Dockets, Guidances, and Regulations
How are laws, regulations, and guidances different?
- Laws: The Federal Food, Drug, and Cosmetic Act (FD&C Act) is a law enacted by Congress. It was amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) in 2009.
- Regulations: FDA develops regulations (also called rules) to implement the FD&C Act and other laws under which we operate. When we issue a regulation, we follow a notice-and-comment rulemaking process for the public to share input on a proposed regulation before we issue a final regulation. Final regulations have the force and effect of law. FDA follows the procedures required by the Administrative Procedure Act to issue regulations.
- Guidances: FDA guidances describe our current thinking on regulatory issues and are not legally binding. To issue guidances, FDA follows the procedures required by its Good Guidance Practices regulation, which makes the guidance development process more transparent and effective.
What is a docket?
A docket is a collection of documents--often available for public review--that stores information related to a rulemaking or other action. The docket folder may contain:
- Federal Register document(s) (such as proposed and final rules and notices of availability of draft and final guidances)
- Materials specifically referenced in those documents
- Public comments
- Applications, petitions, or adjudication documents
- Other documents used by FDA decisionmakers
How do I find a docket?
Go to Regulations.gov, select the Advanced Search option, and check the Open for Comment box. You can search for a specific docket by entering the docket number shown at the beginning of the Federal Register Notice for the proposed regulation. You also can search for a notice of availability for a guidance or a notice requesting comments from the public.
How do I submit my comments?
Submit comments on proposed rules, regulations, and guidance currently open for public comment.