HOW TO COMMENT / The FDA Docket for Regular Folks

 

Related Pages at StripSafely 
Draft Patient Participation Comments
 

 

 
ucm369225

 

It is easy to comment on an open FDA docket online.  (If you would prefer to submit written comments, they can be mailed to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.)

If you choose to comment online, there are three steps:

  • Your Information
  • Your Preview
  • Your Receipt

Don’t worry — it isn’t too hard. We will walk you through each step:

The Docket

Follow the link to the docket you are commenting on (each new docket is a new link, we share each link with our draft comments)

Your Information

fda dcoket nav 1

After deciding what to say (or choosing to share our comments),  this is where you start.

Tip: It is a lot easier to compose your comments in your word processor, rather than try to compose them in the web browser.  

Go to the link for the FDA proposed guidance that you wish to comment on.

Tip: There is a 5000 character limit including spaces. 

Tip: Don’t let the formality of the process intimidate you. Think of it as commenting on Facebook post – it is almost that easy.

 

 This is what those comment sites look like, with one of our sample letters pasted in.

FDA Docket Tour Info

Here’s what the different sections mean (we’ve done the highlighting):

  • You paste your comments in the big box (this sample if from a docket on meters)
  • Yellow: How many characters are left
  • Purple: If you want, you can attach more information in a file
  • Orange: Your name
  • Blue: You can share your contact info, but it is not required
  • Green: IMPORTANT: This box was checked for us by default. You should un-check it, since you are not replying for a third party — you are commenting for yourself and your loved ones. Yay Diabetes Community!
  • Red: This is a required field – Pick “Individual Consumer”

When you’re done, hit “Continue.”

Your Preview

fad docket nav 2

Here’s where you get to look it all over.

FDA Review Commet 2 docket

If you want to make any changes, click on “Edit.”

If you’re satisfied, you MUST click the box that says:  “I read and understand the statement above.” (We highlighted that box yellow in the image blow)

You can’t click Submit Comment without checking that box. (Notice in the sample above Submit is shaded light to show it isn’t active) Once you’ve checked the box and reviewed your comment, hit “submit comment.” See? Easy!

Your Receipt

fda docket nav 3

 

Next, you’ll be brought to your receipt page, showing that your comment has successfully been submitted. It looks like this.

fda docket receipt

You may want to copy the crazy comment tracking number, in case you need it later. (Feel free to look that number up — it is Bennet’s 2¢ on one of the dockets.)

And there: you’re done. Now spread the word to other people who might want to have a say.