided by the public comments to help us formulate the specific policy to be put forth in a subsequent proposed rule.

Once we have issued a proposed rule and received and reviewed the public comments, we decide whether further action is needed.  Based on the comments, we might decide to end the rulemaking process, to issue a new proposed rule, or to issue a final rule.  If we decide to issue a final rule, we publish the final rule in the Federal Register. The final rule explains the regulatory requirements (also known as the "codified" portion), the impact of these requirements on industry or the public, and responds to the comments on the proposed rule.  These regulatory requirements, or codified portion of the final rule, also are published under Title 21 of Code of Federal Regulations.

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Review of Proposed and Final Rules

Once we complete a proposed or final rule, but before it is published in the Federal Register, it may be reviewed by other parts of the federal government.  For example, we are part of the Department of Health and Human Services (HHS), so the Office of the Secretary of HHS or other HHS sister agencies may review a draft rule before it is published.  In addition, we may consult with non-HHS agencies when working on a rulemaking that has a broader impact.

If proposed or final rules are deemed "significant" pursuant to Executive Order 12866, the Office of Management and Budget’s (OMB) Office of Information and Regulatory Affairs (OIRA) must review them and coordinate review with other Federal agencies that have an interest in the issues.  In these cases, we work with OIRA to obtain appropriate clearances.  More information about EO 12866 and OIRA’s role in the review of significant regulations can be found on the Office of Information and Regulatory Affairs Q&A's page.

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