Guidance, Dockets, Laws and Regulations Overview
How do laws, regulations, and guidance documents differ?
- FDA is ruled by a set of laws and routinely issues regulations and guidance documents.
- The Federal Food, Drug, and Cosmetic Act (FD&C Act) is a federal law enacted by Congress. It and other federal laws (such as the Family Smoking Prevention and Tobacco Control Act) establish the legal framework within which FDA operates.
- FDA develops regulations based on the laws set forth in the FD&C Act or other laws under which FDA operates. FDA follows the procedures required by the Administrative Procedure Act to issue regulations. This typically involves "notice and comment rulemaking" process for public input on a proposed regulation before issuing a final regulation. FDA regulations are also federal laws, but they are not part of the FD&C Act.
- FDA follows the procedures required by its "Good Guidance Practice" regulation to issue FDA guidance. FDA guidance describes the agency’s current thinking on a regulatory issue. Guidance is not legally binding on the public or FDA.
What is a guidance document?
A guidance document represents the Food and Drug Administration’s (FDA) current thinking on a particular subject and provides information to assist in understanding and complying with relevant regulations and statutory requirements.
What is a draft guidance document?
Before issuing a final guidance, FDA often publishes a draft guidance in order to solicit comments from industry, other stakeholders, and the general public.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.
This is an opportunity for all stakeholders and the general public to be part of the regulatory 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:
- One or more Federal Register documents (rules and notices)
- Materials specifically referenced in those documents
- Public comments
- Applications, petitions or adjudication documents
- Other documents used by decision makers
How do I locate a docket?
Log on to www.regulations.gov When entering your search terms on the Regulations.gov homepage, check the box in the search area that reads, "Open for comment." This selection will bring back only items that are accepting comments.
Once your search results come back, you can narrow them by using the filters at the top of the screen. To limit your results to proposed rules and notices only, check the boxes by these items.
In what form do I submit my comments?
Comments may be submitted electronically or mailed.
How do I submit my comments?
Once you locate a document that is open for comment, click the "Submit a Comment" link either on the Search Results screen or the actual document details. Then type or attach your comment, enter any required fields, and click the "Submit" button.
Where do I submit my comments?
If you are submitting comments electronically: www.regulations.gov
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
For additional questions on this process: