Under FDA’s good guidance practices regulations at 21 CFR 10.115(f)(3), external parties can submit drafts of proposed guidance documents for FDA to consider. All proposed draft guidance documents should be marked “Guidance Document Submission” and be submitted either in paper to the address found on the Dockets Management page or electronically.
Submitting drafts of proposed guidance documents electronically requires adapting the "Comment" function on www.regulations.gov under the shell docket number that FDA has designated for submitting specific submissions to FDA’s Dockets Management Staff (DMS). To submit a draft proposed guidance document electronically, please follow these instructions:
- In your internet browser, go to www.regulations.gov.
- Type FDA-2013-S-0610 in the "SEARCH for" field. Select "Search" on the blue button to the right or "Enter" key on your keyboard.
- You will be directed to the shell docket titled “Specific Electronic Submissions Intended for FDA’s Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions).”
- Select the "Comment Now!" button. Instead of a "comment" you will be submitting your electronic Guidance Document Submission and preferably a cover letter.
- In the comment box, indicate that your Guidance Document Submission and cover letter are attached. Click on the "Choose file" button to upload your Guidance Document Submission file(s). So that you can be provided with a letter that acknowledges receipt of your guidance document submission and provides your unique docket ID number, check the box that states, “I want to provide my contact information,” and enter your Email address. Select a stakeholder Category.
- Your uploaded Guidance Document Submission file(s) will be listed and the information you provided will be displayed.
- Select the "Continue" button to preview and make any edits to your electronic submission.
- Read and check the disclaimer box. You must agree with the disclaimer to submit your Guidance Document Submission.
- Select the "Submit Comment" button. This action will submit your Guidance Document Submission to the system.
- You will receive a receipt with a tracking number automatically generated by www.regulations.gov. The Guidance Document Submission will be assigned a unique docket ID (FDA-YYYY-D-XXXX) and you will receive a letter acknowledging its receipt. Information about your Guidance Document Submission will be publicly viewable only in that assigned docket ID and not in the shell docket for specific electronic submissions. If you do not receive your assigned docket ID within three business days, you may call DMS at 240-402-7500.