Anonymous comments of any kind are not accepted. 21CFR 10.20(b) requires that "A submission is to be signed by the person making it, or by an attorney or other authorized representative of that person." Therefore, no anonymous submittals are permitted or accepted.
All submitted comments become public information and may or may not be published on the Internet. Any comments on the Internet can be viewed by anyone with Access to the Internet. Comments are also available in the Public Reading Room for anyone who wishes to view them.
When you click on the Enter Docket Comments link you will be taken to the Electronic Comment Submission Form Screen. On this page you will see a list of all Dockets that are currently open for comment. There are four columns of information in this list: Docket ID, Title, Release Date and Comment Period Ends. For additional information on the Dockets, you can click on the Docket Summary Report link. This retrieves a list that displays the Docket ID, Full Title, Summary and any date information for all of the Dockets available for comment.
You can submit a signed and written comment in any of the following ways:
Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane
Rockville, MD 20852
When you click on the Enter Docket Comments link you will be taken to the Electronic Comment Submission Form Screen. On this page you will see a list of all Dockets that are currently open for comment. Click on the Go link in the Submit Comment column for the Docket you want to comment on. This retrieves the Docket Comment Form. Enter the required information. Enter any optional information as desired, click on the Continue button. A screen appears with kink to the available areas of the docket that you can comment on. Select a link to continue. Enter your comment. If you wish to comment on another issue on the docket, click on the Add Another button and repeat this process until you have entered all of your comments. Then click on the continue button. This will retrieve a review comment submission screen showing you all of the information you have entered. At this point you can modify your comments. When you are ready to save them. Click on the Save Comments button.
To attach a file: Enter your comments. On the Review Comment Submission page there is a section in the middle of the page below the comments. An example of this section is shown below: Click on the Browse button and locate your file. Select the File Type from the Drop-down list (Zip and EXE files are not accepted as attachments). Click on the Attach File button. (Note: You may repeat this process to add additional files.) To save your comments and attachments, click on the Save Comments button. You will receive a confirmation message.
When you click on the Enter Docket Comments link you will be taken to the Electronic Comment Submission Form Screen. On this page you will see a list of all Dockets that are currently open for comment. There are four columns of information in this list: Docket ID, Title, Release Date and Comment Period Ends. The Comment Period Ends column displays the last day that you can submit comments on each Docket.
On rulemaking documents that address several key issues, it aids the review of each comment when it is clear which area/issue they are addressing. Paperwork Reduction Act notices always ask for comments on four specific issues, therefore, the four specific issues are made available to the commenter. On all dockets there is a General Comment section provided.
When your comment(s) have been successfully submitted, you receive a confirmation message displaying your submittal on the screen. A comment number is displayed in the Top Portion of the screen above the comments section. An example of a comment number is: EC-1. The Docket Number and the Comment Number (Example: 02Q-1234 EC-1) is your unique confirmation number.
The temporary number us assigned upon submission. It is used by the Agency to track the comment until and after the Actual Comment Number is assigned.
Zip Code entry is required for any and all United States Addresses. It is not required for other countries.
Last revised: 21 JAN 2004