Draft Guidance Questions & Answers

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What is a draft guidance document?

Before issuing a final guidance, FDA often publishes a draft guidance in order to solicit comments from industry, other stakeholders, and the general public.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.

How do I submit my comments on a draft guidance document?

The Federal Register notice announcing the availability of a draft guidance includes instructions on how to submit comments. You may submit comments electronically or by mail.
 

Where do I submit my comments?

Submit written comments to:
Division of Dockets Management
Food and Drug Administration
5630 Fishers Lane
Room 1061, HFA-305
Rockville, MD 20852

Submit comments electronically at http://www.regulations.gov.

When should I submit my comments on a draft guidance document?

You may submit your comments and suggestions regarding a guidance document at any time (including after the comment period closes). However, to ensure that your comments are considered before FDA begins work on the final version of the guidance, submit comments before the deadline. The deadline date is published in the Federal Register notice that announces the availability of the draft guidance.

How will I know that FDA received my comments?

FDA’s Division of Dockets Management is responsible for receiving and processing comments for all FDA dockets. Call (301) 827-6860 to verify receipt of your comments or go to http://www.regulations.gov.