Guidance, Dockets, Laws, and Regulations
- How do laws, regulations, and guidance documents differ?
- 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What is a draft guidance document?
Before issuing a final guidance, FDA often publishes a draft guidance in order to solicit comments from industry, other stakeholders, and the general public.
FDA carefully considers all comments received when writing the final guidance. The most useful comments provide suggested alternative language and/or provide data to support the positions taken. The draft is an opportunity for all stakeholders and the general public to be part of the process.
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) (rules and notices)
- Materials specifically referenced in those documents
- Public comments
- Applications, petitions or adjudication documents
- Other documents used by FDA decision makers
How do I find a docket?
Go to Regulations.gov to search by keyword. Once your search results come back, you can narrow the results by using the filters at the left side of the screen. To limit your results to proposed rules and notices that are open for comment, check the boxes by these items.
How do I submit my comments?
Submit comments on proposed rules, regulations, and guidance currently open for public comment. In Regulations.gov, you will see a "Comment Now" button. Type or attach your comment, enter any required fields, and click “Continue."
Where do I submit my comments?
If you are mailing comments:
Center for Tobacco Products
Document Control Center
Building 71, Room G335
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002